Global Service Providers Guide 2019 by Enhesa Product

Global Service Providers Guide 2019 The guide to global chemicals management and control services

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Foreword

Foreword Welcome to the ninth edition of the Chemical Watch service providers guide and directory. Since we launched our first guide in 2011 the need for information about the breadth and depth of the service providers market for compliance solutions, advice on chemicals management strategy and tips on best practice has intensified as the number and complexity of chemicals-related regulations around the world has grown. Chemical Watch aims to help companies uncover the areas of chemicals management where they need to improve, and to connect them to the service provider community that can help them get to the next stage in their journey. This guide is a key tool in helping companies make those connections. The survey results show that there is a shortage of skilled chemicals management staff. This is good news for people entering the sector or progressing their careers - salaries are rising and few people think staffing levels will fall over the next 12 months. Many regulatory affairs departments are likely to be feeling the pressure, and so service providers remain set to play a vital role in ensuring compliance levels are high. Within corporations, regulatory teams are, to some extent, connected with colleagues in other disciplines, but there is plenty

of scope for further integration. This year’s survey included, for the first time, some questions taken from Chemical Watch’s new diagnostic tool, and the responses suggest there is a rough 50:50 split between companies where chemicals management departments are integrated with others such as procurement and sales, and those where such integration is yet to happen. By maximising the effectiveness and efficiency of chemicals management and regulatory compliance practice, we hope that such team’s will gain a more influential voice within their companies. The fact that only half of survey respondents said compliance is seen as adding value to their business shows there is still a long way to go before this potential is realised. Finding the right experts to complement in-house teams can be challenging, but we hope that this guide will make your task that bit easier. Geraint Roberts Editorial director

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Contents

Introduction.........................................................................5 Chemical Watch diagnostic tool and industry benchmark...................................................................7 Global regulation............................................................. 13 Careers and Salary Survey............................................ 22 Demand to continue unabated.................................... 33 REACH: the end of the beginning................................ 46 TSCA: Smooth implementation hit by upheaval..... 51 Technology: enabling optimisation............................ 54 Chemicals management and control........................ 58 Living the REACH story.................................................. 62

Profiles.................................................................66 Acta.....................................................................................66 APC.....................................................................................68 Apeiron-Team NV............................................................ 70 Arcadis...............................................................................72 Arcerion GmbH................................................................ 74 ARCHE Consulting.......................................................... 76 Artemisa............................................................................ 78 bibra toxicology advice & consulting......................... 80 BIG vzw.............................................................................. 82 Blue Frog Scientific Limited.......................................... 84 Bureau Veritas.................................................................. 86 CEHTRA............................................................................. 88 Charles River.................................................................... 90 ChemAlert......................................................................... 92 CHEMDOX......................................................................... 94 Chementors Ltd............................................................... 96 Chemleg............................................................................ 98 ChemSafe.......................................................................100 Chemservice..................................................................102 China National Chemical Information Center.......104 ChIR - Chemical Innovation and Regulation..........106 CIRS..................................................................................108 CIS Center.......................................................................110 Citoxlab............................................................................112 CSB Online......................................................................114 Danish Technology Institute.......................................116 Decernis...........................................................................118 DEKRA..............................................................................120 DHI ....................................................................................122 DXC Technology............................................................124 EBRC Consulting...........................................................126 ERM..................................................................................128 Eurofins............................................................................130 Exponent International Limited.................................132 CW Research Ltd, trading as Chemical Watch is the leading global provider of independent intelligence and insight for product safety professionals managing chemicals. We help businesses across value chains stay ahead of the dynamic chemicals management agenda by providing access to in-depth knowledge, tools and a network of experts. Our aim is to empower our members to transform product safety management and unlock the full value of regulatory compliance within their business. Because we are not tied to any trade associations, government or campaign group, we are able to offer objective news and analysis for all sectors. CW Research Ltd, Talbot House, Market Street, Shrewsbury, SY1 1LG, UK Tel: +44 (0)1743 818 101 Fax: +44 (0)1743 818 121 email: cw.enquiries@chemicalwatch.com www.chemicalwatch.com US office: +1 (202) 803 5869 CEO & co-founder Mamta Patel mamta.patel@chemicalwatch.com Director Julian Rose julian.rose@chemicalwatch.com Managing director Stuart Foxon stuart.foxon@chemicalwatch.com Editorial director Geraint Roberts geraint.roberts@chemicalwatch.com

Contents

Fieldfisher LLP...............................................................134

Niche Profiles

Verisk 3E..........................................................................210

3S-SafelyServingScience............................................214 Altox a/s...........................................................................214 Anthesis-Caleb...............................................................214 Arrow Regulatory Ltd...................................................214 asseso AG.......................................................................215 Auxilife Scientific Services Pvt. Ltd...........................215 Bootman Chemical Safety..........................................215 chd global........................................................................215 Chem-Academy.............................................................216 COSANTA........................................................................216 CS Regulatory Ltd.........................................................216 Dangerous goods..........................................................216 DR MACH Chemical Compliance & Competence.217 E3 Strategic Partners...................................................217 ECT Oekotoxikologie GmbH.......................................217 Enviresearch...................................................................217 eSpheres..........................................................................218 Eurideas Language Experts.......................................218 Grow Smart Chemical Compliance.........................218 INFOTOX..........................................................................218 Jongerius Consult BV..................................................219 Kalium Solutions...........................................................219 Kerona Scientific Ltd....................................................219 LKC Switzerland Ltd.....................................................219 Linge Agroconsultancy................................................220 mediator A/S..................................................................220 Only Core Chem............................................................220 Oriental Chemical Information Co., Ltd...................220 Peter Fisk Associates...................................................221 PFA-Brussels..................................................................221 REACH Orphan Substances Consortium bvba ROSC..............................................................221 REACHReady.................................................................221 ReachSpektrum.............................................................222 REACHWise....................................................................222 SCAS Europe..................................................................222 Siam S.L...........................................................................222 Selerant............................................................................223 SenzaGen........................................................................223 Tox Focus, LLC...............................................................223 toXcel................................................................................223 Toxicon............................................................................224 VRS Regulatory..............................................................224 WSP UK Ltd....................................................................224

Yordas Group.................................................................212

A-Z listing.........................................................226

FoBiG................................................................................136 GBK GmbH Global Regulatory Compliance...........138 Gensuite...........................................................................140 H2 Compliance..............................................................142 Hohenstein Group.........................................................144 I+K AG, Compliance-Footprint AG............................146 INERIS..............................................................................148 Intertek.............................................................................150 KAELTIA Compliance Services..................................152 Kelley Drye & Warren....................................................154 KFT Chemieservice GmbH.........................................156 knoell................................................................................158 Lisam Systems..............................................................160 Logic SDS........................................................................162 National Chemical Emergency Centre (NCEC).....164 Nexreg..............................................................................166 Normachem...................................................................168 Ramboll Environment and Health.............................170 REACH Global Services S.A........................................172 ReachCentrum SA........................................................174 REACHLaw.....................................................................176 Redebel Regulatory Affairs S.C.R.L..........................178 ReFaC...............................................................................180 Risk & Policy Analysts Ltd (RPA)...............................182 Royal HaskoningDHV...................................................184 RTC, Research Toxicology Centre S.p.A..................186 SCC...................................................................................188 Smithers Viscient..........................................................190 Sphera Solutions...........................................................192 Staphyt.............................................................................194 Sustainability Support Services (Europe) AB.........196 TEAM Mastery s.r.l........................................................198 The Compliance Map Ltd...........................................200 ToxMinds.........................................................................202 Triskelion B.V..................................................................204 TÜV SÜD Industrie Service GmbH............................206 UMCO GmbH.................................................................208

Chief customer officer Emma Chynoweth emma.chynoweth@chemicalwatch.com Sales & marketing director Richard Butterworth richard.butterworth@chemicalwatch.com Global marketing manager Ryan McErlean ryan.mcerlean@chemicalwatch.com Global sales manager Louise Osborne louise.osborne@chemicalwatch.com Publishing manager Henry Tipping henry.tipping@chemicalwatch.com Publishing assistant Francesca Cotton francesca.cotton@chemicalwatch.com Writers Elaine Burridge, Keri Allen, Rosa Richards, Frank Zaworski, Charlotte Niemiec and Emma Chynoweth Production James Lumley james.lumley@chemicalwatch.com Designer Harrison Tanner harrison.tanner@chemicalwatch.com Account managers Sonja Davidson sonja.davidson@chemicalwatch.com Lotte Spencer lotte.spencer@chemicalwatch.com

Distribution policy Copying of this document including electronic circulation is not permitted without consent of the publisher. Disclaimer While Chemical Watch takes every effort to ensure the accuracy of this guide, we cannot take responsibility for any adverse consequences arising from actions taken in response to our content and we recommend that readers take appropriate professional advice. Designed and typeset by Ministry of Design, Bath, UK www.ministryofdesign.co.uk Printed by Trident Printing, London. Printed on 9 Lives 80 recycled stock. First published 2019 Copyright and Database Rights © 2019 CW Research Ltd. All rights reserved Photo credits: page 7: AdobeStock©olly, page 13: AdobeStock©James Thew, page 22: AdobeStock©Drobot Dean, page 33: AdobeStock©Jacob Lund, page 46: AdobeStock©ARTENS, page 51: AdobeStock©Tierney, page 56: AdobeStock©183077832, page 60: AdobeStock©102937333, page 62, cha.europa.eu©

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Introduction

Introduction Chemicals Management and Control For the ninth time, Chemical Watch has surveyed its chemical management community – chemical companies, service providers and firms in other sectors – on the market, drivers and trends in jobs and salaries. Added to the qualitative research we have done, this is the most comprehensive view available of the state of the industry. Between last November and February this year, more than 600 industry professionals took part: half were based in Europe and almost a third in North America. The remainder were mainly based in Asia, with a few in Latin America and the Middle East. Last year, we predicted that the last REACH registration deadline would not affect the Regulation’s status as the major market driver of demand for service providers. And so it proved. Five of every six survey respondents placed any aspect of REACH as the most important, with a shift from registration to other aspects like evaluation, dossier updates and other means of improving data quality, authorisation and enforcement-related needs. Service providers generally remain upbeat about the state of the market. The inevitable drop-off in demand for REACH registration services has been compensated for by other aspects of REACH work and other EU regulations, notably in the biocides, medical devices and food contact arenas, plus poison centre notifications. Outside the EU, the reformed US Toxic Substances Control Act (TSCA) is also creating work for many, while the legislation being implemented in Turkey and South Korea are also becoming important. The UN Globally Harmonized System (GHS) of classification and labelling is constantly under revision across different markets and will always create a steady stream of work. Of course, not all of the market drivers are based on regulation. It is notable that customer and supply chain demands have climbed from well down the list to be ranked the top non-regulatory driver of business for service providers. This seems to be going hand-inhand with an increasing internationalisation of the market, in which global companies want global service providers. Certainly, the trend for them to set up offices and laboratories in multiple new markets to meet emerging demand is clear enough. The state of the market naturally shapes the responses about the jobs market for CMC and regulatory professionals. There had been fears that the end of REACH registration might lead to a steep decline in opportunities and even job losses, but our survey suggests that the market remained strong throughout 2018. Indeed, demand for people with the right skills is actually growing because of the ever more complex array of regulatory requirements needing to be managed. There remains something of a skill shortage, which will only increase as older regulatory professionals retire over the next few years and there are too few mid-career people to replace them just as the need for them grows. Some service providers shared their ideas about how the industry can respond to this challenge. Overall, our career and salary survey did not show a huge variation on previous years in terms of expectations about staffing levels, job security, job prospects and wider opportunities. Regulation remains a reasonably well-remunerated field, though not one where big pay rises and bonuses are to be expected. On the negative side, there is a continuing trend towards job dissatisfaction; although more are satisfied with their job than not, the level of disgruntlement has increased year-on-year. Another notable fact is that there were more women than men among our survey respondents. While we should hesitate to base too much on that sample, this certainly seems to be one of the less male-dominated parts of the chemicals industry, which is still a very traditional industry, populated mainly by men in their late middle ages.

The generally positive outlook among service providers extends to the short and medium-term future. Most see the trend towards more and more complex regulation continuing to create demand for their services, with many different regulations in different regions of the world being cited as likely to push this. There also appears to be a growing trend for SMEs to seek the help of service providers because they cannot deal with the sheer complexity of regulation on their own any more but still have to address the issue. However, the precise services most in demand can fluctuate. Last year, for instance, although laboratory services remained the largest single retained service, the proportion spent on representation and management nearly doubled, while spending on legal services, IT and software and information all fell. There also seems to be a long-term trend towards having separate, rather than integrated, compliance divisions within the major players. As well as the articles we always include in this guide, there are four more covering the specific regulatory issues related to REACH, TSCA, chemical management and emerging technologies that will assist with and challenge chemical regulation. Anyone who still has not got the message that 2018 was only the ‘end of the beginning’ should read the article on REACH to see the scale of the challenges ahead, not least when it comes to nanomaterials. What emerges most clearly from our look at chemical management trends is that chemicals companies are increasingly incorporating this into their wider environment, health and safety (EHS) systems, partly in response to pressure from circular economy initiatives, downstream users and NGOs. This process is in itself being facilitated by sophisticated software that makes such things possible, including reliable external hosting of the kind of information that companies traditionally kept in-house for security reasons. The need for that software in turn arose, in part, out of REACH and the need it created for much more extensive supply chain communication. Disruptive emerging technologies, like artificial intelligence, machine learning, cloud computing and blockchain security systems, will expand both the challenges and the opportunities involved exponentially. Every company in the chemical industry will have to keep a watching eye on these technologies, because these will make possible means of compliance that were not possible before, which could be a burden to those who do not get to grips with them properly or a competitive advantage to those that do. Technology, as ever, will be a double-edged sword. Last year, we opened the concluding paragraph of the introduction with the words “And then there is Brexit. Almost everything about this thorny issue remains up in the air at the time of writing”. It still does, so whenever you read this, the key word about this will probably still be ‘uncertainty’.” For service providers, however, this is also an opportunity. Many are already picking up work and saying that they expected far more still if the UK were to leave the EU without a deal. Likewise, there is anecdotal evidence that international trade tensions are leading to increased demand, because of increased scrutiny at borders and the rising cost of non-compliance. All in all, there is every reason the companies featured in this guide will remain busy for the foreseeable future. Dr Andrew Warmington – guide editor www.chemicalwatch.com/SPG

Global Chemical Product Innovation and Development

A scientific and regulatory consulting firm providing strategic, comprehensive support for global chemical registration, regulation, and sustained compliance. • Global Chemical Notification and Regulatory Support (North and South America, Europe, Asia) • Biocides, Pesticides, Antimicrobials, Nanomaterials, Food Contact, Cosmetics • Hazard Communication, GHS Classification and Labelling, SDS • Global Agent and Representative Services • Testing Strategy and Co-ordination • Toxicology & Ecotoxicology • Transport of Dangerous Goods • Dossier Preparation and Expert Review • Data Compensation

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Brussels, Belgium +32 2 588 48 85

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Industry practice

Chemical Watch diagnostic tool and industry benchmark

To build a picture of chemicals compliance and management within organisations, some questions were added to our annual survey this year. The questions, says Chemical Watch CCO Emma Chynoweth, are a much simplified version of a diagnostic tool being developed by Chemical Watch. This tool will help companies to identify strengths and weaknesses in their chemicals management activities, and specifically to identify actions to: OO surface the value of compliance to their businesses, and OO take steps towards building a long-term product safety strategy. Over the past couple of years, we have spoken to over 100 companies who have identified these two areas as critical if they are going to develop long-term, sustainable and effective businesses. The diagnostic tool, which consists of a self assessment questionnaire coupled with a review by our in-house analyst team, is currently being built. It is expected to be validated by a core group of companies in the next couple of months and then launched mid-year. Here we provide some of the findings relating specifically to the new questions in this yearâ&#x20AC;&#x2122;s Service Providers Guide survey.

Figure 1 â&#x20AC;&#x201C; Number of staff dedicated to chemicals management - Upstream chemicals All >1000 501-1000 251-500 51-100 26-50 11-25

What the data shows

In response to questions on how many people worked in chemicals management, we segmented the results by type of company and size. Focusing on those companies that identified themselves as upstream chemicals concerns [Figure 1], and employing over 50 people (that totalled 220 entities in total), most 58 had less than five people dedicated to chemicals management, 31 had between 5-10 employees, around 10 reported having between 11-25 and 26-50 people, two companies reported having between 51-100, and two to having over 250 people in this function. Of the 53 organisations that identified as engineering companies, 13, had less than five people dedicated to chemicals management, nine had between 5-10, two had 11-25, and one had 26-50. Four reported having no-one dedicated to this role [Figure 2].

5-10 <5 0

number of respondents

Figure 2 â&#x20AC;&#x201C; Number of staff dedicated to chemicals management - Engineering 26-50 11-25 5-10 <5 0

number of respondents

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For the 31 companies that identified as consumer product manufacturers [Figure 3], 16 had less than five people dedicated to chemicals management, six had between 5-10 people, two had between 11-25, and one each in the higher categories. Four reported having no-one dedicated to a chemicals management role.

Figure 5 – Number of chemicals of concern 37

Figure 3 – Number of staff dedicated to chemicals management - Consumer products

1 - 10 10 - 25

101-250

25 - 50 50 - 100 100 +

51-100

11-25

Figure 6 – Number of substances contributing to sustainable development

5-10

1 - 10

17 0

10 - 25

25 - 50

number of respondents

50 - 100

The figures appear to indicate that the number of people working in this function in companies downstream of the chemical sector is relatively low. In future years, we may look to draw comparisons with other functions, such as HR or marketing. We also asked companies how many substances they were managing in their products, and of those how many were chemicals of concern, and how many they considered to be contributors to sustainable development goals. Most companies [Figure 4], (83) seem to be dealing with between 100-1,000 substances; 60 report managing between 1,000-10,000 chemicals – but significant numbers, between 42 and 28 are handling 1-50 and 50-100 respectively. 23 deal with over 10,000 substances, and 33 say they have none. Figure 4 – Number of chemicals in products 23

33 0

1 - 50 50 - 100 100 - 1,000 1,000 - 10,000

10,000 +

Regarding chemicals of concern [Figure 5], 83 respondents report having between 1-10 to manage; 46 deal with 10-25, 29 deal with 25-50 and 27 have 50-100. Thirty-seven companies manage over 100, and 38 say they have none. For substances that contribute to sustainable development [Figure 6], 40 companies felt none did, 16 organisations said more than 100 did. Other than these outliers, most companies (78) thought about 1-10 substances they dealt with contributed to sustainability.

100 + 78

Corporate priorities

In the areas of corporate leadership, company culture and policy, most respondents (67% of 278 who answered the question) said that chemicals compliance is prioritised in their organisations, 9% said it was not prioritised. Some 60% of companies are reactive towards compliance, with 13% saying they were not. In terms of how compliance is viewed internally, 56% of respondents said it is seen as adding value to the business, while 17% said that is was not. This result contrasts to anecdotal feedback received from companies, that chemicals management is often seen and treated as a burden or cost to the business. Regarding how organisations view different opportunities relating to chemicals management, most respondents (70%) rated its contribution to facility and worker safety highest, followed by new product development (69%) and new business opportunities (65%). Enhanced corporate strategy, procurement and customer service were rated lowest – but the figures are all close at between 60-64%. Some 285 respondents answered these questions. Turning to business risks associated with chemicals management, 90% of organisations said that ongoing compliance was the biggest concern, followed by business disruption (85%), and being found incompliant and facing penalties (80%). Threat to brand reputation and handling chemicals of concern are ranked fourth and fifth biggest risks by 79% and 78% of respondents. Occupational disease and associated claims were seen as the lowest business risk, by 60% of respondents, followed by threat to intellectual property (62%) and cost of substitution and loss of market (69%). Some 48% of respondents said their organisations are agile when it comes to regulatory and non-regulatory compliance

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Industry practice

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drivers; 5% said they were not, and 47% said they are agile some of the time. We also asked if chemicals management is integrated into aspects of the business, including sales, marketing and procurement, and senior management [Figure 7]. Some 19% (of the 300 companies responding) said it was not, 26% said it was partially, and 55% said that it was integrated. In fact, 59% of organisations agreed with the statement that the business saw value in such integration (12% disagreed); but 52% said their compliance function did not see this as valuable (although only 4% disagree). This is somewhat concerning, as one of the key drivers identified by Chemical Watch in talking to customers is the importance of compliance in facilitating product sales, and maintaining business reputation. Further, the survey results reveal that only 39% of companies responding calculate the costs and benefits of compliance; 19% say they do not conduct this type of analysis; and 42% say they do some work here. Figure 7 – The extent to which the chemicals management function is integrated within business functions of responding organisations Agree

Disagree

A closer look at drivers of sound chemicals management

Neither

Integrated within business functions 55%

19%

26%

Value win integrating the compliance function 59%

30%

12%

CRC compliance function 52%

44%

Effective processes to anticipate upcoming reglatory and non regulatory requirements 46%

15%

39%

Costs/benefits associated with compliance 39% 0%

19% % of participants

42% 100%

Around 46% of respondents have effective processes in place to anticipate regulatory and non-regulatory requirements; 15% do not, leaving a further 39% that have partially effective processes. Over the coming months we will assess the results to see if we can develop a robust benchmark.

Optimising chemicals management

marketing and selling products, and of course senior leadership. Information to be communicated includes, as a minimum, regulatory requirements but extends to activities that generate tangible business benefits and value from knowledge of safer chemicals. We are calling this ‘business integrated’. OO Third, the organisation is using and benefiting from its strong internal capabilities on chemicals management in its value chain. By fostering strong relations with suppliers and customers it has a good knowledge of the chemicals critical to its business up the supply chain as well as supporting customers in their efforts to manage product safety. We are calling this ‘connected value chain’. OO Fourth, the benefits of the three previous stages can be demonstrated as value to the business, as the organisation can maximise the sale of products, protect its reputation, avoid disruption to its business, as well as having an efficient and effective compliance capability, over the long term. This final step, we are calling ‘product safety confidence’. As such, the tool can be used to drive a transformation process within an organisation.

We know from talking to many of our customers that the safe management of chemicals isn’t perfect. Even in the largest of multinationals, it is challenging to keep on top of many aspects – from knowing what substances are being bought and sold, to tracking emerging or changing legal and customer requirements. The diagnostic self-assessment questionnaire encapsulates our knowledge of activities that need to be considered for companies to optimise their chemicals management activities. The aim is to generate a set of activity-based recommendations designed to help companies unlock value in compliance, and make progress towards transforming product safety. That transformation follows a four-step ‘maturity’ journey. OO First an organisation has to have a well-led, organised, managed and resourced compliance function. It has to have the capacity to track compliance needs and put into practice activities that ensure it is responding appropriately to both regulatory and non-regulatory drivers. What we call ‘compliance foundation’. OO Second, compliance activities and knowledge need to be connected to all parts of the business that are impacted, or have an obligation, relating to chemicals management. This ranges from R&D and product development, through to procurement and production and logistics, to the business of

Here we give a brief walk through the structure of the diagnostic tool. Upfront, the diagnostic tool is not another audit. We know audits and standards for environmental, safety and quality activities are essential for doing business and are an indicator of good management. But often we hear companies complaining that they don’t drive change or optimisation. That’s where our tool comes in...and it is important for companies to understand, if they want to improve and adapt to ensure sound chemicals management threads through the fabric of their organisations, and to derive tangible value from it, then they need to invest time, and honesty, in completing the self assessment section of the diagnostic tool. This section starts with corporate drivers, including elements on: OO leadership; and OO corporate culture and policy, which will surface how chemicals management features strategically and within company policies. We then get down to operational drivers, including the structure, people, and systems used to ensure chemicals management activities can function well and deliver positive outcomes. Regulatory and product safety specialists live in a dynamic world. They are juggling growing customer demands for safer and more sustainable chemicals, as well as a tidal wave of new and evolving regulations impacting both chemicals in general, and the products they are used in. Against this backdrop, two goals our customers find particularly challenging are: OO achieving compliance against a dynamic backdrop of ever changing, and increasingly complex, regulation; and OO proactive risk management which entails keeping a close watch on new developments and assessing their likely impact. The diagnostic drills down into both these areas to examine companies’ abilities to achieve both effectively by tackling current and future compliance needs and addressing the key components of risk assessment and mitigation. There is also a specific section on value chain drivers – again to examine a key challenge faced by those working in chemicals management. Finally, it looks at how companies measure performance using measured data and cost benefit analysis/RoI to drive and optimise their chemicals management activities. www.chemicalwatch.com/SPG

Industry practice

BIOCIDES Biocidal Product Family Consortia Product Assessment Report (PAR) In house training BPR/risk assessment/IUCLID

REACH Applications for Authorisation

PLANT PROTECTION PRODUCTS Active substance and product renewals National addenda Data gap analyses (conventional and low risks substances) FOCUS/workers/consumer exposure modelling and higher tier risk assessments

Socio-economic analysis Chemical Safety Assessments (evaluations, audits and updates) CHESAR/IUCLID

When regulations get all too foggy Let us point you in the right direction

Global regulation

OV ERV IEW

Global regulation

Europe and US dominate demand for services

Despite the passing of the last registration deadline, REACH is still the main driver of business for service providers. Elaine Burridge reports The REACH Regulation’s status as the major market driver of demand for service providers remains unchanged one year on. The focus, now that the final deadline for registration passed on 31 May 2018, is on evaluation and authorisation activities, plus other key tasks. The vast majority – 83% – of respondents to Chemical Watch’s latest survey placed any aspect of REACH at the top of their list of regulatory drivers, followed by any aspect of US regulation [Figure 7]. REACH also occupied third, fourth and fifth places with evaluation-related activities and dossier updates; obligations and authorisation for substances of very high concern (SVHCs); and registration, respectively. All four sub-groups surveyed (chemicals, life sciences and similar; consumer products, cosmetics and similar; all other

manufacturers; and, service providers) also ranked various REACH obligations highly but they were not always top of the list. US regulations dominated in two of the groups. California Proposition 65 led the list for consumer products, cosmetics and similar [Figure 8]. For the ‘all other manufacturers’ category, California’s Safer Consumer Products Regulation (SCPR) was the key driver, followed by California Proposition 65. For service providers, conflict minerals legislation was the primary focus, with the EU classification, labelling and packaging (CLP) Regulation second and REACH activities in third and fourth place. Chinese and South Korean regulations also featured in the top priorities of different sub groups.

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Global regulation

Figure 8 â&#x20AC;&#x201C; Leading regulatory drivers for survey participants REACH (any)

83%

US (any)

60%

EU REACH evaluation related activities/dossier updates

58%

EU REACH SVHC obligations and authorisation activities

56%

EU REACH registration

54%

EU CLP Regulation

52%

China regulations

45%

US: California Proposition 65

43%

South Korea (K-REACH)

39%

Biocidal product regulations

35%

US: TSCA New Substance Notifications

34%

Food contact material regulations

34%

RoHS regulations

30%

Packaging regulations

29%

National GHS classification, labelling and inventory notification regulations

28%

Turkey regulations

27%

US: TSCA risk evaluations

26%

Nanomaterials risk assessment

26%

US: HazCom 2012 (GHS) Standard

23%

POPs (Implementation of the Stockholm Convention on Persistent Organic Pollutants)

23%

Circular economy

23%

Japan regulations

22%

Conflict minerals legislation

20%

Cosmetics regulations

19%

US: California Safer Consumer Products Regulation

19%

International Maritime Dangerous Goods (IMDG) Code

19%

International Carriage of Dangerous Goods by Road (ADR)

19%

South Korea (K-BPR)

18%

Canada Chemicals Management Program

18%

Taiwan regulations

17%

Brazil regulations

16%

Australia regulations

15%

Russia regulations

14%

Agrochemical regulations

14%

Medical devices regulations

14%

PIC (Prior informed consent implementation of the Rotterdam Convention)

14%

Mexico regulations

13%

India regulations

13%

Other US state legislation (Washington, Vermont etc)

13%

Canada Workplace Hazardous Materials Information System (WHMIS)

13%

Thailand regulations

12%

Malaysia regulations

12%

New Zealand regulations

11%

Pharmaceutical regulations

11% 0%

20%

40%

60%

% of participants

Global Service Providers Guide 2019

80%

100%

SERVICES

y REACH and chemical safety y Biocides y Agrochemicals y Cosmetics y Medical Devices y Food and Nutraceuticals y Food Contact Material y Pharma y Safety y Regulatory Affairs y Pre-clinical development y â&#x20AC;&#x153;In silicoâ&#x20AC;? evaluations y Ecolabel y Legal Affairs y Consortia / Task Forces

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Global regulation

Figure 9 –Top main drivers by sector Chemicals, life sciences and similar

Consumer products, cosmetics and similar

EU REACH evaluation related activities/dossier updates

US: California Proposition 65

EU REACH registration

EU REACH SVHC obligations and authorisation activities

EU CLP regulation

South Korea (K-REACH)

EU REACH evaluation related activities/dossier updates

EU REACH SVHC obligations and authorisation activities

EU REACH registration

China regulations

Food contact material regulations

Cosmetics regulations

US: TSCA New Substance Notifications

US: California Safer Consumer Products Regulation

All other manufacturers

Service providers

EU REACH SVHC obligations and authorisation activities

EU REACH evaluation related activities/dossier updates

US: California Proposition 65

EU CLP regulation

EU REACH registration

EU REACH evaluation related activities/dossier updates

EU REACH SVHC obligations and authorisation activities

RoHS regulations

Biocidal product regulations

China regulations

South Korea (K-REACH)

EU CLP regulation

China regulations

South Korea (K-REACH)

US: California Proposition 65

While some service companies – perhaps inevitably – saw a drop-off in demand after last year’s final REACH registration deadline, their workload has been boosted in other areas, such as compliance checks and evaluation decisions under REACH, as well as requests for support under other regulations, notably the EU Regulations on biocidal products and medical devices. Other key work drivers include K-REACH in South Korea, the KKDIK regulation in Turkey, and TSCA in the US.

Plugging the registration gap

Enviresearch saw its REACH workload drop after the 2018 deadline. However, José Sobreiro, senior regulatory specialist and REACH manager, says the Regulation still accounts for an important part of its services as a result of ‘newcomers’ – companies importing into the EU for the first time – along with providing support on authorisation and downstream user chemical safety reports (DU CSRs), for which demand has increased considerably. Lynn Bergeson, president of the Acta Group and managing partner of Bergeson & Campbell in the US, adds that a significant increase in activity in the European biocides and food contact arenas, and under Turkey’s KKDIK, has compensated for any loss of demand for REACH registration services. Acta continues to receive large volumes of requests under REACH, often concerning evaluation, authorisation, restrictions, disputes, legal support and data sharing. “Data compensation for Acta’s lead and joint registrations, in particular, has kept our staff busy since May 2018, as cost reconciliation and reimbursements are ongoing for countless joint submissions,” Ms Bergeson says. “REACH has certainly been transformative,” says Alex Ortiz, vice president of global regulatory content at Verisk 3E. “While it has moved into more of a maintenance mode, many enforcement activities and a focus on improving data quality – registration dossier, supply chain communication documents, authorisation and much more – keep this Regulation front and centre.” Verisk 3E notes, too, that the other significant regulatory driver this year is Annex VIII of the CLP Regulation, which requires companies placing hazardous mixtures on the EU market to provide information about them to member state poison centre Global Service Providers Guide 2019

authorities. The first deadline of 1 January 2020 applies to substances placed on the market specifically for consumer use. Bibra’s principal toxicologist and managing director, Richard Young, says its BPR workload has risen substantially in recent months. Changes to the medical device Regulation have driven greater demand for its consultancy services, which is set to grow further in 2019. “Currently, work related to REACH evaluation is in high demand,” he says. We expect to see this continue, as well as an increase in the need for updates to dossiers, particularly spontaneous updates pre-empting any forthcoming Echa checks. Improvements to read-across approaches, in line with the Echa read-across assessment framework document, and testing proposals, are also likely to form part of forthcoming dossier update work.” Echa has announced its intention to put older dossiers under increased scrutiny this year, along with focusing more heavily on compliance checks. In October 2018, the German Federal Institute for Risk Assessment (BfR) published a report showing that around one third of registration dossiers in the highest tonnage bands do not comply with REACH requirements.

Regulatory priorities

Speaking to Chemical Watch about Echa’s priorities for the year ahead in February, executive director Björn Hansen said the agency’s first strategic priorities were to identify and manage the risks of substances of concern, and to streamline the interaction between registration, evaluation and risk management processes under both REACH and CLP. Germany’s Chemservice says the primary driver under REACH now will be more high-level toxicological and ecotoxicological consulting as a consequence of the dossier and substance evaluations followed by (draft) decisions from Echa. CEO Dieter Drohmann adds that requests for support for REACH compliance and advocacy, as well as for authorisation and restriction processes are increasing. For global software provider Sphera, REACH remains an important driver of change in Europe specifically as it relates to hazard communication, which the Regulation skews towards risk and risk mitigation communication, according to Frank Arcadi, vice president of product stewardship solutions.

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“Formulators are now figuring their approach to producing sound safe use information for mixtures, as required by REACH,” says Mr Arcadi. “We face many opportunities where lead component identification (LCID) and safe use mixture information (Sumi) support are important aspects of a solution. That said, the main driver in Europe right now is all about poison centre notifications.” Jan Holomek, managing director of ReachSpektrum, a consultancy based in Prague, is still seeing latecomers registering under REACH. His work is currently focused mostly on dossier updates, safety data sheet (SDS) authoring (including exposure scenarios), authorisation and application development. The larger service providers are also shifting their focus to meet demand outside Europe. While for many REACH will continue to be the top driver of business, requests are rising for other international activities, such as registrations under K-REACH in South Korea or KKDIK in Turkey, says Mathias Rietzel, senior manager for chemicals regulatory affairs at Scientific Consulting Company (SCC).

Non-regulatory drivers

For survey respondents, the top non-regulatory driver of their businesses is customer and supply chain demands, which has jumped to pole position from eighth place previously [Figure 10]. Brexit makes an entrance in second place, having not featured at all last year, while economic growth is third. Government policies and spending still ranks high, although it has slipped to fourth place from third in 2018. Downsizing has become much less of a factor this time round having ranked second in 2017. Figure 10 – Leading non-regulatory drivers for survey participants Customer and supply chain demands 56% Brexit 44% Economic growth 41% Governmental policies/spending 39% Redistribution of regulatory compliance responsibilities within organisations 29%

Services most in demand

Laboratory services were those most in demand last year. Verisk 3E sees companies’ requirements for good laboratories as essential. “There is a growing desire to reduce animal testing to prove that chemicals are safe. Therefore more in-lab tests are required along with a thorough analysis of data. Improvement and development of quantitative structure-activity relationship (Qsar) methods are also essential,” Mr Ortiz says. Consultancy services ranked second. Sphera notes that similar services to those offered under REACH are being required in other countries as they adopt parallel policies. Brexit will also produce new opportunities for service providers, as will the biannual revision of the UN Globally Harmonized System (GHS). Sphera says the challenge associated with the UN GHS revisions is the timeline in which countries adopt the changes as the legal process is different in each country. “Once changes are adopted, some countries make them effective immediately and some countries provide a transition timeline. SDSs and labels need ‘just-in-time’ compliance.” SCC’s Mr Rietzel says the clear challenge for poison centre notifications is that the required tools are not yet ready. He adds that several organisations, in particular the International Association for Soaps, Detergents and Maintenance Products (Aise), have publicly commented on the problem and expressed their concerns about industry’s ability to be compliant on time. Services under the BPR relate mainly to preparing product dossiers, mostly for product families (where some are organised as consortia) and also the defence of biocidal active substances. Mr Rietzel points also to rising demand for Only Representative (OR) services for substance registrations.

Regional drivers

Standards 28% NGO pressure 23% Non-statutory voluntary corporate initiatives/CSR 18% Downsizing of inhouse chemical management and control teams 15% Outsourcing of business support functions (by client organisations) 14% Increased commercialisation/better management of service provider business 12% 0%

For SCC’s Mr Rietzel, the key non-regulatory driver is “business demand for more international presence”. To address this, SCC set up a subsidiary in Japan in 2018 to “better support and advise local clients and also to be better in touch with local authorities.” For Lisa Zhong of the production registration and compliance department at the China National Chemical Information Center (CNCIC), the main non-regulatory business drivers include health, safety and environment (HSE) matters, and chemical-related industry, market and information consulting. Demand for legal and consultancy services is growing in Asia, she adds. Verisk 3E also points to voluntary initiatives from NGOs or consumers to ban certain ingredients from products. Beyond that, it sees companies focusing on seeking efficiencies in their own operations by transforming their strategies and tools for compliance. Meanwhile, product stewardship and advocacy initiatives are key areas for Chemservice, Dr Drohmann says.

20%

40% % of participants

60%

Demand from outside the EU is strong. Chemservice cites South Korea, Turkey, Brazil, Russia, Taiwan, Thailand, Vietnam and the US as key countries for services, while Verisk 3E sees interest for chemical registration and its 24-hour emergency response services in other Asian countries, such as Taiwan, the Philippines and Thailand, while noting a rise in requests from Japan and China. Acta’s Ms Bergeson has seen a sharp spike in requests for services in the Middle East, South and Central America, and Africa, on a broad range of needs. These include testing, chemical regulation, trade, import-export, the GHS and standard consultancy services. US legislation remains a key driver, not surprising given that implementing TSCA is now in full swing. Ms Bergeson says since the new law was enacted in June 2016, chemical producers and importers are mindful of enhanced scrutiny by both the EPA and consumers for ‘high risk’ chemicals and looking for opportunities to abandon legacy substances in favour of less toxic and more sustainable alternatives. “Chemical producers are equally challenged to demonstrate that their products pose no unreasonable risk under foreseeable conditions of use and more chemical consortia are working www.chemicalwatch.com/SPG

Global regulation

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together to pool resources and engage in leveraged advocacy,” she comments. New chemical notifications are increasing as the review process is more predictable than it had been after TSCA was first revised, she adds, but the process is now far more complicated. Tobias Schulte, division director chemicals management at Germany’s UMCO Consulting, says its primary areas of demand are for legal and consultancy services in Canada, the US and Mexico, and in Asia, especially China, Japan and South Korea. Meanwhile Beijing Oriental Chemical Information (OCI) reports consultancy work in Vietnam as a major area of demand, and adds that investment in staff is a key priority. Service providers are finding staffing a challenge, particularly finding people with the right qualifications. “We are looking for more experts with ideally a broad range of international regulatory and toxicology know-how, coupled with command of multiple languages, or native speakers,” says Mr Rietzel of SCC. In contrast, Verisk 3E sees the largest investment in IT. Geographically, it sees increased investment in Southeast Asia, especially Thailand and Vietnam.

Data and digitisation

Automation, artificial intelligence (AI), data analytics, robotic and next-generation wireless technologies are just some of the virtual tools available that are creating numerous means to handle chemical risk management. These, says Mr Ortiz of Verisk 3E, will improve the quality of health and safety compliance and lead to new organisational and operational compliance paradigms. Companies, he adds, are looking to streamline compliance processes, with a focus on automated and cloud-based systems.

There is a soft trend of companies trying to reduce the footprint, cost and risks to their IT infrastructure by outsourcing or hosting it in whole or in part, according to Mr Arcadi of Sphera, who notes that traditionally, this was rarely considered because of the critical need to protect confidential business information (CBI). However, as confidence grows in hosting security, and options to have private secure hosting get more robust and popular, Sphera is seeing more companies considering hosted approaches. Another trend is demand for more in-depth product portfolio analysis, requiring additional reporting and analytics capabilities. Tina Armstrong, principal scientist at global consultancy Arcadis, says more companies are moving toward common data platforms to maintain their product information and integrate their raw material and product level composition information with regulatory compliance tracking capabilities. However, SCC’s Mr Rietzel believes that in some areas of chemical risk management, there is still a lack of suitable “top notch” digital solutions, for example tools for eSDSs for mixtures or for poison centre notification. REACH is more than likely to continue featuring high on chemical companies’ agendas for some years to come. As Michael Cleuvers, managing director for industrial chemicals and biocides at German consultancy Knoell, points out, this is the beginning rather than the end of the REACH story. And, as implementing other REACH-like regulations and numerous other new chemical rules and amendments around the globe continues, it is hard to see a time when service providers are no longer busy.

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Careers and Salary Survey

Uncertainty keeps CMC careers market strong

Keri Allan summaries the key figures from Chemical Watch’s annual survey and discusses the state of the jobs market The job market for chemicals management and control (CMC) and regulatory professionals in 2018 was consistently strong and saw higher demand for people with the right skills. “Not only in Europe, but globally,” says Dieter Drohmann, managing director of the consultancy Chemservice. “We’re seeing some of the strongest demand for experts in biocides legislation and REACH in Europe, but also K-REACH and regulatory affairs experts in Korea.” “There hasn’t been a clear surge for any ‘specific’ role, but an area that has emerged more in 2018 is REACH compliance,” says John Sherratt, chemical regulatory affairs recruiter at UK-based VRS Regulatory. “Companies have been recruiting people to look after supply chain compliance. These may be formulators, so they’re not the people that have got to do registrations, but they are very concerned about the security of supply of their raw materials. “A number of companies have recruited people to focus on REACH compliance – looking at the registration status and checking with clients of all the raw materials and components,” he continues. “We saw a couple of these roles in 2017, but last year there were quite a lot more.” Yet not all legislative changes are creating jobs. Terry Leyden, president of US-based recruitment firm the Leyden Group, says that the revision of the US Toxic Substances Control Act (TSCA) did not lead to many new permanent opportunities. “Much of that work has been managed by consulting firms which offer expertise in regulatory science. I think companies will have an initial push to meet TSCA requirements and then it will diminish, not requiring long-term employees,” he says.

Demand and supply

As regulations have become more numerous and complex, companies acknowledge they need permanent staff to help manage these demands. In response to tasks becoming more complicated, there has been a big push from companies to recruit experienced personnel with key regulatory skills. However, it quickly became clear to recruiters and businesses alike that demand outstripped supply. Lee Lovekin, recruitment manager at NES Global Talent, says it has become increasingly challenging to recruit skilled, permanent staff. Other recruiters agree that there are shortages of experienced professionals Global Service Providers Guide 2019

across all skill sets and many of them attribute this on the increasing number and complexity of regulations organisations must now manage. “I would say the main factor is the continuing increase in complexity of chemical regulations,” Mr Sherratt says. “There’s also been a lot of changes in biocides – that’s another area where the workload has dramatically increased. The amount of work, and its complexity, have basically outgrown the availability of experienced people who can do those jobs.”

The next generation

Mr Leyden believes the big issue in the chemical regulatory community is a serious shortage of people with five to ten years of experience. Over the next few years, as the senior experts retire, there will be nowhere near enough mid-career, experienced people to replace them, he says. Companies are responding to all these challenges in a variety of ways. Some are holding out for experienced professionals, something that has created an upward pressure on salaries; others are looking to bring in employees with comparable skills, perhaps in a different regulation, and cross-train them; others are recruiting trainees who they can develop in-house. “They’re looking for people who’ve got potential, an interest in the area, that they feel can learn quickly. While those people get skilled up, these businesses are replying on external consultants. I believe their aim is to build in-house knowledge so in time all the work can be managed by in-house staff,” says Mr Sherratt. Dr Drohmann believes the sector will need more fresh blood to flourish, and that it is important to make studying natural science degrees more attractive. “It looks like natural sciences are attracting fewer and fewer students,” he says.” Chemistry and biology should be pushed more and made to be more ‘sexy’. However Mr Sherratt notes that recruiters are seeing a steady number of young people interested in going into regulatory affairs. Although there are no courses dedicated to chemical regulations, several master’s courses offer modules on the topic and this has led to an increase in new graduates that want to go into the sector, he adds.

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Careers and Salary Survey

SD Au S th - S or a in fe g ty So D ftw at Au ar a S Cl to e he Ch as m et So em si at fic ic ftw ic at ar al i o Ha e Ma n Ca Da za na lc ta rd ge u ba ou G m la en se s S to So HS r t ftw & s ub st Ha ar Re an So za e gu ce la ftw rd to ar La ry e be Co lli m ng pl ia nc e

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Career trends

The trends and issues identified by the recruitment professionals and consultants we interviewed were explored in more detail in the seventh annual Chemical Watch survey of salaries, pay rises, bonus levels and career prospects in the CMC sector. Of those who took part in the survey, just over 80% are 31-60 years old [Figure 11], and just over half are women [Figure 12]. The majority categorise themselves as specialists or technicians (38%) or project and team managers (27%), followed by senior managers (20%), directors or associate partners (7%), government or agency officers (5%) and junior or graduate trainees (3%) [Figure 13].

14]. The rate at which staffing levels will increase is expected to remain almost the same as observed in the last survey, down from 38% to 37% [Figure 15]. Figure 14 – Staffing trends Decreasing

Static

Increasing

% of participants 100%

11% 90% 80%

Figure 11 – Age profile of participants

70%

<30 6.2%

>60 13.2%

57%

60%

59%

50%

31– 40 22.0%

40% 30% 20%

51– 60 30.0%

37%

30%

10% 0%

Last 12 months

Next 12 months

Figure 15 – Year-on-year staffing trends

41– 50 28.6%

Decreasing

Figure 12 – Gender profile of participants

% of participants 100% 8%

Static

57%

59%

56%

35%

32%

34%

2012

2013

2014

Increasing

56%

57%

38%

37%

2015

2016

2017

2018

90% 80% 70%

Male 48.2%

Female 51.8%

60% 50% 40% 30% 20% 10%

Figure 13 – Job titles of participants Director/ associate/ partner 7%

Junior/ graduate trainee 3%

Officer (government/ agency bodies) 5%

Specialist/ technician 38% Project/ team manager 27% Senior manager 20%

Slightly fewer respondents report decreasing staffing levels in the previous 12 months than the previous year (11% versus 6%) while the same percentage as the previous year (6%) expect to see staffing levels decrease over the next 12 months [Figure

For the third year running, the percentage of people who believe that job security in the sector is increasing stayed at 21% [Figure 16]. However more participants feel that job security is decreasing; this number was five percentage points up on last year [Figure 17]. Job prospects continue to be seen as better globally than within participants’ own countries [Figure 18]. However, although similar percentages of respondents see their job prospects in their own countries (86.4%) and globally (96.4%) as being stable or good, as in 2017, the gap between the two statistics widened compared to the year before. Regarding career progression, the difference participants see between good opportunities within their own company and the wider jobs market is shrinking [Figure 19]. Over one third (35%) stated they believe progression opportunities are good within their own company compared to 36.2% last year, while 58.5% believe that opportunities are good in the wider job market, compared to 63% last year. www.chemicalwatch.com/SPG

Careers and Salary Survey

The safety of YOUR PRODUCT How the Business sees it:

How Competent Authorities see it:

How Downstream Users see it:

How NGOs see it:

How Consumers see it:

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Less secure

Similarly secure

Figure 19 – Career progression opportunities Poor

More secure

% of participants

Good

% of participants

100%

100% 90%

80%

70%

60%

36.52%

38.46%

50%

40%

30%

20%

21%

22%

Across all roles

In own role

10%

27%

60%

66%

50%

12%

13%

90%

59% 35%

10%

0% In your company

Decreasing

Static

Increasing

% of participants 100% 13%

10%

15%

Wider jobs market

Meanwhile, job satisfaction has dropped from 57% to 54%, in line with the trend in recent years [Figure 20]. While those neither satisfied or dissatisfied with their job stayed at 33%, the percentage of participants dissatisfied with their job dropped by two percentage points to 13%.

Figure 17 – Year-on-year job security

90%

Neither

Careers and Salary Survey

Figure 16 – Job security compared with 12 months ago

13%

Figure 20 – Job satisfaction

80%

Dissatisfied 13%

70% 60% 50%

68%

67%

64%

71%

66%

40% 30% 20% 10%

20%

23%

21%

2013

2014

2015

2016

2017

2018

Neither satisfied or dissatisfied 33%

Satisfied 54%

Figure 18 – Job prospects Poor

Stable

Salary trends

The overall average salary has risen compared to the previous year, up from €46,400 to €55,900. [Figure 21].

Good

% of participants 100%

90%

14%

80% 70%

43%

60%

52%

50% 40% 30%

53%

20%

35%

10% 0% Globally

In your country

www.chemicalwatch.com/SPG

Careers and Salary Survey

Women in the survey were bringing home a higher average salary of €48,600 than men, with €45,500 [Figure 23]. As expected, age also affected average salaries. Participants aged 61-65 earn the highest average salaries (€53,300), closely followed by those aged 46-50 (€52,200). The 21-25 band earns the lowest, at €33,900 [Figure 24].

Figure 21 – Average salary by job description EHN management 66.6 Regulator

Figure 23 – Average salary by gender

46.7 Product safety/stewardship

Male 59.9

45.5

Regulatory affairs management

Female 48.6

56.6 Business management/development

26.2

Euros 000s

Other job function

Figure 24 – Average salary by age

46.4 Toxicologist/chemist/scientist

21-25 33.9

50.4

26-30

Consultant

39.8

64.0

31-35

Average salary

44.6 36-40

55.9

49.4 0

41-45

Euros 000s

49.3 46-50 52.2

Looking at average salary by sector, the highest paid respondents work in chemicals, life science and similar areas, followed closely by consumer products and cosmetics. The lowest paid are those working for trade associations or professional bodies. Asia-Pacific is on a par with North America, with an average salary of €45,100 in 2018, while those working in Africa and the Middle East, and Latin America, had the lowest average pay, at €26,600 and €23,100 respectively.

51-55 45.6 56-60 47.7 61-65 53.3 >65 39.5

Figure 22 – Average salary by location

Europe

47.7 North America 45.1 47.4 Rest of world 40.3 39.2 Average 55.9 46.4 10

40 Euros 000s

Global Service Providers Guide 2019

Average pay rises excluding promotions were down on the previous year at 1.3% compared to 2.7% in 2017 [Figure 25]. They ranged from 1% in Europe to 1.4% in North America and 2.8% across the rest of the world. When promotions are included, the average pay rise was 1.7%. Promotions alone resulted in average rises of 3.9%, much lower than the 2017 figure of 9.5%.

72.1

Euros 000s

Previous survey

Current survey

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A positive outlook

Figure 25 – Average pay rise Excluding promotions

Including promotions

Only promotions Europe 1.0 1.3 3.3 North America 1.4 1.7 3.8 Rest of world 2.8 3.3 5.4 Average 1.3 1.7 3.9 0

3 %

The average bonus in 2018 for those eligible to receive one was 11.3%, up slightly from 11% in 2017. Across the globe, bonus figures were close, ranging from the lowest in North America (9.9%) to 13.6% in the rest of the world. Figure 26 – Average bonus (if entitled)

Overall, these results show that the outlook for jobs in the CMC and regulatory sector remains cautiously positive. Job security is not as high as it was last year, but fewer respondents believe that we will see see staff cuts over the next 12 months. In addition, job satisfaction has risen – as has the average salary. Looking forward, although political uncertainty around Brexit remains, businesses and recruiters believe strong demand for CMC and regulatory professionals will continue this year. This is because regulatory departments continue to be very busy and companies can only see more work if and when Brexit happens. Indeed, Dr Drohmann sees Brexit as an opportunity. “We’ve just opened a new office to service the UK – something our clients mandated. If Brexit happens there’ll be a ‘UK REACH’, which will mean duplicating systems and a need for more people,” he says. Mr Sherratt is cautiously optimistic. He says the main concern is ‘Brexiting’ potentially hitting companies with increased costs or delays, as this often leads to an automatic freeze of headcounts. However, if this does occur, he thinks that companies will respond by increasing fixed-term contract roles to help out on an interim basis. “I think demand will stay strong, but it may just evolve slightly as companies look at how best to get the resources they need,” he says. Mr Lovekin agrees that the future looks bright, even if it is uncertain. “There was talk that companies would hold off making any big business decisions, but people are starting to move forward now,” he says. “The larger companies weren’t so concerned – they’ve got the scale and experience behind them to understand the risks and make things work. “In the grand scheme of things it was the small to mediumsized companies that were more concerned about where to base new projects and so have taken the option to position these projects in Europe. However, there is still a lot of investment happening, in the UK and elsewhere.”

Europe 12.1 North America 9.9 Rest of world 13.6 Average 11.3 0

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Global Service Providers Guide 2019

Service Provider Outlook

SERV IC E P ROVID E R O U T LO O K

Demand to continue unabated

The increased volume and complexity of global chemical regulation looks set to keep service providers busy. Elaine Burridge reports Service providers are largely in upbeat mood when talking about their prospects for the future. This is, perhaps, not surprising given the volume of chemicals-related regulations around the world that are being overhauled or put in place. REACH still figures high on their agendas. The cliff-edge fall in demand that some expected after last year’s final registration deadline has not happened. Many say demand for registration services fell but overall, requests for other services, such as evaluation, authorisation and dossier updates have increased. Our survey shows that laboratory services remained most in demand, accounting for 26.5% of survey respondents’ total spend, up from 21% in 2017 [Figure 27]. Consultancy jumped up one place to second at 17.4%, while training shared third position with representation and management.

Equipment

Laboratory

Other services

90%

50% 40%

Training 10.5% Representation & management 10.6%

Laboratory 26.5%

10%

8% 3% 7%

6% 9%

12%

13%

13% 12%

14% 14%

16%

47% 28%

2% 3%

7% 6%

1% 7%

19%

12%

8% 11% 5%

14%

8% 20%

21%

17%

27%

30% 18%

8% 7%

7% 7%

5% 3%

28%

24%

19%

27% 6%

20%

13%

30%

10% Legal 9.7%

33%

Consultancy 17.4%

IT & software 7.9%

Training

Legal

Equipment added

60%

Information 5.0%

Information

Representation & man.

100%

70%

Other services 4.5%

Consultancy

IT & software

80%

Figure 27 – Services retained by participants

Equipment 7.8%

Figure 28 – Changes in the proportion of spending on service provider types

25%

27%

3% 4%

35%

12%

2010

2011

2012

2013

2014

2015

10% 11%

17%

18%

17%

2016

2017

2018

The amount of work completed on average by in-house teams in 2018 remained broadly in line with levels seen in 2017 [Figure 29]. Given the number of new chemical regulations or those being amended worldwide, this level is unlikely to fall in the year ahead.

There were some significant changes in spending during 2018 compared with the year before [Figure 28]. Investment in representation and management nearly doubled, and spending on training, equipment and laboratory equipment also rose. In contrast, spending on legal services nearly halved with drops posted too for IT and software, and information. Consultancy was little changed year on year. www.chemicalwatch.com/SPG

Service Provider Outlook

increased presence in the FCM space will present an abundance of opportunities for Acta in 2019,” Ms Bergeson says.

Figure 29 – Percent of chemical management work performed by in-house teams 80-100%

40-60%

60-80%

20-40%

Opportunities beyond REACH

0-20%

% of participants 100% 90% 80%

35%

36% 53%

70%

49%

53%

48%

49%

50%

53%

30%

26%

25%

23%

10%

11%

6% 4%

60% 27%

25%

30%

13%

15%

20%

10%

50% 40%

10% 0%

12%

15%

12%

2010

2011

25%

31%

28%

2012

2013

2014

2015

2016

2017

Strong outlook for 2019

15% 2018

European chemical hazard and risk assessment company Bibra is optimistic. “Our pipeline for 2019 is already 80% booked,” says principal toxicologist and managing director Richard Young. “Discussions with partner organisations and contract research organisations, particularly those well-versed in the conduct of in vitro assays and extended, one-generation reproductive toxicity studies (Eogrts), suggest 2019 will be a busy year all round.” Mr Young goes on: “Echa is starting to put older REACH dossiers under increased scrutiny, leading to the need for updates – either spontaneously or as a result of evaluation decisions. BPR submissions now have to consider endocrine disrupting potential in much greater detail, and the new medical device Regulation and changes to ISO 10993 testing guidelines are driving increased demand for our services in these sectors.” Meanwhile, Alan Ritchie, associate director for REACH and product stewardship at consultancy WSP Group, is anticipating increasing demand for support in substances in “embattled” areas such as substances of very high concern (SVHCs) and poison centre notification, under which there is a deadline looming for consumer products. “Within REACH, we are seeing demand for new product registration and help with processing of letters of access,” he says. “Companies are trying to sell LoAs but have no idea how to price them. In addition, we are seeing increased demand for extended safety data sheets as companies play catch-up with the requirements for higher tonnage registrations of hazardous substances.” Lynn Bergeson, president of the Acta Group and managing partner of Bergeson & Campbell, cites ongoing demand for expert services for Turkey’s REACH-like law, the KKDIK. Customers are requesting assistance with regulatory analysis, pre-registration and legal support and the looming pre-registration deadline of 31 December 2020 should prompt companies to address their obligations this year, she says. Acta has seen consistently positive levels of demand under the US Federal Insecticide, Fungicide and Rodenticide Act (Fifra) and TSCA, and connected to the EU Regulations on biocidal products and food contact materials, helped in the latter case by its new Brussels office. “We expect that strategic partnerships and our

Global Service Providers Guide 2019

Compliance services group Verisk 3E notes that other legal updates in 2019 include the Japan Industrial Standard (JIS), which addresses classification, labelling and SDS regulations, and the Philippines’ full implementation of the UN Globally Harmonized System (GHS) for classification and labelling of chemicals, for which the last deadline, covering mixtures, is due to take effect in 2019. “Most significantly, per Annex VIII of the EU CLP, are the changes in requirements when notifying poison centres of all chemicals that may end up in consumer products,” says Alex Ortiz, vice president of global regulatory content at Verisk 3E. Even though the implementation deadlines are phased, starting with consumer use on 1 January 2020, manufacturers that typically sell chemicals only in bulk are already starting to think about how they will comply because there is always a chance that their chemicals can end up as ingredients in a consumer product. Therefore, he says, most will try to comply by the first deadline. Another area of strategic focus for certain service providers is medical devices. The MDR is being phased in over three years, with full compliance required from 26 May 2020. ChemSafe’s managing director, Antonio Conto, says it mainly intends to develop medical device and plant protection products services this year. Similarly, Germany’s Scientific Consulting Company (SCC) launched a new group to provide registration support for the medical devices industry in January 2019. There has been a shift in companies’ approach to internal chemicals management and control (CMC) over the last five years [Figure 30]. More respondents (35%) saw a switch to separate compliance divisions, compared with 31% last year, while the number moving towards integrating compliance management fell from 20% to 14%. The number reporting no change in their management approach remained at 51%. Figure 30 – Integration changes at survey respondents over the last 5 years Move towards general management 14%

Move towards separate compliance divisions 35%

Remained the same 51%

When asked about their frequency of retention [Figure 31], 22-57% of respondents said they use outside assistance occasionally, rather than frequently (9-29%) or permanently (3-18%). These figures suggest more respondents are seeking help strategically than last year, when the year’s figures were: occasionally 17-34%, frequently 2-20% and permanently 2-8%.

Service Provider Outlook

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able to provide registrations under REACH but many will fail to continue with more complex services as follow-up.”

Figure 31 – Frequency of service retention by survey participants Permanent

Frequent

Satisfaction slip

The number of satisfied survey respondents slipped again in 2018, for the fourth consecutive year. However, the small percentage of dissatisfied respondents remained flat year on year [Figures 32 and 33].

Occasional

Consultancy/advisory 11%

49%

28%

Representation & management 6%

16%

Figure 32 – Change in overall satisfaction levels

34%

Dissatisfied

Legal services 13%

44%

28%

100%

37%

90%

IT & software solutions 19%

19%

28%

25%

56%

40%

35%

3% 9%

25%

27%

26%

29%

30%

78%

73%

71%

72%

71%

68%

67%

66%

2011

2012

2013

2014

2015

2016

2017

2018

30%

Other services

50%

Equipment

3% 9%

60%

Training 6%

19%

70%

37%

25%

80%

Information services 13%

Satisfied

% of participants

Laboratory 11%

Neither

21%

20% % of respondents

100%

10% 0%

Globalisation trend

SCC’s Ingo Walter, senior manager regulatory affairs – chemicals, says there is a clear trend for the handling of substances on a global basis, rather than by a market-by-market approach. The company founded an affiliate in Japan in 2018 in response to increasing demand for international registration services and is establishing more collaboration partnerships with local consultants in other key markets. The increasing complexity and globalisation of regulations will be primary drivers of growth for the larger service providers, says Dieter Drohmann, CEO of German consultancy Chemservice. In Europe, he adds, smaller consultants will not be able to address the new tasks under REACH, for instance high-level toxicological and ecotoxicological services, so broadly. In addition, customers are demanding more support in areas like product stewardship and advocacy as more chemicals and SVHCs come under scrutiny. In February 2019, Chemservice opened three new subsidiaries – in Spain, to cover Spain, Portugal, Italy and Latin America; in the UK, to support the UK industry and suppliers to the UK market, particularly in light of Brexit; and in the US. Verisk 3E similarly opened an office in China last year, adding to one in Japan. “Clients need both broader and in-depth expertise as the global regulatory puzzle is getting more and more complex and requests from authorities require expert knowledge. It is an excellent market for experts, but not for beginners,” says Michael Cleuvers, managing director for industrial chemicals and biocides at German consultancy Knoell. “Besides our geographical expansion in the Americas and the Asia-Pacific region, we are continuously diversifying our service portfolio to cover any kind of chemical, in any kind of product and any target market, no matter what the final use is.” Jan Holomek, managing director of ReachSpektrum in the Czech Republic, says industry consolidation will continue with ‘basic service’ providers disappearing and those offering higherlevel expertise growing. He comments: “Almost anyone was

2010

Figure 33 -Satisfaction levels in 2017 & 2018 Dissatisfied 4%

Neither 29%

Satisfied 67%

Dissatisfied 4%

Neither 30%

Satisfied 66%

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Service Provider Outlook

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With regard to pricing [Figure 34], satisfaction levels fell by 2 percentage points to 34%. Dissatisfaction levels climbed again, up 4 percentage points to 15%. This was significantly up from 2016 when the survey recorded only 3% dissatisfaction. Once again, the number of respondents indicating they may change their current service providers hardly changed at all [Figure 35]. Figure 34 – Satisfaction levels of survey participants with prices charged for services

Service Provider Outlook

Figure 36 – Most important choice factors for survey participants Expertise of key staff 76% Proven experience on similar projects 75% In-depth knowledge of country specific regulations 65%

Dissatisfied

Availability

15%

51% Comprehensiveness/accuracy of proposal

Satisfied

50%

34% Ability to operate on a global scale

49% Appropriate accreditation/certification 47% Contract price 44%

Neither

Recommendation from peers

52%

22% ISO9001 or equivalent (quality management)

Figure 35 – Interest level of survey respondents in changing suppliers

29% ISO14001 or equivalent (environmental management) 23%

Possibly

Yes

Independence of supplier organisation

% of participants

21%

100%

Inhouse equipment/software 19%

90% 80%

Large size of supplier organisation

46%

39%

47%

44%

47%

40%

42%

43%

42%

6% Proximity to your office

70%

60% 0%

50%

20%

40%

60%

80%

% of participants

40% 51% 30%

53%

51%

52%

2014

2015

2016

2017

2018

44%

48%

46%

10%

2011

2012

2013

48%

20% 10% 0%

6% 2010

When it comes to relationships [Figure 37], a strict adherence to project protocols retained pole position, while having service level agreements in place was second. Building long-term relationships with members of staff slipped to third from second place in 2017.

The two most important choice factors for survey respondents were the expertise of key staff (76%), followed by proven experience on similar projects (75%) [Figure 36]. In third place was an in-depth knowledge of country-specific regulations (65%). These topics retain the same ranking as the year before but their percentages are lower this time.

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Service Provider Outlook

Figure 37 – Most important relationship factors for survey participants Strict adherence to project protocols 54% Service level agreements in place 42%

been preparing contingency plans at great time and cost, without knowing exactly what the regulatory landscape in the UK will look like post-Brexit. The main focus has been chemical registrations held under REACH, although there has also been a need to support UK firms in contingency planning for biocidal product registrations. Enviresearch expects this demand to continue in early 2019, with further substantial support required if the UK leaves the EU without a withdrawal agreement.

Team growth

Building long-term relationships with individual staff

The vast majority of respondents expect their internal teams will increase or be stable over the next 12 months and the next five years [Figure 38]. However, fewer than before expect an increase in the short-term – 44% versus 48% in 2017. Longer-term, 63% were anticipating their internal teams to expand.

40% Suppliers keeping costs as low as possible 27% Regularly reviewing (and at times changing) suppliers

Figure 38 – Anticipated future need for in-house staff

23% Regular face-to-face meetings

Increase

Increase significantly

18%

Decrease

Paying more to get better value

Static

Decrease significantly

Next 12 months

10% Use of penalty clauses

39%

51%

4% 0%

10%

20%

30%

40%

50%

60%

Next 5 years

% of participants

Software services

Global software providers Sphera says those chemical companies that expand their markets through organic growth or consolidation need to have software systems which can grow with them. In 2018, says Frank Arcadi, vice president of product stewardship solutions, the projects performed by Sphera’s team required coverage of more than 25 countries and it continues to receive requests from customers for coverage of more than five and up to 50. In the coming year, Sphera expects strong demand for software services that support product compliance, automating the authoring of both SDSs and labels that comply with countryspecific versions of the GHS. “Chemical regulatory changes are moving at warp speed around the world. As we provide software systems and global regulatory content, maintaining our systems and content to provide compliant SDSs and labels is at the top of our agenda.” Verisk 3E’s Mr Ortiz adds: “We expect companies to start moving from on-premise to cloud-based solutions at a faster rate as well as chemical management systems – tracking supply chain changes and regulatory updates – that also incorporate an authoring solution in addition to tools for tracking and investigating emerging chemical regulations.” Service providers expect the trend for outsourcing to continue to grow, especially from SMEs, as the complexity and frequency of legislative changes continue and it becomes harder for these companies to maintain the multiple and specialist skills required to keep pace. SCC’s Mr Walter comments: “While some big players seem to rely more on their in-house capacities, we however see an ongoing trend for more outsourcing for SMEs. These companies simply don’t have the capacity to have good knowledge about all the different chemical or sector-specific regulations, or about all the international markets.” Service providers also expect extra work as a result of Brexit, although the extent of this depends on whether the UK leaves the EU with or without a deal. Scott Watson, regulatory affairs specialist at Enviresearch, says chemical manufacturers have Global Service Providers Guide 2019

14%

49%

28%

100%

% of participants

And most respondents expect their external service requirements to increase both over the next 12 months and the next five years – 52% and 56% respectively compared with 53% and 64% in 2017 [Figure 39]. Figure 39 – Anticipated future need for external service Increase significantly Decrease

Increase

Static

Decrease significantly 1%

Next 12 months 4%

48%

42%

Next 5 years 8%

48%

36%

% of participants

100%

Over the next 12 months, survey respondents anticipate the largest increases in demand for external sector services [Figure 40] in information (65%), then training (61%), followed by IT and software (54%). Apart from the catch-all ‘other’ category, most respondents – 69% and 67%, respectively – were expecting demand for equipment, and representation and management to remain steady.

Figure 40 – Anticipated future need for external sector services in the next 12 months Increase

Static

Decrease

Consultancy/advisory 51%

43%

Representation & management 29%

67%

Legal services 38%

59%

Laboratory 41%

50%

IT & software 54%

45%

Information 65%

34%

Training 60%

38%

Equipment 23%

70%

Other(s) 9%

86%

5% 100%

% of participants

These percentages rise, however, for anticipated increases five years ahead [Figure 41]. Information remains top at 70%, with training next at 68% and IT and software at 65%. Most service providers expect demand to remain stable for representation and management (59%), and equipment (58%).

Consultancy and advisory services, training, IT solutions, information and laboratory were the top areas for requiring assistance [Figure 42]. Within the first category, the majority of respondents wanted help with regulatory interpretation (69%), product compliance (62%), chemical safety assessments (60%), environmental risk assessments (54%) and supply chain communications (53%). In relation to training, most support (66%) was needed for bespoke or in-house training courses, while for IT solutions, supply chain management and environmental, health and safety (EHS) were the most requested, at 60% and 53% respectively. The information category most needed was regulatory/policy tracking (59%) while the most needed laboratory service was ecotoxicology testing (57%).

Other factors

International trade tensions are also having a positive impact on demand on consultancy services, says Tina Armstrong, principal scientist at global consultancy Arcadis. This, she says, is because of the increased scrutiny that is occurring at borders and the rising cost of non-compliance. The China National Chemical Information Center (CNCIC) expects pesticides registration and new chemical notifications to be the main drivers of growth, according to Lisa Zhong of its production registration and compliance department. The biggest challenge will be how to provide high quality and sustainable global services to support clients. Regionally, Europe, the US and Asia continue to dominate demand for services. Some providers are also seeing this increase in the Middle East with some mentioning South America as another region of opportunity. In Acta’s view, customers will prioritise service providers that can provide timely and reasonably priced expert services under a range of global regulations. Certainly there are no signs that the trend to outsource is going to slow down in the near future. The challenge, as always, will be to maintain an up to date knowledge base and diverse skill set on a myriad of chemical laws around the world while fulfilling customers’ demands on a variety of regulatory matters.

Figure 41 – Anticipated future need for external sector services in the next five years Decrease

Static

Increase

Consultancy/advisory 59%

32%

Representation & management

38%

59%

Legal services

3% 47%

50%

Laboratory

6% 38%

56% IT & software

1% 66%

34%

Information

2% 28%

70% Training

2% 68%

31%

Equipment 58%

33%

Other(s) 41% 0%

50% % of participants

9% 100%

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Figure 42 â&#x20AC;&#x201C; Anticipated future need for specific external sector services in the next five years

Increase Regulatory interpretation Product compliance Chemical safety assessments Environmental risk assessment Supply chain communications Registration strategies Health effects assessment Product stewardship Consumer product safety Hazard & exposure modelling Data management Assessment of data quality Consultancy/ Testing strategies advisory Health & safety Safer alternatives assessment Safety of nanomaterials Workplace risk assessment (exposure) Product safety testing Data-gap analysis (QSAR) Corporate strategy/strategic planning Occupational hygiene Ecolabelling Product Inspection (on-site) SVHC advisory services Chemical transport/warehousing advice Registration services Dossier preparation Representation (OR, 3rd party etc) Representation CLP notification & management Management (Sief, consortium etc) GHS notification Business process outsourcing (BPO) Regulatory/policy tracking Chemical hazard database Information Managed regulatory content (Material) safety data sheets Ecotoxicology Human health toxicology Alternative approaches to testing Monitoring processes (on-site) Environmental fate & degradation Laboratory Environmental monitoring SVHC testing Product testing Physical & analytical chemistry Exposure testing Supply chain management EH&S (Material) safety data sheets Consortia/registration management IT solutions Supply chain communications Regulatory information management Laboratory information management Inventory management Bespoke/inhouse training CPD/CES certified training Training Training courses/webinars Environmental sensors Workplace air quality monitors Equipment Chemical identification/detection Insurance Logistics Public relations Other Lobbying/advocacy Emergency response 0%

Static

69% 62% 60% 54% 53% 49% 47% 46% 40% 40% 39% 39% 37% 35% 35% 35% 34% 33% 30% 30% 28% 28% 26% 25% 26% 35% 36% 34% 30% 26% 24% 17% 59% 49% 27% 24% 57% 41% 40% 40% 39% 37% 35% 30% 30% 25% 60% 53% 47% 44% 43% 42% 43% 41% 66% 32% 32% 29% 25% 23% 32% 31% 30% 21% 20%

Decrease

30% 38% 40% 44% 44% 47% 48% 48% 59% 55% 57% 56% 61% 57% 56% 61% 62% 58% 66% 69% 64% 67% 67% 66% 69% 56% 62% 54% 66% 68% 68% 76% 41% 51% 64% 71% 40% 54% 57% 59% 55% 57% 62% 65% 63% 74% 40% 45% 47% 53% 54% 56% 55% 58% 33% 64% 63% 68% 73% 75% 62% 67% 65% 72% 76%

% of participants

2% 0% 1% 2% 2% 4% 5% 6% 1% 6% 4% 6% 2% 7% 9% 4% 4% 9% 4% 2% 8% 6% 7% 8% 5% 9% 2% 12% 4% 6% 8% 7% 0% 0% 9% 5% 2% 5% 3% 1% 5% 6% 3% 4% 7% 1% 0% 2% 6% 3% 3% 2% 3% 1% 1% 4% 5% 3% 3% 2% 6% 2% 5% 8% 4% 100%

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Service Provider Outlook

REACH beyond 2018

EURO P E

REACH: the end of the beginning

The end of the last REACH registration is only a stage in the evolution of the Regulation. Rosa Richards reports REACH has generated a large dataset of toxicological knowledge which can also fulfil other purposes. However, although the last registration deadline for existing substances passed in 2018, new substances must still be registered and existing dossiers must be updated with new scientific knowledge on the safe use of chemicals. The other main REACH processes – evaluation, authorisation and restriction, are also continuing. Suzanne Wiandt, head of unit for the REACH helpdesk at Baua, Germany’s Federal Institute for Occupational Safety and Health, says it continues to give valuable education and support in terms of registration and REACH in general and there is still some way to go to reach the goal of the safe use of chemicals. Paul Thomas, managing director of Cehtra, adds: “The irony of REACH is that the highest tonnage bands – the substances with highest exposure to humans and the environment – often have the poorest quality data sets, while more recent dossiers for the low tonnage substances have much higher data quality, based on scientific judgement with improved quantitative structure-activity relationships (Qsars).”

When to update?

Echa deputy executive director Jukka Malm says that updating registrations with the latest knowledge on the safe use of substances in the supply chain is good practice and must be done if new data become available, but this is not yet happening at the level expected. The problem, notes Dr Thomas, is that there is no obligation to update regularly. Nor is it clear how the ‘expected level’ is defined or described, or how the agency arrived at an estimate of the level of dossier updates. Echa regularly screens the database to identify cases of concern where additional information should be requested or regulatory action may be needed. However, Dr Wiandt says that data quality is not yet fit for purpose. “During substance evaluations, you realise that there are still unanswered questions, the data from industry is really hard to assess,” she says. Dr Thomas points out that any dossier submitted using Iuclid 5 software should now be updated to Iuclid 6, which is a step change in format. Even if there is no change in content (for a 1-100 tonnes dossier), it takes at least one day to change the format to pass technical completeness checks, plus technical work. Global Service Providers Guide 2019

For a large tonnage (>1,000) dossier, it could take a week. Echa really needs to enforce updates, in his view. For many smaller companies, the ultimate goal was to get a registration number; they may have no incentive to update, since many pre-2015 dossiers were submitted using read-across in order to avoid undertaking large numbers of studies. “Read-across is now a much tougher scientific process requiring justification,” Dr Thomas says. “Resubmission with a completely different approach would be needed, with significant effort to demonstrate that risk assessment is appropriate. In our experience, many companies don’t see the need to update dossiers and may not see the urgency until it becomes an issue of law.” There is also a disincentive for companies to increase the tonnage band of a substance, in his view, as this would require a more detailed registration; it is better to seek alternative methods, for example to split tonnage between new legal entities to ensure a lower band.

Complicating factors

The European Commission is expected to clarify the obligations for updating dossiers sometime this year. Echa will facilitate this by simplifying IT tools and processes. Echa’s Enforcement Forum’s seventh project (Ref-7) will verify how companies can comply with the obligation to make updates. Majella Cosgrave, a toxicologist at the Health and Safety Authority in Ireland, points out that national enforcement authorities (NEAs) also receive cases of potential non-compliance related to registration within incorrect tonnage bands from Echa’s own screening activities. Some countries have already initiated investigations of these and may include them as part of their Ref7 inspections. Producers and importers are generally up to speed with the ongoing requirements of REACH, says Dr Thomas. Formulators have been less involved but they see the downstream impacts; distributors are often less clear about their obligations. Larger companies tend to be more engaged with advice from Echa and more aware of the need to update dossiers than SMEs. Siefs officially ceased to exist on 1 June 2018 but Neil Hunt, lead on nanomaterials research at Yordas, notes there is no mechanism yet to replace them. (At the time of writing,

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their continuation was due to be recommended in a pending implementation Regulation.) “SMEs may be caught by surprise that a lead registrant asks for payment to update a dossier when they thought the process was done and dusted. This highlights the need for manufacturers and importers to remain part of a Sief,” he warns. Exposure scenarios are another challenging issue, especially for SMEs. Companies are unsure about the obligation to write them, especially if there are joint registrants, as well as when to write them, what to include and how to make them user-friendly while providing all necessary information. Releases to the environment are not always easy to measure and there are many different guidance documents to choose from. Echa’s Exchange Network on Exposure Scenarios has developed a plan for improving communication of exposure scenarios through supply chains. Mr Malm explains that the network initially focused on manufacturers and importers in order to generate good data and tools for effective communication but now the focus is more on downstream users, so as to increase the number of sectors and companies using the tools to ensure safe use of chemicals. Meanwhile, Mr Thomas points out that customs inspections are a weak point for REACH as it is difficult to know how to implement border controls. This issue will be addressed in 2019 by Ref-7, which will aim to enhance cooperation between NEAs and customs and to establish procedures. According to Dr Wiandt, the closely related EU classification labelling and packaging (CLP) Regulation is still not yet well understood. For example, Baua’s helpdesk receives questions on how to classify and label mixtures, which indicates that implementation has not yet been achieved and improvements are needed. An emerging issue, says Dr Cosgrave, is the control of internet sales of chemicals. Echa’s Enforcement Forum found that over 80% of sales were in breach of the CLP requirement to inform buyers of the hazards of the product. A wider EU project tackling this area will be undertaken in 2020. Mr Malm and Dr Cosgrave believe that harmonised classification and labelling is working well under the CLP but the former adds that Echa is concerned about self-classification by industry. There are clearly conflicting classifications in the classification and labelling database portal. One future issue, says Dr Cosgrave, is the ever-falling size of consumer packaging versus the amount of information required on the hazard label, plus uncertainty about how well consumers read and understand labels before they use chemicals. Nonetheless, the REACH dataset is a valuable resource. It can be used, for instance, to model and predict the toxicology of new substances for certain endpoints, for example using Qsar models. Animal testing, however, may still be required for shorter-term effects. Echa also aims to create synergies with other legislation on safe use of substances, product safety, construction materials, waste legislation and environmental emissions, for example. The processes of REACH can be interlinked with other legislation; the agency aspires for companies and authorities to use the same data and assessments to meet the requirements of various pieces of legislation, Mr Malm says.

An EU-funded project is producing guidance on read-across, grouping and classification of nanomaterials. However, registrants may be required to undertake this work before a best practice methodology has been developed. Dr Hunt recommends keeping a close eye on EU projects and guidance documents. There are questions over how to define a similar set of nanoforms. Meanwhile the NanoGravur project, funded by Germany’s education ministry, has produced methods for grouping nanomaterials according to the potential for exposure, hazard and risk. Although the Commission is assuming that dossiers will be updated before 2020, Dr Hunt adds, guidance documents will probably take time to prepare, due to consultation periods. Industry may find it only has a couple of months from guidance becoming available to complying with updated requirements. Mr Thomas says that the world has taken note of REACH and many countries are updating their nanomaterial notification processes accordingly, or will do so. However, it is hard for formulators to sell worldwide, as they do not want to reformulate their products for different countries with specific restrictions in place. He predicts that worldwide notifications will be needed in future, but there is currently no body to oversee them. Even OECD guidelines are not accepted in every country and definitions of ‘nano’ still vary. Other major regulatory challenges for which industry needs to prepare include Brexit, international regulatory alignment, poison centre information requirements and the recent amendment to the EU waste framework Directive to facilitate the circular economy. The amendment is a major issue as all suppliers of articles must identify SVHCs. Information must be systematically provided to Echa for waste operators and for transparency to consumers – a huge task all round. Dr Wiandt asks how, given that no resources have been allocated for Echa to create a central database to store information on SVHCs in materials and products, key expectations and goals will be met. Dr Thomas, finally, stresses the importance of conveying to business departments that this is “the end of the beginning phase of REACH not the beginning of the end”. 2019, he predicts, will probably see chemical regulation budgets drop, only to be reinstated due to requests from Echa.

Nanomaterials issues looming

A major issue on the horizon for REACH is the registration of nanomaterials and nanopowders. Mr Malm says that, in practice, industry is not systematically applying the registration process to these. Revised dossier requirements for nanomaterials will come into force in January 2020 and will require manufacturers and companies marketing powders to undertake characterisation and investigate whether nanomaterials are present or not. Companies will need to check whether they are making nanomaterials, says Dr Hunt. If so, can the materials be defined? Can read-across be justified across sets or is extra testing needed? www.chemicalwatch.com/SPG

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Revised TSCA

NORTH AM ERIC A

TSCA: Smooth implementation hit by upheaval

The US is implementing the updated TSCA but government shutdowns and other issues are causing frustrations, says Frank Zaworksi Under the Lautenberg Chemical Safety Act (LCSA), which amended the Toxic Substances Control Act (TSCA) in 2016, the EPA’s New Chemicals Programme involves increased requirements in terms of compliance and information gathering. Chemical manufacturers and their service providers are having to rise to the challenge. Lynn Bergeson managing partner at law firm Bergeson & Campbell, says that the company and its consulting affiliate, Acta Group, are working extensively in TSCA-related matters, including legal interpretations of the new law, assisting in risk evaluations of existing chemicals, negotiating Consent Orders under TSCA Section 5 relating to new chemicals and addressing enforcement challenges. “The work is brisk, challenging, interesting and cutting-edge, given the newness of Lautenberg,” Ms Bergeson says. How the industry and service providers are coping with the specific challenges varies, she adds. These challenges include: OO risk-based assessment; OO the pre-manufacturing notices (PMNs) that must be submitted at least 90 days prior to activity for a substance to be included in the TSCA Chemical Substance Inventory, which lists all existing substances manufactured, processed or imported in the US that do not qualify for an exemption or exclusion under TSCA; and OO significant new use rules (Snurs) that oblige companies to notify the Environmental Protection Agency (EPA) before chemical substances and mixtures are used in new ways that might create concerns. “We have long urged entities subject to TSCA to prepare PMNs smartly and comprehensively, and begin now to access the conditions of use of existing chemicals in preparation for responding to regulatory and/or commercial challenges,” says Ms Bergeson. “Businesses for the most part have been slow to respond and have paid a heavy price in being saddled with restrictions on new chemicals. These will likely be regulated, as chemical evaluations of high priority substances can be expected to elicit unfavourable risk determinations in certain markets.” She adds that smart, forward-looking companies are more mindful of the business opportunities and are doing things

differently to avoid restrictions that could prove commercially significant. “One way we’ve noticed many companies engaging with new TSCA requirements created by LCSA, particularly risk evaluations for existing chemicals, is through trade associations,” says Ari Lewis of consulting firm Gradient. “These are frequently coordinating a common response for the first ten chemicals undergoing risk evaluation, and they are also working to anticipate the next batch of chemicals that will go through the prioritisation process in 2019.”

Rising to the challenge

Chemical manufacturers are coping well with the new requirements under LCSA, according to Jim Cooper, vice president of petrochemicals at the American Fuel and Petrochemicals Manufacturers (AFPM), which is also assisting. For example, the EPA recently asked the AFPM to supply information on the role of perchloroethylene in chemical production. It was able to provide information and data on how perchloroethylene is used to produce catalysts. Irene Hantman, counsel at Verdant Law, which offers chemical risk assessment science services among other things, also says that the chemical industry and service providers are coping well with the new requirements under LCSA. “With the increasing number of chemical and product-related regulations and green chemistry initiatives, the need for legal counsel has increased,” she says. “The EPA has always taken a risk-based approach under TSCA, but the mandated throughput of new risk evaluations under LCSA, as well as the higher standard for PMNs, has resulted in increased information demands on industry,” says Jessica Kneeland of Gradient. “It is increasingly looking to alternative sources of toxicity information – the so-called new approach methodologies (NAMs), such as in vitro testing, high-throughput assays, readacross and chemical grouping, to fill data gaps.” Ms Kneeland adds that industry often uses service providers with specific expertise in these methods. “Most new PMNs now come with Snurs that place restrictions on chemical uses,” she says. “Companies need to make sure they have monitoring systems in place that track substance evaluations and restrictions, so www.chemicalwatch.com/SPG

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they can ensure compliance with restrictions and provide data to inform the EPA’s ongoing prioritisation and risk evaluation work. They often turn to service providers, and sometimes trade associations, for help.” After two years, companies are learning to cope with LCSA, although many are still frustrated with the delays, according to Julie Byrne of Verisk 3E. “More companies are interested in training their staff to better understand their TSCA obligations,” she observes. “Companies are more interested in using quantitative structureactivity relationship (Qsar) tools to limit the need for testing or to better provide guidance on what testing is required. With the increase in TSCA submission fees and increase in review time, companies are asking for strategies to help in obtaining TSCA clearance faster and with less cost.” Ms Byrne also notes that additional training of industry staff earlier in the development process is providing a better understanding of the change from a hazard approach to a riskbased assessment. “Service providers are helping companies in collecting the pertinent information and performing the risk assessments,” she adds. Previously, companies often did not want to include chemicals with a Snur in their products, Ms Byrne says. “Education of companies about what conditions of a Snur can mean a business is helping in the understanding of review outcomes.”

Current issues

The EPA intended the process of notifying substances to the TSCA inventory to be completed in October 2018. However, Ms Bergeson says, chemical manufacturers and service providers are still waiting for the final active inventory. The process of notifying chemicals to the inventory created more work for service providers. “The process was much smoother than industry thought it would be,” she says. “The EPA did an excellent job of implementing the new law and providing a reliable and efficient process for complying with it.” Changes brought about by 2016 amendments to TSCA resulted in significant delays for the PMN approvals process. And, despite efforts to bring the caseload down to its normal size, the agency’s backlog of reviews hit an all-time high late in 2018. This was exacerbated by the partial shutdown of the federal government that lasted for a record 35 days at the turn of the year. During this, the EPA was largely closed and many parts of it, like other federal agencies, were left with a skeleton staff. The Office of Chemical Safety and Pollution Prevention (OCSPP), for instance, was reduced to 11 employees. Martha Marrapese, attorney at Wiley Rein, says that, because PMN filings could continue during the partial shutdown, whereas no work was done to review them during this period, “any progress the EPA has made on processing new chemical filings is being wiped out”. Meanwhile, Robert Helminiak, vice president of legal and governmental relations at the Society of Chemical Manufacturers and Affiliates (Socma), added in December that the backlog of new substance reviews is “inevitably going to get worse”. The association has long had concerns with the new chemicals programme under the reformed TSCA, he said, and the shutdown meant it would be “more problematic going into the new year”.

EPA plans

Regarding the TSCA new chemicals programme, EPA administrator Andrew Wheeler said in mid-January that the agency will publish and take comments on the next version of its decision-making framework, which will specify the policies it is using in its PMN reviews and the justification for its approaches. The existing new chemicals process has come under fire from consumer advocates and Senate Democrats, who claim the EPA

is approving new substances for commerce without a publicly available policy. Additionally, Mr Wheeler said, the EPA would ensure that all new PMNs and their attachments – including health and safety studies – are posted online in the ChemView portal within 45 days of being received, following confidential business information (CBI) review. This is scheduled to take effect from 31 March. The agency will also publish a notice of all PMNs, test marketing exemptions (TMEs) and notices of commencement (NOCs) received in the Federal Register each month. Each PMN reviewed and subject to a final determination will also be available in ChemView, along with underlying documents supporting that determination, Mr Wheeler added. At the time of writing, when any of the above would be effective was still anyone’s guess. The EPA’s active-inactive inventory notification process finished for chemical manufacturers and importers in February 2018 and (optionally) for processors in October 2018. “Approximately half of the chemicals on the TSCA inventory were notified as active in commerce as a result,” says Gradient’s Ari Lewis. “Going forward, manufacturers, importers and processors need to ensure that their chemicals are not only on the TSCA inventory, but also designated as active. If that’s not the case, a notice of activity form is required prior to commercial activity. The active inventory designation is now included with the inventory listing information in commonly used databases, so it is relatively straightforward for companies to determine the status of particular chemicals.”

Challenges continue

Chemical manufacturers and service providers will face continuing challenges as the new TSCA rules emerge. “The provision of efficient and effective consulting services, whether scientific or legal, is a key challenge in 2019,” says Ms Bergeson. “Delivering results is the key to success and service providers will be challenged to do so quickly and efficiently.” Recovery from the effects of the partial government shutdown could be a challenge that continues well into 2019 and beyond. Ms Marrapese said at the time that the slowdown was delaying new product launches, and that companies are looking outside of the new chemicals programme for conducting business. “An unintended consequence of all this is that some companies may have to continue to use older chemistry that is already on the TSCA inventory for a longer time instead of safer, new alternatives they have under development,” she said. “The partial shutdown affected industry by putting on hold PMNs and Snurs, and agencies such as EPA were operating with skeleton staffs,” FPM’s Jim Cooper says. “Companies who have made large investments for the research and development of new chemical substances are anxious to bring these products to the market and start recouping their investments.” There are questions, too, about whether the EPA will ‘count’ the shutdown days toward its 90-day PMN review period. Socma’s Robert Helminiak guesses that it will not, but admits this is “unprecedented territory”. Furthermore, it could impinge on the agency’s ability to address other, more tenuous targets, like the transparency commitments Wheeler recently made. Ms Bergeson says that institutional capacity will be devoted to playing catch-up on tasks required by law for some time to come. Accordingly, big-picture goals may be set aside.

Priorities for 2019

In 2019, the EPA is required to begin the chemical prioritisation process for 40 existing chemicals, of which 20 are expected to be designated high priority to proceed to full three-year risk evaluations. “The first ten should be completed before the end of the year, Gradient’s Jessica Kneeland says. “Companies with an interest in any of the first ten chemicals, or any chemicals on the 2014 TSCA Work Plan, are keenly watching to see which chemicals EPA takes on and how the new prioritisation process works in practice. In the absence of www.chemicalwatch.com/SPG

Revised TSCA

Technology

sufficient data, the LCSA calls for the agency to take a cautious approach to characterising risk,” she adds. “Industry will want to cooperate with the EPA to ensure that decisions are based on the best available data, and service providers can help manage that information and provide appropriate scientific context, particularly around NAMs. These new assessments may have implications for all aspects of the product life cycle, which will likely necessitate more engagement throughout the supply chain.” Helping customers understand what information the EPA requires for TSCA submissions to mitigate concerns during the review process will continue to be a challenge, Ms Byrne says. “Delays in the release of TSCA reset information and reviewing draft assessments for the first ten priority chemicals as well

as continued delays in TSCA notification review and increasing assignment of Snurs will be the challenges in 2019,” she says. Others will be preparing customers for the 2020 Chemical Data Reporting (CDR) and helping them review the new list of priority chemicals. Brian Sansoni of the American Cleaning Institute says the shutdown “created an incredible backlog in programmes important to the supply chain, especially the new chemicals review process.” EPA staffers will no doubt take a long time to catch up with information requests and deadlines related to the LCSA. “It may be a few months before we can really understand the entire impact of the shutdown on the EPA programmes and processes on which industry relies,” he says.

TE CH N O LO G Y

Technology: enabling optimisation

What do emerging technologies offer the industry when it comes to regulatory compliance? Charlotte Niemiec assesses their prospects “We are entering the fourth industrial revolution, or Industry 4.0,” declares a 2018 Deloitte report on digitalisation in the chemical industry. Technological advances are expected to be a significant driver in the years to come and companies slow to get behind innovation in this space will be at a competitive disadvantage. Key disruptive technologies, notably artificial intelligence, machine learning, robotics, cloud computing, drones, global positioning systems, Internet of Things devices, wireless sensor networks and blockchain security systems, will challenge the chemical industry, but also present enormous opportunities for growth. “Every chemical manufacturer should at least monitor digital trends, both within its industry, as well as across the value chain,” the report concludes. Over the next decade, energy demands, resource scarcity and the growing importance of chemical safety all mean that companies further down the supply chain will have to adapt and modernise their processes. Gauging by advances to date, industry might expect to see a marked speeding-up of innovation, fed by a gamut of interconnected devices and wireless monitoring, a tightening of security and a new era of opportunity for data analysts. Technology is no silver bullet, says Mike Laprocido, a strategic adviser to the chemicals sector at software company SAP. “Until recently,” he says, “chemical industry business executives have not viewed IT as strategic. Technology is not necessarily driving change in this industry – executives want to talk first about business outcomes and then find ways to reach their goals, some of which may include technology.”

Global Service Providers Guide 2019

Blockchain: a boon for security

‘Blockchain’ was a contender for the business buzzword of 2018. With advances in cloud computing, wireless networks and the proliferation of big data, security is a top concern and experts are investigating whether it can be tightened using blockchain. Don and Alex Tapscott, authors of Blockchain Revolution (2016), define it as “an incorruptible digital ledger of economic transactions that can be programmed to record not just financial transactions but virtually anything of value.” One of its advantages, according to the European Association of Chemical Distributors, is that “being collectively validated and shared, once information is transferred and appended to the ledger transactions it cannot be tampered or reverted, therefore reducing if not eliminating the risk of fraud”. The technology is currently valued at almost $150bn. The security blockchain offers makes it an attractive business option for supply chain management. In a June 2018 White Paper, the US Center for Supply Chain Studies looked at how it could help companies comply with the 2013 Drug Supply Chain Security Act (DCSCA), which requires manufacturers of pharmaceutical products sold in the US to serialise or uniquely identify them. After thorough testing of various scenarios, the team found that blockchain data proved highly resistant to corruption and concluded that “many of the industry’s current regulatory challenges may be successfully addressed as blockchain (and supporting) technology continues to evolve.” It holds promise also for confidential business information concerns by restricting access only to parties with a defined ‘need to know’. These possibilities extend into supply chains across multiple industries, especially when used in conjunction with other

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Technology

technologies. For example, in chemical storage and distribution, manufacturers could attach radio-frequency identification tags on storage tanks during transport and use IoT technology to send data back via blockchain, greatly enhancing the traceability and tracking – and therefore the safety and security – of their supply chains. Technology can also play a large role in global compliance, adds Chris Williamson, vice president of the Safe ERP practice at NexTec Group. “Rules and regulations around things like material safety data sheets and hazardous materials are changing with increased frequency. Today, chemical companies can work with software that provides real-time updates, keeping them informed on business rules and workflows in key areas such as logistical regulatory compliance rules and material safety handling.”

Big Data: help and hindrance

Analytics giant SAS defines ‘big data’ as a large volume of data, both structured and unstructured, that a business generates each day. What matters, says SAS, is not the amount of data, but what organisations do with it. Big data can be analysed for insights that lead to better decisions and strategic business moves. Analysing data helps to reduce time and cost in business or develop new products. It can aid in determining the cause of failure, calculate risk portfolios or detect fraudulent behaviour. Collectively, the chemicals industry holds an enormous amount of data. Authorities around the world have collected gigabytes of information on chemicals. A thorough understanding of this could reduce the need for animal testing, lower costs to industry and contribute towards a more sophisticated monitoring system. Data collection is taking a more central role, but it does not provide a full solution – information must be formatted, organised, optimised and analysed before it can be used effectively. In last year’s Tenth World Congress on Alternatives highlight report, titled Big data in the 3 Rs [reduction, refinement and replacement of animal tests]: outlook and recommendations, the authors, led by Procter & Gamble’s Catherine Mahony, say the way existing toxicological data is organised does not take advantage of the opportunities that big data and machine learning present. They argue that the data should be reorganised to focus on mode of action instead of endpoint, data sharing encouraged and universal naming systems adopted. Some inroads have been made – for example, big data acquisition and the creation of large databases have helped to improve and develop new quantitative structure-activity relationship (Qsar) tools – but more knowledge is required. The authors question whether toxicologists are prepared for big data analysis. “Future 21st century toxicologists should possess a mix of molecular and cellular technology and data scientist skills. This will require investment in toxicology training programmes so that our future toxicologist is able to extract the information from Big Data that allows them to answer the crucial scientific questions that will move the safety sciences forward.” Chris Milan, vice president of sales at NexTec, agrees. “I believe, as we are able to share more data with customers, suppliers and even competitors, this will allow companies to take advantage,” he says. “But the data needs to be concise and delivered in an easy format, it needs to be secure and protected, and companies will have to get more comfortable with that over the next five years. I still worry about ‘analysis paralysis’ – uncertainties over how to interpret the data and making bad business decisions. This will evolve and get better.” SAP’s Mike Laprocido believes that, in the short term, big data and analytics have the highest potential to deliver value to industry. “This is because the industry tends to play in a lot of markets and applications, especially in speciality chemicals where a company like Dow or BASF will have tens of thousands of product-marketapplication combinations. The industry has difficulty discerning the best use of their scarce resources under ever-changing market conditions. As a result, they allocate these resources sub-optimally and get sub-par returns on those investments. Data analysis can help with this.” Global Service Providers Guide 2019

Ethics and agriculture

Advanced technology is not without its ethical questions. Who owns the data collected? How do we level the playing field between smaller companies and larger – between those able to afford (and protect) new technology and those that cannot? Precision agriculture is one example of an area where technology is already being used extensively to increase yields and help secure food supply. Mihalis Kritikos, author of Precision agriculture in Europe: Legal, social and ethical considerations, a study by the European Parliamentary Research Service (EPRS), points out the many challenges of technology in relation to this field. The main challenge is to develop a framework for use that is fair to the farmer and protects his data. Many believe that farmers own their data, but in practice this is not always the case. Nor is it clear how they can effectively share the benefits created by the use of their data, and, says Mr Kritikos: “Strangely, ‘computed’ data is currently seen as being owned by the one who did the computing.” “What will happen when big multinational companies that develop seeds and/or agricultural machinery acquire data analytics companies for the development of behavioural patterns and business models for each aspect of farming?” Mr Kritikos asks. “The use of surveillance systems and monitoring procedures in precision agriculture also raises issues of the security of data processing operations, including vulnerability to cyber-attacks and hacking of the food system.” Precision agriculture can be seen as a case study for other industries. To get the most out of new and emerging technology, it seems we first need to find a safe and effective framework in which it can operate.

Physical technologies

Outside of software and information transfer, physical technologies are gaining ground. For example, robots that automate tasks that would take longer – or may be unsafe – for humans to achieve, such as those that clean the inside of petrochemical storage tanks, robotic ‘arms’ in laboratories or milk robots in the dairy industry. Mr Laprocido believes artificial intelligence and machine learning will have the biggest long-term impact in the years ahead. They have the potential to automate standardised processes, such as invoice matching and payables, and can dramatically compress the development time for new products. Currently, he says: “This is largely accomplished through trial and error, but this use case promises to provide recipes for new applications that have a high profitability of success in the first or second iteration, as well as the potential to compress the bench-to-pilot-to-production cycle”. NexTec’s Chris Milan adds that AI will enable managers to make smarter decisions across many different areas, including customer service, quality, process improvement, better production scheduling and preventive maintenance scheduling, which will reduce operating cost and, in turn, increase profits. Additive manufacturing, or 3D printing, is also gaining traction as costs decrease and more companies develop usable materials. The process has many advantages: it uses less material, it can be cheaper and items can be ‘printed’ quickly. Current applications see technicians printing new equipment in the lab or components manufacturers printing new parts in minutes. In the future, we may be able to print food, drugs or medical devices as required, in the field. And the increasing use of additive manufacturing could help support the UN sustainable development goals by producing goods locally, thus reducing emissions from air or ship transportation. Some industry influencers believe it has the potential to change the way many items are manufactured and render the traditional ‘factory’ concept redundant. There is still not enough material to make this a reality, even though the market for new materials is booming. In 2016 Processing Magazine noted: “While more than 3,000 materials are used in conventional component manufacturing, only about 30 are available for 3D printing. To put this into perspective, the market for chemical powder materials is predicted to be more than $630m/year by 2020.”

Chemical management

CH EM IC AL M ANAG E ME N T

Compliance still king but proactive action increasing

Chemical management is going beyond safety and looking at wider issues more holistically. Rosa Richards reports Chemicals companies are increasingly integrating chemicals management into wider environment, health and safety (EHS) systems, while retailers are developing safer chemical policies in partnership with their supply chains. Circular economy initiatives are encouraging product recycling and greener design to avoid hazardous substances in end-of-life products, but ‘legacy’ substances in products from previous regulatory regimes still require segregation to ensure the safety of recycled consumer products. Historically, chemical management has focused on safe handling and use of chemicals in the supply chain and at end users, and on maintaining workplace safety during manufacturing, says Pamela Spencer, senior director of regulatory and product stewardship at Angus Chemical. Today, she says, industry is more proactive, replacing toxic chemicals with safer alternatives where possible and integrating green chemistry principles into manufacturing and product development. “Chemicals management is a collective approach driven by end-user demand and consumer trends, together with the industry’s commitment to sustainability,” says Dr Spencer. “It requires transparent access to critical composition and handling information, as well as comprehensive understanding of the life cycle impact of a given product.” Chemical companies have a responsibility to integrate chemical safety communication such as safety data sheets (SDSs) into their enterprise resource planning (ERP) systems, as well as using bolt-on communication tools, says Paul Ashford, managing director of Anthesis-Caleb. However, it is more complicated further down the supply chain, for formulators or makers of articles. Most purchasing systems are running on a ‘bill of materials’ system for products bought, rather than a ‘bill of substances’ which would identify substances present, he says, so it can be a challenge to identify and track chemicals at each stage of the supply chain. On-site chemical management for EHS is straightforward, as regulations require companies to be aware of the chemicals present and their understanding is therefore improving. However, transmitting information through the supply chain can be very difficult, due to proprietary issues like secret formulations.

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Chemical companies are starting to use digital initiatives and chemical management programmes focused on portfolio control and safe use more holistically, notes Ingrid Sekki, marketing and sales manager at REACHLaw. These can also help identify and track substances of very high concern (SVHCs) in products. Digital platforms are helping to monitor and measure the impact of regulatory changes on chemical products and services, allowing manufacturers to redesign products and formulations.

NGO initiatives

The NGO Safer Chemicals, Healthy Families’ Mind the Store campaign scores retailers on their chemicals management strategies in order to drive positive change, says Mike Schade, its campaign director. An ‘annual report card’ ranks retailers based on a combination of 14 chemical management criteria, which, he says, provide a roadmap for how retailers and other end users can improve their approach to chemicals management. Companies, Mr Schade adds, are uniting around lists of chemicals of high concern, for example the stewardship list Walmart uses to eliminate reproductive toxins from personal care and household cleaning products. Other businesses are coalescing around classes of chemicals of high concern, like per- and polyfluoroalkyl substances (PFASs), phthalates and halogenated flame retardants. This method, he says, has helped drive such chemicals out of products, packaging, operations and manufacturing. From 2016 to 2018, the average grade on retailers’ report cards improved from D+ to C+ and last year saw a stronger drive to remove toxic chemicals from consumer products. However, there is some scepticism about the use of risk-based substance lists by retailers or product manufacturers to achieve this. Mr Ashford believes a restricted list can be a blunt instrument, potentially leading to substitution by chemicals which are not necessarily any safer. Anthesis is increasingly providing consultancy to downstream users in North America, due to restricted substance lists and calls for transparency. “We need better tracking of chemicals, especially in the final product,” Mr Ashford explains. “This could be through improved communication techniques, such as barcoding and blockchain, to track substances through the supply chain and manage confidentiality issues, such as protected formulas.” He

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Chemical management

predicts that communication will become more dynamic, with joint decision making for substances of concern. Recycling depends on material purity. For example, PET bottles are a relatively pure source material, but if the sources are mixed, it is hard to know what is present without analysis in order to recycle it safely. There is also major concern that recycling materials can reintroduce chemicals of concern into consumer products at levels adverse to human health. Research by the Healthy Building Network, published in 2015, showed that cheap recycled PVC added to flooring contained legacy substances including lead, cadmium and phthalates. Mr Schade says that retailers and brand owners should be aware of the financial, legal and reputational issues at stake if their recycled products are found to contain substances of concern. There is a need to set restrictions on hazardous substances in recycled materials, such as toxic flame retardants and phthalates. There is also a need to align the definitions of hazardous substances at the interface between waste and chemical regulations in the EU, Mr Ashford points out. “Authorities, policy makers and industry, “ says REACHLaw’s Ms Sekki, “need to be fully committed to circular economy thinking and develop appropriate tools and regulations to facilitate decision-making between recovery and disposal at the waste stage.” There may be a need for regulations around a product’s end of life under REACH, Mr Ashford says. SVHCs are being phased out but are still present in many recyclables, depending on the product life cycle. Insulation foams containing chlorofluorocarbons (CFCs), for example, will appear in waste streams far into the future. Decisions will have to be made about permitting a recycled product containing SVHCs to be marketed to maximise the circular economy versus destroying it in order to prevent exposure to humans and the environment. Mr Schade sees a real opportunity for manufacturers to ensure these risks are controlled to achieve a circular economy free of chemicals of high concern. REACHLaw, meanwhile, has noticed a change in commitments from large chemical companies and governments towards achieving sustainable development goals, arising from the change to practising responsible chemical management both internally and along supply chains in the EU and beyond. Mr Schade concurs that, for the last ten to 20 years in the US, industry has gone beyond just achieving regulatory compliance for chemicals management, developing robust safer chemicals policies. “Meeting laws simply won’t be enough – consumers are demanding the phase-out of hazardous chemicals, so if chemical risks are not managed, massive lawsuits, product recalls, and loss of reputation and market share can result,” he says.

Industry takes a lead

However, critics say the US government is rolling back consumer protection from exposure to chemicals. Some of the ways the revised TSCA has been implemented are not aligned with the original safeguards set out in the bipartisan reform signed into law by President Obama. For example, the US EPA originally considered a wide ban on the production and sale of paint strippers containing methylene chloride but after lengthy delay, it announced a ban which excludes commercial uses of such products. Meanwhile, retailers have acted in response to investigations by the Centers for Disease Control and Prevention, which linked deaths to the use of these paint strippers, lawsuits, and campaigns by NGOs. Lowe’s, Sherwin-Williams and Home Depot voluntarily banned them in mid-2018 and at least eight other companies have since followed suit. Mr Schade says the federal government is ‘asleep at the wheel’ when it comes to regulating chemicals and protecting consumers, communities, and workers from their hazards. Society is suspicious of chemicals used in products, says Mr Ashford, and the drive for transparency in the US reflects this. Global Service Providers Guide 2019

Dr Spencer says Angus Chemical has built a robust programme around chemical safety assessment and regulatory decisions, while reducing the time, resources and financial investment required to bring a new product to market by using new tools. Early toxicity screening of new chemicals using new approach methodologies has enabled the company to evaluate opportunities to use green chemistry principles, such as manufacturing process modifications to reduce or eliminate toxic solvents. Angus is also collaborating with various organisations, such as the Health and Environmental Sciences Institute (HESI), the Green Chemistry and Commerce Council (GC3), to drive broader adoption of new chemical management tools and technologies. In the next five years, Dr Spencer sees a continuing trend towards chemical reuse, recycling and upcycling – transforming them into higher value products. In addition, she predicts a shift towards designing for safety, not just controlling hazards.

Consumer pressure

Mr Ashford notes that REACH is forcing chemical manufacturers to better understand the uses of their substances. Societal pressure from NGOs asking retailers what is in their products is set to continue, with questions continuing through the supply chain. REACH is likely to place restrictions on the use of a substance for one purpose but not another, with more intervention from the regulatory perspective on the supply chain. Meanwhile, REACHLaw predicts that the complexity of chemical regulations will increase and solutions will be sought to improve the integration of chemical, product and waste legislation. This will oblige regulatory departments to stay up to date with regulation globally and throughout the lifecycle of chemical products and find sustainable responses for their business, says Mrs Sekki. Mr Ashford highlights the need for companies to better understand what they are buying, selling and processing. Tracking chemicals across boundaries and regions will be imperative for improved transparency and better communication. Mr Schade predicts that sensors and other new technologies could make it easier to identify chemicals of concern in products, packaging and supply chains and adjust their purchasing behaviour or campaigning accordingly. He also says that American consumers will become even more vocal about the need for strong chemical management policies and transparency, due to growing federal inaction. Individual states will continue to fill the gap and leverage their power to ban harmful chemicals and promote greener solutions. In the next five years, Mrs Sekki predicts “more and more companies will place a strong focus on implementing responsible chemical management programmes in their organisations, working towards sustainable production free of chemicals of concern or ensuring their safe use”.

Living the REACH story

This is an abridged version of an article first published in March in which Mamta Patel spoke to Echa executive director Bjorn Hansen, tracing his involvement with Europe’s groundbreaking chemicals policy and hearing his thoughts about today’s challenges. Europe’s ambitious industrial chemicals law reached the end of its first phase in 2018 after a decade of relatively smooth operation, far from the predictions of its unworkability when REACH was first mooted. But entering its 11th year of implementation, the law has also yet to convince many of its supporters who had hoped by now to see some clear evidence of its impacts in reducing the risks of chemicals. The bones of the EU chemical policy were laid out in the European Commission’s 2001 White Paper, A Strategy for a Future Chemicals Policy, itself the culmination of five years rumination over the failures and successes of previous regulatory systems. While acknowledging the need to encourage European industry’s competitiveness, the White Paper overturned the status quo with the ‘precautionary principle’ and the concept of ‘no data, no market’ which, for the first time, put the burden of providing data on chemicals’ safety and carrying out adequate risk assessments on industry. Such was the chemical industry’s dread of this cumbersome law, with its comprehensive substance registration requirements, that concerted lobbying at the highest level ensued on both sides of the Atlantic with governments intervening in an unprecedented fashion even before the first draft was published.

Right place, right time

Someone who has lived this history from REACH’s conception as one of the chief authors, to assuming leadership of Echa last year, is Bjorn Hansen. Dr Hansen left the Marie Kruses School in Farum, Denmark, in 1981 with a strong interest in mathematics and physics that took him to the State University of New York to obtain first degrees in pure and applied mathematics, and economics. He returned to Europe to obtain a PhD in probability theory at Eindhoven University of Technology in 1988 and continued as a postdoctorate in this field in Germany until, in 1991 he got a job as a Global Service Providers Guide 2019

statistician at the European Commission’s Joint Research Centre (JRC) in Ispra, Italy. How did a Dane with a mathematical bent come to develop a lifelong career in chemicals policy? “I was all set to become a professor in my field when, through a series of events, this offer came my way to work in Ispra. I believed it was a ‘once in a lifetime opportunity’ and also that I was young enough to go back to my original field if I needed to.” Within a short time of starting work at the JRC, the centre was told to develop a database (Iuclid) for the capture of chemicals safety data under the 1993 EU Regulation on the evaluation of existing chemicals. “I just happened to be in the unit at the time and they didn’t have too many alternatives so they asked me,” Dr Hansen recalls. He was therefore in place when a “grand opportunity” came along to lead the work, in which the JRC was asked by the Commission to establish a European Chemicals Bureau and continue to work on predictive chemicals toxicity modelling in the form of quantitative structure-activity relationships (Qsars). “From day one at JRC I was trying to convert what I was doing into something that could be used in legislation to protect citizens. It was an absolutely fascinating area: it was all so necessary.” The need to apply logic and science to policy needs presented a compelling challenge and a lesson that he feels is important to bring home to the 500-strong team of experts he now leads at Echa. Within a few years of adoption, it became clear that the existing substances Regulation was making far too slow progress. In 1998 a Commission report found that only 110 chemicals had been identified as ‘priority substances’, with comprehensive risk assessments completed for 38 and, of these, regulators had been able to conclude risk management for only 16. Still, Dr Hansen contends, it was the most productive risk assessment programme the EU had at the time. Efficiency of decision making was improving and experience accumulated to add to the community acquis, but everyone knew things had to move faster.

The timeline for getting the chemicals safety data we need under REACH is influencing the speed at which we can move forward to a circular economy in Europe Developing the REACH proposals

In 2003, Dr Hansen left the chemicals bureau to join the Commission’s environment directorate, DG Environment, in Brussels. “I could look back at ten years of the existing substances Regulation, knowing what was wrong with the system, and then I was part of a very small group being given the chance to fix it. It was another once in a lifetime opportunity’.” He recalls well the “extremely strong” political controversies that the Commission’s White Paper was met with. What saved it, he believes, was the decision to open a parallel track of technical thinking: “Basically the idea was to show that what we had proposed could work. Then an amazing thing happened. We had 15 Reach Implementation Project (RIP) working groups with up to 50 people in each, many from industry working with policy makers. I would say almost everything got sorted out … even industry people came round to the view that it could be done.”

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The achievement of the RIPs proved again to Dr Hansen that a strong technical-policy interface is essential for sound decision making. But it gives him concern for the situation today. In the last decade, the steady centralisation of chemicals policy and legislation in the EU has meant that many ministries have reduced their staff and ‘outsourced’ the science with fewer people overall. He cites the example of constantly missed targets in the approval of substances under the 2012 EU biocidal products Regulation as a sign of reduced capacity at member state level. The same factor has led to Echa providing significant support to member states to help them comply with their statutory roles under the REACH Regulation, such as preparing dossiers for evaluation and restriction, submitting these, guiding the scientific committees in coming to conclusions on the dossiers and then submitting their decisions to the Commission. “Yes, we do REACH every day, and you can see it makes sense for us to apply our expertise. But there is a fundamental question – should Echa be doing this? REACH, and the other laws we are here to regulate, need to be seen as robust mechanisms and the agency as a trustworthy machine. This is something for policy makers and member states to consider.” Dr Hansen left the Commission in 2007 to work on creating the agency foreseen by REACH to manage its implementation. After a year in Helsinki, he returned to the Commission where he eventually headed the chemicals unit of DG Environment. But ten years later, when the Echa executive director position came up again, he could not resist the urge to guide the agency through its next phase. Even with the EU’s powerful REACH engine and the unprecedented amount of data it has collected, the significant holes within this means there are still questions about the risks posed by many chemicals placed on the EU market in substantial quantities. Substances entering the EU market via imported articles is another problem. However, many companies which have engaged in REACH compliance say the information it demands is raising awareness within their own firms and across global supply chains. Ten months into leading Echa, Dr Hansen faced angry challenges at the European Parliament plenary last October, with MEPs pointing out that a recent German study had shown many REACH registration dossiers lacked adequate data to enable an evaluation of whether those substances pose a risk. They demanded that Echa live up to its duty as a regulator and hold companies to account, upholding the ‘no data, no market’ principle of the law. Dr Hansen does not deny the problem and has made addressing non-compliance a top priority for Echa. “We are moving in the right direction but we are behind schedule,” he says. One conclusion he has reached, a year into his post, is that “the agency’s role must first and foremost be to protect human health and the environment. By doing this right, Echa contributes to a well-functioning internal market, competitiveness and innovation. Echa, he says, can continue and accelerate implementation of REACH, the Regulation on classification, labelling and packaging (CLP) and other laws. “Through that, we are basically preparing the ground for an improved chemicals policy in Europe.” Moreover, EU leaders have set their sights on competing in an increasingly turbulent and competitive global economy by creating a solid knowledge base and leading on circular economy thinking, which they believe will empower companies to innovate to compete effectively in future. Knowledge about chemical risks is fundamental to this. Dr Hansen illustrates this with three examples: OO To achieve the EU’s ambition to create a circular economy that enables the sustainable use of resources, it will be essential that industries make the right choice of materials. That can only happen when they know enough about the chemicals that make them up. All attempts to create waste management and recycling infrastructures will founder unless they are fed with the right materials. “So, the timeline for getting the chemicals

safety data we need under REACH is influencing the speed at which we can move forward to a circular economy in Europe.” OO The perfect world that REACH strives for is to create a comprehensive, consistently accurate database of information about chemicals that will allow manufacturers to make the right choice of materials, through confident use of tools based on predictive toxicology in order to assess in advance their potential impacts in different applications. However, with the imperfect knowledge we have today, one consequence for innovation is that new chemicals can often become a victim of their own success. This is because, under REACH, full data packages are only mandated when chemicals are placed on the EU market in quantities above 1,000 tonnes per year. But by the time a chemical is enjoying this level of market success, the manufacturer of that substance has invested heavily in production, marketing and sales and has usually yet to recoup the anticipated value of that investment. This is a costly time to find out there is a problem that requires that chemical to be restricted or even subject to authorisation. It is therefore in industry’s interest to prioritise the need to provide adequate data for the substances already registered and those that are yet to come. “The quicker we can get comprehensive knowledge about the chemicals registered, the more innovative we can be. Companies have a choice to make – to invest in that knowledge now in order to gain a competitive edge in five to ten years’ time”. OO The knowledge base and experience built in the EU in the last decade can become a powerful catalyst for other countries to increase their understanding and ability to manage chemicals in their own markets. Through the three core instruments that Echa manages – REACH, the CLP Regulation and prior informed consent Regulation – “we actually can have any model of chemicals policy that you could ever invent,” Dr Hansen says. It should therefore be possible to map the chemicals control laws of other countries against at least some of the provisions of these three chemicals laws. If that is true, he says, it provides the key to the EU sharing its knowledge and experience with other regulators to enable them to devise their own laws – “The whole world does not need REACH.” As well as the right legislation for each country, the second prerequisite to manage chemicals effectively is the competence of its industry. Here, the EU can also facilitate by cooperating with its own industry partners to help build capacity in other countries. The tools and ideas to share the knowledge have already been developed by several actors, such as the OECD. He says: “The EU has a lot to offer the world and the cost is not immense.” What stands in the way of this promise is the need to build trust by openness over intentions, including that creating convergence of data formats and chemical management tools like Iuclid will benefit European companies wanting to compete abroad, but also vice versa. There is an imperative for governments to collaborate more effectively, Dr Hansen says. The sustainable development goals for 2030, adopted by 193 governments in 2015, set a new collective policy framework to address the most pressing issues adversely affecting the development of populations globally. Inherently, they require governments to fulfil their longstanding pledges to minimise the risks of chemicals, but this needs to be made more explicit within the context of the goals. Dr Hansen says: “It must be recognised that chemicals safety is pertinent to many, not just one, of the goals: You cannot achieve equality, you cannot remove poverty, without minimum global chemical standards. This recognition is vital for efficient allocation and targeting of resources.”

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Living the REACH story

Profile: Acta

SERVICE AREA BREAKDOWN

Information 10%

CONTACTS

IT & software 5%

Website

www.actagroup.com

E-mail

lbergeson@actagroup.com

Head Office

2200 Pennsylvania Avenue NW, Suite 100W, Washington, DC 20037, USA

Tel

+1 202 266 5020 EU office +32 2 588 48 85 UK office +44 (0) 330 223 0610 China office +86 108 453 4538

Contact

lbergeson@actagroup.com

Directors

Lynn L Bergeson and Lisa M Campbell

Ownership

Private company, affiliated with: Bergeson & Campbell, PC B&C® Consortia Management, LLC

Locations

US, UK, EU, and China

Founded

2000

Legal 10%

Consultancy/advisory 40%

Representation & management 30%

GLOBAL OFFICES UK: 26 Cross Street, Manchester, M2 7AQ, UK EU: Place du Luxembourg 2, 1050 Brussels, Belgium China: 1009 Tongguang Tower, No 12 Nongzhanguan Nanli, Beijing, China 100125, The Acta Group has affiliates in Shanghai, Nanjing, and Xi’an, China; and Seoul, South Korea. SERVICES PROVIDED General consulting services

OVERVIEW The Acta Group (Acta) is a leading international specialist in chemical product approval, compliance support, business strategy, and regulatory defence, providing a full-range of support for the process of developing, commercialising, and sustaining industrial and specialty chemicals, biocides, cosmetics, metals, food contact chemicals, products of biotechnology, nanotechnology and medical devices. Acta professionals are scientists and business and regulatory consultants. This combination and our wealth of experience in and out of laboratories, global chemical companies and government agencies makes Acta an exceptional resource for companies in the chemical space. Acta maintains offices in the US, UK, Europe, and China, and offers expertise with regulatory programmes and chemical product approvals in North America, the European Union (EU), South and Central America, Asia, the Middle East, and the Pacific Rim. VITAL STATISTICS

Training 5%

2017/18

Turnover, group

Turnover, chemical service provision

No. of offices

No. of countries represented

>25

Staff, group

35+

Staff, chemical service provision

35+

We represent and counsel individuals, business entities, trade associations, and industry associations. Our fundamental goals are to solve our clients’ existing problems and to minimise future difficulties. We take a multi-disciplinary approach in assisting our clients. Attention must be paid to the interplay of all branches of government and interest groups. Our capabilities, borne of site and issue-specific experience, combined with our national and international view on policy and regulatory developments, position us to handle all these tasks with judgment, creativity, and efficiency. Global product registration and agent services (only representative services) Regulatory chemical product notification, registration, and technical defence under the framework of global chemical programmes, including REACH, biocidal products Regulation (BPR), globally harmonised system of classification and labelling of chemicals (GHS), Toxic Substances Control Act (TSCA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Korean REACH (K-REACH), the Canadian Environmental Protection Act (Cepa), China Order No 7, and California Safer Consumer Products Regulations. Acta concentrates on obtaining, maintaining, and supporting product approvals and efficiently overcoming commercial or regulatory impediments to the successful and profitable marketing of approved products. Jurisdictions we are active in are: North and South America, UK, EU, Switzerland, Turkey, Middle East, Australia and New Zealand, Malaysia, China, Japan, South Korea, Taiwan, Philippines, Singapore, and Indonesia. Data compensation support services and trade infringement/ competition issues Acta is engaged in numerous data compensation and competitionrelated issues at the global level. Activities range from supporting, evaluating, preparing, and managing data cost on behalf of the data owner as well as for those entities seeking data access. As a result of recent activities in association with the REACH legislation, many clients continue to evaluate and pursue competition-related issues. We are actively engaged in data compensation and competition-related disputes. Technical document preparation activities – hazard, exposure and risk assessment Undertaking the appropriate document preparation and coordination to support registration and post-registration activities (ie chemical

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substance dossier preparation, exposure assessments, hazard assessments, specific effect analysis and assessments, petitions, response to comment documents, inquiries, and safety data sheet (SDS) preparation).

STAFF SELECTION Lynn L Bergeson – President

Acta offers comprehensive global services, including substance classification, SDS preparation/review, label formulation/review, and guidance on strategic approaches to GHS adaptations. Tailored training programmes are also available.

Ms Bergeson has for over two decades assisted individual companies and a wide range of trade groups and ad hoc consortia on chemicalspecific legislative and regulatory matters. Ms Bergeson’s practice areas include TSCA, FIFRA, REACH, and related international chemical notification, registration, and strategic product defence and product approval litigation matters.

ACCREDITATIONS

Jane S Vergnes, PhD, DABT –Vice President, Scientific Affairs, Director of Toxicology

GHS, classification, labelling and packaging (CLP) services

Occupational Health and Safety Assessment Series 18001; International Organisation for Standardisation (ISO) 9001; ISO 14000 PARTNERS B&C® Consortia Management, LLC Bergeson & Campbell, PC CLIENTS Acta EU’s clients are involved in many businesses, including basic, specialty, agricultural, and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; medical devices and diagnostic products; fibres; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution and consumer product sectors. CASE STUDY 1: Successful European Chemicals Agency (Echa) appeal Provided strategic technical support to our European legal counsel, Field Fisher Waterhouse, in the first successful appeal under the REACH legislation. It is important to note that at the time of the appeal, the technical completeness check (TCC) tool was not available. Echa rejected the dossier based on the premise of incompleteness. A successful appeal was performed without the need to petition Echa further. The substance was granted registration, a registration number assigned and appeal fees returned. CASE STUDY 2: Data compensation issue Prepared strategic counselling and documentation to support and submit data compensation dispute/appeal under the REACH legislation. Reviewed and issued response to Echa’s position on the data-sharing dispute. Initiated documentation to support a petition for competition law infringement in association with conduct under the framework of REACH. Our work in this area builds upon our significant and extensive data compensation work in the US under FIFRA. In other roles, we perform analysis of data valuation in association with the data rights to be granted.

An esteemed toxicologist with an impressive track record of success directing global product stewardship for Fortune 500-listed chemical companies, Dr Vergnes has particular expertise in toxicological testing within the regulatory framework of REACH and TSCA, including study design, laboratory practices, and data requirements for new chemical introductions. Karin F Baron, MSPH – Senior Regulatory Consultant Ms Baron has more than 15 years of experience leading hazard communication, industrial hygiene, and EHS programmes for multinational chemical companies. Her primary areas of practice include hazard and risk assessment and communication, industrial hygiene and EHS programmes, US FDA regulations pertaining to food contact materials, GHS and SDS, and the transport of dangerous goods. She is a certified by the Dangerous Goods Advisory Council. J Brian Xu, MD, PhD, DABT – Toxicologist Dr Xu is a board-certified toxicologist, an MD in pathology, holds a PhD in pharmacology and toxicology, and has over 15 years of industry experience as a senior toxicologist and scientist. Dr Xu designs safety testing, risk assessment, product safety, and regulatory compliance programmes and works with clients to place, manage, and monitor toxicological and clinical tests ensuring Good Laboratory Practices (GLP) at laboratories in the US, EU, and China. Emma Louise Jackson, CBIOL, MSB – Regulatory Specialist Ms Jackson has more than a decade of experience in testing and regulatory compliance in the EU, the Americas, and Asia. She offers particular expertise in worldwide chemical notifications, data analysis, preparing test plans, and managing to completion large and complex compliance projects quickly, cost-effectively, and harmoniously across multiple jurisdictions. Zameer Qureshi – Legal Consultant to Acta EU Mr Qureshi is a chemical regulatory and international business lawyer based in the UK. Mr. Qureshi has an in-depth understanding of UK and European Union (EU) laws related to Acta EU’s practice areas, and he deploys this knowledge to assist Acta clients in achieving and maintaining compliance across multiple global regulatory frameworks. A native English/Urdu bilingual, Mr. Qureshi is also conversant in Hindi and can read Arabic.

CASE STUDY 3: Import tolerance

Michael S. Wenk, M.S. – Senior Regulatory Associate

Provided strategic regulatory counselling on the development of import tolerances/exemption from tolerances for raw and/or processed agricultural goods exported from Europe into the US that have been treated with pesticides that are not registered in the US under FIFRA, and can be expected to have residues. Worked extensively with the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA) staff to bring cases to successful resolution. In addition, worked extensively with enforcement personnel in cases where commodities have been inadvertently imported bearing residues of unregistered pesticides and resolved matters successfully.

Mr Wenk is an internationally-recognized expert in chemical registration and regulation in Central and South America, and the Middle East. Mr. Wenk offers clients particular expertise in categories including food contact substances, biocides and pesticides, fertilizers, oil and mining chemicals, and pulp and paper products, and in regulatory due diligence for chemical companies involved in mergers and acquisitions. James E. Greenhalgh, MCHEM – Regulatory Assistant Mr. Greenhalgh assist clients with registration and sustained compliance of industrial, plant protection, biocidal, and other chemical products in the EU and UK. Mr. Greenhalgh provides support to Acta’s regulatory specialists in the areas of analytical chemistry and good laboratory practice.

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Profile: Acta

Profile: APC

SERVICE AREA BREAKDOWN

CONTACTS

Consultancy/advisory 100%

Website

www.apc.eu.com; https://biocides.apc.eu.com

E-mail

enquiries@apc.eu.com; biocides@apc.eu.com

Head office

Unit 3, Cromwell Business Park, York Road, Wetherby, LS22 7SU, UK

Tel

+44 (0)1937 587962

Contact

Lesley Young, Manda Vince

Offices in the EU, Brazil and Australia. Agents in Japan, plus an additional consultant network covering Europe, South America, Africa, Asia, Australasia.

Directors

Business Unit Director: Manda Vince

SERVICES PROVIDED

Ownership

Private

Locations

UK (Wetherby and Ringwood), France (Mollégès and Lyon), Poland, Czech Republic, Hungary, Austria, Australia and Brazil

Founded

2001

GLOBAL OFFICES

Regulatory dossier services Plant protection (chemical and biological) active substances and products Extensive experience in data gap analysis, drafting of data waivers, data extrapolation, risk assessments, dossier preparation, placement and monitoring of studies, including efficacy development programmes. Many of these projects required an innovative and bespoke approach and our highly experienced team can support you in this way. APC is also experienced in obtaining international registrations outside the EU including Africa, Asia and CIS countries.

OVERVIEW Since its inception in 2001, APC has steadily grown to have offices across Europe, Australia and Brazil, together with a global network of consultants covering more than 40 countries. Due to its recent acquisition by Staphyt and closer working with Staphyt’s existing regulatory team, APC now provides clients with access to over 60 regulatory and scientific experts (chemists, agronomists, toxicologists and environmental experts), who can address a broad range of regulatory challenges. Our global network of external experts provides additional expertise and local language skills, resulting in strong relationships with various regulatory bodies around the world, and enabling APC to design bespoke regulatory solutions for our clients’ needs. APC can provide sound regulatory and technical support for biocides (Regulation 528/2012), plant protection products (Regulation 1107/2009) and general chemicals (REACH – Regulation 1907/2006). Dedicated APC project managers are assigned to each client from the beginning. They become the focal point for communications, providing the client with valuable strategic advice and timely support throughout each project, to submission and during evaluation, to approval. VITAL STATISTICS No of offices No of countries represented Staff, group Staff, chemical service provision

Global Service Providers Guide 2019

Biocides APC Biocides was launched early in 2018 to further raise the profile of services that we were routinely providing to our existing clients for biocides. APC’s team of experts have experience in the submission and support of active substance and biocidal product dossiers for various PT groups, including the conduct of higher tier environmental and nondietary human risk assessments. In addition, our network of consultants can complete, submit and follow-up applications for our clients’ products during the transitional period, before the approval of the active substance. REACH and GHS APC provides a range of services from third party/only representation to dossier preparation and risk assessment for CSR’s. Our experts have experience of various exposure modelling tools required for CSR’s, including ART, Stoffenmanager, EUSES, ConsExpo, BEAT etc. APC can prepare CLP/GHS proposals for MSDS’s and dossiers. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2001

Company registered in England

2018

2005

French office opened

2008

UK Wetherby office opened

>40

2009

Polish office opened

>400

2010

UK Ringwood office opened

>60

2012

APC Brazil and APC Australia opened

2015

Lyon (France) and Prague (Czech Republic) offices opened

2016

APC celebrates 15 years. Lyon office expands. Hungary office opens

2017

Expansion of Czech Republic office

2018

Launch of APC Biocides. APC joins Staphyt Group.

CASE STUDY 1: European plant protection product support at product renewal APC prepared a dRR for the renewal of the authorisation of a product in different Member States across the EU. This product was used on a wide range of crops, which involved a complex environmental risk assessment. As a first step, APC’s environmental and efficacy experts reviewed the application dates and timings (BBCH stages) across the different crops to identify the critical risks. The efficacy and residue trials programme was then tailored to support the revised rates and timings, in order to support the maximum number of crops at the renewal of the authorisations. In the environmental fate and ecotoxicity section, problems were identified in surface water and groundwater, including the relevance of metabolites in groundwater. Strategies used for solving the problems included the performance of new environmental fate studies, correcting the application parameters according to the application type for specific crops, and higher tier modelling. These solutions were successful and the product was approved by the zonal Rapporteur Member State. CASE STUDY 2: Technical equivalence and data matching One of the active substance data matching programmes for protected study dossiers that APC managed was for an insecticide with many complex metabolites and some very challenging environmental issues. In this project we were able to save our client >€1m of studies by drafting skilful waiver arguments and having detailed negotiations with the EU RMS. APC led the successful negotiations for access to protected vertebrate studies with the primary data holder. Our client was therefore able to maintain all their existing national registrations at a cost well below what was initially expected. CASE STUDY 3: Out of season trials Using our large network of consultants, APC was able to organise out of season trials in South Africa, Australia and New Zealand in order to speed up the acquisition of data needed to confirm the performance of a new formulation. Our field efficacy experts were then able to justify the inclusion of this data as supporting evidence showing comparability with EU conditions where appropriate. This initiative resulted in a registration being obtained one year earlier than first anticipated. CASE STUDY 4: REACH registration non-phase-in substance APC assisted a PPP manufacturer with their REACH preparations by undertaking a full analysis of their marketed products and undertaking REACH registration procedures for the relevant substances. Within this, APC identified the requirement to register non-phase-in substances with Echa, and took the relevant action to achieve this, filing enquiry dossiers with Echa, and then using the results of this, and our in-house expertise, to undertake a data gap analysis. We then oversaw the completion of any data gaps by reviewing data access agreements with previous registrants, or by constructing expert data waiving arguments for submission to Echa. This led to a full REACH registration for the substances in question.

STAFF SELECTION Manda Vince – Business Unit Director Manda joined APC in June 2018, to drive APC’s strategy in conjunction with Staphyt. Manda has an extensive range of experience. She spent 5 years at a similar European consultancy where she led a team of consultants delivering work for major plant protection clients and managing client relationships. Her previous experience in plant protection came from several years at the UK Chemical Regulations Directorate (formerly Pesticides Safety Directorate), where she led the evaluation of several dossiers for new active substances from the regulator’s perspective. With over 26 years’ experience in Central UK Government and its Agencies, Manda has also held several senior leadership positions in strategic and delivery roles, including negotiating major contracts, managing relationships with customers and in business change and improvement. Andrew Murray – Director of Development and International Business Andrew’s career started in 1978 with Shell Research where he was involved in both field R&D and ecotoxicology roles. In 1985 he joined Rohm and Haas where he was the UK and Ireland R&D Manager. In 1996 Andrew moved to Inveresk Research International Limited where he helped co-ordinate a field trials department as part of the CRO’s services. Andrew joined Hockley International Limited in 2001 where he was the registration and technical manager registering agricultural, public health and veterinary products with distributors and consultants worldwide together with the provision of appropriate technical support to allow the market development of the products. In 2011 he joined APC as a project manager with responsibilities including management and development of APC’s international business, together with field study development and biocidal projects support. Andrew is APC’s Director of Development and international business, responsible for management of APC offices in Australia, Brazil, Poland, Czech Republic and Hungary, together with the running of the network of local country consultants. Lesley Young – Head of Regulatory Affairs Lesley has over 14 years of regulatory experience with plant protection products gained from working at the UK Competent Authority (CRD formerly PSD) and at APC. She has a comprehensive working knowledge of EU regulatory requirements including relevant guidelines and EC Regulations as they pertain to existing and new active substances and plant protection products. Lesley has extensive experience in leading and co-ordinating multi-disciplinary teams in both evaluating applications for plant protection products whilst at CRD, and in managing submissions across the EU on behalf of clients. Projects include data gap analyses and preliminary risk assessments, active substance and product renewals, zonal applications and mutual recognition, and the provision of regulatory strategic support. Lesley has made regulatory presentations, led training events and represented clients at pre-submission meetings. François Walker – Manager, APC France François is a Senior Regulatory Manager and Manager of the APC France office. François has experience in agrochemicals (including biopesticides) and biocides, gained from both industry and consultancy. François has experience in all areas of managing and making regulatory submissions. He is also one of APC’s residue experts. Working across many EU member states, François is experienced in the provision of regulatory advice and has developed cost effective regulatory strategies for a range of clients. He has placed and monitored a wide range of regulatory studies especially in the areas of residues, toxicology and ecotoxicology. François has been involved in the preparation and management of national/zonal product dossiers, and also active substance dossiers in compliance with current directives.

www.chemicalwatch.com/SPG

Profile: APC

Profile: Apeiron-Team NV

70 Scientific services A selection of our services: OO REACH registration dossiers from A to Z: Generation and maintenance of registration dossiers including substance identification, hazard assessment, study monitoring, exposure and risk assessment, PBT assessments, dossier updates and follow-up; OO REACH authorisation dossiers: strategy development, chemical safety assessment, analysis of alternatives, socio-economic analysis, supply chain communication; OO other REACH related topics: support during evaluation, support during BoA, RMOA generation, eSDS compliance training, company specific eSDS support, DU-CSR generation, mixture classification, Annex XV dossier generation, representation of clients in consortia OO BPR related services: authorization strategy development, biocidal product dossier generation from A to Z incl. biocidal product family concept integration, data gap analysis, study monitoring, PAR generation, follow-up with authorities, technical equivalence dossier preparation, Art. 95 listing,…

CONTACTS Web site

www.apeiron-team.eu

E-mail

info@apeiron-team.eu

Head office

Berten Pilstraat 4, 2640 Mortsel, Belgium

Tel

+32 3 808 20 67

Contact

Elke Van Asbroeck

Directors

Elke Van Asbroeck and Hiram Moerman

Ownership

Private company

Locations

Mortsel (Antwerp), Belgium

Founded

2009

OVERVIEW Our mission is to support industry with cost efficient implementation of complex chemical related regulations. We provide a high level of expertise in chemicals management in the entire supply chain for the relevant regulations as well as for internal responsible care objectives. We are a highly motivated team of doctors in toxicology and chemistry and engineers with industrial experience. As a company of over ten people and a limited number of sub-contractors with niche knowledge, we provide specific expertise, while being able to act flexibly and maintain our client focus. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

> 10

Staff, chemical service provision

> 10

SERVICE AREA BREAKDOWN

Training 10%

Other 5%

Information 10% Representation & management 10%

Strategic support and Industrial services Apeiron-Team provides tailor-made advice for a cost-efficient implementation of regulations, taking into account the global business strategy and required flexibility of the client. We provide assistance in the development of chemicals management systems and product stewardship programmes. Examples of our services: OO several audit programmes; OO set up of monitoring programmes (occupational hygiene); OO engineering support for the implementation and documentation of strictly controlled conditions for intermediates; OO advice on import/export strategy to ensure business continuity; OO position papers and communication with authorities; OO scientific advocacy in the pre-authorisation process; OO development of Risk Management Options Analysis for individual companies or associations OO strategy for comments during evaluation and/or during preauthorisation process; OO strategy deployment for authorisation dossiers; and OO integrating chemical legislation in circular economy business models. Training Apeiron organises workshops on various aspects of the REACH and biocides implementation process. Examples: in-house workshop on REACH (pre)-authorisation, course on eSDS compliance, understanding REACH and its business impacts, Iuclid for REACH and for biocides, PNECs and DNELs, SVHC in articles, etc. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2009

Apeiron-Team NV was founded

2010

Successful REACH registration of >100 substances.

2011

Expansion of services and experience in REACH-like legislations, global SDS requirements, eSDS related products eg DU-CSRs.

2012

Expansion of our services with the “E” of evaluation and “A” of authorisation within REACH. Scientific advocacy for several projects (related to restrictions, SVHC status, authorisation and evaluation). China REACH notifications (in collaboration with Chinese experts).

2013

Generation of three authorisation dossiers. Organisation of workshops on the (pre-) authorisation process. Addition of biocides- and cosmetics-related services to our portfolio.

2014

Submission of two authorisation dossiers for trichloroethylene. Preparation of REACH Registration dossiers. In function of substance evaluation, commenting on the basis of scientific and regulatory arguments. Defence of substance under scrutiny for PBT.

Consultancy/advisory 65%

SERVICES PROVIDED Regulatory services We assist in the interpretation of legal texts: REACH, REACH-like legislations, CLP, biocidal product Regulation (BPR), cosmetics Regulation, EU and national nano legislations, food contact, RoHS, waste legislation, circular economy. Global Service Providers Guide 2019

2015

The two TCE authorisation dossiers received a 12-year review period. Preparation of several chromate authorisation dossiers. Submission of a Union authorisation under the BPR.

CASE STUDY 2: Overcoming regulatory hurdles in circular economy

2016

Submission of 2 EDC and 2 chromate authorisation dossiers. Generation of Union authorisations under BPR. Implementation of circular economy business models.

2017

Successful conclusion of a BoA case on additional Persistence testing; Submission of an authorisation dossier on behalf of an NGO; Development of a RMOA methodology

2018

Successful submission of > 150 registration dossiers due by the May deadline. Generation of 3 authorisation dossiers.

Several companies have approached us on the regulatory hurdles to implement circular economy-based business models. While safeguarding the principles of safe chemicals management, strategies are developed with the clients to comply with the chemical regulations in a cost-effective manner. The business models in circular economy are often not considered in the legislation. Apeiron-Team supports its customers in discussions with authorities to find solutions. Apeiron-Team has advised successfully on cases in the recycling of industrial goods and consumer goods.

ACCREDITATIONS OO OO OO

European registered toxicologists (ERT) Environmental advisor (Milieu Coordinator) Strategic advisor SME

PARTNERS Burgess Regulatory Services Ltd, eftec, Jongerius Consult CLIENTS Our references are situated in several industries and cover the entire supply chain from manufacturing to recycling: OO petrochemical industry, fine chemicals, toll manufacturing, food industry, polymer industry, refinery, tyre industry, pharma industry, textile industry retail. TESTIMONIALS “Apeiron-Team are professional and experienced, driven and engaged. With their expertise they translate the tangle of the REACH legislation into practical, concrete guidelines and actions” – BP Chembel “Apeiron-Team is a no-nonsense company delivering their services on time, in full and in budget” – Monument Chemical “For us, Apeiron-team distinguish themselves from other excellent consultants because they are able to think further in the benefit of the company together with us. We consider them as one of us” – Christeyns “During the long process of authorisation (approx. two yrs) Apeiron confirmed numerous times that our choice for them as partner was right: The work delivered exceeded our expectations. Not only have I never experienced such a pro-active consultancy so far in my business life, but they deliver excellent and high-quality work. They are approachable at any time and pick things up even before we realised it is needed. In addition, Apeiron has an almost unrivalled network of contacts to almost every import person in this line of business.” – Vlisco. CASE STUDY 1: REACH authorisation application: from strategic support to dossier generation The REACH authorisation process is complex and business critical. Vlisco (textile industry) requested our support for the authorisation of trichloroethylene, a non-threshold substance. In a first step, the dossier strategy was developed by means of in-house workshops with the company’s management. In a second step, an authorisation application was generated. A company specific exposure scenario was prepared, demonstrating minimisation of emissions.This was supported by the (bio)monitoring data generated during the course of the project. In the analysis of alternatives a long list of potential alternatives was assessed, followed by a short list, demonstrating that the potential alternatives are not technically feasible, not economically feasible and not resulting in a risk reduction. Several non-use scenarios were discussed and the most plausible one was identified. This formed the input for the socio-economic analysis. A review period of 12 years was requested. On the basis of the arguments and research plan that was provided, RAC and SEAC confirmed this review period was considered justified. In a final step, the Commission also granted 12 years.

CASE STUDY 3: Board of appeal case on PBT Apeiron-Team, on behalf of their client and together with their legal partner Steptoe and Johnson, challenged the request for additional P testing in the context of substance evaluation, before the Echa Board of Appeal (BoA). The case was defended and won on the basis of lack of proportionality. This was the first case PBT case won by the appellant and the first in which the BoA decided in favour of the appellant in a case of scientific uncertainty. Explorative science with unclear interpretation as requested by the member state was avoided in favour of scientifically proven testing methods. The case showed that a close collaboration of technical-scientific and legal support results in a strong defence of substances. CASE STUDY 4: Union authorisation of a biocidal product family A Union authorisation dossier for a biocidal product application was prepared based on the biocidal product family (BPF) concept. This within product type 4. The composed biocidal product family, and its metaSPCs, was evaluated in detail together with the client to ensure that the different criteria of a BPF were fulfilled. Furthermore, a detailed data gap analysis was performed taking into account the data that was available and previously submitted under the BPD and the new data requirements stipulated in the BPR. All available information was integrated into Iuclid. In a final step, a draft risk assessment covering the complete BPF was generated. Both the BPF composition, data gap analysis and risk assessment were discussed with the evaluating CA before submission and are currently under evaluation. STAFF SELECTION Elke Van Asbroeck – ir (Bio-)chemical engineer Polymer chemistry/ waste and recycle OO Cost-efficient regulation implementation, import/export strategy OO Authorisation process, generation of authorisation dossiers OO Advocacy OO Circular economy Hiram Moerman – ir Chemical engineer OO Specialised in process chemistry OO Product stewardship/GPS OO Authorisation process, generation of authorisation dossiers OO Auditing OO Consortium/project management Dr Katrien Monsieurs – PhD Organic Chemistry OO Specialised in organic synthesis OO REACH dossiers: registration and authorisation OO Substance identification & human toxicology OO Read-across OO PBT assessments Dr Tine Vandenbrouck – PhD Ecotoxicology OO Specialised in mixture effects OO REACH dossiers: registration and authorisation OO Biocidal product dossiers OO Senior exposure assessor OO ERT certified toxicologist OO

www.chemicalwatch.com/SPG

Profile: Apeiron-Team NV

Profile: Arcadis

SERVICES PROVIDED We help companies to identify and manage their business risks, enabling them to market their products in a safe, responsible, and globallycompliant manner covering the whole product life cycle (production, use, waste). Our practice focuses on the following services:

CONTACTS Website

www.arcadis.com

E-mail

PSSinfo@arcadis.com

Product stewardship programmes and audit services Includes compliance programme development and implementation, auditing, due diligence, and post-merger integration assistance.

Head office

Gustav Mahlerplein 97-103, 1082 MS Amsterdam PO Box 7895, 1008 AB Amsterdam, The Netherlands

World-wide regulatory surveillance Includes continuous regulatory monitoring for emerging and existing chemical (e.g., REACH, GHS) and product regulations (e.g., WEEE, RoHS, MDR, batteries, and waste), and impact assessments for individual products, product lines and portfolios.

Contact

Europe: alain.vassart@arcadis.com +32 492 972 330 Switzerland: karina.urmann@arcadis.com +41 44 732 92 81 North America: tina.armstrong@arcadis.com +1 410 279 8637

Directors

Barbara Hudec (EMU Lead, Strategic Environmental Consulting), Tim Strongman (Global Lead Strategic Environmental Consulting)

Ownership

Public company

Locations

350+

Founded

1888

Implementation of global product compliance and stewardship information management systems Includes evaluation of off-the-shelf data providers and data management solutions, and the implementation of software solutions supporting product stewardship, product compliance, sustainability, environmental, health and safety (EHS) compliance and operational risk management. Chemicals and biocides regulatory management Includes registration and authorisation support for REACH and REACH-like regulations, country-specific chemical licensing/permitting, classification, labelling, and packaging for GHS and national variants, hazard communication support, biocides authorisation, plant protection product authorisation, EU Medical Device Regulation, (EC) 1107/2009, RoHS, and US FIFRA, TSCA and California Proposition 65 assistance. Consortium management for REACH and EU BPR Includes dossier strategy (e.g., product family, union vs. national authorisation, testing strategy), dossier preparation, read-across justification, communication with third parties (SIEFs, MS CA, ECHA), financial management and role as Trustee.

OVERVIEW Arcadis is the leading global natural and built asset design and consultancy firm working in partnership with our clients to deliver exceptional and sustainable outcomes through the application of design, consultancy, engineering, project and management services. Arcadis differentiates through its talented and passionate people and its unique combination of capabilities covering the whole asset life cycle, its deep market sector insights, and its ability to integrate health & safety and sustainability into the design and delivery of solutions across the globe. VITAL STATISTICS Turnover, group Turnover, chemical service provision No of countries represented

2017/18

Staff, chemical service provision

Laboratory services and scientific solutions Includes in-house ecotoxicology, biodegradation, and physico-chemical testing in compliance with OECD’s Good Laboratory Practice (GLP), laboratory support services, and toxicology and risk assessment. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1888

Parent company, Heidemij, formed in the Netherlands

€3.4bn

1998

Global company becomes Arcadis

€13m

2002

Establishment of a product stewardship Centre of Excellence in North-America

2006

Arcadis Belgium becomes a product stewardship Centre of Excellence

2008

Arcadis acquires LFR Levine-Fricke in the USA, a leader in the conduct of environmental safety field studies, to support the registration of plant protection products.

2012

Arcadis acquires BMG Engineering Ltd in Switzerland, a leader in product stewardship, ecotoxicology and REACH

70 27,000+

Staff, group

Agrochemical fate and exposure Includes conduct of environmental and consumer safety field studies, aquatic and terrestrial modelling, risk assessment, and registration support for plant protection products, e.g., FIFRA and (EC) 11077/2009.

70+

SERVICE AREA BREAKDOWN

Training 4% IT & software 10%

ACCREDITATIONS

Laboratory 11% Information 5% Representation & management 15%

Global Service Providers Guide 2019

Consultancy/advisory 55%

European registered toxicologists (EuroTox); European registered chemists; Diplomates of the American Board of Toxicology (DABT). The Arcadis ecotoxicology laboratory is GLP certified and accredited according to ISO/IEC 17025. The international Arcadis team is also GLP certified to conduct environmental fate and consumer safety field studies to support the registration of plant protection products.

PARTNERS Arcadis has a broad network of partners with whom we work together on an ad hoc basis (CROs, legal advisors, other consulting companies). TESTIMONIALS References can be provided upon request. CASE STUDY 1: Application for authorisation under REACH Arcadis is assisting an international pharmaceutical company to compile applications for authorisation for several substances and uses. Support includes scoping of uses, comprehensive data gathering within the company and in-house preparation of the Analysis of Alternatives, SocioEconomic Analysis and the Chemical Safety Report. Arcadis further provides support in the identification of exemptions and overall strategy development.

CASE STUDY 5: Collection of Public Monitoring Data to Support Plant Protection Product Re-authorisation in Europe To support the re-registration of a plant protection product (PPP) in the European Union a data search for publicly available groundwater and surface water monitoring data was conducted for the PPP and its principal breakdown products across 16 countries in the European Union. The data search was conducted by performing online database searches and contacting regulatory agencies, authorities, and organisations that may collect these data. Searches were supported by Arcadis personnel located within the targeted countries to leverage the potential to gain access to data sources and facilitate contact and interaction with local authorities. The data collected were cleaned, duplications removed, processed, and compiled into a single data structure to facilitate detailed statistical analysis. Analytical results were identified in data sources from 14 of the 16 selected countries and more than 620,000 individual analytical results for the PPP and its breakdown products were identified across 25 data sources.

CASE STUDY 2: Biocidal product regulation: business impact assessment

STAFF SELECTION

Arcadis supports an impact assessment of the EU Biocidal Product Regulation and its Swiss counterpart for a pharmaceutical company. An in-depth training is provided to the EHS managers of all EU sites with a focus on their business. Apart from a general overview of the regulation, typical products and uses present in the pharmaceutical sector are mentioned, grey zones in the legislation are discussed and interpreted. Also, a template for product inventory and evaluation of obligations is developed. After completion by the sites, Arcadis reviews the compliance status and develops an action plan to mitigate business risks related to the use of biocidal products. In parallel, Arcadis acts as helpdesk for the EHS managers.

Christina Inhof, MSPH, DABT, chemical regulatory affairs/toxicology Over the last 15 years, Christina has provided a wide range of product stewardship and regulatory toxicology services to clients in the consumer products, pharmaceuticals, and chemicals industries. She specializes in hazard communication, including preparation of GHS-compliant SDSs and labels in various countries, and European chemical regulations, including REACH and CLP. She regularly provides general toxicology support to clients, including literature reviews of human health toxicity of individual and related chemicals. She is also experienced with new product regulatory compliance assessments for chemical and biological products in over 25 countries. She recently assisted a client to develop a compliance tool for US TSCA chemical data reporting.

CASE STUDY 3: Utilising a common information platform to standardize product stewardship processes across a complex organisation A large medical device organisation, motivated by regulatory changes including the EU Medical Device Regulation, was driven to implement a common product stewardship platform across all global businesses to enforce common processes and best practices, bolster compliance certainty, protect market access, and facilitate innovation. Arcadis supported this company with commercial product stewardship solutions expertise, digital solution development resources, information and data technologists and subject matter expertise including: OO technical architecture and deployment support; OO business process standardization and best practice guidance; OO organisational change management; OO data governance; and OO solution sustainment and long-term planning. CASE STUDY 4: Embedded Staff Support Program Realising that substantial professional judgement was necessary to use commercially available SDS software solutions for their product applications in the consumer goods and pharmaceuticals sectors, a multi-national company contracted Arcadis to provide dedicated staff teams in both Europe and the United States. Between five and eight full-time Arcadis staffers have worked closely with this company’s R&D, transportation, and toxicology groups incorporating testing data and product knowledge to customize over 4,000 SDSs in the past 2 years. Furthermore, Arcadis has provided more than 6 bespoke/dedicated staff support at this client’s offices and at Arcadis offices during the last 5 years to help manage and implement specific project workflows, augmenting this company’s own product stewardship staff beyond SDS authoring.

Andy Newcombe, agrochemical product stewardship Andy has more than 28 years of experience in the design, conduct, and management of complex, higher tier agrochemical fate and transport studies including studies conducted at the field, regional, national, and continental-scales. He has successfully negotiated with European member state and North American regulators on behalf of agrochemical companies on environmental fate issues associated with their products and has considerable experience in providing clients with litigation support. Elizabeth Sotherland, Information Driven Performance and Product Stewardship Specialist Liz has nearly eight years of global environmental regulatory and product stewardship experience, providing support to multinational medical, automotive, chemicals, and consumer goods companies. In recent years, this has included the development, deployment, and continued implementation and maintenance of product- and regulatory-data management systems for continued product stewardship compliance. Alain Vassart, Sr REACH/batteries/recycling and waste expert Alain has more than 20 years of experience in the chemical and recycling industry. He was an active member of the EU Copper Task Force (plant protection), participated in the VRA on copper and was past chairman of the copper compounds REACH consortium. Alain has actively contributed to the development of EBRA (European Battery Recycling Association – www.ebra-recycling.org), currently taking the role of Secretary General. He is managing several REACH consortia including the administrative and financial side. Karina Urmann, chemical regulatory affairs expert Karina heads the Product Stewardship Solutions department at Arcadis Switzerland. She has ten years of regulatory and product stewardship experience with chemical and pharmaceutical companies. She has specialised in European legislations such as REACH, CLP and BPR and the corresponding Swiss legislation supporting clients to ensure legal compliance internally and for their products.

www.chemicalwatch.com/SPG

Profile: Arcadis

Profile: Arcerion GmbH

arcerion

SERVICE AREA BREAKDOWN

REACH | CLP | Seveso | Biocides

IT & software 5%

CONTACTS Website

www.arcerion.com

E-mail

info@arcerion.com

Head office

Arcerion GmbH, Gabrielenstr. 15 80636 München, Germany

Tel

+49 89 38899797

Fax

+49 89 38899798

Contact

Anne Feldhaus

Directors

Dr Michael Piber, Executive Director Dr Florian Wrage, Managing Director

Ownership

Private limited company

Locations

Germany

Founded

2007

Laboratory 10% Information 10%

GLOBAL OFFICES München, Germany Hamburg, Germany SERVICES PROVIDED Consultancy/advisory Regulatory support & interpretation (REACH, CLP, Biocides, Seveso); OO product compliance assessment and implementation (including certificates of compliance); OO environmental risk and health effects assessments; OO hazard and exposure modelling; OO SVHC advisory/REACH authorisation; OO data management/Data-gap analysis; OO reducing of animal testing/(Q)SAR, read-across; OO Brexit implications on suppliers of chemicals; and OO chemical transport/warehousing advice OO

Arcerion is an experienced full service and consulting provider aimed at assisting companies to comply with chemical control legislation. Our main activities deal with the implementation of European control legislation like the REACH and CLP Regulations, as well as the Seveso II/ III-directives. Our regulatory consulting is aimed to support our clients through the regulatory duties and to enable them to maintain a secure market access for their products. Our objective is to facilitate the most efficient and cost-effective implementation of the requirements of all applicable control legislation. All of our consultants have a solid background in chemical industry, management consulting and academia – combining strong commercial experience and technical expertise. Arcerion’s industry specialists have been dealing with the implementation of REACH and CLP since these regulations came into force in 2007, and have been supporting the implications of the Seveso-III directive since 2012. 2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2019

Consultancy/advisory 40%

Representation & management 30%

OVERVIEW

VITAL STATISTICS

Training 5%

Representation and management OO REACH registration services (including inquiries, notifications, Sief representation, completion of data requirements); OO dossier preparation and submission (IUCLID files); OO CLP implementation (incl. authoring of eMSDS, CSA/CSR); OO only representative of non-EU manufacturer (REACH art. 8); OO transfer or UK based REACH registrations to continental EU; OO third party representation (REACH art. 4); OO supply chain management and communication; OO consortium and letter of access (LoA) management; OO Sief representation and management; OO 24/7 emergency phone services; OO management of downstream user obligations (REACH art. 31 to 38); and OO preparation of applications pursuant Seveso-III directive. Information/IT solutions OO (Material) Safety data sheets / product labels; OO supply chain management; OO exposure scenario/chemical safety assessment management; OO consortia/registration management; OO regulatory information management; and OO chemical inventory management. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007

Arcerion GmbH founded in Munich, Germany

2008

REACH registration and Only Representative department created

2011

Opening of laboratory facility for the assessment of pyhschem. properties in Kassel, Germany

2013

Successful preparation of more than 100 REACH registration dossiers

Certified Expert pursuant 5. BImschV (German Seveso Directive) ChemVerbotsV (Dangerous substance directive), and KrW-/AbfG and TgV (Dangerous waste directive); member of DGSV (German technical and scientific experts association); member of the EU EEG qualified expert group for chemistry; REACH Ready approved service provider.

label pure substances pursuant to EC/1272/2008 with his existing IT solutions, the classification and labelling of custom made mixtures according to CLP causes difficulties since the 2015 deadline. The classification of newly produced preparations has to be performed manually. Solution provided by Arcerion: We develop and implement a custom specific IT-solution aimed to generate product labels and MSDSs for all relevant preparations of the client’s product portfolio. The CLP compliant classification is based on an up-to-date EH&S chemicals database. Result: The client is able to generate CLP compliant product labels for custom-made mixtures within a fully automated work-flow. The delivery of hazard communication by REACH/CLP compliant MSDSs is integrated in the production process. Changes in chemical legislation are taken into account at the time of the generation of labels and SDSs by utilising Arcerion’s chemical data base.

PARTNERS

STAFF SELECTION

We work with a number of different partners (including laboratories for process safety toxicological and environmental fate) to extend the services offered to our clients.

Dr. Michael Piber – Director Michael holds a degree in organic chemistry. Michael was a faculty member of the LMU University, Munich, providing instruction in organic chemistry. He has more than 15 years of experience in consulting in different industries. Before joining Arcerion, Michael led the REACH and CLP-implementation of a leading European chemical industry company. Michael leads the Munich office of Arcerion and focuses on the European and North-American regions. His areas of expertise include chemicals and Seveso regulatory support, as well as corporate strategy for the chemical industry. Michael is the legally responsible person as REACH only representative for Arcerion’s non-European manufacturer or formulator of products that are exported to the European market. In recent years he has been heavily involved in assisting North American companies to prepare for and comply with REACH and CLP.

2014

Acquisition of Chemtrade Pvt Ltd

2014

Opening of a new office with Biocide/Seveso department in Hamburg, Germanyw

2015

Launch of IT-system and database for the automated creation of CLP-complaint MSDS for preparations

2016

Consortia and letter of access group created

ACCREDITATIONS

CLIENTS Arcerion serves more than 100 clients in Europe, North America, Africa, Australia and Asia across multiple industry sectors including industrial – and petrochemicals, food, mining, pharmaceutical, specialty chemicals, electronics and consumer products. TESTIMONIALS We do not disclose our clients publically. Specific references can be provided to potential clients upon request. CASE STUDY 1: REACH compliant supply chain for a consumer goods manufacturer Situation of the client: A China based manufacturer of consumer goods (including detergents and cleaning agents) exports products to the EU market, which are made of numerous raw materials. While some of the raw materials are sourced from the EU, others are manufactured outside of Europe, including some substances which are exempted from the obligation to be REACH registered (pursuant Annex IV/V). The Chinese manufacturer wishes to proof REACH compliance of the exported goods to his European customers – without disclosing the identity of all raw materials to his European customers. Solution provided by Arcerion: We assess the status of all raw materials/substances used for products exported to Europe. We assure and verify that all volumes of the substances are either registered by an only representative, or sourced in the EU and already registered before re-import to Europe within the same supply chain, or exempted from the obligation to be registered. By recording and documenting the necessary information for all raw materials, Arcerion is able to ensure overall REACH compliance for the Client’s products. Result: The client receives consistent and unified certificates of REACH compliance (including tonnage certificates) by Arcerion. The client is able to proof compliance to his European customers, while keeping certain data confidential. CASE STUDY 2: CLP compliant labelling and hazard communication of specialty chemicals preparations Situation of the client: A German specialty chemicals producer is challenged by the obligation to classify all of his products according to the CLP regulation. While the producer manages to classify and

Dr. Florian Wrage – Director Florian holds a degree in environmental technology. His area of expertise include chemical control legislation and global regulatory management. During his graduate studies he worked in the research on the fate of fluorinated chemicals in the environment. Florian leads the Hamburg office of Arcerion and focuses on the Asian region. Florian is in charge of the REACH department, where he is responsible for the complete spectrum of services for (co-)registrants, including the creation and successful submission of Iuclid dossiers, compiling chemical safety reports (CSR), and providing overall supply chain communications. In recent years Florian has been involved in assisting Asian companies to prepare for and comply with REACH and CLP. He is an expert safety data sheet and exposure scenario author. Before joining Arcerion, Florian was the competent person with regard to the Seveso regulation of a German power plant operator. Hakim Shaheen – Principal Consultant Hakim is a toxicologist with more than 20 years of experience in the assessment of health risks of industrial chemicals, agrochemicals and biocides. His area of expertise include chemicals regulation, regulatory toxicology, hazard assessment and communication. He provides toxicology expertise to Arcerion’s clients in the industrial and specialty chemicals sector. Hakim is an expert in developing strategies to avoid animal testing by applying read-across or (Q)SAR. Over the course of his career, Hakim has managed the preparation of more than 200 chemical registrations in the EU, Korea and the USA. Hakim is responsible for the support of Arcerion’s clients with regard to biocide regulations. Lin Cheng – Project Manager Lin holds a degree in business administration. She has several years’ experience in consortia management. Her responsibilities include management of lead registrant projects, Sief organisations and letter of access management. Lin has advised companies from Europe, Asia and North America on REACH compliance issues since 2013.

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Profile: Arcerion GmbH

Profile: ARCHE Consulting

GLOBAL OFFICES Tiensevest 132 3000 Leuven, Belgium Tel: +32 16 28 49 01 CONTACTS

SERVICES PROVIDED

Website

www.arche-consulting.be

E-mail

info@arche-consulting.be

Head office

Liefkensstraat 35d, 9032 Gent-Wondelgem, Belgium

Tel

+32 9 216 70 38

Contact

Marnix Vangheluwe

Directors

Marnix Vangheluwe

Patrick Van Sprang

Ownership

Private company

Locations

Gent and Leuven, Belgium

Founded

2009

REACH The REACH Regulation is the biggest piece of chemical legislation ever. ARCHE Consulting is well placed to help updating your REACH dossiers plan and assist you with the fulfilment of your obligations as producer, importer, distributor and/or downstream user. Next to updating and follow-up of REACH compliance ARCHE Consulting is quite active in providing technical services together with associated SEA partners in the field of REACH Authorization/SEA/restriction Join our REACH Orphan Substances Consortium (ROSC!) Orphan substances are those substances that have no or limited data and no existing organisation working on them. ARCHE Consulting acts as a technical partner to the ROSC consortium, which is an initiative together with two other renowned and experienced service providers. For more information visit our dedicated website www.rosconsortium.eu

OVERVIEW Several key services are provided for ARCHE Consulting such as the development of registration dossiers for biocidal products and plant protection products. Another key area of expertise is the preparation of REACH-related risk assessments and full dossiers for inorganic substances such as metals, alloys, slags, etc and, as such, the ARCHE experts have been involved in the preparation of many guidance documents (eg ECHA) on these topics. Other key services include classification of substances and complex mixtures (GHS/CLP), and setting and/or evaluation of (site-specific) environmental quality standards and performing environmental risk assessments of medicinal products for human use. In addition, ARCHE is also a certified material health assessor, assisting companies towards certifying their products in line with the Cradle Certified Products Programme CM (cradle-to-cradle). VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

IT & software 5%

Training 5%

Representation & management 15%

Biocides and plant protection products (PPPs) ARCHE Consulting offers a one-stop-shop for the registration of your biocides and ppp products or active substances. We furthermore generate and manage consortia for biocidal products or active substances. ARCHE has extensive expertise and a proven track record in delivering solutions to problems at all stages in the registration/review of biocides and PPPs. Offered services include: (a) consortia management for biocidal product; (b) effect and exposure assessment for active substances and products; (c) data gap identification and designing higher-tier studies; (d) exposure modelling (FOCUS suite of models, Euses, Consexpo, EASE); (e) higher-tier exposure scenario development; (f) CLP; (g) dossier preparation, submission and follow-up; (h) client representation in meetings with regulatory authorities; (i) product stewardship; and (i) training Iuclid for biocides. Cradle to Cradle certificationÂŽ As an authorised Cradle to Cradle material assessor, ARCHE assesses healthy and sustainable products under the Cradle to Cradle certified CM Products Programme. The Cradle to Cradle product standard addresses five quality categories relating to human and environmental health: (a) material health, (b) material reutilisation, (c) renewable energy and carbon management, (d) water stewardship, and (e) social fairness. The ultimate goal of the Cradle to Cradle Certified CM Products Programme is to encourage continuous improvement, innovation, and formulation of products that benefit humans and the environment. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2009

Foundation of ARCHE (staff: five people).

20102012

Expansion of the team to 16 people, with offices in Ghent and Leuven.

20132018

Further expansion to more than 30 people, and further development of the services on biocides, plant protection products and cosmetics.

PARTNERS

Consultancy/advisory 75%

PietConsulting ECTX-Consulting ROSC Toxicological Consulting REACHlaw Vander Straeten Consulting Services ERMC (Dr Mike Holland) EBRC Consulting

Global Service Providers Guide 2019

CLIENTS

STAFF SELECTION

Industrial clients and consortia related to the following chemical substances: OO metals including: Cu, Ni, Mo, Pb, Zn, Hg, V, Co, Fe, Se, Sb, Sr, Mg, Bi, Te, Ti, etc; OO organic compounds: chlorinated flame retardants, organic acids, plasticisers, amines, , plant protection products; OO complex materials: Cu slags, Ti slags; and OO other inorganic substances: Ca, B, NaOH, KOH, sulphur dioxiderelated substances (SO2, sulphites, thiosulphates, dithionites), lime, nitric acid, phosphoric acid. OO Several Biocide consortia such as Sodium chloride (Active chlorine generated from NaCl by electrolysis) consortium, Permethrin and in situ peracetic acid consortium.

Patrick Van Sprang − Managing Director ARCHE Consulting Patrick Van Sprang graduated as master of science in engineering (environmental technology) at Ghent University (1988). At Ghent University (1994-2000) he was responsible for the research group aquatic ecotoxicology. He was co-founder of EURAS, a consultancy company specialising in environmental risk assessment. Patrick Van Sprang is the main author of the environmental part of several risk assessments (eg Cu, Ni, Pb) and contributed to the metal risk assessment guidance document (Merag).

TESTIMONIALS “ARCHE Consulting played a key role in helping us to achieve our approval by ECHA as an art 95 listed supplier for Geraniol in PT 18 and PT19. They were always available, knowledgeable, thorough and were instrumental in guiding our responses and submissions to help insure the successful outcome. We look forward to maintaining an ongoing relationship for our future regulatory requirements with ARCHE Consulting.” – Antoine Birron, Director, TerpeneTech Ltd. “IMOA has worked for the last decade with the environmental scientists working at ARCHEConsulting, and they have proved for IMOA/MoCon to be a very wise investment. We can therefore highly recommend ARCHE with regard to their technical expertise and knowledge on environmental issues (aquatic and terrestrial), organisation of research projects, and data interpretation.” – Sandra Carey, International Molybdenum Association (IMOA) “ARCHE Consulting has proven to be a very valuable consultancy partner for DeLaval over the past few years. DeLaval was able to benefit from the in-depth knowledge of the ARCHE scientists on the European biocidal Regulations (BPD/BPR) and we can only recommend to others the training we received on several aspects of risk assessments (both human and environmental).” Adelheid De Ketelaere, Regulatory Affairs Manager EMEA, SEA PPMQ&AH DeLaval NV. More testimonials can be found at www.arche-consulting.be

Marnix Vangheluwe − Managing Director ARCHE Consulting Marnix Vangheluwe graduated as master of science in engineering (biochemistry) at Hogeschool Gent (1989). In 1991, he obtained a master in environmental sanitation (Ghent University). At Ghent University (19922000) he was responsible for the research group sediment ecotoxicology. He is the main author of the metal risk assessment guidance documents (Merag) and the official REACH Appendix R.7.13-2. Frederik Verdonck − Senior Science Project Manager Dr Frederik Verdonck obtained his PhD degree in bio-engineering on probabilistic risk assessment at Ghent University (Belgium). At ARCHE Consulting, his main expertise area comprises the implementation and application of statistical and modelling approaches in exposure, effects and risk/safety assessment. Currently, Dr Frederik Verdonck is the leading expert in developing and implementing new tools in the field of exposure assessment. As a certified trainer, he also deals with training programmes on various REACH and BPR risk assessment topics. An Ghekiere − Senior Science Project Manager An Ghekiere graduated as Master of Biochemistry in 2001 and obtained her PhD in Bio-engineering on endocrine disruption in invertebrates at Ghent University (Belgium) in 2006. From 2002 until 2010 she worked on projects (ENDIS-RISKS and INRAM; risk assessment of micropollutants in estuarine and marine environments. At ARCHE Consulting, she is responsible for the biocides and PPP services. As a ERT certified toxicologist she also deals with human and environmental risk assessments.

CASE STUDY 1: Active substance renewal and product registrations for plant protection products (PPPs) ARCHE Consulting collaborated with a task force to obtain renewal of their active substance for use in PPPs. Upon submission and evaluation of the dossier, ARCHE entered into discussion in 2016 with the regulatory bodies, mainly on topics related to environmental fate and ecotoxicology, aiming to successfully complete the active substance renewal. These activities, as well as addressing questions of regulators to preparing zonal core registration dossiers and national addenda, were part of the services provided to clients in the crop protection industry, and have led to multiple product authorisations across the EU. CASE STUDY 2: REACH registration dossiers for low-tonnage substances (2018 deadline) ARCHE as technical partner of the ROSC (the REACH Orphans Substances Consortium) prepared the REACH registration dossier for strontium and barium by the 2018 deadline. CASE STUDY 3: Consortia for biocidal products Since 2015, ARCHE is generating several consortia to jointly prepare biocidal product family dossiers. The main goal is to share the burden of costs for fees, testing and dossier preparation between all members. ARCHE Consulting is responsible for the consortium management, testing coordination and dossier preparation including risk assessment, whereas FieldFisher has been acting as our legal partner for these projects.

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Profile: ARCHE Consulting

Profile: Artemisa

78 Submission of dossiers; post submission work/ product stewardship (communication with national enforcement bodies on as need basis, compliance with annual reporting duties, national electronic registers, etc); OO Data Gap Analysis (DGA); OO facilitation of communication with local authorities in local language; OO strategic advice taking national specific rules into consideration; and OO project management in cases of multiple submissions into multiple countries. Areas of expertise: OO plant protection products; OO fertilisers and supplementary soil substances; OO adjuvants; and OO biopesticides. OO OO

CONTACTS Website

www.artemisa.si

E-mail

registrations@artemisa.si

Head office

Artemisa d.o.o., OpekarniĹĄka 30, 1235 Radomlje, Slovenia

Tel

+386 8 181 00 20

Contact

Ms Bojana Zgonec: bojana.zgonec@artemisa.si

Directors

Ms Bojana Zgonec

Ownership

Ms Bojana Zgonec

Locations

Slovenia, Slovakia, Poland

Founded

2018

Biocide products regulatory services in Eastern EU and beyond Services: OO preparation of submission documents under EU transitional measures and/or BPR in local language and according to national requirements; OO IUCLID dossier preparation; OO SPC translation services into multiple languages; OO submission of dossiers, handling applications via R4BP; OO post submission work/ product stewardship; OO facilitation of communication with local authorities in local language including national help desks; OO strategic advice taking national specific rules into consideration; and OO project management in cases of multiple submissions into multiple countries.

OVERVIEW Supporting chemical industry to comply with the regulatory requirements in place in the EU as well as at the national level of individual countries in Eastern and Central EU (CEE) countries and beyond. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

NA 3

No of offices No of countries represented

Staff, group

10 9

Staff, chemical service provision

Information 2% Training 2%

Consultancy/advisory 95%

SERVICES PROVIDED Agrochemical regulatory services in Eastern EU and beyond Services: OO preparation of submissions of registration dossiers for zonal, MR, renewal and other procedures; preparation of documentation in local languages adjusted to national requirements including label and SDS preparation

Global Service Providers Guide 2019

Poison centre notification OO help with fulfilling national requirements with poison centres; OO submission of documents to national poison centres; OO facilitation of communication in national language; OO follow-up and updating poison centres with new data Detergents OO identification of the status of your detergents and surfactants in the light of the EU legislative framework and your obligations resulting from it; OO preparation, translation/adaptation or review of the labelling for your detergents to be compliant with the national requirements and EU rules; and OO representation of your company in national associations, serving as a liaison between your company and the local community.

SERVICE AREA BREAKDOWN

Representation & management 1%

Medical devices We can help you: OO understand the data requirements and procedures to be followed in order to place medical devices on the markets; OO take different national requirements into consideration in cases where relevant; OO help you solve borderline cases in case of any doubts; and OO facilitate communications with the authorities in the pre- and postsubmission phase.

SDS services OO SDS adaptation to specific national requirements and in the national language for a specific country; OO SDS updating, reformatting or editing to accommodate changes in legislation (REACH, CLP, ADRâ&#x20AC;Ś), classification changes of the product, product composition, company specific information; and OO SDS extension to Extended Data Sheets (eSDS) to comply with your substance Chemical Safety report (CSR). Translation and Proofreading Support OO Translations of general texts OO Translations of technical texts from the following expert areas: Agriculture, Chemistry, Regulatory, Security in the workplace, Business, Environmental, Healthcare OO Proofreading of general and technical texts, labels, MSDS-es, SPC and PAR documents.

Translation services into multiple languages offered: slv, cro, ser, de, fr, slo, cz, pl, hu, rus, en, ro, bg, alb, mac, it, lth, li, est We are able to provide a high quality support also in other languages per specific request. Business Seminars OO Training in regulatory matters OO Internal trainings upon request Strategic Advice OO Preliminary Assessment of your portfolio or individual products taking the EU status of your substance as well as data protection rules into consideration; OO study Generation support by commissioning and supervising generation of studies; and OO advice on the data requirements in place in different countries of the region we are covering, with all the nuanced differences and local specifics which need to be taken into consideration for successful registration of your products. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2018

Company establishment (spin-off from TSGE)

2018

Branch offices establishment in PL and SK

CLIENTS Our clients would typically be multinational as well as generic companies, who would originate from Western EU. Artemisa would help them place their products on the market in Eastern EU countries and countries outside the EU by preparing all necessary documentation according to national rules and in compliance with the national legislation and data requirements. Artemisa would also take care of the compliance of already registered products in the post-registration phase. CASE STUDY 1: PPP registration following Art. 43 in a very short timeframe Our client had a very short timeline to prepare and submit Art. 43 PPP application in one of a very challenging Eastern EU countries. Thanks to our reliable local partners and good contacts to the authority Artemisa team was able to deliver the submission in time.Our ability to act quickly and in a flexible manner is contributing to the success in achieving complete registrations in different Eastern EU geographies. CASE STUDY 2: Data package preparation for multiple EU countries With experience and large network of local partners we were able to minimise the extent of data and documentation (including local testing) for the client. With that we have confirmed our knowhow and ability to optimise data packages for multiple markets and regions wherever possible. Additionally, we have the ability to handle the entire registration process on behalf of the client especially in cases, where multiple countries and short timelines are involved.

STAFF SELECTION Bojana Zgonec – Managing Director and Founder Prior to founding Artemisa in 2018 Bojana worked for TSGE, an international consulting company as Managing Director between 2009-2018. Before moving into a regulatory consultancy role in 2006 she has gained experience as a registration manager, working for Bayer CropScience and Pinus TKI d.d. Over the last 20 years Bojana gained extensive experience in regulatory affairs and business development in Eastern Europe. Her carrier is a blend of working experience with multinational company, local generic company and associate cooperation with a partner linked with the self-employer status experience. As Managing Director of Artemisa she has created a successful network of offices in Slovenia, Poland and Slovakia with dedicated team of experts. She is fluent in Slovenian, English, French, German, Croatian and Serbian and has basic understanding of Russian. Liana Skok – Principal Expert Liana has started her career as PPP registration manager in 1995 with Ciba company. She has continued her carrier in Novartis and Syngenta as person responsible for registration work in the ex-Yugoslavian countries (Slovenia, Croatia, Bosnia, Macedonia, Kosovo, Serbia and Albania). Prior to joining Artemisa in 2018 she worked for TSGE, an international regulatory consultancy company as senior regulatory manager (20122018). Since June 2018 is Liana with Artemisa in position of Principal Regulatory Expert. With extensive experience in regulatory affairs she provides advice to clients on the national registration requirements under national, Eastern European and Balkan region legislation and liaises with regulatory authorities. She prepares submissions (zonal and national) for Eastern European and Balkan countries. She is fluent in Slovenian, English, German, Croatian and Serbian and has basic understanding of Macedonian. Viktor Prachar – Principal Expert Viktor joined the Centre for Chemical Substance and Preparations in 2001 where he was Head of the Biocides Unit, national Competent Authority for Biocides. For 10 years Viktor was national representative at the EU CA meetings and Standing Committee for Biocidal Products. Viktor is Associated Professor at the Slovak University of Technology. In 2014 he moved to regulatory consultancy and joined TSGE. Since June 2018 is Viktor with Artemisa in position of Principal Regulatory Expert BP and PPP Slovakia and Czech Republic Combination of Viktor’s extensive experience covering the areas of science, work in regulatory bodies and consultancy for private sector is ideal for proper understanding the needs of clients, thorough interpretation of requirements of authorities and facilitation of discussions between private sector and national/EU bodies. Viktor is fluent in Slovak, English, German and Czech.

CASE STUDY 3: Translation of SPCs in multiple languages in a very short timeframe Under BPR our client had a very short timeline to prepare and submit high quality national versions of Summary of Product Characteristics (SPC) in more than 6 languages of the EEC ( SI, SK, CZ, BG, RO, PL, HU, CR ). Thanks to our staff speaking fluently Eastern European languages and having a thorough regulatory knowledge, all national SPC versions were prepared within the required deadline. In this way we contributed to the success in obtaining authorizations in a timely manner. In addition we prepared national versions of product labels and SDS assuring high compliance of all elements with the approved SPC and content of the authorization decision.

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Profile: Artemisa

Profile: bibra toxicology advice & consulting

SERVICE AREA BREAKDOWN IT & software Training 1% Information 1% 3%

CONTACTS

Representation & management 10%

Website

www.bibra-information.co.uk

E-mail

info@bibra.co.uk

Head office

Cantium House, Railway Approach, Wallington, Surrey, SM6 0DZ, UK

Tel/ Fax

+44 (0)20 8619 0770

Contact

Ashleigh Ace, Commercial Director

Directors

Richard Young, Managing Director and Toxicologist Anne Edwards, Director and Toxicologist James Hopkins, Toxicology Director and Chairman Peter Watts, Toxicology Director

Ownership

Private company

Locations

Founded

1961, acquired by current management 2005

Consultancy/advisory 85%

GLOBAL OFFICES Surrey (Greater London) SERVICES PROVIDED Data searching, gap analysis and development of testing strategies We perform searches for data in line with the relevant regulatory requirements (e.g. Reach, including in our TRACE database). Retrieved information can be quickly assessed for relevance and reliability to satisfy the data requirements. Additional laboratory testing can be minimised by expertly exploring opportunities for data waiving, read-across, and use of Qsar to create weight-of-evidence approaches to fill data gaps. If further testing is necessary, we can advise on testing strategies to minimise both the use of animals/overall costs to the client, while maintaining scientific integrity. We assess the impact of the results of new tests conducted and provide ongoing expert guidance on what is really needed.

OVERVIEW Bibra toxicology advice & consulting Ltd is one of the most experienced and successful chemical hazard and risk assessment organisations in Europe. We utilise the expertise of a large team of highly skilled and outstandingly qualified toxicologists with the finest, independently owned toxicological databank in the world. This unique combination of worldclass knowledge and consulting skills with an outstanding information system means we can provide superior quality solutions to virtually all the problems faced, both by toxicologists and related company managers, in a highly-efficient and cost-effective manner. Bibra has been working successfully with industry and government departments for many years across a broad range of sectors; for example industrial chemicals, agrochemicals, biocides, pharmaceuticals, medical devices, e-cigarettes, food/drink and cosmetics. We have built an enviable reputation for our ability to handle both large and small projects, and to deliver high quality consulting and information services to tight deadlines. We are a leading supplier of REACH compliance services, assisting chemical manufacturers, importers and downstream users with all their REACH responsibilities since the regulation came into force, through the most recent (2018) registration deadline, and continuing with updates and responses to Echa Evaluation decisions. VITAL STATISTICS

2017/18

Turnover, group

ÂŁ2m

Turnover, chemical service provision

ÂŁ2m

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2019

Dossier preparation, including CSA/CSRs (DNEL/DMEL derivation) Highly skilled in working directly in Iuclid, preparing the technical dossiers required under REACH and the biocidal products regulation (BPR), and in describing toxicological data in a robust but efficient way. Very experienced in interpreting/evaluating toxicity studies and working with appropriate assessment factors to derive risk-based levels of tolerable exposure (DNELs/DMELs). Accurate input of information into Iuclid facilitates the overall chemical safety assessment (CSA) and production of the final chemical safety report (CSR) for submission to Echa. We can also advise on relevant classification/labelling, the use of alternative methods (e.g. read-across and Qsar),and conducting TK and PBT/vPvB assessments. Working with partners, we cover all aspects of REACH and BPR. Extensive in-house toxicological database (TRACE) and databank For over 55 years, bibra has been scrutinising emerging toxicological literature, expert reviews or pronouncements, and indexing them systematically (by toxicity endpoint and chemical). Much of this scientific literature is held in-house in our technical library and quickly accessed using its associated database, TRACE. This unrivalled resource (listed as a valuable data source in Echa guidance) allows instant access to relevant documents and is critical in helping us produce the finest hazard and risk assessment work for our clients, in the most timely and costeffective manner. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1961

Formation of BIBRA

1961

Establishment of Toxicology Information and Advisory Department

1961

Began to build the technical library

1987

TRACE, a database designed to source data, from the tech library (databank), was developed

2000

TRACE, and associated databank, independently assessed as the finest toxicological data source of its type, worldwide

2003/5

Toxicology Advice & Consulting Ltd and Bibra Information Services Ltd established as vehicles to facilitate management buyout of Information and Advisory Department, including TRACE

CASE STUDY 2: Urgent request for help with chemical safety report

Our toxicology directors, principal toxicologists and senior toxicologists are all Royal Society of Biology/British Toxicology Society and European Registered Toxicologists (EUROTOX). We are a Gold REACHReady approved supplier.

We have been working with a number of clients to help out with specific areas of their REACH registration dossiers (both large- and small-scale. In one case, we were asked at short notice to help improve an existing Iuclid dossier on a petrochemical additive manufactured in the EU at >1,000tpa. This involved the peer-review and improvement of previously drafted ESRs and associated endpoint summaries, the revision of the CSR, which included calculation of DNELs and PNECs, a PBT/vPvB and exposure assessment, risk characterisation step, and documentation of the necessary risk management measures and operational conditions (RMMs/OCs). The size and capabilities of our team meant that, despite the late notice and tight deadline, our client was able to successfully submit their registration dossier in time.

PARTNERS

CASE STUDY 3: REACH Evaluation

Enviresearch Ltd Linmark Consulting Gmbh REACHWise TSG Consulting wca environment Ltd

We are receiving more REACH Evaluation work from registrants. For example, we were approached by a client that had received a draft decision on a Compliance Check, following an Echa evaluation of their REACH registration dossier. Echa requested the need for an EOGRTS and identified issues with the read-across approach. Working within strict deadlines, we liaised with our client and Echa, and drafted a formal response to the draft decision. Following receipt of the Final Decision, bibra put together a proposal to update the dossier, improve the read-across justification, and ensure that Echa ‘s other concerns were addressed in order that the registration dossier remained in compliance with the regulations.

2005

The new combined entity began to trade as bibra toxicology advice & consulting from Sutton, Surrey offices

2010

Relocated to new, larger offices in Wallington, Surrey

ACCREDITATIONS

CLIENTS Our several hundred clients span across a variety of industries; a selection of which is listed: OO REACH OO Biocides and Plant Protection Products OO Pharmaceuticals and Medical Devices OO E-cigarettes and other nicotine delivery systems OO Food and Food-contact materials OO Consumer Products (including cosmetics) TESTIMONIALS “For [us], it is essential to have access to an expert toxicology consultant that can provide high-quality, comprehensive and clear output on our time-sensitive projects with minimal oversight. In this regard, bibra continues to exceed our expectations” Johnson Matthey “We acknowledge that bibra toxicology and consulting provide services that are highly regarded among the international scientic community” Efsa “Our interaction with the expert toxicology consultants at Bibra has been very positive. They have provided us with a first class and highly professional service and the report they produced for us was exactly the information that we were requiring to take our programme of work forward to clinical evaluation” Technostics CASE STUDY 1: Complex REACH registrations involving a large category of inorganic substances We have worked on a substantial number of successful REACH registration submissions over the past 10 years and are notably currently supporting a consortium of companies with the mammalian toxicology aspects of their REACH obligations for a group of >70 related metal compounds. The work has involved the evaluation of a large number of proprietary studies and published literature, assessment of Annex III compliance, complex data-gap analyses and the development of appropriate integrated testing strategies (to minimise the amount of animal testing required) including advice on possibilities for read-across and weight-of- evidence approaches, drafting of endpoint study records (ESRs) in Iuclid, calculation of DNELs and CSR generation, and production of complex read-across justification reports compatible with the Echa RAAF.

STAFF SELECTION Richard Young – Managing Director and Principal Toxicologist Richard has been at bibra for over 15 years, where he has gained extensive experience reviewing and critically evaluating toxicological data on a wide-range of chemicals (including, more recently, e-cigarette ingredients and emissions). He has been heavily involved in REACH for the past 10 years, leading the bibra team to support a number of companies and consortia with their registration submissions (including the registration of >70 related metal compounds) and also managing REACH Evaluation projects following ECHA draft/final decisions. James Hopkins – Toxicology Director and Chairman James has worked at bibra for 43 years; he is a toxicology director and chemical health risk assessor of high repute, and led the management buyout in 2003. The new company, bibra toxicology advice & consulting, performed impressively under James’ guidance. James has wide experience in reviewing/evaluating toxicological data for a range of chemicals in a cross-section of industries. He has also compiled numerous critical reviews of chemicals and several strategy documents for national governments (including the UK Environment Agency and Health Canada). Peter Watts – Toxicology Director Peter is a bibra veteran of 42 years; his vast experience includes reviewing and critically evaluating toxicological data and providing health risk assessments on numerous chemicals for government departments and industrial organisations. He helped in the preparation of the REACH Guidance on Information Requirements, has authored WHO-IPCS CICADS and Environment Agency CLEA reports, acted as a temporary adviser to the WHO, and has provided peer-review services for OECD SIAMs (and CoCams). Chris Waine – Senior Toxicologist Chris joined bibra at the beginning of 2013 after gaining an MChem in Chemistry with Forensic Science from the University of Manchester and spending a year researching nanomaterials at UCL. Chris has been involved in preparing health hazard and risk assessments for clients from a range of industrial sectors including food, household products and medical devices.

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Profile: bibra toxicology advice & consulting

Profile: BIG vzw

SERVICE AREA BREAKDOWN Training Legal 5% 5% IT & software 10%

CONTACTS Website

www.big.be

E-mail

info@big.be

Head office

Technische Schoolstraat 43A

2440 Geel

Belgium

Tel

+32 14 58 45 47

Fax

+32 14 58 35 16

Contact

Zita Snellinx

Directors

Paul Martens Chairman Es Goossens General Manager

Ownership

Non-profit

Locations

Belgium

Founded

1979

Consultancy/advisory 40%

Information 30% Representation & management 10%

GLOBAL OFFICES Belgium SERVICES PROVIDED REACH BIG can assist your company as consultant or act as Only Representative or Third Party Representative. BIG has experience in registration dossiers as well as member as Lead Registrant and in managing SIEF and supply chain communication. We also assist Downstream Users with their compliance check and possible Downstream User Chemical Safety Assessment. CLP Classification and labelling of substances and mixtures in compliance with Regulation (EU) No. 1907/2006 and amendments (CLP). Performing Classification and Labelling Notifications and product registrations as stipulated in Art. 45.

OVERVIEW

AUDITS

BIG is an independent information and emergency call centre for dangerous goods (substances, mixtures). Information is gathered on physico-chemical and (eco)toxic properties, as well as regulations on safety, health, environmental protection and transport related to hazardous materials. Based on these data BIG delivers a large number of products and services to clients from diverse sectors, including: industry, emergency services, governmental and inspection services, healthcare and academia

BIG performs REACH compliance audits, checking whether strictly controlled conditions are met, if the necessary Risk Management Measures are implemented in line with the received Exposure Scenario’s. BIG also screens and authors (e)SDS’es,

VITAL STATISTICS

2017/18

Turnover, group

N/A

Turnover, chemical service provision

N/A

No of offices

No of countries represented

BIOCIDES BIG provides registration under the biocides regulation OTHERS BIG will be able to assist companies in UK chemical legislation related issues post-BREXIT. BIG also provides products and services concerning information on hazardous materials for the Belgian, Dutch, French, Swiss and German fire brigades and first responders CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Staff, group

1979

BIG was founded a cooperative project

Staff, chemical service provision

1981

Database with 15 000 substances established in 4 languages

1982

BIG is established as non-profit organisation

1983

BIG is first 24/7 available emergency center for firefighters in regard of hazardous materials

1989

Belgian representative in ISPRA committee

1995

BIG continues as an independent non-profit organisation and expands its services for industry

2003

2 x 4-year project for European Commission, DG JRC IRMM evaluating reference materials

2008

Offering REACH services as consultant and OR

2019

Team of 45, database containing more than 60 000 substances, mixtures and articles related to 3 million synonyms in 17 languages

Global Service Providers Guide 2019

Profile: BIG vzw

ACCREDITATIONS ISO 9001 : 2015 Quality Certificate PARTNERS BIG has partners in different fields of expertise in order to offer the best possible solution for our clients CLIENTS Our clients include as well the multinational as SME companies in Europe and more global, but always with an interest in the EU market and from diverse sectors. Besides industry BIG can also count emergency services, governmental and inspection services, healthcare and academia amongst its clients TESTIMONIALS Specific references can be provided for potential clients on request STAFF SELECTION Zita Snellinx, PhD – Sr REACH Consultant Zita obtained a PhD degree in Biological Sciences. In 2002 she started at BIG and has gathered now more than 12 years of experience as a consultant and has been active on REACH since its earliest beginnings. She is currently Coordinator of the REACH-team at BIG and as such also responsible for specific REACH implementations and updates in the BIG database. On top of this she is account manager for some of our key accounts. Bruno Reiners, MSc – Chemical Safety Advisor/REACH toxicologist Bruno graduated as a Master in Biomedical Sciences. He joined BIG in October 2008 as Chemical Safety Advisor and now has more than 10 years of experience. He is in charge of performing risk assessments and evaluating toxicological tests required under REACH. As a Chemical Safety Advisor he also performs risk assessments in regards to health and safety legislation. He has a degree in Safety Management and is also HAZMAT-advisor for the fire departments in case of CBRN incidents. Marleen Vermeulen, MSc – Consultant Marleen graduated as a Master in Biology. She joined BIG in September 2013 after gathering over 7 years of experience as Quality Control Coordinator in the Life Sciences industry. At BIG, she is account manager for several of our clients and in charge of providing expertise to clients in regard to environmental regulations. She is also responsible for implementing environmental legislation in the BIG Database. She also conducts chemical safety assessments under REACH. Marjolein Van Genechten, MSc – Jr REACH Consultant Marjolein has a Master degree in Biology and joined the BIG REACHTeam in 2017. She supports clients to become REACH-compliant and executes the preparation and submission of registration dossiers to ECHA. Her profound and broad knowledge on the different aspects of the REACH Regulation have proven their worth in many complex cases.

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Profile: Blue Frog Scientific

SERVICE AREA BREAKDOWN Representation & management 20%

CONTACTS Website

www.bluefrogscientific.com

E-mail

info@bluefrogscientific.com

Head office

Quantum House, 91 George Street, Edinburgh, EH2 3ES, UK

Tel

+44 (0) 131 523 1412

Contact

Damien Carson

Directors

Damien Carson Tom Hargreaves

Edinburgh, Scotland, UK Cardiff, Wales, UK Dublin, Republic of Ireland

Ownership

Private limited company

SERVICES PROVIDED

Locations

UK Republic of Ireland

Founded

2006

Consultancy/advisory 80%

GLOBAL OFFICES

OVERVIEW Blue Frog Scientific is an independent regulatory consultancy, providing scientific and regulatory affairs solutions to companies in all sectors of the chemical industry. Blue Frogâ&#x20AC;&#x2122;s philosophy is achieving regulatory compliance through the application of good science, innovative thinking and clarity; ensuring that all submissions are prepared efficiently and to a high standard. We offer scientific and regulatory affairs services with particular experience in agrochemicals, biocides, chemicals, human pharmaceuticals, veterinary medicines, and consumer products. Based in the UK and Republic of Ireland, our core team of consultants coordinate operations and our comprehensive network of associates (including technical specialists, legal support and financial accounting) ensures that we can assist our clients in all areas of regulatory compliance. We have particular in-house strengths in chemistry, toxicology, ecotoxicology, environmental fate, and regulatory affairs. We utilise our network of associates when we need leaders in specialised fields to address issues requiring an expert opinion, statement or report. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2019

Scientific consultancy OO regulatory testing design and study monitoring; OO intelligent testing strategies; OO ecotoxicology and environmental fate; OO environmental hazard and risk assessment; OO toxicology; OO human health hazard and risk assessment; and OO compilation of dossiers and expert reports. Regulatory affairs OO regulatory affairs for chemicals, human medicinal products, veterinary medicinal products, agrochemicals and consumer products; OO project management; OO product defence; OO consortium and task force management; OO only representation of non-EU chemical companies under REACH. Agrochemicals Blue Frog Scientific and associates offer a full dossier service for registering plant protection products throughout Europe. Our range of services provides cost effective solutions to support placing your products on the European market. Key sectors of experience include: OO insecticides: pyrethroid, neonicotinoid, organophosphate and carbamate; OO herbicides: organophosphorus, phenylpyrazole; OO benzoylcyclohexanedione, chloroacetanilide; OO fungicides: triazole, anilinopyrimidine, amide, pyrazole; and other: semiochemicals and biopesticides. Biocides (BPR) Blue Frog Scientific provides a comprehensive range of services to the EU biocides sector. Our technical and regulatory specialists can assist with any scope of project, from full planning and execution of active substance and/or product registrations, to discreet problem solving with hazard or risk assessments, and responding to eCA questions during the evaluation phase of submissions. Our service provision to Clients is always designed on a case-by-case basis, to ensure that our Clients receive a service tailored to their needs ensuring accurate scoping and realistic budgeting.

Chemicals (REACH and CLP) Blue Frog Scientific provides a full technical and administrative registration service for chemical substances under Regulation (EC) No 1907/2006 (REACH). Our team is highly qualified and experienced in preparing registration dossiers, chemical safety assessments, coordinating with Siefs and consortia, and liaising with regulatory authorities during and post dossier submission. Key sectors of experience include: OO monomers, process chemicals, coatings and catalysts; OO oilfield chemicals and petroleum products; OO fragrances and flavourings; OO pharmaceutical intermediates; OO substances of unknown or variable composition, complex reaction products or biological origin (UVCB); and OO transported isolated intermediates (Article 18). We also provide supply only representative services in accordance with Article 8 of REACH for non-EU companies that manufacture or formulate chemical substances and mixtures. Consortium/Sief management Blue Frog Scientific has developed a model for managing the financial and administrative challenges of consortia and task forces. We are currently managing consortia and Siefs under REACH as well as other groups of companies collectively working on research and development projects. Our services include: OO provision of a consortium bank account; OO accounts payable and accounts receivable; OO VAT and tax accounting; OO purchase contract management; OO teleconferencing facilities; and OO data storage and management via the secure Blue Frog Scientific extranet.

ACCREDITATIONS European Partner: Society of Environmental Toxicology and Chemistry (SETAC). Member of the Only Representatives Organisation (ORO). Associate Member of the European Oilfield Speciality Chemicals Association (EOSCA) CLIENTS Blue Frog Scientific supports a global client base of chemical, pharmaceutical, veterinary, agrochemical and consumer product companies, ranging from SMEs to large multinational corporations. We take our clients’ confidentiality very seriously and will not disclose their identity. STAFF SELECTION Damien Carson BSc PhD – Director An expert in regulatory affairs, chemical hazard and risk assessment with more than 15 years’ experience across a wide range of sectors in the chemical and biocide industries. Tom Hargreaves BSc (Hons) – Director An expert in environmental hazard and risk assessment, with more than 20 years experience in veterinary medicinal products, human pharmaceuticals, agrochemicals and chemicals. Nigel Halsall BSc PhD – Associate Director An expert in environmental hazard and risk assessment with more than 25 years experience in the agrochemical industry.

Environmental risk assessment of human medicinal products (HMPs) and veterinary medicinal products (VMPs) Blue Frog Scientific has extensive experience in assessing the potential environmental risk posed by human pharmaceuticals and veterinary medicines. Key sectors of experience: OO HMPs: AIDS, chronic kidney disease, ataxia, an.-inflammatory, hypertension, diabetes; OO VMPs: antibiotics, parasiticides, coccidiostats, antipyretics; OO all classes of cattle, swine, sheep, poultry; OO oral drenches, injectables, pour-ons, in feed, in drinking water; and OO product defence, particularly for two ‘priority list’ substances. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006

Formation of chemical regulatory services team within BMT Cordah Limited, part of the BMT group of companies.

2007

Development of REACH technical consulting services supporting a global client base.

2008

Development of human pharmaceutical and veterinary medicine consulting services supporting a global client base.

2010

Management buy-out of Chemical Regulatory Services business by D Carson and T Hargreaves, forming Blue Frog Scientific Limited.

2010

Development of agrochemical consulting services.

20112018

Sustained growth leads to major expansion of company with new staff and offices to support growing client base.

2016

Development of biocides consulting services

2018

Formation of Blue Frog Scientific in Republic of Ireland

www.chemicalwatch.com/SPG

Profile: Blue Frog Scientific

Profile: Bureau Veritas

GLOBAL OFFICES Argentina, Australia, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, India, Norway, Sweden, USA SERVICES PROVIDED CONTACTS Website

www.bvhse.com

E-mail

infohse@dk.bureauveritas.com

Head office

Bureau Veritas , Oldenborggade 25-31, DK-7000 Fredericia

Tel

+45 7731 1000

Contact

Tomas Riegels-Jørgensen

Directors

Jacob Færgemand (DK)

Ownership

Private company

Locations

1400 offices and laboratories worldwide

Founded

1828

Regulatory advisory services Bureau Veritas works in partnership with our clients and develop longterm partnerships. Our team of experts have a solid experience with the following areas: OO REACH consultancy and support for registration; OO chemical management consultancy; OO as REACH Qualified Partner you are ensured a unique overview of the REACH area and an exclusive change to display it effectively; OO Safety data sheets: consultancy and preparation in compliance with REACH and other regulations; OO exposure scenarios; OO REACH only representative; and OO food contact material

OVERVIEW “Bureau Veritas is like an encyclopaedia we can consult when we need chemical consultancy,” as expressed by a client. Having more than 76.000 employees within the fields of chemical management, testing, dangerous goods, certification, inspection, classification and much more this statement is not far from being true. At Bureau Veritas we provide a single point of contact to achieve safety, quality and environmental compliance and performance. Our client portfolio consists of private companies (SMEs and large companies), authorities, and organisations. Bureau Veritas is a Business to Business to Society company, contributing to transforming the world we live in. We provide innovative laboratory testing, inspection and certification solutions and help clients across all industries address challenges in quality, health and safety, environmental protection, enterprise risk and social responsibility. VITAL STATISTICS

2017/18 EUR 4689,4m

Turnover, group

Turnover, chemical service provision

Consultancy OO Classification, Labelling and Packaging of chemical products (GHS and CLP) OO Life Cycle Assessment (LCA) and Environmental Product Declaration (EPD) OO Eco-labelling especially the Nordic Swan Ecolabel and the EUEcolabel for many different product categories – all of them with a purpose to enable business and consumers to choose between the environmentally best services and products OO Chemicals in toys and hobby material OO ATEX OO Legal surveillance Software Easy and efficient management of chemicals with CHESS®. The web based software combines, presents and distributes information about chemicals and their handling. Structure, overview and a high degree of user friendliness characterise all work processes combined with the on demand documentation. With more than 20 languages you do not have to let your international plans limit you. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1828

Company established in order to make shipping safer

1830

An office was opened in Paris and in 1833 the head office moved to the capital of France due to intensive demand

1910

Automotive pioneer by applying technical controls to the automotive industry

1920

During the modern industrial revolution Bureau Veritas encouraged progress and expansion in the rail industry by providing inspection services

1960

Post-WWII the world experience a construction boom and as a response Bureau Veritas reinforced our expertise aiming at protecting people and improve energy efficiency

1996 & 2001

Bureau Veritas acquired two well-established companies in the USA – ACTS and MTL – which strengthened the company’s position within consumer product services.

2007

In Denmark the two consultancy companies, Chemtox and Trotters, were acquired which gave Bureau Veritas a significant knowledge and experience boost within HSE management.

2018

Bureau Veritas is involved in the energy transition and emphasizing sustainable solutions

1,400

No of offices

140

No of countries represented Staff, group

76,000

Staff, chemical service provision

50-100

SERVICE AREA BREAKDOWN

Training 10%

Other 5%

Legal 10%

Consultancy/advisory 40%

IT & software 10%

Laboratory 25%

Global Service Providers Guide 2019

ACCREDITATIONS

STAFF SELECTION

Bureau Veritas is accredited by more than 30 different authorities e.g. DANAK (Denmark), UKAS (UK) and ANAB (USA). Having more than 60 accreditations Bureau Veritas provide accredited certification locally in various countries. Bureau Veritas is a notified body for the ATEX Directive 94/9/EC. Bureau Veritas is an Accredited Ex Certification Body (CB) and Test Laboratory (TL) under the IECEx scheme, offering compliance to a growing list of international markets, including China, Korea, Australia, Russia, Brazil, and many others. IATA Accredited Training School

Tomas Riegels-Jørgensen – Sales Manager With more than 15 years’ employment within Bureau Veritas, Tomas Riegels-Jørgensen has obtained great experience with chemical services, environmental and health consultancy in particular within REACH.

CLIENTS Serving more than 140,000 clients in more than 140 countries our global customer portfolio incorporates manufacturers, distributors and retailers across many industry sectors. As well as trade associations, government bodies, and educational institutions. TESTIMONIALS “CHESS® solved our challenges with finding a global solution to safety data sheets and chemical management to perfection. It was the perfect match for us”. “The short cuts, automatic updates and links that CHESS® contain as well as the interaction with our other systems have been time-saving for us.” “Bureau Veritas is like an encyclopaedia we can consult when we need chemical consultancy,” CASE STUDY 1: Regulatory consultancy (REACH) Bureau Veritas acted as Only Representative and ensured REACH registrations to the European importers of barbecue briquettes legally could import and distribute the product to the European market. The main tasks were: OO Only Representative (OR) according to REACH; OO preparing REACH joint submission registration based on Letter of Access and technical dossiers; and OO registrations of substances and secure go-to-market for the clients products. The benefits that the client obtained were: OO access to the EU-market on time before deadlines; and OO optimised authority application and approval. CASE STUDY 2: Consultancy (Eco-labelling) Our collaboration with the client, a key player within the textile business, started in 2013 when the client was looking for a partner who could renew their EU-Ecolabel. Since then the partnership expanded and now includes: OO Inspections at suppliers located primarily in Africa and Asia; OO various ad hoc tasks; and OO eco-labelling.

Peter Bendtsen – Senior Consultant (REACH) Peter Bendtsen brings extensive knowledge within REACH related services to Bureau Veritas and plays a significant role in our team of chemical engineers. His core expertise encompasses preparation of REACH registrations for clients, preparation of safety data sheets according to REACH, product safety compliance audit and consultancy and RoHs, WEEE interpretation consultancy. Moreover, Peter Bendtsen works with mapping of chemical substances and products /articles in accordance to REACH and other EU regulations. Bente Hviid Nesting – Senior Chemical Engineer/Advisor With more than 26 years’ experience within consultancy in connection with chemistry, safety and occupational health Bente Hviid Nesting is one of the key figures in Bureau Veritas’ team of experts. During her career, she has primarily been involved with: OO consultancy about EU directives and provisions regarding chemicals like REACH and CLP; OO consultancy of clients who purchase articles e.g. toys, food contact materials and cosmetics regarding applicable rules within these areas; OO assessment of ingredients in articles to be marketed within the EU; OO assessment of and consultancy regarding test of toys, food contact materials, etc; OO consultancy about eco-labelling of products like e.g. textiles including inspections at production sites; OO consultancy about general classification and labelling of chemicals and preparation of safety data sheets; and OO Handling of REACH registrations in IUCLID. Christina G. Jacobsen – Consultant Christina G. Jacobsen joined Bureau Veritas in 2014 after completing a Bachelor of Chemical Engineering, and in 2017 she became a certified Dangerous Goods Safety Advisor. Since her start at Bureau Veritas Christina has primarily focused on consultancy within chemistry, safety, occupational health, environment and dangerous goods. Within a short period of time she has specialised in: OO preparation of REACH registrations using IUCLID and REACH-IT. OO Classification and labelling of chemicals; OO preparation of safety data sheets for EU companies; OO product notifications in Denmark; OO CLP notifications; and OO MAL code calculations. In addition to EU regulation, Christina has provided consultancy about national regulations mainly Danish regulation.

CASE STUDY 3: Regulatory consultancy (REACH) On behalf of our client who produces, sells and markets a desiccant Bureau Veritas acted as Only Representative and ensured REACH registrations so the European importers of products containing desiccant legally could import and distribute their products to the European market. The roles that Bureau Veritas played were acting as Only Representative (OR), preparing REACH joint submission registration based on Letter of Access and technical dossiers and registrating substances and securing go-to-market for the clients products

www.chemicalwatch.com/SPG

Profile: Bureau Veritas

Profile: CEHTRA

GLOBAL OFFICES CEHTRA SAS – Bordeaux, Lyon, Paris, France CEHTRA Europe – Waterloo, Belgium CEHTRA UK – Nottingham, UK CEHTRA SL – Madrid, Spain CEHTRA India – Kerala, India CEHTRA North America –Toronto, Canada CEHTRA Germany – Hamburg, Germany

CONTACTS Website

www.cehtra.com

E-mail

contact@cehtra.com

Head office

15 rue Aristide Briand 33150 Cenon

Tel

+33 557775610

Fax

+33 557775620

Contact

Paul Thomas

Directors

Dr Peter Jenkinson, France and UK Dr Nathalie Ledirac Dr Paul Thomas Philippe Adrian, Belgium Nathalie Hanon, Spain Jason Nugent, Canada

Ownership

Private company

Locations

France, Belgium, UK, Spain, India, Canada, Germany

Founded

2001

SERVICES PROVIDED Regulatory dossier services CEHTRA provides clients with bespoke services for regulatory dossiers for the following markets: Biocides, Chemicals, Cosmetics, Pharmaceuticals, Plant Protection, Food and Packaging and Medical Devices. Our services include CADDY dossiers, E-SDS, IH, Training and Worldwide notifications. CEHTRA also provides Only Representative (OR) services in the UK and in Europe. We use, verify and validate the algorithms of software such as Ecetoc TRA, FOCUS (for pesticides and biocides) and ART and improve on existing tools (e.g. by adding a module to allow speedy formatting of final dossiers or work on Consexpo). Industrial hygiene and worker exposure studies With almost 20 years of experience in a wide variety of industrial sectors, from pesticides to general chemicals, and a comprehensive understanding of the tools used in risk-data interpretation, including generation of exposure limits, CEHTRA is able to provide you with the answers and support in industrial hygiene adapted to your specific needs.

OVERVIEW CEHTRA offers scientific and innovative solutions ensuring regulatory compliance of chemicals according to international obligations: from portfolio strategy to the notification of chemicals, from human exposure to site audits. CEHTRA provides high quality regulatory services, to companies committed to the safety of their products, at optimal cost. VITAL STATISTICS

2017/18

Turnover, group

€7m

Turnover, chemical service provision

50% 8

No of offices

No of countries represented Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Legal Training 6% 2% IT & software 7% Representation & management 10%

Global Service Providers Guide 2019

Consultancy/advisory 75%

Consortium and Sief management We offer a complete service that can either be used as a stand-alone or combined with the technical services provided by CEHTRA. We ensure that the milestones and deadlines of your project are met while building the spirit of fairness and transparency, while maintaining strict confidentiality. We can help you with the preparation of consortium agreements, maintaining contact lists, archiving, billing and all the aspects required for effectively running consortia and Siefs. Specific Expertise Our experts have been successful in proposing and supporting complex issues for CMR classifications, modifying acceptable exposure limits and other critical substance-related end-points at member state or EU level. We have also successfully used our knowledge in clinical toxicology and epidemiology to support several of our clients in court cases. Reach Authorisation and Prioritisation / Anticipation In order to predict the inclusion in the ECHA Candidate list, CEHTRA offers a Regulatory Watchdog service meaning that you will be informed of the probability of your substance being included in a 3, 5, or 10 year horizon. The service covers substances already commercialised and those currently being developed thus ensuring their mid-term use. In-Silico Modelling services KREATiS SAS, a subsidiary of CEHTRA, specialises in in silico predictions (High-Accuracy Qsars), which may be used to replace laboratory studies in many regulatory dossiers such as REACH (more info on www.kreatis. eu). Global Notification. We offer OO global regulation strategies; OO testing programmes; OO scientific expertise; and OO registration dossiers.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2001

Company established

2004

Opening of UK office

2008

Opening of Brussels office

2008

Opening of Lyon office

2009

Opening of India office

2011

Opening of North America offices

2012

Opening of ChemAdvocacy

2014

Opening of KREATiS

2016

Integration into H2B Group

2018

Opening of Madrid office

2019

Opening of German office

ACCREDITATIONS Our consultants have either an MSc and/or PhD or equivalent. Senior members of our team hold recognised accreditations such as Eurotox registered toxicologists (ERT) and ecotoxicologists (British Toxicology Society or Société Française de Toxicologie), or similar such as Dangerous Goods Safety Advisor (DGSA), Certified Industrial Hygienist (CIH). PARTNERS KREATiS, LTS REACH OR, ChemService GmbH, ECOonline, Global Regulatory Communications, Microeconomix CLIENTS Chemical companies, flavours and fragrances, petrochemicals, cosmetic companies, plant protection industry, biocides, veterinary products, pharmaceuticals. TESTIMONIALS Available on request STAFF SELECTION Peter Jenkinson − PhD, GT – CEO CEHTRA SAS and Manager of UK Office Peter Jenkinson has a PhD in reproductive toxicology and over 30 years’ experience in the CRO industry specialising in genetic toxicology. Latterly he was the director of the Chemical Business Unit at Harlan Laboratories with a primary role of developing the REACH services of the company. In March 2010 he joined CEHTRA to open the UK office and has provided expert toxicology advice, particularly for study monitoring and data interpretation. Paul Thomas PhD, ERT − Executive Vice President CEHTRA, Manager of Lyon Office and President KREATiS Paul Thomas has a PhD in aquatic ecotoxicology and over 20 years’ experience with industrial chemicals, agrochemicals and biocides gained at CIT, ATOFINA and AkzoNobel. He joined CEHTRA in 2008 as director of CEHTRA Lyon specialising in REACH-related services and is manager of the CEHTRA ecotoxicology team. Paul has contributed strongly to numerous successful registrations. In 2014 he founded KREATiS and is still highly involved in R&D and the company’s scientific development. contributing to the development of several innovative new Qsar models

Philippe Adrian PhD –Manager of Brussels Office Philippe Adrian has a PhD in soil science and over 20 years’ experience with agrochemicals and biocides. Prior to his current position he worked as a research scientist in Germany. Later he worked at CNRS in France and then Rhone-Poulenc Agrochimie and FMC. In 2001 he founded CEHTRA with Pierre-Gerard Pontal and manages the environmental fate team. He has developed modelling expertise for pesticides according to current models, as well as biocides using relevant TGDs. Nathalie Ledirac PhD, ERT – R&D Director and Manager of CEHTRA Bordeaux Nathalie has a PhD in cellular and molecular aspect of biology and 16 years’ experience with agrochemicals. She worked as a research scientist at INRA in France on pesticide toxicity and has also participated in private research on drugs for pharmaceutical industries (HMR, Galderma). She joined CEHTRA in 2006 as a regulatory toxicologist and provides expert toxicology advice in study monitoring and data interpretation. She develops close partnerships with private and academic research by increasing the scientific participation of CEHTRA experts in research projects (research programmes, publications, model development for pesticides, accreditation, etc). Stephane Pierre, PhD – REACH Authorization Manager Stephane is a qualified pharmacist with a PhD and a master’s degree in toxicology. His thesis focused on the health hazard effects (principally carcinogenesis) of environmental pollutants and his post-doc fellow on new bacterial enzyme mechanism. He qualified as a European Registered Toxicologists (ERT) in 2016. Stéphane worked previously as REACH authorization project manager and REACH team leader in EcoMundo consulting company. He holds expertise in several toxicological problematics (Exposure scenario, data evaluation, data gap analysis, study monitoring, classification, DNELs calculation, etc).) and in socio-economic analysis. In CEHTRA he manages the REACH authorization team. Nathalie Hanon, MSc – Manager of Madrid Office and Biocides Nathalie holds an engineering degree in natural sciences from the Gembloux Agricultural University (Belgium). She has over 20 years’ experience in regulatory affairs, 8 in Plant Protection Products and 12 in the Biocide business. Among her activities she has led a Regulatory department in charge of active substances, products dossiers and business regulatory strategies in a major biocides production company. She has recently become Manager of CEHTRA SL (Spain) and leads our Biocides group. Jason Nugent MSc – Manager of CEHTRA NA Jason is a highly experienced chemical registration specialist who has worked within the North American chemical industry for more than 18 years. Over the course of his career, Jason has managed and participated in the preparation of more than 400 chemical registrations in Canada, USA, the EU, China, Australia, and Japan. In recent years he has been heavily involved in assisting North American companies to prepare for and comply with REACH. Charles Alarcon PhD, CIH – Industrial Hygienist Charles has a PhD in geochemistry and over 15 years’ experience as an industrial hygienist and was one of the first in France to obtain the prestigious CIH certification (still one of only ten in France). He joined CEHTRA in 2009 developing exposure scenario in REACH dossiers and e-SDS. Through audits and other site studies, and using currents models in risk assessment, he has gained a large experience in many industrial sector activities and acquired a unique understanding of health and safety industrial culture.

Profile: Charles River

SERVICE AREA BREAKDOWN Consultancy/advisory 5%

CONTACTS Website

www.criver.com

E-mail

askcharlesriver@crl.com

Head office

251 Ballardvale Street, Wilmington, MA, US 01887

Tel

+44 1875 614545 (UK) /1-877-CRIVER-1 (US)

Fax

+44 7802951646

Contact

Karen McCusker

Directors

James Foster

251 Ballardvale Street Wilmington, MA 01887 United States

Ownership

Public limited company

SERVICES PROVIDED

Locations

Global locations and offices

Founded

1947

Services to meet global registration requirements Charles River has supported the chemical industry for over 40 years. Drawing on this extensive experience, we offer a full range of studies to meet the requirements of REACH, TSCA as well as other global notification and registration requirements.

Laboratory 95%

GLOBAL OFFICES

OVERVIEW Charles River is the market-leading provider of contract testing services to the pharmaceutical, chemical and agrochemical industry and has been providing high-quality research models and laboratory animal support expertise since 1947. Our unique safety assessment portfolio spans the entire research and development process, allowing for flexible, customised approaches to support both single-study and broad-based programmes. With facilities in Europe, North America and Asia, we are well-positioned to help optimise the discovery and development of our clientsâ&#x20AC;&#x2122; drugs, chemicals, agrochemicals, medical devices and therapies. Our customer base includes major pharmaceutical and biotechnology companies, as well as leading companies in the chemical and agrochemical sectors, academic institutions and government research centres. Always leading with science, our exceptional team of toxicologists, pathologists, veterinary surgeons, regulatory specialists and support personnel designs and conducts safety studies ranging from acute to chronic toxicity and carcinogenicity studies. Charles River is also at the forefront of the industry in the fields of developmental and reproductive toxicology, inhalation toxicology and other specialty toxicological assessments. We offer an expanding portfolio of in vitro methods to replace traditional in vivo studies where possible. All of our studies are conducted to GLP and are supported by the highest quality analytical services, including bioanalysis, central laboratories, immunology, drug metabolism and pharmacokinetics and formulation development. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No. of offices No. of countries represented Staff, group Staff, chemical service provision

Global Service Providers Guide 2019

17 14,000 -

Regulatory support Charles River can advise and assist in many ways, including designing a registration strategy for REACH that suits the needs of a substance and/or portfolio. We partner with clients across the whole process, from helping to assess data requirements and evaluating data, to helping with dossier preparation. For non-EU manufacturers we can also perform the role of only representative. We can also advise on the cost-effectiveness of taking a more global approach to design a suitable testing strategy by including endpoints and studies to fulfil a wider range of regulatory study requirements. We provide human and environmental hazard, exposure, and risk assessments to meet the requirements of all major global regulatory authorities, including determining testing strategies for the use(s) of substance(s). Physico-chemical testing Our service includes all the characterisation and physico-chemical studies necessary to support worldwide registrations for both active ingredients and formulated products. We offer a full range of testing services, either as packaged or standalone studies conducted to the appropriate guidelines. Acute toxicology A full spectrum of regulatory-compliant studies is offered to evaluate oral, dermal and inhalation toxicity, dermal and ocular irritation, and skin sensitisation. In vitro models are available to assess dermal irritation or corrosivity and ocular irritation. An in chemico assay is available to assign skin corrosion classifications, while in silico models are also offered to identify corrosive or irritation potential. Repeat, reproductive and chronic toxicology We routinely perform repeated dose studies from short term to chronic, including carcinogenicity possible via oral/dermal/inhalation exposure. Reproductive toxicology screening to OECD 421 and 422 are available, as well as developmental toxicology in rats and rabbits. Our portfolio of multigenerational studies also includes the Extended One-Generation Reproductive Toxicity Study, required to satisfy OECD Guideline 443.

Genetic toxicology Studies typically follow a tiered approach beginning with an in vitro Ames test and progressing to short-term in vitro assays, including mouse lymphoma and chromosomal aberrations assays, and in vivo assays such as rodent micronucleus test and/or comet assay. In addition to standard study designs, we are also able to offer customised protocols for the rapid screening of candidate molecules for toxicity profiles. Ecotoxicology Charles River offers a comprehensive range of aquatic and terrestrial ecotoxicology testing services to assess the environmental risk of chemical, pharmaceutical, biocide and agrochemical products. We design studies to meet specific data requirements that take into account the properties of the test item and its potential routes of environmental exposure. Our scientists are skilled in the handling of difficult test items (e.g., volatile, unstable, complex and poorly soluble mixtures), and our facilities are specifically equipped to support complex test situations. Most ecotoxicology tests can be conducted with a radiolabelled test item if necessary. Environmental fate studies Charles River has over 25 yearsâ&#x20AC;&#x2122; experience conducting environmental fate studies to meet European, US and Japanese regulatory requirements. We perform the in-life phases of environmental fate studies in environmentally controlled incubation rooms or incubators. Selfcontained flow-through incubation systems (aerobic and anaerobic), with the flexibility to accommodate different trapping systems for collection of volatile products, are available for radiolabeled degradation studies; a similar flow-through apparatus is used in photolysis studies. Sealed systems are available for investigations with volatile test items, as well as systems for collection and quantification of reduced radiolabeled volatile products. We can obtain test systems such as sediment, surface waters and soils from a variety of local and international geographical sources. Prior to study conduct, we fully characterize all test systems and confirm their viability. Endocrine disruptor screening programme Charles River offers custom endocrine disruptor screening programme (EDSP) consultancy and testing services, combining excellent project communication and support from our dedicated team of experts. With rapid turnaround times, we are also able to shorten timelines with our testing program. Our experts can help at every stage, from initial data gathering through evaluation and interpretation for hazard/risk assessment. All studies are validated and performed according to GLP principles.

TESTIMONIALS Testimonials can be provided on request. CASE STUDY Our clients and their programmes are protected by our strict confidentiality agreements; therefore, we are unable to discuss specific case studies. All our study directors have extensive experience ranging from five to over 25 years, giving them the depth of expertise required to deliver to the highest standard on studies and provide a flexible, solutions-driven approach to the design of both individual studies and entire registration programmes. With emphasis on quality and technical excellence, enforced through continuous training, internal audit programmes and proactive communication, our scientific staff will work together with your own teams to produce work of the highest standard to meet your registration requirements. STAFF SELECTION Director, Laboratory Sciences OO Joined Charles River in 1988 OO Has responsibility for all aspects of the services provided by Charles River to chemical, agrochemical and veterinary product companies Operational Area Manager, Chemistry OO Joined Charles River in 1988 OO Experienced in xenobiotic metabolite identification, residue analysis and analytical chemistry OO Responsible for managing a team of study directors handling physicochemical, analytical and stability studies Head, Environmental Fate and Metabolism OO Joined Charles River in 1994 OO Oversees the design and conduct of studies intended to characterise the fate of chemicals in the environment and to study the nature of metabolites and metabolic pathways using a range of chromatographic and spectrophotomic techniques Head, Regulatory Affairs OO Joined Charles River in 2010 OO 20 yearsâ&#x20AC;&#x2122; experience in agrochemical, biocides and chemical regulatory affairs OO Leads a team of more than 20 regulatory affairs experts, which provides support for the registration of chemicals, biocides, agrochemicals and pharmaceutical products

Analytical support A validated analytical method is required to support many product chemistry and (eco) toxicology tests. Experienced analysts are available to establish new analytical methods or to transfer existing methodology using a wide range of up-to-date equipment. All required physico-chemical properties for substances can be tested. The storage stability and shelf life of the formulated product can be determined under a variety of specified storage conditions. Solid, liquid, semi-solid and aerosol formulations can all be evaluated using real-time and accelerated storage stability testing. We have dedicated facilities to stress the material using monitored heat, humidity or light parameters. ACCREDITATIONS AAALAC, GLP, GCPv, GEP, GMP CLIENTS A broad range of companies producing pharmaceutical, agrochemical, chemical, biocide and animal health products. Our client base includes consortia, start-ups, virtual companies and SMEs as well as global corporations.

www.chemicalwatch.com/SPG

Profile: Charles River

Profile: ChemAlert

SERVICE AREA BREAKDOWN

Training 5%

CONTACTS

Other 5%

Consultancy/advisory 20%

Website

https://rmtglobal.com/

E-mail

info@rmt.com.au

Head office

5 Ventnor Avenue

West Perth

Australia

Tel

+61893221711

Australia – Perth, Melbourne and Canberra

Fax

+61893221794

SOFTWARE & SERVICES PROVIDED

Contact

info@rmt.com.au

Directors

Dean Apostolou, Managing Director; Amanda Miles, Director Client Services

Ownership

Private

Locations

Australia – Perth, Melbourne and Canberra

Founded

1991

Chemical Safety Management Software ChemAlert offers companies and its employees: OO extensive quality SDS data base; OO inventory tracking and management; OO independent research and multiple international compliance standards; OO comprehensive toxicity & regulatory data; OO product reports ad labelling; OO interest profiles and notifications; OO mobile application; OO secure cloud hosting; and OO chemical footprint assessment and tracking

IT & software 50%

GLOBAL OFFICES

OVERVIEW RMT is an internationally recognised chemical and risk management technology provider with a reputation for relentless innovation, scientific analysis and project excellence. RMT has developed and supports ChemAlert, which is recognised as one of the world’s most respected chemical safety management systems, backed by a comprehensive suite of services and support for clients around the world. ChemAlert provides a depth of knowledge and research which is available through our software and the experienced professionals in our Science and Technology teams. Regulators are driving stringent new changes to the global framework, requiring organisations to responsibly manage Chemicals of High Concern within their supply chain. ChemAlert assists by enabling clients to respond efficiently whilst managing compliance, reputational risks and their global chemical footprint. VITAL STATISTICS

2017/2018

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

>60

Staff, chemical service provision

>40

Global Service Providers Guide 2019

Information 20%

Safety Data Sheet Authoring GHS format SDSs with content tailored to suit the appropriate statutory requirements for the intended countries of use. Authored by university qualified Scientists. Hosting sites for SDSs available. Chemical Safety Audits Review and report on existing chemical management procedures including Dangerous Goods storage and segregation. Provide recommendations of best practice based on relevant legislation/ standards. Chemical Inventory Implementations Configuration of company specific data to reflect quantities and storage locations of chemicals used, enabling accurate reporting procedures and high-level overviews of chemical types used by the organisation. Subsequently facilitates the replacement of chemicals with less hazardous ones. Training Flexible training options available to assist users maximise use of ChemAlert (chemical management software)). Options include Public Training (open to subscribers and non-subscribers), Site Training (specific to an organisation) and eLearning (computer-based learning system). Additional topics such as the SDSs, Labels, the GHS and Dangerous Goods are also covered. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1991

RMT was founded by Dean Apostolou to forge new online models of managing risk and performance. RMT commenced as a consulting partner specialising in chemical and industry risk management.

1993

ChemAlert 1 released

1997

ChemAlert 2 released

2001

BHP Billiton invest into RMT

2003

Intranet based ChemAlert add-on service released

2004

Melbourne office established

2007

ChemAlert 3 released as web-based application

2008

RMT purchased BHP Billiton shareholding

2010

RMT signs partnership with Mitrais to provide self-hosted installation packages

2013

Canberra office established ChemAlert 4 released with new inter face RMT signs partnership with Global Switch for data centre services

2018

ChemAlert 5 released with Chemical Footprint focus

ACCREDITATIONS Quality Endorsed Company – Accredited to ISO9001:2015 GHS Compliant across the Globe CLIENTS More than 1000 Global clients across 28 countries in industries of: Oil & Gas, Mining, Manufacturing, Health, Pharmaceutical, Aviation, Federal, State and Local Governments and Universities TESTIMONIALS Refer to website – https://rmtglobal.com/ CASE STUDY 1: Consolidating Chemicals Inventory OO Client: Top Tier Science/Research Organisation OO Inventory consisted of over 60,000 chemicals, some of which were over 50 years old (legacy/reference/experimental chemicals), many without corresponding SDSs OO Gap analysis performed and up to date SDSs provided for chemicals which were lacking OO Alternative suppliers were suggested moving forwards, for relevant chemicals where the manufacturer had since been incorporated/ ceased trading OO Status allocated to each chemical product to ensure complete transparency OO Monthly milestones met to guarantee completion of transition process OO Scientific Services continue to work closely with organisation to ensure SDS and chemical compliance into the future CASE STUDY 2: Providing Safer Alternatives OO ChemAlert provides organisations with the power to locate safer chemical alternatives via the Chemical Footprint feature OO Alternative chemicals are suggested based on their impacts on human health as well as the environment OO For example, in collaboration with mining companies and ChemAlert, CRC is constantly striving to create ‘electrical cleaning solutions’ that do not contain CMRs. OO Consequently creating safer alternatives to Dichloromethane, Tetra and Trichloroethylene CASE STUDY 3: Improving SDS Information OO Manufacturer: Multinational Laboratory, Pharmaceutical and Research Corporation OO University qualified Scientists review and verify each SDS before it is entered into ChemAlert OO Where potential errors are identified, manufacturers are contacted to

clarify/amend their SDSs SDS failed to classify chemical with mandatory GHS classifications as per regional competent body (H301 – Toxic if swallowed & H314 – Causes severe skin burns and eye damage) Manufacturer advised an error had been made and the SDS corrected with the inclusion of H314 & H301, leading to accurate hazard communication being delivered to users

STAFF SELECTION Dean Apostolou – Managing Director and Founder With the understanding that 90% of our everyday environment is of our own creation, Dean’s passion has always focussed on understanding the impacts these man-made systems have in occupational and environmental health and creating practical yet breakthrough solutions. With a background in industrial research at major international chemical and public health organisations, Dean has lead the development of the ChemAlert platform, enabling many thousands of organisations globally to forge viable commercial paths that manage chemical risk and the escalating threat of sustainable ecological stability, human health, and community prosperity. Amanda Miles – Director Client Services With 1000 clients in 28 countries, the role of implementing and sustaining our chemical and enterprise risk platforms in diverse industries and organisations seeking very specific outcomes is Directed by Amanda Miles. Not only is Amanda responsible for establishing and sustaining effective relationships with senior management but leverages these relationships also provide the insights into current and future needs enabling RMT teams to continue to enhance the value derived from their technology investments with us. With a foundation in information technology and international experience in global telecommunications and commercial television organisations, Amanda returned to Australia in 1999 to take up Senior Solutions Consultant role and was appointed to the role of Client Services Director in 2007. Vince Pacecca – Chief Scientific Officer Vince holds a Bachelor of Science (Pharmacology and Biochemistry), with further qualifications in Occupational Health and Safety and Hygiene. Possessing over 20 years of experience in chemical management, Vince has developed a detailed knowledge of the legislative requirements and hazardous communication frameworks within Australia and around the world. As a subject matter expert on the Globally Harmonised System (GHS), and an experienced presenter and facilitator, Vince has presented several white papers and delivered keynote addresses at conferences all over the world. Greg Mlodawski – Chief Technical Officer Greg was appointed CTO at RMT in 2001 after previously holding various technical management roles with industries varying from software development to research departments within government organisations. Greg holds a Bachelor of Science degree and is responsible for making technical strategic decisions, leading innovation and change and providing his technical expertise to projects. Greg has direct oversight in driving RMT’s Information Technology direction, technical support and technical delivery including dependent projects and the delivery groups. Francine Ryan – Director Strategy & Growth Francine is responsible for leading the sales, marketing and growth strategies of RMT. Francine has strong orientation and experience in translating strategy into actionable execution. She has extensive international expertise in business analysis, strategic planning, management and sales. Francine joined RMT in 2018 following a career of more than 20 years leading high-performance teams within global client centric organisations in a variety of industries including technology, biotechnology, financial and professional services. Francine holds a Bachelor of Commerce, is member of the Institute of Chartered Accountants in Australia.

www.chemicalwatch.com/SPG

Profile: ChemAlert

Profile: CHEMDOX

GLOBAL OFFICES Austria (Head Office), USA SERVICES PROVIDED

CONTACTS

Where does CHEMDOX® help? The CHEMDOX® software supports experts in all tasks regarding hazardous materials management:

Website

www.chemdox.com

E-mail

office@chemdox.com

Head office

Salztorgasse 1/2A 1010 Vienna Austria

Tel

Europe: +43 1 5321489 0 Americas: +1 888 8369462

Contact

Anton Zrzavy

Directors

Anton Zrzavy

Ownership

UCS – unique computing solutions gmbh

Locations

Austria, USA

Founded

2011

SDS authoring software Generate SDS efficiently and ‘translate’ your SDS into 40+ countries, taking into account official languages, national legal terminology, as well as national regulations. You can automate your SDS creation process by using templates and rules maintaining all the flexibility required when authoring your documents. Thanks to the lively exchange with all CHEMDOX® users, a wide variety of applications or use cases are constantly being adapted and optimised, or expanded by new ones. Even special use cases – such as private labelling – are handled efficiently. Classification calculators Improve regulatory compliance when classifying chemicals according to several regulations (e.g. GHS, transport, national regulations). CHEMDOX® regulatory calculators provide automatically computed classification suggestions. Regulatory coverage Cover global regulatory requirements on a best practice level and up-todate for all major markets in e.g. Europe, Asia, Americas.

OVERVIEW The CHEMDOX® company provides an outstanding software solution for the chemical industry: OO Classify chemicals according to numerous regulations OO Generate high-quality safety-related documents in the most efficient way OO Assure regulatory compliance What our clients like about us? The CHEMDOX® software has been developed by experts for experts. It’s efficient, open, flexible and supports compliance. It is easy to use, easy to integrate, and easy to automate. All this, based on state-of-the-art technology and an outstanding customer support. Good software adapts to the needs of their users. This is what we believe in. This is what we work on every day. The CHEMDOX® company is a 100% subsidiary of UCS – unique computing solutions gmbh – developing high-quality software since 1999. VITAL STATISTICS

2017/18 2

No of offices No of countries represented

Europe, Americas

Staff, group

50+

Staff, chemical service provision

20+

SERVICE AREA BREAKDOWN

Hazard labelling software Create multilingual hazard labels with our flexible label editor or integrate CHEMDOX® with your existing solution. SDS distribution Distribute SDS automatically with no manual effort. System integration and data exchange The CHEMDOX® software provides easy and state-of-the-art integration with other IT systems via its comprehensive API. Furthermore, the electronic exchange of data improves productivity and quality. Technical data All benefits of a web-application with the perfect usability of a desktop application; OO state-of-the-art technology makes CHEMDOX® future-proof; and OO freedom of choice regarding hardware, operating system, and installation scenario. OO

Training, support and professional services Updates & Support At least quarterly, CHEMDOX® updates ensure that the software is up-to-date and in accordance with regulatory changes. Our team of experts provides continuous support via e-mail or on the phone. Training To get the most out of CHEMDOX®, we offer introductory, individual, and open trainings for users, as well as technical trainings (e.g. development with the CHEMDOX® API, system integration, etc.) especially tailored to your needs.

Training 20%

IT & software 80%

Global Service Providers Guide 2019

Chemical management software With the CHEMDOX® software, its legal content and its substance database, managing your chemicals is easy and efficient. Track your substances to stay up-to-date and compliant. Based on this, the generation of your hazard communication documents and regulatory reports is a matter of a few simple steps.

Installation and Implementation Install CHEMDOX® easily on a server – accessible for one or more users – or a specific workstation in your company. No matter which option you choose, installation is just as smooth and intuitive as using the CHEMDOX® software. If you still need help, we are here for you. Hosting For your comfort, CHEMDOX® can also be installed on our servers and is accessible via an internet connection. Configuration and customisation options OO Configuration of CHEMDOX®; OO connection of your ERP system to CHEMDOX®; OO data transfer or migration from other programs; OO implementation of interfaces with other systems; and OO custom development of special software modules. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1999

UCS – unique computing solutions gmbh

2011

CHEMDOX GmbH

2016

CHEMDOX Inc.

PARTNERS OO OO

Several regional consulting and sales partners worldwide; and several software partners (ERP, Labelling, etc.)

CLIENTS CHEMDOX® clients range from medium to multinational companies across all industries and the chemical supply chain: OO government agencies; OO substance producers; OO formulators; OO industrial users (e.g. automotive); OO consulting firms; and OO distribution companies etc. TESTIMONIALS

CASE STUDY 3: A multinational company wants to avoid differences in product information or documentation due to multiple software installations in their subsidiaries. OO centralisation of product and regulatory information, as well as documentation in CHEMDOX®; OO working remains decentralised taking into account official languages, national legal terminology, as well as national regulations and national GHS-implementations; OO web-application with the perfect usability of a desktop application but without the need for a local client installation; OO multilingual user interface including regional specifics (e.g. date, time or number formats); OO fine grained permission settings, versioning, change history, statutory retention; OO quality improvements and efficiency gains due to collaboration across the subsidiaries; OO interfacing with multiple IT systems - keeping ERP system and CHEMDOX® in sync - generating labels in a high through-put production environment with variable data like batch numbers, individual barcodes, etc; and OO distributing technical information and technical datasheets generated with CHEMDOX® to different systems. STAFF SELECTION CHEMDOX® Team The CHEMDOX® staff includes professional, qualified, and skilled experts from the areas of chemistry, law, and software engineering. We are working as a team to constantly improve CHEMDOX® and our outstanding customer support. CHEMDOX® Partners Our certified partner network extends the CHEMDOX® team offering local presence and specific knowhow. Therefore, we engage in targeted, long-term partnerships with renowned suppliers of complementary products and services. For our customers, the regional availability of professional services and regulatory expertise, as well as the possibility to professionally integrate CHEMDOX® into the existing infrastructure is of great use.

We work very closely with our customers, appreciate their inputs, and strive for a durable, long-term partnership. Find out for yourself: We would be happy to connect you with one of our customers. CASE STUDY 1: A major player in the automotive industry has to implement a chemical management solution due to compliance reasons. OO manage and check SDS and regulatory information provided by suppliers for plausibility; OO automatically track the regulatory status of substances in use (classification calculators); OO comply with Global Automotive Declarable Substance List (GADSL); and OO integrate with SAP® for substance volume tracking and VOC reporting. CASE STUDY 2: A consulting firm has to replace the software solution for their main service: Safety Data Sheet (SDS) authoring. OO migration of 25.000+ products to CHEMDOX®; OO comprehensive regulatory and language support; OO respect customer’s corporate identity when authoring SDS; and OO strong focus on accuracy and efficiency.

www.chemicalwatch.com/SPG

Profile: CHEMDOX

Profile: Chementors Ltd

GLOBAL OFFICES Finland, Hong Kong, Vietnam SERVICES PROVIDED REACH We help you plan and carry out necessary tests for substance identiﬁcation and inquiry, we assist you with assessments and statements to be submitted as well as with dossier preparation and further discussions with the authorities. We help replace discontinued substances and we provide GLP certiﬁed laboratory services. Understanding, correct interpretation and evaluation of data and research reports acquired from sources of variable quality is of outermost importance for the quality of the safety assessments. Access to the EU market is achieved, with our help and support.

CONTACTS Website

www.chementors.eu

E-mail

info@chementors.eu

Head office

Raisionkaari 55, FI-21200 Raisio, Finland

Tel

+358 40 7473393

Contact

Dr Jan Nylund

Directors

Jani Määttä, CEO Jan Nylund, COO

Ownership

Private

Locations

Raisio/ Finland, Hong Kong, Ho Chi Minh City/ Vietnam

Founded

2009

Only Representative services Non-EU manufacturers and importers have to use a European company as their representative, that is an only representative (OR), to carry out their REACH registration procedures. Choosing a reliable and competent OR is an important decision to make as the only representative enables access to the EU market for the client’s products. The OR is liable under EU law that the requirements and obligations set by the regulation are met. We have the experience, knowledge and expertise to take on the responsibilities as your OR. Chementors is a member of the Only Representative Organisation (ORO), an accredited ECHA stakeholder body.

OVERVIEW Chementors provides chemical safety services to companies affected by REACH, CLP, the biocidal products regulation and the cosmetic products regulation. We offer top notch research and expert services to support our customers’ registration tasks. We help you with the whole process starting from data acquisition, testing strategies and data evaluation to preparation of the final registration documentation using ECHAs tools Iuclid, Chesar, R4BP and REACH-IT. VITAL STATISTICS

2017/18 -

Turnover, group Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

Legal 5%

Training 5%

IT & software 10% Laboratory 5% Information 5%

Representation & management 20%

Global Service Providers Guide 2019

Consultancy/advisory 50%

Exporters to Asia With our Hong Kong and Vietnam offices as bases we make your life easier if you plan to start operations with chemicals in Asia. We facilitate your export efforts and offer our network for a smoother and faster entry and market introduction. For China we offer through our partners an integrated package of service for New Chemical Registration, i.e. China REACH (IECSC). CLP – SDS authoring and translation with local legislation Our extensive experience in handling and classiﬁcation of chemical substances and mixtures enables us to help you with challenges connected to the CLP/GHS system. We prepare, review and translate safety data sheets (SDS), extended SDS (eSDS) and labels, covering all EU languages and many more. All designed with your brand in mind. We help with the interpretation and adaption of the exposure scenarios to be attached to the SDSs in an eSDS. We advise you on different options on labelling and classification. We advise you how to modify your product if we see some feasible options! Substance substitution – R&D-services, formulation Increasingly stringent regulatory enforcement and changes in the classifications of substances strongly challenges R&D departments to arrive at suitably functional, environmentally sustainable solutions while maintaining and improving product performance. With thorough experience in sciences relating to detergency and other colloid/surface phenomena, we tackle formulation problems and challenges experienced in today’s techno-chemical and cosmetics industry. Cosmetic safety assessment and responsible person The Cosmetic Product Safety Report (CPSR) is divided into two parts. Part A provides information on safety and important properties of the product, in addition to an evaluation of the toxicological profile of its components. Part B comprises an overall safety assessment of the product, taking into account known hazards and exposures leading to an evaluation of risks and margin of safety (MoS) in order to determine acceptable ways of use.

Usually the manufacturer or importer assumes the identity of the responsible person. The distributor within the EEA could also be required to take on the role of the responsible person, if they place a cosmetic product on the market under their own name or trademark or if they modify a product already on the market. Alternatively, the manufacturer or importer may authorise a representative to act on their behalf as a responsible person. The obligations of the responsible person are to ensure that the product is safe for its intended use and that it is used in a safe way, and to ensure that all requirements under the regulation are fulfilled. Chementors may act as your responsible person and ensure your legal presence on the EU market. Human health and environment assessment Determination of safe exposure levels and suggestions for risk management measures to control exposure based risks are needed when preparing chemical safety assessments, reports and waivers. Our experts help you with the calculations and evaluations as well as with supporting measurements to determine critical conditions in your processes and uses. Biocides and consortia The biocides regulation (BPR) require that safety assessments are performed also on formulated products, contrary to REACH which only applies to substances. Cooperation with other producers of biocidal products is possible under certain circumstances. We assist you in negotiations with other stakeholders, co-registrants and consortia to achieve the most costeffective solution for the authorisation challenges you may face. Simplified authorisation, product families and mutual recognition in other member states are noteworthy options. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2010

Approved service provider in REACHReady Matchmaker programme, United Kingdom

2012

Merge with FinnREACH Ltd

2013

Office in Tampere and Kokkola, Finland

2013

Partner in Shanghai, China

2015

Joining Smart Chemistry Park in Raisio, Finland

2015

Office in Hong Kong, China

2017

Partners in Guangzhou, China and Tokyo, Japan

2018

Office in Ho Chi Minh City, Vietnam

ACCREDITATIONS REACHReady Matchmaker programme in UK and the Only Representative Organisation (ORO), Reliable Partner (FIN). PARTNERS Trade organisations, consultants, laboratories and companies in China, Vietnam, Japan, USA and several EU countries. On-going process to find partners in ASEAN countries (Vietnam, Thailand etc.) CLIENTS EU: Metso Minerals Ltd, Oriola Ltd, Mayer Industries Estonia, KiiltoClean ASIA: Radico India, Hock Chemie China, Salicylates & Chemical Pvt India, Aarti Industries India

TESTIMONIALS “As we came up with the thought to open EU markets with our cosmetic products we realised that requirements by the European regulations would be strict and complicated. Without special consultancy, the mission would have been impossible. We contacted Chementors and ever since our cooperation has been efficient and profitable. Chementors is covering all regulatory issues for us including the only representative (REACH) and responsible person (cosmetics) responsibilities. Being dynamic and a customer caring company we have been really lucky to find Chementors as our partner.” – Sanjeev Bhatt, Director – Radico, India CASE STUDY 1: Biocides We took care of all practical issues for the registration of a biocide active substance. The work included data gap analysis – testing strategy – test planning and organising – literature review – safety and risk assessments – authority negotiations – dossier preparation. One challenge was to develop a cost-efficient testing strategy and plan as the initially available data turned out to be unreliable and incorrect. CASE STUDY 2: Toll manufacturing and ECHA ECHA’s fees are based on the size of the toll manufacturer. This results in an unfair situation for small innovative companies that choose to outsource the production to toll manufacturers, especially if the toll manufacturer is a big company. Chementors sorted out the options the small company has and what the authorities stand points are. STAFF SELECTION Dr. Jan Nylund – PhD in Physical Chemistry, Pharmacy COO, partner. REACH, BPR, cosmetics, CLP, regulatory affairs, 20+ years of experience in chemical industry and safety assessments, R&D and formulation work Mr. Leif Viklund – MSc Biochemistry REACH, CLP, BPR regulatory affairs and submission. Expert on QSAR, Read Across, IUCLID, R4BP, Chesar and additional exposure scenario (ES) software including ES assessments. Ms. Maria O’Shea – MSc Environmental Science and Technology REACH, CLP, BPR regulatory affairs and submission, five years at Echa – junior scientific officer, dossier evaluation and helpdesk, Chesar (Development Team), NONS follow up activities, GLP activities. Mr. Jani Määttä – MSc Chemical Engineering CEO, partner; A 14-year background as CEO and partner in enterprises manufacturing and developing industrial chemicals, now settled in Vietnam, in charge of Chementors´ global mind setting and evolution. Mr. Kenneth Bergroth – MSc Chemistry and Biochemistry REACH, CLP, SDS-authoring, Chemical industry (R&D, production, EHSQ), Organization for the Prohibition of Chemical Weapons (OPCW) – inspector six years, ISO 9001, ISO 14001 and OSHAS 18001 auditor (IRCA). Ms. Satu Salomäki – MSc Organic Chemistry Cosmetics, pharmacy, toxicology and risk assessment; cosmetic safety assessment, Dangerous Goods Safety Advisor (DGSA) incl. IATA. Mr. Antti Aalto Sales director, partner; A ten-year background as an entrepreneur, has been positioned since 2015 in Hong Kong and Vietnam for networking and adopting the Chinese and South East Asian business culture.

www.chemicalwatch.com/SPG

Profile: Chementors Ltd

Profile: Chemleg

SERVICE AREA BREAKDOWN Training 10% IT & software 15%

CONTACTS Website

www.chemleg.com

E-mail

info@chemleg.com

Head office

Altıntepe Mah. Istasyon Yolu Sk. No:3/1 Maltepe/ Istanbul, Turkey

Tel

+90 (216) 706 1307

Fax

+90 (216) 706 1284

Contact

Ms Elif Koç , Mr Gökhan Ardıç

Ownership

Limited company

Locations

Turkey

Founded

2017

OVERVIEW CHEMLEG is a consultancy company in Turkey providing “chemical regulatory compliance” services to the enterprises aligned within chemical industry for helping them to commercialize their products. All our staffs have more than ten years professional experience in carrying out the process related with chemicals technical information and chemical legislation in the chemical industry. Our experienced consultants provide chemical regulatory support for the companies to have competitive advantage in global market by providing accurate and quality service quickly. CHEMLEG always offer consultancy service with the highest quality at competitive and moderate prices. Chemical regulatory consultant combines legislation and chemistry for the work CHEMLEG does. So, our technic staffs are good educated and experienced persons for chemistry and biochemistry. Our experienced consultants always direct the companies to the most available and accurate way to follow the responsibility for chemical regulations. Our staffs have certificates (SDS, CAE for KKDIK), which are obligatory for the relevant Turkey regulations, that are included our service area. CHEMLEG has not only global networks but also local networks especially such as trade and university associations, technical universities and laboratories. Our core service areas are; OO Only Representative service for KKDIK (Turkish REACH), Turkish CLP Regulation and Turkish BPR; OO KKDIK (Turkish REACH) compliance services; OO SDS/MSDS authoring services; OO SDS certification services for Turkish SDS; OO preparation of “label” and “technical information form” for general chemicals; OO Turkish BPR Compliance Service; OO -CLP compliance (Turkish CLP-SEA and EU CLP) and GHS compliance services; OO Turkish detergent regulation compliance services; OO non-medical veterinary products registration services; OO training and consultancy services; OO CHEMLEG is partner with TELEMATIC for providing EPY SDS authoring software; and OO technical translation services.

Global Service Providers Guide 2019

Consultancy/advisory 30%

Information 10% Representation & management 35%

SERVICES PROVIDED Only representative (OR) Service KKDIK (Turkish REACH) regulation; OO Turkish BPR regulation; OO Turkish CLP regulation. OO

KKDIK Compliance Services OO CHEMLEG provides companies service to be in compliance with KKDIK Regulation requirements. Registration, that will be done within the scope of KKDIK, will be realized in two steps pre-registration and registration respectively. Restrictions will go into effect gradually. CHEMLEG services; OO to be done pre-registration; OO join and follow-up all activities in the pre-SIEF and SIEF; OO performing all necessary communications with the consortium; OO carry out all the relevant transactions behalf of our customers; OO determination of chemical characterization of the substances; OO data management and data-gap analysis; OO preparation of registration dossiers including the uses, robust study summaries, CSR, CSA, risk assessment report etc.; OO translations of technical documents/test reports in preparation of the registration dossier; OO uploading/submission of the registration dossier to KKS in Turkish by the chemical assessment experts; OO establishing of the substance inventory list under annex-17; OO communication with the supply chain. Turkish Biocidal Product Regulation Compliance Services Companies which will market their biocidal products in Turkey should obtain biocidal product license for their products. Our services; OO determination of the product’s scope; OO preparation of the BP license dossier; OO management of the licensing process; OO technical evaluation and suitability assessment for the physicochemical analysis and efficacy test methods; OO management of the analyses/efficacy test procedures; OO assessment and translation of toxicologic, eco-toxicologic tests, risk assessment reports; OO getting license of the biocidal product. Turkish CLP Regulation Compliance Services OO classification of substances/mixtures supplied to the market; OO labelling and packaging of harmful substances/ mixtures; OO notification of hazardous substances to C&L (SEA) inventory through KKS; OO follow up the updated information of the substances; OO determination of label and packaging dimensions of hazardous substances and mixtures.

Turkey SDS Regulation and Label Compliance Services Safety data sheets should be prepared in accordance with the Turkey SDS regulation by certified persons. In this context CHEMLEG authorise SDS and check/ review SDSs prepared by the supplier and certificate them. CHEMLEG sales EPY SDS authoring software including technical and regulatory support. OO preparation of safety data sheets; OO checking the safety data sheets compliance with the relevant regulation; OO certification of safety data sheets after review. SDS Software CHEMLEG has a partnership with TELEMATIC for providing safety data sheet and label software to the Turkish market. EPY is a modular, integrated software suite developed specifically to help chemical companies comply with the regulations governing chemical products. In addition to full compliance with the Turkey and European regulation, the possibility of creating SDS and hazard labels has now been added for the Chinese, the USA and Canadian markets. We as CHEMLEG also provide training, regulatory and technical support on EPY. ACCREDITATIONS Member of Istanbul chamber of commerce; SDS authorized certificate; Chemical assessment expert certificate. PARTNERS TELEMATIC (Italy) for EPY SDS authoring software. CLIENTS CHEMLEG’s clients are the companies working in chemical industry and associated industry in all over the world such as United Kingdom, USA, Norway, Italy, Germany, France, Bulgaria, Belgium, Netherlands etc. Our clients span manufacturers, importers and downstream users in raw material, biocides, paints-coatings, cosmetics, cleaning-products, petrochemicals industry etc. CHEMLEG also works with the consultancy companies, located in England, Finland, Italy, China, USA and Germany, to serve their clients for the compliance of Turkish chemical control regulations. The names of the companies we work with are not disclosed due to confidentiality. However, upon request, it can be expressed by obtaining approval from our customers.

Gökhan ARDIÇ He is chemist and health & safety expert. He has master’s degree on this field at Marmara University. He has more than eight years experiences on the chemical regulatory services especially safety data sheet authoring. He has compiled almost ten thousand SDS including many languages by now. He has a certificate obtained from the competent authority to author Turkish safety data sheet. He has also exceptionally good information on the field of classification, labelling and packaging (Turkey SEA / EU CLP) regulation. He also gives the training on safe usage and storage of chemicals in a university. He is the responsible person for the SDS authoring software in CHEMLEG and providing technical and regulatory support for the companies which use this software. His specialities briefly: SDS authoring (including e-SDS with exposure scenarios), product safety, chemical management, capable of assessment toxicological and ecotoxicological test results from CSR, chemical labelling, technical and regulatory support. Mehmet YOLCU He is a chemist and has master’s degree on B class health & safety expert. He is trainer for “chemical assessment expert”. He has more than eight years experiences on the chemical regulatory consultant especially such as Turkish CLP/CICR and EU REACH regulation for Turkish exporters. He carried out thousands of C&L, CICR and SDS notifications for the companies. In addition of these he delivered many collective/ individual trainings for KKDIK, CLP, SDS regulations. He managed the project scope and processes for the EU REACH, Turkish CLP, CICR and Turkish SDS regulations for the companies. He provided support for the companies, located in Turkey, about their responsibilities within the scope of EU CLP and EU REACH during they would export their products to European union member countries. he identifies of the requirements of the roles in relation to chemical control regulations. He delivers training on the process management of the KKDIK regulation and EU REACH regulation. He determines how to handle by interpreting the provisions of the new or updated chemical regulations. CHEMLEG’s other members Other members of CHEMLEG are environmental and chemical engineers. All members have SDS authorized and chemical assessment expert certificates. They have experience from three to seven years with the area of chemical regulatory consultancy such as EU REACH, KKDIK, SDS authoring, biocidal products. They have deep experiences to interpret about toxicological and ecotoxicological tests. Also, they are competent for management of the regulative of the chemicals and providing accurate consultancy to the companies from industrial areas experiences.

STAFF SELECTION Elif KOÇ Elif is master’s degree of chemist. She is the responsible person for managing and application of the full process of regulatory compliance for KKDIK and biocides departments in CHEMLEG Consultancy ltd. She has CAE certificate. In order to enable companies to manage their internal KKDIK compliance process, she delivers KKDIK training within Technical University. Also, she delivers KKS utilization training for the companies. She worked as a research assistant at Istanbul Technical University for the scientific and technological research council of Turkey projects for years. She worked R&D departments as analytical method development & validation specialist for active substance and impurities. Then she moved to consultancy company as biocide department team leader. She managed lots of international companies’ biocidal products requirements for Turkey. She is experienced to manage physical and chemical properties of the product, analyses methods, toxicologicalecotoxicological profile. She carried out the first submission in Turkey for a biocidal product to be used for the purpose of R&D and managed all the process. Also, she is experienced in chemical technical advice on KKDIK substance characterization thanks to her technical background. She has more than ten years experienced in the chemical industry as a researcher and regulatory specialist.

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Profile: Chemleg

Profile: Chemsafe

100

SERVICES PROVIDED Worldwide regulatory affairs consulting Chemsafe assists its clients with a range of regulatory affairs services Worldwide ranging from the legal side to all the technical matters in order to comply with international and national chemical control legislation. Our technical staff has a great experience in all aspects of REACH, CLP, SDS and has prepared a great number of registration dossiers and chemical safety reports (CSA/CSR) and also had provided expert advice on specific areas of REACH, such as data evaluation and/or study monitoring. Chemsafe has a vast experience in programme, project, SIEF and consortia management.

CONTACTS Website

www.chemsafe-consulting.com

E-mail

chemsafe@chemsafe-consulting.com

Head office

Chemsafe Srl, Via Ribes, 5, 10010 Colleretto Giacosa (TO), Italy

Tel

+39 0125 538888

Fax

+39 0125 538475

Contact

Dr. Antonio Conto, Managing Director

Directors

Dr Antonio Conto, European Registered Toxicologist (ERT), Managing Director

Ownership

Private company

Locations

Italy

Founded

2001

REACH and CLP/GHS Chemsafe provides its clients with strategic, legal and technical support in order to comply with REACH and CLP/ GHS as well as SDS and e-SDS preparation. Our technical support includes full dossier preparation (as LR or JR), data gap analysis, review and analysis of physico-chemical, environmental fate. It also includes ecotoxicology and toxicological data, CSA/CSR preparation, human and environmental exposure scenarios (ES) and Risk Assessment, and application of alternative strategies to testing such as using a read-across approach and QSAR. IUCLID 6 preparation and submission to ECHA. SIEF and consortia management We can help our clients with a full/partial SIEF and/or Consortia management system, including preparation of all kind of legal agreements, LoA, data sharing, archiving, billing and all the necessary management activities.

OVERVIEW Chemsafe’s vision is to offer regulatory and technical/scientific solutions and services in the field of chemical safety with a “key point” approach and customer care attitude. VITAL STATISTICS

2017/18

Turnover, group

€2.5m

Turnover, chemical service provision

€2.5m

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

Legal 5% IT & software 5%

Training 5%

Laboratory 5% Information 10%

Representation & management 20%

GLOBAL OFFICES Chemsafe Srl, Colleretto Giacosa (TO), Italy

Global Service Providers Guide 2019

Consultancy/advisory 50%

Only representative (OR) and third party representative (TPR) In 2008 Chemsafe started to act as an only representative (OR) for non-European manufacturers and fulfilling the pre-registration and later registration obligations as prescribed in Article 8 of REACH Regulation. ChemSafe is acting as OR for different types of companies coming from USA, Switzerland, South America, Middle East and Far East countries. Furthermore we can act as a third party representative (TPR) for companies not wanting to disclose their identity to others. Legal advice We advise our clients on legal aspects of chemical trade around the world and related chemical control regulations. Biocides and agrochemicals Our team can prepare and submit technical dossiers for authorisation of active substances and for registration of formulated products. We can also prepare the technical equivalence data for active substances. We coordinate the regulatory strategy with the national and/or international authorities in order to deliver a successful dossier for biocidal products and agrochemicals. Coordination includes study monitoring for toxicology. Eco-toxicology, efficacy studies (laboratory and field) as well as phys-chem. and analytics. First product with two actives submitted in Italy by Chemsafe. Pharmaceutical and Medical Devices services Pharma 1) Safety: OO OEL/OEB/ ASL evaluation + PDE; OO ERA (environmental risk assessment); OO “in silico” evaluation (DEREK, SARAH, METEOR); OO extractables and leachables toxicological evaluation; and OO quantification / qualification of impurities. 2) GMP: OO DMF preparation in CTD format (module 3, section 3.2.S) for the European registration, US and Canada; OO OQS (overall quality summary 2.3P and 2.3.S); and OO preliminary evaluation of all documentation for the dossier and DMF preparation. 3) GLP activity: OO From candidate profiling to preclinical development.

Medical devices OO Strategic/regulatory consultancy as per new EU Reg. 745/2017; OO MD class identification; OO biological evaluations; OO Human Health Risk Assessment; OO technical dossier preparation; OO quality system application; and OO liiason with Regulatory Bodies.

CASE STUDY 2: REACH dossier work

Cosmetics OO General regulatory support for cosmetic products; OO Competent person designation; OO data evaluation, data gap analysis, read-across methodology, in silico method application, testing programme design, and study monitoring/coordination; OO PIF (product information file) or PSR (product safety report); and OO administrative activity, including robust study summaries and substance information sheet (SIS) with ingredient evaluation.

CASE STUDY 3: legal case

Petrochemicals We advise our clients on legal aspects of control regulations. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2001

Started up in Italy as a ‘one man’ company.

20072008

REACH and OR services offered.

2009

Biocides and agrochemicals group creation.

2010

Technical consortia advisers for three international consortia. Staff increase to ten people.

2011

Petrochemicals derivatives, wastes, cosmetics and pharmaceuticals consortia management. Staff increased to 12 people.

2012

Pharma Business services inaugurated

2015

Operational offices moved to Parella (TO)-Italy.

2017

New Business development Manager ISO 9001:2015 Certification (under implementation)

More than 360 REACH dossiers done, including lead registrant and joint submission dossiers are our background; including some for UVCB substances. An important number of CSR, and hundreds of safety and extended safety data sheets (SDS and e-SDS) had also been done by our team.

In 2012 Chemsafe successfully settled a legal case with the European authorities on behalf of one of our European clients. STAFF SELECTION Dr Antonio Conto – Managing Director Biology degree, European Registered Toxicologist (ERT). Founder of Chemsafe. >28 years of experience in the regulatory toxicological and chemical fields. Dr. Paolo Rossi, BDM Chemical Area Biotechnologist. More than 8 years experience in the Business Management activities at international level. Dr. Lara De Luca – Head of the Chemical Business Unit Industrial chemist, with more than 12 years experience. Risk assessment, exposure scenarios, CSR/CSA. Dr. Francesca Fasano – Head of Biocides and Agro Business Unit Industrial chemist, with more than 10 years experience. Biocides, agrochemicals and ecotoxicology. Dr. Marco Rodda – Head of Pharmaceutical Business Unit Biologist, safety evaluation of drugs, OEL, PDE, e-CTD. Pre-clinical projects Dr. Federica Carra, Responsible for Quality System implementation Chemical-Pharmaceutical Technology Degree Qualified Person for Pharma companies Implementation of the ISO 9001-2015 in Chemsafe activities.

ACCREDITATIONS Chemsafe is a full member of ORO, the RO (Only Representatives Organisation) Chemsafe is a member of the Industrial Union of Turin, Italy PARTNERS Chemsafe is 100% privately owned. CLIENTS Our clients are manufacturers and importers involved in the market sectors of: chemicals, pharmaceuticals, agrochemicals, biocides, cosmetics, food, medical devices, nanomaterials and petrochemicals worldwide. Their size goes from multinational companies to SMEs and national authorities. TESTIMONIALS Any companies requesting testimonials or references will be provided with them upon individual written request. CASE STUDY 1: REACH testing programme Working together with a global supplier of hydrocarbons Chemsafe created a comprehensive testing/study programme for REACH registration of a wide range of products for that client.

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Profile: Chemsafe

101

Profile: Chemservice

102

VITAL STATISTICS

CONTACTS Website

Turnover, group (w/o CEHTRA)

~ €10m

Turnover, chemical service provision

~ €10m 19

No. of offices (incl. CEHTRA) www.chemservice-group.com

E-mail

contact@chemservice-group.com

Head offices

Chemservice GmbH Herrnsheimer Hauptstr. 1b, 67550 Worms, Germany / Chemservice S.A. 5, an de Laengten, 6776 Grevenmacher, Luxembourg / Chemservice Asia Co. Ltd. Technical Innovation Building B-201, 202, 15, Jonggaro, Jung-gu, 44412 Ulsan, Korea

Tel

2018

+49 6241 95480 0 / +352 270776 1 / +82 52 223 6232

Fax

+49 6241 95480 25 / +352 270776 75 / +82 52 223 6230

Contacts

Karl-Heinz Reis (Germany) Dr Dominik Kirf (Luxembourg) Ah-Reum Seo (Korea)

Directors

Dr Dieter Drohmann, CEO Karl-Heinz Reis, Director Global Regulatory Affairs Dr Dominik Kirf, Director Toxicology & Risk Assessment Thomas Schaefer, Director Data & System Services Ah-Reum Seo, Director Asia Pacific Doris Peters, Director Consortia Dr Jaime Sales, Director Iberia Lara Dickens (aka Hoadley), Director UK Christy Leeper, Director Americas

Ownership

Privately owned group of companies

Locations

Germany, Luxembourg, Korea, France, Switzerland, Spain, UK, USA and CEHTRA offices

Founded

2007

OVERVIEW Chemservice is a leading global consultancy to the chemical industry and its value chain. As an independent service provider, we support our clients in regulatory affairs, national and international chemical regulations, toxicology, risk assessments and environmental sciences. We use our scientific, technical and strategic know-how to overcome regulatory barriers globally, giving our clients a competitive edge. We are an interdisciplinary team of chemists, biologists, toxicologists and environmental scientists. Working with our partners in the fields of health and safety, consortia management, representation of interests and socio-economic evaluation, enables us to give our clients comprehensive advice, even beyond the bounds of chemical regulations. Adding up the professional records, the Chemservice staff has more than 1000 years of regulatory affairs experience. Our business philosophy? Dedication to find the best solutions to suit your needs!

Global Service Providers Guide 2019

No. of countries represented Staff, group (incl. CEHTRA)

ca. 120

Staff, chemical service provision

ca. 110

SERVICE AREA BREAKDOWN

Training 5%

Other 5%

IT & software 10% Consultancy/advisory 45%

Information 15%

Representation & management 20%

GLOBAL OFFICES Chemservice GmbH, Worms, Germany Chemservice S.A., Grevenmacher, Luxembourg Chemservice Asia Co. Ltd., Ulsan and Seoul, Korea Chemservice EHNS GmbH, Worms, Germany Consortia Management GmbH, Worms, Germany ChemCehtra SAS, Bordeaux, France ChemAdvocacy S.A., Grevenmacher, Luxembourg Chemservice Schweiz GmbH, Morschach, Switzerland Consortia Asia Co. Ltd., Ulsan and Seoul, Korea Chemservice Iberia, Castellón, Spain Chemservice UK Ltd., Maidstone, United Kingdom Chemservice Americas LLC, Helena (MT), USA CEHTRA offices (Canada, Belgium, France, India, UK) SERVICES PROVIDED Global regulatory affairs consulting We provide a broad range of services to assist you in complying with national and international chemical control legislation. The application range for chemistry is extensive. Therefore, chemical control legislation is comprehensive in order to assure product safety, producer liability and consumer and environmental protection to regulate the marketing of chemical substances. Beside inventory notifications, we conduct registrations of biocides, cosmetics and food contact materials. With our offices and regional partners, we support you to comply with international chemical regulations like REACH, K-REACH and China-REACH. Trough our newly established entities, we also offer regulatory consultancy for the Swiss, South American and US market; being as well prepared for any upcoming decisions on UK chemicals law. REACH and GHS/CLP We provide you with strategic and technical support for REACH and GHS/CLP. The technical support includes, for example, data gap analysis, registration cost evaluation, testing strategy proposals, placing/ monitoring/reviewing of studies, registrations, dossier preparation, compilation of chemical safety reports, exposure, hazard and risk

assessments, PBT/vPvB evaluation and support on authorisation, REACH-IT and Iuclid assistance, C&L notification, safety data sheet and label creation. Through our legal entity ChemAdvocacy, we provide REACH authorisation and restriction services (including SEA), advocacy and product stewardship consulting. Our affiliate Chemservice EHNS supports you on EH&S issues and provides company representatives like health and safety experts.

CLIENTS

Consortia, Sief and Letter of Access management Consortia Management GmbH provides independent secretariat, trustee and accounting services to REACH consortia, Siefs and lead registrants in order to enable the chemical industry and its value chain to fulfil their joint registration obligations according to the REACH regulation. Our automated online Letter of Access (LoA) tool “REACH LoA Shop” provides an efficient LoA management for Sief members to acquire access rights for a specific substance for the submission of the joint REACH registration dossier. Moreover, the tool will free up resources at lead registrant or consortia level and provides professional accounting support – including trustee account management.

CASE STUDY 1: Global inventory strategy and registration

Only representative and third-party representative In accordance with REACH, non-EU manufacturers must have appointed an Only Representative (OR) within the EU to implement the substance registration process. We assume this role on your behalf, and thereby play a pivotal role in the successful marketing of your products in the EU. Furthermore, we provide trustee services for indirect non-EU supply chains with final import into the EU. The importers of these non-EU manufacturers no longer have registration obligations and are being regarded as downstream users. We also act as your third-party representative according to REACH Article 4.

We are a global consultancy to the chemical industry and its value chain. Our clients range from multinational chemical companies to SMEs, formulators, traders, retailers and OEMs. We do not disclose our customers publicly, but provide reference names and testimonials upon request.

We have significant experience in global inventory registrations and conducted around 200 notifications to the Turkish inventory, 400 nominations to the inventory in Taiwan and 75 notifications to the Thai inventory. For multiple clients we have supplied global inventory strategies for new substances and conducted notifications to chemical inventories, e.g. Australia (AICS), Canada (DSL), China (IECSC), South Korea (ECL), New Zealand (NZIOC), Philippines (PICCS) and USA (TSCA). CASE STUDY 2: REACH-Code-Model

2007

Start-up in Luxembourg

2008

Opening of Chemservice office in Germany

2009

Launch of Consortia Management GmbH

2010

Opening of Chemservice office in Korea

The REACH regulation does not distinguish between direct and indirect imports into the EU. Consequently, trade outside the EU followed by imports into the EU is more difficult. This applies in particular, if several companies are involved along a non-EU supply chain, formulating substances in preparations with secret compositions. In a multistage non-EU supply chain, the manufacturer generally does not know in which products, in which quantity and by which route, its substance is imported into the EU. The components of which their products are made and who their suppliers and customers are, constitute confidential business information (CBI) closely guarded by traders or formulators. Neither the non-EU manufacturer (represented by the OR) nor the importer can meet their obligations without disclosing such CBI, hence risking the loss of their business. To address this problem, we have developed a software-based solution – the REACH-Code-Model. Many companies with multistage non-EU supply chains have already signed up to this system. A web based tool will be available soon.

2011

Launch of Chemservice EHNS GmbH Launch of JV ChemCehtra in France

CASE STUDY 3: REACH dossier work

2012

Launch of ChemAdvocacy S.A. with office in Luxembourg

2014

Relocation of Chemservice GmbH to new office in Germany

2015

Opening of 2nd office in Korea (Ulsan)

2016

Chemservice acquired a two-digit share of CEHTRA

2017

Chemservice acquired REACh ChemAdvice GmbH (effective 1 January 2018)

2018

Launch of Chemservice Schweiz GmbH in Switzerland Launch of Consortia Asia Co. Ltd. in Korea Complete integration of REACh ChemAdvice GmbH into Chemservice GmbH

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

2019

Establishment of three new Chemservice entities: Chemservice Iberia, Spain Chemservice UK Ltd., UK Chemservice Americas LLC, USA

ACCREDITATIONS We are a member of ORO, the Only Representative Organisation in Brussels and comply with the quality standards of ORO. Dr Dieter Drohmann is chairing ORO as president.

We are experienced in the preparation and submission of more than 800 Tier 1, 2 and 3 REACH dossiers, including member and lead dossiers. Moreover, a significant number of new substance registrations (nonphase-ins), inquiry dossiers, PPORDs, chemical safety reports and extended safety data sheets were successfully completed. On behalf of our clients, we have conducted more than 2500 C&L notifications. CASE STUDY 4: Korean REACH Chemservice Asia has performed many new substance notifications to the Korean Inventory under the TCCA legislation. Our K-REACH experience is based on ca. 60 small volume substance registrations, 25 substance registrations and ca. 70 exemption confirmations. We act as OR, with around 400 substances contracted, and have considerable experience in managing K-REACH consortia. With the establishment of Consortia Asia Co. Ltd. in 2018, we further strengthen our role as K-REACH consortium manager, providing secretariat and financial services as well as LoA and data access management to K-REACH registrants.

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Profile: Chemservice

103

Profile: China National Chemical Information Center

104

SERVICE AREA BREAKDOWN

Laboratory 15%

CONTACTS

Other 2%

Website

www.chemhse.com www.cncic.cn

E-mail

regulation@hse.cncic.cn

Head office

No. 53 Xiaoguan Str Anding menwai, Beijing, China

Tel

+86 10 64421139

Fax

+86 10 64428331

GLOBAL OFFICES

Contact

Lisa Zhong

Directors

Min Shui Yubin Jie Victor Lu

Beijing office (Headquarters): NO. 53, Anwai Xiaoguan Street, Beijing 100029, China Tel: +86 10 64421139. E-mail: regulation@hse.cncic.cn

Ownership

China state owned company

Locations

Beijing, China

Founded

1959

Information 14%

Representation & management 9%

SERVICES PROVIDED China new chemical substance notification service CNCIC is the most professional consulting firm handling China New Chemical Substance Notifications. More than a third of the notification dossiers approved by the authority are developed by CNCIC. CNCIC provide services including: OO regulation consulting and LA-OR service; OO Affirmative of Inventories of Existing Chemical Substances; OO data evaluation and data gap analysis; OO strategies of tests, waiver statements, QSAR; OO test arrangements and monitoring; OO professional test summary translation; OO chemical risk assessment; OO SDS and labelling; OO organisation and submission the notification dossier; OO following-up and informing of the notification process; OO communicating with the authorities; and OO maintenance after notification;

OVERVIEW China National Chemical Information Center Co., Ltd.(CNCIC), based in Beijing and formerly named the Scientific and Technological Information Research Institute of the Ministry of Chemical Industry, has a history of 60 years with chemical and technical professors, we have overall approximately 400 stuffs, providing services such as chemical industry consulting, professional exhibitions, standards drafting, chemical regulations consulting etc. Our product registration and compliance department has been dedicating to acting as a professional technical group on compliance with the regulations in China and abroad. With our extensive database resources on HSE (health, safety and environment), it has been of great technical assistance to hundreds of chemical manufacturers and suppliers in: OO new chemical substance notification; OO globally harmonized system of classification and labelling (GHS); OO hazardous chemical substance registration; OO pesticide registration; OO cosmetic new substance registration; OO food related products registration; OO disinfectant products registration; OO pharmaceutical registration; OO K-REACH services; OO CSCL/ISHL services; and OO Taiwan TCSCA/OSHA notification VITAL STATISTICS

Pesticide registration CNCIC provide services including: OO data gap analysis; OO registration budget, cost control and work plan preparation; OO test arrangements and process monitoring; OO pesticide registration dossier preparation and submission; OO pesticide data authorization; OO pesticides risk assessment report; OO communication and coordination with the authority; and OO post notification management;

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented Staff, group Staff, chemical service provision

Global Service Providers Guide 2019

Consultancy/advisory 60%

1 400 25

Globally harmonized system of classification and labelling of chemicals (GHS) related services in China CNCIC provides GHS related services in China, including: OO identification and classification of chemical hazards, and risk assessment; OO preparation of GHS-SDS and precautionary labels; OO search and query services for data necessary for classification; OO test arrangements for identification and classification of chemical physical hazards; OO 24h emergency hotline service; and OO registration of hazardous chemicals. Disinfectant products registration CNCIC provides notification services according to the disinfectants related regulations, including: OO regulatory compliance evaluation; OO test arrangement and monitoring; OO prepare the declaration dossier for clients; and OO renewal registration.

Food related product compliance and notification service CNCIC provides notification services according to the food related regulations, including: OO regulatory compliance evaluation; OO test arrangement and monitoring; OO create and submit the notification dossier; OO attend the technical review meeting on behalf of clients; OO prepare the supplementary data after the accreditation council; and OO communication with authority during the notification and assist clients to solve the potential problems.

ACCREDITATIONS

Cosmetic new materials notification CNCIC provides notification services to the authority, including: OO new cosmetic ingredient administrative licensing notification; OO domestic special functional cosmetics product administrative licensing notification; OO domestic non-special functional cosmetics product record certificate application; OO import of non-special functional cosmetics record certificate application; and OO import of special functional cosmetics administrative licensing notification.

TESTIMONIALS

K-REACH services CNCIC provides K-REACH notification services including: OO pre-registration; OO data gap analysis, data exemption, QSAR and statements; OO consortium management; OO test arrangements and monitoring; OO preparation of Korean SDS and label; OO risk assessment report; and OO K-REACH registration dossier creation and submission. CSCL/ISHL services CNCIC provides full supports on CSCL/ISHL notification including: OO new chemical confirmation; OO data gap analysis, data exemption, QSAR and statements; OO test arrangements and monitoring; OO risk assessment report; OO registration dossier creation and submission; Taiwan TCSCA/OSHA CNCIC provides Taiwan chemical notification services including: OO data gap analysis; OO data exemption, QSAR and statements; OO test arrangements and monitoring; OO pre-registration and TPR service; OO preparation of SDS and label; OO risk assessment report; and OO maintenance after notification. Pharmaceuticals registration CNCIC provides Pharmaceuticals registration services including: OO review technical documents; OO import and technical support; OO studies placement and monitoring (non-clinic studies, clinical studies phase I to IV; bioequivalence tests etc) OO organisation and submission the registration dossier; OO following-up and informing of the registration process.

CNCIC is the biggest and most famous chemical research institute, consulting firm, and information/regulation service provider in China with 60 years of history. It has played an active role in building China chemical HSE, and national environmental standards/regulations. For years, CNCIC has provided instant, efficient, and professional services in Chinese standards/regulations for more than 1000 domestic and overseas manufacturers and traders.

“CNCIC provides instant and professional service to help us successfully notified our new chemical substance product so that we can export our product to China smoothly,” says a chemical producer. Another client says: “It takes less time and gets more professional services for us to commission CNCIC for China chemical regulation issue. They are worth trusting!” STAFF SELECTION Minyan Liang Minyan Liang is a Senior Engineer with 13 years of experience in Chinese chemical regulation consulting services. She is the sales director, focusing on Chinese chemical regulations, Standards, with an emphasis on new chemical substance notification, toxicology and ecotoxicology. She has led more than 100 new substance notification projects and has rich experts and resources in compliance services. Lisa Zhong Lisa Zhong, Certified Toxicologist by Chinese Society of Toxicology, is a Senior Engineer with ten years of experience in chemical regulatory affairs. She has been focusing on new chemical substance notification, test managements and monitoring. She has participated in more than 150 new substances general notification and supervise more than 800 substances tests. She has extensive experiences in chemical regulatory compliance services. Richard Tong Richard Tong focuses on Chinese chemical regulations, supporting clients solve problems in China New Chemical Substance Notification. Richard is a Senior Engineer with 13 years’ experience in chemical regulatory consulting services. Richard has plentiful experience in new chemical notification; he has successfully achieved more than 700 registration certificates for simplified notification and more than 100 registration certificates of general notification. He has extensive experience in regulatory compliance, toxicology and ecotoxicology testing etc. Amy Yu Amy Yu is manager of pesticides registration team. Amy graduated from Beijing University of Chemical Technology in 2005, with 13 years of experience in China and overseas pesticides registration. She led more than 200 pesticide registration projects, and Led 28 new ingredient registration, she has extensive experience in domestic and foreign pesticide registration regulations. Ans she leads a specialised and professional team for agricultural chemicals compliance services.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1959

Science and Technology Information Research Institute of China Ministry of Chemical Industry (STIRI) established in Beijing, China. In the planned economy era of China, it was part of Chinese government.

1984

The Economical Information Center of the Ministry of Chemical Industry (EIC) was established.

1992

STIRI and EIC was merged into China National Chemical Information Center (CNCIC), a China state owned company.

2017

China National Chemical Information Center was changed to China National Chemical Information Center Co., Ltd. www.chemicalwatch.com/SPG

Profile: China National Chemical Information Center

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Profile: ChIR - Chemical Innovation and Regulation

106

GLOBAL OFFICES University of Algarve, Faculty of Science and Technology, Campus de Gambelas, 8005-139 Faro, Portugal; University of Barcelona, Gran Via de les Corts Catalanes, 585 08007, Barcelona Spain; Alma Mater Studiorum â&#x20AC;&#x201C; University of Bologna, Via F. Selmi, 2, 41206, Bologna, Italy; Heriot-Watt University, Riccarton, Edinburgh EH 4AS, United Kingdom.

CONTACTS Website

www.emmcchir.org

E-mail

emmcchir@ualg.pt

Head office

University of Algarve, Gambelas Campus 8005-139 Faro, Portugal

Tel

+35 1 289 800 003

Fax

+35 1 289 800 025

Contact

Isabel Cavaco (Programme Coordinator)

Directors

Emilio Tagliavini (University of Bologna, Italy) Teresa Fernandes (Heriot-Watt University, UK) Daniel Sainz (University of Barcelona, Spain) Ana Rosa Garcia (University of Algarve, Portugal)

Ownership

Public institutions

Locations

Portugal, Spain, Italy, UK

Founded

2012

SERVICES PROVIDED Higher education and training The ChIR is a European Joint MSc Degree, offering a 2nd cycle Higher Education (MSc) Degree officially registered in Portugal, Spain, Italy and the UK. The ChIR offers training in the fields required for chemical safety management: design of safe chemical substances; sustainable industrial implementation of chemical processes; management and marketing of new chemical substances; assessment of toxicology risks; assessment of environmental risks; assessment of physical and chemical risks; safety of nanomaterials; and REACH and international regulations on chemical safety. Internships The ChIR is open to collaboration with industry stakeholders. Collaboration may involve internship placements of students within the fields described above, or research projects on common interest topics. Symposium The ChIR organises annually an international symposium on chemical innovation and regulation, aimed at bringing together the industry, research and higher education students.

OVERVIEW The Masters Course in Chemical Innovation and Regulation (ChIR) is a joint MSc degree offered by the Consortium of the University of Algarve, University of Barcelona, University of Bologna and Heriot-Watt University. Students study in at least two different countries, and gain from the enlarged academic offer, experience and services of four universities. The degree has duration of two years: one year of 30 optional standalone, one-week modules, and one year of research. Modules are offered in the fields of design of new safe chemical substances, industrial processes, marketing and public perception of the chemical risk, assessment of chemical, toxicological and environmental risks and international chemical regulations. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

4 4

No of countries represented

13,976

Staff, group

Staff, chemical service provision

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2012

ChIR Consortium created

2012

Erasmus Mundus Master Course award by the European Commission, under the Erasmus Mundus Action 1 Programme, as an example of excellence in the European Higher Education Area

2013

1st edition. Host: University of Algarve, Portugal

2014

2nd edition. Host: University of Barcelona, Spain

2015

3rd edition. Host: University of Bologna, Italy

July 2015 1st Symposium on Chemical Innovation and Regulation. Host: University of Barcelona, Spain 2016

July 2016 2nd Symposium on Chemical Innovation and Regulation. Host: University of Bologna, Italy 2017

5th edition. Host: University of Barcelona, Spain

July 2017 3rd Symposium on Chemical Innovation and Regulation. Host: University of Algarve, Portugal 2018

SERVICE AREA BREAKDOWN

4th edition. Host: University of Algarve, Portugal

6th edition. Host: University of Algarve, Portugal

June 2018 4th Symposium Chemical Innovation and Regulation. Host: University of Barcelona, Spain ACCREDITATIONS Training 100%

Global Service Providers Guide 2019

Course accredited as a 2nd Cycle Higher Education Degree by the competent bodies in Portugal, Spain, Italy and the UK.

PARTNERS OO OO OO OO OO OO OO OO OO OO OO OO OO OO OO OO OO

University of Sao Paulo (Brazil) Central South University (China) Hokkaido University (Japan) University of Pune (India) Universidad de la Republica (Uruguay) Norsk Institutt for Luftorskning (Norway) Centro de Química Estrutural (Portugal) Portuguese Chemical Society Federacion Empresarial de la Industria Quimica Espanola Toyo University National Institute for Materials Science, Japan Hovione, Portugal Caviro, Italy Microperi Blue Growth S.r.l., Italy Universidade National de La Plata Indian Institute of Science Echa – European Chemicals Agency (Finland) (included in the agency’s graduate scheme)

CLIENTS/CANDIDATES As an official Higher Education Degree, the ChIR accepts candidates with adequate background, who: hold a higher education diploma issued by a competent higher education authority attesting the completion of a degree equivalent to a 1st cycle (BSc, 180 ECTS), in a field where chemistry plays an important role. This may be a degree in chemistry, chemical engineering, biology, pharmaceutical sciences, biochemistry, environmental engineering, chemical engineering, food engineering, or equivalent; and demonstrate command of the English language. All candidates are evaluated for acceptance to the course. TESTIMONIALS “Hollistic, innovative and integrated approach covering different aspects from design, industry, marketing, assessment, and regulation of chemical substances. Allows you to create your own study plan based on your preferred modules. Develop technical, social, innovative, and research skills.” “It is a life changing programme in every aspect” “You can choose from a vast group of modules and really expand your knowledge” “The ChIR has given me the courage to transition into the regulatory field from academia. Though I have yet to be formally accepted into my desired position, I am quite excited to try a relatively new field. More than academics (and in my experience the professors are outstanding), the cultural exchange (including new languages) in my mobility programme has allowed me to grow as a person, and perhaps that’s what pushed me

Daniel Sainz Garcia – Programme Director, University of Barcelona Degree in Chemistry by the Universitat de Barcelona (UB) (1981); PhD in Chemistry by UB (1989). 1989-1990 Spanish MEC fellowship at Institut für Technische Chemie und Petrolchemie in Aachen (Germany) 1986-1995: Associated Professor at UB From 1995: Professor of Inorganic Chemistry at UB 2002-2008: Delegate of the Rector for Safety, Health & Environment at UB 2005-2010: Member of the Commission of Environmental Quality, Sustainable Development and Health and Safety from Conference of Rectors of Spanish Universities 2009-2012: Member of the Spanish National Commission on Prevention of Occupational Risks at the university Author of 20+ peer-reviewed papers in Homogeneous Catalysis and four books on quality and safety in Chemistry Emilio Tagliavini – Programme Director, University of Bologna Degree in Chemistry from the University of Bologna 1979. From 1983 Lecturer of Organic Chemistri at UniBo. From 1992 Associated Professor in Organic Chemistry at University of Napoli. From 1993 Associated Professor of Organic Chemistry at UniBo. From 2005 Full Professor of Organic Chemistry at UniBo. From 2004 to 2010 head of the Degree Course in Environmental Sciences and of the Master Degree in Chemistry of UniBo. Supervisor of Master students in Chemistry and in Environmental Sciences. Supervisor of PhD students in Chemistry and in Environmental Sciences. Author of about 80 peer-reviewed papers Teresa Fernandes – Programme Director, University of Heriot-Watt Worked in the assessment of effects of pollutants on natural systems for last 20 yrs. 2006-2009: external scient. expert of the EC Scient. Commit. on Emerging and Newly Identified Health Risks. To date: external scient. expert on Risk Assessment of the Scient. Commit. of the EC; adviser to the ISO/TC 229 Task Group on Nanotechnology and Sustainability, and to the Irish EPA in the area of Nano ecotoxicology. Member of the Network of excellence NanoimpactNet and of the recently established “Nanosafety Cluster”, where she is a co-chair of the Working Group ‘Hazard’. Member of the Nanotechnology Advisory Council of the Society of Environmental Toxicology and Chemistry. Invited speaker at a wide range of international conferences and meetings.

to test the waters of new career track. So, thank you, ChIR, for giving me that boost to move forward!” “Diversity and exposure to life in Europe and to international students.” “Another best thing that I appreciate about ChIR is the variety of the courses and how they are set up into modules. We have the freedom to choose and take the modules according to our interest and background.” STAFF SELECTION Isabel Cavaco – Programme Coordinator, University of Algarve Degree in Chemical Engineering by Instituto Superior Tecnico (IST), PT (1992); PhD in Chemical Engineering by IST (1998). From 1998. Lecturer of Analytical Chemistry in UAlg; From 2004: collaborated and lectured in national masters (UAlg) and in the EMMC in Water and Coastal Management and the EMMC in Quality in Analytical Laboratories in PT, PL, ES, NO, China and Colombia. 2008-2013 Programme Coordinator of the Erasmus Mundus Master Course EMQAL. Since 2012 – Programme Coordinator of the ChIR. Supervised and co-supervised 21 master and one doctorate students. Published 25 papers in international peer-reviewed journals in bioinorganic chemistry. www.chemicalwatch.com/SPG

Profile: ChIR - Chemical Innovation and Regulation

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Profile: CIRS

108

GLOBAL OFFICES CIRS China – 288 Qiuyi Road, Binjiang District, Hangzhou, China CIRS Korea – 583, Yangcheon-ro, Gangseo-gu, Seoul, South Korea CIRS Ireland – Regus Harcourt Centre, Dublin, Ireland D02 HW77 CIRS USA – 3100 Clarendon Blvd., Arlington, VA 22201

CONTACTS Website

www.cirs-reach.com

E-mail

service@cirs-reach.com

Head office

11/F, Bldg 1, Dongguan Hi-Tech Park, 288 Qiuyi Rd, Binjiang District, Hangzhou, China

Tel

0086 8720 6574

Fax

0086 8720 6533

Contact

David Wan

Directors

Lucy Li, President of CIRS Group Walt Lin, Vice President of CIRS Group Hangsik Yim, Managing Director of CIRS Group Korea David Wan, Managing Director of CIRS Ireland and USA Junho Lee, Director of CIRS Group Korea

Ownership

Private company

Locations

China (Hangzhou, Beijing and Nanjing), South Korea(Seoul), Ireland (Dublin 2), USA(Arlington),

Founded

2007

SERVICES PROVIDED Global GHS compliance service North American SDS and labelling, EU CLP SDS and labelling, China SDS and labelling, Asia Pacific SDS and labelling; China chemical consumer product labelling, China 24hrs emergency telephone number service. Global chemical notification EU REACH only representative, EU REACH registration, China New Chemical Substance Notification, China Hazardous Chemical Registration, K-REACH/K-BPR and Kosha Registration, Taiwan TCSCA and Osha registration, chemical notification in other Regions: Japan, Philippines, US and Australia etc. Food and food-related product service in China Health Food Registration and Filing, Infant Formula Milk Powder Registration, Food for Special Medical Purpose (FSMP) Registration New Food Raw Material Registration, New Food Additive Registration Pre-packaged Food Regulatory Compliance, Formula Review on Prepackaged Food, Label Review and Translation of Pre-packaged Food Regulatory Compliance on Food contact material and article (FCM), New Food Contact Resin and Additive Registration (FCN) Cosmetics and ingredients registration in China CFDA registration, new cosmetic ingredient registration, toxicology safety assessment, formula and label review, the customs clearance assistance, regulatory compliance testing. Medical devices registration in China Medical devices registration (recording), clinical trial, quality management system (QMS) consulting, compliance analysis and project assessment

OVERVIEW CIRS is an independent product safety and chemical management consulting service provider. We provide valued product regulatory compliance service, tailored solution and original information to help industries gain competitive advantages, including chemical, cosmetics, food, disinfectant, detergent, consumer goods and medical device. VITAL STATISTICS

Pesticide and disinfectant registration in China Notification for disinfection products, pesticide registration, regulatory consulting service for disinfection products and pesticide products, permit assistance for import and export pesticide product or nonpesticide used products.

2017/18 -

Turnover, group Turnover, chemical service provision

No of offices

No of countries represented

Staff, group Staff, chemical service provision

2007

Foundation, Hangzhou, China

Approx. 50%

2008

CIRS Ireland established

2009

Member of IDA of Ireland

2010

China first Chemical Safety Report completed by CIRS

2011

Sponsor first Summit Meeting on Chemical Regulation in AP Partnership with JEMAI and become JAMP member Nanjing Office established

2013

CIRS Testing Centre (C&K Testing) established

2015

Sponsor first summit meeting on cosmetics regulation in AP CIRS Beijing Subsidiary established

2016

Milestone of the 100th typical notification of China REACH

2017

CIRS Group USA, Inc. established

2018

CIRS Group Korea Co., Ltd. established Partnership with Chemsafe Sponsor first CIRS EU workshop in Dublin Member of IEA of Ireland

Other 5%

Laboratory 15%

Consultancy/advisory 45%

Information 10% Representation & management 15%

Global Service Providers Guide 2019

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

300

SERVICE AREA BREAKDOWN

Training 5% IT & software 5%

Testing service China eco-toxicology, SVHC list testing, China RoHS, in vitro testing, consumer goods safety testing, hazardous chemical testing, food contact material testing (EU, US and China)

ACCREDITATIONS China certified SDS service provider, CNAS Laboratory, JAMP membership certificate, China metrology accreditation, CPSC lab accreditation, IDA Ireland support, IEA member PARTNERS Chemsafe, JEMAI, Eurofins, Doruksistem, KTR, Flashpoint, ExperTox, Arcadis, Cafe24, SRICI, Cekindo CLIENTS CIRS has worked with more than 4,000 clients and partners across many industries, including chemical, cosmetic, biocide, agrochemical, food, medical device and consumer goods. 70% Chinese chemical companies are using CIRS’s services, including global GHS, China REACH, EU REACH, K-REACH etc. Over 500 international corporates are using our services to fulfil their product regulatory obligations in EU, China, South Korea and other target Countries/Regions. 50% of clients have been working with CIRS for more than five years and 80% of them have been working with CIRS for more than three years. STAFF SELECTION Queenier Yang – Team Leader/Senior scientist, CIRS HQs Eight years experiences on EU REACH, K-REACH, US TSCA, Canada DSL/NDSL, Australia NICNAS, etc. Her team completed more than 1800 registration dossiers, including 100+ LR dossiers. By using Qsar and readacross expertly instead of testing, she also succeeds in complying with K-REACH and DSL/NDSL for chemical industry. Grace Ma – Team Leader/Senior scientist, CIRS HQs Nine years experiences on China REACH, Taiwan Chemical Regulations (TCSCA and Osha), and non-testing methods (Qsar, read across, etc). She has published several pieces of peer-reviewed SCI paper on Qsar and toxicology. The Qsar models built by her applied for two items of computer software copyright and two patents. Dozens of Qsar reports authored by her have been accepted by the technical review committee of China REACH, EU REACH and Taiwan chemical regulations. Bruce Wang –Team Leader/Senior scientist, CIRS HQs Seven years experiences on China new chemical substance notification and more than 170 typical notifications of new substances have been completed by his dedicated team as well as more than 1500 simplified notification. In addition, he has a store of experience in chemical risk assessment and China GHS.

Charles Chang – Deputy GM/Senior Consultant, CIRS Nanjing Ten years experiences on chemicals management software solution. He has solid knowledge and experience on global chemical regulation, restricted substances list, full substances declaration and supply chain communication practice. The systems developed by his team both for article and mixture/substance compliance and safety management have been applied by many manufacturers, importers and retailers. Yiseul Kim – Senior consultant, CIRS Korea Eight years experiences on the field of chemical regulations in Korea, US and Europe. She has supported the clients with major chemical regulatory updates compliance around the world such as TCCA and K-REACH amendment. Especially she has generated more than 1,000 SDSs along with hazardous chemical managements in Korea under KOSHA. Eric Xiong – Chemical Sector Manager, CIRS HQs Ten years experiences on in product stewardship and regulatory compliance for chemical industry in EU, China, Korea and other AP Countries. His team has provided solutions for hundreds of enterprises to achieve chemical regulatory compliance in EU, China, Korea and other AP Countries. Especially his team has acquired hundreds of certificates for typical notification and thousands of certificates for simplified notification under China REACH. Christine Chuang – Team Leader/Senior consultant, CIRS HQs Seven years experiences on chemical regulatory consulting service and provided comprehensive services and strategies for 11 of top 500 famous enterprises to fulfil their regulatory obligations in EU, China and Korea. Her team is also providing service for EU SME companies to help them to achieve chemical regulatory compliance in EU and AP Countries. Bryan Zhou – Team Leader/Senior consultant, CIRS Ireland Five years practical experiences on global chemical regulatory including EU, China, Korea and other Asian countries. Especially, his team has expertise and outstanding knowledges in EU REACH registration and OR transfer service, Global GHS and how to help EU company to fulfil their obligations under K-REACH. Edwin Wen – GM/Senior consultant, CIRS Beijing Nine years experiences on China medical device regulatory service. He leads dedicated team to assist global medical device companies in developing regulatory compliance procedures for placing medical device product and formulating the solutions of regulatory approval, clinical trials, quality assurance and manufacturing or distributing license in China.

Cloris Pan – GHS Team Leader/Senior scientist, CIRS HQs Six years experiences and plenty of in-depth research on global GHS implementation along with hazardous chemical managements in Asia Pacific. Since 2013, more than 20000 SDSs have been authored by her team as well as more than 50 tailored training for industries and China governments. April Guo- Personal Care Sector Manager/Senior consultant, CIRS HQs April Guo works in CIRS Group for more than seven years and leads the personal care team to assist global well known cosmetic companies and ingredient suppliers in regulatory compliance for thousands of products each year. She is always invited to give the training to foreign cosmetic companies in international regulatory conference. Cathy Yu – Food Sector Manager/Senior Consultant, CIRS HQs Six years experiences on providing China food and food contact material regulatory compliance services for global companies. She manages CIRS’ food service sector, which focuses on food contact material, new food contact additive/resin, health food, FSMP, infant formula, as well as pre-packaged food.

www.chemicalwatch.com/SPG

Profile: CIRS

109

Profile: CIS Center

110

GLOBAL OFFICES Russia SERVICES PROVIDED Regulatory support (Russia and other EAEU countries) We provide a broad range of services on regulatory support and business strategy for companies that import chemicals to Eurasian Economic Union (EAEU) territory (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan) such as: OO regulatory strategy and advice; OO chemicals state registration under the Decision of the Customs Union Commission of May 28, 2010 No. 299; and OO preparation campaign to forthcoming requirement of technical regulation of EAEU “On the safety of chemical products” (TR EAEU 041/2017).

CONTACTS Website

www.ciscenter.org

E-mail

info@ciscenter.org

Head office

Lyusinovskaya ul, 36/1 Moscow, Russia

Tel / Fax

+7 495 128 95 45

Contact

Natalia Druzhinina

Directors

Igor Ayzenberg

Ownership

Non-profit organisation

Locations

Russia

Founded

2008

Russian SDS Import of chemicals to the Russian Federation has to meet national requirements on safe handling, transportation and storage. This includes compilation of a Russian SDS according to GOST 30333 and Recommendations R 50.1.102-2014. SDS shall be performed in the Russian language and should undergo expertise and registration which are the main focus areas of CIS Center. We provide our clients with the best level of service on the verification and registration of the Russian SDS.

OVERVIEW Partnership “Coordinating Informational Center of CIS Member States on approximation of regulatory practices” (CIS Center) is an expert organisation in the field of chemicals regulation. Our mission is to provide professional consultancy support to chemical industry and government bodies regarding chemicals safe management throughout the whole product life cycle with focus on environmental and safety aspects. Рarticipation in the international fora and bodies such as APEC Chemical Dialogue, UN GHS Sub-Committee, SAICM and OECD Chemicals Committee enable us to provide our clients with services based on the best international practices and solutions. Since 2009, CIS Center has been holding the annual chemical conference, training seminars and discussion events with the representatives of government, industry and the scientific community, acting as a platform for constructive dialogue on topical issues of chemicals regulation. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No. of offices

2 1

No. of countries represented Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 20% Legal 5%

Consultancy/advisory 50%

IT & software 5% Information 15%

Representation & management 5%

Global Service Providers Guide 2019

Hazard classification and labelling according to Russian national standards Chemicals hazard classification and labelling according to Russian legislation has a number of important features, especially with regards to transport information. Our experts can help you classify your product in accordance with the following national standards: OO classification of chemicals and mixture (the series of standards); OO labelling of chemicals. General requirements; OO dangerous goods. Classification and marking; and OO marking of cargoes. CIS Center will help you choose the right classification code and handling marks and prepare the proper label. Risk assessment and risk management CIS Center activities lie in the field of exposure assessment, risk estimation and evaluation of chemicals in order to minimise negative impact of chemicals on human health and the environment in accordance with the best available risk management practices. Additionally CIS Center provides training courses on chemical risk assessment and management for the chemical sector of Russian industry, Customs Union officials and regulatory experts. Environmental product declarations CIS Center provides assistance on voluntary environmental declaration to companies of Russian chemical sector, exporting chemicals abroad, as well as intending to participate in public procurements of importing countries, which tenders require to provide: OO life cycle assessment of the products and processes to estimate the real impact on environment; and OO supporting documentation (including environmental product declarations). In 2018 CIS Center became a hub of the International EPD System, the system for environmental product declarations registration. Proficiency Testing Programs (PTP) CIS Center has a licence to provide proficiency-testing programs to wide range of products according to Russian and interstate standards (GOST R / GOST). CIS Center is the only organization authorised by ASTM International (American Society for Testing and Materials) to offer the ASTM proficiency testing programs in Russia and CIS countries. CIS Center in conjunction with ASTM continues and expands the PTP for laboratories,

through interlaboratory comparative tests on the measurement of the composition, and properties of petroleum products (gasoline, diesel fuel, motor oil, crude oil, rubber mixtures etc). In 2018 an international PTP on polypropylene was successfully completed, the results of Russian laboratories were weighed on a world stage. In 2018 CIS Center has signed an Agreement with IIS (Institute for Interlaboratory Studies, the subdivision of SGS) to organize different interlaboratory crosschecking programs under IIS (SGS) logo in the territory of Russia and EAEU. Standardisation CIS Center coordinates activities of several national and interstate technical committees (TC) including TC 339 “Safety of raw materials and substances” and TC 60 “Chemistry”. Our experts are directly involved in the development of the national and interstate (on the territory of CIS members countries) standards regarding chemical production and safe handling, including the GHS implementation. Sustainable development One of the core activities of CIS Center is an elaboration of sciencebased methodological approaches, programs and tools supporting the sustainable development. This includes implementation of the best available techniques (BAT) and improving resource efficiency of manufacturing companies. Training CIS Center organises workshops and conferences in the field of chemical control and safety regulations. We run regular training sessions and seminars on the following topics: OO classification, labelling and SDS development under the Russian national standards; OO compliance with the requirements of the technical regulations of EAEU “On the safety of chemical products” (TR EAEU 041/2017); and OO chemical risk assessment and management etc. Other CIS Center is a partner of UL (ChemADVISOR, Inc.) and an official distributor of LOLI database and global chemical regulatory reports in Russian-speaking territory. Our team have localised the LOLI Database and some other IT products for the Russian market. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2008

CIS Center founded in Moscow, Russia with the full name Coordinating informational Service Center for enterprises. Assistance in the field of chemical safety.

2013

CIS Center authorised by ASTM International; CIS Center became an official partner and distributor of ChemADVISOR products in Russian-speaking territory.

2015

CIS Center and CRAD Cevre Risk Analiz Den. Ve Egitim Hiz. A.S. became partners; Renaming “Coordinating Informational Service Center for enterprises. Assistance in the field of chemical safety” into “Coordinating Informational Center of CIS Member States on approximation of regulatory practices” (the short name remains the same – CIS Center).

2016

Organisation of the round table on the topic “Technological environmental legislation and BAT economic efficiency”; Participation of the CIS Center experts in the joint OECD-UN GHS Committee project on the assessment the potential development of a Global list of chemicals, classified according to the GHS.

2018

Opening of the International EPD System hub in Russia under the EPD International AB and CIS Center umbrella; Agreement with IIS (Institute for Interlaboratory Studies, the subdivision of SGS) to organize different interlaboratory crosschecking programs under IIS (SGS) logo in the territory

PARTNERS ASTM International, ChemAdvisor, CRAD Cevre Risk Analiz Den. Ve Egitim Hiz AS, EPD International AB. CLIENTS CIS Center assists a broad range of companies of the chemical and petrochemical industry. We work with both large international companies and SMEs. CASE STUDY 1: Technical regulation on chemicals safety The technical regulation “On the safety of chemical products” of the Eurasian Economic Union (EAEU) was adopted on March 3, 2017 within Decision No.19 of the Council of the Eurasian Economic Commission (EEC). The expected year for entry it into force was set as 2021. Before this year, the additional work shall be done by members states as well as industry to be prepared for the new requirements. In particular, industry shall be ready to submit required data on manufactured or imported substances (including substances in mixtures) to competent authority at the stage of developing the inventory. This is very important since such procedure will avoid more difficult and expensive new substance notification requirements in the future. We provide our clients with consultance support and trainings on technical regulation that will help them stay abreast of the latest activities in this matter. CASE STUDY 2: Russian SDS Russian SDS creation is not obligatory until 2021 when the technical regulation of the Eurasian Economic Union named “On the Safety of Chemical Products” will enter into force. However, the reality is that customs may have their specific requirements and usually demand to show this document at the custom border. In our practice we are often faced with a situation where companies urgently ask us to help with Russian SDS verification. They want to get them verified and registered as soon as possible: otherwise they will lose a lot of money due to the delay at customs. Such companies are usually aware of Russian SDS, but think that if they translate an existing SDS (eg EU-SDS) into Russian it will be enough. Unfortunately, they are often unaware that although Russian safety chemical legislation harmonised with GHS, it has a number of distinct features (specific format with title page, period of validity, dual classification, obligatory links to the sources of provided information etc.). This means that direct and even proper translation of the SDS into Russian is not the right solution. CIS Center believes that it might be practical to develop Russian SDS and label in advance that helps safe time and money by avoiding delays at customs. STAFF SELECTION CIS Center team CIS Center is a team of experienced professionals in the field of chemicals management throughout its life cycle. Our scope of activities includes hazard classification, risk assessment, expertise and registration of Russian SDS, labelling and more. Our experts participate in the meetings of the UN GHS Sub-Committee of Experts on the GHS, APEC Chemical Dialogue, OECD Chemicals Committee as well as SAICM and UNITAR activities. Our specialists are directly involved into the development of Russian national and interstate standards and always possess up-to-date information on national and international chemical control legislation.

of Russia and EAEU; Organisation of the international conference on actual issues of chemicals regulation with focus on TR EAEU 041/2017 that was held in Astana, Kazakhstan www.chemicalwatch.com/SPG

Profile: CIS Center

111

Profile: Citoxlab

112

SERVICE AREA BREAKDOWN Other 5%

CONTACTS Website

www.citoxlab.com

E-mail

contact.france@citoxlab.com contact.hungary@citoxlab.com

Laboratory 80%

Head office

Citoxlab, B.P. 563, Evreux, France

Tel

France +33 (0)2 32 29 26 26 Hungary + 36 88 545-300

Fax

France +33 (0)2 32 67 87 05 Hungary +36 88 545-301

Contact

Director of Business Development and Project Management clientservices@hu.citoxlab.com

Directors

Olivier Foulon, Citoxlab France Alyson Leyshon, Citoxlab Hungary Jeanet Logsted, Citoxlab Denmark Andrew Graham, Citoxlab North America Phil Attison, Citoxlab USA Guy Leclerc, AccelLAB, a Citoxlab Group Company Philippe Courbe, Atlanbio Erno Dudas, Solvo

Ownership

Private company

Locations

France, Denmark, Hungary, Germany and North America

Founded

1969

GLOBAL OFFICES Citoxlab has facilities located in France, Denmark, Hungary, Germany and North America. SERVICES PROVIDED

OVERVIEW Citoxlab offers a comprehensive range of pre-clinical services for pharmaceutical, biotechnology, chemicals, cosmetics, medical devices and food companies worldwide. Our scientists and regulatory experts provide customised advice to help your development projects progress in the most effective way. Following the creation of the Group in 2011, Citoxlab has now more than 1500 employees working at nine sites in France, North America, Denmark, Germany and Hungary. Proximity, the latest technologies and easy access to scientists, make Citoxlab your one-stop CRO for pre-clinical research. We offer maximum flexibility and expertise, major factors that guarantee the quality of your non-clinical programmes. VITAL STATISTICS Turnover, group Turnover, chemical service provision

2017/18 > €150m n/a

No of offices

No of countries represented

All

Staff, group Staff, chemical service provision

Global Service Providers Guide 2019

Consultancy/advisory 15%

1500 900

Chemical, biocide and agrochemical testing for registration To meet the wide range of regulations in force around the world for chemical, biocide and agrochemical product registrations, many of the largest international companies entrust Citoxlab with their physicochemistry, ecotoxicology and mammalian regulatory testing. Experts with in-depth knowledge of authority requirements can advise you about the most appropriate testing for your active ingredients and products, to meet your international registration or classification and labelling needs. For REACH and other chemical notifications, we provide complete regulatory packages and data-gap studies. We also propose a one-stop service for studies from QSAR and characterisation to ecotoxicology and long term rodent toxicology studies. We are experienced in dealing with a wide range of chemistry, including metals and UVCBs, and perform studies by all administration routes. Cosmetics Citoxlab has been working with industry in the development of cosmetics, skin care products and perfumes (ingredients and finished products) for more than 45 years. Since the ban on animal testing for cosmetics came into effect, we have been at the forefront in implementing new in vitro alternative assays. Today, we offer one of the most extensive ranges of in vitro tests in Europe for safety assessment: regulatory toxicology tests in vitro for topical (skin/eye) corrosion and irritation (EpiSkin irritation/corrosion – OECD431/439, BCOP – OECD 437, ICE –OECD438, EpiOcular™ Eye Irritation test -OECD 492), skin sensitisation (DPRA – OECD 442C, KeratinoSens™- OECD 442D, h-CLAT – OECD 442E), phototoxicity (UV/Vis spectrum –OECD101, photo-3T3 NRU – OECD 432);and transcutaneous absorption/penetration, as well as all genotoxicity and cytotoxicity tests. Studies are conducted in a GLP environment. Additional services include state-of-the-art genomics techniques (NGS, Affymetrics genechips), flow cytometry, cellular and image analysis, and bioanalysis techniques. Citoxlab is a member of EU-NETVAL (European Union Network of Laboratories for the Validation of Alternative Methods) and involved in EURL-ECVAM validation studies that serve to assess the reliability and relevance of alternative methods with a potential to replace, reduce, or refine the use of animals for scientific purposes. General toxicology and expert services Citoxlab is your one-stop CRO for general toxicology studies, whether you are in the pharmaceutical, biotechnology, chemical, medical device, food additive, veterinary or crop protection industries. From method development and the first investigational new drug screening tests, through pharmacokinetics, genomics and safety assessments, to full toxicology packages including reproduction, embryo-fetal/juvenile

development and carcinogenicity, our experts can provide you with customised advice and offer you a whole range of GLP-compliant studies. Inhalation toxicology Citoxlab, Hungary has performed more than 300 studies via the inhalation route over the past five years ranging in duration from acute to six months. OO OECD TG 403 – acute LC50 inhalation; OO OECD TG 436 – acute toxic class inhalation; OO OECD TG 412 – sub-acute inhalation; OO OECD TG 413 – sub-chronic inhalation; and OO EUR 20268 EN – quantifying inhalable fraction. Partner with our team of senior inhalation toxicologists and aerosol specialists. We provide support and guidance at all stages of programme development. Technical facilities and expertise include: OO exposure/administration suites; OO inhalation delivery in rodents and non-rodents; OO TSE directed flow (flow-past) systems: OO nose-only or oro-nasal exposure; OO prevents re-breathing; OO restraint designed to minimise thermal stress; OO maintains homogeneous breathable atmosphere at all levels of the inhalation tower; OO state-of-the-art technologies to generate powder, liquid or vapour atmospheres; OO early stage toxicology evaluation with intra-tracheal aerosol delivery; and OO experienced with fibres. Ecotoxicology and biodegradation Citoxlab offers a wide range of laboratory based ecotoxicology and biodegradation studies to meet current ecological and nature preservation concerns and the needs of industries, including chemical, plant protection and biocide sectors. We have specialised expertise in complex substances such as metals, UVCBs and polymers. The design of each study, including media preparation and analytical services, is tailored to ensure your compound registration programme-meets regulatory requirements for aquatic and terrestrial environmental risk assessment. OO Ready biodegradability test (OECD 310); OO activated sludge, respiration inhibition test (OECD 209); OO aerobic and anaerobic transformation in soil (OECD 307); OO soil micro organisms: nitrogen transformation test (OECD 216); OO aerobic and anaerobic transformation in aquatic sediment systems (OECD 308); OO terrestrial plant growth test (OECD 208); OO aquatic toxicology (acute, long term, reprotoxicty); OO terrestrial (short and extended/reprotoxicity studies); and OO avian (acute and reprotoxicity studies); Under the EU REACH regulations and for CLP, an integrated assessment of persistence, bioaccumulation and toxicity (PBT) is required, based on the evaluation of expected chemical behaviour and toxicity in the environment. OO Citoxlab offers testing services that address the required PBT assessment of chemicals, agrochemicals and biocides. Medical device testing AccelLAB is a Citoxlab Group contract research organisation (CRO) dedicated to the medical devices and biotechnology industry which specialises in the fields of the cardiology and the orthopedics. AccelLAB offers a completely integrated research centre allowing to lead efficiency and safety studies of renowned quality, AAALAC accredited and successfully audited by the FDA. AccelLAB has a staff of around 100 people and the facilities (about 40,000sq feet total) are equipped with the state of the art technologies in the fields of surgery and medical imaging like scanning and MRI. OO Study design and protocol preparation; OO in vivo experimentation in pigs, sheep, dogs and rabbits; OO recognised expertise in experimental surgery and vascular intervention;

complete clinical pathology; complete histopathology; OO robust regulatory environment; and OO state-of-the-art imaging, including: digitised angiography, portable digitised X-ray, OCT, utrasound (IVUS, TTE, TEE, ICE and 3D), CT-scan, MRI, Faxitron, micro-CT. AccelLAB areas of expertise: OO Restenosis (stents, absorbable scaffolds and drug coated balloons, coronary and periphery); OO structural heart disease (TAVR, apical closure device, LAA closure device, surgical valves); OO cardiac rhythm management (pacemakers, defibrillators); OO heart failure (reperfusion devices, cell therapy, gene therapy and pharmaceutical approaches); OO bone defects and fracture repair (orthopaedic implants and biologics); OO osteoarthritis and articular cartilage repair; OO posterolateral (PLF) and intervertebral fusion; OO otorhinolaryngology-ENT (bioresorbable stents) ; OO dermatology (wound healing, dermal fillers); and OO ophthalmology (oculoplasty). OO OO

Juvenile, developmental and reproductive toxicology Citoxlab offers you juvenile, developmental and reproductive toxicology studies accepted by worldwide regulatory authorities for the safety testing of pharmaceuticals, biologics, gene-therapy products, food additives, chemicals, agrochemicals, veterinary medicines and consumer products. Studies cover the whole scope of juvenile, developmental and reproductive toxicology, testing for potential effects on fertility, through embryofetal, post-natal and juvenile stages, up to second generation reproduction. Specialised evaluations can be combined in your juvenile/DART studies, such as neurobehavioral testing, sperm analysis, developmental immunotoxicology, neuro-histomorphometry, skeletal development and genomics. Routine testing includes, ICH S5, OECD 421, 422, 414 (rat and rabbit), 440, 441 and OECD 443 Extended one generation studies with neurotoxicity and immunotoxicity. ACCREDITATIONS GLP certified, AAALAC accredited, ISO 9001, ISO 14001, ISO 50001 CLIENTS Citoxlab works with the major players in each industrial sector. STAFF SELECTION David Esdaile – Director of Science and Regulatory Affairs David Esdaile has over 30 years experience in all areas of toxicology testing including project development, acute, sub acute and chronic studies in mammalian species, carcinogenicity, inhalation, reproduction toxicity, genotoxicity, dermal toxicity, skin sensitisation, skin penetration, structure-activity assessments, ecotoxicity and physical chemistry. François Spezia – Head of the Developmental and Reproductive Toxicology François Spézia, who is a European registered toxicologist, has more than 35 years experience, has developed and validated several in vitro and in vivo models for evaluating adverse effects on reproductive functions (eg embryotoxicity, fertility). Dr Spezia offers expert consulting in all topics related to chemical-induced reproductive and developmental toxicity testing. Guy Leclerc – CEO of AccelLAB, a Citoxlab Group Company AccelLAB was founded in 2004 by Dr Guy Leclerc, an Interventional Cardiologist who headed the department of Cardiology and Cardiac Surgery of the Centre Hospitalier de l’Université de Montreal (CHUM).

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Profile: Citoxlab

113

Profile: CSB Online

114

SERVICE AREA BREAKDOWN Consultancy/advisory 25%

Information 45%

CONTACTS Website

www.csb-online.de

E-mail

info@csb-online.de

Head office

Düsseldorfer Str 113, 47809 Krefeld, Germany

Tel

+49 2151 652086 0

Fax

+49 2151 652086 9

Contact

Lars Dobbertin

Directors

Lars Dobbertin

Ownership

Privately owned company

Locations

Germany

Founded

1996

Representation & management 30%

SERVICES PROVIDED REACH We actively support our clients since 2007 in all questions and services with regard to the requirements of the REACH Regulation. Our wide expertise and diverse skills enable us to provide expert services for all requirements and challenges companies are facing.

OVERVIEW Coming from a chemical trading background, CSB is a family operated company that was founded back in 1993 as Büro für Umweltservice in the legal form of a personal company, with the focus on providing services for the preparation of safety data sheets (SDS) for its clients in the chemical traders’ and formulators sector. Very soon companies from Japan and the US became the main group of customers, which they are still today. As business grew the legal form was changed to the form of a German GmbH in 1996 and the name was changed to C.S.B. Gradually, we built an interdisciplinary team with experts ranging from EHS specialists over human and ecotoxicologists to technical advisors for CLP/GHS. Our employees worked in many different companies and have experience in the chemical trading and industry sector, but also on the authority side, with several ex-employees of the German competent authority (Baua). With this strong team, we nowadays offer a large range of services with regards to European Legislations, inter alia REACH, BPR and CLP/GHS. VITAL STATISTICS Turnover, group

2017/18 -

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2019

Our fields of expertise include: Only representative services Serving as OR for a wide variety of worldwide customers since the introduction of REACH, we are able to use our knowledge and experience as OR to support companies in efficient supply chain management. With our interdisciplinary team we fully comply with the legal requirements for ORs. Administrative services We actively manage Siefs and consortia for our clients. We are representing our clients in several consortia, eg in the Iodine REACH Consortium, where we take part in the Steering and Technical Committee. Furthermore, we manage several Sief, respectively data sharing, agreements according to the new implementing regulation (EU) No 2016/9. Management and organisational services Together with our clients we develop strategies for their product portfolios and analyse their products to be able to determine the actual needs. This already helped several clients to better understand their portfolios and enabled them to set up action plans and prepare strategies to achieve compliance for their products. Registration services We manage, according to the actual needs of our clients, the complete registration processes for all types of registrations. In most of our projects we have managed the complete registration process (from an administrative and scientific point of view) in house, effectively reducing the burden of costs for our clients. Scientific expert services We offer a relatively wide variety of scientific services and experience with regard to REACH registrations. In the context of the data gap analysis at the beginning of each project we develop an individual testing strategy – together with our client – including alternative methods, read-across or Qsar, we act as study monitor for tests which are prepared new and evaluate study reports for all relevant endpoints (phys-chem, toxicology or ecotoxicology). Based on these results, we prepare the complete Iuclid 6 dossier and, where needed, perform the chemical safety assessment (CSA) and prepare the chemical safety report (CSR). Follow up services After initial submission of registrations, we offer support to update dossiers and manage requests by authorities in the context of dossier and substance evaluations. Besides support in registration processes we offer several other services, inter alia: OO Management of authorisation processes OO Downstream-user consulting;and OO preparation of downstream-user CSR

GHS/CLP With our experienced and well established team, we offer professional services for all regulatory needs concerning the “Globally Harmonized System”. For Europe, the most important ones include: Safety data sheets We are able to prepare SDSs for all European and EEA countries, USA, Canada, Australia, most South-American and most Asian countries (including Japan). For the European market, we also prepare extended safety data sheets (eSDS). Since the foundation of the company we have prepared SDSs for 40,000+ individual products and are currently actively managing 8,000+ products within our maintenance service for chemical traders, manufacturers and formulators including advice on compositions to minimise classifications. Notifications to the European C&L-Inventory We notify substances to the C&L-Inventory and update those entries where necessary. Notifications acc. to article 45 of CLP/New notification requirements acc. to Annex VIII CLP We prepare and where needed, manage dangerous mixture notifications for most European countries under the current regulatory systems. Due to the harmonization of requirements up from January 1st 2020 we enhanced our capabilities and will offer: OO Preparation of the mixture notification OO Generation and management of UFIs OO Submission through ECHA submission portal OO Ongoing management of mixtures BPR With the long-time involvement of our staff in the biocides legislation we offer several services to fulfil the requirements of the BPR: OO approval of active substances; OO application for national authorisation and/or mutual recognition of biocidal products; OO application for Union authorisation of biocidal products; OO application according Art 95; OO application for technical equivalence; and OO chemical similarity service. Besides the listed services, we also offer all relevant organisational and scientific expert services mentioned in the REACH description also in the field of biocides. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1996

Company founded by Heinz Dobbertin

2000

Introduction of SDS department

20072008

Introduction of REACH department

20092010

First representation of a client in a REACH consortium. First submissions of lead and joint dossiers.

2015

Adding in-house toxicology capabilities Introduction of Biocide department

2016

First application for product authorisation under BPR

2017

Lars Dobbertin appointed as General manager

2018

Expanding to US with Chicago office Successfully managed the REACH 2018 deadline

2019

Acquisition of ReFaC Ltd. (UK)

PARTNERS OO OO OO

LAUS GmbH (GLP certified test laboratory), Kirrweiler, Germany Olaf Konzack (specialised lawyer) Cologne, Germany GGSB (Dangerous Goods Safety Advisor), Mönchengladbach, Germany CRC-US, Chicago, USA

CLIENTS We serve clients varying from small to large sized chemical manufacturers, formulators and traders worldwide. Our clients are active in most industry sectors, inter alia specialty chemicals, detergents, pharmaceuticals, biocides, veterinary products, food additives etc. CASE STUDY 1: Biocidal active substance For one client, we currently work out a strategic and scientific approach to apply for a new innovative active substance. Within this project we helped our client understand the requirements and necessities under the BPR for his specific substance and envisioned product. Afterwards, we worked out a full fledged data-gap-analysis and plan to present at the competent authority to initiate the application process. CASE STUDY 2: REACH authorization project For a larger international client we currently managing the REACH authorization of several substances within one product line. The success of the authorization is crucial for our clients production sites and ongoing European business. Within the project, we developed a strategic approach, which fits the products characteristics and together with our client we are working out the risk assessment, search for alternatives and socio-economic analysis. CASE STUDY 3: Safety data sheet management Non-compliance of SDSs is a big topic for authorities and industry alike. Complying to the ever increasing regulatory requirements is becoming an issue for many companies. Within our SDS maintenance service we make sure that our clients SDSs are compliant acc. to GHS/CLP and also national rules. We actively manage product portfolios of our clients ranging from 10 to 3000+ products. Through our maintenance service we make sure that all SDS stay up to date to the latest regulatory requirements. Furthermore, we support our clients in managing their suppliers and customers, communicating directly or through our client with those parties. Due to our flexibility we can offer holistic approaches to SDS management or work out tailor made solutions acc. to the clients’ needs.

ACCREDITATIONS Member of the German VCH (Chemical Distributors Association) Active in FECC working groups

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Profile: CSB Online

115

Profile: Danish Technology Institute

116

SERVICE AREA BREAKDOWN Other 22%

CONTACTS

Training 14%

Website

www.dti.dk/biocides

E-mail

mkl@dti.dk

Head office

Gregersensvej 3, DK-2630 Taastrup

Denmark

Tel

+4572202337

Contact

Morten Klamer, Project Manager

Directors

President Søren Stjernqvist; Vice President Mette Glavind, Building and Construction; Vice President Sune Dowler Nygaard, Life Science

Ownership

Self-owned and not-for-profit Institute

Locations

Denmark

Founded

1906

Laboratory 34%

GLOBAL OFFICES Denmark SERVICES PROVIDED Physico-chemical properties For the introduction of biocidal products on the market, we provide data required for authorization in accordance with BPR. Physico-chemical testing is performed in compliance with OECD and OPPTS guidelines, CIPAC methods or other methods referred to by BPR.

OVERVIEW Danish Technological Institute (DTI) offers consultancy and services for aspects connected with the development, testing and approval of biocidal products within a wide range of business areas. Physico-chemical testing of disinfectants, preservatives, pest control or antifouling products are performed in accordance with the EU Biocides Regulation No. 528/2012. Validation of analytical methods for detection and identification of active substances are offered. Efficacy testing of various product types are performed according to relevant standards. Antimicrobial effects on biofilms are tested in various systems, and the efficacy of building materials such as paint systems and wood preservatives is tested both in laboratory and field testings’. The laboratories are accredited according to EN ISO/IEC 17025 by DANAK. DTI also offers support in the preparation of BPR dossiers (IUCLID, R4PB). Studies of plant protection products (PPP) are conducted in our laboratories in compliance with OECD Guidelines, OPPTS Guidelines, CIPAC methods, SANCO and FAO. Products and technologies (biostimulants, pesticides, etc.) can be tested according to EPPO guidelines in GEP accredited field trials or large-scale trials with georeferenced sensor data. VITAL STATISTICS

2017/18

Turnover, group

€151 m

Turnover, chemical service provision No of offices No of countries represented Staff, group Staff, chemical service provision

Global Service Providers Guide 2019

Consultancy/advisory 30%

€31 m 9 1 1074 50

Analytical methods DTI offers development and/or validation of analytical methods for determination of active substances listed in the ECHA register. Our scientific staff has excessive experience in analyzing various substances formulated as disinfectants, preservatives, pest control or antifouling products (e.g., Penflufen in wood preservatives). For chemical analyses, analytical techniques available include GC-MS-MS, GC with ECD, FID, NPD, TCD detectors, LC-MS-MS, LC with UV, DAD or fluorescence detectors, ICP-OES and ICP-MS, and IC. All instrumentation is considered suitable for analytical methods according to BPR. Storage stability studies Stability studies are offered to demonstrate the shelf-life claime d for the biocidal product (accelerated, long-term and low temperature stability). The studies include demonstration of physical, chemical and technical properties of the biocidal product. Efficacy testing, Product type 1-4 DTI offers efficacy testing of disinfectants used in the medical area, food industry and institutional areas and the veterinary area (Product Types 1-4). This includes efficacy testing for the evaluation of the bactericidal, fungicidal, sporicidal, and virucidal activity of chemical disinfectants and antiseptics according to EN standards and test conditions given in EN 14885, e.g.,EN 13727, EN 1276, EN 1656, EN 13624, EN 1650, EN 1657, EN 14348, EN 13697 and EN 16615. Efficacy testing, product type 6-10 Accredited efficacy testing according to international standards of in-can preservatives, paint systems, wood preservatives, and other building materials against bacteria, fungi and algae (Product Types 6-12), e.g., EN 113, EN 152, EN 927, BS3900 and EN 15458. Treated articles and biofilm Testing of the antimicrobial effect of other biocidal products, e.g., treated articles and efficacy against biofilm in various systems according to relevant EN standards, ASTM standard tests or customized methods. Counselling regarding choice of relevant test methods to fulfill the requirement within BPR and other legislation. Customization of analytical methods according to the specific need of the customer and interpretation of results from performed tests. Possible test for treated articles and efficacy against biofilm, e.g., ISO 22196, ASTM E2149-13a and ASTM E2799 (MBEC Assay).

Environmental risk assessment and fate For more than a decade, DTI has performed laboratory and semifield leaching tests and risk assessment. The NT Build 509 semi-field standard was developed at DTI for wood preservatives, but has shown its relevance for PT 6-10. Other methods include TS 15119-1, -2 and EN 16105. Product stewardship DTI offers support in planning of test strategies and data gap analysis as well as performing the necessary studies to support a BPR dossier. We offer assistance in preparation, submission of dossiers for product authorization and contact with authorities (IUCLID, R4PB). Plant protection products (PPP) DTI offers.physical and chemical testing of pesticides (PPP). Physicochemical testing is performed in compliance with OECD and OPPTS guidelines, CIPAC methods or other validated methods. Our laboratory perform analysis of biocidal and PPP products accredited, e.g., fungicides, herbicides and insecticides. Field trials DTI offers independent testing of pesticides, biostimulants, liquid fertilizer and other technologies in the field. Since 2008, we have been GEP certified, and we have experience with many types of trials in both small plot and large scale trials. We can give advice on choice of design, analytical methods and statistics. In our OnFarmPlus concept we use georeferenced sensor data and advanced geostatistics in order to maximize the power and validity in conclusions. We also have more than 40 years of experience with performance testing of paint and wood preservatives in temperate and tropical environments according to e.g. EN 330, EN 252 and TS 12037. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1906

Founded by Gunnar Gregersen

1972

Present campus in Taastrup/Copenhagen opened in presence of Her Majesty Queen Margrethe II

1973

DTI became a GTS Institute – Approved Technological Service Institute

1990

Merging between DTI and Jutland Technological Institute

2001

Acquisition of Swedcert AB, Sweden

2009

Merging between DTI and Danish Meat Research Institute

2016

Merging between DTI and the GTS Institute Agrotech

ACCREDITATIONS EN ISO/IEC 17025 PARTNERS Various projects in corporation with all major universities in Europe as well as larger companies and medium-sized enterprises (SME). CLIENTS A range of small- and medium-sized SMEs as well as large companies in Europe.

STAFF SELECTION Morten Klamer, PhD – Product Manager Morten has a background as microbiologist and has more than 16 years of experience in efficacy testing of paint systems, wood preservatives, and other building materials. He is the Danish representative in the European standardization committee for wood preservatives (CEN/TC 38) and also follows the work in the committee for paint and varnishes (CEN/TC 139). Besides, he is also in charge of the leaching tests performed at DTI for building materials (PT 6-10) according to, e.g., TS 15119, NT Build 509, EN 16105 and environmental risk assessment based on these tests. Sine Johannesen, PhD – Consultant Sine is an experienced analytical chemist. She joined DTI in April 2017 after 6 year of employment in the agrochemical industry. She has previously worked as a study director of laboratory studies performed in accordance with OECD Principles of Good Laboratory Practise (GLP). These studies include validation of analytical methods for determination of active ingredients and storage stability studies. Sine is in charge of testing of physical, chemical and technical properties of biocidal products performed at DTI and provides counselling on product specific test programmes. Helle Stendahl Andersen, MSc – Senior Consultant Helle is in charge of efficacy testing of disinfectants and other biocidal products and is also responsible for the development and implementation of new microbiological test methods for efficacy testing. She is the Danish representative in the European standardization committee for chemical disinfectants and antiseptics (CEN/TC 216). She has more than six years of experience in counselling regarding choice of relevant test methods according to requirements from BPR and other authorities. Eva Jacobsen, MSc – Team Manager Eva has more than 20 years of experience within organic chemistry and the development of analytical methods (GC, GC-MS, HPLC, LC-MS, etc.), e.g., for known and unknown active substances, solvents, and formulation ingredients. Part of her work comprises analysing biocidal products and plant protection products (PPP, pesticides) and water from leaching tests. She advises and proposes analysis programs on behalf of the authorities and industry, and she is an experienced project manager as well as quality co-ordinator. Thomas Sørensen, BSc – Consultant Thomas has more than 20 years of extensive experience with product development in coatings necessitated by legislation (REACH and BPR) as well as design and set-up of custom-made tests for determination of biocidal efficacy in relevant product matrices and industrial process equipment. He is an expert in industrial R&D within development and combination of biocides and their interaction with components, raw materials, and production processes in a range of consumer products such as paint, coatings and adhesives. Lotte Buch, MSc – Specialist Lotte has more than 10 years of experience with coordination and execution of GEP trials from trial planning, design creation and field work to documentation and report writing. She also coordinates all plant protection product trials in the Danish national field trials.

TESTIMONIALS Specific references can be provided for potential clients on request.

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Profile: Danish Technology Institute

117

Profile: Decernis

118

GLOBAL OFFICES USA, Canada, Chile, Germany, UK, Italy, France, Spain, Russia, Thailand, Japan, Philippines CONTACTS

SERVICES PROVIDED

Website

www.decernis.com

gComply Regulatory Compliance Database gComply Plus Enterprise Compliance System

E-mail

info@decernis.com

Head office

1250 Connecticut Avenue

Horizon Scanning Daily Risk Monitoring Food Fraud Database Global Food Adulteration Library

Washington, DC 20036

USA

Tel

1.240.428.1800

Fax

1.301990.1086

Contact

sblackie@decernis.com

Directors

Pat Waldo, CEO Kevin Kenny, COO Dr. Ruud Overbeek, CSO Dr. Chetan Parmar, CFO

Ownership

Private

Locations

World-wide

Founded

1993

Supply Chain Management Supplier Risk Monitoring System Consultancy and Advisory Services CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Decernis delivers technology-enabled global risk management solutions for product development, compliance, safety, regulatory and market access. 2017/18

Turnover, group

Privately held

Turnover, chemical service provision

Privately held 12

No of offices

212

No of countries represented Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Consultancy/advisory 10%

Decernis acquires Food Fraud Database from USP https://decernis.com/decernis-acquires-food-frauddatabase-from-usp/

Consortium

Decernis and Pulp and Paper Industry Launch Solution to Standardize Information Transfer for Global Compliance in Supply Chain Management https:// decernis.com/decernis-and-pulp-and-paper-industrylaunch-solution-to-standardize-information-transferfor-global-compliance-in-supply-chain-management/

Standardisation HEINEKEN and Decernis Launch the New Standard in Food Contact Materials Supplier Compliance Management https://decernis.com/heineken-anddecernis-launch-the-new-standard-in-food-contactmaterials-supplier-compliance-management/

OVERVIEW

VITAL STATISTICS

Acquisition

Award

Decernis selected as Top 10 Supply Chain Solution Provider https://decernis.com/decernis-selected-top10-supply-chain-solution-provider/

Government Partnership

Decernis /FSSAI partnership since 2017 https:// decernis.com/decernis-food-safety-standardsauthority-india-announce-regulatory-cooperation/

Government Partnership

Decernis /Japanese government partnership https://decernis.com/decernis-japan-nihs-extendpartnership-agreement/

Corporate Developments

Siemens, Deloitte, SpecPage, Plastics Industry Association, Intertek https://decernis.com/aboutus/ partners/

PARTNERS Steptoe, SpecPage, Deloitte, Intertek, Siemens CLIENTS Chemical industry, food, beverage and food additive industry, food packaging industry, consumer goods industry, flavour companies, paper industry, e.g., BASF, Heineken, Sappi Europe, Archroma, BIM Kemi, Ecolab, Kemira, Kolb, Kurita, Mare, Mayr-Melnhof, Mondi, Omya, Pfleiderer, Servophil, Smurfit Kappa, SNF, Solenis, Stora Enso, Synthomer, Trinseo, UPM TESTIMONIALS

IT & software 90%

Global Service Providers Guide 2019

HEINEKEN and Decernis Launch the New Standard in Food Contact Materials Supplier Compliance Management Washington, D.C., 22 March 2018 – Decernis LLC (www.decernis.com) the leading provider of technology and content solutions for product compliance, safety, and risk management and Heineken N.V. (www. theheinekencompany.com) announce the joint deployment of the latest

generation of food contact materials and packaging supplier compliance management at HEINEKEN delivered through the Decernis Supplier Compliance Management System. The goal of the partnership is to gain efficiencies and reduce waste. Soliciting and providing supplier documentation now becomes a few clicks of a button to create reusable compliance building blocks. Information is collected, validated, stored and shared within one centralized document and project management system. Decernis will also aid in the automatic, rule-based validation of HEINEKEN’s compliance questionnaire. The system was implemented and delivered to HEINEKEN worldwide in the first quarter of 2018. Marc Brouwer, Global Lead Packaging Materials and team lead on the project said, “With Decernis we have created the new global standard in Food Contact compliance here at HEINEKEN that we believe will further HEINEKEN’s reputation of brand excellence and harmonize and substantially lower the cost of food safety management to our Global network of breweries and suppliers.” Patrick Waldo, Assistant Director, Special Project team lead at Decernis noted, “I am proud of the work we did with HEINEKEN, because the Decernis way of supplier compliance management can model the complexities of brand owners, food manufacturers, converters as well as the upstream raw material manufacturers so that they work together towards a common goal.”

gComply provides the current, necessary, and relevant global knowledge and regulatory library to determine the compliance status of your products, components, materials, ingredients and/or substances. A powerful web-based regulatory reference database providing access to over 100,000 regulations across 212 countries, allowing you to scan applicable requirements relevant to your business or products. Using over 5 million terms across 40 languages, gComply is updated monthly, providing you a user friendly searching and cross-referencing tool at your fingertips. Customizable with your own private library of data, documents, and customer standards. With gComply you have the ability to: OO Search and find applicable regulations and amendments in identified countries or regions relevant to your products OO Search for specific criteria in particular regulations OO Find regulatory updates or changes with ease OO Quickly review a variety of regulations applicable to an individual ingredient or substance OO English translations of important regulations available OO Offered in a variety of modules for your specific needs: Food and Beverage, Food Contact and Packaging, Food and Feed Contaminants, Consumer Products (Cosmetics, OTC Drugs, Electronic Products, Household Goods etc), Customer Standards, Product Safety and Inventories, Toxicology.

CASE STUDY 1:

CASE STUDY 3:

Horizon Scanning: Intelligence-gathering solution using big data analytics providing insights and trend analysis that impact compliance requirements, enable market access, and increase speed to market for your products through the automatically monitoring and tracking of global events and regulations. What challenges must I face tomorrow with new draft requirements or developments in the marketplace? How do I manage change? These are fundamental challenges for manufacturers and processors. How do I gain as much time as possible for advocacy and if I need to reformulate? How can I take advantage of opportunities and avoid delays? Using Decernis’ patented “Horizon Scanning” technology, your business can proactively monitor regulatory changes that affect your products. Decernis Horizon Scanning is able to provide emerging issues insights; a personal and real-time solution for daily and global monitoring including: The sources of information for Decernis Horizon Scanning include our expert editorial team, direct feeds of information from our governmental partners, and automation. Decernis Horizon Scanning is a Big Data Analytics solutions that scans official journals, scientific developments, social media and NGO’s at over 1,200 pages per minute and crossreferences developments against a Lexicon of 5 million terms across 40 languages and over 200 countries. Decernis summarizes over 2,500 regulatory and scientific events per day. Our patented technology can easily enable you to monitor developments in a customized way for your entire product and ingredient portfolio, and for the topics of concern to your business. OO Significant developments and hot topics OO Proposed and final regulatory notifications OO Scientific opinions OO Market developments and consumer trends OO Product recalls OO Warning announcements OO Issue Management OO Translations of summaries in Analytics

gComply Plus is an enterprise-Level system providing your business intelligent and integrated “Compliance Management” solutions to manage a component or a Bill of Materials in order to compare your product formulas with regulatory and market requirements and allowable regulatory limits, globally. gComply Plus simplifies complex global regulations into an easy-toidentify Compliance Management Dashboard providing you with an effective and automated way to manage and control the compliance of your products. gComply Plus provides a governance process to manage the development of products. It provides “what-if” analysis and can be integrated with the client’s own policies. gComply Plus is a logicbased solution that links to Decernis regulatory library to provide the authoritative source document supporting any conclusion. gComply Plus integrates with the clients own systems. It can be easily deployed as a remotely hosted system or as a module integrated with your product lifecycle management (“PLM”) system (e.g. Oracle, SAP, Siemens, SpecPage, etc.). gComply Plus can also synchronize with all Decernis solutions to provide you with one seamless solution to manage and control your products and supply chains. With gComply Plus you have the ability to: OO Prepare a chemical, material, ingredient, and product level compliance analysis OO Analyze and compare global threshold requirements for additives and contaminants OO Author global declarations of compliance for a product, material, or ingredient OO Manage change OO Search for and obtain information concerning global regulatory status and requirements OO Upload your formulations and recipes and analyze their compliance OO Provide an archive of compliance data and material acceptance processes utilized to support auditing and institutional memory

CASE STUDY 2:

STAFF SELECTION

Pat Waldo, CEO Kevin C. Kenny, COO Dr. Ruud (Rudolf) Overbeek, Chief of Strategy and Business Development Dr. Chetan Parmar, CFO

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Profile: Decernis

119

Profile: DEKRA

120

SERVICES PROVIDED

CONTACTS Website

www.dekra-process-safety.co.uk

E-mail

process-safety-uk@dekra.com

Head office

Phi House, Southampton Science Park, Southampton, SO16 7NS, UK

Tel/ Fax

+44 (0) 23 8076 0722/ +44 (0) 23 8076 7866

Contact

Dr David Firth, Mr Daniel Baker

Directors

DEKRA SE

Ownership

Wholly owned subsidiary of DEKRA SE

Locations

Worldwide

Founded

1925 (DEKRA)

Process safety engineering – specialist consulting Implementing process safety programmes requires specialised skills and competencies. Process safety excellence requires technical and management proficiency – sometimes in-house and sometimes called in to respond to a specific requirement or unique situation. Whatever your specialist technical needs, we have the skills and breadth of experience to support your business. Whether you are carrying out a process safety review, implementing safety audits or ensuring compliance with standards or regulations, we have the up-to-date resources and skills to complete the task. If you require help with problem solving or incident investigation, you can rely on impartial advice and support from our experienced team whenever you need it.

OVERVIEW The breadth and depth of expertise in process safety makes us globally recognized specialists and trusted advisors. We help our clients to understand and evaluate their risks, and work together to develop pragmatic solutions. Our value-adding and practical approach combines specialist process safety management, engineering and testing. We seek to educate and grow client competence to provide sustainable performance improvement. Partnering with our clients we combine technical expertise with a passion for life preservation, harm reduction and asset protection. As part the world’s leading expert organization DEKRA; we are the global partner for a safe world. VITAL STATISTICS

2017/18

Turnover, group

€3.1bn

Turnover, chemical service provision

€700m

No of offices

30+

No of countries represented

80+ 44,000+

Staff, group

500+

Staff, chemical service provision SERVICE AREA BREAKDOWN Equipment 10% Training 5%

Laboratory 50%

Consultancy/advisory 30%

Representation & management 5%

GLOBAL OFFICES DEKRA SE, Handwerkstr 15, D-70565 Stuttgart, Germany

Global Service Providers Guide 2019

Process safety management – consulting Process safety management is the bedrock of excellence in process safety performance. Our global teams of PSM specialists provide the experience, knowledge and insight to support you with all the elements of your PSM programmes, whether they are concerned with process hazard assessment, risk analysis, mechanical integrity, commitment to process safety, learning from experience or management of change. Whatever the maturity level of your PSM programmes, we can help you: OO design and create relevant PSM programmes; OO support your company in implementation monitoring and sustainability; OO correct and improve deficient programmes; and audit PSM programmes, comparing with best practices worldwide.

Process safety information – laboratory testing Good process safety practice demands a thorough understanding of the hazardous physical and chemical properties of materials you process. However, we recognise that data alone is rarely useful – it is the interpretation of the data and its implication for your plant that really makes a difference. We can manage your entire materials testing requirements, offering a turnkey service that not only collects data through rigorous experimentation and testing but also interprets and reports the results. Our global network of testing facilities gives your business full access to cutting-edge techniques and dedicated laboratory testing teams. We offer more than 300 standard testing procedures, as well as the research capability to conduct unusual or complex customised testing. The result is an expert and trusted service that not only delivers quality controlled results, but removes the pressure on resources, continuity and compliance associated with in-house testing. Material testing Our laboratories in the UK can handle powdered materials, gases or vapours, even if they are toxic or highly active and can offer a fast turnaround service if required. We strive to ensure only essential testing is undertaken, that our reports are comprehensive and meaningful, and that specialists are on hand to provide expert advice on the interpretation of results. We pride ourselves on providing a broad range of fire and safety services; including fire risk assessments. Laboratory testing Our CPE teams provide laboratory testing data with expert consultancy, for the identification and assessment of exothermic reaction hazards, thermal stability screening, reaction and adiabatic calorimetry, runaway simulation, engineering solutions and emergency vent design (DIERS). Laboratory testing services also available include: OO explosivity, CRH and exothermic chemical reactions, fire and thermal instability and consulting and testing for energetic material assessment, propellants, pyrotechnics and explosives. Regulatory consulting The regulations for placing chemicals on the market and for using chemicals have become a lot more complex and diverse during the last decade – within the EU and on a global scale. DEKRA experts provide consulting services for assuring marketability of our clients products, by

classification according to CLP and other regulations; preparation of safety data sheets; support with the identification of restrictions on a specific market; registration or notification of substances and mixtures on a specific market. We also support companies with the use of hazardous products, by carrying out risk assessments; hazardous substances use clearance management; preparation of applications for authorisation according to REACH. In order to provide our clients a comprehensive service, we can rely on our DEKRA accredited measuring agency for hazardous substances, our global expert network and our laboratories. Regulatory testing Our services include the complete range of physico-chemical tests required for European regulatory purposes. Through our colleagues at DEKRA, we can also provide expert testing for: OO physico-chemical analysis; OO RoHS testing; OO REACH SVHC candidate list substance testing; OO materials testing; and OO product testing, eg toys, food contact materials, etc. Both REACH and CLP require information to be put into an SDS data sheet. Our range of laboratory services from our GLP compliant testing facility enable compliance and regulation for: OO aerosols, explosives and oxidisers; OO pharmaceuticals and agrochemicals; OO biocides and plant protection products; OO explosives and oxidisers; and OO transportation of dangerous goods following the UN Manual of Tests and Criteria (ADR, IMDG, IATA, RID etc).

temperatures were established and respected across the process whilst quantifying runaway reaction scenarios and determining emergency relief system requirements for the identified scenarios using DIERS methods for two-phase relief – ensuring a safe system of work was validated and documented. CASE STUDY 2: Supporting a global manufacturer and marketer of differentiated chemicals, we tailored an extensive portfolio of tests of a diverse selection of materials under both REACH and CLP criteria were established and respected across the process whilst quantifying runaway reaction scenarios and determining emergency relief system requirements for the identified scenarios using DIERS methods for two-phase relief – ensuring a safe system of work was validated and documented. CASE STUDY 3: Co-operating with a number of service providers from Europe to the Far East, we have carried out a range of physico-chemical properties testing for REACH registration of products across a broad range of applications, while acting as study managers for a range of toxicology and ecotoxicology test programmes. CASE STUDY 4:

1986

Foundation of Chilworth Technology Ltd.

1991

Chilworth Technology Inc established in US.

1995

Received Good Laboratory Practice accreditation.

2001

IChemE safety and environmental awards winner.

DEKRA operates the hazardous substance use clearance for a big producing company in the automotive sector for more than ten years now. All new substance requests of R&D, as well as of production, are processed by DEKRA experts. They check the product’s classification and the occupational conditions during use. Approval will only be granted if all hazards are under control. Here, quick reactions are just as important as responsible expert decisions. Through this business process outsourcing, the client benefits from high availability, flexibility and scalability of our expert resources.

2003

Chilworth goes global; capabilities established in France, Italy and India.

CASE STUDY 5:

2008

Chilworth acquires Spanish facility.

2009

Acquired JCI, the UK’s electrostatic measurement experts.

2011

Wholly acquired by DEKRA, Europe’s leading safety provider.

2013

New office and laboratory open in Shanghai and a new office for the Netherlands and Benelux.

2018

Rebranded to DEKRA Process Safety

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

DEKRA prepared applications for the authorisation of the use of two REACH annex XIV compounds. The Cr(VI) compounds are used in the repair of helicopter transmissions and cannot be substituted. DEKRA prepared the CSR (chemical safety report), carried out measurements and performed modelling on occupational and environmental exposure. The SEA (socio-economic analysis) was set up with support of a specialised partner company. DEKRA prepared and submitted the IUCLID file and supported the company through ECHA’s question rounds and trialogue.

ACCREDITATIONS

STAFF SELECTION

Good Laboratory Practice (UK); ISO9001 (UK); OHSAS18001 (UK); ISO 17025 (US); CNAS (China)

Dr Stephen Rowe – Managing Director – Process Safety UK With more than 20 years’ experience in process safety, Steve has particular expertise in chemical reaction hazards testing, exothermic reaction hazards consulting and dust, gas and vapour flammability testing and consulting programmes.

CLIENTS We work with a number of multi-site, blue-chip clients in a variety of processing industries including the petrochemical, chemical, pharmaceutical, food, drink, paper and packaging, plastics and rubber, agrochemical, automotive, aerospace and power generation sectors. CASE STUDY 1: Our Chemical Process Evaluation laboratory worked intensively with development chemists at a global producer of pharmaceuticals to characterise a range of materials’ stability limits and examine the thermodynamics and kinetics of the formation reaction and subsequent steps of the process. Using a range of techniques, we were able to identify onset conditions for the decomposition and ensure that safe process

Dr David Firth – Global Sales Director – Process Safety Covering all areas of process safety, David has many years of experience working with customers in a variety of industries including chemicals, pharmaceuticals, agrochemicals, paint, polymers, adhesives, electronics, fuel additives, synthetic fibres and many others. Mr Daniel Baker – Laboratories Manager – Process Safety EMEA Responsible for the management of our laboratories, Daniel has more than a decade of experience in testing and project management and brings a wealth of knowledge on regulatory test requirements. As a qualified DGSA, he provides guidance on the implication of results on classification of products.

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Profile: DEKRA

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Profile: DHI

122

GLOBAL OFFICES Australia, Austria, Brazil, Brunei, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, India, Indonesia, Italy, Malaysia, New Zealand, Norway, Peru, Poland, Romania, Singapore, Slovak Republic, Spain, Sweden, United Kingdom, USA, Vietnam.

CONTACTS Website

www.dhigroup.com www.tox.dhigroup.com

E-mail

jet@dhigroup.com

Head office

Agern Allé 5, DK-2970 Hørsholm, Denmark

Tel

+ 45 4516 9200

Fax

+ 45 4516 9292

Contact

Jens Tørsløv, Head of Projects

Directors

Antoine Labrosse, Chief Executive Officer Arne Rasmussen, Chief Financial Officer

Ownership

Private

Locations

51 worldwide offices and operations

Founded

1964

SERVICES PROVIDED REACH and regulatory compliance services globally DHI provides expert services within registration of chemicals in the EU and globally. We offer our customers a one stop solution for regulatory services worldwide: OO Guidance and strategic counselling on chemicals legislation and registration tasks; OO Preparation of registration dossiers, safety assessments and testing strategies integrating use of non-test methods as QSAR and readacross; and OO Strategic decisions on substances of very high concern. OO Application for authorisation, analysis of alternatives and SEA. DHI offers to facilitate consortia, third party representation and only representative (OR) services.

OVERVIEW DHI is a global and independent consulting and research organisation within the fields of water, environment, health and toxicology. It is our aim to assist industry in complying with the regulation on chemicals and chemical products, globally. Further we ensure product safety through assessment of possible impact on humans and the environment. Our extensive knowledge in this field provides support to both industry and authorities around the world. Our integrated approach combines chemical consulting and profound insight in regulatory requirements with leading edge IT solutions. VITAL STATISTICS

2017/18

Turnover, group

€110 m

Turnover, chemical service provision

€3,4 m

No of offices

No of countries represented

27 1,100

Staff, group Staff, chemical service provision

SERVICE AREA BREAKDOWN IT & software Training 1% 1%

Laboratory 40%

Representation & management 4%

Global Service Providers Guide 2019

Consultancy/advisory 54%

Product stewardship, regulatory services and software tools DHI offers company specific GHS strategies for global companies as well as classification and labelling of chemical substances and mixtures. Preparation of safety data sheets, exposure scenarios and tools for chemical management, SDSs and exposure scenarios. Training courses and webinars offered in CLP, SDS, exposure assessments and related areas. Provider of chemicals management systems and content for SDS software including worldwide lists on classification, substance names, exposure limits, CAS numbers, phrase modules with 4,500+ phrases in more than 40 languages. Environmental laboratory The DHI GLP certified environmental laboratory offers: OO OECD ecotoxicological studies in water environments OO Standard and tailored tests on biodegradability, ecotoxicity, endocrine disrupting effects and bioaccumulation of chemicals. OO whole effluent testing of offshore and other discharges; and OO testing under the scheme for pharmaceuticals according to the European Medicine Agency (EMA). Biocides and pesticides DHI offers regulatory and documentation assistance to industry and authorities: OO consortia management for BPR authorisation; OO preparation of dossiers on biocidal active substances, biocidal products and biocidal product families; OO preparation of dossiers on active substances and plant protection products; OO exposure and risk assessment OO data search, data gap analyses, testing strategy OO toxicological and ecotoxicological evaluations; and OO phrasing of claims, notifications and expert reports. Medical devices, pharmaceuticals and cosmetics Within medical devices, cosmetics, medicinal products, veterinary medicine, DHI supports industry and authorities with human and environmental risk and safety assessments and documentation. Services include data screening, literature searches, evaluation of biocompatibility, comparative evaluation of materials/toxicity, QSAR for prediction of toxicological effects of chemical substances, preparation of cosmetic dossiers, safety assessments (CPSR with database) and selection of tests in accordance with ISO 10993 and regulatory services (EMA, FDA, ISO 10993, ICH).

Food and feed safety, drinking water Regulatory advice, and safety or risk assessments of food contact materials, novel foods, dietary supplements, food and feed additives, contaminants, naturally occurring toxins, technical processing aids, whole foods and drinking water. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1964

Danish Hydraulic Institute (DHI) founded

1973

Approved as Authorised Technological Service Institute by the Danish Minister for Higher Education and Science

1982

VKI laboratory accredited by DANAK, the Danish Accreditation Fund

1989

VKI laboratory authorised to carry out test in compliance with the OECD principles of GLP

2000

Designated as a resource centre for the Global Water Partnership

2001

Merge with VKI Institute for the Water Environment

2004

Designated the United Nations Environmental Programme (UNEP) Collaborating Centre for Water and Health

2005

Merge with Danish Toxicology Centre (DTC) and establishment of the Environment and Toxicology unit.

2013

Offices in 30 countries around the world

ACCREDITATIONS DHI works in accordance with the quality management system standard: OO ISO 9001 as certified by Bureau Veritas. PARTNERS Consultancy: KIST-Europe (Korea). Software supplies: ECOonline DHI Environment and Toxicology is engaged in an R&D partnership that aims at reducing the use of harmful chemicals in products. CLIENTS DHI Environment and Toxicology provide regulatory compliance services to a range of industries and industrial organisations within chemicals and metal industry, pharmaceutical and medico. We have a strong foothold in Korea together with our Korean Partner, KIST. TESTIMONIALS Specific references can be provided to clients upon request. CASE STUDY 1: European Biocidal Products Regulation (BPR) approval of ECA Consortium for active substance Within a short time span, DHI assisted 15 companies with formation of the ECA Consortium – a non-profit association dedicated to promote the use of ECA (Electro Chemical Activation) technology. DHI assisted in the communication between the European regulatory bodies (EU Commission and ECHA – the European Chemicals Agency), the ECA Consortium and member state authorities. DHI also prepared data gap analysis, quantified a detailed cost analysis study and completed an active substance dossier containing more than 250 endpoints including a thorough exposure and risk assessment. The dossier was submitted before deadline and subsequently approved by ECHA resulting in all members and associated members of the ECA Consortium successfully listed as approved biocidal active substance and product suppliers under Article 95 list of BPR which sets the legal basis for placing active substances or products on the market in the EU.

CASE STUDY 2: Registration in Korea (K-REACH) DHI has a successful partnership with the Korean Institute of Science and Technology (KIST) and offers access to Korean speaking specialists in K-REACH. Our services include OR representation in Seoul. DHI offers Consortium management via our Korean partner and preparation of K-REACH registration dossiers. Further services include compliance with the Korean BPR legislation. STAFF SELECTION Jens Tørsløv, PhD – Head of Projects Extensive experience as project manager with references within REACH registration and CSR, analysis of alternatives, industry strategy on SVHC and application for authorisation. Jens Tørsløv joined the management team of Department of Environment and Toxicology DHI in 2007 and plays a key role in coordination and marketing of the REACH services. He has more than 25 years’ experience providing services to industry and authorities on environmental and human risk assessment of chemicals, industrial pollution control, capacity building. A position by the Commission (ECB) during the years of preparation of REACH gave a solid background within the REACH legislation and its practical implementation. Helle Westphal, MSc, Pharmacy – Head of Department Expert knowledge of European chemicals REACH legislation and broad knowledge on other parts of the European regulation related to chemicals, cosmetics etc. Helle Westphal has 25 years of experience in strategic and practical consultancy in health and environmental issues, including development and implementation of chemicals management systems and cleaner technologies in a number of companies. Toxicological risk assessments and a good general knowledge of the European environmental regulation. Twenty years of management experience. Michael Fink, MSc, Biology – Senior Expert Biocidal regulatory expert specialized in how industry can manoeuvre according to the requirements of the BPR and the associated regulations. He has evaluated toxicological risk assessments, human exposure scenarios and efficacy of dossiers on biocides on behalf of both the authorities and industry. He is highly experienced in providing strategic advice for industry in planning cost efficient authorizations of biocidal products and biocidal product families. Experience in managing consortia and highly skilled in negotiating with ECHA and member state authorities. Poul Bo Larsen, MSc, Pharmacy – Chief Toxicologist Has more than 25 years’ experience in regulatory toxicology and human health risk assessment of chemicals/chemical pollutants. Has been employed at the Danish Technological Institute, the Institute of Toxicology at the National Food Agency and for more than 14 years at the Danish EPA. Participated as a national expert on human health risk assessment of chemicals in various working groups at national level in OECD and the EU including the Risk Assessment Committee at ECHA. Has worked with regulation and assessment of hydrocarbons and with the EU risk assessment document and regulation and assessment of manufactured nanomaterials within EU and OECD.

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Profile: DHI

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Profile: DXC Technology

124

SERVICE AREA BREAKDOWN Consultancy/advisory 20%

CONTACTS Website

www.cdxsystem.com

E-mail

cdx-info@dxc.com

Head office

DXC Technology, EntServ Deutschland GmbH, Berliner Straße 111, 40880 Ratingen, Germany

Tel

+49 (2102) 948 0 (Germany) +1 586 298 2340 (US)

Contact

Marcus Schneider

Directors

Michael Eberhardt Joachim Löffler

Locations

Global

Founded

April 2017 merger of CSC Corporation and HPE Enterprise Services

GLOBAL OFFICES Global CDX offices for IMDS in China, South Korea, Japan, U.S. India, Egypt and Germany. SERVICES PROVIDED

OVERVIEW As the world’s leading independent, end-to-end IT services company, DXC Technology (NYSE: DXC) leads digital transformations for clients by modernizing and integrating their mainstream IT, and by deploying digital solutions at scale to produce better business outcomes. The company’s technology independence, global talent, and extensive partner network enable 6,000 private and public-sector clients in 70 countries to thrive on change. DXC is a recognized leader in corporate responsibility. The company was formed on April 1, 2017, by the merger of CSC and the Enterprise Services business of Hewlett Packard Enterprise. DXC Technology has successfully guided the world’s largest enterprises and government agencies through successful change cycles. With some 130,000 employees worldwide, the company’s deep experience gives it a clear and confident vision to help clients navigate the future. DXC Technology is a Fortune 500 company and represented in the S&P 500 Index. The company works to create greater value for clients, partners and shareholders, and to present growth opportunities for its people. DXC Technology is ranked among the world’s best corporate citizens. DXC Technology is provider of two of the world’s leading Supply Chain Communication services for reporting of Hazardous Materials and Substances under regulations such as REACh, RoHS, California Proposition 65. IMDS is the automotive industry’s service of choice and de-facto standard for reporting under ELV and has a proven track record of 19 years in the industry. CDX is a cross-industries multi-regulations service, offered since 2011 and supporting our customer base in reporting against a manifold of regulatory requirements. VITAL STATISTICS Turnover, group

2017/18 ~ $ 25 billion

Turnover, chemical service provision

Not disclosed

No of offices

Not disclosed

No of countries represented Staff, group Staff, chemical service provision

IT & software 80%

70 130000 ~70

CDX The focus on global environmental protection continues to grow daily with rules and regulations designed to address hazardous substances in products, as well as reduced waste and recycling efforts. As an IT services company, DXC Technology (DXC) leads the way in environmental compliance by enabling manufacturers to collect, maintain and analyze material data across all levels of their supply chain with the Compliance Data Exchange (CDX) solution. OO Source information about Substances of Concern (SoC) in products; OO compile comprehensible, coherent representations of product’s SoC content; OO understand their material compliance status by analysis of their whole assets; OO manage their suppliers’ reporting requirements; and OO swiftly and adequately react on customer requirements. In order to achieve this, CDX supports a Multi-Tier cross-industries approach, providing interfaces to industry standards such as: OO IPC1752A; OO IPC1754; OO IEC62474; and OO IMDS (International Material Data System). CDX helps you implement global legal requirements that address: OO Conflict Minerals (read more about our CMD Manager in CDX); OO ELV; OO Hong Kong Convention (IMO); OO REACh; OO RoHS; OO CalProp 65. IMDS The IMDS (International Material Data System) is the automobile industry’s material data system. Initially, it was a joint development of Audi, BMW, Daimler, DXC, Ford, Opel, Porsche, VW and Volvo. Further manufacturers have meanwhile joined the community and IMDS has become a global standard used by almost all of the global OEMs. Talks are being held with further manufacturers regarding their participation in IMDS. In IMDS, all materials used for automobile manufacturing arecollected, maintained, analysed and archived. Using the IMDS, it is possible to meet the obligations placed on automobile manufacturers, and thus on their suppliers, by national and international standards, laws and regulations. ACCREDITATIONS ISO9001 Quality Management System Certification ISO27001 Information Security Management System (ISO/IEC) 17025:2005 Biometrics Test Laboratory System

Global Service Providers Guide 2019

PARTNERS Most providers of major ERP, PLM Systems cooperate with us, and some actually partner, most notably SAP, Siemens PLM, Dassault Systèmes, Tetra Tech, EPR Consulting and RSJ Technical Consulting.

CASE STUDY 4: CDX OO

OO OO

CLIENTS

OO OO

Cross-Industry large customer base ranging from major global players such as automotive OEMs, manufacturers in the AD&S industry, general manufacturing to Small and Medium Enterprises. Overall a customer base of more than 180.000 companies using our services at a daily basis.

OO OO OO

TESTIMONIALS “HP has set clear expectations with our direct suppliers regarding conflict minerals. Our goal is that our products should be conflict mineral-free. […] HP created a cloud-based software solution to help other companies with their supply chain engagement and conflict minerals compliance. Our commercial CDX service, which we have also used ourselves, supports the review, storage, traceability, management, and aggregation of Templates. […]“ (HP 2013 Living Progress Report, p.45) CASE STUDY 1: IMDS OO OO OO OO

43 OEMs; full supply chain of close to 130000 companies; 320000 registered users; and 73 million provided product declarations

CASE STUDY 2: CDX OO

OO OO

CDX is used broadly in the electronics industry among companies seeking full or partial material declarations for their material reporting; industry preferred compliance and sustainability solution for the Association of Equipment Manufacturers (AEM.org) family of companies manufacturing equipment for Construction, Agriculture, Mining, Forestry & Utilities; strong participants in the International Aerospace Environmental Group (IAEG.org), working to implement solutions for the Aerospace and Defense industries; focus on data specific for their respective industries; BOSCH has selected CDX as part of their solution for sourcing and analyzing compliance information; integration in core supplier portal (SupplyOn); sourcing of compliance data throughout the supply chain and creation of a chain of liability; coverage of all cross-industries compliance schemes (i.e. REACH, RoHS, Batteries, Packaging, Conflict Minerals etc.); implementation of customer specific rules, analyses and communication tools; and onboarding of major suppliers commenced, more to follow

CASE STUDY 3: CDX OO

OO OO OO

OO OO

AEM (Association of Equipment Manufacturers, US – global) has selected CDX as their reference service for Material Compliance Reporting (http://www.aem.org/News/Newsroom/ Releases/?HL=AEM-Inks-Deal-with-HP-Compliance-DataExchange-(CDX)-Service&R=1089 ) sourcing of compliance data throughout the supply chain; establishment of a chain of liability; coverage of all relevant compliance schemes cross industries (including several US local rules); implementation of industry specific requirements; major criteria: advantages and mechanisms of IMDS as automotive standard; and upcoming IPC 1752 implementation & interfaces as well as SAP integration as major drivers in decision.

CDX selected by HP over third party competitors as service of choice for sourcing of Conflict Minerals relevant data; best feature set on the market; extensive validation functionality; customer specific modules; on-boarding process and mass communication of requests; flexibility and strong response times in implementing specific requirements; usage of CDX actively promoted by HP to supply chain; future support for other compliance regulations through CDX; support of SAP interfacing; possible support of many local regulations in consumer electronics due to product centric data model; focus on products allows for modular use (reuse, standard products) of supplier data; open data format and state-of-the-art interface allow integration of various processes and systems; and low pressure on supply chain in regard to operational and implementation cost.

STAFF SELECTION Thomas Frühbuss Thomas is the Account Business Executive for the International Material Data System (IMDS) and the Compliance Data Exchange (CDX) since 2012. During that time he has managed two IMDS contract renewals, with the most recent 5-year renewal signed in 2017. Thomas’ main focus is customer and partner relationship management, commercial topics, strategic product development and sales for IMDS and CDX. Frank Nottebom As Account Delivery Executive for DXC’s International Material Data System (IMDS) and DXC’s Compliance Data eXchange (CDX) Frank Nottebom is responsible for the global delivery, as well as for the strategic and operational directions of the two environmental compliance reporting services. Frank’s responsibilities include the operations, continuous optimization and modernization, as well as functional enhancements of the IMDS and CDX services in close cooperation with the clients. He is representing DXC in the Automobile Industry’s IMDS Steering Group since more than 15 years. Under Frank’s lead the CDX services and web application were initiated in 2011. Peter Müller Peter is Senior Consultant in the IMDS and CDX. Together with car manufacturers he implemented the IMDS and is part of the IMDS Steering Committee. With his knowledge and expertise he contributed to the setup of CDX. He is expert for hazardous materials control systems for various industries and consults companies in the collection of data over their supply chains with the objective towards product compliance. Chuck LePard Chuck LePard is the lead Americas Representative supporting the regions 60,000 users of the DXC Technology IMDS & CDX cloud analytics product material compliance, corporate responsibility and sustainability solutions. Chuck has been helping clients in diverse industries realize business value by delivering superior engineering, manufacturing, product compliance & I.T. solutions for over 35 years.

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Profile: DXC Technology

125

Profile: EBRC Consulting

126

GLOBAL OFFICES EBRC Consulting GmbH Raffaelstraße 4 30177 Hannover Germany CONTACTS

SERVICES PROVIDED

Website

www.ebrc.de

E-mail

info@ebrc.de

Head office

Raffaelstraße 4, 30177 Hannover, Germany

Tel

+49 511 898389 0

Fax

+49 511 898389 10

Contact

Torsten Grewe

Directors

Dr Rüdiger V Battersby

Ownership

Privately owned

Locations

Germany

Founded

1993

Industrial chemicals – REACH EBRC offers comprehensive scientific, regulatory and administrative support on industrial chemicals, including: OO data gathering, literature searches, and evaluation; OO data gap analysis, closing of data gaps, and study monitoring; OO chemical safety assessment (CSA) and report (CSR); OO PBT and vPvB assessment; OO technical dossier (Iuclid 6); OO identification of known uses; OO development of exposure scenarios for HH and ENV; OO risk characterisation; OO classification and labelling; OO safety data sheets; OO consortium and Sief management; and OO preparation of CLH dossiers

OVERVIEW EBRC is a privately-owned consulting organisation based in Hannover, Germany, providing consulting services with a focus on chemical, biocidal and agrochemical industries. Specialised scientific experience is available in all key disciplines relevant for product safety with respect to human health and environment. Task force management and coordination of industry consortia is another important aspect of our work. VITAL STATISTICS

2017/18 -

Turnover, group Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training IT & software 5% 5% Representation & management 15%

Consultancy/advisory 75%

Global Service Providers Guide 2019

Agrochemicals Active substance approval and national product registration. EU notification of active substances governed under regulation (EC) No 1107/2009: OO support of existing substances in the context of the renewal programme of the EU (AIR); OO support of new active substances; OO completeness checks, validation of existing studies, literature surveys; and OO full dossier preparation including risk assessments, literature search report, submission and defence of dossiers in the review and evaluation process. Product registration dossiers for national authorisations in EU member states including zonal dossiers: OO aII dossiers (dRRs) for registration and re-registration of plant protection products, label extensions and formulation changes; OO services include compilation of all required documents, conduct of exposure and risk assessments, biological dossiers, advice in closing data gaps, the supervision of experimental studies, as well as submission of the application to competent authorities and attendant contacts/services during the registration process; and OO previous experience (among others) includes herbicides, fungicides, insecticides, rodenticides, nematicides and growth regulators. Biocides EBRC provides experienced support for all key phases of the evaluation and registration process of biocides. Dossier preparation and defence in the regulatory process both for active substances and biocidal products are our primary services. OO active substances (Inclusion into the BPR list of approved substances (Reg. (EU) No 528/2012)) OO biocidal products (registration/authorisation in EU member states) OO task force/consortia management; and OO evaluation of substances – as specified for industrial chemicals and agrochemicals above.

Special services EBRC has in-house experienced scientific support for a wide range of statistical services: OO statistical (re-)evaluation of data; OO implementation of EU-models and/or scenarios (eg as given in OECD emission scenario documents); OO ready-to-use spreadsheet solutions for various applications (eg substance specification); OO probabilistic exposure assessments; OO derivation of species sensitivity distributions; and OO Bayesian approaches for (occupational) exposure assessments. Based on long-term involvement in major EU risk assessment projects, EBRC is very familiar with handling extensive databases, including: OO importing and (re-)structuring of data; OO online generation status update reports; and OO provision of web-interfaces for data-entry and analysis. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1993

Foundation of EBRC (initial staffing: six people)

2016

Continual growth, leading to a current staff count of 58

CLIENTS A wide range of companies producing agrochemicals, biocides and industrial chemicals and/or formulated products. CASE STUDY 1: MEASE On behalf of EUROMETAUX, EBRC developed a tool for the estimation and assessment of occupational exposure (MEASE) which combines approaches from the EASE expert system, from the TRA tool and from the health risk assessment guidance for metals (HERAG). It represents a widely-used first tier screening tool for occupational inhalation and dermal exposure to metals and inorganic substances. CASE STUDY 2: HERAG (Health Risk Assessment Guidance) With its extensive background in metals risk assessments, EBRC was contracted from 2005-2007 by the European Metals Industry to compile a guidance document for the human health risk assessment of metals and inorganic metal compounds. The HERAG documents provide guidance to the worldwide regulatory and scientific community on several aspects of risk assessment methodology for metals where classic tools developed for organics are not applicable. CASE STUDY 3: RiCoG The rigorous containment guide (RiCoG provides guidance to registrants of isolated intermediates on how rigorous containment (RiCo) of their intermediates can be assessed and documented according to the stipulations of regulation (EC) 1907/2006 (REACH). In an integrated assessment of SCC for an entire process (adopted from an approach published by Hirst et al. [2002]), RiCoG can be used to prioritise individual process steps requiring higher tier assessments, and provides an easy and structured way to assess and to document RiCo for the remaining process steps. Experts from various metals’ industries have contributed with their practical experience to the development of RiCoG.

STAFF SELECTION Rüdiger Battersby – Director Dr Rüdiger Battersby is the founder and director of EBRC. After his PhD in biochemistry, he took up a position as manager of a contract research organisation in Hannover (IBR), from where he switched to EBRC. Apart from his responsibilities as managing director and principal coordinating toxicologist, he acts as supervisor for all of EBRC’s agrochemical, biocidal and industrial chemical risk assessments. His professional expertise encompasses involvement in the German government’s review programme (BUA) on existing chemicals, representation of industry consortia in RA conducted under the ESR programme (793/93) and at EU-TCNES level, as well as the conduct of several dozen occupational exposure surveys in various sectors of the chemical industry. Among other professional activities, he is an appointed member of the German Expert Gremium for Chemicals Safety of the German Chemical Society. Arne Burzlaff – Senior Registration Manager Industrial Chemicals Dr Arne Burzlaff graduated as a chemist (2000) and obtained a PhD in technical chemistry/biotechnology (2005). He worked for the German Federal Institute for occupational safety and health, Division for Chemicals and Biocides Regulation (2005-2007), on dossier evaluation for biocides, collaboration in EU working groups and scoping issues on borderline cases among legal frameworks. Since 2007 he has been working at EBRC as senior scientist/toxicologist. In this position he has been compiling REACH registration dossiers, with a focus on human health hazard assessment and risk characterisation, and initiation and monitoring of experimental studies on industrial chemicals. Andreas Büsing – Senior Registration Manager Agrochemicals Andreas Büsing graduated as a biochemist at the University of Hannover (1984). After years of experience in biochemical analytics with specific emphasis on the development and validation of immunoassays, he has been working at EBRC as registration manager for agrochemicals since 1999. His main responsibilities at EBRC include the co-ordination and supervision of dossiers for product registration and active substance approval under Regulation (EC) No 1107/2009, with focus on ecotoxicological risk assessments, data gap analysis and monitoring of experimental studies on active substances and plant protection products. Silke Burger – Senior Registration Manager Biocides Dr Silke Burger graduated as a biologist (2000) and obtained a PhD in molecular biology/toxicology (2004). Since 2006 she has been working at EBRC as registration manager for biocides. In this position she has been compiling dossiers in support of active substances approval according to Directive 98/8/EC and BPR (Reg. (EU) No 528/2012) and registration of biocidal products with a focus on human and environmental exposure assessments and risk characterisations, and further initiation and monitoring of experimental studies on active substances and biocidal products. Daniel Vetter – Senior Consultant Special Services Daniel Vetter graduated as Dipl-Ing agr at University of Hannover (2003). His main responsibilities at EBRC include the development and implementation of novel statistical techniques in human health risk assessments. He developed MEASE, an assessment tool for occupational exposure providing first tier estimates of inhalation and dermal exposure to metals. As part of his current work, he incorporates probabilistic techniques into the HEC (human equivalent concentrations) approach.

CASE STUDY 4: Development of standard handling frequencies of rodenticide baits Due to the non-existence of robust figures describing the handling frequency of baits by professional pest control operators, EBRC was entrusted by the rodenticides industry to derive a suitable proposal. Data were collected from various (quite heterogeneous) sources (industry and pest control business) and analysed statistically. Based on this analysis, the European Commission and EU member states agreed on default bait handling figures which are the current standard for operator exposure assessment and have been a key prerequisite for including anticoagulant rodenticide active substances in Annex I of Directive 98/8/EC. www.chemicalwatch.com/SPG

Profile: EBRC Consulting

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Profile: ERM

128

GLOBAL OFFICES We support our clients in all countries globally. SERVICES PROVIDED CONTACTS

Strategy & Systems product stewardship programme development; OO information management / IT enterprise sustainability systems; OO substitution of hazardous chemicals; OO auditing; OO post-merger integration; and OO product due diligence. OO

Website

www.erm.com

E-mail

rudolf.wilden@erm.com

Head office

Frankfurt: Siemensstraße 9, 63263 Neu-Isenburg, Germany

Tel

+49 6102 206-247/ +49 6102 206 202

Contact

Dr Rudolf Wilden, Director of Product Stewardship

Directors

430 Partners globally, including Sarah Medearis (US), Samir Menon (US), Jo Lloyd (UK), Simon Aumonier (UK), Richard Elsmore (UK), Carolyn Thomas (UK) Alison Hamer (UK), Andrew Goodyear (UK), Euros Jones (Belgium), Rudolf Wilden (Germany), Robert Janssen (USA), Cecile Rousseau (France), James Leu (Taiwan), Amy Wang (China), Wilhelm Pfleger (Germany), Jürgen Towara (Germany), Hermann Wilhelmy (Germany)

Ownership

Private limited company

Locations

140

Founded

1971

Global registration and authorisation of chemicals OO training/ impact assessments; OO preparation of lead and member registration dossiers; OO chemical safety assessments; OO CLP notifications; OO study design & monitoring; OO socio-economic analyses (SEA); OO analyses of alternatives (AoA); OO preparation of applications for authorisation; and OO Sief management. Global registration of biocidal actives and products OO regulatory support for active substances and biocidal products; OO compilation and submitting active dossiers for a wide range of product types; OO routine submission of national registrations; and OO study design & monitoring. Global registration of agrochemicals OO preparation, submission and regulatory support of dossiers and national draft registration reports ; OO track record of successful approvals and national authorisations; and OO study design & monitoring.

OVERVIEW Environmental Resources Management (ERM) is one of the world’s leading providers of EHS and sustainability management, technical consulting and IT implementation services, with considerable experience in providing global product stewardship services. Global product stewardship (GPS) is positioned within ERM as a strategic growth initiative with a recent focus on agrochemicals and biocidal products. ERM offers integrated product service across all divisions within the company. ERM has more than 200 professionals with extensive specific GPS experience located at various offices worldwide.

Regulatory support OO new market entry planning; OO ad-hoc regulatory support; OO legal registers (product compliance); and OO horizon scanning for new regulations.

VITAL STATISTICS

Audit & Field Monitoring Studies OO supplier audits (TfS) & supplier risk assessment; OO compliance audits & preparedness checks; OO groundwater monitoring / eFate modelling; and OO wastewater monitoring / mass flow calculation.

2017/18 $643m

Turnover, group Turnover, chemical service provision

$38m 160

No of offices No of countries represented

40 > 5,500

Staff, group Staff, chemical service provision

>200

SERVICE AREA BREAKDOWN Training 10%

Hazard communication including safety data sheet (SDS) authoring Data collection /management, data entry/ review, classification support for chemical products and dangerous goods, safety data sheet and label authoring, SDS and label review and improvement

Lifecycle assessment and product sustainability OO carbon footprinting and emission inventories; OO lifecycle management (LCM) also to ISO14040; OO design for environment (DfE); OO environmental product declarations (EPDs); and OO lifecycle analysis (LCA). CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2018

IT & software 20%

Consultancy/advisory 60%

Representation & management 10%

Global Service Providers Guide 2019

2017

Extension of service portfolio to cover food contact support services; and Development of Data Brokerage activities through ReachCentrum, an ERM Group company. ERM Wins 10th REACH authorization project with all completed projects receiving maximum review period (12 years)

2016

OO OO

Acquisition of JSC; and Successful implementation of global chemical registration programmes including EU, US, CA, China, South Korea, Japan, Philippines, AUS+NZ

ACCREDITATIONS ISO 9001 and ISO 14001 PARTNERS Partner of Cefic, ACC, Sphera, SAP, Lisam, Enablon CLIENTS In the past five years we have worked for more than 70% of the Global Fortune 100 and more than 50% of the Global Fortune 500 companies. TESTIMONIALS “Our company has a long history with JSC (an ERM group company). I have found the entire team to be extremely knowledgeable and professional in all engagements. Specifically, JSC’s expertise on biocidal products has been second to none across the industry. I highly recommend their services and assistance with biocidal active substance dossiers, biocidal products registrations and guidance on efficacy testing. The technical depth and quick response we have experienced on every request has helped us navigate challenging and ever-changing global biocidal products regulations.” Senior Regulatory Specialist, Milliken Chemical. CASE STUDY: Strategic Advice for Major Biocidal Product Manufacturer Guiding the client’s business to achieve product approvals under national biocide legislation for their portfolio of multi-active products. This timely engagement with ERM has allowed the company to position its full product range correctly in 20+ member states. The work has involved alignment of ca 50 product compositions and the associated classification, label claims and supporting data. This was conducted to achieve the short term need to update national approvals, but ERM was able to offer a longer term perspective and create a data package for each product that anticipated upcoming EU regulatory requirements. The cooperation resulted in a more efficient targeting of resource and better forward planning. The client obtained increased market certainty and business confidence as their product range transitions from national legislation to EU legislation.

Patrick Rose, Human Safety Consultant Toxicologist with 40+ years in contract research, industrial toxicology and consultancy. His main areas of expertise are in agrochemical, biocide and general chemical regulatory toxicology. Dr Mark Lafranconi, Senior Toxicologist, DABT DABT certified toxicologist with nearly 30 years in the industrial sector designing, implementing, interpreting, and reporting hazard and risk assessment studies for evaluating human health effects and risk management of chemicals used in consumer products. Maryann Sanders, Technical Director, North America An experienced Product Stewardship professional with 25+ years of expertise in regulatory affairs, toxicology and microbiology. She has experience in regulatory submission, auditing, training, and addressing unique client challenges. Richard Elsmore, Partner He has worked in technical, regulatory and business management positions and has been involved with a number of industry bodies on the implementation of the EU legislation and in the area of efficacy testing and claim support. He is also a director of the British Association for Chemical Specialities (BACS). He sits on the BSi Technical Committee on disinfectant standards (CH/216). Alison Hamer, Partner Alison has extensive experience supporting clients on regulatory matters related to plant protection products; including in the specific area of biologicals and biostimulants. Alison has a PhD in fungal ecology. Dr Cécile Rousseau, Team Leader Southern Europe MSc physical chemistry and analytical methods, PhD Environmental chemistry and modelling, with 12+ years’ experience in the chemical sector, competent authorities and product stewardship services for REACH-CLP and biocides. Nick Choi Team Leader, ERM Korea Biochemist with extensive experience in various chemical regulatory schemes including TCCA, EU REACH, TSCA, and K-REACH with a focus on dossier compilation, consortium management and data sharing negotiation.

STAFF SELECTION Kathleen Sellers, PE Technical Director Assists clients in building and auditing global product sustainability programmes and fulfilling specific regulatory requirements for chemical registration and reporting, hazard communication, and other product compliance requirements. Recently published her fourth book, Product Stewardship, Life Cycle Analysis and the Environment (CRC Press). Dr Alfred Wiedow, Senior Toxicologist, DABT 35+ years of regulatory toxicology experience from working in the chemical industry, a governmental agency and academic research institutions. He is a recognised scientist in the fields of human and ecological toxicology and risk assessments. Dr Tim Barber, Principal Scientist 25+ years of experience supporting the chemical industry with expertise in environmental geochemistry, fate and transport modelling, ecotoxicology, and risk assessment. Evaluated environmental issues associated with down-the-drain disposal, biodegradation and sorption in wastewater treatment plants, and environmental risks associated with land-applied biosolids and discharge to surface water.

www.chemicalwatch.com/SPG

Profile: ERM

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Profile: Eurofins

130

SERVICE AREA BREAKDOWN Consultancy/advisory 10%

CONTACTS Website

www.eurofins.com

E-mail

info-munich@eurofins.com

Head office

Brussels, Belgium

Tel

+49 89 899 650 0

Fax

+49 89 899 650 11

Contact

Dr Iris Pfisterer

Directors

Gilles Martin, Chief Executive Officer

Locations

650 locations worldwide

Founded

1987

Laboratory 90%

GLOBAL OFFICES Eurofins is located globally in 45 countries. Our main testing facilities for chemical / REACH services are located in Germany, UK and the USA. SERVICES PROVIDED

OVERVIEW With more than €2.97bn annual revenues in 2017 and over 45,000 staff in more than 650 laboratories across 45 countries*, Eurofins is a global leader in the pharmaceutical, food and environmental testing market and offers also an unparalleled range of testing and support services for the chemical, agrochemical, biocide and cosmetic product sectors. As one of the most innovative and quality-oriented international players in its own industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the demands of regulatory authorities around the world. The acquisition of EAG laboratories in 2017 sees the addition of a highly complementary business to the existing Eurofins services in terms of capabilities/capacities and particularly geography, making the combined company the only global solution provider capable of providing a full suite of services for our clients in the Chemical industry to perform required research services for government regulatory approvals in North America, Europe, Asia and Latin America. This enables us to support you with all steps of the regulatory processes for REACH, BPR, agrochemicals and cosmetics. In vivo toxicology services are offered in cooperation with BSL BIOSERVICE Scientific Laboratories Munich GmbH. *reported in 2018 VITAL STATISTICS Turnover, group No of offices No of countries represented Staff, group

2017/18 >€2.97 bn >650 45 >45.000

For the chemical, agrochemical, pharmaceutical, veterinary medicine, biocides, cosmetics and food industry Eurofins offers a broad scope of biological safety studies, which meets the international regulatory requirements and includes the following services. Toxicology for chemicals, agrochemicals, biocides and food additives In our AAALAC-accredited facilities, we offer all toxicology services relevant for chemicals, agrochemicals and biocides. This includes the classical in vivo studies from acute to repeated dose and teratogenicity studies. In addition, Eurofins puts a high emphasis on alternative in vitro testing strategies with regard to the 3R’s strategy for refinement, replacement and reduction of animal studies. We have established a large range of in vitro assays for many endpoints. Our services include: OO irritation/corrosion (in vitro/ in vivo); OO sensitisation (in vitro /in vivo); OO dermal absorption (in vitro/in vivo); OECD 427 / 428 OO genetic toxicity (in vitro/in vivo); OO acute toxicity; OO repeated dose toxicity; OO reproductive and developmental toxicity (DART); OO toxicokinetics, ADME; OO carcinogenicity; OO neurotoxicity; OO endocrine disruptor testing; and OO mode of action studies. Avian Toxicology With one of the largest and most respected avian toxicology laboratories in the world, we offer unparalleled skill in performing avian acute and reproduction studies, as well as the ability to develop and conduct specialty studies designed to meet client-specific needs. Ecotoxicology and Aqua-toxicology testing We offer the full suite of acute and chronic aquatic and terrestrial toxicology services required to assess the acute and chronic effects of chemicals on amphibians, earthworms, honeybee and select non-target insects, as well as freshwater and saltwater invertebrates and fish in an AAALAC-accredited, GLP-compliant environment, and are capable of supporting a large number of concurrent studies. Sediment toxicity and terrestrial plant testing Testing and study design expertise in terrestrial and aquatic plant testing and evaluation of products to sediment dwelling organisms. Greenhouse facilities provide ample space for testing multiple species and advanced study designs. Sediment testing includes freshwater and marine acute and chronic tests.

Global Service Providers Guide 2019

Environmental fate and biodegradability testing Unparalleled experience in the identification and quantification the fate of test substances in soil, water and other complex environmental matrices, complemented by in-house radiolabeling and structural elucidation expertise Biodegradation screening and testing (OECD 301, 310, 314, 303 etc). Environmental fate testing (OECD 307, 308, 309, 106). All these studies can be performed including metabolite identification. Specific expertise in the context of REACH is in the field of biodegradability screening and simulation testing. Residue analysis Unparalleled method development know-how in the challenging discipline of residue chemistry, along the full complement of ground and surface water monitoring, dislodgeable foliar residues, magnitude of residue analyses, as well as worker and domestic exposure studies. Radiolabelling and custom synthesis We offer a full range of 14C custom radiolabelling services, the synthesis of unlabelled reference compounds (metabolites and impurities) and analytical chemistry services (including GLP certification if required). Our expert chemists can prepare C-14 labelled molecules of almost any complexity and have a strong background supporting regulatory studies acquired over many years in the life science and chemical industries. REACH services We offer the full portfolio of studies, required for the different tonnage levels according to Annex VII-X of the REACH directive. Based on the large variety of chemicals tested for the previous REACH deadlines, we created a strong expertise to effectively support you with any registration obligations, e.g. for NONS or also for global registrations. Furthermore, as ECHA will continue with the evaluation of the registered substances and testing proposals, we are happy to perform those higher tier studies for you and support you in updating your dossier. Studies like 90-day toxicity (OECD 408), reproductive and developmental toxicity (OECD 414) and also the EOGRTS (OECD 443) are performed at our facilities on a routine basis. Endocrine disruptor screening and testing We have specific expertise in this field and the majority of studies listed in the conceptual framework of OECD 150 can be offered. We have in-house histopathology services to evaluate the potential of chemicals to affect endocrine-sensitive tissues in fish, amphibians and frogs and also offer regulatory support. With the ED topic in Europe gaining more clarity, we are ideally placed to support you. In vitro safety testing for chemicals and cosmetics OO mutagenicity, clastogenicity, carcinogenicity; OO skin and eye irritation/corrosion – several models; OO dermal absorption; OO photo-induced toxicity; OO reproductive toxicity (embryonic stem cell test); and OO sensitisation – DPRA, Keratinosens, hCLAT, GARD, Sens-IS Furthermore, for cosmetics Eurofins provides a complete service portfolio including in vitro toxicology, clinical safety studies, clinical efficacy studies and consumer research and sensory evaluation. Regulatory services, testing strategies and individual study designs With around 30 years of experience with regulatory studies, our team of scientists will provide you with expert advice not only for standard studies, but also for individual study designs and testing strategies, taking into account substance properties as well as interdependency of many studies required for example for REACH, cosmetics and agrochemicals. In addition we are backed up by an experienced regulatory division within Eurofins that can support you regarding regulatory issues of agrochemicals and biocides starting from data gap analysis until dossier preparation as well as post submission support. SVHC and restricted substances under REACH SVHC testing on products: laboratory testing provides information on SVHC substance identification and concentration to help companies meet their REACH SVHC obligations. By means of different analytical methods (GC/MS, ICP-MS, NMR, UV-vis, IR etc. ), Eurofins can provide a comprehensive screening test of your whole product to ascertain if any substance in the candidate list is present in any of the components of the product.

BOM (Bill Of Materials) assessment We can help to manage and monitor your supply chain by helping to collect BOM from your suppliers. This information is essential in the process of controlling the occurrence of any SVHC through your supply chain. Based on BOM, and subsequent BOS (Bill Of Substances) generation, our experts can help to assess your product and evaluate the likelihood of containing any SVHC in any of the components of the product, hence helping to save testing costs and focusing the analytical efforts on those specific components that would have been evaluated as risk materials. Restricted substances testing Eurofins offers also a wide range of analytical tests to cover specific restricted substances under REACH Annex XVII. The substances listed under this Annex are specifically restricted in certain products and materials and for certain uses. That means, not all these restrictions may apply to your specific product. Our experts will help to assess your product and propose a test plan to cover those tests that may apply to your article based on its use and its composition. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1987

Foundation of Eurofins Scientific Continuous growth and acquisitions

1997

IPO on the French Stock Exchange

2008/09

Establishment of Eurofins REACH Services

currently

Global leader in the pharmaceutical, food and environmental testing market

ACCREDITATIONS Good Laboratory Practice (GLP) DIN EN ISO IEC 17025 Good Manufacturing Practice (GMP) FDA approved AAALAC Accreditation Radioactive handling permission CLIENTS Chemical industry, Agrochemical industry, Biocides industry, Cosmetic industry, Food industry, Medical device industry, Pharmaceutical/ biotech industry, Personal Care Products and Veterinary Medicine. STAFF SELECTION Dr Angela Lutterbach, Head of Testing Facility Eurofins Munich Dr Lutterbach has more than 30 years of experience working in the contract research industry and holds the position Head of Testing Facility at Eurofins Munich since 2001. Dr. Philip Allingham, Chief Operations and Compliance Officer in vivo Toxicology Dr Allingham is biologist and European Reg. Toxicologist with more than 17 years of experience in animal facility management and in performing regulatory in vivo studies. Vincent Dreze, BU Manager Eurofins Regulatory Since 2017, Vincent Dreze has been the Business Unit Manager for Eurofins Agroscience Services Regulatory Group. Previously, Vincent headed up the Regulatory Affairs Department of ISK Biosciences Europe NV. Brad Dayton, Client Services, North America With more than 20 years’ experience in the Life Sciences industry, Brad is responsible for EAS Group client services in the North American region. David Carver; Synthesis – Eurofins Selcia David Carver has more than 25 years’ experience in the life-sciences industry and supports our clients with advice on 14C labelling and synthesis strategies.

www.chemicalwatch.com/SPG

Profile: Eurofins

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Profile: Exponent International Limited

132

GLOBAL OFFICES Global head office (Exponent Inc): 149 Commonwealth Drive, Menlo Park, CA 94025, US Plus numerous other offices in the US, UK Germany, Switzerland and China

CONTACTS Website

www.exponent.com

E-mail

jreddy@uk.exponent.com

Head office

The Lenz, Hornbeam Business Park, Harrogate, North Yorkshire, HG2 8RE, UK

Tel/ Fax

+44 (0)1332 868000/ +44 (0)1332 868099

Contact

Julian Reddy

SERVICES PROVIDED REACH services Exponent’s consultants have significant experience in the provision of a wide range of pre and post registration REACH support to our clients. Pre-registration services include initial work such as regulatory strategy and advice, supply chain review, data evaluation and waiving, Qsar and the use of intelligent testing strategies, followed by study placement and monitoring. We prepare and submit registration dossiers in IUCLID and chemical safety reports including exposure assessments, using Chesar, higher tier modelling and if necessary risk characterisation. We also provide post-submission support during dossier and substance evaluations, updates of registrations and completion of authorisations applications. Exponent has significant experience in project management and Sief and consortia management and following Brexit we can also act as your only representative registrant or third party representative in both the EU and UK.

Ownership Wholly owned subsidiary of Exponent Inc. Locations

Harrogate, Derby, London and Edinburgh, UK; Basel, Switzerland

Founded

2002

OVERVIEW Exponent is one of the world’s largest regulatory, engineering and scientific consultancies providing innovative solutions to complex technical problems. Exponent International Limited is a wholly owned subsidiary of Exponent Inc and is the European arm of the Chemical Regulation and Food Safety practice. Exponent combines unparalleled technical expertise with the ability to focus this knowledge to meet our clients’ needs within short timeframes. Our ability to create multidisciplinary teams of scientists, regulatory consultants and project managers means that we can help our clients meet all aspects of their chemical regulatory obligations in a cost efficient and timely manner. We have the expertise and in-house resources to perform rapid-response evaluations to provide our clients with the critical information that they need to make day-to-day strategic business decisions. VITAL STATISTICS

2017/18 Est US$18m

Turnover, group Turnover, chemical service provision

Est US$5m 3

No. of offices No. of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training Information 5% 5% Representation & management 20% Consultancy/advisory 70%

Global Service Providers Guide 2019

Global chemical notifications Our consultants have considerable experience in compiling and submitting chemical notifications worldwide; to all countries that operate a relevant scheme. We can prepare and submit dossiers for Australian, Canadian, New Zealand and Swiss registrations and can act as sole representative notifier utilising our Swiss office. We have a network of well-established local agents to help with the preparation and submission of regulatory documentation in China, Japan, Korea, the Philippines, Taiwan and Turkey and can call upon the experience of our US colleagues for TSCA notifications. Biocide services Exponent’s biocide group has a wealth of regulatory expertise gained from working as government regulators, in industry, contract research organisations and as independent regulatory consultants. We have a proven track record of assisting clients achieve active substance approvals and product authorisations under the biocidal products Regulation (EU) No 528/2012 (BPR) and biocidal products Directive (98/8/EC). We are experienced in the interpretation of data, scientifically defensible data waiving and complex exposure modelling / risk assessments. We assess and construct product/family dossiers under the BPR, using IUCLID and R4BP. We also assist clients to achieve authorisations under global national regulations in many non-EU countries. We provide consultation on regulatory strategy, product stewardship, portfolio management, task force/consortia management/ representation and bespoke training packages. Cosmetic and consumer product services Our cosmetics regulatory and safety team has provided assistance to cosmetic product brand owners and to retailers who are established in the UK, EU, US, Australia and China selling through both traditional retail and on-line channels to a global market. Services provided include ‘hot line’ regulatory consultancy, provision of cosmetic product safety reports, ingredient safety reports, product formula and labelling reviews, product information auditing, help with ingredient selection, advice for new product development and investigation of production issues. While we can offer consultancy as needed, we also offer a ‘full service’ where we take on full responsibility for a product being sold in the EU and act as the responsible person, for this service the Exponent company name and address is printed on the product label. After Brexit companies selling products in the UK will need a UK Responsible Person and UK address on the product label. As Exponent can offer both UK and EU addresses we can provide continuity of compliance for our clients.

Other regulatory regimes Exponent’s consultants have significant experience in assisting clients with EU agrochemical and food regulatory requirements including food contact notifications. For agrochemicals we can assist with regulatory strategy, data gap analysis, study monitoring, risk assessments and completion of active substance and product registration dossiers. This includes in-depth support such as managing compounds to Annex I inclusion. For clients in the food industry we can develop strategies for technical and regulatory challenges, develop food safety systems and help meet regulatory requirements, including submission of application dossier for authorisation of for food additives, food contact materials, novel foods and health claims. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1967

Parent company Exponent Inc formed.

2001

Novigen Sciences formed.

2002

Novigen acquired by Exponent. Exponent International Limited established in the UK.

2006

Exponent REACH team formed.

2008

Derby, UK office opened.

2010

Basel, Switzerland office opened.

ACCREDITATIONS ISO 9001 certified PARTNERS We have no formal partners, but use an informal network of legal firms, CROs and in-country agents to provide the best service to our clients for REACH and global chemical notifications. CLIENTS Exponent Inc has worked with more than 5,000 clients and Exponent International has undertaken work for over 500 clients globally. Exponent has provided regulatory support to a range of companies across many industries; companies ranging from SMEs working in one industry to global corporations conducting business in all areas of the chemical industry. TESTIMONIALS “Exponent International has consistently provided high-quality REACH and biocides services and support to our company for over five years. They produce work of the highest quality at competitive prices and are always prepared to go that bit further to ensure that they can deliver what we need within challenging deadlines. Their excellent technical knowledge and abilities mean that they are always the company we go to when we need help in these areas.” − Regulatory Affairs Manager, global cleaning and maintenance products manufacturer “I am so impressed with how this went – how incredibly dedicated and persistent you all are. Your work is invaluable – you exceeded my expectations and I feel confident that this work will make a big impact on the product that will ensure its success. I look forward to working with you in the future!!!” – Producer Design Team. “Exponent provided support and expert knowledge in the lead up to an important new product launch. We see them as an ideal partner and support, working alongside our in-house technical team.” Senior Technologist. “Congratulations to you and your crew at Exponent working on this project and many thanks for all the efforts and support over the past few years.” – Global Regulatory, New Technologies Lead

CASE STUDY 1: Provision of technical support to an organometallic consortium Since 2009, Exponent has provided technical support to a consortium of organometallic substance manufacturers. Exponent performed the technical work required for all their substances registered to the 3 REACH deadlines. The tasks that have been undertaken in support of this project are identification of data gaps, use of intelligent testing strategies to address gaps and where necessary, placing and monitoring of studies. In addition Exponent was responsible for the preparation and update of the registration dossiers in IUCLID 6 and for the production of CSRs, proposing use descriptor codes for exposure assessments and in generating exposure scenarios. Due to the properties of the substances, creative yet pragmatic solutions have been necessary to demonstrate safe use and to deal with questions from ECHA and the Member State Competent Authorities. In addition we have and continue to provide a considerable amount of support for post registration activities including compliance checks as part of a dossier evaluation and substance evaluations, the COLLA initiative, harmonised classification and labelling discussions with ECHA and also reclassification proposals. CASE STUDY 2: Global regulatory support Exponent provides ongoing regulatory support for a major client ensuring they meet all their regulatory obligations globally. In particular we provide strategic advice for all jurisdictions that have a notification scheme in place and also those where regulations are emerging so the client are aware of any actions they will need to undertake to stay in compliance. Where possible we work to ensure that legislative requirements from a number of countries can be effectively overlapped and that data requirements are minimised. Exponent prepares and submits the technical dossiers and risk assessments that are required and this includes higher tier notifications in countries such as China and Korea. We handle all post submission obligations including annual reporting and first importing documentation. CASE STUDY 3: Exponent has provided assistance from data package development right through to active substance approval and product authorisation. This involved providing initial strategic advice, data gap analysis, data interpretation, study placement and monitoring, devising robust waiving strategies and bridging argumentation, exposure modelling, human health and environmental risk assessments, preparation and submission of the dossier and attending working group and competent authority meetings during the evaluation process. Discussions were held with the evaluating competent authority to confirm acceptance of the proposed product families, prior to Exponent’s specialists compiling the dossiers in IUCLID. Our team also performed technical equivalence assessments. This is just one example where Exponent’s expertise has contributed towards a positive outcome for our clients. Overall, our highly trained scientists have written over 30 active substance dossiers and numerous representative product dossiers across 17 product types, within the ongoing EU biocides review and for new biocidal active substances. STAFF SELECTION Mr Julian Reddy – Head of Industrial Chemical Notification Services Mr Reddy leads Exponent’s Industrial Chemicals business and is a very experienced regulatory project manager who has directed complex regulatory programmes for over 25 years Ms Alison McGuire – Head of Biocides (Europe) Ms McGuire leads Exponent’s EU Biocides business and is an experienced regulatory consultant with over 25 years’ experience working in chemical regulation. She has extensive knowledge of all aspects of the EU biocide regulation.

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Profile: Exponent International Limited

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Profile: Fieldfisher LLP

134

GLOBAL OFFICES Amsterdam, Barcelona, Beijing, Belfast, Birmingham, Bologna, Brussels, Düsseldorf, Frankfurt, Guangzhou, Hamburg, London, Luxembourg, Madrid, Manchester, Milan, Munich, Paris, Rome, Turin, Venice, Shanghai, Silicon Valley.

CONTACTS Website

www.fieldfisher.com

E-mail

claudio.mereu@fieldfisher.com

Head office

Riverbank House, 2 Swan Lane, London, EC4R 3TT, UK

Tel

+44 (0)20 78614000

Fax

+44 (0)20 7488 0084

Contact

claudio.mereu@fieldfisher.com

Directors

Claudio Mereu, Partner, Brussels Koen Van Maldegem, Partner, Brussels

Ownership

Limited Liability Partnership

Locations

Founded

1835

SERVICES PROVIDED Chemicals With more than 20 years’ experience in EU chemical law – compliance, consortia management and litigation, we provide a broad spectrum of chemicals-related advice, and have substantial experience in dealing with the most significant REACH implementation and compliance issues relevant for individual companies or groups of companies. We advise both private clients and consortia. We have particular expertise in assisting companies in challenging Echa and Commission’s decisions before the Board of Appeal and the European Court. For example the team has been acting against Echa in relation to a Sonc decision, which it successfully annulled before the Board of Appeal. The team has defended consortia on the inclusion of respiratory sensitisers in the candidate list as well as the inclusion of chromium trioxide in the authorisation list. We assist clients with regulatory compliance and data sharing, including breaches of contractual and legal requirements, dispute resolution concerning REACH, biocides and agrochemicals.

OVERVIEW Fieldfisher is a full service European law firm comprising over 700 lawyers, 300 of whom are partners. The EU Regulatory Group advises international clients on domestic and EU law on large and complex multijurisdictional matters. It combines advisory, consortia management and litigation work on REACH, pesticides and biocides (EU and national levels) thereby constituting the go-to firm for product defence. We advise and represent clients on matters arising under several areas of EU products legislation, including general product safety and eco-design requirements, and more broadly EU market access legislation. Our main areas of expertise relate to chemicals, pesticides, biocides, cosmetics, food and food packaging, pharmaceuticals, medical devices, IT and other electronic products, autos and auto parts, toys and sports equipment, textiles and apparel, and other consumer and industrial products. We also address related data protection and data privacy, competition and other business law issues that arise when drafting and negotiating commercial agreements or setting up and running consortia under REACH, BPR and pesticides laws. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

1300

Staff, group

Staff, chemical service provision SERVICE AREA BREAKDOWN Training Consultancy/advisory 5% 10% Representation & management 10% IT & software 5% Legal 70%

Global Service Providers Guide 2019

Agrochemicals/pesticides/fertilisers/biostimulants We advise major pesticide manufacturers on the European re-registration programme laid down by Directive 91/414 and its replacement Regulation 1107/2009, including the renewal programmes under the socalled AIR regulations. We provide legal assistance on a variety of issues ranging from initial notifications of pesticide active substances, joint and individual company dossier preparation and submission, including zonal applications and mutual recognition across jurisdictions, the creation of Task Forces and related data protection issues, including compliance with European competition laws (both at EU-wide and member state level). We have been active in challenging regulatory restrictions and negotiating data compensation agreements during the re-registration process, including relevant arbitration proceedings in several EU countries, as well as the re-submission of dossiers. We have negotiated many data sharing/ compensation agreements and successfully handled arbitration and litigation cases in various EU countries relating to data access. We also have a significant expertise on the new Regulation on fertilisers/ biostimulants. Biocides The biocides team provides legal advice on data protection, data sharing, dossier submission and evaluation, regulatory requirements under the biocidal products Regulation (BPR) as well as overlap with other legislation, such as the REACH Regulation and legislation on medicinal products, cosmetics or medical devices. It frequently advises on the national Member State regulations of biocidal active substances/product type combinations during the review programme. Its expertise encompasses all EU member states. It also helps and provides advice on making biocidal product authorisation applications in the member states. The team advises on data sharing/ compensation agreements, as such or in the context of distribution/ purchasing or other arrangements. It has an in-depth knowledge of the free-rider and EU competition law issues at stake. The team is also guiding a number of active substance/ product type combinations through the EU review programme for existing active substances, including counselling and representation before the European Commission and Echa. The team has represented clients in judicial proceedings with Echa, Members States Courts and EU Courts.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

CASE STUDY 2: CCSG

2007

Fieldfisher’s office and EU Regulatory practice established in Brussels

2010

The team won an interim Order from the President of the EU General Court to suspend an Echa decision regarding the REACH candidate list – the first of its kind. This extended the suspension of the Commission decision not to include napropamide in Annex I to the PPPD until the conclusion of the assessment of new data on napropamide under the so-called “re-submission” procedure.

2011

The team filed the first ever appeal before the Echa Board of Appeal and successfully obtained reversal of the Echa decision thereby maintaining client details as confidential.

We successfully represented CCSG (CEFIC chemicals association) in a case against the European Commission in the European Court of Justice on a matter related to classification of coal chemicals. The European Commission was supported by Denmark, Germany and The Netherlands. On 22 November 2017, the Court decided that the Commission had committed a manifest error of assessment. This was a landmark ruling in the area of classification and a big victory for the Fieldfisher team. The General Court’s judgment, which was backed by the CJEU decision, has far-reaching consequences for EU chemicals litigation. The case sets an important precedent since, to our knowledge, it is the first time that it was clearly held that the Commission, and indirectly ECHA, has committed a manifest error of assessment in the review of chemicals.

2012-2015

The team filed groundbreaking annulment actions before the European General Court against commission regulations adopted under REACH (for clients such as PPG, Hitachi, Polynt, VECCO, EEIG or the International Cadmium Association).

2016-2018

The team manages about 40 consortia under REACH, BPR and pesticides renewals and acts as financial trustee and legal secretary.

ACCREDITATIONS The Legal 500 ‘Responsive and well-resourced’, Fieldfisher’s team is ‘without peer in the EU chemical regulatory area’. (2018) Chambers & Partners Strong Brussels-based environmental law practice, acting for industry associations and international companies. Advises on the creation and running of REACH consortia. Frequently represents clients in contentious mandates related to REACH, biocides and pesticides, notably challenging decisions made by the ECHA or local authorities. Acts for clients on environmental product safety mandates. Active on WEEE and RoHS directive compliance. Also advises on data sharing agreements and data protection. Koen Van Maldegem and Claudio Mereu are recommended. (2018) CLIENTS We advise and represent both private clients, including major chemical/ pesticides/biocides, medical devices and pharma companies, small innovative companies, as well as groups of companies (industry associations, task forces or consortia) and have more than15 years’ experience in consortia and task force management. CASE STUDY 1: SI Group andf Oxiris We successfully represented SI Group and Oxiris in a dispute against Echa before Echa Board of Appeal concerning the annulment of Echa

CASE STUDY 3: HITACHI & POLYNT Our assistance includes advice on dossier evaluation and completeness check, litigation before ECHA BoA and before the EU Courts. More particularly, we represented Polynt and Hitachi in a case before the General Court and the European Court of Justice against the European Chemicals Agency (ECHA) concerning the identification of HHPA and MHHPA as Substances of Very High Concern (SVHC) on grounds of “equivalence of concern” (respiratory sensitization). This case raised critical aspects for the inclusion of respiratory sensitizers in the list of SVHC and therefore constitutes a landmark judgment. (Hitachi & Polynt, Case sT-135/13 and T-134/13; C-323/15P and C-324/15P).. STAFF SELECTION Claudio Mereu – Joint Managing Partner, EU Regulatory partner, Belgium Claudio’s practice focuses on European Union law, with an emphasis on chemicals (REACH), pesticides, biocides and life sciences. He advises on regulatory compliance issues, task force/consortia formation, product defence strategies and product circulation across the EU. He handles product approval processes in the EU, related litigation before European courts and Echa Board of Appeal, and advises companies on business law and antitrust matters relating to their international agreements. He regularly represents chemical companies before the European institutions, member state authorities, scientific committees, and the European courts. Koen Van Maldegem – EU Regulatory Partner, Belgium Koen’s practice focuses on EU regulatory, business and competition law, with an emphasis on chemicals, pesticides, biocides and cosmetics. He advises international and Belgian companies on regulatory compliance and free movement of products throughout the EU. His expertise covers regulatory counselling at the EU and member state level regarding data protection, data sharing and data compensation, task force formation and management, distribution and supply agreements for pesticides, biocides and chemicals, and he is specialised in solving the antitrust issues that may arise in these areas. He also handles product defence litigation before European and national courts.

substance evaluation decision requesting new studies with additional parameters. The argumentation, both legal and technical, is based on three please in law: (i) infringement of procedural requirements, (ii) error of assessment under substance evaluation process since no risk has been properly identified and (iii) violation of proportionality and animal welfare principles. We worked closely with technical consultants during the preparation of the appeal. The hearing before the Board of Appeal took place on 21 March 2017 and the decision rendered in 2018, which was a victory for our client.

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Profile: Fieldfisher LLP

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Profile: FoBiG

136

SERVICES PROVIDED REACH registration FoBiG provides full-scale scientific support to meet industry’s REACH obligations: OO Iuclid 6 files (including literature searches, data gap analysis, evaluation of data reliability, application of read-across and category approaches and inquiry dossiers for new substances)/all endpoints (physico-chemical properties, human health, environmental fate and ecotoxicity); OO classification and labelling according to CLP Regulation; OO PBT/vPvB assessments; and OO (Chesar-based) chemical safety reports (including hazard assessment, derivation of DNELs, DMELs, and PNECs, exposure assessment and risk characterisation). Up to now, FoBiG was/is involved in preparing registration dossiers for hundreds of substances/categories for small and large companies.

CONTACTS Website

www.fobig.de

E-mail

info@fobig.de

Head office

Klarastraße 63, 79106 Freiburg i Br, Germany

Tel

+49 761 386080

Fax

+49 761 3860820

Contact

Klaus Schneider

Directors

Klaus Schneider, General Manager

Ownership

Private company

Locations

Germany

Founded

1992

OVERVIEW FoBiG is a privately owned consultancy specialising in toxicological and ecotoxicological risk assessment, with now more than 25 years of experience in exposure assessment and risk characterisation. FoBiG’s REACH experience dates back to 2001 with participation in, among others, Cefic- and VCI-sponsored projects. FoBiG successfully prepared numerous registration dossiers for phase-in and new substances. Furthermore, we provide ample experience in authorisation under REACH: FoBiG successfully prepared many authorisation dossiers for threshold and non-threshold Annex XIV substances and is involved in further authorisation projects at various stages of the application. Further projects deal with providing support for Corap-listed substances (substance evaluation) and for substances targeted by Echa dossier evaluations. VITAL STATISTICS Turnover, chemical service provision

2017/18 €1m 1

No of offices No of countries represented

Europe-wide

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

REACH dossier and substance evaluation and restrictions FoBiG provides scientific support to companies whose substances are targeted in dossier and substance evaluations and are affected by restriction proposals. Services include problem analysis, dossier refinement and communication with competent authorities/committees. Substance evaluation decisions often require performance of new studies. FoBiG provides support in comparing quotes from CROs and acts as study monitor for all kind of studies (physico-chemical endpoints, environmental fate and ecotoxicity and toxicity studies). Biocidal product authorisation Together with RegisGate partners (see www.regisgate.eu) FoBiG offers full-scale services for authorising biocidal products according to the Biocidal Products Regulation (BPR) scheme, including data gap analysis, preparation of the Iuclid-based dossier and communication with competent authorities/Echa. FoBiG provides ample experience eg on authorising disinfection products and biocidal products with in situgenerated active substances. Cosmetics ingredients and products FoBiG prepares cosmetic ingredients assessment reports for ingredient suppliers and performs cosmetic products safety evaluations. Pharmaceuticals and medical devices Scientific services for pharmaceutical companies and for manufactures of medical devices include: OO derivation of PDE (permitted daily exposure) according to EMA guidelines for residual substances (eg for use in cleaning validation); and OO assessment of impurities, including application of TTC (threshold of toxicological concern) approaches.

Training 2% Other Information 1% 5% Representation & management 2%

Consultancy/advisory 90%

Global Service Providers Guide 2019

REACH authorisation Together with partner RPA Ltd, FoBiG prepares complete dossiers for submitting applications for authorisation with: OO CSRs according to authorisation requirements, including a refined exposure assessment to demonstrate implementation of suitable RMMs/OCs and acceptable remaining risks; OO analysis of alternatives; OO socio-economic analysis; OO complete application for authorisation dossier (Iuclid 6); OO support for communication with Echa during the process (eg in PSIS meetings); and OO post-submission services (eg communication with Echa and Rac/ Seac on submitted dossiers, trialogue meetings). Up to now FoBiG was/is involved in preparing applications for authorisations for 8 substances for more than 40 companies and numerous uses.

Consumer products Potentially harmful substances in consumer products such as textiles and toys rank high in public awareness. FoBiG prepares hazard assessments and develops exposure scenarios to derive scientifically sound product evaluations.

Occupational toxicology (Company-specific) occupational exposure limits (OELs) for threshold and non-threshold substances (the latter based on an analysis of exposure-risk-relationships according to a German methodology) support companies in their internal evaluations with regard to occupational safety and health. In various projects FoBiG analysed the methodology to derive OELs and investigated possibilities for improvements, eg by using doseresponse modelling and probabilistic approaches to hazard assessment. Other services FoBiG provides regulatory support and (eco)toxicological risk assessments in various other areas such as food safety, environmental contaminants and effects assessment for industrial plants requiring permissions. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1986

Founded as personal company by Fritz Kalberlah.

1992

Reorganised as private company (GmbH) with company partners Fritz Kalberlah, Klaus Schneider, Martin Hassauer.

2009

New company partner Jan Oltmanns.

2018

Fritz Kalberlah and Martin Hassauer retired, long-term staff members Ulrike Schuhmacher-Wolz, Karin Heine, Eva Kaiser and Markus Schwarz entered as company partners.

PARTNERS FoBiG established a successful partnership with RPA Ltd for authorisation projects, providing full-scale services for preparing applications for authorisation. Together with partners Battelle, Hydrotox and ECT FoBiG formed RegisGate (www.regisgate.eu), a sophisticated consortium providing services for biocidal product authorisations. CLIENTS OO

OO OO

Chemical and pharmaceutical companies (from multinational to small- and medium-sized); EU institutions (eg Efsa, several Directorates General (DG) of the European Commission); and (German) federal and other authorities (eg BfR, Baua, UBA). Stakeholder organisations (eg VCI, trade unions).

CASE STUDY 1: Read-across for filling data-gaps Application of read-across and category approaches for filling data gaps in registration dossiers: Read-across proved to be the most successful strategy during the first two REACH registration phases for filling data gaps. Cases, where FoBiG successfully applied read-across in registration dossiers include: OO category formation/grouping based on structural relationship; OO read-across from metabolites to parent compounds or vice versa; and OO read-across along homologous structural changes. At the same time Echa (see Echa’s RAAF – Read-across assessment framework) asks for detailed justifications for applying read-across approaches, which require in-depth analyses of toxicokinetic and other available data. Read-across hypotheses and justifications need to be carefully documented as part of the registration dossiers. Approaches used for read-across are one of Echa’s focuses in dossier evaluation.

CASE STUDY 2: Application for authorisation: refined CSR For non-threshold substances such as carcinogens key to a successful application for authorisation is: OO use of exposure-risk relationships, which are scientifically sound and acceptable to RAC; OO documentation of implementation of suitable measures to reduce emission and exposure and OO refinement of the exposure assessment to derive realistic exposure estimates. In order to be able to demonstrate minimisation of risks and to conclude on low remaining risks associated with the use for which application is sought. Experience from authorisation projects clearly shows that CSRs from registration dossiers need to be improved with regard to exposure assessment. Detailed descriptions of the technical processes and the conditions of use and availability of measured data (eg air and/or biomonitoring measurements), which may be supported case-by-case by Tier II exposure modelling (eg by ART, RISKOFDERM, ConsExpo etc.), are key to a successful application. In addition to workers exposure characterisation, assessment of exposure of humans via the environment is an essential part of the authorisation CSR. New challenges for authorisation come with the increased Annex XIV listing of PBT/vPvB substances and endocrine disrupting chemicals (EDC), for which no established assessment methodology exists. In recent projects, FoBiG developed suitable assessment strategies for these types of substances to inform the CSR/SEA interface. Therefore, FoBiG provides profound experience for all kind of Authorisation endpoints (carcinogenicity, reproductive toxicity, PBT/vPvB properties, EDCs). CASE STUDY 3: Dossier and substance evaluation: refinement of CSR and supply chain information With more and more substances being added to the Corap list, substance evaluation becomes an additional important activity within REACH. Companies, whose substances are concerned, should adopt a proactive position, communicate with the competent authority, and try to reduce existing concerns. At the same time companies may receive Echa decision letters as a result of dossier evaluation and are requested to update registration dossiers. Requirements for additional studies are often based on ECHA’s rejection of category approaches, which then need to be improved to comply with the requirements of ECHA’s RAAF (see above). FoBiG supports companies by providing study monitoring services, working on dossier updates and communicating with ECHA and CAs. STAFF SELECTION Klaus Schneider, PhD, DABT Key areas: toxicological risk assessment, method development. Ulrike Schuhmacher-Wolz, PhD, ERT, Fachtoxikologin DGPT Key areas: reproductive toxicology and endocrine disruptors. Jan Oltmanns, MSc, PgDip Key areas: Exposure assessment (workers, consumers, environment). Karin Heine, PhD, ERT, Fachtoxikologin DGPT Key areas: computational toxicology, read-across. Markus Schwarz, PhD, Fachökotoxikologe (GdCh/SETAC) Key areas: Environmental fate modelling and ecotoxicology Eva Kaiser, PhD Key areas: hazard assessment, C+L., dose-response modelling.

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Profile: FoBiG

137

Profile: GBK GmbH Global Regulatory Compliance

138

SERVICES PROVIDED EHS Auditing, Risk Analysis and Certification with cfp ® We are a licensed partner of Compliance Footprint AG in Zurich an carry out audits for the purpose of certification under the Compliance Footprint System (cfp). cfp provides a unique and innovative system of evaluation, a practical aid for inspection of safety data sheets (SDS), availability of dangerous goods labels and dangerous goods transportation logistics. Cfp defines a new standard for conformity checks of the supply chain with respect to existing regulatory laws. Your benefits: free market incentives for responsible handling of dangerous substances and goods are created by purchasing certified commodities; as consumer interest in finished goods increases, companies have the opportunity to comply with the proper standards; simplified and fast customer clearance; reinforcement of sales network. Simplified search for legally compliant supply/delivery partners We can determine where these parameters stand and which level of compliance exists in your companies for these for the designated areas.

CONTACTS Website

www.gbk-ingelheim.com

E-mail

gbk@gbk-ingelheim.de

Head office

Koenigsberger Strasse 29, 55218 Ingelheim, Germany

Tel

+49 6132 98 290 0

Fax

+49 6132 84685

Contact

Bjoern Noll

Directors

Bjorn Noll Ulrich Mann

Ownership

Private company

Locations

Germany and China

Founded

1986

OVERVIEW The GBK GmbH global regulatory compliance is an international consulting company and full service provider around the themes of environment, health and safety. The range of services include product registration in chemicals inventories in Europe, USA and Asia and the GBK-EMTEL Emergency number for global transport of dangerous goods. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

2 2

No of countries represented Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training Legal 5% 5% IT & software 5% Information 5% Representation & management 10%

Consultancy/advisory 70%

GLOBAL OFFICES GBK GmbH Headquarter based in Ingelheim, Germany , GBK China Corp. Ltd in Shanghai, China.

Global Service Providers Guide 2019

EMTEL ® Emergency Telephone number An emergency telephone number for dangerous goods transportation is mandatory in numerous countries including the USA and Canada, and it is required by many air carriers (IATA). According to regulation 1907/2006/ EC, this emergency number must be included on any safety data sheet. GBK’s Emergency Telephone Number (EMTEL®), offers 24/7 immediate telephone assistance, if there occur problems during transport or handling of dangerous goods/hazardous materials. This comprehensive service ensures assistance not only in the case of spillage, fire or contamination, but also medical advice for toxicological incidents. Our EMTEL® service: OO access to a professional emergency call centre (24 hours /7 days/365 days per year); OO emergency telephone number in 190 languages; OO fulfilment of your legal obligations; OO realisation of all airline and shipping company requirements; OO medical advice in case of poisoning; OO additional service in the USA: waste management; OO fulfilment of regional requirements on an emergency service; and OO comprehensive support in case of accidents with chemicals. Your benefits OO you provide us with the required information – we’ll take care of the rest; OO we take on your legal responsibilities; OO you assume the responsibility to an external service provider; and OO it is valid for all deliveries to any destination worldwide. International EHS Consulting We help you with all issues around REACH, GHS, product registration and authoring of safety data sheets. Article 45 CLP regulation introduces European wide product registers: The Member States designate one or more places that are responsible for handling information from importers and downstream users that bring a mixture into circulation, and gather significant preventive and safety measures to be used particularly in emergencies. This information includes the chemical composition of the mixtures placed on the market and classified as hazardous on the basis of their health and physical effects, including the chemical identity of substances in mixtures for which a request for use of an alternative chemical name has been accepted by the Agency in accordance with Article 24. Registration – We guide you through the maze of laws. We perform product registrations in chemical inventories in Europe, USA and Asia (Japan, China, Korea, Philippines and Australia). We offer this to the necessary advice and assume all duties associated with registration, including with regard to labeling and MSDS. Product registrations are carried out in particular in the following areas:

REACH Services substance-/product registration in Europe, USA and Japan, China, Korea and Australia (other countries on request); and OO consulting services in connection with the registration. Your benefits OO compliance together with reduced costs; OO legal responsibilities met by an external adviser; service with more than 30 years of professional experience; and OO excellent price/performance ratio OO

Dangerous goods safety advisor/dangerous goods services OO Due to major accidents occurring during the transport of dangerous goods, the German implemented a responsible person in each legal OO entity who takes over the responsibility for all issues concerning the transportation of dangerous goods: the Safety Adviser. Safety advisers quickly became a success story. Starting in Germany in 1989, the European Union adopted this important role within the “Safety Adviser Directive”, Directive 96/35/EEC on 3rd June, 1996. Since 2001, safety advisers have been mandatory in all ADR/ RID member States. All relevant training programmes have been surpassed in the U.S. The directive offers the option of transferring this activity to an external expert. Service specification: OO taking over the responsibility of safety adviser for all modes of transport (road, rail, barge, sea); OO classification/labelling of substances and preparations including evaluation of suitable packaging; OO ongoing consultation for your organisation; OO development of process-oriented checklists; OO regular training to ensure your employees always act in compliance with all applicable regulations; OO periodical audits guarantee to detect possible weak areas; and OO providing an IATA/DOT/IMDG compliant 24/7 emergency telephone number. Your benefits: OO we take on your legal responsibilities; OO reduction of internal fixed costs; OO fully experienced advisers offering high quality services; OO legal and organisational consulting regarding EHS; and OO fast and reliable responses adapted to your needs. Trainings and Seminars We offer a wide range of trainings and seminars, conducted by our worldwide experts. GBK GmbH is established in the market as an important and well-known company. An essential element is the organisation of instruction, training and conferences in the areas of chemicals, legislation, handling of hazardous materials and the transport of dangerous goods. A wide range of training courses are offered by experts from all over the world. All trainers are experienced professionals in their field providing state-of-art training. For that reason many companies rely on the competence and high quality of our courses and seminars. Some training courses (examples) OO Asian-Pacific and Chinese chemical legislation. OO United States and Canadian Hazard Communication. OO MSDS/SDS Authoring expert training. OO Training for Dangerous Goods Safety Advisers. OO Dangerous Goods Training. TP1 – Guideline for hazardous materials transportation The BMVI announced new guidelines regarding the electronical documents for the transport of dangerous goods on road , rail and inland waters. These guidelines are valid since January 1st 2016. Until now it was only allowed in Germany to use an electronical transportdocument when you have a printer on-board with you, anytime ready to print out.GBK offers a reliable solution for this including an GBK-EMTEL Emergency call number in 24/7/365 format. The GBK-EMTEL Emergency must be readable installed on the vehicle when you use the electronical format of the transport document of dangerous goods.For all companies which working with the transport of dangerous goods this new guideline is a great opportunity to optimise your process and to save cost.

Our GBK experts will help you to recognise this and to integrate our GBKTP1 Portal into your daily process of transport of dangerous goods. Your benefits: OO clearly reducing operating costs thru optimizing and completely switch the process to electronical document management also now for dangerous goods; OO Future Readiness & Innovation: This national step by step introduction is already a part of the European-union-wide and international targeted solution for usage of electronical transport documents; and OO The data protection and encryption of the transport documents at the TP-1 Server is based on the latest technology. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1986

Foundation of the GBK as dangerous goods Office

2008

Acquisition of GBK by Björn Noll and winner “German dangerous goods Award 2008”

2010

Co-founder of compliance footprint AG, Zurich

2012

Moving into the new GBK company building in Ingelheim

2017

Opening GBK China Corp. Ltd. In Shanghai

PARTNERS NRCC, CIRS, GIZ, BMZ, BVMW, CFP, IKW, VCI, VDSI, VCH,BGI,DLSV. Furthermore we have a global Network of partner for collaboration, governmental institutions and local regulatory specialists to offer our customer a global support. CLIENTS The over 1,000 customers include both medium-sized companies from the chemical industry and 73% of all German DAX-listed companies in particular in the fields of chemical, pharmaceutical and automotive. CASE STUDY Based on our customer base from all different Industrial fields and verticals we can offer a wide range of case studies which matches your business or is at least comparable. Further details available upon request. STAFF SELECTION Bjoern Noll , owner and managing director Björn Noll is since May 2008 managing director and owner of GBK global regulatory compliance in Ingelheim and is engaged with dangerous goods logistics and international chemicals law for over 20 years. As EU hazardous goods officer he has all the necessary qualifications for all modes of transport. In addition, Mr. Noll is vice chairman and spokesman of the division of dangerous goods of the VDSI and also member of various working groups, just as he has published several articles on topics from the hazardous material and dangerous goods in all known specialist printer as a author. Ulrich Mann , member of the senior management team Ulrich Mann is lawyer also specialist solicitor for transport-/logisticlaw and within GBK member of the GBK Senior Management Team. He is responsible for the consulting of companies in dealing with hazardous materials. Since 1988 Mr. Mann is engaged with dangerous goods issues, as well as with the chemicals legislation and worked for companies such as Infraserv GmbH & Co. Hoechst KG and Infraserv Logistics GmbH, where he spent many years during his professional career. Mr. Mann was founding member and editor of the journal “Der GefahrgutBeauftragte” and can demonstrate numerous publications and book publishing GBK team worldwide The highly motivated, educated and experienced GBK team will provide you with excellent services and is dedicated to meet your individual needs with a high level of quality and flexibility. Our colleagues with degrees in different sciences are engineers or doctors in Chemistry in, law and further EHS fields. They can offer you our services in German, English and Chinese language www.chemicalwatch.com/SPG

Profile: GBK GmbH Global Regulatory Compliance

139

Profile: Gensuite

140

CLIENTS OO OO OO

CONTACTS

OO OO

Website

www.gensuite.com

E-mail

nikhilkumar.mantripragada@gensuitellc.com

Head office

4680 Parkway Drive #400 Mason, Ohio 45040 USA

Tel

(513)-774-1000

Fax

Insert text

Contact

Nikhil Kumar Mantripragada

Locations

USA, India, China, Mexico, Canada, UK, France, Australia

Founded

1997

OVERVIEW Gensuite enables companies to implement robust cross-functional compliance & management systems – locally, globally and across diverse operating profiles. Our comprehensive cloud software suite features intuitive, best-practice process functionality, flexible configurations and powerful extensions. For over two decades, we’ve helped companies manage safe & sustainable operations worldwide, with a focus on fast return on investment (ROI), service excellence and continuous innovation. Join over 1 million users that trust Gensuite with their compliance and EHS&S software system needs SERVICE AREA BREAKDOWN

Training 50%

IT & software 50%

GLOBAL OFFICES USA, India, China, Mexico, Canada, UK, France, Australia SERVICES PROVIDED Regulatory Compliance Chemical Safety Assessment Hazard Communications Stewardship CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2018

Environmental Product Award

2018

Verdantix Smart Innovator

2017

OH&S New Product of the Year Award – SDS System

2017

Golden Peacock Innovative Product & Service Award

Global Service Providers Guide 2019

GESargento Comcast Thyssenkrupp Ingersoll Rand Black & Decker Essilor Perrigo

CASE STUDY 1: Transitioning to a globally harmonized system of classification and labeling of chemicals (ghs) for hazard communication compliance. A globally recognized pharmaceutical company worked with industry experts to changeover 8,000 chemical products and train employees to a new chemical management system to meet the United Nations’ GHS standard. Business profile International pharmaceutical manufacturer headquartered in the US; OO 10,000 employees across 23 sites; and OO publically traded. OO

Business needs The company needed to deploy a comprehensive HazCom and chemical management system with: OO support services to assist with content migration & maintenance, system implementation and employee training; and OO secondary container labels for additional chemical standard compliance. Specific EHS/IT needs OO easily accessible Safety Data Sheets (SDS) for over 8,000 chemical products; OO expanded GHS labeling capabilities, including adding Quick Response (QR) codes to labels; and OO mobile capabilities to streamline the chemical management process. Gensuite solution Gensuite’s SDS System provides comprehensive HazCom and chemical management, including an approved chemical product inventory with associated SDSs, GHS pictograms, and the ability to generate precautionary & hazard code container and shipping labels. OO Includes an up-to-date, high-quality repository of ~190,000 current SDSs, with GHS content for over 30,000 chemical products; OO continuous content maintenance assured by the Gensuite services team; OO intuitive employee search on desktop and Mobile; OO integrated container and shipping labels with easy to readprecautionary & hazard statements; and OO mobile capabilities, available on or offline, with Quick Response (QR) code functionality. Results & benefits Gensuite was able to successfully migrate the company’s existing approved chemical list into the SDS system and provide training to employees for global chemical management. OO SDS System set up and launched in 4 weeks for 23 global locations; OO 8,000 SDSs uploaded in 6 weeks; OO chemical approval workflow enabled for systematic review, approval or rejection of new site chemical product requests.

Profile: H2 Compliance

142

GLOBAL OFFICES (Chemical) Ireland (Cork and Dublin) USA (Albany, NY) Poland (Warsaw) UK (Lutterworth)

CONTACTS Website

www.h2compliance.com

E-mail

info@h2compliance.com

Head office

Unit 14D Nutgrove Office Park Rathfarnham Ireland

Tel

01 2989136

Contact

Kevin Hoban

Directors

Kevin Hoban John Hayes Grant Kinsman

Ownership

Part of the Landbell group of Companies

Locations

5 (Chemical)

Founded

2006

SERVICES PROVIDED REACH Registration Manufacturers and Importers of Chemicals in the EU have obligations under REACH for the submission of substance dossiers. H2 Compliance support the determination of alternatives, cost determination and full project management to completion. The regime is now changing significantly with lower tonnage thresholds, requirements for Updates and management of the financial and contractual engagement with SIEFs. Only Representative H2 Compliance support a very significant number of non-EU companies taking over duties of their importers by acting as Only Representative. A complex service requires deep knowledge and appreciation of supply chains, technical service execution, financial management and communication with both clients and their customers.

OVERVIEW H2 Compliance is a full-service Chemical and Environmental consulting firm. We support our clients to ensure compliance and market-access by applying our breadth of knowledge to the business complexities of topics from REACH, SDS and Labelling, Biocides, and Chemical Management Software. With support services through our offices across Europe and the USA and the recent acquisition by the Landbell Group, H2 Compliance is further deepening its services into Environmental and the Circular Economy – further expanding its support into the Articles, IT and Electronics and industries, particularly with services in WEEE, Batteries, Packaging as well as software offerings into that space. VITAL STATISTICS

2017/18

Turnover, group

Not declared

Turnover, chemical service provision

Not declared Total: (15) Chemical (5)

No of offices No of countries represented

>20

Staff, group

300

Staff, Chemical & Environment service

Training 5%

Laboratory 5% Information 10%

Representation & management 25%

Global Service Providers Guide 2019

BREXIT As the UK’s Withdrawal from the EU marches forward, companies must prepare a parallel set of REACH-Like activities to remain on the market. H2 Compliance, with its UK Legal entity is able to support companies navigate the complexities that this significant change is presenting. From Only Representation (in the UK and transfers out to preserve Registrations), to supply chain mapping, to full execution of obligations, H2 Compliance is deeply embedded in this activity, helping clients plan for a transitional period, though also preparing for the impacts of a Hard Brexit element1 ™ Software A centralised management platform is nowadays essential for determination and deployment of chemical regulatory obligations. We use our platform for management of all services and also license to clients who wish to manage, budget, execute, communicate and provide business continuity to their organisation Poison Centre Notifications With the realignment of this activity and centralisation through the auspices of ECHA, H2 Compliance is engaging with clients and preparing their data accumulation in advance of the Jan 2019 Consumer deadline. Our new software platform allows a client to manage, and most importantly, maintain their technical, data management and financial activities.

SERVICE AREA BREAKDOWN

IT & software 10%

Authorisation The Authorisation process involves the progressive replacement of certain Substances of Very High Concern (SVHCs) which must be granted permission to remain on the EU market, for certain uses and for a limited period. The complex application process requires companies to build a case for a substance’s continued use, balancing the socio-economic benefits and impacts with the risks it presents to man and/or the environment. A thorough assessment of potential alternatives and their associated risk is also required to ensure the replacement is better than the substance it replaces. H2 Compliance has built a deep regulatory expertise in this space to optimise a successful outcome.

Consultancy/advisory 45%

GHS/CLP Services The obligations for continuous development of Safety Data Sheets and supporting Labels remains a core obligation for those placing hazardous products onto the global marketplace. With our toxicological and regulatory knowledge, supported with our international network partners, we build and maintain programs for our clients portfolio of products

Global Chemical Regulatory Support The chemical regulatory arena is changing rapidly. Companies shipping worldwide need to keep up to date with the changing regulations, and different regions or countries have their own specific registration / notification requirements that companies must adhere to in order to maintain compliance. Some countries have live requirements in place, with Korea most noteworthy for 2019. China, Japan, Switzerland, Turkey trigger ongoing obligations while many emerging regulations require careful observation and preparation. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006

Company established, opened Dublin Office

2007

Cork office opened

2009

USA Office

2011

Recognised by Irish Small Firms Association

2012

Deloitte Technology Award for company growth

2016

H2 Compliance acquired by The Landbell Group, Germany

2017

Polish Office opened

2018

UK Office opened

ACCREDITATIONS Approved REACH Ready Gold Member Member of Only Representative Organsisation Co-Sponsor of the Green Alley Circular Economy Awards PARTNERS OO OO

Redstone USA (SDS) Safebridge Consultants Inc USA (Industrial Hygiene)

CLIENTS H2 Compliance has over 250 customers across a diverse range of industries. Core clients are from the Pharmaceutical Industry, Medical Devices. Petroleum, Fragrances, Polymers, Metals sectors. TESTIMONIALS Stewardship Services: “H2 Compliance was carefully selected to allow us to continue to meet the changing needs of our new and existing client base. We based decisions on their ability to provide all required regulatory support within one compliance organisation. With their assistance we have successfully met the REACH and SDS deadlines without issue. I have found the team to be highly flexible with our deadlines, effective with providing accurate information, and most importantly, focused on our needs.” Michael Goluszka, La-Co Industries, USA Dossier Services: “H2 Compliance supported us for the construction of Lead Dossiers; which were submitted on time and to budget. The company brings a wealth of experience to this technical area and have a high quality of communication and project management. We have always found communications to have due regard for the confidential nature of the relationships within the consortia environment. We have found the relationship with H2 Compliance to be strong and we are happy to recommend the firm for this type of activity.” Diversified Chemical Industry, USA Case Study 1: Pharmaceutical and Healthcare Support H2 Compliance has deep expertise within the pharmaceutical industry whether through gap analysis, team development or strategic advice on intermediates and strictly controlled conditions.

H2 build full registration dossiers and upgrades to NONS dossiers including CRO oversight, RSS and submission. H2 are commended on their collaborative platform, “element1” used for professional execution, data availability and total transparency. Our clients enjoy the fixed price model we typically operate, flexibility in working hours and deep strategic thinking. “I wish all of our partners and consultants were as easy to work with as H2 Compliance” – says a top ten pharmaceutical client CASE STUDY 2: Product stewardship programmes to assure ongoing market access H2 Compliance has developed and implemented a product stewardship programme for a global blue-chip firm. The initial distinct strands of support have developed into an integrated programme with the establishment of a formal role within the company to manage the product life cycles and organisations. H2 Compliance provided the tools, structure and strategies for a robust and cost-effective product stewardship programme. The client has placed their trust in the experience and knowledge of H2 Compliance and there have been no market interruption issues since. CASE STUDY 3: Biocides support – a systems approach The use of Biocides in the EU comes with certain obligations to ensure safe and compliant use. H2 Compliance has built an on line application, which allows a company to build associations between Sites, Biocidal Products and the Active Substances. The dashboard view allows for strategic management of biocidal products on site, better visibility of the status of products and actives, and minimisation of product diversity across sites STAFF SELECTION Kevin Hoban – Chief Operations Officer Co-Founder of H2 Compliance. More than 25 years of experience in Industry, heads up business development, commercials, software activities as well as the Only Representative practice. Qualified MSc Industrial Chemist and Environmental Engineer. Grant Kinsman – CEO A Mechanical Engineer with more than 30 years’ experience in the IT and consulting industry. Extensive global technology, scale-up, finance, business and marketing experience. Beth Bidstrup – Director, North America Coming from a Pharmaceutical background with more than 20 years’ experience in the space, Beth is a certified Industrial Hygienist and leads services delivered into the Pharmaceutical industry and well as services delivered more generally into the North American market. Dr John Hayes – Director With over 20 years’ experience in the IT and Pharmaceutical space, John is a qualified Biotechnologist and Doctor of Physical Chemistry. Deep experience in Regulatory Affairs has characterised his career which is now applied to leadership of the Environmental Consulting activities within the group. Roseleen Murphy – Manager, REACH Services With 10 years of industrial experience before joining the Irish Competent Authority where Roseleen worked a further five years prior to joining H2 Compliance more than five years ago. Holding a BA in Science (Microbiology) and an MBA (Health Safety and Welfare), Roseleen leads the Joint Dossier and Authorisation practices within H2 Compliance. Colin Smith – Manager, Chemical Hazard and Risk European Registered Toxicologist and Chartered Biologist with deep experience within the Irish Competent Authority, UK Ministry of Defence coupled with industrial experience including biocides manufacture and laboratory management. Colin has served as technical advisor within CARACAL, drafted technical annexes to the CLP legal text and is now responsible within H2 Compliance for GHS/CLP, Lead Dossier risk assessment and strategy, Biocides and Cosmetics.

www.chemicalwatch.com/SPG

Profile: H2 Compliance

143

Profile: Hohenstein Group

144

SERVICE AREA BREAKDOWN

CONTACTS Website

www.hohenstein.com

E-mail

info@hohenstein.de

Head office

Schlosssteige 1

74357 Boennigheim

Germany

Tel

+49 7143 271 0

Fax

+49 7143 271 51

Contact

Martin Cieslik, Head of International Sales

Directors

Prof. Dr. Stefan Mecheels Dr. Stefan Droste Florian Girmond Dr. Timo Hammer Prof. Dr. Hoefer

Ownership

Privately owned

Locations

50 offices worldwide

Founded

1946

Training 5% Legal 2%

Other 13%

Consultancy/advisory 5% Information 5%

IT & software 5%

Laboratory 65%

GLOBAL OFFICES Headquarters: Hohenstein Group, Schloss Hohenstein, 74357 Boennigheim, GERMANY Offices: Bangladesh, China, Germany, Hong Kong, India, Pakistan, Turkey, USA, and many more. SERVICES PROVIDED Product and regulatory testing In our state-of-the art laboratories in Germany, Bangladesh, India, Hungary and Hong Kong, we are able to test a wide range of quality features and properties on all kinds of textiles and many other products. The focus is on ensuring an optimal performance, serviceability and marketability of the tested products, taking into account all relevant laws and standards. Based on our long-standing experience and our customers’ specific requirements, we are able to draw up individual test programmes tailored to their individual needs.

OVERVIEW Hohenstein was founded in Boennigheim (Germany) in 1946. Currently, over 1000 employees are working at its headquarters, laboratories and offices based in Europe, Asia and America. The international client base does not only include companies along the entire textile value chain but increasingly also customers from other branches such as the automotive industry, medicine and consumer goods. Today, Hohenstein is an innovative service partner for textile testing, inspection and certification. We combine our testing capacities and research activities to a unique service portfolio including third-party certifications such as OEKO-TEX®. Our Hohenstein mission is to help our clients develop and manufacture high quality products that succeed in the marketplace. VITAL STATISTICS Turnover, group Turnover, chemical service provision

2017/18 €85m -

No of offices

No of countries represented

Staff, group Staff, chemical service provision

Global Service Providers Guide 2019

1030 428

Product stewardship Hohenstein offers companies an international network of expertise in textiles to assist them in the fields of social, environmental and economic sustainability along the textile supply chain. Apart from many other services, the OEKO-TEX® system provides a one-stop solution for implementing comprehensive product responsibility throughout the textile value chain. The product safety ensured by the STANDARD 100 by OEKO-TEX® remains a key element of this commercially well-established system and is supplemented by a range of other practical tools enabling companies to successfully implement sustainability, transparency and responsibility on all operational levels. Product performance Textiles and textile chemicals are used in a wide range of application areas today. As a consequence, our Hohenstein experts can provide support for a wide variety of branches, from the health care sector to the automotive industry up to domestic appliances or the armed forces. We offer specific and targeted support when optimizing your products and will work in close co-operation with you to develop innovative products and processes. DETOX / ZDHC services Hohenstein enables business partners along the textile chain to assess and verify the status of their chemical management systems including the quality of their wastewater and sludge with regard to the Detox goals of the Greenpeace campaign.

Profile: Hohenstein Group

145

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2013

Hohenstein developed a test programme to assess the aerobic breakdown of textile products over a defined period of time by burying them in the soil in controlled conditions. The Hohenstein Biodegradation testing services allow to evaluate the eco-toxicological safety of products.

2014

Hohenstein’s HUMskin is based on a modified biopolymer and simulates the physiological, mechanical and topographic properties of healthy human skin. By using HUMskin to carry out ex vivo tests, all external influences can be completely excluded. The test conditions are standardised so that the results can be reproduced at any time.

2016

Hohenstein has been testing and verifying textile chemicals by means of the ECO PASSPORT by OEKO-TEX® since last year. This system verifies your formulations for chemicals of concern including many or all chemicals listed in currently existing manufacturing restricted substances lists (MRSL).

ACCREDITATIONS Recognised test centre in compliance with DIN EN ISO/IEC 17025 and inspection centre in compliance with DIN EN ISO/IEC 17020, accredited by the German National Accreditation Body (DakkS). PARTNERS OEKO-TEX® Association CLIENTS The ECO PASSPORT by OEKO-TEX® certification serves to examine textile chemicals used as aids in production. As an oil manufacturer for the industry, Total is one of the first providers of coning oils to have its Lissolfix APZX 1350 / 1500 / 4800 products certified and is already planning additional ECO PASSPORT by OEKO-TEX® certifications.

www.chemicalwatch.com/SPG

Profile: I+K AG, Compliance-Footprint AG

146

SERVICES PROVIDED Safin.net, Trade.net, cfp.net: to manage SDS, label, import/export HS code, controlled substances, compliance certification, global connectivity to safe use information via cloud IT, via QR code, via dedicated cockpit App. Safin.net, Trade.net, cfp.net: OO to manage SDS, label, import/export HS code, controlled substances, compliance certification, global connectivity to safe use information via cloud IT, via QR code, via dedicated cockpit app; OO integrated solutions to achieve regulatory compliance and positive market impact at low operational cost; OO intelligent data processing capabilities: - expert system functionality to facilitate GHS/CLP-, Transport-, HSand Storage/Warehouse- classification - regulatory control to identify substance import/export restrictions; - assistance to compose, to translate and to deliver SDSs; - capability to allow for XML based SDS transfer; - integration to deliver customised labels, including communication via QR code; - enabling data interface to enterprise systems, e.g. SAP; and - enabling data interface to chemical registration systems, e.g. to facilitate biocide registration in accordance with the Swiss biocide VBP directives; and OO compliance certification, in partnership with compliance footprint AG. OO

CONTACTS Website

www.i-k.ch, www.compliance-footprint.com

E-mail

weggimann@i-k.ch, hdiener@i-k.ch

Head office

Hadlaubstrasse 154 CH-8006 Zurich Switzerland

Tel

+41 79 404 17 33, +41 44 364 22 33

Fax

+41 44 363 22 36

Contact

Dr Walter Eggimann, Dr Heinz Diener

Directors

See Contact and E-mail.

Ownership

Four board members

Locations

Switzerland.

Founded

1993

PARTNERS

OVERVIEW 25 years of dedication in delivering regulatory solutions to businesses, worldwide and local. I+K AG, in partnership with Compliance-Footprint AG and Business Organisations provides best in compliance solutions with the focus on SDS / SDBTransfer, label, working instruction, chemical/ biocide registration, WCO HS tariff code, controlled substance and compliance certificate. Develops and provides corresponding software, combining core competency in regulatory management with modern cloud/mobile IT. A regulatory solution is the result of professional expertise in both chemistry, IT and business implementation. Operational experience spans from large size global corporation down to middle/small size company. I+K AG combines with core expert partners, fit to purpose, enabling synergy, innovation and beyond average business value. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

global

No of countries represented Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 5%

Consultancy/advisory 5%

IT & software 40%

Representation & management 50%

GLOBAL OFFICES www.i-k.ch: Zurich Switzerland www.compliance-footprint.com: Zurich, Switzerland, Germany Partner organisations: UK, Germany, China , USA Global Service Providers Guide 2019

www.i-k.ch in partnership with www.compliance-footprint.com and their associated partners, i.e. www.gbk-ingelheim.de, www.gcc-bender.de, www.mplogistics.ltd.uk, including dedicated IT partners, others. CLIENTS Wide range of operational experience with international companies, on global scale, covering some 35 languages on SDS and label. Numerous small size companies to deliver solutions on demand. Celebrating 25 years of dedication in delivering regulatory solutions to businesses, worldwide and local. CASE STUDY 1: I+K AG holds beyond 10 years of operational experience with one of the largest chemical companies in processing the entire scope of label requirements at all production sites worldwide, based on the customised label system within SAFIN.net, including data integration with the SAP enterprise architecture, standardising on globalised label templates, allowing for automation in applying the label to drum. CASE STUDY 2: Accomplished integration of Trade.net within the IT enterprise architecture of a global chemical company to process the day-to-day SOP-workflows, global scale, in classifying the import/export HS codes and to identify the inherent regulatory-restrictions regarding import/export of chemical substances. CASE STUDY 3: For a large Swiss energy-producing company, enabled instant access to valid Safety Data Sheets and working instruction documents, across the wide portfolio of purchased chemicals, IT and regulatory know-how based. This in response to frequent regulatory audits (enforcement) and to the legal managerial accountability to ensure the safe use of chemical products, training, risk assessment, substitution to safer products. This legal accountability requires the capability across ‘the big 5’: i) to enable instant access to the valid SDS. e.g. Safine.net based, ii) to have all chemical products correctly labeled, iii) to allow for instant access to hazard and precautionary info, e.g. via QR code, iv) to conduct regular safe use training, aligned with the chemical portfolio, v) to control risk assessment and corrective steps.

Legal compliance Safer chemicals save costs and problems We combine know-how, IT, innovation and global experience.

Understand your chemistry Increasingly complex, stringent legal and market requirements are the challenge of our times. Whether you are an SME or a large corporation. By using expertise and tools, adapted to your specific needs, we help you to fulfill your regulatory responsibilities. We combine over 25 years of global experience, regulatory know-how, IT and vision to transform regulatory complexity, safe use and risk control into a modern communication. Intelligently imbedded into the digital reality of supply chain, circular economy, end-to-end, traceable.

Our global systems are in daily use: safin.net | trade.net | cfp.net “If you connect people with safe use information, they make chemistry safe, creating more innovation, more creativity, more opportunity.”

Partner Organisations

mplogistics.ltd.uk

compliance-footprint.com

gbk-ingelheim.de

Ladungssicherung und Gefahrgutinformation in Theorie und Praxis Programm

I+K AG is part of the company-network driving the SDScomXML standard forward, connecting compliance, safe use and business across supply chain.

Am 07.03.2012 im Kulturhaus Leuna, Spergauer Straße 41a in 06237 Leuna Moderation: Dr. Matthias Hanisch, Verband der Chemischen Industrie e.V., Landesverband Nordost

I+K Information and Know-How Ltd. Hadlaubstrasse 154, CH-8006 Zurich T +41 44 364 22 33, M +41 79 404 17 33 weggimann@i-k.ch, info@i-k.ch 09:30 – 10:00 Registrierung, Warming Up, Kaffee

10.00 – 10.10 Begrüßung Begrüßung und Fokussierung der Teilnehmer auf das Thema Dr. Matthias Hanisch, VCI 10.10 – 11.00 Ausblick auf ADR 2013 und Review ADR 2011, GGVSEB Die aktuellen Entwicklungen gepaart mit einem Überblick über den aktuellen Stand RA Ulrich Mann, GBK Gefahrgut Büro GmbH 11.00 – 11.15 Entwicklungen bei der EU und bei CEFIC

12:30 – 12:45 Ladungssicherungskontrollen: Ergebnisse in Sachsen-Anhalt Hermann Liesen, Polizei Sachsen-Anhalt 12:45 – 13:00 Diskussion und Fragen 13:00 – 13:45 Mittagspause 13.45 – 14:30 Praktische Vorführung Ladungssicherungsmobil, Beladung mit Gurten, Vorstellung von verschiedenen Ladungssicherungsmaterialien Reinhard Köbl, DVR 14.30 – 15.00 Vorstellung des Ladungs-

find out:

www.i-k.ch

Profile: INERIS

148

SERVICE AREA BREAKDOWN Equipment 5% Training 5%

CONTACTS Website

www.ineris.fr

E-mail

prestaweb.dsc@ineris.fr

Head office

Parc Technologique Alata, 60550 Verneuil-en-Halatte, France

Tel

+33(0)3 44 55 67 81 (Reine LANDA)

Fax

+33(0)3 44 55 66 55

Contact

Reine LANDA, Business Development Manager

Directors

Hafid BAROUDI, Business Development and Certification Division

Ownership

French public research body with industrial and commercial activities (EPIC), under the aegis of the French Ministry of Environment

Locations

France

Founded

1990

Laboratory 45%

Established by the French government in 1990 as the National competence centre for Industrial Safety and Environmental protection, INERIS has developed broad expertise in the areas of chronic and accidental risks. INERIS places its expertise as well as its scientific and technical experience at the service of companies in every industry, in order to guide them in their actions with regard to health, safety and environmental protection. INERIS combines experimental approaches with expertise in modelling and risk methodology. It is equipped with physical/chemical analysis laboratories, GLP-compliant toxicology and ecotoxicology facilities, large scale fire gallery and explosion platform, and test facilities that are among the best in France, both for studying accidental phenomena and effects on living beings. INERIS offers multi-disciplinary approaches with the capacity to conduct complex studies in many areas, including chemistry, in vivo toxicology, ecotoxicology, environmental fate and physico-chemical hazards in compliance with various regulatory needs (e.g. REACH, CLP and GHS notifications, biocides, waste (HP 14), transport of dangerous goods, ATEX, etc), or in response to research and development needs.

Turnover, group

2017/18 66 mâ&#x201A;Ź

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

540

Staff, chemical service provision

250

Global Service Providers Guide 2019

Consultancy/advisory 30%

Representation & management 8% Information 5%

GLOBAL OFFICES

OVERVIEW

VITAL STATISTICS

Other 2%

France: main site in Parc Technologique ALATA, Verneuil-en-Halatte (60, North of Paris), Waste recovery platform ARDEVIE in Aix-en-Provence (13), Centre for Monitoring Ground and Underground Risks in Nancy (54), structural strength laboratory in Bourges (18). SERVICES PROVIDED Regulatory services INERIS offers services according to REACH regulation and its implementation. The testing capabilities and the expertise permit a complete offer for the registration of substance in accordance with the requirements of REACH. It includes the development of Iuclid dossier and the chemical safety report according to the exposure scenario and management measures to ensure a high level of protection for workers, general population and environment. In the context of 3R strategy, INERIS can also provide with advice on the selection of the best alternative in integrated approaches for testing and assessment of your substance (Qsar, PBPK modelling and read-across). INERIS can help industrials for the selection of the best substitution option. Physico-chemical testing INERIS has various equipment and facilities allowing an extensive range of experimental assays to study the physical and chemical properties of substances. For chemical characterisation and determination of purity and stability of compounds, in-house analytical techniques available include: GCMS, GC with different detectors (FID, ECD, TSD, PFPD), LC with UV and fluorimetric detectors, LC-MS-MS, LC-HRMS, IC coupled to amperometric and conductometric detectors, ICP-OES and ICP-MS among others. INERIS also has expertise in developing and validating challenging analytical methods for a very broad range of substances in different matrices (water, air, soil, waste, biogas, etc.). A range of physical characterisation techniques are available: transmission and scanning analytical electron microscopy and XRay Fluorescence for morphology and composition of materials, particles and aerosols; laser diffraction, quasielastic light diffusion and centrifugal sedimentation for particle size quantification. Physico-chemical hazard characterisation includes: flammability, explosivity of gas, liquid and dust materials by means of standard testing and specifically designed test methods, calorimetric study of hazardous chemical reactions, and standard testing of self-reacting substances and explosives. INERIS can also study the thermal degradation of substances and materials by using tubular furnaces (from 50 to 1600Â°C).

Toxicological testing INERIS provides customized and regulatory in vivo toxicology studies in its GLP-compliant rodent facility of 1000 m². With a particular attention towards animal welfare (in compliance to Directive 2010/63/EU), this state-of-the-art facility is composed of mice and rat housing areas and innovative experimental installations allowing exposure to chemical agents, including nanoparticles, by inhalation (nose-only and whole body), and to electromagnetic fields. The facility is also set to perform behavioral testing, surgeries, and ex vivo analyses. INERIS provides services ranging from hosting a team project, supplying animal housing and equipment, to performing complete studies. INERIS also performs in vivo studies following OECD test guidelines: OO acute tests (OECD 402, 423 and 436); OO repeated dose 14-day preliminary tests (range finding assays); OO repeated dose 28-day toxicity tests (OECD 407 and 412); OO repeated dose 90-day toxicity test (OECD 408); and OO developmental and reproductive toxicity tests (OECD 421, 422 and 443). In addition, in vitro research can be provided with a specific expertise in pulmonary toxicology. Ecotoxicological testing INERIS provides experimental assays and expertise in general ecotoxicity of chemicals and environmental matrices. It develops and performs biological assays to characterize the hazards towards the aquatic, benthic and terrestrial compartment, as well as an expertise for the environmental fate of chemicals. The study design, including test item preparation, test design and analytical phase is adapted to each specific requirement. The following acute and chronic tests are performed routinely, according to European test methods or OECD test guidelines: OO aquatic tests: short and long-term toxicity on invertebrates (Daphnia magna, OECD 202 and 211; Ceriodaphnia dubia, ISO 20665), growth inhibition test on aquatic plants (algae, OECD 201; duckweed, OECD 221), fish lethality test (OECD 203) and activated sludge respiration inhibition test (OECD 209); OO terrestrial tests: deshydrogenase activity of Arthrobacter globiformis (ISO 18187), lethality and reproduction tests on earthworms (OECD 207 and 222), emergence and growth of higher plants (OECD 208), and growth, fertility and reproduction of nematodes (ISO 10872); OO sediment tests: Chironomids (OECD 218 and 219), Hyalella azteca (ISO 16303) and Myriophyllum (OECD 239, ISO 16191) toxicity tests; and OO environmental fate: ready biodegradability (OECD 301) and inherent biodegradability (OECD 302). INERIS has also developed an expertise in the ecotoxicity of emerging substances including nanoparticles (sample preparation, nanoparticles characterisation, etc), ionic liquids and drugs residues. Nanoparticles hazard assessment INERIS has a complete in vivo (rat models) nose-only inhalation system (HCT) to expose animals to nanoparticle aerosols, with associated metrology, TEM and physico-chemical characterisation of nanoparticles. It participates also in the development of standardised technologies and assays for regulatory use in toxicology and ecotoxicology (eg assessment of air-liquid interface (ALI) exposure system for in vitro pulmonary nanotoxicology). The S-NANO platform offers operational solutions for risk management throughout the lifecycle of nanomaterials: determination of safety parameters of combustible powdered nanomaterials (flammability, explosiveness, static electricity), use and development of the most effective instruments for testing, metrology and characterisation for use on nanomaterials, analysis and modelling of the behaviour of powders at the nanometric scale (rheology, suspension, dispersion potential) and investigation of granulation and agglomeration mechanisms, assessment of the emissivity of nanoparticles by materials in ambient air (dustiness) and by manufactured products containing nanomaterials when subject to external mechanical (abrasion, use), thermal (combustion, incineration), ultra-violet or chemical aggressions throughout their lifecycle.

Multi-disciplinary approach INERIS services include various areas of expertise: characterisation of products, substances and materials, and capacity to generate an ATEX (physico-chemical properties, physical hazards related to substances, mixtures and to explosion of flammable liquids, vapours, gases, dusts and powders, explosive rapidity, etc), transport of dangerous goods, authorisation to operate application hazards study (industrial sites and ICPE-class facilities). INERIS also has more than ten years’ experience in nano-safety for the assessment of chemical and toxicological hazards of nanomaterials, workers and population exposure and the evaluation of associated risks. Regulatory expertise on behalf of companies consists in appraising the compliance of equipment or systems with regulations, standards or frames of reference, particularly through certification, or providing, at the request of the authorities, an independent expert opinion (third party expert appraisals) on the validity of regulatory dossiers. Expertise, consultancy and training aim to transfer know how to those concerned by risk management (companies, local authorities, stakeholders, etc.) through a comprehensive and narrowly targeted range of services. ACCREDITATIONS INERIS is ISO 9001 certified by AFNOR for the following activities: research and development, consulting, appraisal, certification, product testing, development, and also training in occupational hazards and industrial environment. INERIS is compliant with Good Laboratory Practice (GLP) in the areas: toxicity testing, environmental toxicity studies on aquatic and terrestrial organisms, studies of behaviour in water, soil and air, bioaccumulation, analytical and clinical chemistry testing. INERIS is accredited by COFRAC in compliance with NF EN ISO/CEI 17025 (testing and calibration body), 17043 (interlaboratory comparisons ILC), 17065 (certification body), cf. www.cofrac.fr, under n°1-0157, 2-1251, 1-2291, 5-0045. CLIENTS INERIS works with more than 2,000 clients around the world from various industry sectors and disciplines: chemistry, paints and coatings, cosmetics, food, oil, gas and petrochemicals, automotive and heavy equipment manufacturers, construction, marine, consumer electronics, nanotechnology, etc. CASE STUDY: Accompanying client for a REACH dossier Unique importer of a substance, at a tonnage above 1T/year (Annex VII), then above 10T/year (Annex VIII): validation of existing assay reports; in silico (read-across) feasibility evaluation and bibliographic expertise; guidance in providing physicochemical identification data on the substance for Annex VI; OO definition and proposal of assay strategies for the development and validation of physico-chemical analysis methodology to quantify the test item in different media; for toxicology, ecotoxicology and physico-chemical characterisation; OO realisation, at the same geographical site, of required physicochemistry, in vivo toxicity and ecotoxicity experimental assays; OO guidance along the process, on the assay strategy based on obtained results; for example, guidance for mutagenesis in vitro assays, and selection of the necessary follow-up in vivo assay for proposal to Echa; and OO reporting and preparation of all sections of the Iuclid file, including the chemical safety report (when applicable). STAFF SELECTION Reine LANDA – business development manager reine.landa@ineris.fr

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Profile: INERIS

149

Profile: Intertek

150

GLOBAL OFFICES OO OO OO

CONTACTS

OO OO

Website

www.intertek.com/green/chemicals/

E-mail

regulatoryaffairs@intertek.com

Head office

33 Cavendish Square, London W1G 0PS, UK

Tel

+44 161 245 8071

Contact

Jeremy Ramsden

Directors

Sir David Reid, Chairman; André Lacroix, Chief Executive Officer; Ross McCluskey, Chief Financial Officer

Ownership

Public

Locations

Intertek is an industry leader with more than 43,000 employees in 1,000 locations in over 100 countries.

Founded

The Intertek story starts at the inception of the modern testing industry. The history of Intertek goes back over 130 years, and evolves from the combined growth of a number of innovative companies.

OO OO

Germany – Leinfelden-Echterdingen, Tel.: +49 711 27311 196 UK – Manchester, Tel.: +44(0)161 245 8071 Italy – Bologna, Tel.: +39 051 0562930 US – Washington, DC, Tel.: +1 302-287-3650 Canada – Ontario, Tel.: + 1 905 542 2900 China – Shanghai, Tel.: +86 (21) 6073 7735 India – Mumbai, Tel.: +91 22 67976900

SERVICES PROVIDED Assurance – enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and quality management systems. We offer the complete solution for global, regional, or local health and environmental regulatory compliance. Testing – evaluating how your products and services meet and exceed quality, safety, regulatory, sustainability and performance standards. Inspection – validating the specifications, value and safety of your raw materials, products assets and processes. Certification – formally confirming that your products and services meet all trusted external and internal standards. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2016

Intertek expands chemical regulatory services to meet ongoing demands of TSCA Reform with the opening of an office in Washington, DC.

2016

Intertek Partners with Assent Compliance to address challenges in restricted substance management.

2016

Intertek aligns chemical regulatory and scientific consultancy under global Health, Environmental & Regulatory Services business line.

2018

Intertek expands its Total Quality Assurance offering for sustainability with ATIC services global platform.

OVERVIEW Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 43,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely. VITAL STATISTICS

2017/18 £2,769m

Turnover, group

Turnover, chemical service provision

1,000+

No of offices

100+

No of countries represented

43,000+

Staff, group

5,000+

Staff, chemical service provision

ACCREDITATIONS Ms Joyce Borkhoff – Active member of the Industry Coordinating Group (ICG) for the Canadian Environmental Protection Act (CEPA), Responsible Distribution Canada (RDC), the Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers (ETAD), Cosmetics Alliance Canada, Colour Pigments Manufactures Association (CPMA), and Canadian Paints and Coatings Association (CPCA). Mr Dan Bastien – Former Head Client Services Unit, Environment and Climate Change Canada and Government Representative at the at the ICG for the CEPA. Dr Rose Passarella – Active Member of the American Chemistry Council (ACC), ACC’s Confidential Business Information (CBI), Risk Prioritization and Chemical Data Reporting (CDR) Work Groups to support US Toxic Substances Control Act (TSCA) activities and implementation of the Lautenberg Chemical Safety for the 21st Century Act (LCSA); US Bar of Pennsylvania and New Jersey; founding member of STRIDE (Scientific Technical Research Institute of Delaware); and certified mentor for SCORE.

SERVICE AREA BREAKDOWN

Other 100%

Dr Michael Leise – Board member of Only Representative Organisation (ORO) AISBL, representing credible REACH only representatives active within the European Economic Area. Dr Rainbow Zhang – Member of Council of Chinese Society of Toxicology (CST) and a Committee Member of the Society of Toxicity Testing and Alternative Methods, CST.

Global Service Providers Guide 2019

CASE STUDY 1: A step-wise strategic approach to registration leads to higher success The regulations governing the registration of biocides across the globe are complex and diverse, which requires a thorough understanding of the local legislations, ensuring the biocide product is well defined, and the claims are substantiated in accordance with these legislations. To support the introduction of a new biocide product in multiple jurisdictions, Intertek’s global team of regulatory and toxicology experts worked together in completing feasibilities assessments for the associated countries to identify roadblocks and develop a global test strategy to support the registrations, prior to submission of the applications to the competent authorities. Avoiding these roadblocks and aligning study placement saved the registrant time and money, as well as ensured that the submitted application successfully completed the full review process and resulted in approvals for sale and use. CASE STUDY 2: Intertek’s global network of experts helps clients achieve cost-effective registrations worldwide Keeping up with changes in regulatory landscapes and differences in pre-market approval programs for new products, novel ingredients, and unique raw materials is challenging. When you add a need for reliable safety assessments, in conjunction with protecting confidential information, the challenge can seem insurmountable. Recently, Intertek was asked by a chemical company located in North America for help in understanding and complying with the regulations to gain access to new markets in Canada, U.S., Australia, the EU, China, Japan, South Korea and the Philippines. Sending chemicals into these regions requires compliance with the new chemical notification programs in each of the jurisdictions and submission of sensitive product information by the local importer to the government agency for safety/risk assessment and pre-market clearance. Intertek’s global team worked seamlessly with the chemical company to develop and implement a smart global testing plan for each applicable new chemical to ensure that studies run were completed in a way that would maximize their acceptability across as many of these jurisdictions as possible. The new requirements under TSCA for affirmation before a company can proceed to the US marketplace are increasing the scrutiny of the assessments and offered additional challenges to proactively address the requests for additional data and avoid the common extended timeframes using preliminary inhouse screening approaches. Although the North American company agreed to provide the necessary information, they were reluctant to submit confidential information through the local customers. Intertek was able to work with both the client and their customers in each jurisdiction to prepare and submit the robust dossiers, and act as local country agent/only representative in some of these countries, while maintaining the confidentiality of the data and reaching compliance for import/manufacture of the volumes required by the businesses. We protect our customers’ competitive advantage with efficient, economical and timely global market access. STAFF SELECTION

Torben Nörlem, Esq – Chief Legal Counsel Regulatory Services Torben Nörlem has an LLM in law from the legal faculty at Copenhagen University and 16 years’ experience working with product related legislation and regulatory framework. Torben has been working as chief counsel for health and environment with Intertek since 2008. Torben was responsible for legal affairs related to the REACH legislative process and was a participant of the Danish government negotiation team during the negotiations in the European Union. He was also responsible for implementation and administration of EU rules regarding chemicals in electronics in Denmark. Dr Michael Leise – Senior Expert Consultant, Regulatory Affairs Dr Michael Leise’s responsibilities include consulting on notification strategies for chemicals worldwide, test-programme development, chemical risk assessment, negotiations with authorities and scientific bodies. He studied at Heidelberg, researched in Boston at MIT and has worked for many years as HSE expert at one of Ciba’s most important manufacturing sites in Germany. After transferring to Ciba’s headquarters in Basel, he led a global regulatory team and was involved in product stewardship prior to joining Intertek in 2010 with the acquisition of Ciba Expert Services. Michael is author and co-author of more than 20 peerreviewed publications in international scientific journals. He has also written numerous publications on regulatory affairs of chemicals and has frequently given presentations in different corporate, national, and international fora. Dr Chris Brennan – Manager; Toxicology & Regulatory Services, Health and Environmental Services Dr Chris Brennan is one of Intertek’s global experts in cosmetic safety and regulatory affairs. He has extensive experience in providing regulatory support to the global cosmetics and personal care industry. He also has expertise in chemical classification and SDS authoring. His background is originally organic and medicinal chemistry specializing in drug design and hit-to-lead, medicinal, combinatorial and analytical chemistry within the pharmaceutical industry. Chris is author and co-author of peer-reviewed publications in international scientific journals and holds several patents for drug design. He is a recognized speaker and has written numerous publications in regulatory affairs and safety of personal care products. Dr Rainbow Zhang – Senior Manager; Health, Environmental & Regulatory Services, China As a regulatory toxicologist with over 10 years of experience, Dr Zhang has extensive expertise in international new chemical notification programs and product safety assessment strategies. She has successfully delivered compliance solutions to more than 200 global chemical manufacturers. Dr. Zhang leads a team of regulatory experts with abundant experience in the registration& notification of (new) substances under China MEP Order No. 7, Taiwan TCSCA/Osha, KREACH/CCA and EU REACH. The scope of services for this team also covers food contact materials and cosmetic formula risk assessment and new ingredients registrations. With GLP experience and regulatory expertise, the team helps industry address challenging regulatory requirements in a timely and cost-effective manner, through the development and successful execution of test data, and providing expert judgment of waiving statements.

Ms Joyce Borkhoff – Vice President, Chemicals Group, Intertek Scientific and Regulatory Consultancy Services As a regulatory chemist with more than 25 years’ experience, Joyce Borkhoff helps the chemical industry understand and complywith global regulations controlling the manufacture, importation, distribution, and use of new and existing products. Her technical and regulatory acumen enable Joyce to develop and deliver health, environment, safety, and stewardship programmes that address all regulatory obligations and contribute to the development and success of corporate business strategies. Joyce’s leadership and advanced mediation skills enable her to successfully represent the interests of the chemical industry in bilateral and multi-stakeholder regulatory forums that tackle the development and evolution of a wide variety of legislative and regulatory amendments.

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Profile: Intertek

151

Profile: KAELTIA Compliance Services

152

SERVICE AREA BREAKDOWN

IT & software 5%

CONTACTS

Training 5%

Information 10%

Website

www.kaeltia.com

E-mail

info@kaeltia.com

Head office

Calle Margarita Salas, nº 2, 1º K, 33204, Gijón, Spain

Tel

Line 1: +34 984391044 / Line 2: +34 984391280

Contact

Dr Elisa Capellán, elisa.capellan@kaeltia.com

Directors

Dr Elisa Capellán

Ownership

Private company

Spain

Locations

Spain

SERVICES PROVIDED

Founded

2011

KAELTIA offers an effective and experienced support in managing the complex and constantly evolving regulation on the following areas:

Representation & management 10%

GLOBAL OFFICES

OVERVIEW KAELTIA is an enthusiastic and motivated consultancy company formed by experienced and highly-skilled PhD and MSc scientists with a chemistry, toxicology, environmental and agronomic profile. Our experience in the chemical regulatory framework has allowed us to deal efficiently with several projects on time, within budget and to the required standards. KAELTIA’s managing director as well as the project managers have extensive experience of regulatory affairs gained in industry, contract research and consultancy. We offer a qualified and efficient regulatory service to chemical industry with the help of our valuable, highly-experienced, proactive and committed staff, which is continuously updated on the regulatory requirements, with fluid communications with our clients and the relevant competent authorities. We strongly believe that the effective project management is the key to offer a good service, so we invest great part of our time to train highlyqualified scientists and to improve our services for the benefit of our clients. We offer our regulatory services in the areas of plant health, animal health, environmental and human health. We believe that this wide expertise across related regulatory areas enables us to offer a greater service value to our clients. KAELTIA has developed a worldwide network of partners that allows us to provide our clients with up-to-date knowledge in the country legislation, establishing good relations with local competent authorities. Our core values are efficiency, honesty, reliability and professionalism. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices No of countries represented

1 Global

Staff, group

<10

Staff, chemical service provision

<10

Global Service Providers Guide 2019

Consultancy/advisory 70%

Plant health Areas of expertise: OO plant protection; OO fertilisers; OO biostimulants; OO basic substances; OO botanical extracts; OO microorganisms; OO pheromones; and OO valuation of organic waste. Services that KAELTIA offers in the plant health area: OO strategic advice and guidance; OO data gap analysis: data available vs data required; OO preliminary risks assessments for human and environmental health; OO pre- and post-submission meetings; OO preparation of EU dossiers for authorisation and renewal; OO preparation of EU mutual recognition applications; OO preparation of national registration dossiers in Europe (during the transitional period); OO preparation of National registration dossiers in North and South America, Asia, Australia and Africa; OO technical equivalence dossier for new active substance source; OO toxicological, environmental and consumer risk assessments; OO modelling and development of exposure scenarios; OO expert judgments to avoid unnecessary testing; OO read-across and Qsars; OO study commissioning and monitoring with accredited laboratories; OO Consortia creation and coordination ; OO CLP/GHS classification of substances and mixtures; OO preparation of SDS and commercial labels according to local requirements; OO data sharing; OO liaison with the authorities; OO follow-up of the registration process until the product approval; OO third party representative services; and OO literature review. Animal health Areas of expertise: OO biocides; OO veterinary products; OO Feed registration; OO Feed additive, and OO Medicated feeding stuffs.

Services that KAELTIA offers in the animal health area: OO strategic advice and guidance; OO data gap analysis: data available vs data required; OO preliminary risks assessments for human and environmental health; OO pre- and post-submission meetings; OO preparation of EU dossiers for authorisation and renewal; OO preparation of EU mutual recognition applications; OO preparation of National registration dossiers in Europe (during the transitional period); OO preparation of national registration dossiers in North and South America, Asia, Australia and Africa;technical equivalence dossier for new active substance source; OO toxicological, environmental and consumer risk assessments; OO modelling and development of exposure scenarios; OO expert judgments to avoid unnecessary testing; OO read-across and Qsars; OO study commissioning and monitoring with accredited laboratories; OO CONSORTIA creation and coordination for biocides; OO CLP/GHS classification of substances and mixtures; OO preparation of SDS and commercial labels according to local requirements; OO data sharing; OO liaison with the authorities; OO follow-up of the registration process until the product approval; OO third party representative services; and OO literature review. Environmental and human health Areas of expertise: OO biocides; OO medicinal products; OO cosmetics; OO REACH; OO CLP/GHS; OO nanomaterials; OO endocrine disruptors; OO medical devices; OO food additives; OO food contact materials; OO detergents and surfactants; OO processing aids; OO treated articles; and OO toy safety. KAELTIA offers their services in the following countries: OO EUROPE: Spain, Portugal, France, Italy, Greece, Cyprus, Germany, Belgium, Austria, Bulgaria, Croatia, Denmark, Hungary, Ireland, Lithuania, Norway, The Netherlands, Poland, UK, Czech Republic, Romania, Sweden, Turkey, Ukraine; OO AFRICA: Algeria, Tunisia, Morocco, South Africa; OO AMERICA: US, Canada, Brazil, Argentina, Chile, Colombia, Costa Rica, Ecuador, Mexico, Peru, Venezuela, Bolivia, Panama, Guatemala, Honduras, El Salvador, Nicaragua, Dominican Republic; OO ASIA: UAE, South Korea, Kuwait, Qatar, China, Israel, Indonesia, Malaysia, Thailand, Russia.; and OO OCEANIA: Australia.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2011

Foundation of KAELTIA.

2012

Expansion of the team and further development of services on biocides and plant protection products.

2013

Further development of services on plant health products and human health.

2014

Further development of services on animal health products: veterinary area.

2015

Expansion of the team.

2016

Expansion of the team and development of a consortia IT System for EU biocides.

2017

Development of a consortia IT System for EU plant protection products.

2018

Expansion of the Team.

PARTNERS KAELTIA has a worldwide network of partners that allow us to offer efficient regulatory services with the most updated local/country rules at any time. CLIENTS KAELTIA supports a global client database of chemical, biocidal, agrochemical and veterinary companies, ranging from SMEs to large multinational corporations. Our client list is maintained on a confidential basis and their identity cannot be disclosed. STAFF SELECTION Elisa Capellán – PhD – Director Founder of KAELTIA Compliance Services. OO Extensive international regulatory affairs consultancy experience. OO Project management and team coordination. OO Consortia management and data sharing. OO Human and environmental health risk assessments. OO

The rest of the team All the staff are professionally qualified and skilled in technical dossier preparation, risk assessments and modelling, and study design and monitoring.

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Profile: KAELTIA Compliance Services

153

Profile: Kelley Drye & Warren

154

CONTACTS Website

www.kelleydrye.com

E-mail

jgreen@kelleydrye.com

Head office

3050 K Street, NW Washington, DC 20007 United States

Tel

202.342.8849

Contact

202.342.8451

Directors

Joseph Green

Ownership

Joseph Green

Locations

Washington, D.C.; New York, NY; Los Angeles, CA; Houston and Austin, TX; Chicago, IL; New Jersey; Connecticut; Brussels;

Founded

1836

OVERVIEW A powerhouse firm with the heart of a boutique, Kelley Drye & Warren LLP values the success of our clients above all. Skilled practitioners in the areas of regulatory compliance, litigation, real estate, corporate and bankruptcy combine talents to address the unique complexities of our clients’ legal challenges. We are practical in our advice and creative in our approach. Founded in 1836, for more than 180 years, Kelley Drye has provided legal counsel carefully connected to our client’s business strategies and has measured success by the real value we create. We apply a wealth of experience to 21st century business problems. Kelley Drye is a firm of more than 350 lawyers and other professionals practicing in New York, New York; Washington, D.C.; Los Angeles, California; Austin and Houston Texas; Chicago, Illinois; Stamford, Connecticut; and Parsippany, New Jersey. Outside of the U.S., the firm has an office in Brussels, Belgium. Complex regulatory advocacy Our environmental, health and safety practice advises on complex regulatory matters for large and small corporate clients and national and international trade associations. We are particularly skilled in translating complex business and technical issues into effective positions and advocacy, and in counseling on matters involving regulatory development, compliance and enforcement. Experienced with the range of federal environmental laws and state regulatory programs, as well as with European Union and international requirements, Kelley Drye has particular knowledge in the area of chemicals and toxic substances regulation. We also provide counsel regarding the safety of consumer products. Antimicrobial product registration and marketing under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is another active practice area. Our professionals help navigate the complex product registration requirements of the U.S. EPA and states, as well as provide practical advice on marketing and labelling issues, with an eye towards avoiding pitfalls that can result in onerous enforcement actions. California Proposition 65 presents an array of challenges not only to businesses located in the state, but to any business that manufactures or

Global Service Providers Guide 2019

distributes products that may be sold in California, including through the internet. Kelley Drye attorneys provide “Prop 65” compliance assistance and enforcement defense, including evaluation of whether a product requires a warning and, if so, how best to convey that warning. We assist businesses in developing strategic programs to maximize their understanding of the chemicals in their product and throughout the supply chain, while minimizing any potential liabilities. If a plaintiff “bounty hunter” comes calling with a notice of violation, Kelley Drye attorneys have a wealth of experience defending such actions and, when necessary, negotiating a reasonable settlement. Kelley Drye attorneys are involved in a wide variety of other environmental, health and safety matters on behalf of our diverse clientele. We provide counsel regarding European (REACH, CLP, RoHS) and international chemical and product safety requirements. Moreover, we assists clients with TSCA and Emergency Planning and Community Right-to-Know Act (EPCRA) reporting, including the Toxic Release Inventory (TRI) program. In addition, our practice regularly advises clients on the regulation of hazardous air pollutants under the Clean Air Act, Clean Water Act effluent limitations guidelines (ELGs), and Resource Conservation and Recovery Act (RCRA) hazardous waste determinations and corrective action. We also advise on Spill Prevention, Control and Countermeasure (SPCC) plan development and compliance. Our practice excels with the quick understanding of even the most complicated scientific concepts, especially regarding the science behind the regulation of chemical compounds. Determining what is or is not safe is rarely a black and white issue, and we are valued for our proven ability to navigate clients through and beyond such ambiguity. We balance the critical legal components of a scenario and then present workable solutions and persuasive arguments to help our clients succeed. Our innate ability to set people at ease when resolving challenges or negotiating the right compromise allow us to remain consistently focused on our clients’ specific needs, objectives and financial concerns. Litigation expertise: environmental remediation and contamination Kelley Drye represents clients in significant environmental, energy, and commercial litigation matters across the United States. We are recognized for our work on some of the largest natural resource damages, environmental remediation, and contamination cases in the country. Our decades of work for a broad range of industry clients, as well as states, port authorities, and local governments, also provide our lawyers with uncommon experience and perspective in tackling complex matters that often span litigation, administrative, and political forums. We have defended a number of major industrial companies in claims alleging that contaminants from manufacturing or bulk storage facilities caused property damage or personal injuries to neighboring properties. In successfully handling cases through trial, we have developed expertise in the sub-surface and airborne migration of petroleum and chemical products. In addition, private landowners turn to us as counsel in environmental litigation and related matters across the country. Private property contamination takes many forms, including soil, groundwater, surface water and air issues. Often, the landowner is unaware of historical contamination of the property, or of contamination that has migrated from adjacent or nearby properties. Our attorneys are able to obtain substantial recoveries for clients that partially or completely offset environmental remediation costs associated with these sites. Purchase and sale of environmentally impacted properties Our attorneys routinely negotiate and facilitate mergers and asset sales and purchases of businesses with environmentally impacted properties or environmentally sensitive operations. The firm’s attorneys have particular experience in property transfer issues, easement and leasehold negotiations, sale and leaseback arrangements, indemnity protections, and the negotiation and administration of property cleanup and remediation agreements. We also work through the due diligence process, including evaluation of Phase I and Phase II reports or other site assessments, and review of permits, operational data and agency records, to ensure all appropriate inquiries are conducted and that transactions are structured to account for environmental liabilities.

VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

9 -

No of countries represented

Staff, group

Staff, chemical service provision SERVICE AREA BREAKDOWN

Represent clients in the heavy manufacturing and retail consumer product sectors in enforcement actions brought by federal and state (California) authorities for alleged violations of the regulations governing the labeling and marketing of antimicrobial products. Served as industry stakeholder representative on the EPA committee negotiating a rulemaking to address the reporting of recycled inorganic byproducts under the TSCA Chemical Data Reporting (CDR) rule. Persuaded the Environmental Protection Agency (EPA) to rescind guidance that would have required TRI reporting for the chemicals in steelmaking slag sold for use as a product. Secured for the industrial laundry industry issuance of the first-ever final EPA “no regulation” rule after ELGs had been proposed. Represented the iron and steel industry in convincing the EPA to scale back proposed ELG revisions, resulting in capital cost savings of over $1 billion.

Legal 100%

Persuaded the National Toxicology Program (NTP) not to list “nickel alloys” as carcinogens, and to change the listing for chromium to identify only specific chromium compounds. Developed strategies for compliance with the European Union’s REACH requirements for numerous industry sectors.

GLOBAL OFFICES New York; Washington D.C.; Los Angeles; Houston and Austin, TX; Chicago; Stamford, CT; Parsippany, NJ; Brussels, Belgium. SERVICES PROVIDED Toxic Substance Control Act (TSCA) Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) California Proposition 65 Clean Air Act

Represented a chemical company regarding environmental compliance issues, including an EPA enforcement action and an environmental audit assessment. Represented transportation and waste disposal service providers who assist chemical companies in ensuring proper transportation of their products and disposal of their waste materials. Represented a chemical manufacturing facility in a case that began as a criminal investigation by a state and federal environmental criminal enforcement task force. Assisted in avoiding criminal charges against the company and its employees, and then worked with state and local environmental agencies to avoid civil or administrative enforcement. STAFF SELECTION

REACH, CLP, RoHS

Joseph Green – Special Counsel (DC)

Emergency Planning and Community Right-to-Know Act (EPCRA)

Laura Van der Meer – Partner (Brussels)

Toxic Release Inventory (TRI) Program

Wayne D’Angelo – Partner (DC)

Clean Water Act

William Guerry – Partner (DC)

Resource Conservation and Recovery Act (RCRA)

Paul Sarahan – Partner (TX)

Spill Prevention, Control and Countermeasure (SPCC)

Lauren Valastro – Associate (TX)

Litigation: Environmental Remediation

Andrew Homer – Special Counsel (Los Angeles)

Contamination Cleanup Transactional: Purchase and Sale of Contaminated Property CORPORATE DEVELOPMENTS & ACHIEVEMENTS Obtained groundbreaking “public health” registration for Antimicrobial Copper Alloys under EPA’s FIFRA program. Organised and manage the Manganese Interest Group to address the development of appropriate health standards for manganese. Persuaded the EPA Office of Air Quality Planning and Standards to adopt an alternative risk value for assessing the risks of manganese emissions, in lieu of the outdated Integrated Risk Information System “reference concentration.” Represent manufacturing industries in addressing regulatory challenges related to chromium, nickel, manganese, copper, cobalt and other metals. Successfully resolved numerous actions brought by “Proposition 65” plaintiffs for “failure to warn” for clients in the heavy manufacturing, consumer product and retail sectors. Provide counsel on new Proposition 65 warning regulations and the adoption of warning communication strategies appropriate to clientspecific circumstances.

www.chemicalwatch.com/SPG

Profile: Kelley Drye & Warren

155

Profile: KFT Chemieservice GmbH

156

SERVICES PROVIDED KFT Compliance: REACH KFT Chemieservice has been working with REACH since 2001. Since that time, we have prepared a number of companies for REACH, devised practical solutions by deploying taskforces, and we have assumed numerous registrations for our customers. We offer you: only representative services pursuant to article 8 (REACH); registrations according to article 10/11 and 18/19; and preparations of IUCLID dossiers and CSR (chemical safety reports). Our REACH and management services cover: impact analysis, strategic and operative REACH consulting, portfolio as well as supply chain communication consultation. Our SIEF management provides: project management, financial processing and settlement, trustee services, conducting studies and organisation of data sharing, communication with customers, authorities, and competitors.

CONTACTS Website

www.kft.de; www.kft-academy.com www.kft-chemdoc24.com

E-mail

mail@kft.de

Head office

Im Leuschnerpark 3, 64347 Griesheim, Germany

Tel

+49 6155 8981 – 400

Fax

+49 6155 8981 – 500

Contact

Karl-Franz Torges (PhD), Karin Schmidt

Directors

Karl-Franz Torges (PhD) / Managing Partner, Angelika Torges / authorised officer

Ownership

Private company

Locations

Griesheim (near Darmstadt), Germany

Founded

1995

Generation and maintenance of exposure scenarios We generate exposure scenarios according to legal requirements and the agreed exchange format (EsCom). Furthermore, we create the necessary information for mixtures based on the methods LCID (lead component identification) and SUMI. Biocide substances With an experienced team we handle registrations of biocide substances, coordinate study generation, prepare the dossiers and do the authority management. Cosmetics We check your formulas regarding permissible ingredients or compliance with permissible concentrations and we create the legally required labelling information and the approval of finished labels on your behalf. In addition, we carry out the notification of the products, draw up and verify existing safety assessments or complete product information files and finally, we will guide you through the jungle of ‘borderline’ products.

OVERVIEW KFT Chemieservices’ business is its competence in regulatory and product safety affairs. We ensure our customers’ legal compliance for registrations, documentation as well as environmental exposures. Key elements are our experienced and well-trained staff, modern, sophisticated software and fair compensation of our services. Our responsiveness to individual customer needs is well recognised in the market. VITAL STATISTICS

KFT Communication:

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

1 1

No of countries represented Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

Training 12%

Other 8%

Legal 1% IT & software 1% Laboratory 2%

Consultancy/advisory 40%

Information 24% Representation & management 12%

Global Service Providers Guide 2019

Safety data sheets Generation of safety data sheets (SDS) worldwide in accordance with GHS. SDS are generated according to national implementation of GHS and supplemented by country-specific requirements. Examples for countries and regions are EU, Switzerland, Canada, US, all of Asia, South America and South Africa. We generate SDS in all EU languages, also in Russian, Thai, Malay, and Mandarin Chinese. We also support specific national certifications as required in Turkey. A comprehensive concept of SDS maintenance packages has been successfully introduced allowing customer’s permanent updating of safety data sheets (SDS) pursuant to statutory requirements. The total care service is completed by the latest innovation KFT SDS Control & Care, covering the management of supplier SDS. For our customers, we also offer creation and servicing for a specified number of SDS at a monthly fixed price. Raw materials management Many of our customers have entrusted KFT with the management of their raw material data. This involves the requisition and review of suppliers‘ safety data sheets, and communication with the supplier to eliminate possible deficiencies. We remotely enter the data of the suppliers’ SDS into the customer’s IT systems. In addition, we update the regulatory content data in the customer systems. Our many years ‘experience with SAP EH&S allows us to guarantee proper and professional data maintenance also in these systems. Notification according article 45 CLP Notification of products and articles pursuant to Art. 45 of CLP, the German detergents and cleaning agents Act (WMRG) and product notification in all European countries, Turkey, the US and many other countries.

KFT Services – Emergency numbers: Emergency numbers are important in two respects. First, they must be provided in safety data sheets according to the REACH Regulation (1907/2006/EC). Second, legal regulations on transport, particularly by airlines, absolutely demand emergency numbers – usually on a carriage document or label. At KFT, we offer companies an emergency number service through our partners CHEMTREC and Giftinformationszentrum Nord. Finally, we are also offering an emergency number service for the Chinese market. KFT Academy – Seminars, training and coaching: The very popular and appreciated coaching support has been continuously developed to a broad spectrum of seminars around the compliance aspects of REACH, SDS, GHS / CLP, international chemical regulations, cosmetics, and biocides. The available selection can be found at www.kft-academy.com. In-house training and customised coaching are available on demand at academy@kft.de. Monthly webinars can be accessed free of charge. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

CLIENTS Chemical manufacturers, distributors, importers of consumer goods, biocide substances, pharmaceutical raw materials, hygiene products for veterinary applications, household cleaner formulations and other products. CASE STUDY 1: Services Cosmetic products According to the Cosmetics Regulation manufacturers and importers of cosmetics are responsible for the safety of their products. Among other things, they are obliged to notify all product data in the form of a Product Information File (PIF). At KFT, we OO perform a safety evaluation before the product is placed on the market and create the required safety report OO create and maintain a product information file at your request OO support you with the CPNP-notification required for authorities OO advise you and ensure sound legal protection for all tricky legal questions related to the Cosmetics Regulation OO protect and strengthen your brand and the success of your company in the long term

1995

Foundation of KFT Chemieservice.

1998

First registration according to the existing substances regulation 793/93/EC.

2008

First only representative contract with Brazilian company.

2010

Launch of KFT-ChemDoc24.de

2010

> 3,000 pre-registrations, > 60 substances registered, first biocide substance registered.

2012

Introduction of SDS Control & Care (raw material mgmt.)

2013

Launch of KFT Chemical Compliance Life – a webinar about regulatory chemical compliance news and special topics.

2014

Emergency number service, notification service according to Article 45 of the CLP regulation.

2015

Chemical Compliance Services for cosmetics

2016

Co-operation with Lisam systems to market and implement ExESS software systems; launch of customer days

2017

First international KFT Chemical Compliance Day Turkey

STAFF SELECTION

2018

ISO-Certification DIN EN ISO 9001:2015

Dr Karl-Franz Torges (PhD) – Managing Partner Dr Karl-Franz Torges is founder and managing partner of KFT Chemieservice GmbH. He is working in the area hazardous substances and dangerous goods since 1989 and REACH since 2004. Consulting and training projects and workshops for hazardous materials management, registrations, and chemical compliance. Before he worked several years in the chemical industry.

ACCREDITATIONS VCH (association of chemical suppliers) subsidiary of FECC (European Association of Chemical Distributors) Member of ENES (European network on exposure scenarios) Member of SCHC (Society for Chemical Hazard Communication) PARTNERS Tradas Translations and Consulting Services Laus GmbH (GLP certified testing laboratory) Chemtrec/GIZ Nord (Security number services) KTR Europe GmbH (China and Korea New Chemical Substance Notification Service) LISAM Deutschland GmbH (ExESS chemical compliance software solution) CRAD (Cevre Risk Analiz Denetim), Turkey CIRS Chemical Inspection & Regulation Service Ltd

CASE STUDY 2: Notification service According to Article 45 of the CLP Regulation, manufacturers, market launchers, and distributors must notify the appropriate national agencies of the formulations and contents of hazardous chemical mixtures. However, for companies operating in multiple EU countries it is costly because each country has a different notification process. We know the requirements and processes in all countries and handle the notifications for our clients. CASE STUDY 3: REACH lead registrant support We perform the SIEF survey with the available data in consideration of the interests of other SIEF participants, find the existing data and data gaps, undertake negotiations with data keepers and contract testing labs to close the data gaps. We create the IUCLID file and the CSR and take care of registration with the ECHA. KFT markets the letter of access to other registrants. In addition, we create the SDS with appendix (exposure scenarios) in all EU languages. We provide one-stop service for the client.

Angelika Torges – Member of the Board Board member and heading the division professional services. Experience and responsibilities in these segments since 1989. Certified dangerous goods officer for several companies. Expertise in toxicology, ecotoxicology, chemical compliance i.e. for washing and cleaning agents and has expert certificate for §5 of Restriction Ordinance on Chemicals. Majority of staff are PhD chemists, biologists and experts in food technology with years of experience for material registrations and MSDS. In-house training is a strong focus and sustainable external training is obligatory.

www.chemicalwatch.com/SPG

Profile: KFT Chemieservice GmbH

157

Profile: knoell

158

SERVICE AREA BREAKDOWN IT & software Training 1% 5% Laboratory 5%

CONTACTS

Information 7%

Website

www.knoell.com

E-mail

info@knoell.com

Head office

Konrad-Zuse Ring 25, Eastsite XII, 68163 Mannheim, Germany

Tel

+49 (0)621-718858-0

Fax

+49 (0)621-718858-100

Contact

Dr Thomas Berbner (Chemicals) Deirdre Lawler (Biocides) José João Dias Carvalho (Crop Protection) Dr Albrecht Poth (Medical Devices)

Directors

Dr Hans-Emil Knoell Felix Knoell Dr Runar Eberhardt Torsten Hauck Dr Marika Suhm-Tintelnot Dr Michael Cleuvers

Ownership

Private company, majority-owned

Locations

Germany, UK, Switzerland, the Netherlands, Spain, Portugal, France, China, Thailand, US, Japan, Korea, Tawain

Founded

1996

Representation & management 20%

GLOBAL OFFICES knoell Germany GmbH, Mannheim, Germany knoell Germany GmbH, Berlin, Germany knoell Germany GmbH, Leverkusen, Germany knoell Germany GmbH, Taipei City, Taiwan Knoell NL B.V., Wageningen, the Netherlands Dr Knoell Consult Ltd., Cardiff, UK Cyton Biosciences Ltd., Bristol, UK Knoell France SAS, Lyon , France Knoell Iberia S.L., Madrid, Spain Knoell Iberia S.L., Lisbon, Portugal Dr Knoell Consult Schweiz GmbH, Basel, Switzerland Dr Knoell Consult Shanghai Ltd., Putuo, Shanghai, China Dr Knoell Consult Thai Co Ltd., Chiang Mai, Thailand Knoell K.K., Tokyo, Japan Knoell Korea Ltd., Seoul, Republic of Korea knoell USA, LLC, Garnet Valley, PA, US knoell USA, LLC, Research Triangle Park, NC, US SERVICES PROVIDED

OVERVIEW We are a full service provider in global regulatory affairs for industrial/ specialty chemicals, crop protection, food import tolerances, biocides, veterinary medicine, food and food contact materials, cosmetics and medical devices. Additionally we offer a wide range of services in the field of product safety (e.g. preparation of (extended) safety data sheets, classification and labelling of substances and mixtures) as well as chemical regulatory compliance and product compliance. We work with our clients to ensure that their products comply with the latest developments, in Europe, but also in the US, Canada, South America and the entire Asia-Pacific region (China, Taiwan, Japan, Korea, Australia, and the entire ASEAN region). With a global network of subsidiaries and co-operation partners, we match our services to support business needs. VITAL STATISTICS

2017/18

Turnover, group

> €60m

Turnover, chemical service provision

> €20m

Number of offices

Number of countries represented

Staff, group Staff, chemical service provision

Global Service Providers Guide 2019

Consultancy/advisory 62%

approx. 600 >180

Global registration of industrial and specialty chemicals Dossier preparation and submission: Iuclid 6 files for REACH, TSCA registration including PMN support, registration dossiers for Canada, Korea, China, Taiwan, Japan and the ASEAN countries. Toxicological and ecotoxicological hazard and risk assessment, exposure modelling, post-submission support, communication with authorities, OR- and TPR-services, and full consortia management. Data review and analysis: strategic advice regarding testing and registration strategies, in silico methods (Qsar), read-across and waiving strategies, literature searches, data evaluation, data gap analysis, and study monitoring. Product stewardship: classification and labelling under GHS, CLP, and Osha HazCom; development and management of safety data sheets (SDSs) and extended safety data sheets (eSDSs); supply chain management and communication; management and support of formulators and article manufacturers concerning regulatory compliance in their global markets. Product compliance services Industrial chemicals: determination of customer roles under the different legal regimes in the world, analysis of communication within the supply chains, evaluation of available data on the use of substances of concern in the production chain, communication and trustee function between client and supplier, determination of the compliance status, advice and support in establishing a product compliance status

Global registration of crop protection, biocontrol agents and biocides Strategic advice and consulting, literature research, data gap analysis, completeness checks, study management and monitoring. Dossier preparation, biological efficacy, residues and metabolism, import tolerance dossiers, dietary safety, toxicology, human and environmental exposure assessments, ecotoxicology risk assessment, higher tier exposure and risk assessments (e.g. model coupling, bee studies), assessment of endocrine disrupting properties, IUCLID-dossiers, CADDY-dossiers and dossier submission (R4BP3). Regulatory support, communication with authorities, post-submission, full service provider. Medical Devices and in vitro diagnostic medical devices We support manufacturers of medical devices and in vitro diagnostic medical devices with our comprehensive expertise at every point in the product life cycle. The knoell medical device experts support you to obtain product clearance/approval/registration in global key markets such as Europe, North & South America and Asia. Our services start with the creation of a sound registration strategy and identification of the most efficient route to be able to place the product on the intended market. This includes the preparation of registration dossiers (e.g. 510(k), PMA, STED format) and the necessary accompanying documentation such as design, risk management- and usability documentation. The knoell experts can also perform biological safety assessments, toxicological risk assessments and clinical evaluations of medical devices. Furthermore, we provide effective quality management support which includes the review and/or implementation of global quality management standards (QSR, ISO 13485, MDSAP), conduction of audits (internal, supplier audits) and support with certification bodies (inspection assistance, including on-site support and response to inspectional findings). We also provide training on regulatory requirements for product registration in global key markets (EU, Asia, North/South America), FDA inspectional training, strategies for the efficient conduction of biological evaluations (10993-series, biological safety assessments, toxicological risk assessments) as well as clinical evaluations of medical devices (MEDDEV 2.7.1 Rev 4, EU Medical Device Regulation (2017/745) and EU in vitro diagnostic Medical Device Regulation (2017/746)). Animal health products (pharmaceuticals, immunologicals, feed additives) Our animal health consultancy service provides specialist multidisciplinary technical expertise in quality, safety and efficacy, as well as regulatory affairs for a wide range of product types, for example pharmaceuticals (active substances and finished products), immunologicals, feed and feed additives, borderline products and general care products. We can assist clients at any stage of their project – from product development and clinical testing, through the authorisation procedure and to maintenance of product licences. Within the EU and UK, we can also provide pharmacovigilance, Quality Assurance, and Key Person Cover services for clients, with arrangements already in place to ensure seamless continuity of service post-Brexit. Our broad client base, including multinational animal health companies and SMEs gives us a wealth of varied experience and understanding of every company’s uniqueness.

2010

Acquisition of Cyton Biosciences Ltd., Bristol, UK.

2010

Extension of regulatory affair services to Japan and Asia/ Pacific region.

2010

Foundation of Dr Knoell Consult Shanghai Ltd., in China.

2010

Successful preparation of more than 500 REACH dossiers and more than 400 chemical safety reports.

2010

knoell has been appointed as institution for the training of experts in toxicology.

2012

Foundation of Dr Knoell Consult Thai Co. Ltd., in Thailand.

2012

Opening of a new Office in Berlin, Germany

2013

Foundation of Knoell Iberia SL, in Madrid, Spain.

2013

Acquisition of Critical Path Services, LLC, based in Pennsylvania, US.

2013

Acquisition of Shotwell & Carr, LLC, Carrolton, Texas, US.

2014

Opening of a new office in Lisbon, Portugal

2014

Foundation of Knoell France, SAS, Lyon, France

2014

Opening of environmental fate laboratory, in addition to already existing analytical and bioanalytical laboratory, at Critical Path Services, Pennsylvania, US

2015

Acquisition of Sitmae Reach Services (now renamed to Knoell NL B.V.)

2016

Foundation of Knoell K.K., Tokyo, Japan

2016

Foundation of Knoell Korea Ltd., Seoul, Republic of Korea

2018

Opening of a new office in Taipei, Taiwan

2018

Change of name from Dr. Knoell Consult GmbH to knoell Germany GmbH

ACCREDITATIONS Qualified Cefic – partner. PARTNERS SCAS Japan, SCAS Europe, Domo Salute, Tier3 solutions, Biotek Agriculture, Cekindo, BST Business Science & Technology, AnaPath GmbH, DG Specialtiy Inc., Mourão Henrique Consultores Associados, CRAD CLIENTS We deliver flexible services to globally acting chemical companies as well as to small- and medium-sized enterprises. We work on- and off-site to support our customers’ specific local needs. TESTIMONIALS The Spanish Ministry of Environment described our dossier for a wood preservative as, “the best organised and well-done dossier in comparison with the rest of dossiers received from other companies.”

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

STAFF SELECTION

1996

Foundation, Mannheim, Germany.

2002

Office in Leverkusen, Germany.

2007

Foundation of Dr Knoell Consult Switzerland GmbH, Basel.

Toxicology > 45 toxicologists Global regulatory affairs including consortium management and TPR > 80 specialists Ecotoxicology > 85 ecotoxicologists

2009

Establishment of Knoell Academy for training and in-house seminars covering all our fields of expertise.

2009

Foundation of Dr Knoell Consult Ltd., in Cardiff, UK.

2009

knoell contributed to more than 100 dossiers for plant protection products.

2010

knoell prepared biocide dossiers for 25 active substances (56 products in 15 product types).

2010

Opening of a new office in Wageningen (NL). www.chemicalwatch.com/SPG

Profile: knoell

159

Profile: Lisam Systems

160

SERVICE AREA BREAKDOWN Training 5%

Consultancy/advisory 18% Representation & management 2%

CONTACTS Website

Global: www.lisam.com Regulatory advisory: www.lisam-telegis.fr

E-mail

info.eu@lisam.com

Head office

Rue Jean Jaures 5, B-7190 Ecaussinnes, Belgium

Tel

+32 67 49 00 03

Fax

+32 67 49 02 11

Contact

Michel Hemberg

Directors

Michel Hemberg, Owner & CEO/CIO Lisam Global Thierry Levintoff, Owner & CFO Lisam Global Françoise Saint-Romain, Managing Partner (Regulatory)

Ownership

Private company

Locations

Belgium, France, Germany, UK, Romania, Lithuania, USA, Canada, India, Turkey, Brazil, China, Japan, Luxembourg, Singapore, South Africa, Italy, the Netherlands, Mexico, South Korea, Australia, Argentina

Founded

1999

IT & software 65%

GLOBAL OFFICES Belgium, France, Germany, UK, Romania, USA, Canada, India, Turkey, Brazil, Lithuania, Singapore, Luxembourg (WikiChemia), China, South Africa, Italy, the Netherlands (CHESSOL), Australia, South Korea

OVERVIEW Founded in 1999, Lisam Systems is a global provider of Environmental, Health and Safety (EH&S) compliance management software solutions and services, operating from offices worldwide. By combining an easyto-use, flexible technology built on the Microsoft .NET platform, with the latest regulatory content, Lisam brings innovative, affordable and timely solutions to solve EH&S challenges faced by manufacturers, distributors and users of chemical products. Working with industry associations and partners, Lisam has developed, proprietary, vertical EH&S solutions for the chemical, specialty chemical, cosmetics, aromas and flavourings, detergents, paints, coverings, coatings, plastics and energy industries. Today, around 1400 customers in these industries rely on Lisam’s flagship software, ExESS®, to manage their compliant safety data sheets and labels, designed for all major commercial markets and available in 52 languages. With the recent opening of offices in Australia, Lisam can provide support and Regulatory Services for the 5 continents. VITAL STATISTICS

2018

Turnover, group

€22m

Turnover, chemical service provision

€15m

No of offices

No of countries represented

Staff, group

200

Staff, chemical service provision

150

Global Service Providers Guide 2019

Information 10%

SERVICES PROVIDED Regulatory advisory services Lisam Services (Telegis) is the regulatory expertise department of Lisam Systems, partner of the chemical industry in regulations on health, safety and environment for 20 years. With pragmatic knowledge and experience they will guide you in making strategic decisions and bring support in the following areas: OO safety data sheets: issue of quality SDSs in compliance with REACH and other regulations specific to your activities; OO exposure scenarios authoring: preparation and translation of exposure scenarios in the latest standard format; OO consultancy and regulatory studies: compliance projects on REACH, GHS, CLP, (e)SDS, dangerous goods transport, notifications of hazardous substances, biocides … including preparation of chemicals’ dossiers; OO Poison centre notification (Annex VIII of CLP) ; OO regulatory monitoring and watch, general and on-demand; OO biocides: declaration of biocidal products and quantities, composition validation, monitoring of studies and environmental fate assessment, request for market authorisation, inclusion on list of authorised active substances, labels; OO hazard assessment by in silico methods: predictive evaluation of substance properties and hazards with computer models to guarantee cost and time savings compared to in vitro and in vivo studies; OO REACH only representative: REACH obligations for non-EU manufacturers; and OO REACH third party representative: Lisam acts in your name for data submission, data sharing and cost sharing discussions, while your identity remains confidential. Our regulatory department also includes IT experts to advise you on the most adequate IT environment, install Lisam Systems’ EH&S modules, train your teams and support you with change requests and incidents. ExESS® EH&S Packages ExESS EH&S applications are easy to use and flexible to configure. The system provides a powerful, open strategy for integrating with customer and third-party content. It allows for real-time API integration with a broad range of enterprise systems, and batch integration with built-in integration tools: OO SDS and labels authoring and distribution: user-friendly, comprehensive and globally compliant solution for authoring and distribution of safety data sheets and labels, installed on single workstations, over worldwide corporate networks or accessed and used via the cloud;

chemical management: efficient and effective management of all materials information relating to regulatory compliance, hazard communication, environmental reporting and inventory management; safety management: workplace safety information managed from one centralised database. Easy generation of documents to describe advised handling of chemicals and adequate protective and emergency measures; substance volume tracking: simplification and automation of regulatory volume tracking and reporting, for EU REACH (including SVHC), US inventory update reporting and chemical data reporting, and Japan Chemical Substance Control Law; regulatory content: cost effective, integrated regulatory content such as OEL lists, EU GHS and REACH libraries, US state/federal lists, and choice of fully integrated third-party regional libraries, including BIG for EU, JCDB for Japan, SRICI for China, or ChemADVISOR’s LOLI® for global content and WikiChemia lists part of Lisam; and more solutions for waste management, risk assessment, detergents, fragrances, cosmetics, gas… Our solutions also include a compliance suite integrating an SDS distribution and archival application, a chemicals inventor &, document generation tool based on the SDSCOM xml format.

Training, services and support Our services are proposed in several languages: OO regulatory training: REACH, GHS, CLP, Iuclid, (e)SDS, poison centre notification…; OO introduction and extended trainings on ExESS applications; OO regional trainings: EU, US, China, Japan; OO technical trainings: API, ERP integration, customisation…; OO a helpdesk answering you on the phone or via email; and OO version patches and updates of ExESS issued three times a year guarantee a system aligned with latest regulatory changes. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1999

Creation of Lisam Systems in Belgium

2002

Acquisition of Belgian company ESI (Protheus Software)

2006

Acquisition of Telegis, France, to offer support and regulatory consultancy services

2007

Lisam India opens in association with Kalosoft Systems Technologies

2009

Acquisition of Hemmis, reinforcing development team and integrates ExESS software

2009

Start partnership with EMORI (Japan) to develop the ExESS modules and interface in Japanese

2010

Lisam America opens in Houston, Texas

2012

Lisam UK opens in Hartlepool

2013

Lisam Canada opens in Montréal, Québec

2014

Lisam Deutschland opens in Berlin

2014

Wikichemia, start-up of LISAM dedicated to the sole management of regulatory lists, opens in Luxembourg

2015

Lisam opens offices in Turkey, Romania and Brazil

2016

Lisam opens offices in Singapore, China and Lithuania, Netherlands (CHESSOL)

2017

Lisam opens offices in Italy and South Africa

2018

Lisam opens offices in Australia and South Korea

2019

Lisam opens offices in the Netherlands

ACCREDITATIONS REACH Ready certification Full member of ORO (REACH Only Representative Organisation) EIGA preferred solution Microsoft Gold Partner

CLIENTS With premises and partners around the globe, Lisam applications and regulatory advisory services are adopted by more than 1000 medium and large clients worldwide, in all industry sectors. TESTIMONIALS “Lisam’s ExESS® software centralises all our needs regarding REACH and GHS, and this on a worldwide scale. Employees from 28 offices around the world are connecting to the ExESS software to generate compliant SDS, labels or other documents. We chose the Lisam solution for their worldwide compliance and support, and for their commitment to keep track of legislation changes and implement future GHS whenever released,” – Vice President, Corporate QSHE of a multinational consumer goods manufacturer “After a comprehensive selection process, we chose to work with Lisam Systems and his software, ExESS®, for a number of reasons. Their system offered all functionalities expected and no other system we looked at could match its usability. The people of Lisam Systems fully understood our needs and our process flow. We didn’t need to adapt our way of working to the new system, for it’s so flexible that it adapted itself to our way of working,” – Senior Director HSEQ of a global actor in the petrochemical Industry For confidential reasons, testimonials on our regulatory services will gladly be provided on request. CASE STUDY 1: Gas industry centralised SDS/label software Context: multiple tools used for SDS and labels authoring; OO some subsidiaries using the same tool, but with different approach; OO some subsidiaries sharing a centralised database whilst others use independent ones and no synergy; and OO SDS and labels layouts all different, no efficient working way. Achievements: OO unification of the software’s patchwork under Lisam ExESS®; OO central unique database for all subsidiaries; OO limited migration of data: interface ExESS® with ERP/lab software; OO work done by one is benefiting to all; and OO one corporate standard for all compliance documents. OO

CASE STUDY 2: Global regulatory success stories Lisam Services has been supporting successfully global actors in cosmetics, detergents, fine chemicals, industrial and specialty gases etc with their: OO ingredients, raw materials and products compliancy under REACH OO under other regional regulations; OO early regulatory qualification processes; OO preparation and submission of inquiries as well as individual and joint REACH registration dossiers; and OO creation of thousands of (e)SDSs, meeting different regional GHS implementations. STAFF SELECTION Michel Hemberg, CEO Michel is a founder and majority owner of Lisam Systems. Since June 2012, Michel took over the CEO position, managing the global expansion of the company. Michel got a civil engineer degree in 1986 and worked for 25 years as IBM mainframe consultant in the financial market. Françoise Saint-Romain, Managing Partner Lisam Service Telegis After working in industry then in continued training, Françoise has createdand developed a wide regulatory affairs competence centre over 20 years. She is acting as auditor of ORO (REACH Only Representative Organisation) and is cultivating the synergy between the ExESS EHS software and her regulatory consultancy activities.

www.chemicalwatch.com/SPG

Profile: Lisam Systems

161

Profile: Logic SDS

162

GLOBAL OFFICES

CONTACTS Website

www.logicsds.com

E-mail

office@logicsds.com

Head office

ABG 30 City Road London EC1Y 2AB United Kingdom

Tel

+44 (0)20 3286 0329

Contact

office@logicsds.com

Directors

Mrs Gregory

Ownership

M. Arnould

Locations

UK, France

Founded

2014

OVERVIEW LogicSDS is a highly intuitive and easy-to-use SDS (Safety Data Sheet) software. LogicSDS manages SDS (Safety Data Sheet) according to GHS/CLP (1272/2008) and to international GHS as GHS-US (HCS/Hazardcom 2012 OSHA) or the chinese GHS. LogicSDS includes databases from Annex 6 for GHS/CLP as well as a list of chemical substances from the US chemical inventory or from the proposition 65 list for California. In a European frame, LogicSDS enables the elaboration of SDS of detergents and the editing of hazard labels for these products. LogicSDS is the most economic SDS software on the market allowing to small and medium-sized companies to create their own professionnal SDS. VITAL STATISTICS

2017/18

Turnover, group

N/A

Turnover, chemical service provision

N/A

No. of offices

No. of countries represented

Staff, group

2-5

Staff, chemical service provision

2-5

SERVICE AREA BREAKDOWN Training 5%

Consultancy/advisory 5%

Based on over ten years’ experience in compiling Safety Data Sheets (SDS), we have found that small and medium-sized companies lack the human and/or financial capabilities to compile and manage their own SDS. Moreover, under European and international regulations all companies marketing chemicals or assimilated products have to provide their clients with product SDS which are regularly updated in line with current regulations. The content of an SDS is not only complex, but must also comply with the relevant country’s regulations and be issued in the language of that country or of the area where the product is used. LogicSDS is a software system designed to ensure that the highest number of users find it extremely simple to compile SDS. LogicSDS is developed on an open technical architecture so as to provide every company in every country with a secure IT solution for compiling and/or managing their own SDS. LogicSDS is multilingual allowing preparation of security documents and labels for chemical products, biocidal products, detergents, inks and varnishes, etc. With LogicSDS an SDS can be managed and generated in accordance with GHS/CLP (1272/2008) and international GHS such as the GHSUS (OSHA HCS/Hazardcom 2012) or China GHS. Moreover, LogicSDS has Annex VI databases for the GHS/CLP classification, US Chemical Substance Inventory and also California Proposition 65. LogicSDS is the most economical SDS software available on the market, offering small and medium-sized companies the expertise to compile their own SDSs. Our experts are here too, not just to support you during the initial handling of the tool, but also to provide you with their expertise on European and other regulations. So please visit our site www.logicsds.com and don’t hesitate to request a free trial so you can see for yourself how easy and efficient it is to use LogicSDS at a manageable cost. SERVICES PROVIDED LogicSDS also provides custom-made SDS for external processing and regulatory training courses in the compilation of safety data sheets. LogicSDS is used in the chemical, cosmetioc, paint and detergent industries. It is trusted by major groups such as Areva. CORPORATE DEVELOPMENTS & ACHIEVEMENTS Since its recent launch in late 2014, more than 50 European companies have chosen LogicSDS’ software for its ease of use. The CLP label printing module was launched in early 2015 and the first FDS authoring module license was acquired by ART Fragrance (Lalique perfumes) in August 2015. Following this, LogicSDS developed in 2016 a detergent module that allows to work out the particular labelling for detergents, and at the request of one of Saint Gobain Group ‘s entity, the company then launched a stock management / inventory module, which can be added up to the labelling module. Future developments will consist of launching in 2020 an additional module for exposure scenarios authoring, and an IFRA module for perfumers. CLIENTS AF Art & Fragrance, Biosis, HSH Finishes, MixPlast, PRODIFAC, The Clay and Paint Factory, WV Associates Ltd and more than 50 other companies

IT & software 90%

Global Service Providers Guide 2019

Profile: Logic SDS

163

TESTIMONIALS TEVAROM “The software simplifies and accelerates the writing of SDS and reduces the risk of error” HSH Finishes “HSH is a small company supplying its products world-wide. HSH is very demanding regarding SDS solutions. With LOGIC SDS Software, we find a very easy-to-use solution. The Software offers a lot of advantages: fast GHS-CLP calculation and US GHS versions in 36 languages. Regularly updated, the LOGIC SDS Package significantly improves our responsiveness.” CASE STUDY 1: ORANO, one of the international leaders in the nuclear energy sector, was looking for an FDS authoring solution for its nuclear waste reprocessing site in La Hague (France). ORANO has tested many solutions including Logic SDS software. Its users had limited knowledge of SDS writing and their main goal was to find a simple and reliable tool to label their products properly. LogicSDS has provided them with a test version for a period of one month to allow users to assess the tool’s usability . At the end of this period, ORANO has decided to buy the software for its extreme simplicity of use and has installed it on a server for its internal users. The French distributor Ritme Informatique, also provides a training on how to use it and on regulation STAFF SELECTION LogicSDS’ biggest strength is that it combines expertise and ease of use, partly thanks to its skilled team members, including Dominique Fischer, PhD in computer chemistry and Yves André Lorrain PhD in chemistry. Hugues Arnould, Engineer and regulatory expert joined LogicSDS at the end of 2018 and now brings his expertise in the launch of LogicSDS SAS France which will deal exclusively with the European market.

www.chemicalwatch.com/SPG

Profile: National Chemical Emergency Centre (NCEC)

164

GLOBAL OFFICES UK, Australia, China, Czech Republic, Denmark, Germany, Hong Kong, India, Italy, Japan, Korea, Malaysia, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, The Netherlands, United Arab Emirates, USA CONTACTS

SERVICES PROVIDED

Website

www.the-ncec.com

E-mail

ncec@ricardo.com

Head office

Ricardo plc Shoreham Technical Centre, Old Shoreham Rd, Shoreham-by-Sea, West Sussex, BN43 5FG, UK

Tel

+44 (0) 1235 753654

Fax

+44 (0) 1235 753656

Contact

ncec@ricardo.com

Directors

Jonathan Gibbard

Locations

Founded

1973

Emergency response NCEC’s emergency response services set the global benchmark for the chemical industry with: OO 24/7 chemical emergency response advice and expertise, 365 days a year for supply, transport, manufacturing and non-chemical emergencies; OO provision of intervention advice by qualified chemical experts at the point of incident, rather than relying on sharing information; OO service provision is in line with the CEFIC guidelines for level one (telephone based) emergency response; OO wide range of telephone numbers with over 40 local lines globally including regional and local numbers; OO worldwide multilingual support in over 37 languages; OO supported by liability insurance to cover the advice we provide; OO our number suite and languages support global compliance, including China through our partnership with the National Registration Centre for Chemicals (NRCC). Inbound immediate notification of incidents to internal response teams, including nonchemical incidents; OO support to employees handling raw materials and supplied chemicals onsite; and OO bespoke service tailored to meet your organisational needs.

OVERVIEW For over 45 years the National Chemical Emergency Centre (NCEC) has set the global standard in emergency response and is the first choice for 50% of the world’s top 100 chemical companies. NCEC helps its customers to manage the risks associated with handling chemicals by providing: OO 24-hour multilingual emergency response advice delivered by trained chemists; OO rapid and reliable response to support emergency services and businesses around the world; OO chemical handling and regulatory compliance support; OO REACH consultancy, poison centre notification and CLP support (including SDS authoring); and OO crisis management services to help our customers deal with all types of incidents, crisis and business continuity disruptions. VITAL STATISTICS

2017/18

Turnover, group

£380m

Turnover, chemical service provision

£6.4m

No. of offices

No. of countries represented

21 >3000

Staff, group

Staff, chemical service provision SERVICE AREA BREAKDOWN

IT & software 20%

Global Service Providers Guide 2019

Crisis Management and Business Continuity Services An expert and experienced team who works with you to improve your organisational resilience in responding to a crisis by: OO measuring your crisis readiness capability to identify and address gaps and development opportunities; OO review and support the development of crisis response and business continuity plans and procedures, including business impact assessments; OO bespoke training programmes to achieve your needs, focusing on developing the people’s non-technical skills (making decisions under pressure, crisis leadership, etc.); and OO full suite of exercising capabilities from coaching walk throughs to fully fledged simulation exercises to test the procedures and further develop the people. Software OO Chemdata® – provides instant access to clear and concise chemical hazard information on more than 61,000 substances and is used by all UK and most Australian Fire Services, available for desktop computers and mobile devices; and OO ChemeDox® – document management system, with functionality for COSHH compliance and distribution.

Training 1%

Representation & management 4%

Consultancy OO Classification, labelling and advice on chemical safety legislation and risk management; OO support with poison centre notifications from understanding your obligations through to completing notifications on your behalf; OO SDS authoring and translation services and management software – keeping your safety data sheets legal and compliant with REACH and GHS; OO REACH supporting including dossier evaluation and review, registration support, Only Representative, authorisation applications and consultancy; and OO Dangerous Goods Safety Advisor (DGSA) services.

Consultancy/advisory 75%

Training NCEC provides online and on-location bespoke training courses to teach critical skills for operating across the chemical supply chain, including: OO securing regulatory compliance and handling chemical emergencies; OO bespoke hazmat and chemical spill response training;

OO OO OO

chemical hazard awareness; COSHH assessments; and first aid for chemical exposure.

ACCREDITATIONS Quality assurance Lloyd’s Register Quality Assurance (LRQA) has issued NCEC, as part of Ricardo Energy & Environment, approval for the Environmental and Quality Management System Standards OO BS EN ISO 9001: 2008 Quality Management; OO ISO 14001: 2004 Environmental Management; and OO ISO 27001 Information Security Management. Training OO Training courses are accredited by the Royal Society of Chemistry. PARTNERS NCEC is part of Ricardo plc, as well as the REACH Consultant Network and the Global Chemical Consultants Network. NCEC work on behalf of the Chemical Industry Association and the UK’s Department for Transport to provide chemical emergency advice to all of the UK’s emergency services. NCEC works closely with its global partners, including UMCO (Germany), DHI (Denmark), INERCO (Spain), REACH Global Services (Turkey), NSSS (India), REACH24H (China), Chemtopia (Korea) and JCDB (Japan). NCEC also works alongside the Chemical Business Association (CBA) to provide services to its members. NCEC is a key stakeholder for Hazmat response in the UK and works closely with the Chief Fire Officers Association. NCEC is a REACHready approved supplier. CLIENTS NCEC’s clients include governments, trade associations and over 800 industrial customers. We take client confidentiality seriously and only discuss individual relationships with expressed permission. TESTIMONIALS “We opted for NCEC because of the extensive knowledge and experience its staff have in providing advice to people like our customers, who may have a varied understanding of the chemicals they are using. Particularly important to us has been NCEC’s team of emergency responders. They are great because, while they may have a PhD in chemistry and years of experience in dealing with extreme chemical incidents, they are able to communicate effectively, and provide suitable and practical advice to whoever they are speaking with.” Peter Leighton, Responsible Care Co-ordinator, BASF “With the continual changes occurring in legislation, as well as enhanced security and environmental concerns you need to be supported by credible and internationally recognised technical specialists. NCEC is such an organisation, and… in my opinion, the premier support service for those in the sector. Their technical support is critical in managing The Hazchem Network operation – the UK’s only specialist pallet network for the carriage of palletised dangerous goods.” Ali Karim, Managing Director, Hazchem Network Ltd, Training and compliance “I attended the annual NCEC HazMat event for the first time in 2018, and found it to be exactly what I was looking for… a fantastic networking Hub for new connections, and sharing best practice. The workshops and presentations were very enjoyable, interactive and informative. The NCEC Hazmat event is clearly a centre of excellence and go-to place for anyone who has responsibility for managing the response to chemical incidents. It’s exceptionally well organised. I’ve returned to work with renewed momentum to make improvements, armed with the underpinning knowledge and ongoing support from the

CASE STUDY 1: BASF – exceeding best practice guidelines BASF is one of the world’s leading chemical companies, with more than 112,000 employees working across 350 chemical production sites globally. BASF originally managed its emergency telephone and chemical response requirements internally but decided to appoint a partner after an internal audit revealed that they were unable to meet the CEFIC best practice guidelines of a 10-minute response. Solution: NCEC provided BASF with dedicated emergency telephone decided to numbers for use in areas such as safety data sheets (SDSs), product packaging and transport documentation. It also provides access to experienced emergency responders for advice on chemical regulations or incidents containing chemical substances. Expertise: NCEC currently handles calls directly from BASF customers relating to first aid or seeking advice about handling a spill. NCEC’s emergency response service has provided BASF with greater confidence in delivering professional, knowledgeable and timely response to its customers, ensuring continuity of its respected brand and reputation. CASE STUDY 2: When a poison contract number isn’t enough – providing advice for more effective treatment A hospital in the UK contacted NCEC after five known chemicals were released during an industrial incident at a pharmaceutical manufacturing plant. Four personnel were immediately exposed to hazardous substances and a three person rescue team suffered minor exposure. The patients’ symptoms related to exposure via inhalation and hospital staff needed urgent information to support their medical response. Solution: An NCEC emergency responder reviewed the five chemicals released to identify those most likely to have caused the injuries. The responder identified that three of the five could be discounted because their lower vapour pressures limited exposure via inhalation or posed low hazard. The emergency responder also advised that one of the remaining products would look like steam and smell strongly of vinegar if released, while the other would resemble petrol vapour and have an unpleasant, fishy odour. This was used to understand which chemicals the patients been exposed to and prepare a suitable medical response and was only possible due to the responders chemical expertise. Expertise: The expert information provided by NCEC helped the hospital to deliver a more comprehensive treatment plan (because of the understanding of the physical properties of the chemicals) and enabled the client to provide a high degree of responsible care. CASE STUDY 3: Ethylene oxide – protecting companies from the world’s most hazardous substances across the supply chain NCEC responded to a high risk incident when the driver of a tanker of ethylene oxide was trapped with the shipment by a fire at the delivery site. Solution: NCEC’s emergency response team provided rapid advice to keep the caller safe in a potentially life threatening situation and immediately contacted the client to support their crisis management procedure. Rapid response by the team allowed the client to meet its responsibility to duty of care and reduce the risk of a major crisis. Expertise: NCEC provides emergency notification lines for hauliers and transporters handling some of the world’s most hazardous materials and delivers rapid solutions for potential issues before they become high impact incidents. NCEC plays a critical role in the transport logistics for ethylene oxide and other high consequence goods. This includes arranging for police escorts, securing clearance for transporters if they are forced to deviate from their predefined routes and supporting the recovery of tankers from unsafe environments, such as floodwaters.

NCEC and wider network.” Brian Galsworthy, Fire Safety Advisor & Incident Manager Specialist, AstraZeneca Plc www.chemicalwatch.com/SPG

Profile: National Chemical Emergency Centre (NCEC)

165

Profile: Nexreg

166

SERVICE AREA BREAKDOWN Training 5%

Other 5%

Information 15%

CONTACTS Website

www.nexreg.com

E-mail

info@nexreg.com

Head office

1828 Blue Heron Drive â&#x20AC;&#x201C; Suite 19 London, ON N6H 0B7

Canada

Consultancy/advisory 75%

SERVICES PROVIDED OO OO

Tel

+1 519-488-5126

Fax

519-488-5217

Contact

info@nexreg.com

Ownership

Private

Locations

1 Location

Founded

2005

OO OO OO

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2005

OVERVIEW Nexreg Compliance Inc. is a full-Service chemical product MSDS/SDS authoring, and consumer/industrial label review company. The Nexreg team of consultants and partners are experts on chemical product related regulations in key jurisdictions, and facilitators of chemical product management worldwide. Founded in 2005 with a mission to provide world class, comprehensive regulatory compliance services. Nexreg invests to guarantee that our consultants and clients have access to quality EH&S regulatory information and technology. We have access to multiple regulatory databases, authoring software and the ability to monitor and track industry and government source data. We use these resources to access chemical data, scientific studies, product transport information, official regulatory text, governmental guidance and more. The regulatory needs of our clients have firm deadlines that need to be met; often arising with little notice. We seek to ensure a transparent process from project start to finish, encouraging open and timely communication with our clients. Our turnaround times are the fastest in the industry, and we offer RUSH services to respond to our clients unexpected regulatory needs. We stand behind our work and guarantee its accuracy and compliance with government standards and regulations. All of our service offerings use quality information that can be verified through several sources. Additionally, we employ an extensive review process at each critical stage in a project. If an issue arises, swift and immediate action is taken to achieve resolution. Clients can rest assured knowing that all of our work is fully insured against errors and omissions; reducing or eliminating liability risk. VITAL STATISTICS No of offices Staff, group

Global Service Providers Guide 2019

MSDS Authoring MSDS Translation MSDS Updating MSDS Compliance MSDS Hosting & Management Label Services GHS Compliance REACH Compliance Properties Testing Prop 65 Compliance Health Canada Compliance

2017/18 1 15-25

Founded

ACCREDITATIONS The Better Business Bureau (BBB) The American Industrial Hygiene Association (AIHA). Southern Aerosol Technical Association (SATA). Canadian Federation of Independent Business (CFIB) Society of Chemical Hazard Communication (SCHC) International Sanitary Supply Association (ISSA) CLIENTS Aerosol Products Agriculture Automotive Aerospace Energy Oil and Gas Construction Cosmetics Pulp and Paper Retail and Consumer Products Food and Beverage

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Profile: Normachem

168

SERVICE AREA BREAKDOWN Training 7%

IT & software 3% Laboratory 15%

Consultancy/advisory 45%

CONTACTS Website

www.normachem.it

E-mail

info@normachem.it

Head office

via Roma 14 Fontaniva (PD), 35014, Italy

Tel

+39.049.5940419

Fax

+39.049.8591142

Contact

Michele Zaupa (Sales Manager)

Directors

Gianluca Stocco (CEO)

Ownership

Private company

Locations

Italy

Founded

2007

Information 12%

Representation & management 18%

GLOBAL OFFICES Via Roma 14, Fontaniva (PD), 35014, Italy Viale Sarca 78, Milano (MI), 20125, Italy SERVICES PROVIDED

OVERVIEW Normachem s.r.l. was established in May 2007 in the north of Italy, with the aim to support companies in the complexity of chemicals legislation scenarios, by means of a high degree of specialisation and through sharing of experts’ knowledge, which is one of the objectives Normachem wants to achieve. For the last ten years, we have been working alongside companies to ensure their regulatory compliance, in order to reach a greater competitiveness in the international markets, to grant healthier work places and to place on the market safer and more sustainable products. Thanks to our high experience in chemistry, biology, toxicology and environmental science, Normachem experts can offer an integrated service system capable of ensuring regulatory compliance. A continuous process of research and development, fed by constant legislations study, allows generation of new services: this helps us to share our knowledge with customers and to set up commitment and partnership. VITAL STATISTICS

2017/18

Turnover, group

€ 2,7m

Turnover, chemical service provision

€ 2,7m

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2019

Product Stewardship Every company who sells chemicals must comply with a large number of laws which often are very complex and subject to rapid changes. In this scenario, it is difficult to maintain an integrated and systematic management of every regulatory duty: Normachem is able to grant a day by day helpdesk and operative assistance for anyone who needs support in REACH, CLP, biocides, GHS topics and so on…! More specifically, Normachem can support you in: OO REACH, CLP and biocides inspections/auditing; OO REACH – safety data sheet authoring (in every European language); OO REACH registration dossier (lead/member/full/intermediate); OO CLP – annex VIII – hazardous mixture notification; OO Worldwide GHS – safety data sheet authoring; OO cosmetics: auditing, product safety assessment, training; OO USA/EU conflict minerals: auditing, due diligence and consultancy; OO ROHS directive: auditing, chemical analysis strategy planning and evaluation of conformity declarations; OO exposure scenario authoring and its compliance in workplaces; OO REACH articles chemical analysis planning, monitoring and compliance evaluation. EU-FCM, Food Contact Materials Managing chemicals in workplaces have always been considered as high priority task. At the same time we have to consider all the chemicals that we meet in our everyday life, such as food-like packaging, pieces of cutlery, food-industrial machines and cooking surfaces. Normachem can help you in: OO auditing/inspection for evaluating EU-FCM duties; OO evaluating supplier’s conformity declarations; OO authoring of FCM conformity declarations; OO planning and monitoring migration tests; OO GMP (good manufacturing practices) auditing and implementation; OO risk assessment of specific chemical substances. EU-REACH Only Representative Services As stated by REACH regulation, all Non-European chemical manufacturers who desire to access the European market, must be represented only by an expert European partner. Normachem can offer a full-service package that allows foreign manufacturers to export competitively their chemicals throughout European Union. Normachem offers the following services: OO feasibility study for O.R. representation; OO planning and monitoring of the substance analysis identification; OO preparation and submission of REACH registration dossier; OO safety data sheets and exposure scenarios authoring; OO representativity maintenance.

Biocides and Plant Protection Products (PPP) Companies which intend to place on the European market biocidal products or PPPs need to apply for authorization by the Competent Authority. Authorizing a product entails several technical and scientific activities and, in this scenario, Normachem offers the following services: OO support for biocidal product/family and PPP authorization; OO support for testing strategies and study monitoring; OO drafting of biocidal product/family and PPP dossier; OO support for mutual recognition and technical equivalence; OO support for comparative assessment. Environmental Sustainability Credibility, sustainability and ethics are the main keywords for brand reputation, especially when customers are becoming more and more experienced in “green” claims. Normachem and its experts work alongside companies in order to support their sustainable products and processes. Normachem’s main field of expertise is about chemicals and processes in which they are involved. We can help you through the application of: OO LCA methods (Life Cycle Analysis); OO PCR creation & implementation (Product Category Rules); OO communication in environmental field (e.g. ISO 14024, ISO 14021 and ISO 14025); OO Green Public Procurement consultancy. Workplace Health and Safety Chemicals nowadays are broadly used in every industrial sector, where the responsibility in assuring a continuous production workflow and a safer workplace must have a high priority for employers. At the same time, they must keep the injury risk low, avoid business interruption and be able to face legal compliance shared between European regulations and national laws. Normachem aims to provide an integrated and sustainable support for employers in order to help them achieve a healthy and safe workplace, especially for chemicals. Normachem’s experts are at your service for: OO health and safety Chemical Risk Assessment; OO mediation between REACH and CAD/CMD directives; OO evaluation of legal compliance; OO All Risk Assessments and the Workplace requirements.

ACCREDITATIONS UNI EN ISO 9001:2015 CLIENTS Our range of clients goes from chemical manufacturers and importers (e.g. pharma, agro and bulk chemicals) to downstream users, which are involved in chemical regulatory issues (automotive, mechanical, textile etc) and need to be compliant with EHS STAFF SELECTION Gianluca Stocco (CEO) MS Degree, Chemistry. Started as laboratory manager. Appointed as representative of European SME Company Association on behalf of a European trade association during the REACH and CLP setting up in Bruxelles. Now CEO and President of Normachem Srl. Enrico Boscaro (R&D Manager) Ms Degree, Chemistry. Started as regulatory specialist in Normachem Srl with specialisation in European product stewardship regulations. Now following R&D topics in order to create or improve Normachem regulatory services. Tommaso Castellan (Technical Manager) Ms Degree, Industrial Chemistry. Started as HSE and DGSA specialist in Normachem Srl. Now expert in CAD/CMD, and technical area manager. Giovanni Talamini (Technical Manager) Ms Degree, biotechnology. Trained in National Centre for Toxicology Information, IRCCS Maugeri Foundation. Worked as regulatory toxicologist in Toxicon, then PPPs evaluator in Cattolica University on behalf of Italian Ministry of Health. Now in charge of risk assessment activities. Michele Zaupa (Sales Manager) BSC Degree, Tourism Economy. Started as sales account in Boscolo Hotels in Rome. Afterwards moved to Vicenza in order to work first for Ratio Srl and then for SEAC as sales area manager. Since 2016 Sales Manager in Normachem.

Intermodal Transport of Dangerous Goods NORMACHEM guarantees that your transportation of dangerous goods is safe and without risks. Our aim is to assure an integrated cooperation between combined transport operators, customers, terminals and railway companies in order to handle and solve any kind of problem that may arise at any step of the process. NORMACHEM has an expert team specialized in deliver consultancy for any kind of transportation: OO street/rail (ADR/RID); OO sea (IMDG); OO air (IATA). CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2011

ISO 9001:2008 Implementation

2012

HSE Services Implementation

2014

Risk Assessment and Biocides Services Implemented

2016

Opened second office in Milan, Italy

2017

Plant Protection Products Services Implemented

www.chemicalwatch.com/SPG

Profile: Normachem

169

Profile: Ramboll Environment and Health

170

GLOBAL OFFICES Australia, Belgium, Brazil, Canada, China, Denmark, Dubai, Finland, France, Germany, Greenland, Hong Kong, India, Italy, Malaysia, Mexico, Mozambique, Myanmar, New Zealand, Norway, Poland, Romania, Russia, Singapore, South Africa, Spain, Sweden, the Netherlands, UK, US

CONTACTS Website

www.ramboll.com

E-mail

sbullock@ramboll.com

Head office

Copenhagen, Denmark

Tel/ Fax

+44 20 7808 1420

Contact

Sue Bullock

Directors

Sue Bullock (UK) Dr Martina Vosteen (DE) Dr Bob De Mott (US) Dr Salvatore Giolando (US)

Ownership

Private Company

Locations

300 offices worldwide

Founded

1945

SERVICES PROVIDED Risk management, strategic support and regulatory compliance (REACH, CLP, TSCA, biocides, PPP, cosmetics, food contact materials) Ramboll works in partnership with clients to develop and support product regulatory compliance strategies and prepare robust technical dossiers and risk assessments for substances in industrial, agricultural, biocidal and consumer applications such as cosmetics and food contaminants. We balance clientsâ&#x20AC;&#x2122; technical, regulatory and commercial interests through sound science and strategy. Clients trust us with their most critical problems. We provide strategic, scientific and regulatory support for substances targeted for substitution including impact assessment, applications for authorisation under REACH, supply chain management and audit of product regulatory compliance systems. We help our clients influence development of practical policy, regulation and guidance and communicate effectively with the EC, ECHA and MSCA. Ramboll also acts as consortium manager, only representative and responsible person, and is independent from testing facilities.

OVERVIEW Ramboll is a leading engineering and consultancy company employing 15,000 experts. Our presence is global with representation across Continental Europe, the UK and the Nordics, North America, Middle East and Asia Pacific. We constantly strive to achieve inspiring and exacting solutions that make a genuine difference to our clients, end-users and society at large. Our globally recognised environmental and health practice has earned a reputation for technical and scientific excellence, innovation and client service. Advances in science and technology and evolving regulatory, legal and social pressures create increasingly complex challenges for our clients. We evolve to keep pace with these changes â&#x20AC;&#x201C; by adding new services, contributing to scientific advances or expanding geographically. VITAL STATISTICS Turnover, group (2016)

2017/18 $1,730.1 m (unaudited) -

Turnover, chemical service provision No of offices

300 35

No of countries represented

15,000

Staff, group

Staff, chemical service provision (dedicated)

Product stewardship, substitution and troubleshooting We have tremendous breadth and depth of expertise as well as extensive hands-on process experience, covering: OO toxicology and toxicokinetics OO epidemiology OO exposure modelling, measurement and reconstruction OO risk assessment and mitigation OO ecotoxicology OO environmental fate OO chemistry OO occupational health OO regulatory affairs OO supply chain and stakeholder management OO product vigilance OO advocacy We are ideally placed to advise clients on problems across the spectrum of product safety and stewardship including product substitution and sustainable chemistry. We couple internationally recognised expertise and a reputation as a leader in risk management with client-focused solutions. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

SERVICE AREA BREAKDOWN Laboratory 5% Representation & management 10%

2014

Ramboll acquires ENVIRON.

2016

Ramboll acquires specialist consultancy BiPRO

CLIENTS

Consultancy/advisory 85%

Global Service Providers Guide 2019

Global chemical notifications and regulatory compliance support Ramboll evaluates obligations and provides support for regulatory approvals required to market products across Asia Pacific, America, Europe and Africa. We assess new market opportunities, substance notification and regulatory obligations, classification and labelling (GHS) and packaging. Our established global network covers all sectors and geographies.

Clients span all industrial sectors including industrial and specialty chemicals, pharmaceuticals, petrochemicals, agrochemicals, food and food packaging, cosmetics, medical devices, electronics, manufacturing, aerospace and defence, apparel and consumer products.

TESTIMONIALS

CASE STUDY 7: Product Stewardship

“We are working with Ramboll in a constructive and successful manner on various REACH projects, covering the entire processes (ie preparation of technical dossiers, exposure estimation and hazard and risk assessment)” – Dr Hans Certa, Director, Global Product Safety, SASOL. “Ramboll has been, and is, an essential element in the success of our on-going REACH programme. Their seamless integration into our team and systems creates an unprecedented collaboration that enables high quality, cost effective and timely solutions. Our dossiers have been consistently ahead of schedule and have been fully satisfactory when reviewed by the competent authorities. Ramboll’s professionalism, expertise, and organisational excellence has and continues to contribute to our compliance goals and commercial success.” – James V Hagan, global director, product stewardship and regulatory affairs, Elementis Specialties Inc. “This is just perfect. I will never again be influenced by site arguments in other countries that we should hire local firms to perform risk assessments! If they had agreed to use Ramboll in the first place this whole process would have been so much cleaner and easier. Thank you for all of your hard work on this and in the short time frame requested” – Michelle T Quinn, associate general counsel, regulatory affairs and general litigation, Catalent Pharma Solutions.

Our comprehensive emissions and exposure model characterised releases of the substance across Europe, providing a firm basis for discussions regarding risk management options.

CASE STUDY 1: REACH registration and evaluation We prepare robust substance dossiers, reliably characterising chemical fate and effects on humans and the aquatic environment and setting out practical exposure scenarios to deliver safe use for the environment, workers and consumers. We have extensive experience of both dossier and substance evaluation, and support through the appeal process. CASE STUDY 2: Application for authorisation under REACH

CASE STUDY 8: Endocrine Disruption Identification and comprehensive evaluation of all available data using a weight of evidence approach to assess whether a substance had endocrine disrupting properties. Presentation of the evidence to authorities to inform policy making. STAFF SELECTION Sue Bullock – Principal, product safety and stewardship Supporting strategic, regulatory and technical compliance, risk management, advocacy and policy for chemicals in the environment, the workplace and consumer products. Dr Martina Vosteen – Principal, product safety and stewardship 20 years’ experience in risk assessment and product-related regulatory support for chemicals, biocides and consumer products, including RMOA, restriction and authorisation for REACH. Dr Salvatore Giolando – Principal, product safety and stewardship 29 years’ experience directing and providing leadership in product stewardship programs for chemical products, global supply chains and international product compliance. Dr Robert DeMott – Principal, product safety and stewardship A Board-certified toxicologist with over 25 years expertise evaluating health effects from chemical exposures in the workplace and community. Juliana Ding – Managing Director, Asia 20 years’ experience in environmental and health consultancy, including regulatory advice, product stewardship and supply chain management.

A cross-sector consortium asked us to prepare an upstream application to support the authorisation of chromium trioxide in various critical surface treatments under REACH. It is regarded as the most complex application to date. We continue to support the applicants to implement the authorisation. CASE STUDY 3: Risk Management Option Analysis (RMOA) Technical support to help an industry sector develop and justify to policy makers a more credible and effective RMO for a chemical than inclusion on Annex XIV REACH, and active engagement with stakeholders to inform policy development. CASE STUDY 4: Assured global compliance of new product A company launching a new consumer product worldwide had overlooked product regulations. We advised on regulatory obligations in 50 countries, considering chemical notification, packaging and labelling requirements and optimising the formulation and market claims. CASE STUDY 5: Comprehensive exposure assessment A food packaging producer was concerned when residual levels of a contaminant were unexpectedly found in a key product. We could show that consumer exposure from handling the packaging and ingesting the packaged foods was safe, avoiding regulatory action. CASE STUDY 6: Proposal to reclassify as CMR An industry association asked Ramboll to advise on the basis and technical merits of EC proposals to re-classify a substance as CMR and provide support for technical advocacy for appropriate risk management measures.

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Profile: Ramboll Environment and Health

171

Profile: REACH Global Services S.A.

172

SERVICE AREA BREAKDOWN Training Other 2% Laboratory 3% Consultancy/advisory 3% 14% Information 3%

CONTACTS Website

www.reach-gs.eu

E-mail

info@reach-gs.eu

Head office

Rond Point Schuman, 6 Box 5, B-1040 Brussels, Belgium

Tel/ Fax

+32 (2) 234 77 78/ +32 (2) 234 79 11

Contact

Dr Yaprak Yuzak Kucukvar

Directors

Global Offices Managing Director Mr A Ecmel Yorganci Chairman of the Board Ahmet F Bitlis

RGS SA Brussels, Belgium

Ownership

Private company owned by Chemicals and Chemical Products Exporters’ Association

REACH Global Danışmanlık AŞ Istanbul, Turkey

Locations

Headquarters: Brussels, Belgium; Offices: Istanbul, Turkey

Founded

2008

GLOBAL OFFICES

RGS Istanbul Liaison Office Istanbul, Turkey

SERVICES PROVIDED

OVERVIEW Brussels-based REACH Global Services SA (RGS) and its Turkish branch RGS Danışmanlık AŞ are professional regulatory consulting companies advising clients in the chemicals and allied industries to comply with EU and Turkish chemicals legislations. RGS Group’s experienced staff, based in the EU and Turkey consults to a diverse array of chemical companies, both international and Turkish, operating across a range of chemical industry sectors. Through experience, in-depth knowledge and understanding of the regulations and governments’ regulatory processes, associated policies and guidance documents, RGS offers a wide range of cost-effective services ranging from OR services to; company-specific consultancy services, general consultancy on regulatory compliance issues, training on specific EU REACH and cosmetics legislation compliance, audits or due diligence projects, as well as on Turkish chemical by-laws and Turkish-REACH (KKDIK) compliance services. RGS’s core competencies include only representative (OR) and responsible person (RP) services for non-EU manufacturers assisting them to comply with EU REACH and cosmetics Regulations. RGS also acts as a representative for many national and multinational chemical companies to comply with Turkish chemicals regulations. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Representation & management 75%

Staff, group

Staff, chemical service provision

EU REACH compliance services According to Article 8 of the REACH Regulation it is compulsory for nonEU manufacturers, who export chemicals on its own or in preparations to the EU, to appoint an OR for compliance. The EU importer benefits from being a downstream user and RGS acting as an OR fulfils the obligations of the manufacturer. RGS provides a wide range of services to comply with legal requirements. Our Only Representative Services cover: OO late pre-registration; (currently out-dated) OO registration dossier submission; OO Sief/consortia representation; OO specialised tonnage tracking IT system and certification for compliance of the downstream user (DU)/importer; OO inquiry dossier submission; OO general consultancy services for EU based companies impacting substance registration dossiers, and interactions with regard to the authorities’ requests and inspections; and OO audit and certification services assisting non-EU manufacturers and their EU importers covering compliance evidence. EU Cosmetics Regulation compliance services According to the Regulation (EC) No 1223/2009 notification of a cosmetic product must be submitted prior to placing the cosmetic products into the EU market. Companies manufacturing outside of EU must appoint an RP. RGS acts as an RP and notified hundreds of products to the CPNP portal since 2013. RGS’s experienced team of consultants assists manufacturers to compile cosmetic product information files (PIFs) to comply with the legal requirements. Our cosmetics compliance services cover: OO EU legal representation (responsible person); OO preparation and verification of PIF; OO cosmetic product safety report parts A&B (CPSR); OO formulation and claims review; OO review and guidance on borderline cases; OO review and guidance on necessary corrections on labelling; OO cosmetic product notification; OO scientific and laboratory services (mandatory and claim tests); and OO regulatory compliance support. Turkish REACH (KKDIK) Only Representative services Turkish-REACH abbreviated as KKDIK is published as of 23rd of June 2017. KKDIK is almost a copy paste of the EU REACH Regulation translated into Turkish, but unavoidably there are slight differences to pay attention to, and all implementation, compliance processes are in the Turkish language.

Global Service Providers Guide 2019

However, the spirit of Article 8 of the EU REACH remains identical under Turkish KKDIK regulation. RGS acts as a Turkish OR through its branch office with its consultants highly experienced in the EU REACH Regulation fluent both in English & Turkish. It is critical for non-Turkish manufacturers to choose a well-experienced professional OR in Turkey to successfully comply with the Turkish national legislation.

2018

Turkish chemical regulations representative services RGS represented international companies putting chemical substances alone or in mixtures into the Turkish market since 2010 and notified 2000+ chemical substances to the Turkish Ministry of Environment and Urbanism (MoEU) database according to the by-law on Inventory and Control of Chemicals(CICR) which is repealed by KKDIK as of 23rd of June 2017. Hazardous substances placed on the Turkish market should also be notified separately to the MoEU.

ACCREDITATIONS

RGS, through its Turkish operations acts as a Representative (trustee) alleviating companies of this regulatory compliance burden. Many companies located outside of Turkey placing substances and preparations on the market choose to work with RGS to protect their companies’ confidential business information with professional consultancy services for compliance. RGS also provides SDS authoring & certification services under SDS Regulation in Turkey.

CLIENTS

General consultancy services RGS also offers tailored made training sessions on REACH, EU cosmetics and Turkish chemical regulations (KKDIK and SEA) compliance. Should your company require expertise in regulatory compliance to chemicals or related industry legislation then please do not hesitate to contact us. RGS consults to a diverse array of chemical and allied industry companies, both international and Turkish, operating across a range of industrial sectors. Auditing and certification services are also offered to companies in difficulty to prove compliance during exports into the EU. Other Global Chemicals Legislations RGS offers services to manufacturers ensuring compliance with other chemical regulations in Korea, China, Japan and Taiwan. The scope of work includes but not limited to local Only Representative services, Consortium Management, submission of notifications & registrations in the local language with required data, regulatory update monitoring & annual reporting, liaising with the Authorities when required etc. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2008

REACH Global Services SA. established in Brussels, Belgium Istanbul Liaison Office established in Turkey Appointed as an OR for over 220 companies by the end of the year with hundreds of pre-registrations completed, representing 80% of the Turkish chemicals exportation volume in addition to manufacturers from US, Japan, India, China, Indonesia etc.

2009

Represented hundreds of non-EU companies over five continents as an OR after the pre-registration deadline.

2010

Registered more than 100 substances before the first EU REACH registration deadline.

2011

Notified over 2000 substances under the Turkish By-Law on Inventory and Control of Chemicals on behalf of +150 worldwide manufacturers.

2013

Successfully completed REACH registrations in 2013 Started providing product information file (PIF) preparation services and introduced responsible person (RP) services according to the EU cosmetics Regulation.

2015

Notified 1500+ hazardous substances under the Turkish CLP (SEA) regulation.

2016

Established REACH Global Services Danışmanlık A.Ş. in Istanbul, Turkey. Successfully notified 2000+ cosmetics products into the cosmetics products notification portal(CPNP) by 2016.

2017

Based on 11-Year-Long experience in EU REACH and Turkish KKDIK regulation extended its activities in Korea, China, Japan, Taiwan

Completed 11 years of REACH registration period with 2000+ pre/registration for over 450 manufacturers Pre-registered 2200+ substances under KKDIK as OR/TPR Preliminary preparations of SIEF/Consortia establishment for Turkey in direct communication with the EU REACH Consortia

RGS is a founding member of ORO (Only Representative Organisation), the unique European association, established in 2008 in Brussels, gathering all professional OR companies under the same umbrella, and guaranteeing common standard service quality to their non-EU clients. All RGS staff are certified as Chemical Safety Assessors (KDU) and SDS Authors in conformity with the provisions of KKDIK.

RGS’ client portfolio ranges from multinational Fortune 500 leading worldwide chemical and allied industry companies up to small and medium enterprises. RGS is working for sectors including but not limited to; Petrochemicals, paint, cosmetics, fertilisers, cement, welding, textile agents predominantly pigments, adhesives, iron and steel, metals and ores, plasticisers, automotive, industrial and household chemicals etc. CASE STUDY 1: REACH registrations RGS successfully submitted registrations of a range of substances from oil refineries, petrochemicals, metals, ores, monomers, chemicals used in iron and steel works, plasticisers to Echa in 2010 and 2013. RGS also represents its clients at the consortia and Siefs. RGS works with the largest petrochemical and oil refinery companies in Turkey to comply with REACH obligations and assessed numerous borderline cases including exemptions since 2008. RGS evaluated and assisted many companies to properly redefine the substances to register by contacting the relevant consortia, associations, and more importantly the company’s own production units. RGS took the corrective compliance actions on behalf of the company as our team has years of experience in defining manufacturers’ REACH obligations accurately. CASE STUDY 2: cosmetic product notifications and PIF preparation RGS raised awareness among non-EU companies to choose the right path forward, and to appoint a trustworthy RP to comply with their legal obligations. Several companies that initially worked through their distributors, and facing tricky headaches, contacted RGS to seek for professional assistance. RGS assessed each company’s obligations, advising manufacturers on how to correctly update their registrations through a professional RP. With a written mandate, manufacturers were also able to export their products successfully to the EU and importers could benefit from the notifications done by the RP. STAFF SELECTION RGS Board Members and management have 30+ years of chemical industry experience and international regulatory affairs practice. RGS technical team consists of chemists, chemical engineers, and environmental engineers with masters and PhD degrees from five to 15 years of experience. Our consultants are experienced within the areas of regulatory management of chemicals both in the EU and Turkey, with extensive practices as well as representation of our clients in consortia and Siefs. Our consultants have worked on numerous cosmetic products and labelling, gaining comprehensive knowledge to properly reflect the compliance criterion according to the manufacturer’s needs. RGS team of experts assesses manufacturers current regulatory status and supplies solutions and corrective actions to the companies in urgent need for compliance.

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Profile: REACH Global Services S.A.

173

Profile: ReachCentrum SA

174

GLOBAL OFFICES Global coverage as part of ERM group SERVICES PROVIDED CONTACTS Website

www.reachcentrum.eu

E-mail

info@reachcentrum.eu

Head office

Avenue E van Nieuwenhuyse 6, B-1160 Brussels, Belgium

Tel/ Fax

+32 2 897 0560

Contact

Francesca Furlan

Directors

Vincent Sauvaire, Managing Director Laurent Beuselinck Jean-Francois Bolduc

Ownership

Private company

Locations

Brussels, Belgium

Founded

2006

Business solutions ReachCentrum offers expert consultancy to support REACH implementation within companies and stakeholder groups, assisting customers with effective strategies to fulfil REACH requirements. Lead registrant, consortia and co-registrant support comprises project management, SIEF communication, finance and data management, legal support, letter of access management (LoA e-Shop loashop. reachcentrum.eu), co-registration and training. Post-registration activities include dossier update, evaluation and authorisation support. Beyond EU-REACH Regulation: OO CLP Regulation; OO Biocidal Products Regulation (BPR) – use of the cooperation approach to promote joint submission for product families with same active ingredients and individual company support; OO Agrochemical support; and OO non-European chemicals regulations – e.g. K-REACH, Taiwan REACH. In addition to data brokerage and consortia support, we offer technical provision via ERM offices. REACH Consortia and registrant support Dedicated staff manage consortia and support lead- and co- registrants imeeting their regulatory obligations under EU REACH. This experience has been gained through the 2010 and 2013 REACH registrations, with currently more than 100 consortia and 1500 substances under management.

OVERVIEW ReachCentrum was established in 2006 by Cefic, to help companies fulfil their EU-REACH Regulation requirements through their value chain. It was acquired by ERM, in May 2015 and forms a core part of the product stewardship offering from ERM. ReachCentrum supports clients in relation to chemical regulations including EU-REACH, classification, labelling and packaging of substances and mixtures (CLP) and Biocidal Products Regulation (BPR). Services include: consortia and project management, lead- and co-registrant support, consultancy and brokerage of data for use in product compliance in other jurisdictions. Together, ReachCentrum and ERM provide global support to Clients for product compliance with respect to K-REACH and other global REACH-like legislations. VITAL STATISTICS

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

1 Global via ERM network

No of countries represented Staff, group

Staff, chemical service provision

Legal 10%

Consultancy/advisory 15%

IT & software 5%

Representation & management 65%

Global Service Providers Guide 2019

Project management for biocides ReachCentrum supports companies in the preparation of their authorisation dossiers for product(s) containing certain active substances within certain product types (PTs) under the Biocidal Product Regulation. Activities include customised training for BPR compliance, dossier preparation and risk assessment. Data brokerage and global chemical regulations ReachCentrum actively supports data owners to provide access to data for use in compliance in chemical regulation globally (e.g. K-REACH or Taiwan REACH). Together with ERM, we assist clients in preparing their dossiers for substance registration; using our network of 140 offices, we are able to cover all aspects required for project, technical and legal management. Secured IT-systems, including our Data Brokerage Platform, and processes are in place to support joint registration, access and purchasing data from Europe, data sharing and cost sharing for a successful dossier registration. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

SERVICE AREA BREAKDOWN Training 5%

Authorisation support ReachCentrum and staff have been involved in authorisation activities since the first applications (DEHP). ReachCentrum has deep knowledge of the processes, steps and potential pitfalls in approach. In addition, clients benefit from updates via ReachCentrum’s extensive network and contact to industry associations, REACH authorities in member states, the European Commission, and Echa.

2006

Founded by Cefic (European Chemical Industry Council).

2010

LoA e-shop successfully launched.

2010

Through the LoA e-shop 342 lead registrants allowed their SIEF members to access the registration dossier.

2010

About 900 people attended ReachCentrum events (about 90 events).

2012

Set up of three authorisation consortia.

2014

Submission of the first joint application for authorisation (HBCDD).

2014

Creation of the first biocidal product family (BPF) preconsortium, sodium hypochlorite.

2015

Acquired by ERM.

2015

Launch of K-REACH activities.

2016

Launch of Data Brokerage Platform for K-REACH.

2016

ERM acquisition of JSC (UK). Full technical and administrative support for biocidal products authorisation according to BPR and to non-European Regulations.

2018

Launch of Data Brokerage Platform 2.0 for data sharing with REACH-like legislations.

2018

REACH deadline: LoA e-shop managed more than 900 substances. Over 80 Consortia and many Lead Registrants supported. More than 1500 Letters of Access managed within the 3 months.

PARTNERS OO OO

An ERM Group Company; and Cefic list of preferred partners

CLIENTS ReachCentrum offers its services to a wide range of companies, from major multinationals to SMEs and only representatives (OR) from all over Europe and beyond, including downstream users and distributors. TESTIMONIALS “As a REACH substance coordinator at BASF I very much value the support of ReachCentrum for efficient project organisation, coordination and support of meetings, where a neutral party is needed. We also have good experience with general REACH activities such as handling REACHDossier sales. “ Dr Carina Johansson Manderbach, Product Stewardship REACH BASF. “ReachCentrum was selected first as consortium secretariat based on its experience with consortia management, more particular relating to in financial and communication aspects but also due to their knowledge of REACH authorisation process as such. During preparation for application, ReachCentrum has proven to be very supportive in translating between the language of pure technical service providers and the understanding of our group. Also in reviewing documents for application, ReachCentrum’s input is very helpful.” – Ingrid Brassart, chairperson of the Sodium Dichromate authorisation consortium, Akzo Nobel. CASE STUDY 1: Biocidal product authorisation support ReachCentrum worked with a multinational company to support it in launching biocidal products on European and non-European markets. ReachCentrum provided strategic advice – a global action plan with timelines and costs – for optimised placement of products in the relevant markets. Activities included legal and regulatory advice, technical dossier preparation, and cooperation with local authorities before and after submission of specific documents.

CASE STUDY 3: Analysis of alternatives listed as good example by ECHA A downstream user analysis of alternatives (AoA), figures among a list of good examples published by ECHA. ReachCentrum and ERM worked together and the analysis, submitted by DOMO Caproleuna GmbH for trichloroethylene, was used by ECHA as an example of a downstream user analysis of alternatives. Since ReachCentrum’s acquisition in May 2015, ReachCentrum and ERM have combined their technical and management expertise to support industry in REACH authorisation. Services include regulatory advice, strategic planning, communication facilitation (supply chain, data access), application for authorisation and review of documents, analysis of alternatives and socio-economic analysis, and also setting up interest groups, taskforces and consortia to serve a common goal for registration and evaluation and authorisation. STAFF SELECTION Magdalena Urbanowska – Operations Director Magdalena has several years’ experience in consortia management. During her career, she has been involved in REACH at different levels – administrative, regulatory and technical. As Director of an Industry Association, she has been also responsible for the regulatory affairs and participated in the legislation process for wastes and environmental regulations. At ReachCentrum, Magdalena is responsible for REACH consortia and for authorisation of biocidal products. Since December 2017, she is Operations Director in ReachCentrum, in charge of the day to day management and strategic development of the company. Willi Muenninghoff – Global Business Development Director With over 30 years’ experience in the Chemicals industry Willi joined ReachCentrum in January 2016 and is responsible for consortia management and global regulations. He works with the world-wide platform of ERM to provide clients with global product stewardship support. Data brokerage is a key aspect for delivery on national compliance and Willi has been working with local consultants and clients alike towards consistent approaches in each region depending on need. Adam Shahin – Finance Director Adam is a qualified chartered management accountant (CIMA) and has 15 years industry experience. Adam leads the finance team at ReachCentrum that manages the consortia finances. The team has developed a consistent and robust approach to enable clients meet their data sharing obligations under the data implementing regulations. Jean-Luc Wietor – Project Manager Jean-Luc joined ReachCentrum in September 2018, building on 10 years’ experience in the chemical sector. He previously held roles in financial and strategic marketing as well as in R&D and in public affairs, focussing on CLP, Reach and BPR. He holds a PhD in chemistry from Cambridge University and an MBA from FOM in Düsseldorf.

CASE STUDY 2: Support consortia on data sharing for K-REACH ReachCentrum is currently supporting consortia members with a comprehensive strategy to share existing EU data for K-REACH purposes. Consortia can benefit of legal support, including advises and verification of current EU agreements. An assessment of the financial value of data and studies is managed by ReachCentrum, together with communication with potential registrants in South Korea and analysis of data to be shared. The data is brokered via the data-brokerage platform.

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Profile: ReachCentrum SA

175

Profile: REACHLaw

176

SERVICE AREA BREAKDOWN Training 5% Legal 20%

CONTACTS Website

www.reachlaw.fi

E-mail

sales@reachlaw.fi info@reachlaw.fi

Head office

Vänrikinkuja 3 JK 21. FI-02600 Espoo. Finland

Tel/ Fax

+358 (0)9 412 3055/ +358 (0) 9 412 3049

Contact

Mr Frederik Johanson, Partner, Sales

Directors

Mr Jouni Honkavaara, CEO, Partner Mr Frederik Johanson, Partner Mr Riku Rinta-Jouppi, Partner Mr Mathias Berner, COB, Partner

Ownership

Private company

Locations

Finland, Belgium, India, Turkey

Founded

2006

IT & software 10% Laboratory 5% Information 5%

Helsinki, Brussels, New Delhi, Istanbul SERVICES PROVIDED REACH authorisation and advocacy support services REACHLaw has been a strategic advisor for several SVHC related projects. Through our advocacy support services, we assist companies before authorisation and restriction decisions are made. We help to achieve the best possible outcome for businesses by supporting them during the public consultation phase, as well as with RMOAs, exemption studies and legal consulting. In addition, REACHLaw combines the best expertise and a deep understanding of business and regulatory requirements to provide our clients with a full set of authorisation services. Our support covers the overall strategy and scope of authorisation as well as the development of all the required documents for authorisation (e.g. analysis of alternatives, socio-economic analysis, chemical safety report) and different types of authorisation applications (downstream/upstream/joint/single).

As a leading expert in the registration, authorisation and notification of chemical substances, inside and outside EU, REACHLaw provides chemical regulatory compliance and product safety solutions to fit each customer and their needs. We help companies and organisations to gain market access for their chemical products and we support them with different chemical regulations such as EU REACH & CLP, Turkey KKDIK, SEA and GBF, UK REACH (if applicable), K-REACH and GHS, “Eurasia/Russia REACH” and many more. Furthermore, our out-tasking EHS services will help you manage and control your chemicals and your supply chain globally. Having a multilingual team, REACHLaw is able to serve its clients in the following languages: English, Finnish, French, German, Spanish, Italian Swedish, Hindi, Russian, Ukrainian, Hungarian and Turkish. 2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

45+

Staff, group

30+

Staff, chemical service provision

25+

Global Service Providers Guide 2019

Representation & management 25%

GLOBAL OFFICES

OVERVIEW

VITAL STATISTICS

Consultancy/advisory 30%

REACH and Global Regulatory Compliance Program Services REACHLaw has a unique set of competence and experience, covering more than 10 years of chemical regulatory support for a wide range of industries and we utilize these competences to prepare REACH and Global Chemical Regulatory Compliance Programs for several of our clients. The service is developed to CLIENT specific requirements with the aim of defining compliance actions to take now and in the future to continuously comply with the requirements of REACH (and CLP) and other REACH-like regulations Globally, considering eventual changes in company operations, growth of business as well as the changes in the Regulations themselves. Turkey KKDIK, UK REACH, K-REACH and Eurasia/Russia REACH Compliance Services REACHLaw global chemicals regulatory compliance services helps companies and organisations in adapting to the changing regulatory environment but also provides companies with support with preregistration and registration of their substances placed on the Turkish market, in the UK (if applicable), in Russia and on the South Korea market. At REACHLaw, we are able to help your organisation both as your local Only Representative and as your service provider to comply with the chemical regulatory requirements in these markets. The Turkey KKDIK Pre-registration phase started on the 23rd of December 2017 and the South Koreas K-REACH Pre-registration phase started on the 1st of January 2019. In 2019 it is expected that the UK REACH regulation will become operational requiring companies placing chemicals on the UK market to act in order to maintain access to this market and in Russia, notification of substances to the Russia Chemical Inventory will be required.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

CLIENTS

2006

Established in Helsinki.

2008

Partnerships with 20+ local partners in Asia, Europe, Latin America, USA and India established. 3,000+ REACH preregistrations submitted.

2009

REACHLaw received internationalisation award from the president of Finland. Customers in 40+ countries. Brussels and New Delhi offices opened. REACHLaw delivered more than 50 events globally, having 1,500+ attendees in total.

Major industry sectors served: oil, chemicals, petrochemicals, specialty chemicals, pulp and paper and metals. Downstream users in the chemical, electronics, defence and space sectors. Our customers are manufacturers, importers, traders, downstream users, retailers, industry associations and governmental organisations.

2010

300+ REACH registrations submitted. REACHLaw launched global compliance services outside the EU. The attendees to our events increased considerably reaching more than 2,500+.

2011

Istanbul office opened. REACHLaw supported large companies to ensure compliance with global chemical regulations.

2012

20+ REACH lead registrant cases. First authorisation cases. Several global notifications were completed. REACHLaw became shareholder in eSpheres Ltd: www.espheres.com

2013

REACHLaw launched www.compliantsuppliers.com. REACHLaw supported several hundred REACH registrations, numerous authorisation projects, lead registrant and BPR cases.

2014

Delivering several REACH lead registrations and a large number of authorisation projects. Providing SDSs for mixtures.

2015

REACHLaw launched THEBLOG: www.reachlaw.fi/theblog Providing IT management solutions especially related to supply chain compliance and risk management.

2016

Supporting several companies with advocacy projects. Working on different authorisation cases and supporting 2018 Registrations.

2017

Supporting several REACH registrations. Working on different advocacy support cases and EU country specific product notifications.

2018

Preparing a large number of REACH 2018 Lead registrations and co-registrations. Supporting several companies with their 2019 Applications for Authorisation as well as with their KKDIK pre-registrations. Helping the industry with the development and implementation of in-house REACH compliance programs.

2019

Preparing several large-scale joint Applications for Authorisation. Supporting EU 27 and UK companies to maintain access to the EU/EEA market as well as to the UK market. Preparing large number of KKDIK and K-REACH pre-registrations and advising the industry on Eurasia/Russia REACH requirements.

TESTIMONIALS “REACHLaw has been a true partner to Stepan Company as an Only Representative. The expertise the team has brought to the table has helped Stepan effectively navigate the complex regulatory landscape by enabling efficient portfolio and opportunity management, as well as management of Lead and Co Registration efforts. REACHLaw has been an asset in helping our customers to meet their needs.” – Chris Hammond, Stepan Company. CASE STUDY 1: Authorisation (General case) REACHLaw was commissioned by the world No. 1 lock maker Abloy to conduct an authorisation project for chromium trioxide. The material is an integral part of Abloy’s unique lock design. REACHLaw was responsible for conducting all three parts of the authorization dossiers, CSR, AoA and SEA. In addition, REACHLaw played an important role in the post-submission activities to assure that Abloy will obtain the authorisation with the right review period. In January 2018, a positive Authorisation decision was given by the EC with the review period asked for in the application. CASE STUDY 2: Legal study on authorisation – Eurometaux The Competent Authorities for REACH and CLP (CARACAL) adopted a paper (COM, CA/98/2017), which describes a wide scope of REACH Authorisation for materials that contain substances on Annex XIV as impurities or minor constituents. It raises a number of legal questions and could have a significant impact on the metals/inorganics and recycling industry as well as on Circular Economy objectives. Against this background, Eurometaux contracted REACHLaw to conduct an independent review of the CARACAL paper as part of a legal investigation to clarify the authorisation status of substances in substances (“SiS”) or mixtures (“SiM”). The study established a legal interpretation framework to assess whether authorisation applies and identified a number of concerns with regard to the CARACAL paper. Its outcome is being communicated to industry stakeholders and authorities for further discussions on the correct application of REACH Risk Management Options for SVHC constituents. STAFF SELECTION Mr Tim Becker, MA (Law) – Chief EU Compliance Officer Dr Bernardette Quinn Ph.D. (Chemistry) – Authorisation and Restriction Expert

ACCREDITATIONS

Dr Kati Vaajasaari, Ph.D. – REACH Authorisation and Lead Registration Manager

Internationalisation award from the president of Finland in 2009. Innovative – Growth sustainable company by Europe Innova in 2011. Among 200 fastest growing companies in Finland by Kauppalehti in 2011. Young Innovative Growth Company Programme by TEKES completed in 2012.

Sini Suomela (MSc in Organic Chemistry) – Head of OR and Registration Practise

PARTNERS REACHLaw collaborates with several industry associations and has partners in all of the key areas globally

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Profile: REACHLaw

177

Profile: Redebel Regulatory Affairs S.C.R.L.

178

SERVICE AREA BREAKDOWN

IT & software 5%

CONTACTS Website

www.redebel.com

E-mail

info@redebel.com

Head office

Rue de Chassart 4, B-6221 Saint-Amand, Belgium

Tel

+32 71 853 392

Fax

+32 71 853 618

Contact

Ir. Jean-Yves Lontie – Business Development Manager MIB. Olivier Balhan – Business Development Manager

Directors

Sebastien Dumont de Chassart – Managing Director Tanguy Dumont de Chassart – Director

Ownership

Redebel Holding SA, a private family company, 100% private shares

Locations

Belgium

Founded

1988

Consultancy/advisory 90%

SERVICES PROVIDED

OVERVIEW The REDEBEL Group offers the full range of services for the registration of plant protection products, biocides and chemicals. For about 30 years now, our experts have been helping companies to obtain authorisation for marketing their products in all EU Member States. Located in Belgium, our team offers tailor-made solutions for the resolution of regulatory issues with the European Commission as well as with any of the 28 European National Authorities in order to obtain the approval of active substances and the registration of products. Why choose us? OO a team of more than 60 experts built on about 30 years of existence; OO confidentiality; OO flexibility, human-scale, with easy direct contact, for a privileged and personalised relationship; OO numerous success stories with tangible results; OO ongoing training of our team of experts leading to continuous OO improvement and a drive for progress and excellence; OO presence at all major international conferences; OO a European network: close working relationships and partnerships OO with service providers and laboratories all over Europe; and OO privileged relationships with European Commission and all the 28 national competent authorities; OO worldwide network to access the market VITAL STATISTICS

<€8m

Turnover, chemical service provision

<€8m

No of countries represented

1 28

Staff, group

More than 60

Staff, chemical service provision

More than 60

Global Service Providers Guide 2019

For the chemical, agrochemical and biocide industry, the REDEBEL Group offers a broad scope of support services that meet the international regulatory requirements and include the following: OO 30 years of experience and expertise OO registration of agrochemicals (1107/2009), biocides (EU 528/2012) OO and REACH (1907/2006); OO strong expertise in biostimulants, fertilizers and biopesticides OO risk assessment for such substances and products; OO dossier writing; OO data gap analysis; OO liaison with the competent authorities (EU and national); OO project management – study direction – study monitoring; OO testing of efficacy, selectivity, residues of plant protection products (GLP and GEP certifications); OO research and development of agrochemicals; OO European field trial projects. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1988

Foundation of Redebel SA which specialised in agricultural field trials.

19882000

GEP certification. GLP certification. Creation of the Regulatory Affairs Department. New offices in family farm. Continuous internal growth from two to 20 persons, without any acquisition.

20002014

Development of the company, with a staff increasing from 20 to 55 persons, and the turnover from €1.5m to € 5.5m.

20142016

Building of new offices linked to a ten year expansion project

2016

Creation of Redebel Regulatory Affairs SCRL to separate the field trials business from the regulatory affairs business

2018

Launching of Rhizome: a network of local & independent CRO’s. Rhizome offers the possibility of conducting experimental trials worldwide.

2018

Celebration of the 30th anniversary of our activities

2017/18

Turnover, group No of offices

Training 5%

ACCREDITATIONS Good Laboratory Practice (GLP) Good Experimental Practices (GEP) Toxicologists, ecotoxicologists, environmental fate specialists

Profile: Redebel Regulatory Affairs S.C.R.L.

179

PARTNERS We have a long-term and well established network of partners in all European countries, among laboratories and field trial stations. All partners are rated annually based on several factors (expertise, respect of deadline, communication,â&#x20AC;Ś) for an optimal selection process. STAFF SELECTION More than 60 persons of a high experience and highly educated. Our people are highly educated (master degree, engineer or doctor), divided into chemists, agronomists, biologists, microbiologists, plant pathologists, etc.

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Profile: ReFaC

180

GLOBAL OFFICES Crewe, UK SERVICES PROVIDED CONTACTS

ReFaC provide a complete range of services for those seeking compliance with chemicals regulations. Examples of some of our areas of operation are detailed below.

Website

www.refac.eu

E-mail

Rachel.Green@refac.eu

Head office

Group House, Southmere Court, Electra Way, Crewe, Cheshire, CW1 6GU

Tel

+44 (0)1270 258530

Fax

+44 (0)1270 258444

Contact

Rachel Green, Technical Manager

Directors

Heinz Dobbertin

Ownership

Wholly owned subsidiary of C.S.B. GmbH

Locations

Founded

2007

REACH Regulation ReFaC provides our clients with complete regulatory support for REACH. Technical support from ReFaC typically includes tasks such as; data gap analysis, registration cost analysis, testing strategies and dossier development strategies, read-across proposals and justifications, full dossier development and submission, PPORD notifications, compilation of CSRs, exposure and hazard assessment and reporting including the development and refinement of exposure scenarios, PBT/vPvB assessment and assistance with authorisation and restriction activities. In addition, administrative support such as consortium / SIEF management and LoA management services are provided. Compliance management and regulatory forecasting ReFaC offers a range of services dedicated to ensuring our clients are always one step ahead of any relevant legislation. Services include regulatory health checks, ongoing horizon scanning for specific substances or products, full monitoring and review of new and emerging regulations as relevant for our clients; an area which is likely to be of particular concern over the next year.

OVERVIEW ReFaC provides regulatory assistance to companies, within Europe and from across the world, who seek to comply with regulatory schemes including but not limited to; REACH, CLP, BPR and potential future UK regulations. Our team of regulatory professionals provide efficient and expert services to SME companies, multinational organisations, industry associations and consortia. Wherever possible ReFaC aims to reduce the burden imposed by regulation and provides tailored support to clients in order to maximise the value of our contribution. ReFaC delivers chemical compliance solutions using its own staff and the specialist services provided by its mother company C.S.B. GmbH, which recently acquired ReFaC as a wholly owned subsidiary from the Chemical Business Association Ltd. VITAL STATISTICS

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

1 11

Staff, group

Staff, chemical service provision

GHS/CLP and SDSs We provide our clients with technical support and assistance in order to correctly apply the relevant classification and labelling legislation. Services include reclassification and assessment of substances and mixtures, CLH dossier preparation, CLP notifications, advice on labelling requirements, SDS/eSDS authorship. OR and TPR services ReFaC provides both OR and TPR services to our clients. Our experts successfully manage hundreds of substances on behalf of our OR and TPR clients. Toxicology consulting We provide toxicological support for various areas of legislation including for food contact materials, food additives, REACH, CLP and BPR. Such support includes drafting technical documents as well as study monitoring or testing strategy advice. Biocidal Products Regulation ReFaC are able to assist with all aspects of BPR compliance. Including approval of active substances, application for national authorisation and/or mutual recognition, Union authorisation, Article 95 applications, applications for technical equivalence and assessment of chemical similarity. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007

ReFaC established by leading professionals in the chemical distribution industry

2010

ReFaC acquired by the Chemical Business Association Ltd. (CBA)

2019

ReFaC acquired by C.S.B. GmbH

SERVICE AREA BREAKDOWN Training 5%

Other 5%

Representation & management 20%

PARTNERS ReFaC has a network of partners with whom we work, including Bibra, Charles River Laboratories, Intertek and AMG Analytical Services. Consultancy/advisory 70%

Global Service Providers Guide 2019

Profile: ReFaC

181

CLIENTS ReFaC supports SMEs and large organisations from across the chemical industry, both within Europe and Worldwide. In addition, ReFaC assists a number of industry associations and consortia that require compliance management, consultancy and study monitoring services. CASE STUDY 1: Technical Management for a large Consortium ReFaC provides support and services for a large consortium with >40 substances on a range of technical issues, predominantly concerning REACH registration obligations. This includes the preparation REACH registration strategies including the development and application of readacross strategies, study monitoring and testing strategy development, preparation of lead registration dossiers, risk assessment and exposure estimations for chemical safety reports and eSDSs, advice on classification and labelling and liaising with lead and member registrants. CASE STUDY 2: REACH and Biocides Compliance Management ReFaC has created and implemented a compliance management plan for a formulator/distributor of industrial chemicals and biocidal products OO REACH compliance of products supplied are confirmed annually through correspondence with suppliers and cross-checking registration numbers provided within the ECHA database OO Article 95 list status of biocidal active substance suppliers checked and list of approved active substances reviewed at regular intervals to allow a plan for biocidal product authorisation to be prepared if required CASE STUDY 3: Review of toxicological information for food additives ReFaC prepared documentation that was submitted to the EFSA regarding a number of food additives. Tasks included: OO a review of the available literature regarding exposure to humans, as well as any animal testing data; and OO evaluation of the data and conclusion regarding specific toxicological effects reported for these substances. STAFF SELECTION Rachel Green BSc (Hons), MSc, PGCert – Technical Manager Rachel holds a BSc (Hons) degree in Biochemistry and biological chemistry from the University of Nottingham, a Post-Graduate Certificate in REACH Chemical Management from the University of Hull and an MSc in Applied Toxicology from the University of Surrey. Rachel has more than ten years’ experience in regulatory affairs. Specifically, with advising clients on REACH and CLP requirements, managing complex projects, identifying data needs; preparing regulatory strategies for compliance; preparing and submitting lead registration dossiers and preparing chemical safety reports. In addition, Rachel has considerable experience in preparing read-across strategies and assessing the risk for inorganic chemicals. Rachel is experienced in toxicological assessment of chemicals including exposure and risk assessment. Kim Shillington BSc (Hons) – Technical Officer Kim holds a BSc (Hons) degree in Chemistry from the University of Liverpool. Kim has experience of the chemical industry, having worked as a formulation chemist within the printing ink industry and as product and process developer within flow reactors. In her role at ReFaC, Kim provides regulatory assistance to UK and overseas companies in relation to the REACH Regulation, the Classification, Labelling and Packaging Regulations (CLP) and testing management. In particular, Kim has experience preparing REACH registration dossiers, managing Only Representative responsibilities and providing CLP advice.

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Profile: Risk & Policy Analysts Ltd (RPA)

182

SERVICE AREA BREAKDOWN Training 5%

CONTACTS Website

rpaltd.co.uk

E-mail

post@rpaltd.co.uk

Head office

1 Beccles Road, Loddon, Norfolk, NR14 6LT, UK

Tel

+44 1508 528465

Fax

+44 1508 520758

Contact

Panos Zarogiannis

Directors

Meg Postle Panos Zarogiannis Teresa Fenn Matthew Lambert

Ownership

Employee owned

Locations

UK, Belgium

Founded

1990

Consultancy/advisory 95%

GLOBAL OFFICES RPA: UK, Belgium; RPA Europe: Italy SERVICES PROVIDED REACH authorisation RPA assists industry clients with the development of applications for authorisation of SVHCs under REACH, as well as REACH authorisation strategies more broadly. These studies involve detailed analyses of supply chains, of alternatives and the preparation of SEAs. REACH restriction and CLP classification RPA assists both industry clients and regulators with the collection and analysis of use/exposure data of chemicals and their alternatives and the preparation of SEAs, which may be used to inform the development of a restriction dossier or support industry in defending substances for which harmonised hazard classifications are proposed.

OVERVIEW Risk & Policy Analysts Ltd (RPA) was established in 1990 as an independent specialist consultancy. RPA has gained extensive experience in undertaking impact assessments and evaluations, including the development of quantitative and qualitative methodologies to assess policy impacts, chemicals policy, chemical risk assessment and management. RPA is the market leader in the development and application of socio-economic analysis (SEA) to chemical risk management and is particularly proud of its reputation for preparing applications for authorisation of SVHCs under REACH for industry clients. More recently RPA has started offering services on the assessment of socio-economic impacts from the CLP hazard classification of substances that are subject to the provisions of the Biocidal Products and Cosmetic Products Regulations. RPA has been working with industry clients since 2001 on the implications of the new EU regime for chemical risk management. We have also been working closely with the European Commission (EC) and the European Chemicals Agency (Echa) on the development and implementation of REACH and many other directives relating to chemical risk management. Our experience covers a wide range of industry sectors including bulk chemicals, ferrous and non-ferrous metals, paints and coatings, oil and gas, speciality and novel chemicals (including nanomaterials), etc, and this has resulted in detailed studies on over 50 high profile chemicals. RPAâ&#x20AC;&#x2122;s multi-national staff routinely undertakes detailed analysis and consultation with industry and regulators in most European languages.

Regulations and impact assessment RPA advises industry clients and regulators on the (potential) impacts of regulations and regulatory change. Recent examples include work on REACH, nanomaterials, OELs, WEEE/RoHS, CMRs at work, toy safety, cosmetics, biocides, drinking water and WFD.

VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Focus on EU-28, EEA and candidate countries

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2019

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1992

RPA develops a risk-benefit analysis methodology for chemical risk management for the UK authorities.

1998

RPA wins major framework contract for the UK authorities on chemical risk management leading to numerous risk reduction strategies under the existing substances Regulation.

2000

OECD publishes guidance documents on SEA and chemical risk management prepared by RPA.

2004

RPA wins major framework contract for the European Commission on chemicals.

2009

RPA contracted by industry clients to support applications for authorisation under REACH with a focus on SEA work.

2012

RPA completes three studies for DG Environment reviewing the first years of REACH implementation.

2013

RPA leads the market in supporting seven applications for authorisation of SVHCs under REACH.

2014

RPA clients obtain the first granted REACH authorisations.

2015

RPA supports the submission of another nine applications for authorisation.

2016

RPA leads the EC fitness check for chemicals legislation (excluding REACH).

2017

RPA supports DG Employment in major revisions of the CMD and RPA clients submit first ever Authorisation review reports.

2018

RPA Europe established as an EU legal entity to ensure continuity of services within the EU post-Brexit

PARTNERS RPA works with FoBiG, Ökopol, Bureau Veritas, TNO Triskelion, Milieu, DHI, RIVM, Arche, IEH Consulting, ReachCentrum and Anthesis among others. CLIENTS The OECD, the European Commission (including DG Grow, DG Environment, DG Employment and DG Justice and Consumers). National authorities (including those in the UK, Germany, Sweden, Denmark, France and the Netherlands). European Chemicals Agency, European Food Safety Authority, European Environment Agency, Executive Agency for Small and Medium-sized Enterprises. Numerous European/international industry/trade associations and groups (including AISE, Apeal, Cefic, Cosmetics Europe, DEHP ATF, Etinsa, Eurocommerce, Eurometaux, European Plastics Recyclers, IAEG WG5, ICMM, IMnI, International Zinc Association, Lead Development Association, Nickel Institute, Titanium Dioxide Industry Consortium and UKWIR). A range of companies (from multinationals to SMEs) and consortia, including Bayer Pharma AG, DEZA a.s., Dow Chemicals, Eli Lilly, Grupa Azoty, Grupa Lotos, H&R Group, Lanxess, Rolls Royce, Spolana. TESTIMONIALS “We would like to express personally how much we appreciated your work and your help during the whole authorisation process. Not only the high level of expertise and the extremely efficient and flexible organisation were noteworthy, but the very friendly and warm work atmosphere...” – industry client. “My thanks to you for successful accomplishing of the very ambitious survey programme, as well as the equally challenging work on developing the model for the 2018 registration costs.” – European Commission client. “RPA are committed to the job, responsible, punctual, reliable and always ready to assist and help” – industry client. CASE STUDY 1: Provision of analysis of alternative and socio-economic analysis support services RPA has been providing REACH authorisation support to several consortia of manufacturers and users of SVHC substances. The work includes preparation of analyses of alternatives, supply chain communication to develop information on uses and users’ responses to the loss of the SVHC in question and preparation of socio-economic analyses of the impacts of the loss of the SVHC. As part of this work, we are managing the services of specialist toxicology and risk assessment consultants. As of early 2019, RPA is finalising the preparation of a new round of applications for substances with complex SVHC profiles (CTPht, AO, OPEs), and has lead the preparation of the first three REACH authorisation review report submissions in 2018. CASE STUDY 2: Modernisation of OSH legislation with a focus on reprotoxic chemicals RPA is leading a major impact assessment for the European Commission (DG Employment, Social Affairs and Inclusion), focusing on possible revisions to the EU legal framework regulating occupational exposure to reprotoxic substances. This includes (amongst other issues) an assessment of a potential inclusion of reprotoxic 1A/1B substances into the scope of Directive 2004/37/EC (Carcinogens and Mutagens Directive, CMD). This study follows the Better Regulation Guidelines and will provide a comprehensive assessment of social, economic and environmental impacts of a range of policy options for controlling occupational risks from reprotoxic chemicals.

CASE STUDY 3: Non-Toxic Environment strategies Modernisation of OSH legislation with a focus on reprotoxic chemicals RPA has been providing the OECD, the European Commission and the Danish Environment Protection Agency support in analysing business models for the circular economy, investigating how companies, in particular SMEs, could best approach the substitution of hazardous chemicals in their material cycles. Through different studies, RPA is actively contributing to the definition of ambitious strategies to tackle the economic, social and environmental challenges at global, European and national levels. STAFF SELECTION Meg Postle – Director Meg is an environmental economist and policy analyst with more than 20 years’ experience of consultancy. She has led RPA’s work for the European Commission, the UK government and a range of industry bodies on business, health and environmental impact assessments of REACH and of proposed restrictions and other controls on the use of hazardous chemicals within the EU. As a leading expert on socioeconomic analysis (SEA), she guides the preparation of SEAs to support authorisation and restriction activities. Panos Zarogiannis – Technical Director, Chemicals Policy Panos is a chemist with extensive experience of developing risk reduction strategies for chemical substances under the Existing Substances Regulation as well as SEA-related studies and in the development of TGDs for REACH. He has managed studies in support of the development of Annex XV dossiers and is leading our work for major industrial clients on the development of authorisation dossiers. Linda-Jean Cockcroft – Technical Director, Business, Industry and Growth Linda-Jean has 20 years’ consulting experience, with most of the last six years focused on sustainability, REACH and chemicals regulation. She has a unique combination of both inside-industry and consulting experience and has worked in a number of EU countries. Dave Fleet – Principal Consultant, EU Policy Dave is an economist with wide project management experience and socio-economic analysis expertise. He has extensive experience of managing RPA’s impact assessments and evaluations for the European Commission. Anthony Footitt – Principal Consultant, Chemicals Anthony has 20 years of experience and undertook a great deal of the risk and economics work underpinning the EU REACH chemicals strategy on behalf of the European Commission where this included work on all of the business impact assessments (BIAs) and many subsequent analyses/impact assessments. He was also responsible for much of the modelling work that RPA carried out for the EC on the impacts of introducing the GHS. Marco Camboni – Director (RPA Europe) Marco specialises in the evaluation of the European chemicals legislation and its synergies with the occupational health and safety, product safety and environmental legislation. He has been involved in numerous studies looking at how to better regulate nanomaterials and has recently become the Director of RPA’s sister company ‘RPA Europe. Tom Persich – Senior Consultant, Chemicals Much of RPA’s work on REACH authorisation benefits from Tom’s detailed research and analysis into uses of the SVHCs for which authorisation is being sought. Tom has also prepared core AoA and SEA arguments at sector level for a key set of downstream users. Tom also continues to undertake extensive supply chain mapping activities to assess the potential vulnerability of downstream user groups to the loss of key substances.

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Profile: Risk & Policy Analysts Ltd (RPA)

183

Profile: Royal HaskoningDHV

184

GLOBAL OFFICES HaskoningDHV Nederland BV: Jonkerbosplein 52, 6534AB Nijmegen, The Netherlands Haskoning UK Ltd: Rightwell House, Bretton, Peterborough, PE3 8DW, UK SERVICES PROVIDED

CONTACTS Website

www.royalhaskoningdhv.com

E-mail

IB-NL.Secretariat.Health.Safety.and.Environment@ rhdhv.com

Head office

HaskoningDHV Nederland BV, Laan 1914 no. 35, 3818 EX Amersfoort

Tel

+31 88 348 69 27

Fax

+31 24 323 93 46

Contact

Mr Randy Cleijsen, Mr Tjeerd Bokhout

Directors

Mr Christiaan van Daalen, Associate Director Health, Safety & Environment

Ownership

Private company

Locations

100 Locations worldwide. Key locations: Nijmegen, Amersfoort (NL), Peterborough (UK)

Founded

1881

Regulatory affairs Royal HaskoningDHV provides a full range of regulatory services, varying from consortium management, preparation of technical dossiers including exposure assessment to regulatory consultancy (Food Contact Materials, REACH, CLP, GHS, KKDIK). We have ample experience with dossier quality improvement and updates following or preventing compliance checks by authorities and Echa. We provide services worldwide, but our geographical emphasis is on the EU. Royal HaskoningDHV has gained great experience in the exploration of alternatives for testing, like QSAR and read-across. We support in laboratory selection and study monitoring and have good working relations with multiple laboratories. Royal HaskoningDHV addresses classification and labelling of your substances and provides services related to GHS/CLP implementation and training, harmonisation of C&L and (re-)classification of substances.

OVERVIEW Royal HaskoningDHV is an independent, international engineering and project management consultancy with 135 years of experience. Backed by the expertise and experience of almost 6,000 colleagues all over the world, our professionals combine global expertise with local knowledge to deliver a multidisciplinary range of consultancy services for the entire living environment in 150 countries. We provide a wide range of solutions for multidisciplinary challenges to industry, such as process safety and engineering/design of installations and buildings, occupational and offshore safety, responsible care, and environmental and industrial safety (including impact assessments). By showing leadership in sustainable development, innovation and digitalisation, together with our clients, we are working on solutions to a more sustainable society now and into the future. Royal HaskoningDHV has been working with the industry on chemicals management for several decades and contributed to the implementation of numerous legislative programmes, always with a focus on human and environmental safety. VITAL STATISTICS

2018

(Extended) Safety data sheets Royal HaskoningDHV provides a full safety data sheet service including the preparation of the annex of the extended SDS (eSDS). With our dedicated SDS system we provide a total solution for SDS management. Based on information from e.g. REACH dossiers we can also prepare an annex with exposure information for your substance or mixture. This is accompanied with sound advice on risk management for your workers and the environment, also further down the supply chain. Chemicals management including on-site implementation Royal HaskoningDHV provides a unique combination of knowledge on (eco)toxicology, chemical control legislation, safety and engineering to deliver focused organisational and technical solutions. We see effective communication of (REACH) information on hazards of substances and their safe use up and down the supply chain as the key issue for the next (regulatory) years. This information triggers companies to reassess their local permits, working practices and habits. We understand how to improve the risk management of SVHCs and provide support to demonstrate that the control is at the appropriate level by means of responsible industrial hygiene procedures. Worker and environmental safety (monitoring) studies are part of our daily practice. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1881

Founding fathers Johan van Hasselt and Jacobus de Koning start their business in Nijmegen.

1917

Founding fathers Dwars, Hederik en Verheij start their business in The Hague.

1981

Haskoning is granted the designation ‘koninklijk’ (Royal) at its 100th birthday.

1991

EaSI is developed by Royal Haskoning: a database with hazard information from legislation all over the world

1994

Royal Haskoning developed Rosetta, one of the first programs able to produce multilingual safety data sheets.

2005

RIP 3.10 on characterisation and checking of substance identity is prepared by Royal Haskoning.

2007

Royal Haskoning joins the organisation of ChemCon Conferences.

2012

Merge between Royal Haskoning and DHV.

2013

Royal HaskoningDHV completes a three-year EU-project impact assessment and training for the implementation of REACH in Turkey.

2014

Royal HaskoningDHV submits first full supply chain REACH application for authorisation of two pigments

2018

Royal HaskoningDHV has successfully submitted over 400 (co-)registration and authorisation dossiers.

€608 m

Turnover, group Turnover, chemical service provision

No of offices

No of countries represented

36 5771

Staff, group Staff, chemical service provision

50 – 100

SERVICE AREA BREAKDOWN Legal 5%

Training 5%

IT & software 10% Laboratory 5% Information 15% Representation & management 10%

Global Service Providers Guide 2019

Consultancy/advisory 50%

ACCREDITATIONS

STAFF SELECTION

ISO 9001 / ISO 14001 / OHSAS 18001 / ETHIC Intelligence Anti Corruption

Berend Mensink PhD, ERT – Senior Expert Ecotoxicology Berend Mensink studied environmental sciences and is a registered toxicologist (EuroTox). He is specialised in ecotoxicology and environmental fate and behaviour of chemicals. He holds over 20 years of experience in the chemical industry, including overall management of a laboratory studying properties, fate and effects of chemicals in the aquatic environment. He was responsible for a wide range of product and substance registrations for applications and markets within Europe in the chemical industry, including assessing hazards and risks.

PARTNERS ChemCon Conferences, EPPA SA, The Wercs CLIENTS The clients of Royal HaskoningDHV are located in many different industries. Because we provide more services than chemicals management alone, it has service relations with clients covering a wide variety of solutions. Clients can be in pharma, flavours and fragrances, plastics, petrochemicals, paints and coatings, minerals and metals. CASE STUDY 1: Application for authorisation of two pigments For a producer of inorganic pigments Royal HaskoningDHV prepared an application for authorisation in collaboration with EPPA SA. The application covered the entire supply chain complicating the risk assessment and socio-economic analysis. To determine actual exposure conditions site visits were performed at downstream user sites throughout Europe. The information gathered was used to extensively describe the uses applied for and to refine the risk assessment and demonstrate safe use using Higher Tier modelling (ART). The application for authorisation was supported by an analysis of alternatives showing no suitable substitution candidates. Other project activities included updating the existing lead registration dossier, official meetings with Echa (PSIS and Trialogue) and meetings with Member States and EC to explain the case. These efforts combined resulted in granting of an authorisation by the European Commission in 2016. After this successful project Royal HaskoningDHV has used its experience to work on several other authorisation dossiers for various substances in the past years. CASE STUDY 2: Implementation of REACH in Turkey (KKDIK) For the Turkish government, we worked on a project to strengthen the capacity of the governmental institutions and to establish an institutional structure and legal framework for the implementation of the Turkish REACH-based KKDIK law. In the project we performed an impact analysis for the implementation and determined the required institutional arrangements to be taken. We also provided training to employees of the Ministry, State & Health Institutes and Chemical Industry associations to teach them about management of dangerous chemicals based on REACH and other EU legislation. We improved the registration and inventory systems of chemicals in Turkey and raised awareness amongst manufacturers, importers, downstream users of chemicals and decision makers for the new legislation. The project strengthened the existing capacity of the governmental institutions, thereby making the implementation of KKDIK smoother. CASE STUDY 3: Supply chain communication For a client who formulates over 1,000 different products from over350 substances we created a tool that allows the formulator to make informed decisions on the lead substances used for the risk assessment and communication down the supply chain. After a pilot we were able to prepare sets of only eight different risk management measures for over 30 mixtures produced from more than 80 hazardous substances.

Chris Rietveld PhD, ERT – Senior Expert Toxicology Chris Rietveld studied Chemistry and is a registered toxicologist (EuroTox). He has more than 30 years experience in toxicology, product safety and regulatory affairs (PS&RA). Besides registration of many substances, products and applications in the European market he has experience in the implementation and compliance auditing of REACH, PS & RA regulations and hazard communication systems (SDS, Classification, Labelling and Hazard Register) on chemical sites and large complex pharmaceutical production sites (including R&D). He represented companies in industry associations (VNCI, CEFIC, CEPE) and PS&RA working groups and he was manager of multidisciplinary teams in PS&RA and an analytical laboratory. Tjeerd Bokhout MSc, MBA – Consortium Manager Tjeerd Bokhout is an experienced consultant and project manager on environmental and chemicals management projects in Europe and abroad (mainly Asia). Tjeerd holds both an MSc and MBA and focuses on the business cases of his clients. He has a vast network in the global community on chemicals legislations and has experience in the support of chemical industry and governmental bodies with requirements of REACH. Tjeerd manages several REACH consortia and provides strategic advice on REACH implementation. Tjeerd is also director of ChemCon Conferences, the world’s leading conference on chemical control legislation and trade aspects. Leo van der Biessen MSc – Senior Expert Industrial Hygiene & eSDS Leo van der Biessen has more than 25 years’ practical experience in controlling and managing chemical exposure risk in the chemical process industry and its downstream users. In 1990 he joined a leading health and safety service provider in the Netherlands where he devised chemical risk assessment and control strategies as well as worker protection regimes. He joined Royal HaskoningDHV in September 2002. Since 2008 he has focused on creating realistic risk assessments under REACH, assisting companies with authorisation and the communication of REACH results in the supply chain. Leo was a board member for chemical safety of the Dutch Industrial Hygiene Association and is a lead consultant for classification and labelling issues and Safety Data Sheet services. Randy Cleijsen MSc – Project Manager and Regulatory Consultant Randy Cleijsen holds an MSc in Biomedical Sciences. He is a trained regulatory toxicologist and gained broad experience over the past 10 years, working for the chemical industry across Europe. His core skills are substance registration and authorization, dossier preparation (Iuclid), chemical safety assessment (Chesar) and project management. His current focus lies on safe working principles and their application onsite. He has also been highly involved in the implementation process of chemicals legislation, providing strategic advice and training to clients and their staff.

We estimated that for the entire product portfolio a maximum of 30 sets of safe operational conditions and risk management measures were needed to inform the downstream user on safe use. Our method also allows downstream formulators to determine the contribution of these mixtures to the secondary mixtures produced without having to reveal the exact composition. This will help protect the client’s confidential business information.

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Profile: Royal HaskoningDHV

185

Profile: RTC, Research Toxicology Centre S.p.A.

186

SERVICE AREA BREAKDOWN Consultancy/advisory 10%

CONTACTS Website

www.rtc.it

E-mail

mkt@rtc.it

Head office

RTC â&#x20AC;&#x201C; Research Toxicology Centre S.p.A. Via Tito Speri 12/14, 00071 Pomezia (Rome) Italy

Tel

+39 06 91095263

Fax

+39 06 9122233

Contact

Danilo Bucci, Head Business Development

Directors

Germano Oberto, Scientific and Productive Process Director Stefano Villa, General Services Director

Ownership

I.F.R. Menarini

Locations

Italy

Founded

1972

Laboratory 90%

GLOBAL OFFICES Our facilities are located in Pomezia (Rome), Italy. In addition, we have sales representatives in Germany, France, Spain and Denmark. SERVICES PROVIDED

OVERVIEW RTC is a fully fledged contract research laboratory located in Pomezia near Rome (Italy) with a track record spanning more than four decades. RTC collaborates with a large range of industrial clients including the pharmaceutical, biotech, chemical, agrochemical and biocide industries. Our research staff is composed of a highly qualified team specialised in different areas of toxicological research. In our international and multilingual environment we work in compliance with all relevant international guidelines. We are proud to say RTC was awarded the full AAALAC accreditation in 2012 and has since worked to the highest standards for animal welfare. Our research centre works according to the principles of Good Laboratory Practice and holds the GLP Certificate achieved from the Italian Health Authorities. Furthermore, RTC has repeatedly been inspected by FDA and by the Japanese Ministry of Health and Welfare, our GLP compliance being confirmed on all occasions. RTC can support its clients from a very early stage of the project, offering a full range of experimental and consultancy services in order to ensure a tailored approach. Scientific and technological expertise, combined with skills in project management and communication, qualify RTC as the partner of choice for any product development. Serving our clients is our utmost priority. That is why RTC is deeply committed to serving your needs and attending to every detail of your project. We will guide you during the selection of the experimental design and provide tailored solutions. RTC will ensure close monitoring of each study phase to respect quality and timing. Our staff will constantly keep you informed of progress, every step of the way, since communication and collaboration are essential to achieve success. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group Staff, chemical service provision

Global Service Providers Guide 2019

155 -

Genetic toxicology Genetic toxicology studies fall within our core competences as this study type has been established in RTC since 1972. In chemico and in vitro toxicology Many in vitro studies are already available and further alternative methods are being implemented in order to be in line with the most recent regulatory requirements. General toxicology on rodents, from acute to oncogenicity studies Hundreds of these studies have been performed over the years and this number will increase considering all feedback from Echa relating to the previous REACH deadlines. Reproductive toxicology and juvenile toxicology Reproductive and developmental toxicity studies in rats and rabbits are performed at RTC on a routine basis. The EOGRTS (all cohorts) has been established as well. Analytical support All tox studies are supported by our internal analytical chemistry department. Experienced scientists are available to set up and validate new analytical methods (for both formulation analysis and TK sample analysis) from scratch or to transfer existing methods. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1972

Foundation as CRF

1979

Acquisition by the Menarini Group

1987

GLP certification

2007

Ready for REACH

2014

Full AAALAC accreditation

ACCREDITATIONS AAALAC GLP FDA approved ISO 14001:2004 BS OHSAS 18001:2007 EcoVadis PARTNERS We collaborate with partner laboratories for ecotoxicology, physicochemical properties, inhalation studies and regulatory support. CLIENTS We serve a wide range of clients, from SMEs to global corporations, consortia and industry associations worldwide. Confidentiality agreements preclude the possibility of naming them.

TESTIMONIALS Testimonials can be provided upon request. CASE STUDY Both our clients and their testing programmes are protected by confidentiality agreements. Over the years many different types of compounds have been tested and many customers have qualified RTC as preferred supplier, contributing to the positive outcome of the client’s testing programmes. RTC is committed to comply with currently applicable scientific, legal, regulatory and ethical requirements, guidelines and policies to ensure animal welfare. All studies are carried out by welltrained, duly qualified and experienced personnel. RTC is committed to the 3R principles and shall actively pursue their promotion. In November 1998 an Ethical Committee for Experimentation on Animals was created in order to evaluate the experimental protocols which involve the use of animals and to ensure that experimentation on animals carried out in RTC will be performed according to current laws and regulations. A specific SOP regulates the activities of this committee. As RTC claims to be a right-size CRO, flexibility and proactive attitude are among our core characteristics. Having one location is a positive factor as all laboratories and facilities are close to each other. Our long experience with demanding clients has taught us that on-time delivery is a must. In order to meet our clients’ requirements, a specific project management system has been set up. Within REACH projects a study director is assigned to each single study and a project leader is appointed as central reference point for the specific testing program. At certain intervals of time, agreed upon with the client, an overview of the project is prepared and may include also subcontracted studies.

Cristina Longobardi – Expert in Industrial Toxicology, Senior Study Director OO scientific expert in industrial toxicology; OO biology degree; OO joined RTC in 1990; OO acts as Senior Study Director and/or Project Leader for designated clients in different areas of general toxicology; and OO defines the design of studies intended to support non-clinical development and act as a referee for internal scientific staff and for the client in the area of expertise Francesca Calfapietra – Head, Analytical Chemistry Department OO chemistry degree; OO joined RTC in 2000; OO acts as Senior Study Director and/or Project Leader for designated clients in different areas of analytical chemistry; and OO supervises new analytical method development and validations ensuring the up-dating of scientific, technological and regulatory matters providing support to meet client expectations in the area of expertise.

STAFF SELECTION Silvana Venturella – Associate Scientific Director, Head Business Unit In Vivo Toxicology OO responsible for the Study Director Group and Operational Departments of in vivo studies; OO biology degree; OO joined RTC in 1991; and OO oversees the design and the conduct of the studies for non-clinical development ensuring the up-dating and scientific validity and compliance to national and international guidelines Serena Cinelli – Associate Scientific Director, Head Business Unit Genetic and In Vitro Toxicology OO joined RTC in 1984 ; OO responsible for improvement of methods and techniques to meet current standards in genetic and in vitro toxicology, providing the best up-to-date solutions for safety evaluation of products; OO responsible for the experimental conduction of non-clinical safety studies in compliance with GLP regulations; OO invited professor (specialising master) in environmental mutagenesis; OO author of several peer reviewed publications; and OO member of the American, European, British and Italian Environmental Mutagen Societies (EMGS, EEMS, UKMS, SIMA) and the European Society of Toxicology In Vitro (ESTIV). Rosaria Cicalese – Expert in Reprotoxicity Studies, Senior Study Director OO scientific expert in reproductive, juvenile and neonatal toxicology ; OO biology degree; OO joined RTC in 1990; OO RTC senior foetal morphologist; OO acts as Senior Study Director and/or Project Leader for designated clients in different areas of reproductive toxicology; and OO defines the design of studies intended to support non-clinical development and act as a referee for internal scientific staff and for the client in the area of expertise

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Profile: RTC, Research Toxicology Centre S.p.A.

187

Profile: SCC

188

GLOBAL OFFICES Headquarters Bad Kreuznach (Germany), Office Berlin and SCC Japan SERVICES PROVIDED CONTACTS Website

www.scc-gmbh.de

E-mail

scc@scc-gmbh.de

Head office

Am Grenzgraben 11, 55545 Bad Kreuznach, Germany

Tel

+49 671 298 46-0

Fax

+49 671 298 46-100

Contact

Dr Thomas Roth (Chemicals / REACH, Consumer Products, Cosmetics, Feed & Food Additives)

Directors

Dr Friedbert Pistel, Owner and President Dr Albrecht Heidemann (Agrochemicals and Biorationals) Dr Monika Hofer (Regulatory Science, Pharma Pre-Clinical) Dr Thomas Roth (Chemicals / REACH, Consumer Products, Cosmetics, Feed & Food Additives) Dr Martina Galler (Biocides)

Ownership

Private company

Locations

Germany and Japan

Founded

1989

OVERVIEW SCC – Scientific Consulting Company – was founded in 1989 by Dr Friedbert Pistel. Since then, we have risen to become one of Europe’s largest privately-owned and independent scientific consulting companies, supporting global customers in registration of chemicals, cosmetics, consumer products, agrochemicals and biorationals, biocides, feed and food additives, food contact materials and pharmaceuticals (pre-clinical). VITAL STATISTICS Turnover, group

2017/18 -

Turnover, chemical service provision

No of offices

No of countries represented

2 130

Staff, group Staff, chemical service provision

SERVICE AREA BREAKDOWN Training Other IT & software Legal 3% 1% 2% 2% Information 4% Representation & management 20%

Global Service Providers Guide 2019

Consultancy/advisory 68%

Registration of chemicals – REACH and non-EU regulations SCC provides strategic expert counselling, registration services and lifecycle support for chemicals at international level. Building on longstanding experience with EU REACH precursor programmes, SCC successfully filed more than 600 lead dossiers for phase-in and non-phase-in substances, more than 50 PPORD notifications and well more than 100 inquiry dossiers. Beyond the EU and Switzerland, SCC notified new and existing substances in many international markets, e.g. China, Japan, Korea, Australia, and Canada. SCC also operates a well-established network with competent authorities in the EU and abroad and is recognised as a competent and reliable partner both by authorities (e.g. ECHA) and industry organizations (e.g. Cefic). For all types of substances and across all industry sectors, SCC can provide you with: OO development of registration & testing strategies for chemicals and polymers, as well as organising and monitoring of the studies OO prioritisation and advice on required action for EU REACH and other international frameworks OO inquiry and registration, dossier submission to competent authorities OO data review and identification of data gaps OO literature (re)search and evaluation OO consideration of grouping/category approaches (read-across) OO estimation of substance properties and data generation via QSAR prediction tools, e.g. QSAR Toolbox, EPI Suite, ECOSAR OO support with use descriptors, e.g. PROCs, (sp) ERCs OO human health and environmental risk assessments, incl. exposure modelling (e.g. EUSES, Risk of Derm, ConsExpo, EasyTRA, ART, Stoffenmanager) OO preparation of the chemical safety report OO preparation of the annex to extended Safety Data Sheets (eSDS) OO C&L support (CLH dossier acc. to Annex XV, RAC evaluation) OO defence support for chemicals under authority evaluation or scrutiny (EU: CoRAP, SVHC, compliance checks, restriction, authorization procedure); scientific/regulatory support at EU expert meetings OO Only Representative support OO trustee service for supply chains (non-EU, EU) OO SIEF and consortia support/management, and OO EU Product Notifications acc. to Annex VIII to the CLP regulation (emergency help response). Registration of agrochemicals and biorationals Since 1989, our experts have successfully defended more than 90 chemical and biological active substances both within and outside Europe and compiled hundreds of PPP dossiers for national markets in the EU as well as Asia-Pacific and NAFTA. We are the perfect partner for all types of registration support for your agrochemicals and biorationals, including biostimulants, fertilisers, plant strengtheners, and soil conditioners under plant protection and fertiliser regulatory frameworks. Together with our international network of partners, we monitor recent scientific trends and regulatory developments in major agricultural markets to ensure that our experts are at the forefront in strategic planning and defence, presenting compelling arguments in negotiations with authorities and providing cutting-edge expertise in task force support. Registration of biocides Our biocides experts have successfully submitted and defended dossiers for more than 20 biocidal active substances in nearly all product types (more than 70 active substance dossiers) as well as numerous dossiers for biocidal products and product families in line with BPD 98/8/EC or BPR (Regulation (EU) No 528/2012). We provide our customers with full support on regulatory, scientific and technical questions for both national and union authorisation, including all kinds of risk assessments in all product types and for all uses of biocides. We are experienced in management of active substance and product consortia.

Authorisation of feed, food additives and food contact materials SCC successfully managed more than 50 (re-)authorisations for feed additives. In-depth knowledge and regular follow up of the relevant EU regulations is the key basis for our regulatory and scientific support. Our expertise and connections with authorities and industries enable us to put together the optimal balance of scientific data and expert statements for your products. SCC professionally guides you through the hurdles of the Food Contact Material (FCM) authorisation processes in the EU covering all aspects of the framework Regulation (EC) No 1935/2004, specific European product regulations (e.g. for plastics, for active and intelligent materials) and a variety of directives for further products categories (e.g. printing inks). Notification of cosmetics and consumer products SCC has successfully supported the cosmetics and consumer product industry for more than two decades. In-depth knowledge of the relevant EU regulations (e.g. for cosmetics or detergents) and applicable national regulations is the basis to meet all challenges, e.g. the animal testing ban for cosmetics. SCC has proven experience for exposure and risk assessments of different scenarios. Data gap analysis, dossier preparation, placement and monitoring of studies compliment the fields of expertise. SCC has successfully prepared more than 60 safety dossiers for challenging cosmetic ingredients like hair dyes, UV filters, preservatives, nanomaterials, botanicals and CMR categorised substances. Regulatory science With a skilled team of experts in a broad range of disciplines, our regulatory science business unit forms the backbone of our company, providing special expertise in i.a.: - Data gap analyses, study monitoring and dossier preparation - Exposure modelling and risk assessments for human health and environment - Conceptual work on higher-tier approaches (e.g. in silico (eco)toxicology, population modelling) - Assessment of potential endocrine disruption incl. MoA analysis, AOP concepts and WoE approaches - MRL/Import Tolerances and Codex MRLs Regulatory / scientific and GLP archiving With three decades of experience in the storage of regulatory and scientific data, we offer you sustainable overall concepts for all your regulatory needs. Our proprietary Electronic Document and Dossier Management System (EDDMS) ensures quick, cost and time saving access to all regulatory information, including electronic documents and submission details, at all times and from any location. SCC is also your partner for secure archiving of GLP raw data. In 2004, we were successfully certified as first GLP contract archive in Germany. Since then, we have been continuously recertified by the German GLP monitoring authority. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1989

SCC GmbH founded

1989

Establishment of Agrochemicals and Biorationals business unit

1989

Establishment of Regulatory Science business unit

1996

Establishment of Chemical and Consumer Products business unit

2000

Establishment of Biocides business unit

2004

GLP archive certification

2007

Establishment of Liaison Office Japan

2007

Establishment of Feed and Food Additives group

2014

Establishment of Office Berlin

2018

Establishment of SCC Japan

2019

30 years of regulatory expertise

Profile: SCC

189 ACCREDITATIONS GLP archive (since 2004) PARTNERS We have a global network with CROs, governmental institutions, local regulatory experts and scientists. We can support our clients all over the world. CLIENTS Small to large (global) companies in the areas of chemicals, agrochemicals and biopesticides, biocides, cosmetics and consumer products, feed and food additives and food contact materials. TESTIMONIALS Many of our clients have been customers for a long time, some going back to the start of our company. New clients are often recommended to us via existing clients. CASE STUDY: GROUPING FOR COMPLEX SUBSTANCES UNDER REACH For a demanding class of 30+ highly unstable and reactive substances, many in higher tonnage bands, we managed to set up a category grouping approach enabling us to minimize overall cost and avoid unnecessary animal testing. The key difficulty was to develop complete testing packages based on meaningful bridging studies where many compliance check decisions were already in place. We successfully established the comprehensive picture for the entire group through intelligent testing strategies. Many higher tier tests could even be waived. STAFF SELECTION Dr Thomas Roth â&#x20AC;&#x201C; Head of Chemicals/REACH, Consumer Products, Cosmetics, Feed & Food Additives Dr Roth has a PhD in food chemistry and is a certified expert for toxicology. He has been with SCC for 10 years and is head of Chemicals / REACH, Consumer Products, Cosmetics, Feed & Food Additives since 2017. He previously worked for a large chemical multinational, and has gained considerable professional experience in the evaluation and registration of consumer products and chemicals worldwide. Isabel Kirbach Mrs Kirbach has a masterâ&#x20AC;&#x2122;s degree in chemical engineering. She has been with SCC for 15 years and her focus is on Sief, Iuclid and consortia management since 2006. Dr Ingo Walter Dr Walter has a PhD in food chemistry and is a certified expert for toxicology. He has been with SCC since 2008, focusing on risk assessments, C&L and eMSDSs. Dr Mathias Rietzel-Roehrdanz Dr Rietzel-Roehrdanz has a PhD in Chemistry and joined SCC in 2017. He focuses on international registration of chemicals. Dr Hans-Josef Leusch Dr Leusch is Director of Strategic Business Development. He has a PhD in agronomy. He joined SCC in 2000. Since then, he has held leading positions, being head of Biocides for 17 years and since January 2018 in charge of strategic business development.

www.chemicalwatch.com/SPG

Profile: Smithers Viscient

190

GLOBAL OFFICES Smithers Viscient – Harrogate, United Kingdom Smithers Viscient – Wareham, Massachusetts, North America Smithers Viscient – Snow Camp, North Carolina, North America Smithers Viscient – Tokyo, Japan

CONTACTS Website

www.smithersviscient.com

E-mail

info@smithersviscient.com

Head office

Wareham, Massachusetts, Unites States

Tel

+44 (0) 1423 532 710 (UK) +1 508 295 2550 (US)

Contact

Fiona Brook-Rogers – Marketing Manager – Europe Hope Aubin – Director of Marketing – North America

Directors

SERVICES PROVIDED Environmental fate Environmental fate and metabolism studies include study designs to assess biotic and abiotic degradation, mobility in the environment, bioaccumulation in organisms, along with plant and animal metabolism Plant and animal metabolism Metabolism studies are conducted to determine the nature of residues and the test substance’s metabolic pathways in plants and animals. In addition, confined rotational crop studies can be conducted under field conditions to assess the potential for accumulation and metabolism of soil residue. Smithers Viscient have the capability to perform plant metabolism and confined rotational crop studies with radiolabeled test substances at dedicated sites in both the US and UK.

Ian Siragher – Managing Director – Europe Susan Shepherd – President – North America Ron Biever – Vice President of Operations – North America

Ownership

Private

Locations

US, EU, Japan

Founded

1969

OVERVIEW Environmental testing and regulatory services Smithers Viscient performs environmental and consumer safety contract research and regulatory services for the crop protection, pharmaceutical, industrial chemical and consumer product industries. Smithers Viscient have performed standard guideline and higher-tiered environmental studies for 50 years. We conduct studies that satisfy all global regulatory requirements. Smithers Viscient is a leader that delivers trusted testing services. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

Avian toxicology Avian ecotoxicology programmes include toxicity testing, non-target organism pesticide exposure characterisation and avian endocrine disruption. We offer poultry and catfish feeding studies to assess the nutritional equivalency and safety of feed developed from genetically modified plant material. We offer pesticide exposure characterisation and risk assessment as well as a variety of field studies. Field studies may be conducted on remote agricultural field sites or on study plots. Honeybee and pollinator testing Smithers Viscient conducts all Tier 1 laboratory pollinator studies at our Wareham and Harrogate facilities in addition to field pollinator studies throughout the United States with permanent locations on the East and West coast. Our North Carolina facility is the base of operations for pollinator health effects and residue/exposure studies. Our Fresno California facility allows for staff to be readily available for field studies that must be conducted in California under EPA/CDPR recommendation. Pollination and field trial services guidelines: honeybee acute; OO acute oral (OECD 213); OO acute contact (OECD 214, 850.3020); OO honeybee 10-day chronic adult (OECD draft); OO honeybee larval; OO 7-day (OECD 237); OO 22 day OECD draft; OO bumble bee acute; OO acute oral (OECD 213, modified); OO acute contact (OECD 214); OO solitary bee; OO acute oral; OO acute contact OO honey bee toxicity of residues on foliage (850.3030); OO analytical support; and OO bumblebee chronic (queenless micro). OO

SERVICE AREA BREAKDOWN

Laboratory 100%

Global Service Providers Guide 2019

Ecotoxicology Our scientists are knowledgeable in testing challenging (eg complex mixtures (UVCB), hydrolytically unstable, volatile, low solubility, adsorptive) materials and analytically confirming exposure levels in low parts per trillion (ppt) range in a variety of sediment, soil, diets and aquatic matrices. Smithers Viscient have experience in working with 150 species and has a well-deserved reputation for its work with honey bees, earthworms, arthropods, invertebrates and a variety of fish species. Some stocks of test organisms have been continuously maintained for thirty years.

About residue chemistry services: Smithers Viscient provide GLP-compliant residue chemistry studies for registration and environmental monitoring needs. Our analytical chemists have expertise in method development and method validation, and can design and implement fully customisable multi-residue testing programmes for both active ingredients and metabolites. havefor a wide variety of matrices, including plant materials, soil, water, air, and processed food, animal feed and animal tissues. These methods are fully validated according to the latest EPA and SANCO guidelines. Our experienced chemists quantitatively measure the active ingredient (AI) and its metabolites – or the degradation products produced from the AI. About analytical chemistry services: Smithers Viscient offers a wide range of analytical services using sophisticated analytical instrumentation. We have the expertise, personnel and equipment to provide clients with assistance in analytical method development in support of environmental toxicology studies, biotechnology, manufacturing support, compliant sample analysis, polymer analysis, and surfactant analysis. Smithers Viscient’s analytical chemistry team has experience with particular strengths in method development, chromatography and compound identification. This range of expertise when combined with the latest analytical instrumentation and techniques allows Smithers Viscient to develop, and validate methods for a very broad range of test articles.

Toxicology Smithers Viscient offers toxicology testing services for the agricultural and chemical industries. Smithers Viscient provides a portfolio of services with scientific expertise and project management capabilities that ensure the quality of the data with the convenience of working with one company. Services include: OO general toxicology; OO developmental and reproductive toxicology (DART) – includes Extended One Generation Reproductive Toxicity Study (EOGRTS); OO neurotoxicology studies; toxicokinetics; OO dietary exposure; • subchronic and chronic toxicity studies; OO carcinogenicity studies; and OO Endocrine Disruptor Screening Program (EDSP) assays. ACCREDITATIONS GLP and AAALAC accredited

About product chemistry services: Smithers Viscient performs product composition investigation, identification and quantification of the contents in a technical grade product subject to registration. Our capabilities include screening of ingredients to 0.1% and lower. Smithers Viscient have considerable experience in trace level analysis for the detection and identification of toxicologically significant impurities for preliminary five-batch analysis, as well as experience in structure elucidation, in addition to having extensive experience with a very broad range of test article chemistries. Endocrine disruptor testing Smithers Viscient is active in the area of endocrine disruption in both the US and Europe. Smithers Viscient provides services that meet global regulatory endocrine testing requirements and is a recognised leading team in this field and conducts short-term reproduction assays (OECD 229, OECD 230), fish sexual development tests (OECD 234), the new medaka extended one generation reproduction test (OECD 240) and lifecycle tests. Smithers Viscient has successfully conducted a significant number of FSTRA tests and AMA tests for Tier I studies and our leading ecotoxicology experts are participating in development of the testing guidelines for both US EPA Tier 1 and Tier 2 phases. Our staff can assist clients with other EDSP questions regarding fish, amphibian and avian testing guidelines proposed for Tier 2 testing. REACH testing Smithers Viscient serves a global client base and have all the required official accreditations necessary to provide regulatory studies to support product registrations in full compliance with Good Laboratory Practice Regulations. Our scientists are experts in the design and implementation of experimental protocols offering a wide variety of analytical services in physical and chemical properties, ecotoxicology and environmental fate using state of the art analytical instrumentation. We provide superior quality and value through expert advice, accurate and timely delivery and clear, concise communication. Since only substances are registered under REACH, correct and unambiguous substance identification is essential. REACH environmental data requirements (Annex VII – VIII) include data on physico-chemical properties, ecotoxicological information, toxicology and environmental fate properties.

www.chemicalwatch.com/SPG

Profile: Smithers Viscient

191

Profile: Sphera Solutions

192

GLOBAL OFFICES 24 Greville Street, London, EC1N 8SS, UK 4777 Levy Street, St. Laurent, Quebec, Canada H4R 2P9 Oranjesingel 34, 6511 NV Nijmegen, The Netherlands CONTACTS

SERVICES PROVIDED

Website

www.sphera.com

E-mail

operationalexcellence@spherasolutions.com

Head office

130 East Randolph St, Suite 1900, Chicago IL, 60601, USA

Tel

1-514-337-2114 / 31 (0) 24 329 7424

Contact

Frank Arcadi

Directors

Paul Marushka, President and CEO

Bob Hogue, Chief Financial Officer

Ownership

Privately Held

Locations

United States, Canada, Paris France, London UK, Nijmegen The Netherlands, Bangalore India

Founded

2016 (previous division of IHS)

Sphera provides a complete solution to strengthen and enable companies to stay aligned with current and future legal requirements when managing chemicals. Sphera’s solution is designed to integrate with key ERP and PLM systems enabling consistent support for business compliance processes. Powered by Intelligent Authoring™ and Comply Plus® this comprehensive solution combines software, content and industry expertise, enabling organisations to efficiently monitor and manage product compliance with rigorous regulatory mandates at every stage of the product lifecycle, from product design through manufacturing, shipping and delivery. Sphera supports your company’s compliance programme with these powerful information management capabilities:

OVERVIEW Sphera Solutions, formerly IHS Operational Excellence & Risk Management, is the largest, global provider of software and information services in the operational risk, environmental performance and product stewardship markets. For more than 30 years, we have served over 2,500 customers and a million-plus users in 70 countries to optimise workflows and navigate the complex and dynamic global regulatory structure. Our goal at Sphera is to help customers keep their people safe, their products sustainable and their operations productive. We do this by advancing operational excellence with innovation through software, information from our data and expert-driven insight. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

Global

No of countries represented

600+

Staff, group

150

Staff, chemical service provision SERVICE AREA BREAKDOWN Training 5%

Consultancy/advisory 20%

IT & software 40% Information 35%

Global Service Providers Guide 2019

SDS authoring: Automates the production of compliant safety data sheets in nearly 50 languages, ensuring your customers and employees will have the information they need to ensure safe use of your products and continued access to global markets. This includes a powerful rulebased document generation engine with the ability to produce extended SDS and exposure scenarios with translated ESCOM Phrases. The solution also has functionality to allow easy tailoring of rules so that authors can effortlessly modify and enforce decisions about regulatory variables and grey areas affecting the content of safety data sheets. Furthermore the solution allows for GHS by Design, a unique functionality that allows SDS authors to configure user-defined GHS implementations for any area, country or region with no official GHS regulatory support. Documentation and labels: Simplifies the process of designing, producing and printing labels for GHS, transport and consumer goods regulations. Product compliance analysis: Enables product compliance specialists to proactively plan for and manage impacts of evolving requirements and gain insight into calculated classifications, quickly identify substances of concern in products, and make better decisions. Chemical management: Allows for effective management of inbound and produced chemicals by using a consolidated platform for SDS management, chemical approvals, chemical inventory tracking, including SVT, and environmental reporting. Managed regulatory content: Ensures efficiency in maintaining compliance in the ever-evolving regulatory environment by providing consolidated and validated regulatory data. Sphera continuously monitors global regulations, interprets changes, and delivers application ready updates to data, rules, templates and logic. Integration with key business systems: Facilitates end-to-end business data flow by effectively connecting to other key systems, such as ERP, PLM, LIMS and formulation management applications. Based on many years of experience, we have developed tools that decrease the time-tovalue for implementations and ease sustainability. Sphera also offers a product compliance solution for SAP® EHS: Sphera provides a modular pre-packaged SAP® EH&S solution that delivers regulatory data, rule sets, phrases, templates and configuration tools to accelerate the benefits of your investment. The solution has a state-of-the-art content editor that regulatory experts can use to change the behavior of their core SAP® EH&S system rules and support company specific requirements. It enables the creation and/or modification of rules, viewing of phrases and mapping of rule outputs to a product property tree.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1989

Atrion International is founded

1991

Dolphin Software is founded

2008

IHS acquires Dolphin Software IHS acquires Environmental Software Providers

2009

IHS acquired Environmental Support Solutions

2010

IHS acquires Atrion International IHS acquires Syntex Systems

2011

IHS acquires Dyadem IHS creates Operational Excellence & Risk Management (EHS) Division

2015

Verdantix – Smart Innovators Badge

2016

Verdantix – Green Quadrant Leader

2016

Sphera Solutions founded from previous IHS EHS Division

2017

Sphera Solutions acquires Rivo Software

2017

Verdantix – Green Quadrant Leader

2017

Verdantix – Market Leader, Chemical & Hazardous Waste Management

2017

Environmental Leader – Project of the Year

2018

Sphera Solutions acquires SparesFinder

2018

Sphera Solutions acquires Petrotechnics

CLIENTS For more than two decades, Sphera’s portfolio of solutions has been trusted by hundreds of enterprise-level clients worldwide across a vast array of industries, including chemicals, pharmaceuticals, energy, mining, manufacturing, transportation and consumer goods. CASE STUDY 1: Drom Fragrances Challenge: Drom Fragrances, one of the world’s premier fragrance manufacturers, sought to ensure product compliance with regulations and industry standards in 43 countries – including REACH, CLP and Ifra. Results: Drom consolidated seven systems into one centralised system for product compliance data, standardised material safety data and work processes and saved over ten weeks of cleansing and transforming material safety data. They also simplified data management and production of SDS documentation/labelling and were able to lay the foundation for proactively addressing future changes to product regulations/standards in order to maintain and expand access to markets. CASE STUDY 2: Yara International ASA Challenge: Yara, the world’s largest fertiliser company and a leading chemical manufacturer needed to enhance safety data sheet authoring capabilities to comply with higher requirements from REACH, CLP and other mandates. Yara also wanted to establish a new integrated chemical compliance system compatible with their corporate IT environment and drive continuous improvement of SDS work processes and core business operations. Results: Yara efficiently managed exponential growth of SDS volume to support their business expansion. In the European market alone, they increased from 3,000 SDSs in 2008 to 15,000 SDSs in 2012. Yara was also able to standardise and enhance the quality of SDSs across their global enterprise. The Sphera solution enabled them transparency and accountability for audits by offering the ability to track back to chemical composition and business decision justifications. Yara was also able to streamline work processes by automating distribution of SDSs. CASE STUDY 3: Tikkurila

Meet increasingly tight regulatory requirements and rising customer expectations. Drive operational efficiency to support international growth strategies. Results: Standardized creation of safety data sheets and labelling for more than 2000 products from 4 sites in 4 different countries. Automated translation of up to 15 languages with one system, reducing costs and risk of errors by eliminating dependence on outside contractors working manually. Reduced time to translate typical safety data sheet from one working day to less than one minute. Established a flexible platform and process for rapidly generating documentation in response to regulations and growth into new countries. CASE STUDY 4: Siemens Healthcare Challenge: Meet US OSHA and EU GHS compliance deadlines and maintain access to key markets. Train product stewardship managers about complex GHS requirements. Identify substances of concern in their products to create safer, more sustainable products and respond to customer inquiries . Results: Reassessed 3,500 reagents according to new GHS classifications and updated 70,000 safety data sheets prior to 2015 GHS deadline. Created GHS-compliant SDSs in 20 unique language formats. Avoided product interruption to customers in key GHS-affected markets. Effectively analysed product portfolio to identify substances of concern and respond effectively to customer requests. STAFF SELECTION Francis Trudeau, Solutions Manager: Francis has worked for nearly 20 years in product compliance and chemical management. Trudeau has significant experience in solutions management and development, global regulations and industry standards enforced worldwide. He has worked on a wide variety of projects that support integrated information management solutions, and address legal compliance challenges and the implementation of regulations in databases and software applications. Trudeau is a recognised industry expert, serving both as a featured speaker at international conferences and leading multi-organisation task forces in establishing industry best practices for regulatory compliance. Mary Rudolph, Senior Manager – Global Content: Mary has more than 25 years of international environmental, health and safety experience, including technical and business implementations of authoring services. She offers customers an in-depth and often sought after understanding of the needs of global EHS departments. She has also managed the development of EHS-related databases, including RTECS®, a recognised toxicology database. Carrie Decatur, Senior Regulatory Analyst: Carrie is an internationally recognized expert in GHS at the UN and individual country level. She has been with Sphera Solutions for over 10 years. In her role as Senior Regulatory Analyst she is responsible for the analysis and implementation of global chemical regulations into the Sphera Product Stewardship offerings and the web based training program. She is Chair of the Global Regulatory Focus Group, a monthly client-based forum where regulatory updates and new system implementations are discussed. Carrie has worked in the Services group as a consultant where she utilized her SDS authoring and industry experience to assist clients in implementing product compliance software in an efficient and cost effective manner. Prior to joining Sphera, she worked in the chemical manufacturing arena where she was responsible for HSE and quality programs. Rosemary Feiter, Senior Manager – Authoring Services: Rosemary has over 25 years of experience in a variety of fields that are correlated to product stewardship activities such as R&D, production, quality control, distribution and EH&S assessments. Feiter leads the Regulatory Managed Services team that provides clients with safety document authoring and consulting services. The authors and project managers are regulatory experts that have substantial experience and knowledge of global regulations and industrial best practices having worked on multiple authoring projects for clients with diverse product portfolio.

Challenge: Generate world-class safety documentation and labelling in multiple languages. www.chemicalwatch.com/SPG

Profile: Sphera Solutions

193

Profile: Staphyt

194

SERVICES PROVIDED Areas of expertise: Biocides, Chemicals/REACh, Plant Protection Products, Biologicals, Fertilisers, Cosmetics, Medicines (ERA) OO regulatory advice and strategy; OO data gap analysis; OO field and laboratory study monitoring (GLP and/or GEP); OO IUCLID dossiers for active substances and products; OO draft Registration Report (dRR); OO Biological Assessment Dossiers (BAD); OO technical equivalence dossiers; OO risk assessments for humans, animals, consumers, environment; OO modelling (ConsExpo, EUSES, FOCUS, AOEM, PRIMo, CHESAR, ECETOC TRA, …); OO PBT assessment; OO CLP classification, SDS and labelling; OO transitional registrations of biocides in all Europe; OO poison control center declarations; OO QSAR management; OO OPEX monitoring; OO expert statements, literature search on chemical substances OO building or update of PIF, online notification through CPNP for cosmetics; OO regulatory support in all European countries, including answer to authorities; OO technical and regulatory training; and OO regulatory watch.

CONTACTS Website

www.staphyt.com/regulatory

E-mail

contact@staphyt.com

Head office

23, rue de Moeuvres 62860 Inchy-en-Artois France

Tel

+33 (0)3 21 21 45 21

Contact

Aurély Béghin/Sophie Aviron-Violet/Geoffroy Moulin

Directors

Regulatory Business Director: Aurély Béghin abeghin@staphyt.com

Ownership

Staphyt

Locations

France, UK, Austria, Poland, Czech Republic, Hungary, Australasia, Brazil

Founded

1989

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

OVERVIEW Whatever your area of activity in the field of chemistry, you are automatically subject to numerous and complex regulations, whose respect is essential for your company. We are experts in regulatory chemistry providing an excellent range of work and expertise. Our mission is to keep you informed about the regulations that apply to your activity and to help you provide the authorities with the necessary dossiers in order to be authorised to produce, import or sell your new or existing substance or product. Our team currently consists of over 60 scientists, whose backgrounds cover all areas related to chemical risk assessment: physico-chemistry, analysis, toxicology, ecotoxicology, environment, biological efficacy, etc. VITAL STATISTICS

2017/18

No of Regulatory offices

No of countries represented

30 + 400

Staff, group

+ 30

Staff, regulatory service provision SERVICE AREA BREAKDOWN Representation & management 10%

Creation of Staphyt

2015

Acquisition of Ambrosi Scientific Consulting by Staphyt Group

2018

Acquisition of TB Agrartechnik (Austria) by Staphyt Group

2018

Acquisition of APC by Staphyt Group

ACCREDITATIONS GLP, GEP, Research Tax Credit accreditation and training organism. PARTNERS In addition to our teams, we also work with partners (laboratories and local consultants) on all continents providing local regulatory expertise. This network allows us to submit dossiers through all Europe and beyond. CLIENTS From SMEs to multinationals, our clients are chemical manufacturers, formulators, importers or distributors. They specialise in biocides, chemicals, plant protection and plant nutrition products, cosmetics, medicines. STAFF SELECTION

Training 10%

Consultancy/advisory 80%

Global Service Providers Guide 2019

1989

Our team has expertise in chemistry, toxicology (with qualified pharmacists and toxicologist ERT), ecotoxicology, environment, biology, agronomy, etc. Our experts come from regulatory authorities, product developing companies, grower organisations or testing facilities providing Staphyt Regulatory with a varied and comprehensive experience in regulatory affairs.

Profile: Sustainability Support Services (Europe) AB

196

GLOBAL OFFICES Sweden, with affiliates in India, South Korea, Ireland & United Kingdom. SERVICES PROVIDED Pre-registration/ Late pre-registration (LPR) / Pre-notification Within the scope of Turkish (Turkey-REACH), Korean (K-REACH) and Taiwan Chemical regulations SSS is providing the pre-registration / Prenotification, and other compliance services and is already representing several clients within these regulations. Within the EU REACh, SSS represented over 8000 pre-registered substances for over 900 clients.

CONTACTS Website

www.ssseurope.org

E-mail

sk@reach-onlyrep.eu

Head office

IDEON Science Park, Beta 5, ScheelevĂ¤gen 17, 223 70 LUND Sweden

Tel

+46 46 2850417 & +46 46 2114615

Contact

Shisher Kumra

Directors

Shisher Kumra and Mukta Kumra

Ownership

Private Limited Company

Locations

Sweden, India, South Korea, Ireland and United Kingdom

Founded

2008

OVERVIEW SSS specializes in Global Regulatory Compliance Solutions. Within a decade of its inception in 2008, SSS has emerged as one of the leading names among Global Regulatory Compliance Service Providers and probably the only organization providing ISO accredited chemical regulatory compliance services to its client companies, providing Representation services in Middle-East, Europe and Asia, for respective regulations. Our over 1000 Happy Clients are a testimony to the great rapport we share with them and the fine quality that we offer in our services. This is also reflected in the fact that we have about 99% customer retention (client loyalty) and we have had over 160 companies opting to switch over to us from other service providers, for better and cost effective services. Our extensive experience in compliance support services, and large client base has motivated us to venture into every new regulation that has emerged over the past few years like Cosmetics Regulation, Korea REACH, Turkey REACH and the regulations in Australia, Taiwan, Japan, China, US, Canada etc. SSS is also actively contributing towards the finalization of Indiaâ&#x20AC;&#x2122;s chemical regulation and policy. Ministry of Commerce (GoI) has commissioned SSS for several studies and reports that has served as the basis of the current ongoing activities on Indian chemical policy and regulation. SERVICE AREA BREAKDOWN

Training 10%

Equipment 2%

Legal 10% IT & software 8% Laboratory 10% Representation & management 10%

Global Service Providers Guide 2019

Consultancy/advisory 50%

CLP notification The Classification, Labelling and Packaging (CLP) Regulation, based on UN-GHS, is the only legislation in force in the EU for classification and labelling of substances and mixtures. SSS has successfully completed over 1900 CLP notifications. Registration & Notification SSS has been helping companies to do the registration of their substances within various regulations. Within EU REACH, SSS has registered over 1200 substances for its clients, during the three registration deadlines of 2010, 2013 & 2018. SSS has also registered many substances within Korea REACH during the June 2018 deadline for its clients as well as several notifications under Cosmetics Regulation. REACH & CLP compliant SDS and Extended SDS (e-SDS) SSS is also engaged in authoring 16 point REACH and CLP compliant SDS and extended SDS (e-SDS) for substances and preparations. SDS translation: SSS also provides the service of translating the SDS in over 30 languages, including European member states, Chinese, Korean, Taiwanese, Malaysian, Turkish, Vietnamese, Russian, Serbian, Norwegian etc. (SSS has till date authored over 3500 REACH and CLP compliant SDSs. And over 250 e-SDS) Compliance with K-REACH (Korea REACH) Within the Act on the Registration and Evaluation of Chemical Substances (ARECS) regulation, also known as K-REACH, SSS has acted as Only Representative and has successfully done Annual Reporting as well as the Registrations for its clients. Currently, SSS is engaged in pre-notifying the chemicals, which is to be done between 01.01.2019 and 30.06.2019. SVHC applicability analysis Companies exporting substances and articles to European countries need to confirm the presence or absence of substances of very high concern (SVHC) and the REACH compliance obligations. Cosmetics Regulation SSS has successfully done many cosmetic product notifications. We can do these notifications as per the requirements within the India, US and EU cosmetic regulations. CRO Co-ordination SSS coordinates with a network of reputed CROs (OECD-GLP Certified), wherein we manage toxicological, eco-toxicological, environmental and phys-chem studies on behalf of our external clients, take study contracts and do full study coordination and monitoring on behalf of the sponsor, in the most cost-effective and time-efficient manner. We have facilitated several EU and Asian clients in this manner. Compliance Certificates Compliance Certificates are requested by companies, who are buyers to the clients, whom SSS represents. This could be to confirm OR Appointment, Tonnage coverage or regulatory compliance. SSS has developed tools and systems, namely Supply Chain Communication Portal to ensure due diligence while doing the verifications and inspections.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2008

Established and registered as a private limited company.

2008

Pre-registered over 7,000 substances within REACH.

2009

Professionals trained in Iuclid from REACH Centrum.

2009

Trained over 100 industry professionals in use of Iuclid.

2010

35 REACH registrations successfully completed.

2010

Delivered 1,500 REACH and CLP compliant SDS.

2011

Acquired capacity in Chesar and Qsar.

2011

Mandated as lead registrant for 50 substances.

2012

Mandated as lead registrant over 60 additional substances.

2013

Registered over 225 chemicals by the 2013 deadline.

2014

Over a dozen companies (20 companies) changed over to SSS as the OR from their earlier OR.

2015

Group company is accredited as a certified inspection body.

2016

SSS has an affiliate in S. Korea to offer services pertaining to K-REACH compliance.

2016

OR representation and successful completion of Annual reporting for several clients within K-REACH.

2017

Successful Late pre-registration of over 400 chemicals in May, taking the total count of pre-registrations to over 2200.

2018

Completed registrations for all the requests received well within the last REACH Registration deadline of May 2018.

2018

Successfully completed requested Registrations within the first Korea REACH Registrations Deadline of June 2018.

PARTNERS Confederation of Indian industry (CII), India China International Electronic Commerce Center (CIECC), China; OO Tisamax Technical Co, Ltd (Tisamax), Taiwan OO Randis ChemWise (Shanghai) Co.,Ltd, China OO Associated with Ricardoâ&#x20AC;&#x2122;s CareChem24 chemical emergency helpline services through its Indian group company. Several similar partnerships are being explored in US, Canada, Japan and Turkey. OO OO

CLIENTS SSS has over 1000 clients in the industrial and specialty chemical and petrochemical industry, as well as the following industries: agrochemical, food colour, cosmetic, electrical and electronics, automotive industry, leather, garment and apparel, plastic and rubber, steel, writing instruments, polymers. TESTIMONIALS On the service quality criteria, 98% of our client companies have rated the compliance assistance services being offered by SSS as very good. CASE STUDY 1: SSS group company in India is accredited for an internationally recognised standard for inspection bodies With a view to provide quality regulatory compliance services to its client companies, SSS has helped prepare its Indian group company in getting accredited to an internationally recognised standard for the competence of inspection and certifying bodies. This is probably a first of its kind global achievement for any OR service providing organisation wherein all its compliances shall be inspected and validated prior to completing the compliance process request of its clients. This shall ensure accurate regulatory compliance and conformance with the technical product standards.

CASE STUDY 2: SSS and its sister concern have jointly initiated a Forum for review of global chemical regulatory updates Problem: Indian chemical exporters were finding it difficult to keep themselves updated of the changing chemical regulations & their requirements. Solution: The inaugural meeting of the Forum was held in Mumbai, India in October 2015, to discuss Korea REACH. Since then, SSS has been organizing meetings and events for Indian exporters depending upon the need and has been able to solve their queries and successfully create awareness and understanding about the existing and upcoming regulations like EU-REACH, Korea REACH, Indian Chemical Regulation, UK-REACH (post Brexit) etc CASE STUDY 3: Guidance to many SIEF members for successfully completing their REACH registration in 2013 & 2018 deadlines. Problem: SSS received requests from SIEF members to provide knowhow on the REACH registration process. Solution: The technical team at SSS provided the know-how to the SIEF members relating to the finalisation of their registration dossiers, TCC clearance and submission of the member dossier on the REACHIT by joining the joint submission (JS). Some of these requests were received very close to the deadline and the timely inputs from SSS helped companies meet their registration deadline. STAFF SELECTION Mr Shisher Kumra â&#x20AC;&#x201C; Executive Director Area of expertise includes specialisation in regulatory affairs, legal expertise, chemical assessment, toxicology. Mr Shrirang Bhoot, Chief Technical Officer (CTO) Area of expertise includes REACH data inventory, REACH registration process, environmental toxicology, bio-assay and other regulatory affairs. Also specialisation in softwares like Iuclid, Qsar, Ecosar, dossier preparation, Chesar. Dr Martina Holst Responsible for evaluation of toxicological reports and for dossier quality assurance for toxicological endpoints and CSR. Dr. Zsuzsanna Szepesi Responsible for evaluation of toxicological reports and for dossier quality assurance for toxicological endpoints and CSR. Dr. Anders Bergqvist Responsible for evaluation of toxicological reports and for dossier quality assurance for toxicological endpoints, reviewing the study plans and study monitoring for the toxicological end points. Dr. Yashwant B Responsible for evaluation of eco-toxicological reports and for dossier quality assurance for eco-toxicological endpoints. Dr. Shweta Deoskar Responsible for evaluation of substance sameness reports and for dossier quality assurance, evaluation of read across substances and category development Mr Keith Yongho Jung, South Korean Regulation Executive Manages activities related to K-REACH compliance and coordination with the Korean regulatory authorities as Korean representative at SSS. Mr Mangesh Barbate Area of expertise includes REACH data inventory, dossier preparation, eco-toxicology and specialisation in softwares like Iuclid, Qsar, Ecosar, Mrs Akanksha Nagpure Area of expertise includes chemical safety assessment (CSA), chemical safety report (CSR), toxicology, SDS, CLP and Iuclid software. Mrs Swati Gondhalekar Area of expertise includes REACH and Articles, SVHC assessment and REACH compliance verification.

www.chemicalwatch.com/SPG

Profile: Sustainability Support Services (Europe) AB

197

Profile: TEAM Mastery s.r.l.

198 importers of article, are all responsible for the effective communication flow of information. We provide all the necessary support by distributing standard templates or customised forms to properly manage the communication flow between customers and suppliers. OO Strategic implementation of European regulations Participation to consortia, co-registrant agreements, data sharing, deadline and tonnages for registration are decisions that are managed in order to find the most cost-effective solution and the most convenient choice on the market. OO Chemical management and product stewardship The market will constantly evolve over time. Companies will face new challenges to strategically select secure suppliers and to identify growing sector markets. Our business development experts will support companies with the most effective advice, in compliance with the provisions of the regulation. OO Implementation of IT systems for chemical management Companies will internally develop new management systems to integrate existing tools to monitor the presence of chemical substances, including deadlines, total amounts, risk management measures etc.

CONTACTS Website

www.team-mastery.eu

E-mail

info@team-mastery.eu

Head office

Via Ferrari 14/B, 22100 Como, Italy

Tel

+39 031 269513

Contact

monicalocatelli@team-mastery.eu

Directors

Monica Locatelli

Ownership

Private company

Locations

Italy

Founded

2008

REACH services

OVERVIEW Born in 2008 as a dedicated REACH consulting company, TEAM mastery changed the name in 2017 and now provides a broad range of services in Chemical Regulatory Affairs. The staff are a highly motivated team with specific expertise in chemistry, biology, toxicology, pharmacology, human health, environmental toxicology and risk assessment. Our commitment is to assist customers along the supply chain with our depth of industrial experience and help them in cost efficient implementation of European and global regulations on chemicals. VITAL STATISTICS

2017/18

Turnover, group

2 Mio

Turnover, chemical service provision

2 Mio

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Legal Information 2%

Training Other 5% 1%

Representation & management 15% Consultancy/advisory 75%

SERVICES PROVIDED General consulting services OO Supply chain communication Importers and manufacturers, downstream users and manufacturers/

Global Service Providers Guide 2019

OO Consortia management A lot of experience has been gained on consortia rules and management. We provide also legal advice, agreement documents, meeting location, cost calculation, managing of LoAs. OO Data gap analysis and data collection Gathering existing information is the first step in the preparation of any registration dossier, but is not enough. All these data have to be really collected, in respect to the right to use. The latter requires the negotiation of the conditions for use according also to the quality of the data. Each single study is evaluated and rated to check relevance and adequacy to fill the requirements. OO Testing strategy development, in vitro strategies development, Qsar modelling, read across evaluation. An integrated testing strategy is the first step for cost reduction and building rationale for waiving. International well known partners are helping us in focusing on the right choice. The expertise in Qsar modelling (OECD Toolbox, VEGA, customised models) has been often successful in discussion with the national authorities and scientific working groups OO Managing of analytical identification and inquiry dossiers Our great expertise in analytics and experience in enquiries let us face without problems one of the most critical aspect of REACH regulation. OO PPORD dossier REACH mastery can assist in the preparation of PPORD dossiers OO Test monitoring In case new tests are required, REACH mastery will take care of selecting the most appropriate lab, will review the protocol and check the results. OO Dossier preparation (Iuclid compilation) Dedicated experts are managing Iuclid compilation and informatics tools for submission (REACH-IT). OO Human health and environmental risk assessment The focused experience and the support of high experienced toxicologists let us make of the risk assessment the core part of the developing registration dossier. OO Exposure modelling Exposure modelling can be performed with most of the recognised official tools like EUSES, Ecetoc TRA, EASY TRA, ART, CONS EXPO, RISKofDERM OO CSA-CSR REACH mastery is part of the consultation group of Chesar in Echa. We followed the development of the tool since the beginning and we are among the first experts in Europe to use it. The tool is also used to develop translated exposure scenarios and extended safety data sheets

OO Authorisation dossiers REACH mastery acquired the expertise to develop authorisation dossiers complete with analysis of alternatives and socio-economic analysis OO CLH dossiers REACH mastery can prepare CLH dossiers for re-classification on behalf of industry to be discussed and presented to the member states authorities and within the Member State Committee

2016

Implementation of the group to comply with the needs of the Plant Protection Product Regulation. Presentation of two dossiers after Article 95 disputes in Biocides and two Authorisation dossier.

2018

Technical management and dossiers implementation of the biggest Italian Task Force for the National Authorisation of Sodium Hypochlorite

CLP/GHS services OO OO OO OO OO

Data collection and assessment of classification and labelling; CLP notification; MSDS compilation; extended safety data sheets; and exposure scenarios scaling and translation.

BPR services OO OO OO OO OO OO OO

Full dossier preparation for active substances and products; technical equivalence; testing strategy development; study monitoring; risk assessment; finalisation and discussion with national and EU authorities; and post-submission support

PPP OO OO OO OO OO OO

Full dossier preparation for active substances and products; testing strategy development; study monitoring; risk assessment; finalisation and discussion with national and EU authorities; and post-submission support

PHARMA services OO OO OO OO OO

Medical devices; human health risk assessment; environmental risk assessment; determination of the PDE (permitted daily exposure); and assessment of mutagenic impurities

FEED and FOOD registration OO OO OO OO

Dossier preparation; risk assessment; test monitoring; assistance to customer for Efsa calls for data.

EU cosmetic directive OO OO OO OO OO OO OO

Regulatory compliance support; product notifications; cosmetics ingredient profiles; product information files; clinical studies: design and monitoring; cosmetic product safety reports; and product labelling review and support.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

PARTNERS RTC, QSAR group of Bicocca University, Vitroscreen, CENTRO REACH, CAAT Europe as preferred cooperations. CLIENTS We are working for about 300 customers around Europe; they are manufacturers, distributors, downstream users, from SMEs to international chemical companies involved in many different industrial fields: fertilisers, leather, textile, paper, pharmaceuticals, galvanic, food, cosmetic, polymers and many others. CASE STUDY 1: TIER 3 REACH registration The group has proved itself as one of the most professionally prepared in the European scenario to manage all different aspects of a REACH dossier. TEAM mastery prepared about 20 lead dossiers for the 2013 second Tier registration, many of them with a full study plan ordered and monitored, 40 intermediate dossiers and about 40 joint registrations. UVCBs and difficult substances are the main specialisation area. The group has gained a great expertise in substance identification and difficult inquiries and timely prepared his customers to the 2018 Tier 3 Registration with over 100 lead dossiers. With the implementation of the Corap and the number of ECHA compliance check, a number of dossiers need to be re-evaluated, discussed and improved from the first submission of 2010. TEAM mastery has been chosen to improve the exposure scenarios, read across justifications, and the overall quality of the existing dossiers CASE STUDY 2: Task Force Hypochlorite During 2017 and 2018 TEAM mastery organised together with CENTRO REACH the biggest Italian Task Force for the National Authorisation of Sodium Hypochlorite. Several Family dossiers have been presented including more than 800 products for more than 50 members. STAFF SELECTION Dr ssa Monica Locatelli – ERT– Founder and Director After a degree in chemistry, ten years in R&D and a specialisation in toxicology applied to risk assessment, she has been working in regulatory and implementation of REACH regulation since 2001, when it was still a proposal. The co-operation with many specialists within international companies and universities let her specialise in consortia management and dossier preparation.

2008

Foundation of REACH mastery

Dr ssa Costanza Rovida – ERT– REACH Regulatory Specialist

2010

About 120 successful registrations for the 2010 deadline

2012

Implementation of the group to broaden the regulatory area to biocides

2014

Preparation and submission of the first application for authorisation

2015

Implementation of the group to comply with the needs of the Biocidal Product Regulation and Pharma industry. Presentation of the first accepted CLH dossier and of the first family dossiers for biocidal products to the Italian Member State.

Graduated in chemistry, after 15 years’ experience in the field of analytical chemistry, she worked for three years at the European Commission, participating in two groups of RIP 3.3 (REACH Implementation Project, Technical Guidelines to Industries) and as a leader of a work package in a European project focused on integrated development of alternative toxicological methods to animal testing. She is responsible for the management of individual projects and global customer assistance. Dr ssa Stefano Tortelli – BIOCIDES Regulatory Specialist Graduated in chemistry, he developed experience in project management and human resources, before dedicating to the Regulatory field. Responsible for the Biocide Division development, he is successfully managing the first Italian Task Force on Biocides and the Biocides Regulatory team

www.chemicalwatch.com/SPG

Profile: TEAM Mastery s.r.l.

199

Profile: The Compliance Map Ltd

200

GLOBAL OFFICES UK – Bicester Centre for Innovation, Telford Road, Bicester, OX26 4LD US – 2443 Fillmore St # 380-3154, San Francisco, CA 94115 AU – Level 1/21 Shierlaw Ave, Cantebury, VIC 3126 PARTNERS

CONTACTS

Website

www.thecompliancemap.com

E-mail

tcm@thecompliancemap.com

Head office

Bicester Centre for Innovation, Telford Road, Bicester, OX26 4LD, UK

Tel

01869 255 758

Fax Contact

James Roberts

Locations

UK, US and Australia

Founded

2014

OVERVIEW The Compliance Map Enterprise platform is an all-in-one solution to automate and manage environmental and supply chain compliance obligations. The system covers chemical regulations ranging from Global REACH and RoHS to TSCA, Prop65, and much more. Companies can leverage tools within the platform to automate their supply chain data collection efforts as well as build customer and regulatory reporting forms to meet customer requests. The solution is fully enterprise integrated, enabling transparent synchronisation of BOM and material data and supports the major PLM/ERP systems on the market. Compliance Map monitors all regulations to ensure the platform is always current to reflect today’s regulatory landscape and scales to meet tomorrow’s challenges. VITAL STATISTICS

2017/18

Turnover, group Turnover, chemical service provision 3

No of offices

No of countries represented Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 5%

IT & software 60%

Consultancy/advisory 20%

Representation & management 5% Information 5% Laboratory 5%

Global Service Providers Guide 2019

Compliance Map has partnered with SiliconExpert Technologies (SiliconExpert) to deliver an end-to-end compliance service for clients across the electronics and medical device industries; and The Compliance Map’s fully automated API downloads environmental compliance data from SiliconExpert based on the parts a company sources and then leverages ERP/PLM integrations (such as with SAP, Agile, Oracle) to pull BOM, part and supplier data to facilitate the automatic roll-up of compliance from chemical level all the way to product level. Compliance risk assessments, gap analysis and full customer and regulatory reporting is automated.

Profile: The Compliance Map Ltd

201

www.chemicalwatch.com/SPG

Profile: ToxMinds

202

SERVICES PROVIDED Our core team of industry-experienced toxicology, environmental and regulatory affairs consultants and analysts provide chemical safety, regulatory and product stewardship assistance to the following industries: OO chemicals; OO biocides; OO cosmetics and consumer products; OO pharmaceuticals OO green biotechnology

CONTACTS Website

www.toxminds.com

E-mail

info@toxminds.com

Head office

116, Avenue de Broqueville, 1200 Brussels, Belgium

Tel

+32 (2) 762 91 45

Fax

+32 (2) 762 91 46

Contact

Mr. Alex Rankin

Directors

Dr. Thomas Petry Dr. Francesca Tencalla

Ownership

Private company

Locations

Brussels (Belgium); Bangalore (India); Düsseldorf (Germany);

Founded

2006

Chemical and product safety All our team members possess advanced scientific degrees in toxicology or related environmental health sciences. Our senior consultants are also certified in general toxicology with the American Board of Toxicology (DABT) and/or are registered in the European Registry of Toxicologists (ERT). We focus specifically on the field of predictive toxicology, new risk assessment methodologies, endocrine disruption and skin sensitisation. Our chemical and product safety services include: OO coordination, analysis and registration management of chemical portfolios; OO state-of-the-art toxicology, ecotoxicology & environmental fate assessments; OO Qsar and analogue-based chemical safety evaluations OO ECHA-guideline compliant assessment of endocrine disrupting properties; OO higher tiered human and environmental exposure modelling and risk assessments; OO support of REACH registrations at all stages; OO determination of chemical and mixture classifications under CLP/ GHS legislations; OO client representation and science advocacy with EU regulatory bodies; OO consortium management, 3rd party representation and trustee services; and OO LoA cost determinations and negotiations.

OVERVIEW ToxMinds BVBA is a chemical safety and regulatory affairs firm located in Brussels, Belgium. We are passionate about toxicology and how emerging developments can be utilised to provide our customers with a competitive advantage in the marketplace. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

10 – 25

Staff, chemical service provision

10 – 25

SERVICE AREA BREAKDOWN

Information 10%

Training 5%

Representation & management 15%

Consultancy/advisory 70%

GLOBAL OFFICES Brussels (Belgium); Bangalore (India), Düsseldorf (Germany)

Global Service Providers Guide 2019

Regulatory strategy and compliance Our experience and knowledge is the basis of our registration services. With our in-depth understanding of the data and documentation requirements and our knowledge on how to perform the state-of-the-art risk assessments, we guide our clients through all necessary steps to achieve regulatory compliance. Our regulatory services include: OO portfolio review and regulatory strategy consulting; OO data compilation, evaluation of non-testing approaches and waiving opportunities, final data gap analysis; OO design and management of testing programmes; OO interpretation, quality evaluation and study summary preparation of physico-chemical, environmental fate, ecotoxicology and human toxicology studies; OO human and environmental exposure modelling, covering occupational, residential and dietary exposures as well all relevant environmental compartments; OO higher tiered human and environmental state-of-the-art risk assessment; OO development of Regulation-compliant registration dossiers or submissions; OO REACH Regulation: Iuclid dossiers; Chemical safety assessment and reports OO Biocidal Product Regulation: Development of product authorisation dossiers; OO cosmetics Regulation: Cosmetic ingredient dossiers for SCCS submission; Product information files (PIF); and OO preparation of authority responses and/or advocating and defending scientific approaches with public authorities (e.g., ECHA, EMA, EFSA, and national authorities).

Product stewardship We support our clients in developing their strategies and risk communications for chemicals of public concern to address perceived – but not scientifically justified – risks. We support our clients with the following services: OO client-tailored trainings on topics related to product safety & regulatory compliance; OO principles of human & environmental hazard, exposure and risk assessment of chemicals; OO hazard-specific endpoint training (e.g., skin sensitisation, endocrine disruption, aquatic toxicity); OO regulatory frameworks and related IT tools (e.g., IUCLID software package); OO Qsar & REACH/BPR specific exposure modelling tools OO development of REACH-compliant extended Safety Data Sheets (eSDS); OO development of science-based strategies and documentation to support chemicals or products under regulatory or public scrutiny OO Science advocacy and product defence; and OO communication of (eco)toxicology and risk assessment findings to various audiences with different levels of scientific knowledge. CORPORATE DEVELOPMENTS and ACHIEVEMENTS 2006

Formation of ToxMinds BVBA

2009

Opening of ToxMinds headquarters in Brussels, Belgium

2016

Formation of ToxMinds Deutschland GmbH

2017

Formation of ToxMinds India Consulting Pvt Ltd and office opening in Bangalore, India.

CLIENTS ToxMinds provides (eco)toxicology, product safety and regulatory compliance services to a wide range of multinational companies, SMEs, and industry associations from the chemical, biocidal, cosmetic and consumer product, pharmaceutical and green biotechnology sectors. TESTIMONIALS “We have been working with ToxMinds for many years on various complex toxicology, ecotoxicology and regulatory issues. The professionals there are thorough, knowledgeable and always meet our demands and difficult timelines […]. We continue to rely on ToxMinds as experts in the fields of toxicology, ecotoxicology and EU regulatory compliance.” – Senior regulatory manager, international specialty chemical company. CASE STUDY 1: REACH strategy and registration support to chemical manufacturers In the context of REACH phases I, II, and III, we developed more than 300 REACH registrations for a number of small- and medium-sized firms as well as multinational chemical companies. The majority of the registrations started with a thorough data gap analysis leading to the identification of the most appropriate, time- and cost-efficient registration strategy. Once the strategy was established and agreed upon with the client, we designed and managed any required testing programmes, prepared robust study summaries, conducted human and environmental exposure modelling using state-of-the-art exposure modelling tools and completed all necessary registration documentation. Our clients only needed to upload the registration on the ECHA website.

CASE STUDY 2: Identification of hazards associated with nonintentionally added substances in a food contact polymer We were engaged by a multinational petrochemical company to assess the presence of non-intentionally added substances (NIAS) in a food contact polymer (FCP) that were identified following the change of a catalyst within the polymer manufacturing process. We first worked with the client’s analytical experts to get a suitable analytical characterisation of the NIAS in comparison to previously approved extractable profile of the FCP. Identified new NIAS were assessed for safety (including derivation of MRL) using Qsar modelling and analogue/SAR-based read-across approaches. Additionally, an in vitro genotoxicity testing programme was conducted on our recommendation to ensure the absence of any genotoxicity issues of the new NIAS profile as well as to strengthen the overall assessment. CASE STUDY 3: Human health risk assessment of a biocidal product line for due diligence purposes In the context of an acquisition of a biocidal product line, we supported a multinational consumer product firm in its due diligence evaluations to ensure product safety in line with EU BPR requirements. In this context, we assessed a total of 12 actives being used in various types of insecticidal formulations (CIK, FIK, AIK, liquids/mats). Taking into account all toxicological information identified, we identified the POD studies to derive acceptable exposure limits (AEL) and assessed consumer exposures using the ConsExpo exposure modelling tool. The exposures were compared with acute and chronic AELs to calculate individual and aggregate risk characterisation ratios (RCR) for the relevant routes of exposure (oral, dermal, inhalation) for adults and children. CASE STUDY 4: Identification of safety exposure levels for chemicals used in cosmetic and consumer products For a multinational consumer product company, we established safe exposure levels for more than 750 chemicals. In this context, we collated and assessed information pertaining to the local and systemic toxicity of the chemical in question; determined non-animal based strategies how to fill endpoint data gaps (e.g., grouping and SAR-supported readacross approaches); identified the most appropriate POD study for NOAEL derivation, and determined for each chemical a safe exposure levels (SEL) for consumer product use. assessments were documented in standardised hazard summary templates, which included, for each endpoint, a summary and quality rating of the available data, a description and justification of the POD study as well as the derivation and justification of the SEL. STAFF SELECTION Thomas Petry, ERT, DABT Dr. Petry, Managing Director of ToxMinds BVBA, is a product safety and regulatory affairs consultant with more than 20 years’ industry, consulting and research experience in the human safety assessment of chemical exposures occurring at the workplace through their use or presence in consumer products or via the environment. Francesca Tencalla, ERT Dr. Tencalla, Director at ToxMinds BVBA, is an (eco)toxicology and regulatory affairs consultant with more than 20 years of industry and research experience in the human and environmental safety assessment of chemicals, metals, agrochemicals and pharmaceuticals. Sanghamitra Mishra, ERT Ms. Mishra is heading the ToxMinds India office and is a senior consultant with substantial research and consulting experience in the human health hazard and risk assessment of chemical substances. Ms. Mishra has been instrumental in developing our services in the area of non-animal alternatives, particularly SAR/analogue-based readacross justifications and the identification of mechanism-based testing programmes (AOP) to reduce remaining uncertainties in a proposed read-across approach. www.chemicalwatch.com/SPG

Profile: ToxMinds

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Profile: Triskelion B.V.

204

GLOBAL OFFICES

Triskelion Headquarters: Zeist, The Netherlands First Dutch Innovations Headquarters: Delft, The Netherlands Sales representatives: Japan, USA, Canada CONTACTS

SERVICES PROVIDED

Website

www.triskelion.nl

E-mail

chemistry@triskelion.nl

Head office

Utrechtseweg 48, PO Box 844, 3700 AV Zeist, The Netherlands

Tel

+31 652803578

Contact

chemistry@triskelion.nl

Ownership

Private company

Locations

Zeist, The Netherlands

Founded

TNO, 1932; TNO Triskelion, 2011; Triskelion, a First Dutch Innovations company, 2017

OVERVIEW Your success is our focus. Our aim is to ensure compliance with chemical legislations around the globe, guaranteeing market access for your chemicals and products. We specialize in multidisciplinary projects in which our consultative skills, broad expert knowledge and personal commitment, together with our state-of-the-art equipment, contribute to tailor-made study designs and dependable project management. Triskelion is an ambitious Contract Research Organization (CRO) and is active in the chemical, pharmaceutical, food and feed markets. Over 120 employees serve our clients from all over the world. Triskelion has been a First Dutch Innovations company since 2017. First Dutch Innovations currently consists of over 24 innovative companies, totaling around 800 employees. First Dutch Innovations has committed itself to working closely with other knowledge-based institutions in The Netherlands to create a central platform in which knowledge development and entrepreneurship are combined. VITAL STATISTICS

2017/18 €20M

Turnover, group

€4M

Turnover, chemical service provision No. of offices

No. of countries represented

4 120

Staff, group

Staff, chemical service provision SERVICE AREA BREAKDOWN Consultancy/advisory 15% Representation & management 5%

Laboratory 80%

Global Service Providers Guide 2019

Registration Services & Risk Assessment Looking for a CRO that knows the market and remains compliant under different international regulatory frameworks? Your success is important to us. As a partner, we deal with dossier preparation and updates that ensure compliance of your products – whether these are chemicals, biocides or pesticides. Our experienced team of highly educated chemists, (eco)toxicologists and project managers has a long track record in regulatory services and risk assessments. Personal contact and communication are second nature to us. We provide full support for EU REACH and BPR regulations, evaluating available data and applying QSAR and read-across (including a detailed scientific justification) to fill in possible data gaps. When an additional study is required for your registration dossier, we set up and monitor this to include in your dossier(s). Food Contact Materials Do you have a Food Contact Material (FCM) which needs to be approved by the relevant legislation? Triskelion provides the expertise and capabilities to test and approve/ authorize your FCMs. Our labs at Triskelion are internationally renowned and accepted. Triskelion offers: OO Full support with EU and FDA regulation of FCMs. OO Petitioning of new substances. OO Ample experience with migration testing, modelling and compliance statements. OO State-of-the-art analytical laboratory equipment, enabling the detection of NIAS (Non-Intentionally Added Substances) and oligomers at very low levels. TIM System We believe that an understanding of the results and behavior of a product is required in order to responsibly communicate product information to your users. We develop and apply our own TIM system to simulate gastrointestinal release, stability, digestion and bioavailability of food and feed, as well as chemicals and product formulations. This in vitro system can provide highly relevant data, for instance, to support a given testing strategy, waive studies or form a read-across. Analytical Services With state-of-the-art laboratories and highly trained chemists, we provide analytical services for a wide array of (bio)chemicals in complex matrices.Whether you need to develop a method of analysis, analyze samples from a (eco)toxicity study or generate spectral data for a registration dossier, our experts are available to help. We maintain close contact to help you choose the tailor-made analytical methods that suit you best. Our well-qualified technicians have ample experience with analysis at extremely low concentrations in a wide variety of matrices and with identifying unknown compounds such as metabolites. How we work Project management: Your assignment with Triskelion will always be led by one of our experienced project managers. This is your primary contact person, who manages your project, interacts with the scientific team and ensures that deadlines are met and that the deliverables meet your needs. Your project manager maintains contact with you via phone and/or video conference calls. Quality assurance and reporting: Our GLP reports are consistently subjected to the required auditing and control procedures to ensure compliance. All the documentation you receive (proposals, reports, analytical results, IUCLID files, Chemical Safety Reports, eSDSs) are reviewed by a senior staff member.

Relationship management: In addition to strong project management, our Business Development Managers are there to assist you. Our client services office is there to guide you to the correct technical contacts within Triskelion, who will help you find the right solution. We specialize in multidisciplinary projects in which our consultative skills, expert knowledge and personal care all contribute to tailor-made study designs and reliable project management. It is our people that make the difference. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1932

Foundation of TNO The Netherlands Organisation for Applied Scientific Research.

1946

Creation of the Central Organic Chemistry Institute in Zeist.

2004

Completion of five-year HPV chemicals programs on various chemical groups, including organotins.

2006

Participation in REACH implementation projects (data requirements, exposure assessments).

2007

Commencement of REACH partnership with Sabic Europe.

2010

Successful completion of 325 full and partial REACH dossiers.

2011

Incorporation of TNO Triskelion as a private company. ReachCentrum and TNO Triskelion join forces to offer REACH workshops and training courses.

2012

Extensive application of our exposure experience to the evaluation of risk management options for SVHCs.

2013

REACH 2013 dossiers submitted on time!

2014

First EOGRTS study accommodated in our laboratory.

2015

Expanded presence in areas beyond the EU.

2016

Launch of our new branding campaign with new logo, name and slogan: Research for Better Living.

2017

First Dutch acquires TNO Companies, including Triskelion B.V. The new name for TNO Companies becomes First Dutch Innovations.

2018

Discontinuation of in vivo toxicology and efficacy studies. Analytical and Registration Services continue to operate

ACCREDITATIONS In compliance with GLP (analytical chemistry); ISO 9001 certified; some analytical services under ISO 17025. PARTNERS We work both separately and together with TNO on the development of alternative (bio)analytical methods. When needed, we supply additional services like special evaluations (as SEA) through our network of co-operators. TESTIMONIALS “Triskelion has been supporting BASF SE in a variety of registration activities since the beginning of REACH. We were and we are impressed by the broadness and depth of the expertise, the professionalism in

CASE STUDY 1: REACH registration While the last registration deadline is behind us, the work for compliance with REACH legislation is far from finished. ECHA and member state authorities continue to evaluate dossiers and prioritize substances for further regulatory action (e.g. compliance checks, substance evaluations, restrictions, authorizations). Thanks to the massive amount of experience gained in preparing substance registrations since the beginning of REACH, we can help you in addressing requests from ECHA to provide additional information in your dossiers. We can assist you in keeping your dossiers up-to-date to stay compliant. Should a substance that you produce or use fall under the SVHC list, we can help you to evaluate what steps to take going forward. Our experience in analyzing socio-economic impacts can be used to influence decision-making in the process of risk management options analysis and prior to further regulatory actions, such as the setting of occupational exposure limits, restriction or authorization. We can also assist you in creating successful applications for authorization. CASE STUDY 2: Biocides product family authorization Planning to bring biocidal products of one or more Product Types to the market and need product authorizations under BPR? You may consider using biocidal product families in the authorization process. Make use of our experience in preparing dossiers for groups of biocidal products. What do you need to divide your portfolio? Let us help you in this process. First, select the number of product families and further divide them into meta-SPCs based on the existing criteria for families and meta-SPCs. Following this, critically select the most appropriate representative product(s) to be tested. In this way, we can significantly reduce the required effort, going from a dossier for every product to dossiers for just a few product families, each with a number of meta-SPCs. A full dossier will be delivered, including all elements in IUCLID, SPC tool and (draft) Assessment Reports per biocidal product family, accounting for any substances of concern. Throughout the whole process, we will closely cooperate with your experts to align all activities and agree on the many choices to be made. CASE STUDY 3: Food Contact Materials Questions about the safety of Non-Intentionally Added Substances (NIAS) become more prevalent in the FCM supply chain, as mentioned in article 19 of EU regulation 10/2011. At Triskelion, we have more than a decade of experience in NIAS evaluation. There are several choices to make when commissioning an NIAS evaluation and our in-house analytical experts and toxicologists can advise you on your specific case. The aim in such projects is to optimize the effort to generate the most relevant information on NIAS. Triskelion’s approach for NIAS risk assessment is in-line with the guidelines of the International Life Sciences Institute (ILSI). This involves an analytical screening of the material or food simulants after migration testing, followed by the identification and (semi-)quantification of discovered NIAS. The safety of the presence of NIAS is evaluated through a hazard and exposure assessment.

conducting complex projects and their flexibility to adhere to our time requirements.” – BASF SE “Since 2007, Triskelion has been our preferred business partner for delivering spectral analytical characterization data for numerous substances. Over many years, we have valued the deep analytical expertise and technical mastery of Triskelion’s network of experts and timely delivery of state-of-the-art analytical data and reports, which were crucial for securing the market placement of P&G products. Moreover, Triskelion experts very often demonstrated a co-creative mindset and high level of flexibility for meeting demanding project needs.” – Procter&Gamble

www.chemicalwatch.com/SPG

Profile: Triskelion B.V.

205

Profile: TÜV SÜD Industrie Service GmbH

206

GLOBAL OFFICES Japan, Singapore, China, India, Croatia, Indonesia, Thailand, Vietnam, Serbia, Russia, Ukraine, South Korea, USA SERVICES PROVIDED

CONTACTS

Only representative TÜV SÜD Industrie Service acts as reliable and impartial OR to numerous manufacturers of substances established outside the community. The obligations of an OR outlined in Article 8 of the REACH regulation comprise not only registration but also all obligations for importers under REACH. Calling in an OR has the following advantages: importers need not become active themselves, and manufacturers established outside the EU can bundle notifications and do not have to address each importer individually. We experience that often manufacturers address to us when their previous OR failed to act to their satisfaction or did not fulfil its obligations.

Website

www.tuev-sued.de/reach

E-mail

REACH@tuev-sued.de

Head office

TÜV SÜD Industrie Service GmbH, Westendstr 199, D-80686 Munich, Germany

Tel

+49 / 89 / 5791-1004

Fax

+49 / 89 / 5791-1174

Contact

Dr Dieter Reiml

Ownership

TÜV SÜD Holding AG

Locations

TÜV SÜD Group employs more than 24,000 people in 60 countries in ca. 1000 locations

Founded

1866

OVERVIEW

In-house training and seminars Companies affected by REACH or CLP are seeking advice on how to deal with the challenges caused by REACH in a timely effective manner. Desired training events vary depending on participants’ existing knowledge: OO introductory training courses to gain an overview of REACH and CLP; OO seminars on selected topics of REACH; OO workshops to create solutions under the guidance of an experienced expert; and OO in-house consulting for the ad-hoc solution of characteristic problems.

As a globally recognised expert in all chemical law issues, TÜV SÜD continuously pursues the reform process in the EU and supports companies throughout all steps of REACH and GHS implementation. To assist the companies affected by REACH, TÜV SÜD has established an international REACH network. Our environmental experts are tracking REACH implementation in the EU on an ongoing basis. And in addition, we also help to maintain business secrets of our customers in spite of mandatory data sharing provisions. TÜV SÜD developed a service package custom tailored for small and medium-sized enterprises (SME) as well as for global players and we have expanded our range of services to biocides. An increasing focus is to support companies in securing their supply chain management in conjunction with chemicals legislations. VITAL STATISTICS

2017/18 €2,400m

Turnover, group

Turnover, chemical service provision

1000

No of offices

No of countries represented

24,000

Staff, group Staff, chemical service provision

SERVICE AREA BREAKDOWN

IT & software 10%

Authorisation The authorisation procedure aims to assure that the risks from SVHC are properly controlled and that these substances are progressively replaced by suitable alternatives. SVHC may be included in the authorisation list and become subject to authorisation. These substances cannot be placed on the market or used after a given date, unless an authorisation is granted for their specific use, or the use is exempted from authorisation. Our support extends from the management of authorisation consortia to supporting individual companies in fulfilling their duties in a cost-saving and effective manner.

Any other activities concerning REACH and CLP REACH and CLP shift most of the responsibility for the safe handling of chemicals from the regulatory bodies to producers, importers and downstream users and retailers. The relevant requirements and consequences, however, are not clear at first sight. Consequently, we offer all kind of services related to REACH and CLP, from the starting point to implement REACH via testing in our own GLP accredited laboratory to long-term compliance with chemicals regulations. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1866

Established in Mannheim

1926

Introduction of the “TÜV SÜD mark /stamp” in Germany

1960

Establishing chemical services

1990

Conglomeration of TÜVs from the southern part of Germany to form TÜV SÜD and the expansion of business operations into Asia. Best brand of technical services, testing, consulting, training, certification in all industries worldwide – energy producers and providers, nuclear power plants, chemical industry

2006

Expansion of services in Asean by acquiring Singaporebased PSB Group

2007

Establishing REACH services. Founder member of the “BUSINESSEUROPE REACH Implementation Network”.

Training 5%

Laboratory 5% Information 10%

Consultancy/advisory 35%

ACCREDITATIONS Representation & management 35%

Global Service Providers Guide 2019

GLP

CLIENTS

CASE STUDY 5: SVHC

Due to client confidentiality individuals cannot be named. Our clients from more than 30 countries are active in all fields of industry and professional sectors. We support a network of chemical plants. Company size varies from worldwide operating entities to SMEs. We support clients in all their roles under the REACH regulation and for all types of substances. In 2013 we expanded our range of services to biocides as to the biocides products Regulation.

A EU-based group with legal entities in several member states was seeking support in making an inventory of SVHC of the articles put into market, as well as in implementing a system to comply with the duties to communicate information on SVHC in articles. TÜV SÜD offered an integrated approach over all affected legal entities in order to avoid duplication of work. Representative articles were selected for chemical testing in case of uncertainty on the presence or concentration of SVHC. Testing was performed in TÜV SÜD’s own chemical laboratory. As a result of the investigation and consulting, a unified system was implemented in the entire group. The system ensured full compliance with REACH Art. 33 to 36. Furthermore, supply contracts were amended to increase legal certainty, to avoid the risk of lawsuits and to avoid image problems.

CASE STUDY 1: Consortium management A consortium with representatives from five countries took over to register a series of substances with registration deadlines from 2010 to 2018. The duty to act as lead registrant was shared among the individual consortium members. The main bodies of the consortium are the steering committee, the technical committee and the secretariat. TÜV SÜD rendered consortium management to all bodies. Technical REACH consultancy and financial consultancy was part of the services to be delivered. CASE STUDY 2: Support in REACH implementation An EU manufacturer of articles and substances required support in implementing a REACH system for the entire company. The tasks focused on communication in the supply chain, registration, SVHC, training and organisational building. A team was formed for continuous assistance; the core team was fully integrated in the client’s activities on-site. CASE STUDY 3: Complete service package for lead registrants Several clients from the chemical industry lacked capacity to prepare lead dossiers. TÜV SÜD prepared and submitted the lead dossiers on behalf of the clients. Additionally, all accompanying steps were performed as well: Sief communication, data-gap analyses, testing, expert statements, Qsar modelling, communication within consortium, preparation of safety data sheets, cost calculation of letter of access, handling of letter of access. CASE STUDY 4: Testing strategies and testing The lead registrant of four substances had to conduct studies in order to fulfil the information requirements under REACH. Two of the substances were classified as hazardous according to CLP, the classification of the others was not yet clarified. TÜV SÜD performed all steps to comply with the information requirements. The lead registrant of four substances had to conduct studies in order to fulfil the information requirements under REACH. Two of the substances were classified as hazardous according to CLP, the classification of the others was not yet clarified. TÜV SÜD performed all steps to comply with the information requirements. All available information that had been gathered was assessed for its adequacy for classification and labelling. Cost for data sharing is one of the crucial issues of negotiations in Siefs. High quality data outsell a higher price than data of low quality. Some data gaps were closed by Qsar and read-across. Other data gaps had to be closed by testing following to a meaningful test strategy. TÜV SÜD operates its own GLP testing laboratory capable of performing all testing required by REACH.

CASE STUDY 6: Only representative TÜV SÜD acts as OR for many non-EU manufacturers. In several countries this is performed by involving local TÜV SÜD offices. This approach guarantees direct contact to the end-client and avoids language barriers where applicable. Thus, also smaller non-EU manufacturers can benefit from OR services which are not sufficiently conversant with English and technical terms. STAFF SELECTION Dr Fritz Prechtl Fritz Prechtl is a chemist and certified REACH multiplicator with more than 30 years’ professional experience. Dr Dieter Reiml Dieter Reiml is a molecular biologist and certified REACH multiplicator with more than 30 years’ professional experience. Javier Castro Javier Castro is a chemist and certified REACH multiplicator with 18 years’ professional experience. Ing. Rupert Scherer Rupert Scherer is an engineer and certified REACH multiplicator with 15 years’ professional experience. Dr Yvonne Fery Yvonne Fery is a food chemist, European Registered Toxicologist and certified REACH multiplicator with more than ten years’ professional experience. Other staff Other REACH experts are located in offices in the EU and outside EU. Additional staff are active in testing for REACH and CLP as well as chemical testing.

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Profile: TÜV SÜD Industrie Service GmbH

207

Profile: UMCO GmbH

208

SERVICE AREA BREAKDOWN Other Training 5% Legal 5% 5% Information 5% Representation & management 5%

CONTACTS Website

www.umco.de

E-mail

umco@umco.de

Head office

UMCO GmbH, Georg-Wilhelm-Straße 187, 21107 Hamburg, Germany

Tel / Fax

+49 (0)40 / 555 546 300 / 49 (0)40 / 555 546 357

GLOBAL OFFICES

Contact

Jan Mönster

Germany: Hamburg, Cologne

Anika Biehl Peter Duschek Ulf Ch Inzelmann

SERVICES PROVIDED

Directors

Consultancy/advisory 75%

International chemicals management determination of the status of all the chemical products used or traded by your company with regard to their worldwide marketability; OO auditing and advising regarding chemicals management at company or corporate level and the integration of responsibilities and documentation into management systems; OO determination of classification and labelling in accordance with European and international chemical and dangerous goods legislation; OO authoring and monitoring of SDS and exposure scenarios (for all European regions/languages using UMCO SDS software UHCS); international SDS compilation and monitoring performed in cooperation with our network partners; OO support with regard to worldwide chemicals management, including analysis of national requirements for marketing and use of chemicals and notification/registration in cooperation with our network partners; OO notification of hazardous mixtures acc. Article 45 of CLP regulation OO permanent monitoring of substance and product data with regard to legislative amendments or changes of customer recipes, including the updating of all necessary documents (SDS, eSDS, labels); OO customised interfaces to generate the automatic import and export of data in standard XML format into/from UMCO SDS software UHCS; OO web services for customer specific evaluations, for example current stock or dangerous goods lists and functions; online calculation tool in accordance with the CLP Regulation; OO automated export of data to print direct CLP/GHS labels; OO company-internal hazardous chemical management; OO compliance service for restricted / banned substances in mixtures / articles; and OO data maintenance for hazardous substances, raw materials and products in the SAP EHS system of our customer. OO

Ownership

See directors

Locations

Germany

Founded

1982

OVERVIEW Chemical Compliance Consulting As a consultancy firm with offices in Hamburg and Cologne, we have over 37 years’ experience of strategically partnering our customers, providing them with compliance solutions for the global handling and distribution of chemicals. Our 80 employees look after 1,000 companies in the chemicals, pharmaceuticals, logistics and processing industries worldwide. Through our longstanding consultancy activities, we know exactly what our clients require in their daily operations: expert knowledge, legal certainty and practical relevance. Our service portfolio includes: OO International Chemical Regulations; OO SHE-Management; OO Dangerous Goods Management; OO Regulatory Compliance and Audits; and OO Emergency Management. VITAL STATISTICS

2017/18

Turnover, group

–

Turnover, chemical service provision

–

No. of offices

No. of countries represented

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2019

REACH management Registration management for co-registrants: OO support in joint registration: communication regarding substance sameness and letter of access (LoA); OO compilation of dossiers and submission to the European Chemicals Agency (Echa); and OO only representative (OR) for non-EU manufacturers according to Article 8 of the REACH Regulation. Comprehensive support for lead registrants: OO communication with co-registrants and preparation of contractual arrangements for data and cost sharing; and OO dossier management: collection and evaluation of information for technical dossier and chemical safety report. OO Communication in the supply chain: OO strategies for the communication with suppliers and customers; OO integration of registration information in the eSDS;

support regarding the identification of uses (use mapping); implementation of exposure scenarios in daily practice; and OO consultation regarding substances of very high concern (SVHC). Strategic consulting: OO consultation and evaluation of organisations and structures in order to ensure REACH compliance; OO support related to participation and argumentation in public consultations and other communications with authorities; and OO application for authorisation: consultancy, planning and support. OO

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Biocides management (Biocidal Product Regulation (EU) No 528/2012) Strategic consulting: OO consultation and evaluation of organisations and structures in order to ensure BPR compliance; and OO advising regarding borderline and dual use products Active substance approval and biocidal product authorisation: OO definition of the appropriate strategy; OO preparation of dossiers according to national legislation, in case the transitional period for actives is applicable; OO conduction of literature research, data evaluation and data gap analysis; OO identity, technical equivalence and physical-chemical parameters; OO toxicology and human exposure, environmental fate and ecotoxicological evaluation; OO monitoring of studies; OO communication with authorities and laboratories; and OO preparation and submission of dossiers Safety health environment management OO provision of a SHE manager/officer; OO provision of external company advisors/officers for the fields of occupational safety, emission protection, water pollution control, waste, hazardous incidents, fire protection; OO carrying out of approval procedures; OO advice on storage of dangerous materials; OO explosion protection consultation; OO preparing operating instructions and risk assessments; OO compiling safety reports and further hazardous incident documentations such as safety management systems and corporate alarm and hazard control plans; OO training and instruction (executives, contract workers, employees); OO management systems: ISO 14001, 18001 (OHSAS), 45001, 50001; OO compliance organisation; OO compliance checks (HSE legal compliance); OO conducting internal audits; and OO fire protection. Dangerous goods OO provision of an external Dangerous Goods Safety Advisor (DGSA); OO establishment of a company individualised dangerous goods organisation and analyses for optimising procedures; OO inventory and dangerous goods audit; OO dangerous goods consulting; OO checklists, working and operating instructions; OO verification of correct classification and labelling; OO instruction and training courses; OO preparing and checking of documents; OO information about legislative changes; and OO project organisation. Emergency services OO Emergency telephone number for EC SDS (all European Poison Centres); and OO GlobalChem24 – 24 hour emergency number for chemicals transport and SDS worldwide (together with the NCEC). Training OO training, workshops and seminars in all services provided OO in-house seminars; and OO working and process instructions.

2006

Co-founder of the Global Chemical Consulting Network (GCCN), an entity which provides further services regarding foreign legal regulations.

2012

New development of an independent, proprietary software solution – UMCO Hazard Communication System (UHCS) – for monitoring products and compiling documents for hazard communication.

2013

Customised interfaces for the automatic import and export of data per XML transfer from our UMCO SDS software (UHCS) to ERP systems of our customers.

2015

Development of a proprietary software, in conjunction with the Haufe – Lexware – Group in Freiburg, designed to internally update legal and liability compliance regulation information in the areas of environmental protection and occupational safety. This software allows for a more upto-date, precise and complete understanding of specific operator obligations.

2016

Customised online training for employees about occupational safety and related areas in cooperation with AS-Trainer. These trainings can be adapted to suit the needs of individual company requirements.

PARTNERS OO OO OO OO OO OO

NCEC REACH24H GIZ GCCN Haufe – Lexware-Group AS-Trainer

CLIENTS Our clients include over 1,000 national and international companies, ranging from the chemicals and pharmaceutical industry, traders, warehouses and logistics companies to the manufacturing industry. All along the chemicals value added chain. CASE STUDY 1: Chemical product management OO

compilation of SDS for different chemical traders and producers of chemical mixtures; and more than 60,000 SDS compiled and regularly updated.

CASE STUDY 2: Business process outsourcing OO

assumption of product stewardship and legal chemical product service for paint companies, including determination of classification and labelling for products in all EU regions and languages; and compilation of SDS and CLP / GHS labels.

CASE STUDY 3: REACH consortium management OO OO OO OO

secretariat of the REACH Selenium and Tellurium consortium; financial management, management of subcontractors, trustee; registration management, Sief- and LoA-management; and representation of the consortium in the Eurometaux REACH Forum.

STAFF SELECTION We support our customers with 80 engineers, scientists and legal experts, working on an interdisciplinary basis, to ensure the economic viability, quality, adherence to deadlines and success of projects.

www.chemicalwatch.com/SPG

Profile: UMCO GmbH

209

Profile: Verisk 3E

210

GLOBAL OFFICES Carlsbad, CA, US: Verisk 3E’s headquarters and EHS call centre. Copenhagen, Denmark: European headquarters. Montreal, QC, Canada: supplier data obtainment and management. Bethesda, MD, US: global regulatory data development and operations. Canton, OH, US: authoring software development, operations and support centre. Tokyo, Japan: sales presence and Asia Pacific customer support. Beijing, China: sales and operational hub.

CONTACTS Website

www.Verisk3E.com

E-mail

info@Verisk3E.com

Head office

3207 Grey Hawk Court, Carlsbad, CA 92010, USA

Tel

North America (US): +1 760 602 8700; Europe (Denmark): +45-69918473; APAC (Japan): +81 365512850

Directors

Edmund Webecke, President Matthew Johnston, SVP, Global Business Development & Marketing Alex Ortiz, VP, Global Regulatory Content Leo Oves, Chief Information Officer Jason Rollingson, VP, Operations Clark VanScoder, SVP, Services Andrea Verspay, VP, EMEA Business Development Tamie Webber, VP, Product & Support

Ownership

Owned by public company, Verisk Analytics

Locations

US, Canada, Europe, Asia

Founded

1988

SERVICES PROVIDED Product safety and stewardship tools and R&D decision support Regulatory research and monitoring – subscription-based online reference tools for researching and tracking how chemicals and substances are regulated around the globe. Content coverage is global in scope and includes chemicals, cosmetics, personal care, food contact and food, flavours and beverages. System-integrated data, rules, phrases and templates – integrated chemical, regulatory, toxicity and eco-toxicity data, vendor SDS data, expert rules, multilingual phrases, document and label templates and data loading tools for managing EHS compliance activities in other corporate systems. SDS authoring and distribution SDS and label authoring software – an enterprise software solution suite designed for companies’ in-house EHS staff to produce SDSs, labels, exposure scenarios and other hazard communication documentation. SDS authoring services –outsourced or co-sourced assistance with authoring SDSs, labels and exposure scenarios via Verisk 3E’s own fullydedicated, in-house staff of highly qualified, multilingual authors. SDS distribution – facilitates the dissemination of SDSs to all stakeholders.

OVERVIEW Verisk 3E delivers intelligent compliance solutions that empower companies around the globe to reduce risk, drive continuous improvement and create new growth opportunities. Verisk 3E has set the standard for combining regulatory expertise and enriched global compliance content and transforming it into actionable intelligence to enhance chemical and workplace safety, product safety and stewardship, supply chain stewardship and research and development decision support. VITAL STATISTICS

2017/18 -

Turnover, group Turnover, chemical service provision

No of offices

7 Global

No of countries represented

350+

Staff, group

80%

Staff, chemical service provision SERVICE AREA BREAKDOWN IT & software Consultancy/advisory 10% 10%

Information 80%

Global Service Providers Guide 2019

Chemical and workplace safety compliance SDS and chemical management – a variety of products and services for the management of vendor supplier SDSs. Risk assessment – analyse the toxicity of chemicals used in the workplace to determine risk profile. Dangerous goods transportation – around the clock global hotline access for guidance and classification of shipping hazardous materials for any mode. Emergency response – emergency response for spills, ingestions or exposures and for dispatching emergency responders to an incident. Disclosures, permits and reports – outsourced services for researching, identifying, analysing, tracking, completing and submitting required disclosures, permits and reports. Hazardous waste management and classification services – supports customers’ hazardous waste management obligations, including proper storage and disposal. Supply chain stewardship Supply chain compliance solutions – products and services to facilitate compliance with regulatory and market driven requirements for detailed information about the source and origin of products. Service areas include conflict minerals, RoHS, REACH, California Prop 65 and more. Consulting services Product compliance – Verisk 3E offers a full spectrum of services that address the challenges of bringing a product to market and managing compliance from a global perspective. Global chemical registration, notification and reporting – support for new chemical notification, chemical registration and reporting, including REACH and REACH-like requirements.

EU Poison Centre Notifications – solutions to help companies meet both current and upcoming obligations. TSCA – services range from fully outsourcing TSCA compliance to project-based, function-specific areas. Safer chemical analytics – intelligent hazard and risk assessment and management services that assess the relative hazards of chemicals or products, including predictive toxicology and interim techniques such as read-across and Qsar. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1998

Company founded

2004

Acquisition: Ariel Research Corporation; international expansion

2007

Acquisitions: HSE Systems and MSDS Solutions

2008

REACH and GHS initiatives

2010

Acquired by Verisk Analytics

2013

Launched Supply Chain platform and services

2014

Expanded global presence with office in Tokyo

2017

Rebranded: 3E Company became Verisk 3E

2018

Expanded global presence with office in Beijing

2002 -19

Long-time and frequent industry award recipient: www.verisk3e.com/about-verisk-3e/awards-recognition

ACCREDITATIONS CHMM, CSP, DGSA, CPEA, CSBA, REA, IATA, more. PARTNERS Airsweb, ASD, BIOVIA, Cority, Dotmatics, Enablon, Flashpoint, Gensuite, Intelex, Jaggaer, Kelaroo, Links-AS, Logic1, Logical Data Solutions, Reliance Label Solutions, SAI Global, The Chemical Daily, more. CLIENTS More than 5,000 clients across 35 countries span multiple industries including chemicals; cosmetics; food contact; food; flavours and fragrances; personal care and consumer products; electronics and medical devices; healthcare; industrial, automotive and heavy equipment manufacturers; oil, gas and petrochemicals; pharmaceuticals; retail; utilities. CASE STUDY 1: Cleaning Up Compliance with Verisk 3E Regulatory Compliance Solutions Industry: Global manufacturer and supplier of specialty chemicals and products for water treatment, soil remediation, air purification and waste treatment. Challenge: Monitoring and analysing each regulation by market and then preparing, obtaining, maintaining and distributing thousands of SDSs, Extended Safety Data Sheets (eSDSs) and labels for finished products as well as the laboratory chemicals used at each site. The hazard communication documentation had to be available in more than 24 languages, follow specific GHS formats and contain highly technical information including exposure scenarios. Solutions: SDS Authoring Services, SDS Management, Regulatory Reference and Research. Results: Increased quality of SDSs, more efficient change management, the ability to keep up with global regulations, proactive compliance and significant time savings. “The service that Verisk 3E provides alleviates the burden on our internal resources.Verisk 3E can do our authoring for us so we don’t have to allocate full time personnel. With Verisk 3E handling our SDS obtainment and updates, it frees up our procurement team from time consuming non-value added work.

And with 3E Insight for Chemicals, our team saves hours of research on compliance requirements by being able to instantly access current regulations. By outsourcing time-consuming and specialized tasks we have achieved an estimated 25% to 50% savings in manpower devoted to authoring, regulatory research, SDS updates and obtainment.” CASE STUDY 2: Global Food and Flavours Manufacturer Feeds SAP EHS with Integrated Content from Verisk 3E Industry: Food and flavours Challenge: The global food and flavouring manufacturer did not have a clear understanding of its SDS and labelling requirements. Solutions: Verisk 3E Integrated Content for SAP EHS and an array of services Results: The popular manufacturer leverages Verisk 3E North American and European product safety data, physical-chemical, toxicological and eco-toxicological content (PCTEC), Expert Rules, Templates and Phrases to fuel their SAP EHS platform for SDS authoring. They also rely on Verisk 3E to obtain and integrate their vendor raw material SDS data for use in SDS authoring. The solution has significantly streamlined their compliance processes as well as increased their level of compliance. STAFF SELECTION Dr. Yasmin Chen, Manager of China Authoring Services, Sr. Regulatory Consultant and SDS Author Dr. Yasmin Chen has nearly two decades of experience in authoring and regulatory consulting. She has worked at Verisk 3E for more than 12 years, authoring worldwide Safety Data Sheets (SDSs) for all regulated regions/countries and has worked extensively with all types of industries including chemical, oil, gas, food products, pharmaceuticals and biotechnology. Dr. Chen has strong knowledge of European chemical regulations, including REACH. Hans Plugge, Sr. Toxicologist/Manager, Safer Chemical Analytics Hans Plugge has more than 30 years of interdisciplinary experience in regulatory chemistry and toxicology and hazard/risk assessment. Besides developing Verisk 3E’s 3E Green Score, our proprietary hazard/ risk assessment system (including chemical sustainability and mixture assessment), other responsibilities include regulatory consulting for various clients as well as development of the physical, chemical, toxicological/eco-toxicological databases within 3E Insight for Chemicals. His environmental consulting experience includes US EPA and EU-DG employment. Margret Viborg, Chemical Regulatory Compliance Analyst Margret Viborg has a background in regulatory affairs and a degree in biotechnology. She provides regulatory consulting services including project management, compilations of regulatory overviews and compliance assessments as well as authoring SDSs, classifying and labelling chemicals and managing product registrations, including Poison Centre Notifications.

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Profile: Verisk 3E

211

Profile: Yordas Group

212

SERVICE AREA BREAKDOWN

yordas

Training 10%

Group

IT & software 11%

Business through Science

Consultancy/advisory 40%

CONTACTS

Laboratory 20%

Website

www.yordasgroup.com

E-mail

info@yordasgroup.com

Head office

Lancaster Environment Centre, Lancaster University, Lancaster LA1 4YQ, UK

Tel

+44 (0) 1524 510278

GLOBAL OFFICES

Fax

+44 (0) 1524 510588

The company has offices and representation in the UK, Germany, Italy, USA, Canada, Japan, China and Chile.

Contact

Lucas Gent

SERVICES PROVIDED

Directors

Jonathan Lutwyche Dr Sandra Meijer Adam Rowntree

Ownership

Privately owned

Locations

UK, Germany, Italy, US, Canada, Japan, China, Chile

Founded

2007

Information 5%

Regulatory compliance Global notifications including EU REACH, US TSCA, China MEP Order No. 7, Korea ARECS (K-REACH), Taiwan TCSCA and OSHA, Japan CSCL and ISHL; OO environmental permitting: HOCNF, OSPAR; OO product regulations: toys, cosmetics, detergents, aerosols, RoHS; OO nanomaterials regulatory compliance and safety; OO biocides (EU, Turkey and South Korea); OO hazard communication: global safety data sheets, classification; and labelling to GHS, CLP and other global classification systems, exposure scenarios and eSDS. OO

OVERVIEW Yordas Group is a leading provider of scientific, environmental, and global regulatory consulting services. We have international capability with representation in North America, Asia and Europe, and commercial activities around the world. With offices in the UK and Germany, Yordas Group is well placed to support companies both before and after the UKâ&#x20AC;&#x2122;s exit from the European Union. Our unique collaborative approach is designed to build strong working relationships over time, allowing us to create a customised and integrated service specifically tailored to the needs of each individual customer. Delivering innovative solutions for business, industry and government, Yordas continues to create value and sustainability for our clients. Crosscutting themes such as Product Stewardship, Chemical Notification Systems, Environmental Permitting, and Waste Management are within the broad portfolio of services we provide. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Representation & management 20%

Global

Staff, group

Staff, chemical service provision

Sustainability & Product stewardship OO Sustainability strategy and reporting; OO product substitution and green chemistry; OO integrated Management Systems; OO regulatory monitoring; OO regulatory and supply chain audits; OO Yordas Hive chemical management software; and OO bespoke software solutions. Scientific expert & analytical services OO chemical characterisation; OO chemical safety assessment and reporting; OO analysis of nanomaterials; OO hazard & risk assessment of substances and products; OO data acquisition, testing and management; OO assessment of alternative chemicals and substitution strategies; OO assessment of endocrine disrupting properties; OO systematic review; OO expert assessments: polymer status, exemption from registration, physchem and (eco)toxicological endpoint; OO read across justification and QSAR toolbox; and OO expert witness services and litigation support. Training Classroom courses, virtual classroom and customised in-house training on REACH, hazard communications, IUCLID, Biocidal Products Regulation, OSPAR, Asia-Pacific Regulations and nanomaterials. ACCREDITATIONS Our training courses are approved by the Royal Society of Chemistry. CLIENTS Our global customer base incorporates manufacturers, distributors and retailers across several industry sectors along with multiple trade associations and government bodies.

Global Service Providers Guide 2019

CASE STUDY 1: Meeting SDS requirements around the globe With the final CLP 1272/2008 deadline of June 1st 2017 looming, a leading US producer of minerals, including salt, magnesium chloride and plant nutrition products, needed to update all EU SDS for their portfolio of products. After being let down by their software producer and requiring expert help to bring their SDS into compliance, they were looking for a professional team who could undertake the update and reclassification of their products to bring them into line with CLP. With a product base containing hundreds of individual substances, completing an accurate and compliant hazard classification assessment was proving incredibly difficult for the internal regulatory team. The task was made more complicated by the high number of countries in which the products were placed on the market, with each country requiring an individual SDS and label translation. In total, 460 individual SDSs were needed covering 15 regions. Yordas’ team were able to put together a project plan for the full hazard assessment and translation of all applicable products allowing for a timeline to compliance to be produced. From here, Yordas assisted the client in identifying the most important products for update and efficiently worked through the product portfolio enabling the client’s full product base to have compliant regulatory documentation before the 1 June 2017 deadline. CASE STUDY 2: Ensuring cost effective compliance through scientific expert opinion A major international manufacturer of consumer products was assessing their regulatory obligations under REACH. Because of the nature of their business, their substance inventory was very large and the potential cost associated with achieving regulatory compliance was substantial. Yordas examined the client’s inventory and found that a significant number of the substances listed were of natural origin (e.g. minerals and plant extracts). Depending on their hazard profiles and the specific conditions used to manufacture them, substances that occur in nature or are obtained from natural sources may be exempt from registration in accordance with Annex V of the REACH Regulation. Manufacturing details and hazard data were obtained for each substance that had been identified as a potential candidate for exemption. Yordas assessed this information and also performed detailed literature searches in order to fully evaluate each case. Where substances did fulfil the criteria specified in Annex V, exemption statements were created that captured all the information necessary to demonstrate why registration was not required. By identifying the legitimate cases for exemption from registration, Yordas helped the client to significantly reduce the cost of achieving regulatory compliance. CASE STUDY 3: Yordas Hive helps identify substance relevance for leading home improvement Company Yordas Hive assisted Kingfisher plc in developing a chemical strategy allowing them to anticipate future regulatory action and meet sustainability commitments in complex, international supply chains. To meet their sustainable growth plan goal, kingfisher commissioned Yordas to author a Chemicals Action List (CAL) within which a list of chemicals of concern were identified. This has been used to create product specifications where restrictions apply within its Group QA function and are applied to products managed within its group purchasing teams that source products for its trading brands. For ease of use and transparency, the CAL was organised into a Black List of prohibited and restricted substances, a Grey List of declarable and controlled substances and Watch List of substances either proposed for regulation or with a suspected or known hazard concern. A new Chemicals of Concern (COC) list was created from the Watch List by screening each substance entry against a set of priority criteria agreed with Kingfisher, using the information in Yordas Hive’s Substance Database.

This early warning system allows Kingfisher to develop a regulatory roadmap and anticipate future regulatory action with a view to safeguarding their future business, as well as meet its strong commitment to protect human health and the environment beyond the legal requirements of regulatory compliance. CASE STUDY 4: Biocidal Product Authorisation for a disinfectant product A UK based chemical manufacturer required authorisation of their disinfectant product under EU Biocidal Product Regulation (BPR, Regulation (EU) 528/2012). As a first step, Yordas investigated the possibility for the client to join a consortium submitting authorisation applications for a product families similar to the clients’ products. It was concluded that none of the consortia options available were appropriate for the client’s products and therefore Yordas supported the client in preparing and submitting a biocidal product dossier and application. After evaluating the existing data and liaising with the evaluating competent authority, Yordas devised a testing strategy to fulfil data requirements in the most efficient and cost-effective way. Where possible, Yordas prepared expert assessments rather than commissioning testing resulting in a substantial cost saving for the client. Working to a tight regulatory deadline, Yordas compiled an IUCLID dossier, draft risk assessment and other supporting documentation necessary for a successful submission of a national product authorisation application. The application was accepted by the deadline (by the date of approval of the active substance) and as a result of Yordas’ strategy and scientific support the client was able to fulfil their regulatory obligations to continue to make their products available on the market.. STAFF SELECTION Sandra Meijer – Director: Product Stewardship A recognised expert on chemicals management and product stewardship, Sandra has built up the Yordas Group’s highly regarded Product Stewardship services package which includes the Yordas Hive suite of regulatory compliance tools for industry. Sandra’s extensive knowledge on how global chemicals regulations impact on supply chains, and her work with Yordas Hive has helped us to deliver tailored compliance solutions for large companies in the automotive, aerospace, and retail industries. Alex Paul – Principal: Chemical Regulatory Services Alex manages the regulatory team at Yordas, a role that involves overseeing the delivery of global notifications including Biocides and Lead/Joint Registrations, supporting the provision of Only Representative services to non-EU clients and the business development of services in North American and Asian markets. In addition to maintaining and further developing Yordas’ strong position in Japan through collaboration with our strategic alliance partner JEMAI, Alex supports the regulatory team to develop new services in existing and emerging markets in Asia and South America. Rosalinda Gioia – Principal: Science Rosalinda is an internationally recognised expert on ecotoxicology. She has provided expert scientific advice and policy support to government regulators on chemical risk assessments relating to the oil and gas industry, for which she has authored technical bulletins and papers to the annual meeting of OSPAR’s Offshore Industry Committee (OIC). Rosalinda oversees the delivery of scientific services including technical dossiers for REACH lead registrations and biocides active substance approval and product authorisation, and OSPAR registrations. She also provides technical leadership and advice relating to the environmental fate of chemicals, persistence, bioaccumulation and toxicity (PBT) and risk assessments in the aquatic environments. Neil Hunt – Lead: Nanomaterials Research Neil heads Yordas Group’s services for nanomaterials, substance substitution, exposure scenarios and authorisation, running the training courses for the last two topics. Neil has been appointed to be a member of ECHA’s Partner Expert Group for the revision of the REACH guidance documents on recommendations for nanomaterials. www.chemicalwatch.com/SPG

Profile: Yordas Group

213

Niche firm profiles

214

CONTACTS

CONTACTS Website

www.3s-chem.gr

Website

www.altox.dk

E-mail

info@3s-chem.gr

E-mail

altox@altox.dk

Head office

133, El. Venizelou Str, 16343 Athens, Greece

Head office

Tonsbakken 16-18, DK-2740 Skovlunde, Denmark

Tel/ Fax

+30 2109901150 / +30 2109901151

Tel/Fax

+45 3834 7798

Contact

Panos Drougas

Contact

Pernille Hjaltalin

Ownership

Private

Ownership

Private limited company

Founded

2/01/2007

Locations

Denmark

Founded

1991

OVERVIEW 3S–SafelyServingScience is a distinctive company providing specialised advice and guidance at each-stage-of-chemicals-lifecycle. Our mission is to contribute with knowledgeable care and best practices to our customers’ efforts to: a) identify and harmonise with compliance requirements governing the production, storage, transport and supply of chemicals b) conscientiously fulfil their environmental, health and safety duties and c) gain competitive advantage to accelerate their growth. Our +26y of practical experience in the global supply of chemicals, supported by certified knowledge on Transport-HSEQ management systems, enables us to deliver reliable, quick and cost-effective solutions. Aiming to provide high value-added services, we practice the modern project management principles supported by the latest technology cloud software. We are passionate about creating and sharing value and look forward to offering you the best possible customer experience! SERVICES PROVIDED Here’s a detailed listing for the off-the-shelf deliverables and services we offer: CHEMICAL MANAGEMENT AND REGULATORY COMPLIANCE (SDSs/C&L Studies/REACH-IUCLID Cloud services/SEVESO III/Chemical inventories); ENVIRONMENTAL PERMITS (EIAs/ISO14001*/HazWastes classification [WFD-EWC/ADR-IMDG/IATA-DGR]); HEALTH AND SAFETY AT WORK (Safety officer outsourcing services/ISO18001*/ risk assessments of chemical hazards/ business conduct policies [EH&S]); and DANGEROUS GOODS SAFETY ADVISER (DG transport classification/transport documentation (ADR/RID/IMDG/IATA-DGR)/ independent supplier audits [EH&S, SQAS]). *implementation guidance and internal auditing

Website

www.anthesisgroup.com

E-mail Head office

contact@anthesisgroup.com The Future Centre, 9 Newtec Place, Magdalen Road, Oxford, OX4 1RE, UK

Tel/ Fax

+44 (0)1865 250 818

Contact

Helen Kean

Ownership

Private company

Locations

Europe (UK, Ireland, Germany, Sweden, Finland, Italy), North America, Middle East, Asia Pacific 1994

OVERVIEW Anthesis-Caleb is a policy and regulatory consultancy that has been active in the field of chemical regulation since 1994 and part of the sustainability specialist Anthesis Group since 2014. Anthesis’ clients range from governments, multinational companies and worldwide consortia to small companies with a single substance. Anthesis tailors its support to take account of a client’s internal resources in order to maximise the value of our contribution. The company has a considerable track record in sustainable management recently adding a sustainable procurement support service for our clients. SERVICES PROVIDED OO OO

OO OO OO OO OO OO OO

Altox is a service provider assisting private companies (SMEs as well as large companies), authorities and trade organisations. We aim at finding practical solutions based on science and regulatory requirements. Altox is widely recognised for the development of helpful desk tools to ease implementation of C&L and preparation of SDS. Being independent from software solutions (C&L, SDS) and test laboratories (CRO) it allows for a more flexible approach towards regulatory changes. We also offer extensive and well recognised education programmes, open courses and tailor-made company courses, seminars etc. SERVICES PROVIDED Altox is a consultative company that provides counselling within: REACH and CLP requirements of chemicals and articles (C&L, SDS, ECHA registrations and communication); OO toxicological end ecotoxicological evaluations and reviews; OO biocides (BPR); OO cosmetics (safety assessment, Product Information File, labels, CPNP etc); OO product safety OO other registration services (eco labelling, national product registers, poison centres); OO general HSE counselling (on-site handling, storage, ATEX etc); and OO Scandinavian regulations (eg MAL codes and order on carcinogenic substances). OO

CLIENTS Importers, downstream users and manufactures of chemicals primarily in Europe. Altox also provides counselling to trade organisations, universities and other professionals within the chemical area.

CONTACTS

Founded

OVERVIEW

Consortium and Sief management; REACH – dossier development for registration, evaluation and authorisation/ restrictions; OR and TPR services for EEA and under Brexit; CLP compliance management; SDS authoring and management; product compliance under REACH, RoHS and Extended Producer Responsibility; sustainability strategy development and implementation; sustainable procurement; chemical management including supply chain mapping, design & implementation; and environmental due diligence.

CLIENTS Anthesis-Caleb supports SMEs and large corporations, European and global industry associations and global task forces across a range of industrial sectors and retailers. Currently the company is OR for around 15 companies and provides consultancy support for many more. Anthesis-Caleb also supports more than ten REACH consortia as managers and advisors.

Global Service Providers Guide 2019

Website

www.arrowregulatory.com

E-mail

elicia@arrowregulatory.com

Head office

6th Floor, City Gate East Toll House Hill Nottingham, NG1 5FS

Tel

01159 352243

Contact

Dr Sara Kirkham / Dr Carlo Poncipe / Dr Virginia Gretton

Ownership

Limited Company

Locations

Founded

2016

OVERVIEW Arrow Regulatory has extensive knowledge of chemical legislation, particularly in the EU Biocidal Products Regulation, REACH, CLP and ADR. The company has considerable experience in the development of regulatory strategies, designing test programs and providing tailored advice, in addition to the preparation of dossiers and risk assessments. Working with both international consortia and global partners Arrow Regulatory has experience in obtaining worldwide registrations for chemicals and biocides. Together the Arrow Regulatory team has over 40 person-years of experience in regulatory compliance during which time we have prepared over 50 REACH Lead dossiers and worked on over 30 biocide active substance inclusion dossiers. Arrow Regulatory Limited is able to offer an integrated and tailored service with our experts adding value by applying their thorough understanding of separate pieces of legislation to each company-specific enquiry. Our aim is to provide a high level of service to all clients, irrespective of their size SERVICES PROVIDED Arrow Regulatory Services REACH registration & authorisation; OO Preparation of vulnerability reports for REACH Phase-in dossiers; OO Biocides; product authorisation and active substance Union list inclusion ; OO Human and environmental risk assessment; OO SIEF and Consortium management services; OO Data gap analysis, data evaluation (reliability and acceptance), data-sharing and cost compensation; OO Project management and study monitoring; OO Worldwide product compliance; OO EU OR and biocide EU Representative functions via Eire office; OO Dangerous Goods consultancy for road (DGSA), sea and air; OO CLP, GHS, and labelling advice; and OO Preparation of Safety Data Sheets (SDS). OO

Bootman

Chemical Safety Ltd.

CONTACTS

Website

www.asseso.eu

Website

www.bootmanchem.com

E-mail

info@asseso.eu

E-mail

info@bootmanchem.com

Head office

Frohsinnstraße 28, 63739 Aschaffenburg, Germany

Head office

Diss Business Centre, Diss, Norfolk, IP21 4HD, UK

Tel

+49 6021 15086-0

Tel

+44 (0)1379 640534

Fax

+49 6021 15086-77

Contact

Chris Lewis

Contact

Stefan Oehrlein

Ownership

Limited company

Ownership

corporation

Locations

UK, Republic of Ireland

Founded

2018 (2008)

Founded

1994

OVERVIEW

Asseso offers expert knowledge in product compliance management (PCM) and is certified to DIN EN ISO 9001:2015. The company provides flexible, interdisciplinary services ensuring that products meet all legal requirements when made available on the EU market, for both EU and non-EU companies. Consultants and service providers in one, asseso ensures comprehensive support for its customers. The staff works with a holistic approach and consists of highly qualified, regularly trained engineers and chemists. They are also valued experts for authorities or external bodies. Due to ongoing monitoring and regular exchange in its partner network, new legislative trends are identified and implemented in customers’ internal structure at early stage. Asseso is proud of its longlasting, successful customer relationships.

Bootman Chemical Safety Ltd is an established consultancy, offering a wide range of scientific and regulatory services to support our clients through the process of chemical safety assessment. We have in-depth knowledge of REACH, CLP and other chemical regulations, in combination with expertise in industrial toxicology and risk assessment to serve a worldwide client base. Our sister company in the Republic of Ireland allows us to continue providing a full range of services whatever the outcomes of Brexit.

SERVICES PROVIDED OO OO

OO OO OO OO OO OO

OO OO OO

Compliance check, Product Specifications Development and implementation of tailor-made Product Compliance Management Systems Inventory of Legal Provisions / Effective product data management REACH registration process (strategy, dossier, SIEF and consortia, OR service) Safety Data Sheets (SDS) Classification, labelling and notification of substances and mixtures Poison Centres Notification / UFI Notification and information obligations due to REACH, CLP/GHS, WEEE, RoHS, food contact et al. CE conformity Risk assessment Client-specific workshops and trainings

SERVICES PROVIDED We are focused on providing the best service to our clients whatever the size of project. REACH forms a major part of our work and highlights a number (but not all) of the areas where we provide expertise: OO registration strategy, dossier preparation, prior-registration inquiries, PPORD application, chemical safety assessment including exposure assessments and risk characterisation, only representative/third party representative services, SVHC product statements, study monitoring, support on classification and labelling, safety data sheet authoring or review, preparation of CLP notifications and the list continues!; and OO we also offer technical support to major Siefs/consortia on behalf of clients or as an independent contractor, discussing strategies for registration or evaluation; literature searches and other critical data reviews are also undertaken. CLIENTS Client confidentiality precludes our naming them, but we serve a wide range from SMEs to global corporations. All our clients expect high-quality service and this can be provided to you.

CLIENTS Client confidentiality is guaranteed. We serve more than 150 customers within Europe, USA and Asia. They are manufacturers, importers, retailers and downstream users from different industries and product areas, e. g. toys, interior decoration, electrical or chemical products. Company sizes range from small size companies to global corporations.

CONTACTS Website

www.auxilife.com

E-mail

info@auxilife.com

Head office

Auxilife Scientific Services Pvt. Ltd. A-503, Speciality Business Centre, Balewadi road, Balewadi, Pune-411045, Maharashtra, India.

Tel

+91-7757024864, +91-7757014864

Contact

Dr. Thomas Mueller

Ownership

Private company

Locations

India

Founded

2011

OVERVIEW At Auxilife we aim to provide regulatory scientific solutions to global chemical industry by eliminating regulatory complexities. We pride for understanding client’s specific business needs and provide a customize regulatory solution that elevate business decisions and accelerate growth. Maintaining a high level of efficiency, integrity and strong ethical standards led us celebrate 7 years of success with satisfied clients. SERVICES PROVIDED AUXILIFE offers a complete set of expertise for registering, plant protection products, biocides, fine chemicals, feed & food additives, cosmetics and pharmaceuticals, in EU & India. Key services: OO Data evaluation & gap analysis with study monitoring; Strategic advice for registration & testing; Data review & analysis; Environment and human risk assessment; Classification and labelling; Dossier preparation, submission and post submission support; Liaison with regulatory authorities Auxilife organized expertise into four technical teams: environmental risk assessment, regulatory chemistry and human health assessment, regulatory affairs & project management, bio-efficacy. We also provide policy advice to government authorities and industries. Our services particularly focus on regulatory processes in the Europe and India. CLIENTS We follow an ethical policy to maintain confidentiality of our clients. Auxilife partnered clients are based in Europe, USA and Asia across multiple industry sectors – speciality chemicals, agrochemicals, biocides and pharmaceuticals.

CONTACTS Website

www.chd.com.tr

E-mail

info@chd.com.tr

Head office

Fethiye Mah. Sanayi Cad. Corner+ İş Merkezi No:263 Kat:3, Nilüfer, Bursa, TURKEY

Tel

+90 (224) 999 6223

Fax

+90 (224) 999 6200

Contact

Rauf Öztürk

Ownership

Private company

Locations

Turkey

Founded

2012

OVERVIEW CHD Global is a regulatory consultancy company providing regulatory advice and compliance solution to support its clients’ sustained expansion to the Turkish market. A well-consolidated network of relationship with the national competent authorities as well as a good experience with chemical regulations allows us to offer a professional and cost-effective service. SERVICES PROVIDED CHD Global provides one-stop solutions for regulatory compliance with highly experienced and qualified professionals. We provide; OO KKDIK (Turkish REACH) & SEA (Turkish CLP) compliance service assisting chemical manufacturers, importers and downstream users with all their KKDIK/SEA responsibilities. OO C&L notification service as a pre-registration under KKDIK OO only representative service for non-Turkish companies under KKDIK. OO third party representative service for Turkish companies. OO SDS/eSDS authoring service in compliance with KKDIK and REACH (in all EU languages). OO SDS certification service for Turkish SDSs. OO technical translation service for documents (chemical safety reports, exposure scenarios, SDSs, etc.) required to be in Turkish under KKDIK CLIENTS CHD Global assists as a regulatory compliance partner for Turkish and global players, providing customized services to all size of companies from SMEs to large companies. Our clients are manufacturers, importers and downstream users in many different industrial fields: chemicals, agrochemicals-biocides, petrochemicals, pharmaceuticals, adhesives-sealants, coatings-paints, detergents, polymers etc.

www.chemicalwatch.com/SPG

Niche firm profiles

215

Niche firm profiles

216 ®

CONTACTS

Website

www.chem-academy.com

Website

www.csregulatory.com

E-mail

info@chem-academy.com

E-mail

helpline@csregulatory.com

Head office

Bahnhofsplatz 2, D-16321 Bernau bei Berlin, Germany

Head office

The Old Courthouse, St Peters Churchyard, Derby, DE1 1NN, UK

Tel

+49 3338 75157 0

Tel/Fax

+44 1332380692 / +44 1332380692

Fax

+49 3338 75157 10

Contact

Steven Green, Craig Deegan

Contact

Dr Bjoern Nehls

Ownership

Private company

Locations

Germany, Switzerland

Locations

Privately owned UK and Republic of Ireland with a global network of expert technical providers

Founded

2003

Founded

2007

OVERVIEW

OVERVIEW Chem-Academy organises high-class conferences, congresses and training courses covering a range of topics from the chemical, food contact and pharmaceutical industry. The events distinguish by practical orientation, networking opportunities, and premium speakers from relevant authorities, science and industry. You will meet executives from leading companies of the chemical industry such as manufacturers, distributors, downstream users and service providers. The events reflect the increasing dynamics within a regulated framework, both on a national and on a global level. SERVICES PROVIDED Conferences and courses on chemical regulation and its implementation. CLIENTS A wide variety of clients and delegates from industry, authorities, and service providers.

CS Regulatory Ltd is an independent, privately owned organisation accredited to ISO 9001:2015 successfully providing regulatory assistance to suppliers of industrial chemicals throughout the world. Staff at CS Regulatory offer a combined experience of more than 50 years of professional experience within the industrial environment; we have the expertise to assist you with whatever global chemical regulation requirements you may have. With a network of strategic partnerships throughout the globe we can assist with EU registration for REACH and CLP purposes, worldwide notification of chemicals, representation of clients within Europe, production of associated chemical safety documents, liaison with authorities and product defence, advice on testing strategies and project management of data packages, acquisition of existing data and product stewardship. SERVICES PROVIDED OO OO OO OO

CONTACTS

OO OO

Website

www.stoffenmanager.com; www.cosanta.nl

E-mail

info@cosanta.nl

Head office

Laan van Kronenburg 14, 1183 AS Amstelveen, The Netherlands

Tel / Fax

+31 20 792 00 13

Contact

Albert Hollander, Erika Ustailieva, Henri Heussen

Ownership Locations

Private Limited Company The Netherlands, Germany, Belgium, Finland, Denmark, UK, Austria, Sweden, Poland, Spain, France, Italy, Taiwan.

Founded

2014

REACH and CLP Worldwide notification of chemicals Representation of clients within Europe and UK Production of associated chemical safety documents (MSDS, chemical labelling, hazard assessment, etc) Liaison with authorities and product defence Advice on testing strategies, including administrating and project management of data packages Acquisition of existing data DGSA Services

CLIENTS A broad range of clients, from small niche suppliers to global multinationals with customers throughout the world.

OVERVIEW

CONTACTS

Cosanta B.V. is a knowledge-intensive consultancy organisation. The company provides occupational health and safety, chemical management and sustainability services, combined with training and research. Cosanta is the legal owner and developer of the online platform Stoffenmanager®.

Website

dangerousgoods.com

E-mail

larry@dangerousgoods.com

Head office

14606 Sheraton St, Houston, TX 77039, USA

Tel

(281) 821-0859

Contact

Larry Snellings

Ownership

Privately owned

Locations

USA

Founded

1980

SERVICES PROVIDED Online software: Stoffenmanager® helps organisations to comply with the regulatory and broader ethical and sustainability requirements. Stoffenmanager® is an online system to identify the chemical hazards, control the exposure at workplaces and communicate in an understandable, transparent manner to managers, employees and external stakeholders. The advantages of the system are: – validated quantitative chemical risk assessment model based on more than 6000 measurements; – internationally accepted and included in the EU chemical legislation (REACH R.14); – reliability guaranteed by an independent International Scientific Advisory Board; – sustainable business model providing free basic and fee-based licences; – multilingualism; -technical and expert support for all clients; – more than 35,000 users globally, 50 new per week. Consultancy: support in chemicals risk assessment and control measures, SDS database, performing measurements and biological monitoring, auditing, supply chain management, advising on REACH, CLP, nanotechnology and sustainability. Training: online and physical training of the use of Stoffenmanager®, regulatory compliance and strategy for supply chain communication and chemicals management. CLIENTS Multinational and global businesses, governmental organisations, local industries and SMEs from all sectors, covering the entire supply chain.

Global Service Providers Guide 2019

OVERVIEW Dangerousgoods.com, Inc. is a privately owned corporation with its feet based on solid ground. Since 1980, we have changed and grown with the industry trends and continue to be managed by hands on, quality oriented transportation professionals. The goals of Dangerousgoods.com, Inc. and its employees are to provide quality service and products, customer satisfaction and solutions to problems. We are a hands-on company that specializes in the field of Hazardous Materials Regulations. We provide services to a variety of customers from large chemical companies to small independently owned businesses. The company was founded under the guidance of Larry Snellings, whom many in the Gulf Coast Region consider to be the “GURU” of hazardous materials regulations. SERVICES PROVIDED Safety is a primary concern for ALL employers today. Frivolous law suits, insurance claims, workers comp claims, and a general regard for employee safety have encouraged employers to take a more proactive approach to work related safety programs. Educating and training employees to prevent accidents and injuries is far more practical than paying law suits, legal fees, fines, and penalties for lack of education and training. Dangerousgoods.Com, Inc. offers: OO on-site safety inspections; OO spill response clean up and disposal; OO review and preparation of SDS; OO hazard classification of products; OO design and prototype for UN spec packages; and OO DOT/IATA/ICAO and IMO consultation. We also offer specialized training in the following areas and can customize training and safety programs to suit your needs and budget: OO Handling Hazardous Materials; OO packaging; OO forklift Operational Safety; and OO custom training designed for specific needs.

Niche firm profiles

217

Chemical Compliance & Competence

CONTACTS

Website

www.mach-chemguide.com

Website

www.ect.de

E-mail

info@mach-chemguide.com

E-mail

info@ect.de

Head office

Boernsener Str 16f, 21039 Hamburg-Boernsen, Germany

Tel/ Fax

+49 40 729 10 933/ +49 40 729 10 934

Contact

Dr Bettina Mach

Head office

Boettgerstrasse 2-14 65439 Floersheim/Main Germany

Ownership

Private

Tel

+ 49 6145 9564 0

Locations

Germany

Fax

+ 49 6145 9564 99

Founded

2011

Contact

Dr Jörg Römbke, Dr Anja Coors (Managing Directors)

Ownership

Privately owned independent small enterprise

OVERVIEW

Locations

Germany

We guide you through REACH and CLP and the cosmetic Regulation 1223/2009. We rely on more than 20 years of experience in product safety in the chemical and cosmetic industry.

Founded

1993

SERVICES PROVIDED OO OO OO OO OO OO OO OO OO OO OO OO

Identify your obligations within REACH, CLP and cosmetic regulation; prepare Echa inquiries; prepare dossiers in Iuclid 6; prepare all kinds of notifications; represent your interests in Siefs and consortia; manage SIEFs on behalf of lead registrants; advise on classification and labelling and prepare C&L notifications; prepare product notifications according to Art 45 CLP in several EU countries; conduct safety assessments of raw materials and products; prepare cosmetic product safety reports according to EC 1223/2009; conduct CPNP notifications; and prepare cosmetic product information files (PIFs):

CLIENTS DR MACH Chemical Compliance and Competence focuses on the European chemical and cosmetic industry: manufacturers, importers, distributors and downstream users of chemicals as well as manufacturers and importers of cosmetic products. The clients are large companies as well as SMEs.

OVERVIEW ECT Oekotoxikologie GmbH has been providing ecotoxicological services and consultancy for industry and governmental authorities for more than 25 years. A broad range of ecotoxicological tests are conducted at ECT according to GLP to support the authorisation and registration of all types of chemicals. ECT keeps up with the state of the art by constantly participating in international research projects focussing on the development and standardisation of new experimental test methods and the improvement of theoretical concepts for assessing the risks of chemicals in the environment. SERVICES PROVIDED In the area of terrestrial ecotoxicology, services of ECT range from standard laboratory tests with soil and dung organisms to higher tier tests including field studies. Taxonomic determinations are offered in-house or in cooperation with experienced partners. In the area of aquatic ecotoxicology, laboratory tests with algae, water plants, crustaceans, benthic organisms, and fish are routinely conducted. Experience with non-standard test species, particularly among primary producers is available. Bioconcentration studies with fish and various invertebrates complement the range of offered test systems. As consultancy services, ECT supports the environmental fate and ecotoxicological parts of dossiers, particularly for REACH but also for other regulatory frameworks in Europe. CLIENTS Our clients are companies of all sizes from all over the world as well as regulatory authorities.

CONTACTS

CONTACTS Website

www.e3strategicpartners.com

Website

www.enviresearch.com

E-mail

info@e3strategicpartners.com

E-mail

info@enviresearch.com

Head office

6724 Perimeter Loop Road, #236

Head office

34 Grainger Park Road, Newcastle upon Tyne, NE4 8RY, UK

Dublin, Ohio 43017

Tel

+ 44 (0) 191 243 0687

Tel

(513) 225-5923

Fax

(513) 345-8294

Contact

James Garratt

Contact

Dr. Carol Clinton, P.E., LEED AP

Ownership

Private

Ownership

Private

Founded

2001

Locations

Dublin, Ohio; Berkley, Michigan USA

OVERVIEW

Founded

2012

Enviresearch provide regulatory and environmental risk assessment services across a range of chemical sectors, including, plant protection products, biocides, REACH, human and veterinary medicines. While we are experts in regulatory services, from complete dossiers to managing efficacy trials, we specialise in environmental fate and ecotoxicology, from lower-tier modelling to landscape risk assessments and the evaluations of potential endocrine disrupting chemicals.

OVERVIEW E3 Strategic Partners (E3SP) helps clients in over 30 global jurisdictions to successfully navigate workplace and consumer chemical safety regulations, define and implement sustainability goals, and manage supply chain and public engagement. Wherever clients are in the sustainability spectrum – from baseline international compliance, through management systems, responding to supply chain pressures, or proactively charting the course – E3SP has the expertise to guide performance improvements. SERVICES PROVIDED E3SP provides wide-ranging expertise in analysis of and compliance with global regulatory requirements. Projects include: toxicology health hazard assessments, transport classifications, process hazards analyses, and global hazard communications, including consumer and workplace product labelling and SDS authoring in most formats and languages; regulatory filings, chemical substance and product registration, Prop 65 safe use determinations; sustainability systems for GRI and specialized frameworks, materiality assessments, and reporting; GHG and offsite consequence modelling, prioritizing strategies for reducing water use and waste generation; auditing, management systems and training for EHS, CSR, pesticide, food and drug packaging and other topics; life-cycle product stewardship, supply chain management and employee and public engagement. CLIENTS Clients include multinational corporations and SMEs in the consumer chemical product, automotive, pigment, adhesive and sealant manufacturing industries; mining, education, utility and other sectors.

SERVICES PROVIDED Regulatory advice and support: dossier preparation (dRR format and Iuclid) and submission, technical equivalence, study monitoring and coordination, representation in Sief/consortiums, only representation for non-EU companies, preparation of chemical safety reports (CSR) and SDS, and labelling according to GHS/CLP. Environmental fate: higher-tier approaches for refined assessments, eg, spatial assessments and probabilistic modelling, modelling for core assessments and national authorisations, kinetic evaluations, analysis of field and semi-field data, relevance and reliability reviews of scientific literature. Ecotoxicity and environmental risk assessments: higher-tier approaches eg, bespoke testing strategies such as pulsed exposure, ecological and TK/TD modelling, standard assessments for all groups of organisms, relevance and reliability reviews, assessment of potential endocrine disruptors, environmental assessments for veterinary and human medicines. Efficacy: design and commission of trial programmes, preparation of BADs, comparative assessments. CLIENTS European and worldwide SMEs and large organisations from across the chemical industry.

www.chemicalwatch.com/SPG

Niche firm profiles

218

CONTACTS

Website

www.espheres.com

Website

www.produsebiocide.ro; www.chemicalcompliance.eu;

E-mail

Philip.capel@espheres.com

E-mail

office@produsebiocide.ro; office@chemicalcompliance.eu

Head office

Pères Blancs 4, 1040 Etterbeek, Brussels, Belgium

Head office

37 Salva St, 1st District, Bucharest, Romania

Tel

+ 32 (0)2 740 43 36/ + 32 (0) 473581473

Tel

+40 721 039 610

Contact

Philip Capel

Fax

+4 031 105 38 00

Ownership

Private

Contact

Mioara Simona ILIE

Locations

Belgium, France, Finland, Germany

Ownership

Private company

Founded

2011

Locations

Romania, Central & Eastern Europe, Italy, Moldavia

Founded

2011

OVERVIEW eSpheres, HSE Information management consultants, a Solvay spin-out and global leader in SAP®EHS consultancy delivering health, safety, environment (HSE) software and service solutions to organizations worldwide. Our in-depth IT solutions, SAP®EHS consultancy and out-tasking services help companies and institutions in improving their management of safety, industrial hygiene and occupational health processes. SERVICES PROVIDED SAP®EHS Consulting: eSpheres supports projects and strengthens corporate EHS and IT departments by efficiently providing them with adequate resources to lead and implement SAP®EHS into any organization. We have a wide experience in implementations, project management and maintenance services. We are experts in SAP®EHS and HSE data management and have developed IT-tools to facilitate our customers’ use of their EHS system. eSpheres implement, deploy and integrate the SAP® EHS(M) modules and deliver quick and sustainable results. Expertise in product safety, SVT, Incident & accident, risk assessment, Vendor SDS management, waste management, IDMP and recipe management, global label management; dangerous goods, conflict minerals. Outsourced EHS regulatory content update (SERC, Sphera) for SAP product safety and SDS authoring. SAP®EHS Training: expert Rules creation, SDS release generation but also customer tailored SAP®EHS training programs. Software tools to file, extract and manage EHS data from SDS.pdf into XML, CSV files, to facilitate your HSE data management for SAP®EHS.

OVERVIEW GROW SMART Chemical Compliance is the Chemical Compliance & Regulatory Affairs division that was set up in 2017 as part of Grow Smart Solutions – the first company in Romania offering specific services dedicated to biocides, since 2011. We offer services for the placement of biocides and other chemicals on the European market, and we bring together professionals and partners with years of practical experience, dedicated to responding best to the client’s needs. We offer a mix of regulatory affairs & commercial insights, combined with pre-and-post registration services. Our experience, drive, and expertise make us a reliable service provider. SERVICES PROVIDED Biocides registration: national registration; EU authorisation and mutual recognition; dossier preparation; R4BP, BPR, CLP, SDS and label compliance. Consultancy: EU Regulations compliance for placing chemicals on the Romanian/ Italian/ European markets; support for biocides, medical devices, detergents, cosmetics, pest control, antifouling, preservatives, etc; registration strategies, pre/post registration support. Regional Regulatory HUB: liaison with the competent authorities; support in building product market strategy & development; business representation; product marketing and sales support. CLIENTS

CLIENTS (petro)chemicals, pharmaceuticals, paint, mining and minerals, steel and alloys, pulp and paper, polymers, electronic, semiconductor, cosmetic, automotive industry.

International businesses focused on chemicals’ production and marketing, from small to medium-size and large companies. They have branches and operations in EU, or are seeking representation for their operation in Romania and other EU States.

CONTACTS

Website

www.eurideastranslation.com

E-mail

translation@eurideastranslation.com

Head office

Square de Meeûs 35, 1000 Brussels, Belgium

Tel

+32 (0)2 669 7701 / +32 (0)2 808 4406 / +49 1522 1306186

Fax

+32 (0)2 627 5655

Contact

Kristina Bitvai

Ownership

Private company

Locations

Belgium, Germany, Hungary

Founded

2007

OVERVIEW Eurideas Language Experts provides professional translation and interpretation services. We specialise in chemical, technical, medical translations, as well as in other fields such as EU legislation, law, environment, health and many more. Our native speaker chemical translators are experts of the REACH regulation and other related EU, international and local legislations. We have great experience in translating SDSs and other regulatory documents. We have developed our own unique methodology through years of translating REACH documents, and are therefore able to offer 60% discount for the repetitions. SERVICES PROVIDED We provide translation, certified translation, proofreading, editing services in all EU languages, in many Asian, African and Latin American languages. The translations are always done by a native speaker translator and proofread by a second native speaker translator. We also carry out a thorough quality check on the ready translation. We translate SDSs, Exposure Scenarios, SPCs, labels, reports, patents, marketing materials. CLIENTS We have worked on REACH, BPR and other chemical related projects for Arkema, Cefic, ISOPA, EuPC, Glencore International Imports, HELM AG, Rio Tinto, Wintershall, Molymet, the International Molybdenum Association, the International Lead Association, the Nickel Institute, Syngenta, DonauChem, Euromines, Chemtopia, Tokyo Chemical Industry, Nissan Chemicals, and many more.

Website

www.infotox.pt

E-mail Head office

info@infotox.pt INFOTOX, Lda, Rua de Moscavide 6D, Parque das Nações, 1990-160, Lisbon, Portugal

Tel

+ 351 218 063 659

Contact

Elsa Casimiro

Ownership

Private company

Locations

Portugal and UK

Founded

2004

OVERVIEW Originally, founded in 2004, INFOTOX is a specialist consulting company providing toxicology, human health and environmental risk assessment and advisory services to the private and public sector. SERVICES PROVIDED Our regulatory services include expert support for biocidal products Regulation (BPR) and cosmetic products Regulation, REACH, CLP/GHS, ADR and PIC in terms of: OO dossier data gap analysis; OO Iuclid dossier preparation for BPR and REACH; OO electronic submissions and updates (CPNP, R4BP and REACH-IT); OO toxicological reviews and expert support (including Qsar); OO design of testing programmes (efficacy tests and (eco)toxicity); OO safety data sheets production, review, and translation; OO reviewing and updating marketing/efficacy claims and product label; OO guidance on setting up a post-market surveillance programme; OO BPR specific services: transitional period biocidal product registrations in Portugal/ UK; product assessment report (PAR); consortia for biocidal products; Article 95 listing of active substances; OO REACH specific services: only representative services; production of chemical safety reports (CSR); and OO Cosmetic products specific services: responsible person services; Pif review and compilation; cosmetic product safety reports (CPSR); We also provide a wide range of environmental health services including health impact studies for EIA, soil clean-up and climate change projects. CLIENTS Our clients include regulators, professional organisations, multinational companies and SMEs.

Global Service Providers Guide 2019

CONTACTS

CONTACTS www.jongeriusconsult.com www.reachsupportnetwork.eu www.sumisolutions.eu

Website

www.kerona.ie

E-mail

info@jongeriusconsult.com

Head office

Begijnenhof 26, 6584 CW Molenhoek, the Netherlands

Head office

info@kerona.ie 14 Thomas Hand Street Skerries, K34 A375, Co Dublin Ireland

Tel

+31 615962071

Tel

+353 (0)1 8495284

Contact

Onno Jongerius

Contact

Irene McGrath

Ownership

Private company

Ownership

Private Company

Locations

Netherlands

Locations

Ireland and Spain

Founded

2009

Founded

2014

Website

Niche firm profiles

219

OVERVIEW

Jongerius Consult BV wants to contribute to safe use of chemical products in the supply chain and at the workplace by an efficient and effective implementation of EU chemicals legislation (REACH and CLP) at companies. OO check our services and references at our website(s) OO check our Generic SUMI Method as complete solution for formulators anywhere in the supply chain to process the safe use information in their Mixture SDS. The Reach Support Network provides (SME) companies online access to ready-to-use and practical REACH and CLP compliance solutions for fair prices OO join our REACH Bootcamp to learn REACH for your business case in one day! and OO become member for free to remain informed and to obtain a small welcome gift.

SERVICES PROVIDED

SERVICES PROVIDED Are you a chemical manufacturer, importer, formulator, distributor and/or user of chemical products in the EU and are you looking for strategic/practical support to efficiently comply with the EU chemicals legislation (REACH and CLP)? OO check our website for practical support and project references; and OO contact me to discuss your specific business case in a free call. CLIENTS Our clients are companies and sectors that want to deal efficiently with REACH and related legislation up to safe use of chemicals and in alignment with their business needs. We are proud of our partners, satisfied customers and the many satisfied participants who attended our REACH workshops. We’ll continue to focus on providing added value and making REACH and CLP work for industry.

CONTACTS Website

en.kaliumsolutions.com

E-mail

bcharpentier@kaliumsolutions.com

Head office

771 Jacques-Porlier Boucherville, Quebec Canada, J4B 7X8

Tel

With offices in Ireland and Spain, Kerona Scientific is an award-winning regulatory consultancy providing a wide range of services for registration of biocides, plant protection products, plant biostimulants, fertlisers, chemicals and cosmetics throughout the EU and Middle Eastern regions.

Kerona provides a full range of expert services to support our clients registration in Europe and the Middle Eastern regions, starting with strategic regulatory advice on new product introductions and maintenance and expansion of existing product ranges. Our clients benefit from our multilingual and multidisciplinary team of experts in analytical chemistry, toxicology, environmental fate, ecotoxicology, microbiology and biochemistry. We assist with all aspects of data generation and dossier preparation (data gap analysis, data review, study commissioning, dossier preparation, technical equivalence, risk assessments for human health and the environment). We also provide a wide range of support services (data access negotiations, representation with the EU authorities and consortia, only representative, preparation of SDS/label/SPC, CLP/GHS, SDS authoring and literature searches). Drawing on our experience of over 40 years in regulatory management, we advise on the most efficient and expeditious pathway to success for national and regional authorisation, under transitional arrangements and after active substance approval. CLIENTS We are proud to work with all our clients and delighted that many of the leading companies worldwide have chosen to work with us. Our clients include global multinationals and SME’s from the biocides, chemicals, plant protection, cosmetics, plant biostimulant and biopesticide sectors.

CONTACTS Website

www.LKC-ltd.com

E-mail

LKC@lkc-ltd.com

Head office

Postfach 167, Hauptstrasse, Fuellinsdorf, Switzerland

Tel/ Fax

+41 61 906 8503 / +41 61 906 8509

450 906-6999 ext 1

Contact

Dr David Kane

Contact

Brigitte Charpentier

Ownership

Private company

Ownership

50/50 Brigitte Charpentier / Maurice Rioux

Locations

Switzerland, UK

Locations

Boucherville, Quebec, Canada

Founded

2001

Founded

2015

OVERVIEW Expert partner of the chemical industry, Kalium is by far the best solution for companies. With its new and original concept, Kalium manages all regulatory affairs lowering costs and increasing safety. SERVICES PROVIDED We offer a turnkey service in French and English for companies who want to sell their chemicals in Canada or in United States. Whether you want to sell on the industrial market under WHMIS / HAZCOM 2012 or the consumer products market under CCCR or CPSC, we do everything you need to be fully compliant at all levels. We prepare your documents in terms of labelling, SDS, environment DSL, TSCA, registration, transport etc. We also offer an affordable high-performance software for the creation of SDS that comes with its database. This software not only allows the creation of SDSs but it breaks down the raw materials into CAS number. We create professional customized video training for your company under WHMIS, TDG IATA or IMDG regulations. CLIENTS We have many manufacturing clients in the paint and coatings industry, inks, polymers, pesticides, engine oil, detergents, distributors and importers with or without stores. We also have several government, environmental laboratories and aerospace customers.

OVERVIEW LKC provides European registration and development services to the international chemical and biochemical industry. The LKC team is multi-disciplined, offering both technical and regulatory experience, project management proficiency and strategy planning expertise. Specialty chemical manufacturing clients benefit from our range of scientific, technical and regulatory services to achieve the successful registration of substances and products for crop protection, biocides, veterinary medicines and industrial chemical uses. SERVICES PROVIDED Regulatory: data gap analysis, data evaluation, data waiving, justifications, design, contract and management of data requirements including higher tier studies, chemistry, analytical methodology, mammalian toxicology, ecotoxicology, environmental fate and efficacy studies, PEC-reports and GLP multi-site residue studies. Conducting risk assessments and modelling for dietary, human and environmental exposures. Dossiers: for active substance approval, product dossiers for national registrations, provisional and union authorisations and mutual recognition. CADDY.XML dossiers, Iuclid dossiers, registrations, renewals, PPPAMS, label extensions, EU import tolerances/MRL’s, REACH and CLP dossiers. Technical & Scientific: pre and post submission discussion with authorities, data assessment and compensation, registration success forecasting, maintenance and defence. CLIENTS LKC’s clients are international specialty chemical and biochemical manufacturers who benefit from technical and regulatory services to compete and grow in major competitive market sectors that includes crop protection, public health, veterinary health and chemicals.

www.chemicalwatch.com/SPG

Niche firm profiles

220

CONTACTS Website

www.onlycorechem.com

Website

www.lingeagroconsultancy.nl

E-mail

Head office

info@lingeagroconsultancy.nl Linge Agroconsultancy B.V. Oosterhoutsestraat 95 6678 PG Oosterhout (Gld) The Netherlands

contact@onlycorechem.com Edificio Infante, Avenida D. Joao II, n. 35, Piso 11 – A/D Parque das Nacoes, 1990-083 Lisbon, Portugal

Tel

+351 963705402

Contact

Carlos Miguel Fazendeiro

Tel

+31-(0)481-745045

Ownership

Private company

Contact

Dr Tonnie Engels (Managing director)

Locations

Portugal

Locations

Oosterhout (Gld)

Founded

2018

Founded

2003

CONTACTS

OVERVIEW Linge Agroconsultancy is an independent consulting company. We are specialized in European registration of active substances, biological and chemical crop protection products and biocides. We have the expertise to guide you through the entire registration process of crop protection products and biocides. We carry out assignments for both the government and trade and industry. Linge Agroconsultancy takes care of your regulatory needs and provides you with tailor-made advice. We have short lines of communication and work customer-oriented. Confidentiality is, of course, guaranteed. SERVICES PROVIDED OO

OO OO OO OO OO OO OO OO OO OO OO OO OO OO OO

Registration services and project management for active substances and products (plant protection products, biocides, biopesticides, biostimulants, adjuvants); preparation and compilation of registration and renewal dossiers; efficacy studies / biological assessment dossiers; data gap analysis; identity and physico-chemical parameters; metabolism; toxicity and human exposure; food safety, dietary risk assessment and residues; environmental behaviour (E-fate) including modelling; ecotoxicology assessments, incl. higher tier risk assessments; MRL applications; equivalence check; literature review; task forces; strategic consultancy, registration recommendations; and management and monitoring of relevant studies.

CLIENTS Chemical and biological industry: OO plant protection products; biopesticides; biostimulants; adjuvants; and biocides. As well as authorities, governments, universities, institutes and consultants.

CONTACTS

OVERVIEW ONLYCORECHEM provides high quality cost-effective solutions for the Chemical Industry in areas such as Consultancy, Auditing and Training on Chemicals Legislation, Events, Recruitment, Executive Search and Career Management. Our multidisciplinary team includes experts on EU Chemicals Regulations such as EU REACH, CLP, BPR, REACH Only Representative and EU Representative BPR Article 95, with background in Chemistry, Toxicology, Ecotoxicology, Environment Health & Safety, Transport of Dangerous Goods and deep experience working for more than ten years both in the Chemical Industry and Consultancy. SERVICES PROVIDED Consultancy, Auditing and Training on EU REACH, CLP and Biocides Regulations. REACH Only Representative, EU Representative for CLP Article 45 Poison Centres, EU Representative Biocides Article 95. Other Consultancy Services for the Chemical Industry include Product Stewardship, Green Chemistry & Innovation, Health & Safety and Business Development. Events for the Chemical Industry include Conferences, Congresses, Exhibitions and Networking. Recruitment & Executive Search for the Chemical Industry and Career Management within Chemical Sciences in the EU and at a Global Level. CLIENTS ONLYCORECHEM has been supporting Chemical companies in the EU and Worldwide to successfully comply with Chemicals Legislation allowing the legal continuation on the market, entering new markets expanding their businesses and achieving commercial advantage.

CONTACTS Website

www.oci.net.cn

E-mail Head office

david.chang@oci.net.cn Room 2006, MOMA Towers, Chaoyang North Street No.199, Chaoyang District, Beijing (100026), China

Tel

+86-10-68091928 EXTN 8008

WeChat

13910863852

Contact

David Chang, Cissy Zhou, Wendy Sun

Ownership

Licensed company

Locations

China Beijing, Shanghai, Guangzhou

Founded

2006-06

Website

www.mediator.as

E-mail

info@mediator.as

Head office

mediator A/S, Centervej 2 E, DK-6000 Kolding

Tel

+45 75 54 08 24

Contact

Jens Haugaard

Ownership

Jens Haugaard

Locations

Denmark

SERVICES PROVIDED

Founded

2011

OVERVIEW mediator A/S is a consultant company where all consultants are specialised in working with chemicals impact on human beings and the environment. We take pride in knowing the businesses of our customers and the challenges they face and work alongside authorities to deliver practice-oriented solutions for our customers. SERVICES PROVIDED We give expert counselling about formation of rules and handling of chemicals and their impact on their surroundings. Our services range from the production and update of safety data sheets to assistance on specific chemical substances and products. Furthermore, we offer regulatory advice concerning product launches abroad: we give advice on chemicals, cosmetics, biocides, electrical items etc. In terms of geography, we cover the EU, EAA (EU + Iceland, Lichtenstein and Norway) and Latin America. We know the industry and we provide regulatory lists for a large number of customers every month to keep them up to date on their area. CLIENTS We assist more than 250 active customers from both within Denmark, but also from all over Europe and abroad. We advice both the entrepreneur in the upstart of business and serve as specialists for large scale companies.

Global Service Providers Guide 2019

OVERVIEW OCI (北京正智远东化工) based in Beijing, is one of the earliest legal regulatory services provider in China and Asia, with more than tremendous successful approvals of substances/new ingredients/products in chemicals, food relevant, cosmetics, fertilisers, feed… Aspiration in decade delivery, heritage out century reputation.

OO OO OO OO OO

Multi and comprehensive assessments varies in products / supply chains / regions; compliance check/data gap analysis; China and ASEA chemical registration focus; global policy and regulation news edition and presentation; site RA support and emergence team backup; and strong petition capability of Food-Cosmetics-Feed new additives

CLIENTS DSM, Sasol, Solvay, Arkema, KANEKA, Meiwa, KAO, etc.

CONTACTS

Website

www.pfagroup.eu

Website

www.pfagroup.eu

E-mail

info@pfagroup.eu

Head office

info@pfagroup.eu Saxon House, John Roberts Business Park, Pean Hill, Whitstable, Kent, CT5 3BJ, UK

Head office

Rue Abbé Cuypers 3, 1040 Etterbeek, Brussels, Belgium

Tel

+44 (0)1227 470901 and +44 (0)1227 765117

Tel

[+32] 02 741 2444

Contact

Dr Oliver Warwick

Contact

Dr Oliver Warwick

Ownership

Limited company

Ownership

SPRL

Locations

Belgium

Founded

Originally founded in 1995. Founded as a limited company in 2006

Founded

2016

OVERVIEW

OVERVIEW Peter Fisk Associates is a scientific consultancy that provides high quality and objective scientific/technical and policy support on the regulation of chemicals. We are expert in assessing the regulatory and political landscape within which scientific information on chemical risks is interpreted SERVICES PROVIDED Peter Fisk Associates Limited, works in collaboration with PFA-Brussels SPRL on REACH and other regulatory work including: OO expert advice and technical consultancy in chemistry, toxicology (including toxicokinetic modelling), ecotoxicology, quantitative structure-activity relationships, exposure assessment and modelling (human and environmental), risk management options, supply chain analysis and authorisation support; OO secretariat services, including consortium management and joint submission communications; OO strategy for regulatory compliance. We can provide you with a full service to meet the requirements of chemical regulations, including REACH and CLP requirements, EU cosetcs and biocides regulations, food safety and other areas of chemical regulation and voluntary assessment; OO provision of only representative (OR) services for non-UK exporters; OO strategic needs within REACH risk management; authorisation, restriction, RMO and evaluation. As experts on chemical hazard, risk and control measures we can provide a comprehensive service to identify potential substances of high concern and deliver successful authorisation applications (including working with partners on socioeconomic analysis); OO development of chemicals policy and strategy on substances; product stewardship, advantages and drawbacks of proposals. Our in-depth knowledge of the industry means we can offer clients a solid analysis and understanding of the regulatory framework within which chemicals and products are made and marketed; and OO appeals/awareness. If you are facing legislation challenges, we have the experience and scientific expertise to work with you and your legal representatives to optimise a successful outcome. CLIENTS A wide variety of clients including chemical manufacturers and importers, downstream users and related manufacturing industries, as well as regulatory authorities and government organisations.

PFA-Brussels is a scientific consultancy that provides high quality and objective scientific/ technical and policy support on the regulation of chemicals. We are expert in assessing the regulatory and political landscape within which scientific information on chemical risks is interpreted SERVICES PROVIDED As a wholly owned subsidiary of Peter Fisk Associates Limited, PFA-Brussels SPRL works in collaboration with PFA Ltd on REACH and other regulatory work including: OO expert advice and technical consultancy in chemistry, toxicology (including toxicokinetic modelling), ecotoxicology, quantitative structure-activity relationships, exposure assessment and modelling (human and environmental), risk management options, supply chain analysis and authorisation support; OO secretariat services, including consortium management and joint submission communications; OO strategy for regulatory compliance. We can provide you with a full service to meet the requirements of chemical regulations, including REACH and CLP requirements, EU cosmetics and biocides regulations, food safety and other areas of chemical regulation and voluntary assessment; OO provision of only representative (OR) services for non-UK exporters; OO strategic needs within REACH risk management; authorisation, restriction, RMO and evaluation. As experts on chemical hazard, risk and control measures we can provide a comprehensive service to identify potential substances of high concern and deliver successful authorisation applications (including working with partners on socioeconomic analysis); OO development of chemicals policy and strategy on substances; product stewardship, advantages and drawbacks of proposals. Our in-depth knowledge of the industry means we can offer clients a solid analysis and understanding of the regulatory framework within which chemicals and products are made and marketed; and OO appeals/awareness. If you are facing legislation challenges, we have the experience and scientific expertise to work with you and your legal representatives to optimise a successful outcome. CLIENTS A wide variety of clients including chemical manufacturers and importers, downstream users and related manufacturing industries, as well as regulatory authorities and government organisations.

CONTACTS CONTACTS

Website

www.reachready.co.uk enquiries@reachready.co.uk

Website

www.ROSconsortium.eu

E-mail

Head office

Kings Buildings, Smith Square, London SW1P 3JJ

Head office

karine@ROSconsortium.eu Haverstraat 8 2350 Antwerp (Vosselaar)

Tel

+44 (0) 20 7901 1444

Contact

Rachel Nabudde

Tel/Fax

+ 32 14 75 45 76

Ownership

Contact

Karine Van de Velde

REACHReady is a wholly owned subsidiary of the Chemical Industries Association

Ownership

Private

Founded

2006

Locations

Belgium

Founded

21/05/2015

OVERVIEW ROSC delivers an all-included REACH package. Focus is on consortium management (e.g. for authorisations) and REACH advice for all sorts of companies (metals-inorganicsorganics). ROSC makes REACH manageable, also after the May 2018 deadline. SERVICES PROVIDED Choose from our strategic, technical and administrative services like: cross industry consortium formation/management, dossier and substance evaluations, preparation of safety data sheets from CSR, letter of access management, REACH help/advice or regulatory project management in general, trustee, declarations to anti-poison centrum, etc.

OVERVIEW REACHReady offers a confidential, comprehensive and cost-effective “one-stop shop” service, right through from keeping you informed of all the latest developments, to fulfilling your specific registration and authorisation needs. We aim to save you time, trouble and money. We have established a track record as the place to go for help with chemical regulatory compliance and have thousands of subscribers located all over the world, in every industry sector, working for companies from SMEs to multinationals. Our strong reputation and extensive experience of the chemical and downstream industries makes us the best choice for REACH, CLP and BPR services. Our extensive understanding and knowledge of legislation stems from the in-depth involvement of our parent organisation, the Chemical Industries Association, in its development at every stage. SERVICES PROVIDED Helpdesk; consultancy; training; and matchmaker.

CLIENTS

ROSC has a variety of clients from multinationals to small SMEs: we welcome you all.

CLIENTS OO

Chemical manufacturers; formulators; downstream users of chemicals; article manufacturers; retailers; and service providers.

www.chemicalwatch.com/SPG

Niche firm profiles

221

Niche firm profiles

222

CONTACTS

Website

www.reachspektrum.eu

Website

www.reachwise.eu

E-mail

info@reachspektrum.eu

E-mail

info@reachwise.eu

Head office

Rubeška 393/7 190 00 Prague Czech Republic

Head office

22, St Albans Avenue, London W4 5JP, UK

Tel

+44 (0)20 87470873

Tel

+420 739 463 410

Contact

Peter Douben

Contact

Jan Holomek, CEO

Ownership

Private company

Ownership

Private Company

Locations

UK, Netherlands, Germany

Locations

Prague, Czech Republic

Founded

2007

Founded

2007

OVERVIEW ReachSpektrum was founded in 2007 by the Association of Chemical Industry of the Czech Republic. Since then, ReachSpektrum has provided excellent knowledge and high quality service to all industries dealing with chemicals manufacture and management. SERVICES PROVIDED REACH services: Complete consultancy in REACH Regulation: business impact assessment, regulation interpretation and determination of registration strategy and supply chain communication. Preparation of registration dossier for both lead registrant and for co-registrants. REACH lead registrant secretariat services. Data gap analysis, literature search, testing services in partner GLP labs. SIEF management. Only representative activities for manufactures settled outside EU. Complete REACH Authorisation application development from initial analysis to submission CLP – EU GHS: Classification, labelling and packaging obligations, preparation of new labels and notification to the classification and labelling inventory at Echa. SDS management for all EU countries and several non-EU regions. BPR: Complete consultancy and services in the Biocidal Products area. We specialise in authorisation of BPR, mutual recognition applications and risk assessment. RoHS: Our consultants provide guidance to help companies comply with the requirements of the Restriction of Hazardous Substances legislation in the EU region. Training, workshops: We organise workshops on REACH and CLP Regulation, Iuclid6 and Iuclid Cloud training sessions. The sessions may be tailored to your needs and conducted in your company or in the form of webinar. CLIENTS Aero Vodochody Aerospace; Austin Powder; Barentz; BASF; BorsodChem MCHZ; GOJO Industries Europe; Delfort Group; Honeywell Aerospace; Humatex; Mida LT; Mondi; PRECIOSA; SAP; Synthos Kralupy; TEVA Czech Industries; UNIPETROL; Ministry of Industry and Trade of the Czech Republic; Ministry of Environment of the Czech Republic

OVERVIEW With extensive REACH, CLP and BPR knowledge REACHWise provides tailor-made services to producers and users of chemicals throughout the supply chain. Our focus on these areas means our efforts are targeted. We change complex situations into manageable elements, and provide cost-effective solutions. SERVICES PROVIDED OR and Brexit preparedness: OR service for both the EU27/EEA and UK providing efficient and effective services and maximum flexibility. Impact of REACH, CLP and BPR: finding comprehensive solutions for companies on the best way to approach the REACH, CLP and BPR “problem” and to remain compliant: stay on the market and grow! Sief support: we provide the whole spectrum of Sief and consortium management. REACH registration: our REACH support covers data evaluation and sharing, preparation of the technical dossier, use and exposure requirements, chemical safety assessment and exposure scenarios. Safety data sheets: we prepare and update SDSs (body and annexed ESs) including translations. Exposure scenarios: for individual substances as well as mixtures we ensure they are comprehensive and communicable: you discharge your obligations; your customers find them easy to understand. Downstream uses: using specialist models we ensure that your conditions are compliant even when they deviate from the registrant’s information. Biocides: actives or products, we take care of them: from start to finish, covering all major product types. CLIENTS Our clients receive an efficient service. Hence satisfied customers from the ceramics industry, fertilisers and related industries, fragrance sector, health care sector, home and personal care, lubricants manufacturers and suppliers, metals and minerals sectors, pigments and colorants sector, speciality chemicals industry. Happy retailers include those in the cosmetics sector.

CONTACTS

Website

Website: www.siam-it.com Product website: www.siam-it.com

E-mail

export@siam-it.com

Head office

Ortega y Gasset 17 bajo, 26007 Logroño, Spain

+32 (0) 2 719 0475

Tel

+44 2 037 697 400 + 00 34 941 28 67 49 + 00 33 975 12 19 24

Fax

+32 (0) 2 719 0480

Ownership

Private company

Contact

Dr Rick Stanton

Locations

Europe and North America. 2007

Locations

Sumika Chemical Analysis Service, Tokyo, Japan For parent company: Japan, China, Singapore, Taiwan, South Korea

Founded

Parent company 1972; SCAS Europe 2007

Website

www.scas-eu.be

E-mail Head office

scaseurope07@scas-eu.be SCAS Europe (Sumika Chemical Analysis Service), Leonardo da Vincilaan 19A Bus6 (MC Square Offices) B-1831 Diegem, Belgium

Tel

Ownership

OVERVIEW Since 2007 SCAS Europe (SCASE) has grown to be one of the largest REACH OR service providers in the EU. SCASE also represents our Japanese parent company, Sumika Chemical Analysis Service (SCAS), which is a significant provider of chemical regulatory services in Asia. SCAS provides global notification and multi-regional registration capabilities from our offices in Japan. Countries serviced include Japan, China, Korea, Taiwan, Philippines, Australia, New Zealand and Turkey as well as the US and Canada. Our parent company SCAS is a major analytical service provider with laboratories in Japan, China, Korea and Singapore. Founded in 1972, SCAS has consistently been satisfying requirements of its customers by providing the best analytical solutions in many industrial sectors. SERVICES PROVIDED EU REACH registration and OR for Asia clients; Asia chemical regulation support for Asia and Western clients. CLIENTS From many sectors, including both manufacturers and downstream users, for example in the following industries: chemical, petrochemical, electronics, pharmaceutical, automotive, paint, ink, rubber, fibre and others.

Global Service Providers Guide 2019

OVERVIEW Siam develops and provides an SDS authoring software for manufacturers and companies operating in the chemical sector. Chemeter is now installed in more than 35 countries and contains more than 50 legislations constantly updated under CLP and GHS. SERVICES PROVIDED All our customers with the software installed in their facilities receive an extensive and complete support since the first installation: training on the software, legislative and technical support for their SDS and IT issues, permanent access to our expert team etc. CLIENTS Wide variety of clients from small size companies to global companies are operating now with our software to make their SDS and LABELS. Today we have a well-established international presence through our sales network in many countries like: France, Italy, Portugal, Finland, Poland, Greece, Romania, Sweden, Turkey, Ireland, North America… etc. Our clients are European and non-European companies manufacturing and distributing all kinds of chemical products in many sectors, such as: cleaning, paints and coatings, rubber, detergents, adhesives and sealants, food flavours, fragrances, water treatment…etc.

CONTACTS

Website

www.selerant.com

Website

www.toxfocus.com

E-mail

sales-ehs@selerant.com

E-mail

barbara.vogt@toxfocus.com

Head office

Selerant srl Via Leonardo da Vinci, 19 20060 Cassina de’ Pecchi (Milano) Italy

Head office

8967 Hunters Way, Highlands Ranch, CO 80129, US

Tel / Fax

+1 501 351 4389

Tel

Phone + (39) 02 786203

Contact

Barbara Vogt, PhD, DABT

Fax

Fax + (39) 02 95341389

Ownership

Private company

Contact

Giuseppe Mallozzi

Locations

Ownership

Private Company

Founded

2008

Locations

Milan, New York, Shanghai, Melbourne , Chennai, Paris , Wiesbaden, Kiev, Belgrade

Founded

1990

OVERVIEW Founded in 1990 in Italy, Selerant is a leading global provider of regulatory compliance and Safety Data Sheets Authoring Solutions. Additionally, Selerant provides formula-based PLM software and consulting services within process manufacturing segments of: Specialty Chemicals, Detergents, Paints, Coatings, Flavours, Fragrances and Personal Care/ Cosmetics. Selerant has offices in Europe, United States and APAC region. SERVICES PROVIDED Selerant’s software solutions, dedicated to EHS industries, modular and flexible, help you to manage the complete chemical product lifecycle, from idea to label. What’s more, Selerant ensures technical and regulatory support in more than 30 languages. Hazex SDS Authoring Solution helps you to create and manage: OO Worldwide GHS regulations, OO SDS distribution, OO Transport classification, OO Hazard labelling, OO UFI management, OO Exposure Scenarios, OO EU Cosmetic Regulation and PIF, OO IFRA and more. Devex PLM is a powerful software solution for managing complete chemical product lifecycle, from new product development and formulation, to regulatory compliance, with ability to integrate with ERP. All these tools are designed to reduce time-to-market and accelerate your business. CLIENTS Our customers are global and local companies: producer, developer, and manufacturer in all industries of Environment, Health and Safety.

CONTACTS

E-mail

www.senzagen.com CEO: amh@senzagen.com Sales: andy.forreryd@senzagen.com

Head office

SenzaGen AB, Medicon Village, Scheelev. 2, 223 81 Lund, Sweden

Tel

+46 46 2756200 office / +46 734 221777 sales

Contact

Dr Anki Malmborg-Hager, Dr Andy Forreryd

Ownership

Public company

Locations

Sweden, US

Founded

2010

Website

OVERVIEW SenzaGen markets, sells and performs the in vitro GARDskin (Genomic Allergen Rapid Detection) genome based sensitisation test for skin sensitisation and is the first to make accurate potency classification according to the CLP/GHS standard, GARDpotency. A first in class test for respiratory sensitisation is also available, GARDair. GARD is a new test that, with the highest accuracy available, reveals whether chemical substances are at risk of causing allergies in humans. As a quality-orientated and innovative international player, SenzaGen supports its clients with stringent quality assessments, recommended by ECHA and undergoes ECVAM and OECD validation. The GARD test is available through licence in international laboratories and sold through distributors in EU and Asia. SERVICES PROVIDED High accuracy in vitro sensitisation testing of chemicals. For safety assessment and REACH registrations. Relevant for cosmetics, household and personal care ingredients, pharmaceuticals, biocides, agrochemicals and medical devices. OO skin sensitisation (OECD TGP 4.106); OO potency classification for CLP; and OO respiratory sensitisation. Our scientists and immunological experts also provide customised advice to help your development projects or your challenging ingredient as well as your straightforward testing as part of your sensitisation testing.

OVERVIEW Tox Focus LLC provides the toxicologic and scientific content for REACH, cosmetics Regulation, and other regulatory programmes, drawing upon 20 years experience in corporate and clinical toxicology. The consultancy creates technical Iuclid 6 dossiers for REACH, CLP notifications and harmonisation, weight-of-evidence positions and REACH evaluation responses to Echa/member states. Tox Focus LLC is a qualified risk assessor for the EU cosmetics Regulation and for the US Department of Commerce. SERVICES PROVIDED REACH: quality toxicology assessments and strategic planning for compliance with data requirements of regional chemical control legislation, including data gap filling, adaptations to data requirements, identification of analogues and categories, computer modelling and support (QMRF, QPRF), laboratory test commissioning and monitoring, robust study authoring, construction of Iuclid 6 files with validation reports, chemical safety reports, risk assessments, classification, labelling and packaging (CLP), and evaluation support/dossier defence. EU cosmetics Regulation: product risk assessment certificates and cosmetic product safety reports (CPSR) as part of the product information file (PIF). CLIENTS The Redstone Group, Allnex, Cytec Industries Inc, Unilever, Lucite International, Ineos Europe Ltd, The Cyanide Council, Evonik-DeGussa GmbH, Vertellus Specialties Inc, Air Products and Chemicals Inc, Arch Chemicals Inc, Gerber Scientific International, AW Chesterton Company, Calumet Specialty Products Partners LP, Gulf Bayport Chemicals LP, Mayer Brown International LLP, Abercrombie and Fitch, Monat Global Corp, The Nail Consultants, Ltd, US Department of Commerce.

CONTACTS Website

www.toxcel.com

E-mail

Christine.McAlinden@toxcel.co.uk / info@toxcel.com

Head office

PO Box 93, Ledbury, HR8 9JE, UK

Tel

+44(0)1531 638999 (UK) / +1 703 754 0248 (US)

Contact

Christine McAlinden (UK) / Alan Katz (US)

Ownership

Limited company

Locations

UK, US

Founded

1999

OVERVIEW toXcel’s European and North American offices work closely together to provide a coordinated regulatory resource for seamless development and execution of strategies, designed for cost-effective regulatory approvals, leading to domestic, regional, and global export market expansion. SERVICES PROVIDED toXcel provides a full range of services to support obtaining marketing approvals by governmental agencies, with emphasis on regulatory strategy development and all aspects of preparing applications and dossiers. toXcel advises companies about compliance with REACH, CLP, the biocidal products Regulation, the cosmetics Regulation, the plant protection products Regulation, and other EU registration requirements. We can provide you with a full REACH registration service, or we can support your in-house activities as required. Our experts provide FIFRA, TSCA, and FDA services to our global clientele in our US office. toXcel has global experience in the performance of exposure and risk assessments, environmental assessment, safety and toxicological evaluations, nanoparticles, and the design and management of GLP analytical chemistry, residue, efficacy, environmental fate, mammalian toxicity, metabolism/pharmacokinetics (ADME), and ecotoxicity studies. CLIENTS Our leading consultants focus their collective professional talents on assisting chemical manufacturers, formulators, pharmaceutical companies, personal care/consumer product manufacturers and suppliers, trade associations, law firms, and the food industry.

CLIENTS Our clients range from small size companies to global corporations. Manufacturers, pharmaceutical companies, cosmetic and personal care ingredient producers, food industry as well as research institutes.

www.chemicalwatch.com/SPG

Niche firm profiles

223

Niche firm profiles

224

CONTACTS

Website

www.toxicon.it

Website

www.wsp.com

E-mail

info@toxicon.it

E-mail

alan.ritchie@wsp.com

Head office

Via Robolini 1, 27100 Pavia, Italy

Head office

70 Chancery Lane, London, UK

Tel / Fax

+39 0382 1938015 / +39 0382 1938026

Tel/ Fax

+44 20 3116 6072

Contact

Raffaella Butera, MD

Contact

Alan Ritchie/ Dr Stephen Bounds

Ownership

Private company

Ownership

Private company

Locations

Italy

Locations

UK, Europe, worldwide

Founded

2010

Founded

8 April 1987

OVERVIEW

Toxicon provides a wide range of expert advice services in regulatory fields and in the areas of toxicology, pharmacology and occupational medicine for companies and institutions. Our know-how is based on a solid academic background in risk assessment. Our team consists of specialists in different areas: physicians, pharmacologists, biologists, chemists, biotechnologists, food technologists, economists and lawyers. We believe that complex problems can be solved with success and quality only through teamwork.

WSP provides a wide range of environmental, health and safety, product stewardship and regulatory consultancy services. Our team includes industry professionals experienced in all aspects of chemical regulation. SERVICES PROVIDED

CLIENTS

We now offer a complete range of services to deal with all our clientâ&#x20AC;&#x2122;s regulatory requirements including: OO REACH Registration and Authorisation; including identifying a clientâ&#x20AC;&#x2122;s REACH obligations and developing the registration strategy; SIEF and consortium management; substance registration dossier preparation and submission; socioeconomic analysis; substance authorisation (WSP was the technical advisor on the first application for authorisation to clear ECHA); classification, labelling and packaging (CLP) management and compliance; only representative and third party representative services; strictly controlled conditions audits to validate intermediate status OO safety data sheet (SDS) and extended safety data sheet (eSDS) preparation and management; OO REACH compliance auditing and training; OO a full service for supporting the EU cosmetics Regulation including cosmetic product safety assessments, cosmetics products notification portal notifications and artwork reviews; OO biocidal products Regulation; setting of product families, selection of meta-SPCs, compilation of authorisation dossiers across all products types and review of label claims; and OO poison centre notifications to assist in compliance with the new regulations.

Toxicon assists large companies and SMEs. Moreover, Toxicon works in partnership with institutions, industries and associations for R&D and compliance projects.

CLIENTS

SERVICES PROVIDED Overall services: guidance on regulatory interpretation, compliance support, auditing. REACH: data sharing, Sief and consortium management. Data gap analysis and testing strategy development, including the use of Qsar models. Dossier preparation (inquiry, lead and member registrants) including CSA/CSR. PPORD notification. SDS and e-SDS. Compliance check with exposure scenario (ES), scaling, CSR-DU development. ES development for mixtures. Applications for authorisation including SEA. CLP/GHS: hazard assessment, classification and labelling, notification to Echa C&L inventory and to member states bodies for emergency health response on mixtures. BPR Regulation: data sharing agreements, dossier development for active substances approval and biocidal products authorisation at national and UE level. Cosmetic products: safety assessment, product information file, notification. Medicines: CTD, genotoxic impurities assessment, PDE assessment, environmental risk assessment, provisional OELs for APIs and other chemicals. Occupational medicine: risk assessment and management (CAD, CMD). Other: training for companies, universities and institutions.

CONTACTS Website

www.vrs-regulatory.net

E-mail

jobs@vrs-regulatory.net

Head office

Vantage House, 26a Northenden Road, Sale, M33 3BR, UK

Tel

+44 (0)161 976 2825

Fax

+44 (0)161 976 2561

Contact

John Sherratt

Ownership

Limited company

Locations

Founded

2006

OVERVIEW VRS Regulatory specialise in regulatory affairs and risk assessment recruitment in the chemical, agrochemical and biocide sectors. We have a wealth of recruitment expertise and recruit for jobs at all levels from experienced regulatory professionals to someone just starting their career in the regulatory/risk assessment field. We offer a friendly and personable approach; our goal is to find the right jobs for candidates and the best talent for clients with efficiency and confidentiality. Our work spans the UK and we offer a range of permanent, temporary and contract roles. Specialities: Regulatory Affairs, Registrations, Risk Assessment, Product Stewardship, SDS Authoring, Hazard Communications, Hazard Classification, Chemical Compliance, Notifications, Regulatory Toxicology, Regulatory Ecotoxicology, Environment Fate, REACH, CLP, GHS, BPR, EC 1107/2009. SERVICES PROVIDED OO OO

OO OO

Chemical regulatory affairs recruitment consultancy; we recruit for permanent, temporary/interim roles and provide consultants for projects; advice to employers on salaries, skills availability, recruitment methods; and advice to jobseekers on CV layout, interview techniques, career development.

CLIENTS Our clients are in the chemical, agrochemical and biocide sectors. We work with SMEs and multinationals including manufacturers, distributors, retailers, consultancies, CROs. Also trade associations and regulators/competent authorities.

Global Service Providers Guide 2019

WSP assists a large group of companies to fulfil their REACH obligations ranging from SMEs through to large multinational corporations. Our clients include manufacturers, importers and downstream users. We act as Only Representative for 17 companies and specialise in helping companies respond to their business challenges and effectively manage compliance.

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Hungary Switzerland, USA USA

Japan, Thailand, USA

Germany, HK, representatives globally

China, Hong Kong, France, Germany, USA

Germany

Cambridge Environmental Assessments part of UK RSK ADAS ltd Cardno ChemRisk USA Cardno ENTRIX USA South America, Canada CE.way: Cosmetics Regulatory and Testing Slovenia Solutions Cefas UK CEHTRA 88 France Belgium, Canada, India, UK  Centro Reach Srl Italy CERM USA CFCS Germany Italy Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%

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Chemical staff 2-5 10-25 2-5

Information services

India The Netherlands Turkey UK UK China USA UK Belgium France USA Belgium UK Switzerland Belgium UK UK Finland USA USA Austria Denmark Denmark UK UK Italy

UK, China

Global staff 25-50 50-100 2-5 5,000 plus 25-50 25-50 25-50 100-500 2-5 2-5 5-10 1 1 1 2-5 1 2-5 2-5 2,000-5,000 2-5 1 25-50 5,000 plus 100-500 25-50 10-25 5,000 plus 10-25 25-50 100-500 2-5 10-25 1,000-2,000 100-500 5-10 2-5 2-5 2-5

IT & software solutions

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Other locations USA

Laboratory services

Auxilife Scientific Services Pvt. Ltd AW-ChemAdvice Ayansan Chemical Consultancy Ltd. Co. Battelle UK Ltd Baytouch Ltd Beijing BoardingCard Chemical Consulting Co., Ltd. Beveridge & Diamond, PC bibra toxicology advice & consulting BIG vzw BioQuanta BIOVIA, Dassault Systemes Bird & Bird LLP Blue Frog Scientific Limited bluesign technologies ag Boeije Consulting Bond Dickinson Bootman Chemical Safety Borenius & Kemppinen, Attorneys at law Ltd Bristol Environmental Buckman Bureau for Chemical Engineering TB-Klade Bureau Veritas Bureau Veritas HSE Denmark A/S Burges Salmon LLP Butterworth Laboratories Ltd CAAT-Europe

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Headquarters Germany UK Greece Belgium USA USA UK India Canada UK Switzerland UK USA UK UK Germany Belgium Denmark UK USA The Netherlands China USA UK UK Belgium The Netherlands Germany Belgium Sweden UK Slovenia Hong Kong Canada Germany Croatia France UK

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Page

Representation/management

Organisation 1cc GmbH 24-7 Response 3S-SafelyServingScience Accenture Acta Actio Software Corporation Active Steward Advinus Therapeutics Limited Aegis Regulatory Inc AG-HERA AGREXIS AG Alan Best Alberi EcoTech Alchemy Compliance Ltd. Alemare Solutions ALSTER Consulting > Chemical Compliance Altertox Academy Altox a/s AMEC Environment and Infrastructure Anderson Materials Evaluation, Inc. Annex3 Consulting Annray Test Co., Ltd. Antea Group Anthesis-Caleb APC Apeiron-Team NV Arcadis Arcerion GmbH ARCHE Consulting Argentum Environment Arrow Regulatory Ltd Artemisa d.o.o. AsiaInspection Assent Compliance asseso AG` ATOMIUM ATOUT REACH Austen Business Solutions Ltd

Consultancy/advisory

A-Z LISTING

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REACH Global chemical notifications

Occupational

Food (contact)

Medical devices

Cleaning products

Textiles & apparel

Construction

Aerospace, automotive & engineering

                                                                                                                                                                                                         

          

Toys/children's products

Electrical and electronics

Veterinary medicine

Personal care (inc. cosmetics)



GHS-based regulations

       

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227

Regulatory expertise

CLP



Biocides

Biotechnology

Medical & pharmaceuticals

Industrial chemicals Agrochemicals

Focus of activities

               

 

Further information www.1cc-consulting.com www.24-7response.org www.3s-chem.gr www.accenture.com www.actagroup.com www.Actio.net www.activesteward.com www.advinus.com www.aegisreg.com www.ag-hera.com www.agrexis.com www.alanbestsustainability.com www.alberieco.com www.alchemycompliance.com www.alemare.co.uk www.alster-consulting.eu www.academy.altertox.be www.altox.dk www.amec.com/reach.htm www.andersonmaterials.com www.annex3.eu www.annraytest.com www.anteagroup.com www.anthesisgroup.com www.apc.eu.com www.apeiron-team.eu www.arcadis.com/pss www.arcerion.com www.arche-consulting.be www.argentumenvironment.se www.arrowregulatory.com www.artemisa.si www.asiainspection.com www.assentcompliance.com www.asseso.eu www.msds.com.hr www.atoutreach.fr www.austenbusinesssolutions. co.uk www.auxilife.com www.ayansan.com www.battelleuk.com www.baytouch.com www.bjboardingcard.com www.bdlaw.com www.bibra-information.co.uk www.big.be www.bioquanta.net www.accelrys.com www.twobirds.com www.bluefrogscientific.com www.bluesign.com www.boeijeconsulting.com www.bonddickinson.com www.bootmanchem.com www.borenius.com www.bristolenvironmental.com www.buckman.com www.tb-klade.at www.bvhse.com www.bvhse.dk www.burges-salmon.com www.butterworth-labs.co.uk www.biologie.uni-konstanz.de/leist/ caat-europe/ www.cea.adas.co.uk www.cardnochemrisk.com www.cardnoentrix.com www.ceway.eu

www.cefas.co.uk                                            www.cehtra.com www.centroreach.it                www.Cermonline.com       www.cfcs-consult.com           

Key: Icons above represents the extent to which the company provides the service as follows:  Core service  Service that is occasionally provided  Service provided by partners and third parties

www.chemicalwatch.com/SPG

228

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Clariant Compliance & Risks Compliance Footprint AG Compliance Services International compliance2business Consortia Management GmbH CONUSBAT Regulatory Services Coracle Cosanta Cosmetic Design Laboratories CRAD

100 102

104 106

108 110 112

216

The Netherlands China Portugal The Netherlands Denmark Mauritius China Russia France UK Italy Ireland Switzerland USA Italy Germany Germany UK The Netherlands

USA China

France, Switzerland

Agent in China EU, USA, Canada, China, Thailand, Japan, Vienam, Malaysia Italy, USA, Japan, China USA, Brazil, China USA, UK, China, Japan, Egypt, India, Indonesia, Italy, Korea, Malaysia, Mongolia, Netherlands, New Zealand, Poland, Qatar, Singapore, Turkey Belgium, France, Italy Spain, Italy, UK Denmark Brazil, Romania, India, Singapore Ireland, USA Hungary

USA, UK global offices UK

Germany, Belgium, Finland, UK, Austria

Turkey Representatives in EU, UK, USA, Japan, Korea Crowell & Moring USA CS Regulatory Ltd 216 UK Republic of Ireland CSB 114 Germany  CTT China Currenta GmbH & Co. OHG Germany Cyprotex UK USA Danger and Safety srl Italy dangerousgoods.com 216 USA Europe - China DanGoods Training & Consultancy UK Danish Technological Institute 116 Denmark  Datalab USA David Ryberg Norway de ViB fabriek Netherlands Decernis USA Decernis LLC 118 USA Germany, Thailand, Chile  Defense Logistics Agency USA DEKRA 120 UK 8+ globally  DEKRA Assurance Services GmbH Germany DEKRA Consulting GmbH Germany France, Hungary, Turkey, UK Dell Tech Laboratories Ltd. Canada Delphic HSE Solutions Limited UK Hong Kong Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%

Global Service Providers Guide 2019

10-25 5-10 2-5 10-25 1 1 1 1 5-10 2-5 1 2-5 10-25 50-100

5-10 25-50 50-100

2-5 25-50 25-50

m g m g e e e e

25-50 50-100 100-500

5-10 100-500 5,000 plus 1 10-25 100-500 100-500 50-100 1,000-2,000 1

2-5 25-50 50-100 1 5-10 10-25 50-100 25-50 100-500 1

m i e

5,000 plus 50-100 5-10 10-25 1 5-10 Globally 5-10 10-25

100-500 50-100 5-10 10-25 1 5-10 5-10 5-10 5-10

i i i m g g m i g

2-5

10-25

g g

25-50 5-10 10-25 100-500 100-500 100-500 5-10 10-25 1 100-500 2-5 10-25 2-5 50-100 50-100 1,000-2,000 5,000 plus 25-50 100-500 5-10 10-25

5-10 5-10 10-25 100-500 25-50 25-50 5-10 10-25 1 25-50 1 2-5 2-5 50-100 10-25 10-25 100-500 5-10 50-100 2-5 10-25

g m g g g

m e e e m e g e

g e m g

i g e m g i g e e e e i e e e e e e m e m e m e e e i i m g i i e e i m e m g i g e e e e e i g e e e

m e e

m m i e e e e e i e e e e e g e m m e e e e g g

e m i

e e e e g e e g m g e i a i e g

m e e i m m e g g g g g g

i e

a e e e

g i g g

g e e e

m e

g e e g e

i i e m m g e

Other(s)

50-100 5-10 2-5 10-25 1 1 1 1 5-10 2-5 1 2-5 10-25 50-100

g e e i i

Equipment

Chemical staff 100-500 50-100 5-10 5-10 50-100 5-10

Training

Global staff 5,000 plus 5,000 plus 5-10 10-25 50-100 5-10

Information services

IT & software solutions

UK USA Australia

92 94 96

Germany Belgium, Singapore

Laboratory services

chemtrac® CHEMTREC Chemwatch

90 215 216

Other locations USA, France UK, Netherlands, France

Legal services

Chemservice EHNS GmbH ChemService Srl Controlli e Ricerche Chemtopia Co., Ltd.

Headquarters Canada USA Turkey Switzerland USA Luxembourg Australia Austria Finland Finland UK Ireland USA Israel Germany Turkey UK Finland UK Italy Germany, Luxembourg, South Korea Germany Italy South Korea

CHESSOL B.V. China National Chemical Information Center ChIR - Chemical Innovation and Regulation Chris Braun Consultancy Chymeia ApS CIDP CIRS CIS Center Citoxlab CJV Consulting Ltd

Page

Representation/management

Organisation CGI Charles River CHD Global Chem-Academy ChemADVISOR, Inc. ChemAdvocacy S.A. ChemAlert CHEMDOX Chementors Ltd Chemest Ltd. Chemex Environmental International Ltd ChemHaz Solutions Chemical Consultant Chemical Regulatory Affairs - Israel Chemical Safety Consulting CHEMLEG ChemPharmaServe Ltd Chemphex ChemRegs (UK) Ltd ChemSafe Chemservice

Consultancy/advisory

A-Z LISTING

g e e e e i e e a e g e g i g e

g m g g i m e e e m e m g g g g g e i e e m g e m e e e i g i i g e e e

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg 229

A-Z LISTING US HCS

COSHH

CAD

CMD

Medical devices Regulation

Toy Safety Directive

RoHS

Food contact

Agrochemical registrations

EU cosmetics Regulation

Biocidal products Regulation

New TSCA/LCSA

GHS-based regulations

CLP

REACH Global chemical notifications

Occupational

Food (contact)

Medical devices

Cleaning products

Regulatory expertise

Textiles & apparel

Construction

Aerospace, automotive & engineering

Toys/children's products

Electrical and electronics

Veterinary medicine

Personal care (inc. cosmetics)

Biocides

Biotechnology

Medical & pharmaceuticals

Industrial chemicals Agrochemicals

Focus of activities

Further information                               www.cgi.com/environment www.criver.com                            www.chd.com.tr                www.chem-academy.com                                 www.chemadvisor.com www.chemadvocacy.com                           www.rmtglobal.com                     www.chemdox.com www.chementors.fi                        www.chemest.fi               www.chemex.co.uk        www.chemhazsolutions.com       www.chem-consult.com                                                                www.chemicalsafetyconsulting.com www.chemleg.com                www.chempharmaserve.com      www.chemphex.com       www.chemregs.co.uk       www.chemsafe-consulting.com                                                         www.chemservice-group.com

Chemservice EHNS GmbH ChemService Srl Controlli e Ricerche Chemtopia Co., Ltd.

  

chemtrac® CHEMTREC Chemwatch

                             www.chemtracglobal.com www.chemtrec.com                                  www.chemwatch.net

CHESSOL B.V. China National Chemical Information Center ChIR - Chemical Innovation and Regulation Chris Braun Consultancy Chymeia ApS CIDP CIRS CIS Center Citoxlab CJV Consulting Ltd

                                    

Clariant Compliance & Risks Compliance Footprint AG Compliance Services International compliance2business Consortia Management GmbH CONUSBAT Regulatory Services Coracle Cosanta

                         

Cosmetic Design Laboratories

      

     

CRAD

      

     

Crowell & Moring CS Regulatory Ltd CSB CTT Currenta GmbH & Co. OHG Cyprotex Danger and Safety srl dangerousgoods.com DanGoods Training & Consultancy Danish Technological Institute Datalab David Ryberg de ViB fabriek Decernis Decernis LLC Defense Logistics Agency DEKRA DEKRA Assurance Services GmbH DEKRA Consulting GmbH Dell Tech Laboratories Ltd. Delphic HSE Solutions Limited

          

    

                           



 



                 

    

                                           

         

    

      

www.chemservice-ehns.com www.chemservice.it www.chemtopia.net

                      

                          

                                                

    

    

        

      

                          

                                                                                                      

        

       

        

         

www.chessol.nl www.chemhse.com/english   www.emmcchir.org

   

www.almego.com www.cidp-cro.com       www.cirs-reach.com www.ciscenter.org  www.citoxlab.com  www.cjvconsultingltd.wix.com/ cjvconsultingltd www.clariant.com  www.complianceandrisks.com       www.compliance-footprint.com www.complianceservices.com       www.compliance2business.eu   www.consortia-management.com www.conusbat.com  www.coracle.global      www.cosanta.nl www.     stoffenmanager.nl www.cosmeticdesignlaboratories.   co.uk www.crad.com.tr    



   

      

  

 

     

www.crowell.com   www.csregulatory.com www.csb-online.de www.cttlab.com www.analytik.currenta.de   www.cyprotex.com www.dangerandsafety.it www.dangerousgoods.com www.dangoods.co.uk www.dti.dk/biocides www.datalabsj.com

       www.devibfabriek.nl        www.decernis.com            decernis.com www.dla.mil            www.dekra-process-safety.co.uk www.dekra.de/reach    www.dekra.de/en/reach    www.delltech.com   www.delphichse.com   

www.chemicalwatch.com/SPG

230

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122

217

124 217

126

EcoMundo France Canada, Korea, USA (New-Jersey) Economics for the Environment Consultancy Ltd. UK Belgium (eftec) EcoOnline Norway Sweden, Finland, Denmark, Switzerland Ecotox Services International Australia ECT Oekotoxikologie GmbH 217 Germany Edif ERA UK Edupalli Ramakrishna India EggCentris Belgium EHS Strategies, Inc USA EHSCareers.com, Inc USA elc group UK Czech Republic, India, Romania Elemica USA Europe, Asia Emveo Belgium France, Germany, UK Enhesa Belgium USA, China, Japan, Canada Enthone BV The Netherlands Envigo USA Offices in 14 countries worldwide Enviresearch 217 UK Environmental Assessments Germany Sweden Environmental Science Limited UK EnviroPlanning AB Sweden EPP UK EquiTox France ERM 128 UK Worldwide offices  ES4chem The Netherlands eSpheres 218 Belgium Finland, Germany, France, Netherlands ETC Slovakia EUPHOR USA Eupoc Germany Eurideas Language Experts 218 Belgium Hungary Euro Safety and Health UK Eurofins 130 Belgium Germany, UK, Switzerland, Denmark, Asia, USA  Eurofins Air Toxics USA Denmark, Germany, France, China Eurofins Product Testing A/S Denmark Europe, China, USA Euromines Belgium Eversheds LLP UK Europe, Middle East, Asia Exitss Belgium Exponent International Limited 132 UK USA, Switzerland, China  f_OXYDE GmbH Austria Fanwood Chemical, Inc USA Germany Fera Science Ltd UK Fieldfisher LLP 134 UK Belgium, France, Germany, Italy  Flashpoint srl Italy FoBiG 136 Germany  Foresite Systems USA Formulator Software LLC US Fraunhofer ITEM Germany GAB Consulting GmbH Germany Italy, Cyprus, Slovenia, Spain, Poland Gain Claude France GBK GmbH Global Regulatory Compliance 138 Germany  Gensuite 140 USA  Gentrochema BV The Netherlands GHD USA Australia, Canada, Chile, New Zealand, UK GHS Training & Consulting Canada GHS-expert Ltd Hungary Gillies Associates Limited UK Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%

Global Service Providers Guide 2019

25-50 10-25

50-100 5-10 25-50 100-500 500-1000 5-10 1 5-10 50-100 100-500 1 100-500 2,000-5,000 2,000-5,000 10-25 2-5 2-5 5-10 25-50 5-10 5,000 plus 1 25-50 10-25 50-100 1 10-25 2-5 5,000 plus 5,000 plus 5,000 plus 5-10 2,000-5,000 10-25 500-1,000 5-10 2-5 100-500 100-500 10-25 10-25 25-50 5-10 100-500 50-100 1 25-50 100-500 2-5 5,000 plus 1 1 2-5

5-10 5-10 25-50 5-10 100-500 5-10 1 2-5 10-25 100-500 1 50-100 10-25 500-1,000 10-25 2-5 2-5 2-5 25-50 5-10 100-500 1 25-50 5-10 10-25 1 10-25 2-5 100-500 2,000-5,000 100-500 2-5 25-50 2-5 50-100 2-5 2-5 50-100 10-25 5-10 10-25 5-10 5-10 25-50 50-100 1 10-25 1 100-500 1 1 2-5

g i e g g m m m m g m e i m i

e g a i a

a a e

Other(s)

Equipment

Training

Chemical staff 10-25 50-100 2-5 2-5 25-50 1 1 1 1 50-100 2-5 100-500 1 25-50 2-5 5-10 50-100 2-5 5-10

Information services

Global staff 100-500 1,000-2,000 5-10 2-5 25-50 1 1 1 1 Germany 5,000 plus United States 2-5 China, France, Germany, Japan, Singapore, Taiwan 1,000-2,000 2-5 50-100 2-5 5-10 5,000 plus Spain 5-10 Czech Republic 5-10

IT & software solutions

Other locations Belgium 3 offices worldwide

Laboratory services

Headquarters USA Denmark UK Belgium Turkey Germany India Italy Germany USA United States USA South Africa Germany Canada Belgium USA The Netherlands UK

Legal services

Page

Representation/management

Organisation Dentons DHI DIPHEX Ltd Distefano Law Office DORUKSISTEM DR MACH Chemical Compliance & Competence Dr Prerna Shinde Dr. Andrea Volpato Dr. Philipp Langenbach GmbH DXC Technology E3 Strategic Partners, LLC EAG Laboratories Eagle Environmental EBRC Consulting ECD Compliance ECETOC Ecolab Ecomatters BV EcoMole Ltd.

Consultancy/advisory

A-Z LISTING

m m g a e e e e a e e g e e g m

a e a e e e a a m m e e e g e e e e m a m m e e i g e e e m e m e

m e e

i m

e m

m e

i i i e g m g g i i m

g m m m g e m m e

m m

g e m

m m i g m e g m m g g e

g e e a

e a e a m i g i i m e e i

e e e

g e g

a g e g i g e e m e e

e i e

g e m m m m g e g e

e e e e e

e e g a e

m e m

a m m

e g e i e m e a a m m e e e e e i i i i e e m g m m e e m e

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

EcoMundo Economics for the Environment Consultancy Ltd. (eftec) EcoOnline Ecotox Services International ECT Oekotoxikologie GmbH Edif ERA Edupalli Ramakrishna EggCentris EHS Strategies, Inc EHSCareers.com, Inc elc group Elemica Emveo Enhesa Enthone BV Envigo Enviresearch Environmental Assessments Environmental Science Limited EnviroPlanning AB EPP EquiTox ERM ES4chem eSpheres ETC EUPHOR Eupoc Eurideas Language Experts Euro Safety and Health Eurofins Eurofins Air Toxics Eurofins Product Testing A/S Euromines Eversheds LLP Exitss Exponent International Limited f_OXYDE GmbH Fanwood Chemical, Inc Fera Science Ltd Fieldfisher LLP Flashpoint srl FoBiG Foresite Systems Formulator Software LLC Fraunhofer ITEM GAB Consulting GmbH Gain Claude GBK GmbH Global Regulatory Compliance Gensuite Gentrochema BV GHD GHS Training & Consulting GHS-expert Ltd Gillies Associates Limited

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A-Z LISTING US HCS

COSHH

CAD

CMD

Medical devices Regulation

Toy Safety Directive

RoHS

Food contact

Further information www.dentons.com                      www.tox.dhigroup.com www.diphex.com               www.distefanolawoffice.com www.doruksistem.com.tr           www.mach-chemguide.com     www.andreavolpato.it         www.dr-langenbach.de     dxc.technology                         www.e3strategicpartners.com www.eag.com          www.eagleenv.co.za www.ebrc.de         www.ecdcompliance.com  www.ecetoc.org www.ecolab.com       www.ecomatters.nl     www.ecomole.com/reach-clp          consulting.html          www.ecomundo.eu www.eftec.co.uk      

                                                                                      

Agrochemical registrations

EU cosmetics Regulation

Biocidal products Regulation

New TSCA/LCSA

GHS-based regulations

CLP

REACH Global chemical notifications

Occupational

Food (contact)

Medical devices

Cleaning products

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231

Regulatory expertise

Textiles & apparel

Construction

Aerospace, automotive & engineering

Toys/children's products

Electrical and electronics

Veterinary medicine

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Personal care (inc. cosmetics)

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Biocides

Biotechnology

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Medical & pharmaceuticals

Industrial chemicals Agrochemicals

Focus of activities

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         www.ecoonline.com www.ecotox.com.au www.ect.de  www.edifgroup.com    www.bhu.ac.in  www.EggCentris.com  www.ehsstrategies.com www.ehscareers.com www.elc-group.com  www.elemica.com  www.emveo.be        www.enhesa.com enthone.com www.envigo.com  www.enviresearch.com   www.enas-online.com  www.esldatasheets.com

www.eppltd.com www.equitox.eu                    www.erm.com             

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www.espheres.com      www.ekotox.sk               www.euphoreach.com www.eupoc.com             www.eurideastranslation.com    www.eurosh.com www.eurofins.com           www.airtoxics.com     www.eurofins.com/galten    www.euromines.org  www.eversheds.com     www.exitss.eu            www.exponent.com www.foxyde.com  www.fanwoodchemical.com www.fera.co.uk   www.fieldfisher.com         www.flashpointsrl.com   www.fobig.de           www.foresitesystems.com   www.formulatorus.com      www.item.fraunhofer.de    www.gabconsulting.de     

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  www.gbk-ingelheim.com www.gensuite.com www.gentrochema.nl   www.ghd.com www.ghstc.com www.REACHexpert.eu www.gilliesassociates.co.uk    

www.chemicalwatch.com/SPG

232

ibacon GmbH ICB Pharma ICF International IDRG (International Development of Regulatory Globalization) IES Ltd IFF China IGCON imds professional GmbH & Co. KG INERIS INFOTOX INSCX exchange International Cosmetics & Chemical Services Ltd Intersolia AB Intertek IOM IPO O/Pszczyna iPoint-systems gmbh

142

Germany Poland USA Germany

Taiwan, Japan, China, Spain

USA, UK, Poland

Bangladesh, China, Hong Kong, India, Turkey, USA USA

Belgium, Brazil, China, Russia, India

5,000 plus 2-5

1,000-2,000 2-5

100-500 50-100 2,000-5,000 2-5

100-500 25-50 50-100 2-5

e e m i

m e

2-5 50-100 1 5-10 1,000-2,000 2-5 2-5 5-10 50-100 5,000 plus 10-25 50-100 25-50

e g m g g m g m g

2-5 2-5 1 2-5 50-100 1 100-500 25-50 1 25-50 5-10 2-5 10-25 25-50 25-50 5-10 10-25 100-500 10-25 2-5 2-5 2-5 1 25-50 50-100 50-100 10-25 2-5 5-10 100-500

g e e m e e e m m g g g e m g i i m m e g e e e e e m m m i e a m g g g m

5-10 2-5 2-5 25-50 25-50

m e e e e m e e e e i g e e m

g g g i e

i i

m i i i m e m m i

Other(s)

50-100 50-100 50-100 1 2-5 2-5 10-25 10-25 50-100 2-5 10-25 2-5 2-5 2-5 25-50 100-500

i e e m g m

Equipment

Training

Information services

Global staff 5-10 10-25 5,000 plus 100-500 50-100 1 2-5 2-5 100-500 500-1000 50-100 2-5 25-50 2-5 2,000-5,000 25-50 25-50 1,000-2,000

50-100 5,000 plus 1 France Italy Spain Brazil 25-50 148 1,000-2,000  218 UK & India 5-10 USA, Turkey 5-10 UK 5-10 Denmark, Germany, United Kingdom, Serbia 100-500 150 11+ Countries 5,000 plus  Singapore 100-500 50-100 Austria, France, Benelux, Sweden, UK, USA, Japan, 100-500 China, South Korea Jaehak Jung South Korea China, Vietnam 50-100 Japag Regulatory Consultancy India 2-5 Japan Chemical Safety Institute Japan 1 Jean Warshaw, Esq. USA 2-5 Jones Day Belgium North America, Europe, Japan 5,000 plus Jongerius Consult BV 219 The Netherlands 1 JRF Global India USA, UK 100-500 JSC International Limited UK 25-50 K J Bray & Associates UK 1 K&L Gates LLP Belgium 1,000-2,000 KAELTIA Compliance Services 152 Spain 5-10  Kalium solutions inc. 219 Canada 5-10 Kathrin Lanz Germany 10-25 Keller and Heckman LLP USA Belgium, France, China 100-500 Kelley Drye & Warren 154 USA Brussels 100-500  Kerona Scientific Ltd 219 Ireland Spain 5-10 KFT Chemieservice GmbH 156 Germany 10-25  knoell 158 Germany 100-500  Konica Minolta Business Expert, Inc Japan 2,000-5,000 KREATiS France 2-5 Krogerus Attorneys Ltd. Finland 100-500 Kumi Consulting Ltd UK 5-10 KV Consulting Services BVBA Belgium 1 LAUS Germany France, USA and UK 50-100 LG CNS South Korea Asia, South America, Europe, USA, Middle East 5,000 plus LGC UK 1,000-2,000 Linge Agroconsultancy 220 The Netherlands 10-25 Linmark Consulting GmbH Switzerland United Kingdom, Malta 2-5 Linnunmaa Oy Finland 10-25 Lisam Systems 160 Belgium USA, Canada, UK, France, Germany, Romania, 100-500  India, Turkey, Brazil LKC Switzerland Ltd 220 Switzerland UK 5-10 Logic SDS 162 United Kingdom France 2-5  Loufakis Chemicals SA Greece Bulgaria, Servia, Macedonia 25-50 LSR Associates UK USA, Japan 1,000-2,000 Manatt, Phelps & Phillips, LLP USA 100-500 Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%

Global Service Providers Guide 2019

Switzerland China The Netherlands Germany France Portugal UK USA Sweden UK UK Poland Germany

Offices in over 2 countries

Chemical staff 5-10

IT & software solutions

146

Belgium Switzerland

218

Other locations

Laboratory services

144

Headquarters UK USA Italy USA USA USA Romania Romania Ireland USA China Japan Israel Canada UK UK UK Germany

Legal services



Hunton & Williams I+K AG, Compliance-Footprint AG

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Page

Representation/management



Organisation GlobalMSDS GLTaC, Inc. Golder Associates Gradient GreenSoft Technology, Inc Greenwich Chemical Consulting Grow Smart Chemical Compliance Grow Smart Solutions H2 Compliance Haley & Aldrich, Inc. Hangzhou RUIO Technology Co. Ltd HatoChemi Japan HAZMAT Ltd HDTS Chemicals Inc. herbert smith llp HFL Consulting Ltd Hibiscus Plc Hohenstein Group

Consultancy/advisory

A-Z LISTING

i a a a e a a i a a a e a g e e e e g e m e e e e g g e e e g e m m g g m e m a e e e

g e e i g e

m e g

e m i e e

e i

g e e i e e a e g e e e g e e m e e e m m e

e m

g g e g i e

g e e e e m e

m e

e e e e g e g g m

e a a e e e a e e i i e

i e m e a a g i a m

m m g i g g e a

m e e

e e e e a e m

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

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Jaehak Jung Japag Regulatory Consultancy Japan Chemical Safety Institute Jean Warshaw, Esq. Jones Day Jongerius Consult BV JRF Global JSC International Limited K J Bray & Associates K&L Gates LLP KAELTIA Compliance Services Kalium solutions inc. Kathrin Lanz Keller and Heckman LLP Kelley Drye & Warren Kerona Scientific Ltd KFT Chemieservice GmbH knoell Konica Minolta Business Expert, Inc KREATiS Krogerus Attorneys Ltd. Kumi Consulting Ltd KV Consulting Services BVBA LAUS LG CNS LGC Linge Agroconsultancy Linmark Consulting GmbH Linnunmaa Oy Lisam Systems

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LKC Switzerland Ltd Logic SDS Loufakis Chemicals SA LSR Associates Manatt, Phelps & Phillips, LLP

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A-Z LISTING

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www.ies-ltd.ch

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www.igcon.nl www.imds-professional.com www.ineris.fr www.infotox.pt  www.inscx.com www.Intlcosmetics.com          www.intersolia.com     www.intertek.com www.iom-world.org www.ipo-pszczyna.pl       www.ipoint-systems.com

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www.kotiti.re.kr

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www.jonesday.com www.jongeriusconsult.com www.jrfonline.com www.jsci.co.uk

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         

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Further information www.globalmsds.co.uk www.gltac.com www.golder.com www.gradientcorp.com www.greensofttech.com www.grcci.com www.chemicalcompliance.eu www.produsebiocide.ro www.h2compliance.com www.haleyaldrich.com www.reach24h.com www.hatochemi.com www.hazmat.co.il www.hdtschemicals.com www.herbertsmithfreehills.com www.hflconsulting.uk www.hibiscus-plc.co.uk www.hohenstein.com www.hunton.com www.i-k.ch, www.complinacefootprint.com www.ibacon.com www.icbpharma.com www.icfi.com www.idrgplantprotection.eu

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US HCS

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CMD

Medical devices Regulation

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RoHS

Food contact

Agrochemical registrations

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New TSCA/LCSA

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REACH Global chemical notifications

Occupational

Food (contact)

Medical devices

Cleaning products

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233

Regulatory expertise

Textiles & apparel

Construction

Aerospace, automotive & engineering

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Hunton & Williams I+K AG, Compliance-Footprint AG

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Toys/children's products

Electrical and electronics

Veterinary medicine

Personal care (inc. cosmetics)

Biocides

Biotechnology

Medical & pharmaceuticals

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www.klgates.com   www.kaeltia.com    en.kaliumsolutions.com www.qualisys.eu    www.khlaw.com  www.kelleydrye.com www.kerona.ie   www.kft.de    www.knoell.com www.konicaminolta.com www.kreatis.eu www.krogerus.com  www.kumi.consulting www.kvconsultings.com www.laus.group www.lgcns.com www.lgc.co.uk www.lingeagroconsultancy.nl www.linmarkconsulting.com   www.linnunmaa.fi   www.lisam.com 

www.LKC-ltd.com  www.logicsds.com www.loufakis.gr www.lsr-associates.com www.Manatt.com

www.chemicalwatch.com/SPG

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REACH Advice GmbH REACh ChemAdvice GmbH REACh ChemConsult GmbH Reach Chemical BV REACH Delivery REACH Global Services S.A. REACH Monitor Reach Only Representative Ltd REACH Orphan Substances Consortium bvba ROSC Reach Registration Services REACH24H Consulting Group ReachCentrum SA REACHECK Solutions GmbH REACHLaw REACHLINKED REACHReady ReachSpektrum REACHWise Redebel Regulatory Affairs S.C.R.L. Redeker Sellner Dahs Rechtsanwälte ReFaC RegScan Inc. RegTox Solutions Inc. REGULATORING Consultancy SV Regulatus Renfrey Regulatory and Compliance Consultancy Ltd Ricerca Biosciences, LLC RimaOne Risk & Policy Analysts Ltd (RPA)

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168

221 221

170

172

174 176 221 222 222 178 180

182

Asia-Pacific, EMEA, Americas Italy, Brazil, France, China

USA, UK, Germany, China France, Germany, Poland, Italy, Spain

USA Germany UK

Belgium

Canada, US

Belgium UK

Other(s)

Equipment

Training

e e e e g

i m m m m i m m m i i m e m i m m m

m e e e

e e e

1 5-10 5-10 1 25-50 10-25 2-5 2-5 2-5

i m m m e e m g i

g g e a g e a a a a g m m a a e g e e e e i a a

10-25 100-500 10-25 5-10 25-50 5-10 5-10 5-10 2-5 50-100 100-500 2-5

2-5 50-100 10-25 2-5 25-50 5-10 2-5 5-10 2-5 50-100 5-10 2-5

g m e g g g i i m m g m

1 1 1 1

g e e e e e e m e e e g g e e g e a a a e e e e e m g i

m m e m m

500-1,000 25-50 25-50

500-1,000 25-50 10-25

e e

1 Portugal, Sweden, USA, India, China, South Korea 5-10 UK 5-10 1 USA, Japan 25-50 Turkey 10-25 10-25 Agents: Asia, Middle East 5-10 2-5

The Netherlands, Germany

Information services

i g i g m m e

Germany Germany Germany The Netherlands UK Belgium Spain UK Belgium

Belgium, India, Turkey

m e e m e e m m e m e i e a e g e m m a g a e m e e m m e e e g m g m i e e a e e m m e g e m

5-10 2-5 100-500 1 5-10 5-10 10-25 10-25 5-10 1 2-5 1 5-10 10-25 5-10 1 10-25 25-50 5-10 25-50 10-25 50-100 5-10

China Portugal USA UK USA Belgium UK UK Belgium Belgium UK Finland Hungary Finland UK Canada Norway The Netherlands Germany The Netherlands China UK China

Ireland, USA EU, Taiwan, Vietnam, S.Korea, China, USA

500-1000 25-50 10-25 Sri Lanka, Bangladesh 10-25 1,000-2,000 25-50 Ireland, UK 2-5 Guyana, Barbados, St. Lucia, Antigua and Barbuda, 2-5 St. Vincent and the Grenadines, and Suriname (The Caribbean) 10-25 5-10 2,000-5,000 1 France 10-25 UK, The Netherlands 5-10 100-500 Belgium 10-25 UK 5-10 1 2-5 1 Belarus, Kazakhstan, Moldova, Russia, Ukraine 10-25 2,000-5,000 China 5-10 1 100-500 China, Hong Kong, Germany, UK 25-50 5-10 Global presence 2,000-5,000 USA 10-25 13 in 35 countries 5,000 plus Taiwan 10-25

UK China Belgium Germany Finland China UK Czech Republic UK Belgium Germany UK USA Canada Hungary UK UK

Chemical staff 2-5 5-10 2-5 1,000-2,000 5-10 1 100-500 10-25 2-5 25-50 100-500 10-25 5-10 10-25 10-25 10-25 2-5 1

m e

Canada

Risk Control Services Ltd UK Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%

Global Service Providers Guide 2019

Global staff 25-50 10-25 100-500 2,000-5,000 10-25 10-25 1,000-2,000 10-25 2-5

IT & software solutions

220 221

164

Other locations

Laboratory services

OCI ONLYCORECHEM Pace Regulatory Services Paul Illing Consultancy Services Ltd PeerAspect Penman Consulting Pera Technology Peter Fisk Associates PFA-Brussels pIEt Consulting BVBA Pinnacle Associates Pirjo Heikkilä Polgar ACRO Pöyry Finland Oy Prefusion LLP Primetra Global Regulatory Consultants Proactima AS ProductIP Prosacon GmbH PwC Quality Technical Services LLC Ramboll Environment and Health Randis ChemWise (Shanghai) Co., Ltd.

220

Headquarters USA Denmark USA USA USA USA Hong Kong Hungary USA UK UK USA Canada India Germany Italy Canada Trinidad & Tobago

Legal services

Page

Representation/management

Organisation MB Research Laboratories mediator A/S Mercer Mérieux Nutrisciences Miami Chemical Micromeritics Analytical Services Modern Testing Services (Global) MSDS Europe MSDSWriter LLC National Chemical Emergency Centre (NCEC) National Physical Laboratory (NPL) Neuralog, LP Nexreg Compliance Inc. NimkarTek Technical Services Pvt. Ltd Noerr LLP NORMACHEM S.r.l NovaTox NRM Solutions

Consultancy/advisory

A-Z LISTING

e i g e e e e e g g m e e e

e g e e e i e e e e e

e e

e e g e

e e a e a a e e e e

e e e e e i e e e g e g e g e e

e i e e

m m

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

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Risk Control Services Ltd

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          

US HCS

COSHH

A-Z LISTING

                             

 www.oci.net.cn www.onlycorechem.com www.pacelabs.com/regulatory   www.peeraspect.com www.penmanconsulting.com www.peratechnology.com www.ecotoxchem.co.uk www.pfa-brussels.eu www.pietconsulting.eu www.pinnacleassoc.com

www.polgar-acro.eu www.poyry.com www.prefusion.co.uk    www.primetra.com www.proactima.no/en www.productip.com www.prosacon.eu www.pwc.nl/nl/reach www.qtsinspect.com      www.ramboll.com www.randis.cn, www.randischem. com www.reach-advice.com www.reach-chemadvice.com www.reach-chemconsult.com www.reacheu.nl www.reachdelivery.com www.reach-gs.eu www.reachmonitor.org www.rorltd.com www.ROSconsortium.eu 

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CAD

CMD

Medical devices Regulation

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Food contact

Agrochemical registrations

EU cosmetics Regulation

Toy Safety Directive

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   

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      

Further information www.mbresearch.com www.mediator.as  www.mercer.com www.merieuxnutrisciences.com www.miamichemical.com www.particletesting.com www.mts-global.com www.msds-europe.com   www.msdswriter.com www.the-ncec.com  www.npl.co.uk www.neuralog.com  www.nexreg.com www.nimkartek.com www.noerr.com     www.normachem.it www.novatox.ca www.nrmsolutions.org/

                        

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                  

Biocidal products Regulation

New TSCA/LCSA

GHS-based regulations

CLP

REACH Global chemical notifications

Occupational

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Food (contact)

Medical devices

Cleaning products

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235

Regulatory expertise

Textiles & apparel

Construction

Aerospace, automotive & engineering

Toys/children's products

Electrical and electronics

Veterinary medicine

Personal care (inc. cosmetics)

Biocides

Biotechnology

Medical & pharmaceuticals

Industrial chemicals Agrochemicals

Focus of activities

      

www.reach-rs.com www.reach24h.com/en-us   www.reachcentrum.eu www.reacheck.eu www.reachlaw.fi www.reachlinked.com www.reachready.co.uk www.reachspektrum.eu www.reachwise.eu www.redebel.com www.redeker.de www.refac.eu www.regscan.com  www.regtoxsolutions.com www.regulatoring.com www.rrandcc.com www.ricerca.com www.rimaone.com   www.rpaltd.co.uk www.rcsinfo.com

www.chemicalwatch.com/SPG

236

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

SAP AG SAP Japan Co, Ltd SATRA Technology SCAS Europe SCC Science & Environnement Scitegrity Scivera Selcia Ltd. Selerant SenzaGen ServiREACH, S.A. SFS Chemical Safety SGS Agriculture, Food and Life ShawCor SHES Chemical Consulting Co., Ltd Shridhar Rajappanavar Siam S.L. SIEF-IT SiteHawk Sitmae Reach Services BV Smithers Viscient SOCOTEC - Health and Product Safety Agency spectra Consult GmbH SpetsInterProject Oy Sphera Solutions Spinnaker Coating, LLC Spring Trading Company, LLC Staphyt Regulatory Star Wang Stefanie Merenyi Steptoe & Johnson LLP Stewardship Solutions Ltd Subvise Surface Science Western Sustainability Consult Sustainability Support Services (Europe) AB SustChem Engineering Ltd Syska Voskian Consulting TEAM mastery Ted Simon LLC TEI Analytical, Inc Telematic srl Tenviro Tetra Tech The Compliance Map Ltd. The Economics Interface Limited The Isosceles Group The Martec Group The Redstone Group The Sapphire Group the SDS factory | de ViB fabriek The Windsor Consulting Group, Inc.

184 186

222 188

223 223

222

190

192

194

196

198

200

Germany Japan UK Japan Germany Switzerland United Kingdom USA UK Italy Sweden Spain USA Switzerland Canada South Korea India Spain Poland USA The Netherlands USA France Germany Finland USA USA USA France China Germany USA UK Germany Canada Belgium Sweden Greece USA Italy USA USA Italy Sweden USA UK UK USA USA USA USA The Netherlands

USA, Spain and Japan Canada

1 offices worldwide Singapore USA, Ireland, Greece, Japan, Turkey, The Netherlands

China China, Singapore, South Korea, Taiwan Japan France

USA

10-25 50-100 50-100 5-10 10-25 25-50 5,000 plus 2-5 10-25 50-100 10-25 5-10 25-50 2-5

Other(s)

Equipment

5-10 5-10 25-50 25-50 5-10

Training

5,000 plus 1,000-2,000 100-500 1,000-2,000 100-500 5-10

Information services

Chemical staff 1 10-25 1 1 10-25 50-100 50-100 25-50 1 10-25

10-25 50-100 USA, India, China, Germany, France, Serbia 100-500 Sweden, US 10-25 10-25 25-50 More than 14 countries 5,000 plus 2,000-5,000 10-25 2,000-5,000 France, Italy, Greece, Portugal, Poland, Romania, 10-25 Finland, Ireland, UK, EL 5-10 25-50 2-5 UK 100-500 5-10 2-5 Russia Ukraine 5-10 Worldwide 100-500 2-5 5-10 Poland, Australasia 100-500 500-1000 1 Belgium 100-500 5-10 2-5 10-25 5-10 India, South Korea, Ireland 25-50 5-10 Denmark 2-5 10-25 1 5-10 10-25 The Netherlands 1 Germany, Canada, UK 5,000 plus US, Australia 25-50 1 10-25 Germany, China, Japan, Brazil, Chile 50-100 The Netherlands 10-25 5-10 UK, Germany, Belgium 2-5

TJS Technical Services Inc. Canada TO21 Co. Ltd. South Korea Tox Focus LLC 223 USA toXcel 224 UK USA Toxicon 224 Italy Toxi-Coop Toxicological Research Centre Ltd. Hungary Switzerland, USA Toxikon USA Belgium ToxMinds 202 Belgium India, Germany  ToxServices USA 15 ToxSolve LLC USA Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%

Global Service Providers Guide 2019

Global staff 2-5 10-25 1 1 25-50 5,000 plus 100-500 100-500 1 50-100

IT & software solutions

Other locations

Laboratory services

Headquarters South Africa Ireland USA Ireland France The Netherlands Italy UK UK UK

Legal services

Page

Representation/management

Organisation Riskchem Rivendell International RoHS Ready LLC Roisin McEneany Rovaltain Research Company Royal HaskoningDHV RTC, Research Toxicology Centre S.p.A. SAFENANO Safety Data Services Safeware Quasar Ltd

Consultancy/advisory

A-Z LISTING

g e m i e e g m i g g e m e i e e a e e e e m m g e m e g m e

e m m m g g e e g i g e

i m m g a e

e a a a e e e m e m e

i e e m e e g e i i e e

m e

m m e

e i m

i e

i i i

i i

e i e

g e e

5-10 2-5 2-5 100-500 2-5 2-5 25-50 50-100 1 25-50 5-10 2-5 10-25 1 25-50 5-10 2-5 5-10 1 5-10 5-10 1 25-50 10-25 1 10-25 1 10-25 5-10 2-5

g m g e m e i i g i g e a m e a e a a m e e e m e e m m g g e e m e m m g m e m i e e e e e a m e e e m g m e a a e a m e m e m e g g g g g i e e e g g e e m e e m e i e e i e m m m e e e m g e

5-10

2-5

e e e

2-5 50-100 2-5 10-25 5-10 50-100 100-500 10-25 25-50 1

1 25-50 2-5 10-25 5-10 25-50 5-10 10-25 10-25 1

m i m i g e e m m m

e g

g e a a e e a e e a e e m m e e e e e e

e e a a

e i g

e g

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

                                                                      

        

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                                 

  

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  

                                       

The Windsor Consulting Group, Inc.

      

TJS Technical Services Inc. TO21 Co. Ltd. Tox Focus LLC toXcel Toxicon Toxi-Coop Toxicological Research Centre Ltd. Toxikon ToxMinds ToxServices ToxSolve LLC

        

       

        

    

A-Z LISTING US HCS

COSHH

CAD

CMD

Medical devices Regulation

Toy Safety Directive

RoHS

Food contact

Agrochemical registrations

EU cosmetics Regulation

Biocidal products Regulation

New TSCA/LCSA

GHS-based regulations    

   

   

   

www.rovaltainresearch.com www.royalhaskoningdhv.com www.rtc.it www.safenano.org

              

www.safeware.co.uk

    

www.sap.com     www.sap.com   www.satra.co.uk  www.scas-eu.be                  www.scc-gmbh.de www.sci-env.ch   www.scitegrity.com             www.scivera.com www.selcia.com           www.selerant.com www.senzagen.com www.servireach.com             www.chemicalsafety.com www.sgs.com/en/agriculture-food  www.shawcor.com      www.cae.com www.siam-it.com        



          

                                                                                                                                                                                                 

            

       

Further information www.riskchem.co.za www.rivendell.ie www.rohsready.org

                                              



       

         

               

         

CLP

REACH Global chemical notifications

Occupational

Food (contact)

Medical devices

Cleaning products

         

   

237

Regulatory expertise

Textiles & apparel

Construction

Aerospace, automotive & engineering

Toys/children's products

Electrical and electronics

Veterinary medicine

Personal care (inc. cosmetics)

Biocides

Biotechnology

Medical & pharmaceuticals

Industrial chemicals Agrochemicals

Focus of activities

     

      

                                                          

                      

                          

         

                    

                   

      

                                

       

         

               

                              

         

   

       

        

        

   

         

       

      

    

                     

          

www.sief-it.com www.sitehawk.com www.sitmaereachservices.com www.smithersviscient.com www.socotec.com/en/ www.spectra-consult.de/ www.spetsinterproject.com www.sphera.com www.spinps.com www.springtradingcompany.com www.staphyt.com/regulatory www.merenyi.net www.steptoe.com www.stewardshipsolutions.co.uk www.subvise.com www.surfacesciencewestern.com www.sustainabilityconsult.com www.ssseurope.org www.sustchem.gr www.sysvoskconsulting.com www.team-mastery.eu www.tedsimon-toxicology.com www.teianalytical.com www.epyplus.com www.tenviro.eu www.tetratech.com www.thecompliancemap.com www.theeconomicsinterface.com www.theisogroup.com www.martecgroup.com www.redstonegrp.com www.thesapphiregroup.com www.theSDSfactory.com | www. deViBfabriek.nl www.windsgroup.wix.com/ windsconsultingroup www.tjstechnical.com www.to21.co.kr www.toxfocus.com www.toxcel.com www.toxicon.it www.toxicoop.com www.toxikon.be www.toxminds.com www.toxservices.com

www.chemicalwatch.com/SPG

238



TUV Rheinland of North America TÜV SÜD Iberia S.A.U. TÜV SÜD Industrie Service GmbH TUV SUD Japan UetlibergPartners GmbH UL UMCO GmbH Universit Bordeaux Segalen Vanta Bioscience Verdant Law, PLLC Verisk 3E Vidaris, Inc. VITO NV team EHS Toxicology Services Vivotecnia Research Von Roll REACH GmbH VRS Regulatory W.E. Train Consulting wca environment Weeset Advisors Wiley Rein LLP WILLIAM WILSON Wyeside Consulting Ltd Wilmer Tox Consulting Womble Bond Dickinson (UK) LLP

204

206

208

210

224

USA Spain Germany Japan Switerland USA Germany France India USA USA USA Belgium Spain Germany UK USA UK USA USA UK Switzerland UK

France, Belgium, UK, China, Germany, Japan

Denmark, Canada, Japan, China

Scotland, Italy

United States

WRc plc UK WSP UK Ltd 224 UK Wordwide WTConsulting Switzerland XCellR8 UK YASH Technologies USA Europe, Asia, Australia Yordas Group 212 UK Italy, USA, Japan, China  Zanos Ltd UK Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%

Global Service Providers Guide 2019

m a m e g e m m g i

m e e e e e

a a m g e i

m e e i e g e e e e g e g g

Other(s)

Equipment

Training

Chemical staff 5-10 25-50 5-10 500-1000 50-100 100-500 50-100 50-100 10-25 100-500 500-1000

Information services

Global staff 25-50 25-50 Uited States of America 5-10 Spain, USA, France 1,000-2,000 Europe 500-1000 Japan, USA, Canada (sales offices) 100-500 100-500 Ireland, Spain, Germany, France, Slovenia, Poland 50-100 Germany, China, Japan, India, Taiwan, South Korea 5,000 plus 5,000 plus Europe, China, Japan, Thailand, Vietnam, India, 5,000 plus North America, Brazil, Russia, Australia, South Africa, Germany, China, Hong Kong, India 5,000 plus Taiwan 100-500 Japan, Singapore, China, India 2,000-5,000

IT & software solutions

Other locations

Laboratory services

Headquarters USA USA The Netherlands UK Belgium The Netherlands USA UK USA Hong Kong Germany

Legal services

Page

Representation/management

Organisation ToxStrategies TraceGains Trade Wind B.V. Tradebe UK TRASYS Triskelion B.V. TSG TSGE Consulting TUV Rheinland TUV Rheinland Hong Kong Ltd TÜV Rheinland LGA Products GmbH

Consultancy/advisory

A-Z LISTING

e g

1,000-2,000 25-50 50-100

g e i e e m e e e g g e e e e

100-500 2-5 5,000 plus 50-100 500-1,000 25-50 5-10 100-500 100-500 10-25 50-100 2-5 5-10 2-5 10-25 1 100-500 2-5 1 1,000-2,000

2-5 2-5 100-500 25-50 100-500 10-25 5-10 100-500 2-5 10-25 25-50 2-5 2-5 1 10-25 1 10-25 1 1 50-100

e m e a a m g i e m e e e e e e e g e e e m e e m e e e e m m e e e e m e m m e e m g m m g m g e i e e i i m e g m

100-500 5,000 plus 5-10 10-25 2,000-5,000 50-100 5-10

10-25 50-100 5-10 10-25 50-100 50-100 2-5

i m m e g i e

e e

m e a g e e e

i e e

e e e

e e e e e e

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg 239

A-Z LISTING US HCS

COSHH

CAD

CMD

Medical devices Regulation

Toy Safety Directive

RoHS

Food contact

Agrochemical registrations

EU cosmetics Regulation

Biocidal products Regulation

New TSCA/LCSA

GHS-based regulations

CLP

REACH Global chemical notifications

Occupational

Food (contact)

Medical devices

Cleaning products

Regulatory expertise

Textiles & apparel

Construction

Aerospace, automotive & engineering

Toys/children's products

Electrical and electronics

Veterinary medicine

Personal care (inc. cosmetics)

Biocides

Biotechnology

Medical & pharmaceuticals

Organisation ToxStrategies TraceGains Trade Wind B.V. Tradebe UK TRASYS Triskelion B.V. TSG TSGE Consulting TUV Rheinland TUV Rheinland Hong Kong Ltd TÜV Rheinland LGA Products GmbH

Industrial chemicals Agrochemicals

Focus of activities

Further information                                 www.toxstrategies.com www.tracegains.com                                www.twnl.nl www.tradebe.co.uk        www.trasys.be               www.triskelion.nl                       www.tsgusa.com               www.tsgeurope.com           www.tuv.com/us/green-solutions            www.chn.tuv.com                www.tuv.com           

TUV Rheinland of North America TÜV SÜD Iberia S.A.U. TÜV SÜD Industrie Service GmbH

     

TUV SUD Japan UetlibergPartners GmbH UL UMCO GmbH Universit Bordeaux Segalen Vanta Bioscience Verdant Law, PLLC Verisk 3E Vidaris, Inc. VITO NV team EHS Toxicology Services Vivotecnia Research Von Roll REACH GmbH VRS Regulatory W.E. Train Consulting wca environment Weeset Advisors Wiley Rein LLP WILLIAM WILSON Wyeside Consulting Ltd Wilmer Tox Consulting Womble Bond Dickinson (UK) LLP

                   

WRc plc WSP UK Ltd WTConsulting XCellR8 YASH Technologies Yordas Group Zanos Ltd

     

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