Global Service Providers Guide 2020 by Enhesa Product

Global Service Providers Guide 2020

ANNIVERSARY

The guide to global chemicals management and control services

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Foreword

Foreword Welcome to the tenth edition of the Chemical Watch Service Providers Guide and directory. Since the survey for this the tenth edition of our annual Service Providers Guide was conducted late last year the coronavirus Covid-19 has swept across much of the world, triggering what looks likely to be a global recession and forcing businesses to adjust to a world of home working, social distancing and nimble, short-term planning.

This year we have more than 100 different companies participating in the directory section of the guide. The detailed profile of each company can connect you to the services best suited to support your business needs. The directory is also available online at chemicalwatch.com for the next 12 months and we invite you to continue exploring the intuitive search filter there.

The crisis makes it clear that chemicals can bring vital benefits to society, and that it is crucial that chemical supply chains, manufacturing operations and transportation networks continue to function as smoothly as possible. Chemicals management legal compliance continues, with product stewards and regulatory affairs managers still fulfilling their crucial role.

If we were to redo the survey now, the unpredicted and urgent Covid-19 crisis would dominate our thinking. But instead the survey is a reminder that our members work on a daily basis to protect human health and the environment and the challenges of doing this go on, regardless of the new needs posed by the virus. Chemical Watch sees the crisis in just that light: we are putting rocket fuel into our mission to provide the best insights to help our members weather all challenges when their jobs just got a lot harder.

This guide is designed to help you continue this work. Over the last decade it has established itself as the go-to resource for thousands of regulatory professionals, connecting those working in chemicals management and control to a global marketplace of experts – from consultants and legal representatives, to laboratories and toxicologists. Despite the sudden arrival of Covid-19, the results of the annual survey still provide a valuable peer-to-peer benchmark on key regulatory drivers across industry sectors – as the regulatory landscape continues to evolve and grow in complexity. However we can expect significant changes in the coming months once the longer term impact of coronavirus on businesses and supply chains becomes clear. We are grateful to the Chemical Watch community who take the time to complete this survey each year (averaging more than 800 responses) – it enables us to continue providing the most accurate picture of the chemicals management landscape, the key drivers and trends year-to-year.

Chemical Watch occupies a strong position that enables it to support its members during wider disruptions to markets such as this – increasing news and analysis to help you understand the potential business risks, keeping you connected and abreast with key information through an exciting new virtual events programme and a wide range of webinars, eLearning and online training sessions to choose from. For now, please enjoy reading the following articles and if you have any questions or would like further information on companies included in the guide, please feel free to get in touch. For anything directly related to Covid-19 and how we can support you, please get in touch at covid19@chemicalwatch.com. Henry Tipping Publishing manager

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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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Contents

Contents Introduction.........................................................................5

CRAD................................................................................112

Verisk 3E..........................................................................188

Global regulatory drivers..................................................7

CSB Online......................................................................114

Careers and salary survey............................................ 14

Danish Technology Institute.......................................116

Niche Profiles.................................................. 190

Outlook for service providers....................................... 22

DHI ....................................................................................118

Circular economy............................................................ 34

EBRC Consulting...........................................................120

Echa’s Scip database for substances of concern.. 39

ERBC S.r.l.........................................................................122

A new era for REACH dossier compliance?............. 43

Eurofins............................................................................124

Brexit: Getting down to business................................ 49 US state-level chemicals legislation........................... 54

Exponent International Limited.................................126 Fieldfisher........................................................................128

China’s new and revised chemicals laws................. 58

FoBiG................................................................................130

Profiles.................................................................62

GPC...................................................................................134

Acta.....................................................................................62 Apeiron-Team NV............................................................ 64 Arcadis...............................................................................66 Arcerion GmbH................................................................ 68 ARCHE Consulting.......................................................... 70 Artemisa............................................................................ 72 Assent Compliance........................................................ 74 bibra toxicology advice & consulting......................... 76 BIG vzw.............................................................................. 78 BioGenius GmbH............................................................ 80 Blue Frog Scientific Limited.......................................... 82 Cambridge Environmental Assessments................. 84 Cardno ChemRisk........................................................... 86 CEHTRA............................................................................. 88 Charles River.................................................................... 90 CHEMDOX......................................................................... 92 Chementors Ltd............................................................... 94 Chemical Check GmbH................................................. 96 Chemleg............................................................................ 98

GBK GmbH Global Regulatory Compliance...........132 H2 Compliance..............................................................136 I+K AG, Compliance-Footprint AG............................138 INERIS..............................................................................140 Intersolia..........................................................................142 Kelley Drye & Warren....................................................144 KFT Chemieservice GmbH.........................................146 Knoell................................................................................148 Lisam Systems..............................................................150 Makersite GmbH...........................................................152 National Chemical Emergency Centre (NCEC).....154 Nexreg..............................................................................156 Ramboll............................................................................158 REACH Global Services S.A........................................160 REACHLaw.....................................................................162 Risk & Policy Analysts Ltd (RPA)...............................164 Royal HaskoningDHV...................................................166 SCC...................................................................................168 Sphera Solutions...........................................................170 Staphyt.............................................................................172 TEAM Mastery s.r.l........................................................174

ChemSafe.......................................................................100

Triskelion B.V..................................................................176

CHEMSERVICE..............................................................102

TÜV SÜD Industrie Service GmbH............................178

Chemwatch....................................................................104

UL ....................................................................................180

China National Chemical Information Center.......106

UMCO GmbH.................................................................182

3S-SafelyServingScience............................................190 Altox a/s...........................................................................190 Anthesis-Caleb...............................................................190 Arrow Regulatory Ltd...................................................190 asseso AG.......................................................................191 Chem-Academy.............................................................191 Coracle.............................................................................191 COSANTA........................................................................191 CS Regulatory Ltd.........................................................192 Dangerous goods..........................................................192 E3 Strategic Partners...................................................192 eSpheres..........................................................................192 Eurideas Language Experts.......................................193 Grow Smart Solutions.................................................193 INFOTOX..........................................................................193 Kerona Scientific Ltd....................................................193 LKC Switzerland Ltd.....................................................194 mediator A/S..................................................................194 Oriental Chemical Information Co., Ltd...................194 Peter Fisk Associates...................................................194 PFA-Brussels..................................................................195 REACHnroll.....................................................................195 REACHReady.................................................................195 ReachSpektrum.............................................................195 REACHWise....................................................................196 Rovaltain Research.......................................................196 SCAS Europe..................................................................196 Selerant............................................................................196 Siam S.L...........................................................................197 Sweco...............................................................................197 Tox Focus, LLC...............................................................197 Toxicon............................................................................197 VRS Regulatory..............................................................198

CIRS..................................................................................108

Veeva................................................................................184

WSP UK Ltd....................................................................198

CIS Centre.......................................................................110

VelocityEHS....................................................................186

A-Z listing.........................................................200

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 and co-founder Mamta Patel mamta.patel@chemicalwatch.com Director Julian Rose julian.rose@chemicalwatch.com Managing director Stuart Foxon stuart.foxon@chemicalwatch.com Commercial director Richard Butterworth richard.butterworth@chemicalwatch.com Editorial director Geraint Roberts geraint.roberts@chemicalwatch.com Chief customer officer Emma Chynoweth emma.chynoweth@chemicalwatch.com

Global marketing manager Ryan McErlean ryan.mcerlean@chemicalwatch.com Global sales manager Louise Osborne louise.osborne@chemicalwatch.com Guide editor Kate Lowe kate.lowe@chemicalwatch.com Deputy editor Nick Hazlewood nick.hazlewood@chemicalwatch.com Publishing manager Henry Tipping henry.tipping@chemicalwatch.com Production Francesca Cotton francesca.cotton@chemicalwatch.com Writers Elaine Burridge, Luke Buxton, Rosa Richards, Ginger Hervey, Amanda Ulrich, Ellen Daliday, Clelia Oziel Sub editor James Lumley james.lumley@chemicalwatch.com Design Harrison Tanner harrison.tanner@chemicalwatch.com Account managers Abigail Vanhorn abigail.vanhorn@chemicalwatch.com Sonja Davidson sonja.davidson@chemicalwatch.com Lotte Spencer lotte.spencer@chemicalwatch.com Laura Gwynn laura.gwynn@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 First published 2020 Copyright and Database Rights © 2020 CW Research Ltd. All rights reserved Photo credits: page 7: AdobeStock©Anton Balazh page 14, © Lumina images page 22, iStockphoto, © sanjeri page 34, AdobeStock, © Ivan Tsyrkunovich page 39, © Lauri Rotko page 43, iStockphoto, © Morsa Images page 49, AdobeStock, © Pixelbliss page 54, AdobeStock, © Libery Photo Art page 58, © Xinhua

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Introduction

Chemicals management and control The tenth Chemical Watch survey of the chemicals management industry finds REACH still leading market activity, demand for laboratory services increasing fast and average salaries on the up. Between November 2019 and February this year, Chemical Watch surveyed its chemicals management community to uncover the key factors driving activity in the market as well as employment and salary trends within the sector. Respondents included chemicals companies, service providers, regulatory professionals and more. This is the tenth such survey that Chemical Watch has undertaken, providing a comprehensive view of the state of today’s chemicals management industry, with articles on everything from the market’s key regulatory drivers and recruitment trends, to in-depth reports on Brexit, US state-level legislation and China’s proposed overarching regulation. Since our survey took place the coronavirus pandemic has disrupted industry supply chains and output in many parts of the world. At the time of writing, production in China is beginning to recover, but concerns remain over the impact on demand caused by the spread of the disease across the globe: “In the short run, the impact on the global economy and supply chains is inevitable,” said China’s director of foreign trade Li Xinggian after announcing measures to support international trade on 12 March. He added: “International economic and trade growth will be pressured, which will affect the business resumption of China’s foreign trade firms and their ability to secure new orders.” Concerns which will be shared by other major chemical exporting nations as they look to recovery in the second half of 2020. On a more positive note, our survey findings make clear that the chemicals management and control sector, which both supports and depends on a strong chemicals industry, is in great shape to take on the challenges its clients may face during and after the expected disruption to markets resulting from the virus in the first half of the year.

Market drivers Each year Chemical Watch examines the key drivers of activity in the chemicals management market and this year’s survey has found few changes. As we report on page 7, REACH continues to be the major regulatory driver of service providers’ workloads. Our 714 respondents this year (49% from Europe, 26% from North America and 19% from Asia), placed the Regulation in four out of the top five drivers. Most respondents – 84% – put any aspect of REACH at the top of their list. This was followed by any aspect of US regulation, with REACH back in third, fourth and fifth places with regard to evaluation-related activities and dossier updates, registration and obligations, and authorisation for substances of very high concern (SVHCs). Looking at the top market drivers by sector, all four sub-groups surveyed – chemicals and life sciences, consumer products and cosmetics, other manufacturers, and service providers – ranked REACH obligations either at the top of their list or high up.

How is this reflected in the services customers require? As we report on page 21, the latest figures show demand for laboratory services topped the list again last year, with the share of respondents’ total spend up from 26.5% in 2018 to 42.7% in 2019. Consultancy services retained second position at 20.8%, again higher than 2018’s 17.4%, while IT and software rose to third place with 10.6%. Unsurprisingly in light of the above, REACH dossier and substance evaluation processes promise to keep service providers busy throughout 2020, while many report that the greatest demand for their expertise in the year ahead will centre on major overarching regulations in South Korea, Taiwan, Turkey and Russia, along with other compliance and regulatory needs in Europe. An increasing emphasis on compliance will drive further activity.

Employment trends Meanwhile, as we report on page 14, this year’s survey saw a jump of 4.5% in the overall proportion of respondents predicting staffing to increase during the next 12 months. Indeed recruitment consultants we spoke to for this year’s report say Europe enjoyed one of its strongest years in 2019 with demand for regulatory toxicologists seeing significant growth, and administrative and technical positions such as safety data sheet (SDS) authoring recovering during 2019 to pre-2017 levels. Demand for biocides specialists is on the up thanks to changes in agrochemical regulations while regulatory compliance professionals are also in demand to follow up compliance requests now that REACH registrations have been completed. Knowledge of global regulations and processes is also in demand because of the onward march of notification schemes around the world. While the survey findings indicated some frustration with the opportunities for career progression within their own companies, most respondents were positive about the chances for progression across the industry. The majority also report being satisfied with their jobs. Perhaps the most striking survey finding this year is the increase in the overall average salary from €55,900 12 months ago to €65,100. Leading the pack are product safety/stewardship professionals with an average salary of €82,000, followed by toxicologists, chemists and scientists on €81,800. Meanwhile those working in the government sector command the highest average salary when compared to those working in other sectors.

Looking forward Respondents to the Chemical Watch survey said they expect to see information and training services lead an increase in demand for external sector services over the next 12 months, with the hottest areas being help with regulatory interpretation (74%), product compliance (70%), chemical safety assessments (66%) and supply chain communications (61%).

Interestingly, for the first time, the chemicals, life sciences and consumer products and cosmetics sectors included global strategies for plastics as one of their market drivers.

Survey respondents said they expect to see IT and software services enjoy the second biggest increase in demand. Then in third place, comes consultancy and advisory work.

Supply chain complexity and customer and supply chain demand share pole position as the major non-regulatory drivers, while Brexit has slipped from second position to fourth. Economic growth stays in third place.

Looking further ahead at the next five years, information services remain at the top for predicted growth – with training next, and IT and software in third place. For more, turn to page 22. www.chemicalwatch.com/SPG

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Global regulations

GLOBA L REG UL AT I ON

What are the key regulatory and non-regulatory developments driving work among professionals? While REACH remains the primary driver of work, regulations around the world are requiring increasing assistance, reports Elaine Burridge Thirteen years after it entered into force, Europe’s REACH Regulation remains a key driver of work and regulations around the world. The legislation in its various phases continues to dominate the compliance efforts of chemical manufacturers, users and importers. “The registration element was the main focus for 2019, but this is now shifting to the evaluation stage with increased manual checks from Echa spurring – or enforcing – registrants to update and improve dossiers,” says Richard Lee, director at UK consultancy Coracle, formerly Easy REACH Analysis.

Major regulatory drivers Reading the results of Chemical Watch’s latest survey, REACH once again features as the major driver of workloads. Reflecting last year’s results, respondents place REACH in four out of the top five drivers [Figure 1]. The vast majority – 84% – put any aspect of REACH at the top of their list. This was followed, once again, by any aspect of US regulation, with REACH back in third, fourth and fifth places with regard to evaluation-related activities and dossier updates, registration and obligations, and authorisation for substances of very high concern (SVHCs). Looking at the top drivers by sector [Figure 2], all four sub-groups surveyed (chemicals, life sciences and similar; consumer products, cosmetics and similar; all other manufacturers; and

service providers) rank various REACH obligations either at the top of their list or generally highly, as they did last year. The consumer products sector, however, continues to rank California Proposition 65 as their top driver. What is perhaps most interesting to note here is that, for the first time, the chemicals, life sciences and consumer products/ cosmetics sectors include global strategies for plastics/plastics pollution as one of their drivers. Admittedly, in both cases, it didn’t rate very highly, but it is perhaps reflective of growing initiatives being taken among companies towards producing/ incorporating more reusable and recyclable plastic into their products. The EU’s proposed ban on single-use plastics from 2021 is undoubtedly galvanising much of the shift towards more sustainable and environmentally friendly alternatives. It is noteworthy too that the EU’s waste framework Directive (WFD) and Echa’s substances of concern in products (Scip) database also feature as the fourth driver for all manufacturers and service providers. Echa released a prototype of the Scip database on 18 February so that companies can test their data notifications ahead of the finished database’s launch in October. The agency is developing Scip under a requirement in the revised WFD that aims to promote substitution of hazardous chemicals in articles and complex objects.

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Figure 1 â&#x20AC;&#x201C; Leading regulatory drivers for survey participants 84%

REACH (any) US (any) EU REACH evaluation related activities/dossier updates EU REACH registration EU REACH SVHC obligations and authorisation activities China regulations EU CLP regulation EU REACH Annex XVII restrictions US: California Proposition 65 South Korea (K-REACH) European strategy for plastics Global strategies for plastics/plastics pollution EU CLP Annex VIII Poison Centre Notification US: TSCA New Substance Notifications RoHS regulations Food contact material regulations Circular economy Nanomaterials risk assessment - Revised REACH information requirements for nanoforms EU Waste Framework Directive and Scip Database US: TSCA risk evaluations Biocidal product regulations Packaging regulations Turkey regulations National transposition of GHS on classification, labelling and inventory notification regulations POPs (Implementation of the Stockholm Convention on Persistent Organic Pollutants) Cosmetics regulations Japan regulations Russia regulations Canada Chemicals Management Program Taiwan regulations Australia regulations Chemical Agents Directive (CAD) and Carcinogens and Mutagens Directive (CMD) US: California Safer Consumer Products Regulation WEEE Regulations India regulations US: HazCom 2012 (GHS) Standard Conflict minerals legislation Brazil regulations South Korea (K-BPR) UN Environment Programme (Unep) Medical devices regulations International Carriage of Dangerous Goods by Road (ADR) International Maritime Dangerous Goods (IMDG) Code Thailand regulations Mexico regulations Other US state legislation (Washington, Vermont etc) New Zealand regulations Agrochemical regulations Toy Safety regulations Rest of Asia regulations Philippines regulations Pharmaceutical regulations Malaysia regulations Indonesia regulations Canada Workplace Hazardous Materials Information System (WHMIS) Argentina regulations Rest of LATAM Regulations Pic (Prior informed consent implementation of the Rotterdam Convention) Mercury (implementation of the Minamata Convention) Colombia regulations Israel regulations Veterinary product regulations

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Global regulations

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Figure 2 – Top drivers by sector (in order of importance) Chemicals, life sciences and similar

Consumer products

EU REACH evaluation related activities/dossier updates

US: California Proposition 65

EU REACH registration

EU REACH SVHC obligations and authorisation activities

South Korea (K-REACH)

China regulations

EU REACH Annex XVII restrictions

EU CLP regulation

Cosmetics regulations

EU CLP Annex VIII poison centre notification

EU REACH evaluation related activities/dossier updates

EU REACH SVHC obligations and authorisation activities

EU REACH registration

Global strategies for plastics/plastics pollution

EU REACH Annex XVII restrictions

EU CLP regulation Packaging regulations

All manufacturing

Service providers, including laboratories, consultants, lawyers, etc

EU REACH SVHC obligations and authorisation activities

EU REACH evaluation related activities/dossier updates

RoHS regulations

EU REACH SVHC obligations and authorisation activities

EU REACH registration

EU CLP Annex VIII poison centre notification

EU waste framework Directive and Scip database

European strategy for plastics

EU REACH Annex XVII restrictions

EU waste framework Directive and Scip database

China regulations

EU REACH Annex XVII restrictions

US: California Proposition 65

EU CLP regulation

EU REACH evaluation related activities/dossier updates

EU REACH registration

EU CLP regulation

South Korea (K-REACH)

Conflict minerals legislation

Global strategies for plastics/plastics pollution

As well as those already mentioned, other legislation identified as high on agendas includes regulations for medical devices, biocidal products, cosmetics, food and food packaging, construction products, plant protection products and pesticides, poison centre notifications and classification, labelling and packaging (CLP).

Economic growth stays in third place. Trade tensions between the US and China have weighed on global markets during 2019 and continue to do so into early 2020. More recently, the coronavirus outbreak threatens not just China’s growth this year, but worldwide too, depending on when and whether the epidemic can be contained.

Also in need of external services are K-REACH, Turkey REACH (or KKDIK), US TSCA, Taiwan’s Toxic and Chemical Substances of Concern Control Act (TCSCCA), and the Eurasian Economic Union (EAEU) chemical law, says Michael Cleuvers, director of products and markets at German consultancy Knoell. Global food contact regulations, the EU’s and South Korea’s BPR, and global crop protection regulations are keeping the firm busy, he says.

Matthew Kane, chief operating officer at Swiss-based service provider LKC, says its clients are being affected by the impact of EU member states’ austerity measures and by EU political trends. These, he says, are resulting in resource limitations and non-scientific decisions influencing the regulation of pesticides in Europe. He notes that the EU refit of the pesticides law will be the basis for driving planning and strategy of work for clients in 2020 and 2021 with the highest demand being for data analysis.

Turkish consultancy Chemleg is seeing most demand from its global clients for providing only representative (OR) services for the KKDIK, Turkey BPR and CLP; KKDIK pre-registration services (along with registration for the following years); biocidal products licensing in Turkey; classification and labelling (C&L) notifications and authoring of safety data sheets (SDSs) for products marketed in the country.

Focus on sustainability

Non-regulatory drivers With regard to the major non-regulatory drivers in 2019, these remain unchanged in Chemical Watch’s survey [Figure 3]. Customer and supply chain demands and supply chain complexity share pole position. Brexit, which entered the list last year, still makes an appearance, but has slipped from second position to fourth.

Sustainability features strongly this year in discussions across industry. “A greater focus on sustainability and corporate social responsibility in response to pressure from the public and investors is evident,” notes Sue Bullock, principal at Ramboll. “There is far more interest in ensuring the science behind strategy or marketing claims relating to product stewardship is robust and defensible. Scrutiny from regulators and the public around safety and environmental performance of products is having an effect and we’re helping companies to understand risks across the product lifecycle and take appropriate action,” she says. Consultancy Intersolia says that, while in the past sustainability was something businesses might consider for the sake of their www.chemicalwatch.com/SPG

Global regulations

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public image, it is now an elementary part of corporate strategy for many companies. “The willingness of companies to position themselves sustainably is a significant driver of our business,” says Oliver Kuhlen, country manager, Germany. “Pressure from NGOs for better disclosure of ingredients and use of safer ingredients is challenging the largest manufacturers, distributors and retailers to eliminate toxic chemicals in products and packaging and work towards developing safer chemical policies,” says Alan Johnson, Verisk 3E’s director of portfolio management and strategic alliances. “We are seeing the rise of more retailer mandated supplier requirements, which is putting a strain on many suppliers in many industries.” Figure 3 – Leading non-regulatory drivers for survey participants 47% Supply chains complexity 47% Economic growth

As well as Europe, Ms Sekki says her firm received many requests in 2019 for consultancy and legal services in Turkey, Russia and South Korea, with most demand for only representation in non-EU countries, non-EU notifications/ registrations and SDSs in line with non-EU chemical regulations.

South Korea is currently a “hot spot” for knoell, where Dr Cleuvers says there is a strong demand for consultancy and registration services. He is also seeing a high need in the US for comprehensive consultancy services.

44% Brexit 43%

Work at Germany-based Forschungs- und Beratungsinstitut Gefahrstoffe (FoBiG) is currently focused on providing consultancy and regulatory services, including study monitoring, within Europe, but managing director Klaus Schneider says the company is seeing a rise in demand for such services on other continents.

Consumer concerns on products/services provided by organisations 36% Governmental policies/spending 30% Standards

Regulatory consulting company TEAM Mastery, meanwhile, notes that services provided by testing laboratories – mostly in relation to long-term tests for human systemic toxicity such as OECD 408, 414 and 443 – are currently “saturated” and contract research organisations in the EU are mostly fully booked.

30% Redistribution of regulatory compliance responsibilities within organisations 26% NGO pressure

REACH, BPR and food contact materials are the most-requested areas of work for Dutch firm Triskelion, while relevant nonregulatory areas are good product stewardship, food and feed safety, authenticity, product consistency and worker protection.

23% Non-statutory ‘voluntary’ corporate initiatives/CSR 18%

For Germany’s Tüv-Süd Industrie Service, only representative, letters of access, management, finance management, registration and general consultancy are the major drivers.

Downsizing of inhouse chemical management and control teams 17% Sale/acquisition of organisations by other organisations ('take-over')

With regard to investment, spending on staff continues to be a priority, with IT also high on the list. Australian-headquartered Chemwatch says its key areas for investment are on its regulatory and chemist teams and R&D services. Customer service and training are also other high-investment areas for the company.

15% Relocation of organisations to different countries/regions 11% Outsourcing of business support functions (by client organisations) 10%

Digitalisation trend

Increased commercialisation/better management of service provider business 8% 20%

Demand for services

Maaike Bilau, senior product stewardship consultant with Arcadis, says Asia, Africa and the UK account for most requests for help. In Asia, demand centres on consulting, dossier preparation and laboratory services. In Africa, the dominant need is for consultancy and information services, as it also is in the UK for assistance with Brexit.

Customer and supply chain demands

In general, the majority of service providers’ clients are manufacturers of chemicals, agrochemicals and pharmaceuticals, among others. They range from multinationals, through to small- and medium-sized enterprises (SMEs). Government and research organisations also feature. And Ingrid Sekki, chief marketing and business development officer at Finland’s REACHLaw, has seen increasing demand from downstream users.

40%

60%

% of participants

For Coracle, commercial imperatives and public perception are driving work on environmental and sustainability agendas such as impurity monitoring, restricted substance lists (RSLs) and accreditation by the Zero Discharge of Hazardous Chemicals programme. ZDHC is a global industry collaboration within the sports, fashion, luxury and outdoor industry that aims to eliminate certain chemical groups.

Digitalisation is providing easier access to data and information and service providers report an increasing use of chemical management software in areas such as risk assessment and data submissions. Franҫoise Saint-Romain, senior regulatory affairs specialist and managing partner at Lisam Telegis, says digitalisation is helping to address an increased “right-to-know” pressure from the public and an obligation to supply information of higher quality. The company says the main drivers for its software business remain local implementations of GHS worldwide, such as SDS authoring functionalities, and volume-tracking functionalities for other local REACH-like regulations.

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Global regulation

Service provider outlook

“Digitalisation is helping companies stay up to date with emerging trends and take quicker and more future-leaning actions to prohibit supply chain, R&D and overall product compliance risk,“ says Mr Johnson of Verisk 3E. “We know that the chemicals industry is poised to double over the next few years and companies are drastically changing their business models from linear to more circular forms. Resource scarcity, global warming and waste stewardship have accelerated these changes.” He adds that increasing pressure to safely and efficiently develop, manufacture and market products that contain

chemicals is driving investment in product safety and compliance solutions. However, LKC’s Mr Kane feels the ongoing trend towards digitalisation is a mixed blessing. “Faster communication and wider access to information is tempered by the increase in administrative processes and variability in the standard of applications and consistency of evaluations,” he says. Companies’ ongoing need for support in regulatory compliance and a growing focus on sustainability and product stewardship have kept service providers busy in 2019, and 2020 looks to be another year of the same, geopolitical and economic events notwithstanding.

CAREERS A N D S A L A RY S U RVE Y

What are the prospects for professionals working in chemicals management and control? As the annual Chemical Watch salary and careers survey is published, Rosa Richards examines the career opportunities for chemicals management and regulatory professionals Recruitment in the chemicals management and control (CMC) and regulatory professionals sector in Europe enjoyed one of its strongest years in 2019, says Abid Kanji, director at specialist recruitment agency NonStop Consulting. Demand for regulatory toxicologists, for example, saw significant growth and is now the highest it has been since 2012. Other trends noted by Mr Kanji include a move by individuals working in the chemical industry into consultancy roles following merger activity. “This created gaps which were sometimes not filled, with companies choosing to outsource work to consultants instead,” he says. Some of the salaries being offered by consultancies could prove unsustainable if demand for their services declines, he argues. Meanwhile, demand for biocides specialists is on the up thanks to changes in agrochemical regulations, while administrative Global Service Providers Guide 2020

and technical positions such as safety data sheet (SDS) authoring recovered during 2019 to pre-2017 levels. John Sherratt of agency VRS Regulatory says the job market in the UK in this sector was also strong and consistent during 2019. “As some substances move towards restriction and authorisation, there has been an increase in roles involving advocacy and representation, both in-house and with trade associations,” he says. Regulatory compliance professionals are also in demand to follow up compliance requests now that REACH registrations have been completed. Knowledge of global regulations and processes is also in demand thanks to the onward march of notification schemes around the world. According to Mr Kanji, the availability of candidates with the right combination of technical/regulatory and communication/ engagement skills has improved in recent years, but he has

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concerns over the long term impact of the closure of the University of Surrey’s toxicology degree course – one of only three such courses in the UK. “Our clients will only consider candidates with hands on regulatory experience and a relevant degree qualification,” he says. Generally candidates meeting both requirements stand a very good chance of being recruited when put forward for roles. In France and Germany demand for applicants with the right skills is strong, with a particular uplift noted by Mr Kanji in the Netherlands – all due to tighter chemicals and consumer regulations. For example, tighter regulation of the tobacco industry has seen an upturn in the demand for toxicologists. The forecast for jobs in this sector is certainly strong for 2020. That said, demand for product stewardship specialists in Europe actually fell last year, Mr Kanji says. But future prospects look good. In the UK, Mr Sherratt predicts the creation of more product stewardship roles during 2020. And Mark Wood, acting director of the University of Indiana’s post-graduate product stewardship programme says there is a strong future for product stewardship roles across the globe: “Consumers, investors and regulators are demanding that companies be more forward-looking with regard to all things sustainable”, he says. Major investment firms are increasingly focused on environmental, social and corporate governance issues when making investment decisions. “All these factors place positive pressure on organisations to not just react, but lead with product stewardship,” says Mr Wood.

Chemical Watch salary and careers survey The trends and issues identified by the professionals we interviewed were explored in more detail in the eighth Chemical Watch survey of salaries and career prospects in the CMC sector. Respondents this year were split almost equally between women and men, with 76.6% in the 31-60 age bracket [Figure 4]. The majority categorise themselves as specialists or technicians (36.3%), or project managers (29.6%), followed by senior managers (18.1%), government or agency officers (3.5%), junior or graduate trainees (2.7%) and finally directors, associates or partners (9.7%) [Figure 5]. Figure 4 – Age profile of participants >60 10.0%

Figure 5 – Job title of participants Director/associate/partner 9.7% Junior/graduate trainee 2.7%

Specialist/ technician 36.3%

Project/team manager 29.6% Senior manager 18.1%

The majority of respondents expect staffing levels to remain static during the next 12 months (55%) [Figure 6]. As in the reported in the 2019 guide, fewer respondents predict a fall in staffing levels compared with the previous year (3.6% versus 11.4% ). Conversely, the proportion predicting staffing levels to increase in the next 12 months is greater than for 2019 (41.1% versus 34.1%). This represents a jump in the overall proportion of respondents predicting staffing to increase during the next 12 months of 4.5% over 2019’s survey findings. Figure 6 – Within your company, what is the trend in terms of number of chemicals management and control professional staff Decreasing

3.6%

90%

11.4%

80% 70%

55.0% 54.5%

60%

40%

<30 13.2%

30% 41.4%

34.1%

10% 0% Last 12 months

Global Service Providers Guide 2020

Increasing

50%

31-40 22.8%

41-50 31.1%

Static

% of participants 100%

20%

51-60 22.8%

Officer (government /agency bodies) 3.5%

Next 12 months

When asked about job security, the majority of respondents said that little has changed when compared to a year ago, both when thinking about all roles and just their own (67.6% and 66.8% respectively) [Figure 7].

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Figure 7 – Job security compared with 12 months ago Less secure

Similarly secure

Poor

70%

60%

5.0%

90% 80%

24.3% 27.5%

60% 66.82%

67.57%

40%

30%

20%

20% 21.08%

20.27%

0% Across all roles

In own role

39.2%

50%

40%

10%

Good

100% 12.11%

12.16%

80%

50%

Neither

% of participants

100% 90%

Figure 9 – Career progression opportunities

More secure

% of participants

Service provider outlook

67.6%

36.5%

10% 0% In your company

Wider jobs market

Year-on-year job prospects are reported to be good by 57% of respondents, an increase of 4% on last year’s survey findings [Figure 8]. Most participants regard job prospects across the globe as better than in their own country, but in both cases the perception that job prospects are good has grown in the past 12 months.

By far the highest proportion of participants reported being satisfied with their jobs (57%) followed by neither satisfied nor dissatisfied (32%) [Figure 11]; a slight improvement on last year’s survey which found 54% satisfied with their jobs. The number of participants describing themselves as dissatisfied (13%) has also fallen from last year (10%) [Figure 12].

Figure 8 – Job prospects

Figure 10 – Year-on-year career progression opportunities

Poor

Stable

Good

Poor

% of participants 100%

5.4%

Good

100% 9.3%

90%

25%

37%

40%

24%

41%

40%

34%

35%

36%

35%

36%

2015

2016

2017

2018

2019

29%

28%

40%

38%

31%

2014

27%

24%

80%

80% 37.1% 70%

45.8%

70% 60%

60% 50%

50%

40%

30%

Neither

% of participants

39%

30%

57.5% 44.9%

20%

38%

20%

38%

35%

2012

2013

10%

0% Globally

In your country

In terms of career progression, a far higher proportion of respondents felt opportunities were good in the wider jobs market (67.6%) than in their own companies (36.5%) [Figure 9]. A higher percentage of respondents thought opportunities were neither good nor bad in their own company (39.2%) than thought they were good. Meanwhile, more respondents thought opportunities were poor in their own company (24.3%) than in the wider jobs market (5.0%) – all of which suggests employers may need to increase incentives to retain their staff. Overall though, the proportion of respondents who thought career progression opportunities were poor has dropped (24%) compared to a year ago [Figure 10].

Figure 11 – Job satisfaction Dissatisfied 10%

Neither satisfied or dissatisfied 32%

Satisfied 57%

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(€80,200). A year ago, the highest salaries were to be found in chemicals and life sciences, followed by consumer products and cosmetics. The lowest paid were respondents working for trade associations or professional bodies (€26,700). Service providers including consultants, laboratories and lawyers reported an average salary of €58,100.

Figure 12 – Year-on-year job satisfaction Dissatisfied

Neither satisfied or dissatisfied

Satisfied

% of participants 100% 90%

11%

13%

29%

28%

60%

13%

11%

31%

56%

58%

80% 70%

13%

29%

33%

57%

54%

10%

26%

In the latest survey the highest average salary by gender swung from women to men who reported an average salary of €73,910 compared with women at €68,120 [Figure 14] – a result likely to be a reflection of the makeup of this year’s survey sample. Meanwhile a correlation between age and average salary finds participants aged 51-55 bringing home the highest average salary (€93,400), closely followed by the 61-65 age category (€91,800). Interestingly, the spread of salaries over all the age brackets has a wider distribution this year – from €35,200 up to €93,400 [Figure 15].

32%

60% 50% 40% 30%

65%

57%

Figure 14 – Average salary by gender

20%

Male

10%

68.12

0% 2012

2013

2014

2015

2016

2017

2018

2019

Female 73.91

Remuneration The overall average salary has risen to €65,100 compared with €55,900 in our survey 12 months ago [Figure 13]. Product safety/stewardship professionals are close to the top with an average salary of €82,000 with toxicologists/chemists/ scientists (€81,800) and business managers/developers (€76,300) following closely behind. Occupational hygienists were the lowest paid by job description with an average salary of €41,300.

Euros 000s

Figure 15 – Average salary by age 21-25 43.7 26-30

Figure 13 – Year-on-year staffing trends (€)

35.2 31-35

Business management/development

55.5

76.3

36-40

Consultant

64.5

53.3

41-45

EHS management

72.0

52.2

46-50

Occupational hygiene

81.8

41.3

51-55

Product safety/stewardship

93.4

82.0 Regulator

56-60 85.2

46.3 Regulatory affairs management

61-65 70.9

91.8

Toxicologist/chemist/scientist

>65 81.8

63.2

Other

82.2

100

Euros 000s 0

Euros 000s

Looking at sectors, the highest paid respondents work in government and agencies (€87,600). Not far behind are professionals working in consumer products and cosmetics

Overall, the 2019 survey results reflect real optimism in the CMC and regulatory sector, one hotspot being the UK where Brexit will drive the need for regulatory jobs. Of course, this was before COVID-19 related disruption

www.chemicalwatch.com/SPG

Service provider outlook

OU TLO O K

Positive outlook reigns for service providers Chemical Watch’s annual survey of service providers shows that once again they will be very much occupied this year and beyond with a rising regulatory workload and growing activity in the areas of product stewardship and sustainability. Elaine Burridge reports There are no signs that regulatory requirements affecting the global chemical industry will lessen in 2020 – rather the reverse looks to be true. Service providers predict the greatest demand for their expertise in the year ahead will centre on major overarching regulations in South Korea, Taiwan, Turkey and Russia, along with various other compliance and regulatory needs in Europe. Lynn Bergeson, president of the Acta Group and managing partner of Bergeson & Campbell in the US, expects that REACH dossier and substance evaluation processes will keep industry occupied in 2020. These, she says, have “potentially substantial implications for companies’ product portfolios in terms of regulatory risk management, resources, testing requirements, desirability, marketability and profitability.”

in demand by respondents last year, with the share of respondents’ total spend significantly up to 42.7% versus 26.5% in 2018 [Figure 16]. Figure 16 – Services retained by respondents organisation, by value Equipment 0.2%

Information 5.3%

According to the results of Chemical Watch’s latest annual survey of service providers, demand for laboratory services

Global Service Providers Guide 2020

Consultancy 20.8%

IT & software 10.6% Representation & management 9.6%

“This is true not only for 2020, but for the next three-to-five years,” adds Michael Cleuvers, director products and markets at knoell Germany. There will also be increasing emphasis on compliance. Echa’s executive director Bjorn Hansen has said that the agency will continue to move faster on compliance checks during 2020, having raised its target from 5% to 20% for each tonnage band. Overall, he says, this will mean that 30% of all registered chemicals will be checked for compliance by 2027, when the agency also aims to have gained “full clarity” on all registered substances above one tonne. In February, Echa said it had checked 50% more REACH dossiers in 2019 compared with 2018.

Training 5.3%

Legal 5.5% Laboratory 42.7%

Consultancy services retained second position at 20.8%, again higher than 2018’s 17.4%, while IT and software rose to third place with 10.6%. Training – third in the 2018 poll – saw its share of spending halved to 5.3%. Year-on-year changes in spending are most noticeable for lab services [Figure 17]. Investment also rose on external consulting work and IT and software although it halved for legal services.

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Service provider outlookÂ

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Figure 17 – Changes in the proportion of spending on provider service types

Figure 19 – Integration changes at survey respondents organisation over the last five years

Consultancy

Information

Representation & man.

Training

Legal

Equipment

Laboratory

Other services

Move towards general management 14% Remained the same 51%

IT & software % of participants 100% 90% 80%

9% 0% 7%

Equipment added 0% 0% 7% 8%

3% 0% 10% 7%

1% 0% 8% 3% 7%

7% 0% 12%

13%

12%

14%

70%

2% 0% 6%

19%

13%

14%

60%

16%

50%

40%

18%

33%

28%

47%

20%

2% 7%

7% 6%

12%

14%

11%

17%

8% 43% 27%

Demand focus for 2020

30% 8%

Move towards separate compliance divisions 35%

8% 21%

0% 0% 5%

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019

“A focus by regulators on enforcing data quality and a rigorous approach to authorisation will continue in the EU, which should be good news for those service providers that can provide reliable and integrated support,” says Sue Bullock, principal at Ramboll UK. “However, it is likely to be accompanied by a further cull of substances, with an impact on related activities, where the cost of data cannot be justified based on sales.”

The amount of work completed on average by in-house teams in 2019 remained broadly in line with 2018 for the majority [Figure 18]. Given that the number of additional or amended chemical regulations worldwide is set to continue rising, this level is unlikely to fall in the coming year.

Biocide authorisations and poison centre notifications are other areas of rising demand. Verisk 3E’s director of portfolio management and strategic alliances, Alan Johnson, has seen a “significant increase” in clients looking for ways to optimise EU poison centre notification in compliance with Annex VIII to the CLP Regulation.

30%

5% 3%

20% 28%

24%

10% 0%

25%

27%

19%

27% 6% 3% 4%

35%

5% 17%

12%

6% 18%

10% 11%

17%

5% 10%

21%

Figure 18 – Percentage of chemical work performed by in-house team 80-100%

40-60%

60-80%

20-40%

0-20%

% of participants 100% 90% 80%

35.3%

36.0% 52.9%

70%

49.2%

53.5%

47.8%

49.3%

50.2%

52.8%

51.5%

26.7%

25.3%

40% 30%

12.7%

20%

10.4%

10%

15.2%

11.8%

14.9%

11.8%

2010

2011

Following a series of biocides fact-finding missions, the European Commission reported on 8 January that a “significant” number of biocidal products on the European market lack proper authorisation under the BPR. It added that its findings show “special attention should be paid to [its] implementation and enforcement”. Services relating to food and feed safety, and assessing food contact materials are also growing, says Mr Englebienne, as are assessments of substances and products with endocrine disrupting properties.

60% 50%

BPR approvals and authorisations are lagging far behind schedule and lots of work is still to be done in the next 12 months, warns Pablo Englebienne, senior consultant registration services at Dutch consultancy Triskelion.

25.3%

8.3%

31.4%

25.6%

25.3%

23.3%

27.3%

10.4%

11.4%

5.5% 3.7%

8.5%

4.7%

5.2%

5.1%

29.9% 27.9%

9.0%

8.2%

6.9%

5.9%

3.8%

4.8%

7.6%

7.4%

6.9%

8.6%

9.5%

8.0%

2012

2013

2014

2015

2016

2017

14.7%

2018

5.5% 7.3%

2019

There was no change in respondents’ views on shifts in companies’ approach to internal chemicals management and control over the last five years [Figure 19]. All three categories, namely moving to separate compliance divisions, general management, or remaining unchanged, returned the same split as in 2018.

Meanwhile, UK consultancy Coracle expects a significant update in substance identification work along with requests for more impurity and restricted substance list (RSL) testing. In addition, it is likely that the substances of concern in products (Scip) database – due for launch in October – will also demand further support services. Chemwatch, a safety-focused consultancy headquartered in Australia, is expecting strong growth in demand for expanded 24/7 emergency response capabilities, particularly for augmented reality (AR) and virtual reality (VR) technologies. Another growth area is its radio-frequency identification (RFID) technologies that can enhance the ability to monitor the use and movement of high-value chemicals within an organisation. The use of RFID means stocktaking and audits can be completed in minutes.

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Service provider outlook

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Service retention With regard to frequency of service retention [Figure 20], 26-57% of poll participants say they use outside assistance occasionally, rather than frequently (6-29%) or permanently (2-18%). These figures are broadly unchanged from 2018, although slightly more respondents are seeking help on a permanent basis. Satisfaction levels [Figure 21] are also barely different from the previous year.

provider [Figure 22]. ISO certification does not rate particularly highly –while the size and location of the company continue to be a negligible factor. Figure 22 – Choice factors when provisioning external services Expertise of key staff 79% Proven experience on similar projects

Figure 20 – Frequency of service retention by survey participants

75% In-depth knowledge of country specific regulations

Permanent

Frequent

Occasional

68% Availability

Consultancy/advisory

56%

42%

29%

15%

Comprehensiveness/accuracy of proposal

Representation & management

55%

36%

13%

Ability to operate on a global scale

Legal services

54%

51%

16%

Appropriate accreditation/certification

Laboratory

49% 35%

25%

14%

Contract price

IT & software solutions

48% 34%

21%

17%

ISO9001 or equivalent (quality management)

Information services

34% 35%

23%

18%

Recommendation from peers

Training

26% 57%

27%

ISO14001 or equivalent (environmental management) 25%

Equipment

Independence of supplier organisation

40%

6% 6%

21%

Other services

In-house equipment/software

26%

2% 10%

18% 0%

100%

% of respondents

Large size of supplier organisation 6%

Figure 21 – Change in overall satisfaction levels for survey respondents 80-100%

40-60%

60-80%

20-40%

0-20%

% of participants

90% 35.3%

36.0% 52.9%

70%

49.2%

53.5%

47.8%

49.3%

50.2%

52.8%

51.5%

60% 26.7%

25.3%

30%

12.7%

15.2%

20%

10.4%

50% 40%

10%

11.8%

14.9%

11.8%

2010

2011

25.3%

8.3%

31.4%

20%

40%

60%

80%

100%

% of participants

100%

80%

Proximity to your office 6%

29.9%

25.6%

25.3%

23.3%

27.3%

10.4%

11.4%

5.5% 3.7%

8.5%

5.1%

27.9%

9.0%

8.2%

6.9%

5.9%

3.8%

4.8%

4.7%

5.2%

7.6%

7.4%

6.9%

8.6%

9.5%

8.0%

2012

2013

2014

2015

2016

2017

14.7%

2018

5.5% 7.3%

2019

Expertise and proven experience are rated once again as the most important factors when choosing an external service

The most important relationship factor for survey participants [Figure 23] is a strict adherence to project protocols, which ties in pole position with having service level agreements in place. Building long-term relationships with members of staff follows closely in third place, on a par with the findings of our 2018 survey. Over the coming 12 months, survey respondents expect the biggest increases in demand for external sector services [Figure 24] to be in information and training , followed by IT and software and consultancy/advisory. Apart from the ‘Other’ category, most respondents are expecting stable demand for equipment , representation and management, and legal services. Looking at demand over the next five years, the ranking remains the same but the percentages rise [Figure 25]. Information remains top, but at 75% compared with 70% in 2018, with training next at 72%, up four percentage points, and IT and software at 66%, up one percentage point. Most service providers expect demand to remain stable for equipment (57%) and representation and management (53%).

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Service provider outlook

Drilling down into which specific assistance is required by survey participants during the next five years, most expect increases in the areas of consultancy and advisory services, representation and management, information, IT and software and training [Figure 26]. Figure 23 – Most important relationship factors for survey participants

Figure 25 – Next five years Increase

Static

Consultancy/advisory 64%

42%

Laboratory

45%

IT & software

35%

66%

33%

75%

25%

Training

33%

72%

24%

Equipment

Regularly reviewing (and at times changing) suppliers

37%

28%

57%

Other(s)

Regular face-to-face meetings

15%

20%

Paying more to get better value 17%

83% % of participants

2% 100%

All topics within representation and management are predicted to see an increase in demand. At the top are GHS notifications (71%) and business process outsourcing (70%).

Use of penalty clauses 8%

20%

30%

40%

50%

% of participants

Figure 24 – Anticipated need for external sector services by service providers in the next 12 months Static

55%

42%

65%

Legal services 35%

63%

Laboratory 50%

46%

IT & software 56%

42%

Information 66%

33%

Training 66%

31%

Equipment 25%

69%

Other(s) 89% % of participants

2% 100%

Within the first category, the majority of respondents want help with regulatory interpretation (74%) [Figure 26], product compliance (70%), chemical safety assessments (66%) and supply chain communications (61%). This is an increase on 2018’s levels.

Global Service Providers Guide 2020

Regulatory information management will be the service most requested for the IT solutions sector with training courses/ webinars dominating demand for the training segment.

Outsourcing trend

Representation & management 31%

For the information sector, most support is needed in areas of work on regulatory/policy tracking and chemical hazard databases.

The majority of respondents expect demand for laboratory services to remain static – the only exception is in product testing.

Decrease

Consultancy/advisory

Information

Suppliers keeping costs as low as possible

50%

61%

41%

Increase

53%

49%

45%

Building long-term relationships with individual staff

Legal services

Service level agreements in place

10%

32%

Representation & management

Strict adherence to project protocols

Decrease

There are mixed views on whether the trend of past years to outsource has peaked. Some believe it has, while others say the need to use external providers will continue to grow as companies focus on their core business and turn to experts for their chemical compliance/management efforts. Françoise Saint-Romain, managing partner at Lisam Telegis, says outsourcing remains a good solution because regulatory affairs knowledge and experience is “still rare and requires continuous learning”. Veriske 3E’s Mr Johnson says the retirement of veteran environmental, health and safety professionals from most companies around the world is another factor behind a rise in outsourcing. While noting there is a decrease for the more basic regulatory work, Triskelion sees a rising need in smaller companies that are still lagging behind in implementing their chemicals management. “For endocrine disruption assessments, demand for outsourcing is just starting and will grow substantially,” says Mr Englebienne. Tina Armstrong, vice president product stewardship at Arcadis, thinks the outsourcing trend has peaked in the US, but says multinationals are more likely to use external providers in their extended market countries, such as China, Brazil, South Korea and Taiwan.

SERVICES

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Service provider outlook

Chemicals REGULATORY compliance is a global competition strategy, not a formality!

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•

K O R E A

•

T A I W A N

Figure 26 â&#x20AC;&#x201C; Anticipated need for specific external sector services by survey participants over the next five years Increase

Consultancy/ advisory

Representation & management

Information

Laboratory

Regulatory interpretation Product compliance Chemical safety assessments Supply chain communications Consumer product safety Registration strategies Data management Environmental risk assessment Product stewardship Health & safety Health effects assessment Assessment of data quality Safer alternatives assessment Corporate strategy/strategic planning Hazard & exposure modelling SVHC advisory services Testing strategies Ecolabelling Workplace risk assessment (exposure) Safety of nanomaterials Product safety testing Data-gap analysis (QSAR) Chemical transport/warehousing advice Product Inspection (on-site) Occupational hygiene GHS notification Business process outsourcing (BPO) CLP notification Management (Sief, consortium etc) Registration services Dossier preparation Representation (OR, 3rd party etc) Regulatory/policy tracking Chemical hazard database Managed regulatory content (Material) safety data sheets Product testing Physical & analytical chemistry Ecotoxicology Alternative approaches to testing Human health toxicology Environmental fate & degradation Exposure testing

Static

Decrease

29%

30%

66%

37%

61%

37%

59% 57%

39%

56%

42%

55%

41%

54%

44%

47%

51%

47%

50%

45%

53%

2% 6%

50%

45%

54%

44%

52%

41%

51%

40%

57%

39% 38%

55%

38%

55%

7% 12%

51%

37%

56%

36%

10%

58%

32%

63%

32%

60%

31%

65%

30%

2% 2%

71% 8%

70%

65%

60%

51%

51% 67%

6% 5% 0% 1% 2%

53%

47%

52%

47%

1% 2%

49%

53%

58%

42% 39%

56%

38%

58%

35%

60%

35% 32%

62%

31%

65%

31%

65%

4% 0%

36%

64%

47%

52% 47%

50%

46%

53%

45%

54%

45%

54%

1% 5%

64%

30%

70%

27%

29%

70% 26% 34% 28% 24%

1% 7%

48%

46%

68%

63%

66%

72%

37%

57%

37%

58%

26%

68%

25%

72%

22%

40%

58%

33% 37%

62%

36%

Monitoring processes (on-site) SVHC testing Environmental monitoring Regulatory information management (Material) safety data sheets Supply chain communications Inventory management IT solutions EH&S Supply chain management Consortia/registration management Laboratory information management Training courses/webinars Bespoke/inhouse training Training CPD/CES certified training Chemical identification/detection Environmental sensors Equipment Workplace air quality monitors Lobbying/advocacy Public relations Logistics Other Emergency response Insurance

26%

74% 70%

71%

% of participants

100%

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Service provider outlookÂ

Service provider outlook

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Opportunities ahead The accelerating shift to more sustainable products and a circular economy is also opening up new, avenues for service providers, as are growing demands from consumers for more transparency and information on products. “The concept of green design is not new but evaluating chemicals within existing design tools is challenging,” says Helen Kean, regional director sustainable chemistry, EMEA and APAC at Anthesis. “It is relatively easy to identify a chemical’s intrinsic hazards, but comparing that with an alternative in the lifecycle of the product and at end of life is more challenging. “As the drive for transparency and phasing out chemicals of concern has never been stronger, the appetite for IT tools supporting chemical management and supply chain mapping and solutions will likely grow.” Ms Saint-Romain from Lisam Telegis adds that with pressure from NGOs continuing to ramp up, regulatory compliance obligations will only rise, particularly in developing markets, noting that because of globalisation and increasing local awareness, customers must comply with more than their traditional obligations. Ramboll’s Ms Bullock expects to see a lot more activity around product sustainability and stewardship that will drive the need for better quality data, communication and evidence of safe use throughout the supply chain. “The incentives for transparent and robust product safety and stewardship have never been higher. There is a mass of opportunity for service providers to deliver thinking systems and tools to deliver that.” The circular economy and a move by companies to redefine their strategy towards sustainable growth are key trends, says Ingrid Sekki, REACHLaw’s chief marketing and business development officer. “These trends are pushing service providers to have a holistic approach as the industry needs orientation towards a sustainable growth, and also accurate legal, business and technical support to make sure they are compliant with specific regulations and directives pushing the industry to transform and achieve circularity.”

Key challenges Service providers reported that they are facing a number of key challenges as we begin the new decade, with identifying and hiring suitably experienced and qualified people high among their concerns, along with developing good IT tools and methods.

TEAM Mastery says that testing strategies and using non-animal methods for risk assessment is one of the sector’s biggest challenges, but also offers big opportunities too. The need for accurate information, an audit trail and everything ‘now’ in a digital world often presents a challenge to service providers, says Chemwatch. However, the firm believes that those companies that can provide specialised services and data in easily accessible formats may see some of the biggest opportunities in the chemical safety space. Commenting on the trend of increasing digitalisation and subsequent reduction in businesses offering face-to-face service and ongoing rapport, Chemwatch says: It “seems counterintuitive to be providing a service without the service”. REACHLaw’s Ms Sekki says the complexity of chemical regulations will increase and solutions to better integrate chemical, product and waste legislation be searched for more and more: “This will push service providers to develop further competences in-house to be able to fulfil industry demands and find sustainable solutions for their business needs. In addition, as non-EU chemical regulations are also entering into force, the language barrier will remain a great challenge, especially for service providers lacking specific language skills.”

Looking forwards German consultancies Forschungs- und Beratungsinstitut Gefahrstoffe (FoBiG) and knoell are just two of the many service providers with a positive outlook for the future. FoBiG’s managing director Klaus Schneider cites continuing high demand for its regulatory services. knoell’s Dr Cleuvers says the increasing complexity of global chemical regulations along with new laws being implemented, or amended, soon, are driving demand at his firm. He notes too that as companies are increasingly going global, a rising number are looking for a service provider with worldwide coverage, although he adds that having enough experts on board for all the necessary disciplines is a major challenge. Consolidation and partnerships between service providers will continue, says Ingrid Sekki at REACHLaw, as regulations evolve inside and outside the EU, demanding different competencies, expertise and presence onsite. While REACH and other overarching regulations are likely to dominate requests to service providers in the coming year, the chemical industry’s drive towards a circular economy and a more sustainable future will also require assistance and possibly new skills.

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Service Provider Outlook

Circular economy

CI RCUL A R ECO N OM Y

What opportunities does the circular economy and the focus on chemicals in plastics provide? A global spotlight is being shined on chemicals in products — and with this attention comes new opportunities, says Ginger Hervey Recent years have seen multinational companies make commitments, and sign up to alliances and partnerships that help them manage plastics in a way that eliminates litter and encourages recyclability.

The EU’s plan, in development since 2015, is the most advanced example of a circular economy being implemented overall. But many other countries are also working on plans, including in emerging markets.

At the same time, countries and trading blocs around the world are also adopting policies and plans to promote a circular economy.

Governments and private sector representatives from southeast Asian countries have agreed to cooperate on maximising resources, as well as the separation and proper disposal of waste. And according to the NGO the African Circular Economy Network, more than 20 African countries have adopted circular economy activities – defined as sustainability roadmaps, singleuse plastic bans, e-waste decrees or green economy plans.

In these, whether they be public or private initiatives, chemicals play an important role. Ensuring that hazardous chemicals are not recycled into new products is a difficult endeavour. It is one that could make or break the popularity of the circular economy concept. “It’s very important that this issue is addressed properly,” Peter Börkey, the OECD’s lead on waste management and resource productivity, says. “If it turns out the circular economy transformation is coming along with increased risks to people’s health and increased risk of exposure to hazardous substances … ultimately, recycled materials will become much less popular.”

Where is the circular economy taking hold? However, for the moment, European countries are the “the only ones looking into [the chemicals aspect of the circular economy] in a rather systematic way,” a Mr Börkey says. Although many countries are developing or considering circular economy strategies or roadmaps, he says, for the moment the chemicals consideration is “absent from the discussion” in these countries.

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However, in general, these initiatives are not yet fully considering the role played by chemicals. For example, Algeria, which launched a circular economy strategy in November and is positioning itself as a leader in Africa on the topic, did not mention chemicals explicitly. Instead its five goals, as laid out in a summary shared with Chemical Watch, are: O

preventing high quantities of waste;

encouraging selective sorting to recycle or compost;

minimising health and environmental risks of waste;

applying the polluter pays principle; and

increasing the role of the private sector.

Likely targets This doesn’t mean there is no regulation being developed at the nexus of chemicals and waste. But instead of national oversight,

Circular economy

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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 Ladungssicherungs-Informations-

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beyond Europe it’s the UN and multinational consumer-facing companies that are grappling with how to manage the issue.

and is researching how to replace hard-to-recycle packaging formats like multiple materials and layers.

The UN’s Stockholm and Basel conventions, dealing with persistent organic pollutants (POPs) and hazardous waste respectively, are becoming more important to the average manufacturing or recycling company as the Conventions expand to oversee substances used frequently in electronics and plastics.

“There is no such thing as a sustainable product in unsustainable packaging,” its spokesperson said.

The conventions consider a number of key substance groups including: O

per- and poly-fluoroalkyl substances (PFASs): under the Stockholm Convention perfluorooctanoic acid (PFOA) has been banned and perfluorooctane sulfonic acid (PFOS) restricted globally. The Convention is also considering looking at PFASs as a group; and SCCPs and PBDEs: delegates to the conventions are embroiled in debate over what concentration limits should be set for short-chain chlorinated paraffins (SCCPs) and polybrominated diphenyl ethers (PBDEs), hazardous plasticisers and flame retardants, in waste.

In the latter debate, the EU originally pushed for less stringent PBDE limits in waste than for those in products. But it recently withdrew its request, in a move NGOs called “an important step towards cleaning up its recycling.” This will have implications along the supply chain and recycling process for products containing flame-retarded plastics from vehicles to mobile phones. It also signifies that the debate could be tipping towards standards being equal for recycled and new materials.

Companies’ efforts Companies are increasingly self-policing the materials they use in order to make recycling easier. Some particular groups and materials are likely targets for being phased out or worked around, such as: O

pigments, which can’t be removed once they’re present in materials like plastics; and multi-layer packaging that uses different polymers, which are nearly impossible to recycle.

The French multinational food products corporation Danone, for example, is one of more than 400 companies that have signed up to the Ellen Macarthur Foundation’s New Plastics Economy commitment, which sets six major goals for a plastics circular economy. One of these goals is to eliminate hazardous chemicals from plastic packaging – both in manufacturing and recycling – by 2025. Danone now designs packaging with as few additives as possible, a spokesperson says, adding “Going beyond regulation, we have implemented some extra and stricter policies” such as “an ‘absence by design list’ (a list of hazardous substances) and more strict migration limits for some substances.” The company also does its recycling around the world based on what it calls the “more restrictive” European standards. Global food company Mars says it “is reducing packaging that [it doesn’t] need, redesigning the packaging that [it does] need for circularity”. The company adds that it will eliminate PVC from all its packaging formats by the end of the year, is testing more paper packaging materials to replace plastics where possible,

Biodegradable and compostable packaging “may offer a potential solution ... in regions of the world that lack adequate waste handling and recycling infrastructure,” the spokesperson said, although acknowledging that “biodegradable and compostable packaging is not a solution for litter.” And a spokesperson for food and drink conglomerate Nestlé says the company is also researching “several key areas such as paper and bio-based packaging materials, simplification of non-recyclable materials and alternative packaging delivery systems.”

Opportunities All of these changes to company practices and to country laws could create new opportunities. As companies shift from one process or material to another, lifecycle assessments, or assessments of the impacts of a process or material from beginning to end, will be needed in many areas, Mr Börkey says, in order to ensure that the most environmentally sound option is chosen. New and innovative business models are also being developed to deliver goods and services to consumers, and will need to be expanded and assessed. Finally, as governments and agencies further develop and implement circular economy strategies, there will be a need for more research on what policies are most effective and how they can be implemented most successfully. Beth Simpson, who leads a working group on plastic waste prevention and circular economy development at consultancy Anthesis, says that to date, the biggest focus of concern and regulation of additives in plastics has been for “particularly vulnerable populations”, such as babies and children. “However, as the requirement to reduce and recycle grows, the lack of knowledge about additive use in typical plastic products will be seen as an ever-more limiting factor until there are clear requirements for transparency and potential labelling in the supply-chain, so that these additives can be tracked through the lifecycle,” she says. Some progressive service providers are helping supply chains pilot schemes with tracking systems such as QF codes, and there’s discussion of whether blockchain technologies can be of use. “To really accelerate the process, there needs to be a better understanding of how and why certain additives are used,” Ms Simpson says, “so that any testing regimes can be focused on the most likely chemicals of concern at the product level when such products reach end-of-life.” Anthesis is leading in this area, working with clients to develop relevant databases that help to predict where additives are needed and where they are found, she says “In turn, this type of information also helps product designers focus on selecting materials that might not only use alternatives to the chemicals of concern, but might even avoid the use of additives altogether,” she says.

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Circular economy

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The CHEMICAL COMPLIANCE Company

Europe

EURO P E

What do companies need to do to provide information for Echa’s Scip database for substances of concern in products? Due for launch in October, Echa’s Scip database will require companies to notify substances of very high concern in products. The move is part of Europe’s revised waste Directive in a bid to clean up recycled materials reports Elaine Burridge The 2018 revision to the European waste framework Directive (WFD) mandated the creation of a new database for products, including articles, which contain REACH candidate list substances – or substances of very high concern (SVHCs) – above a threshold of 0.1% weight by weight.

products. We need to identify and locate these materials but there is not enough information available at present in the public domain,” Mr Balduyck says.

Manufacturers, distributors and importers will be required to submit information to the substances of concern in products (Scip) database, being developed by Echa, by the deadline of 5 January 2021.

Echa has released a prototype to the user group and this was made available to companies on 17 February. Bo Balduyck, policy officer at Echa’s governance, strategy and relations unit, says companies can play around with this test version, submitting dummy data and getting used to its functionality. The finished database will be rolled out this October, when companies will be able to enter their legally binding notifications. Data must be submitted via Echa’s Iuclid system. In theory, says Mr Balduyck, the Scip data requirement is just an extension of an existing (REACH) obligation. The two key factors behind the creation of this database, he says, are the EU’s push towards a circular economy along with a need to reinforce the existing (REACH) obligation to pass information along the supply chain on SVHCs. “If we want to achieve a circular economy, we need to make sure that clean materials are recycled so that we do not create an internal loop of hazardous materials and make them into new

Under the amended WFD, member states must:

promote the reduction of the content of hazardous substances in materials and products; and ensure any supplier of an article, as defined under REACH Article 33, provides the necessary information on the presence of SVHCs.

For more than ten years, companies have been required to pass on information on hazardous substances down the chain, but, as Mr Balduyck concedes, this has been poorly implemented. “From the feedback we have had, the overall provision of information about substances of concern is not really happening in most supply chains. The legal obligation has not worked very well and needs to be reinforced.” Echa believes the database will be useful for waste operators, consumers and public authorities. For waste operators, the data will improve their knowledge and help sort products containing hazardous substances from their recycling streams. The agency has started consulting with different waste operators on how they would like to receive the data, for example simple searches or advanced services. Is it enough for them to get the raw data and crunch it themselves, asks Mr Balduyck, who notes the companies still have to make up their minds. www.chemicalwatch.com/SPG

Europe

He hopes that while there is no obligation for waste operators to use the database, they will find it useful over time, and benefit from the added value it could provide in their operations. For instance, the Scip data could mean they need to do less testing, which would save costs. Also, they may want to have reports on different product families, or what types of components are the most hazardous in certain products, for example, washing machines. There is also the potential that waste management companies could develop or refine their technology and sorting equipment if they know certain products contain hazardous chemicals. For consumers, Echa says increased transparency on the presence of hazardous substances will help them to make more informed choices when buying products – as well as giving information on how to best use and dispose of the items. For companies making submissions to the database, Echa is working with several industries, including in the automotive and electronics sectors, to build bridges between their respective IT systems. Mr Balduyck says system-to-system submissions will be the key for big industries to comply. Software provider Assent Compliance notes that while the WFD substance list is similar to the REACH candidate list, it does have different data requirements. It says some of the Scip data types that are not covered under REACH include: article category; linked articles; number of units; substance concentration levels; and material or mixture category. IPC, the association connecting electronics industries, which has been developing its materials declaration management standard – IPC-1752B – to help the sector comply, has been road-testing the data fields needed in the database’s declarations. It has subsequently made a series of recommendations to Echa for improvements, notably for it to: O

produce an official ID for each REACH candidate list update;

publish a list of IDs for each candidate list substance;

provide an enumerated list of safe use information text strings, with an ID for the list and an ID and description for each entry in it; provide an enumerated list of material categories, with an ID for the list and an ID and description for each entry; and supply a separate list of material properties in the material category, including an ID for the list and an ID plus description for each entry. Echa should also set up a user group to further discuss some of these material categories.

The agency says it has already implemented some of IPC’s recommendations, although others need further discussion. For example, companies can protect confidential business information (CBI) by using their own part numbers for articles they are notifying, instead of using their suppliers’ identifiers. However, if multi-sourcing leads to the article being “materially” different, then “strictly speaking” they should be identified as a separate article. The agency also says that it guarantees to protect CBI as it does not intend to publish article identifiers, including brand and model, for “component” articles in a complex object. However, it adds that identifiers linked to an entire product placed on the market will be made available.

Global Service Providers Guide 2020

Echa is also now providing unique pick-list IDs for both materials and articles categories and they will be updated annually in October. Under materials categories, there is now a separate, optional list for additional material characteristics. In future updates to the database, Echa plans to provide an enumerated list of safe use information text strings, with an ID for the list and an ID and description for each entry in the list. The agency will develop the list together with IPC and other leading stakeholders. Aidan Turnbull, co-chair of the IPC-1752B committee and director of the BOMcheck centralised substances declarations web database, points out that it can take several months for a company to receive data across multiple layers in the supply chain. In the meantime, new SVHCs are added to the REACH candidate list biannually. Consequently, companies may need to update their data every six months too as suppliers report these new SVHCs in new articles. Web-based tools and systems provide an efficient way of managing this constantly changing supply chain data. “The way a company exchanges data across its supply chain is just as important as the format that the company uses to collect the data. A web-based network is a much more effective way of exchanging information across several layers in the supply chain than gathering information by email,” Mr Turnbull says. Certainly, for the electronics industry, one of the substances that will require to be notified to Scip, is lead. The metal is restricted under the EU Directive on the use of certain hazardous substances in electrical and electronic equipment (RoHS), but is exempted in applications where there is no alternative. While communicating along the supply chain has been one problem under REACH, the other has been enforcement. This will not be part of Echa’s remit; rather it will be done by national regulatory authorities. The deadline for EU member states to transpose WFD requirements into national law is 5 July. It will then become clear as to what penalties will be imposed or action taken for non-compliance, together with possible exemptions. However, while each country’s legislation may differ on the details, what will remain unchanged is the date for compliance. To be prepared for the early 2021 deadline, Assent advises that companies should confirm the availability of both internal and external resources to manage the WFD requirements; create awareness and set expectations along their supply chain; identify data gaps and prepare to respond to customers’ requests; and collect, evaluate and aggregate data.

Scip TIMELINE Feb 2020

Scip prototype released

5 Jul 2020

Deadline for EU states to transcribe WFD into national law

Oct 2020

Launch of Scip database

5 Jan 2021

Deadline for Scip notification

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A new era for REACH dossier compliance? Full compliance on REACH registration dossiers has become a top priority for EU regulators, and companies are expected to raise their game by improving their quality and regular updating with new chemical safety data reports Clelia Oziel. The past year has seen a number of announcements on dossier compliance as Echa and the European Commission – having cleared the last REACH registration deadline in 2018 – turned their attention to maximising its impact by streamlining rules and increasing inspections. As part of the overhaul, Echa has hiked its dossier compliance check target from 5% to 20%. The aim is to cover 30-40% of all registered substances. And, following a recent review that showed that the current completeness checks do not “fully ensure” that registrants have submitted all the required information, the agency is to introduce revised computerised inspections of dossiers from May. These changes will help identify substances of concern more easily, and better communicate the necessary risk management measures arising from their use, Echa says. The agency will also carry out completeness checks from October on chemical safety reports (CSRs).

toxicologist at Cehtra. This they do by not only listing the potential vulnerabilities of their dossiers, but by also updating their dossiers accordingly: conducting new studies, improving the substance identity information for complex substances, providing better information on use and exposure. But, Mr Rolland adds, some companies are still waiting for Echa to review their dossiers and, in addition, difficulties in reaching consensus among Sief members remain high. After the 2018 registration deadline, there may be less awareness or pressure on SMEs, therefore renewed engagement from authorities and industry associations can help them stay committed to their REACH dossier programmes, he adds. Helen Kean, technical director at consultancy Anthesis, agrees: “Many saw the registration as the end of the process and I think we all needed to draw breath. However, those working with REACH day to day know that registration was only just the start.”

Meeting the demands

For SMEs, or companies for which the business case to support a registration was borderline, a more reactive stance is now likely, she says, and they will need external support.

How are companies planning to square these demands with existing, and often stretched, resources, especially in the case of small and medium-sized enterprises? And how aware are they of the changes that are coming?

Sue Bullock, principal at Ramboll – a leading engineering and consultancy company – says that as each substance and data set is different, developing robust registration strategies requires substantial expertise and experience.

“Some companies are proactive and choose to anticipate and review the dossiers,” says Mathieu Rolland, senior

It is impossible to provide a ‘one-size fits all’ approach, Ms Bullock says, adding that cherry-picking data is not defensible.

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Moreover, data is rarely perfect, she says: “Our job quite often involves unpicking and explaining results from sub-optimal studies, as well as connecting various lines of reliable evidence to provide insight on a particular endpoint or effect.” And cost is a significant issue with this new phase of REACH compliance possibly proving to be more expensive than the registration deadline for some substances, Ms Bullock adds.

Compliance The revised procedures were brought in as a response to findings that many registration dossiers are not up to scratch. On closer inspection many have passed automated checks, even though they lack some of the basic required evidence. Good quality dossiers containing all required hazard information are key for a proper exposure and risk assessment; without them REACH cannot attain its goal of protecting humans and the environment. Those registrants and co-registrants that have fully complied should celebrate the increased scrutiny, experts say. Yet even the dossiers that were considered ‘good quality’ at the time of submission might not meet expectations now, due to constantly evolving scientific data and new substance evaluations. According to Dr Laetitia Six, scientific adviser regulatory affairs at Belgian-based Apeiron-Team, the challenges are setting priorities, finding resources, and reaching agreement within substance information exchange fora (Siefs) for voluntary dossier updates.

Dossier updates With new rules and guidance on making regular dossier updates down the pipeline, companies will soon find they have nowhere to hide. Following the 2018 publication of the second REACH Review, the Commission set out a plan with Echa that included 15 action points established in cooperation with member states and industry. A more recent report from the same project, published in March, revealed that nearly half of all dossiers in the medium – 100-1,000 tpa – tonnage band could be non-compliant with respect to ecotoxicity. However, it added that in general, compliance for this band may be better than for the high tonnage band. The Commission is also working on a draft implementing Regulation to clarify Article 22 of REACH that deals with a registrant’s duties once a dossier has been registered, although industry has objected to the proposed short timelines. In recent years, Echa has made separate data cooperation agreements with Cefic and metals industry body Eurometaux that aim to help registrants update their substance dossiers. As part of this, Cefic has launched a voluntary action plan and pilot project with Echa. In January, Sylvie Lemoine, the organisation’s executive director of product stewardship, told Chemical Watch the plan would require a “huge” commitment from signatories, additional resourcing, more testing and systematic review of the dossiers. Nevertheless, in the eight months since it began, some 170 members have already signed up, meaning that the scheme encompasses thousands of dossiers covering 60-70% of

substances registered above 100t and close to 75% of those more than 1,000t. Another task many companies face is that so-called favourable conditions granted for the registration of ‘phase-in substances’ – chemicals that were already on the market when REACH began in 2007 – ended last year. This means that rather than calculating the average tonnage of a substance on the market based on the three preceding years, they now need to record tonnages annually.

Updating responsibilities Germany-based Chemservice says lead registrants have a specific responsibility. If a lead dossier is not updated, it is difficult to update the member dossier, says the consultancy‘s managing director Dr Dieter Drohmann. It is urging clients to start making updates before regulators take action. By doing this regularly, clients can spread their costs and this means that each change is not significant, it says. Apeiron-Team’s Dr Six says dossiers submitted in 2010 and 2013 will need to be updated, possibly from a scientific but definitely from a technical, point of view given the changes made at Echa’s end. The company is helping clients to evaluate those dossiers that would benefit from a proactive update the most. “We identify weak points and ensure these are tackled and updated prior to receiving a DDL [draft decision letter] from Echa.” But Dr Kean at Anthesis says it wants to avoid a mandatory cycle of advising ‘no change’ when there is no good reason to update a dossier. Although, it says, this can be difficult when the guidance continues to evolve. On the other hand ‘no-change updates’ can be significant work to justify especially for non-EU clients juggling multiple issues elsewhere in the world. Ms Bullock from Ramboll says that the proposed amendment to REACH setting down timelines for updates and steps to extend the completeness check to include uses and CSR, will drive some improvements. However, the scale and cost of compliance remains substantial, as do the challenges of enforcement. Uncertainty around what might be acceptable can lead to reluctance to carry out potentially unnecessary new testing, or ultimately improve risk assessment. And dossier improvements that require testing will drive further hard decisions about commercial viability of substances, including possible disappearance from the market and potentially stifling innovation, Ms Bullock says. Many in industry are waiting to see whether the guidance from the joint Echa-Cefic project – expected mid-year – is sufficiently generic to help registrants across the board.

Grouping/evaluations Another goal for regulators is more effective screening of registered substances. Echa will in future consider substances in groups and says that by 2027, it will have screened all registrations submitted by the 2018 deadline, across all tonnage bands. It is also aiming to simplify and accelerate the substance evaluation process under REACH.

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However, the consultants contacted by Chemical Watch gave a mixed verdict on grouping.

that end need to be very clear, she adds, but the approach can positively impact industry if they act quickly enough.

While such an approach can create greater engagement by including more stakeholders, it can lead to certain strategic, low-volume uses of substances not receiving sufficient attention, says Mr Calder from Assent Compliance. These could include applications in aerospace, defence, medical and heavy equipment.

Cost increase

Grouping makes sense, according to Dr Kean at Anthesis, “but you need to be clear what is a group and who generated that group.” There needs to be a sound scientific basis, she adds. Ramboll’s Ms Bullock also sees some dangers. Echa is grouping substances by linking each with every other substance mentioned in a read-across capacity within each dossier without any reference to its validity or the quality of the dossier, she says. That means a substance may be ‘grouped’ by reference to a tenuous link in an unrelated (possibly poorly-prepared) dossier. Registrants, she says, have to take care of the consequences. There is a significant concern here, and it increases further when Qsar is also referenced during the process, Ms Bullock adds. This compels industry to prove a negative. Ramboll’s role has been to review and rebut poor read-across in these cases. Meanwhile, she says, the data set necessary to justify grouping may be almost as extensive as that required for individual substance assessment. Moreover, the outcome of the evaluation process is not always clear cut. For example, should concerns around endocrine disruption always trigger an extended one-generation reproductive toxicity study (Eogrts), she asks. Dr Laetitia Six says companies need to act now for substances they suspect Echa will treat as a group. Their proposals to

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A big question that needs an answer is whether companies are willing to pay for more data. Dr Kean at Anthesis says there are players who see the costs of evaluation as a necessary evil of doing business in Europe and others that will try to avoid any further costs until the last moment, or indefinitely. Dr Six says that if the costs relate to additional data requirements, for example those specified in Echa’s final decision letter (FDL) and in agreement with the REACH annexes/ tonnage band of the company, these are typically quite well accepted. But if they are made on a ‘voluntary basis’ to improve the quality of the dossier, it is less obvious that companies will be willing to pay more. Dr Six says that if the expected costs of additional testing are too high, companies can be seen to “cease manufacturing or lower their tonnage band to limit their requirements”. On the whole, industry is keen to improve dossiers, especially the larger players holding a number of lead dossiers. However, most are not ready to write blank cheques, and experts argue that there needs to be a complete change in the provision of use and exposure information. It is also not certain that the new measures will increase testing costs. Echa’s dossier evaluation project will determine if prioritisation on improving data requires more testing or whether alternative methods exist.

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Brexit: Getting down to business With this year’s negotiations set to determine the course of the UK’s departure from the EU, what obstacles can the chemicals industry expect to navigate and how can it best weather the potential storm? Luke Buxton reports It took the UK more than three and a half years to formally leave the EU and there’s now less than a third of that time to agree on a set of complex trade deals that will directly affect the chemicals industry for many years to come. Critics, including the new European Commission president, Ursula von der Leyen, say the eleven-month transition period – from 31 January to 31 December – is simply not long enough to execute all the necessary business. During this period, the UK, and companies based there, will continue to implement EU law. What happens after that is a source of continuing speculation. “It is clear that chemical and other companies are using Brexit as an opportunity for assessing their supply chains”, say ERM partners Jo Lloyd and Linda-Jean Cockcroft, ‘considering if and where reorganisation is needed and analysing how best to drive business value through their product stewardship programme in the post-Brexit context. This is true not just for EU and UK companies, but for all companies doing business in the UK.” More attention will be paid to data-sharing negotiations and preparation of relevant contractual arrangements for compliance with the respective relevant chemicals regimes (in the UK and EU), according to a team at international law firm Steptoe & Johnson. “Revision of consortia and taskforce agreements will also be required.” From service providers, clients will require “monitoring and strategic advice on compliance with the two – over time potentially diverging – chemical regimes.”

What should companies in the supply chain expect? Below is a breakdown of the challenges respective actors will likely face and advice on the steps to take.

Companies in the UK exporting/importing chemicals In a scenario where the UK is out of EU REACH, for example, UK registrations and authorisations obtained by companies in the country will need to be transferred to entities in the trade bloc. “EU27/EEA companies which import from the UK, and who were previously downstream users, may suddenly become importers under EU REACH and potentially have new REACH registration duties if not supported by suppliers,” REACHReady’s Nishma Patel says. In parallel, REACH registrations and authorisations obtained before the end of the transition period would need to be resubmitted in the UK to continue to manufacture and import chemicals in the UK once the country is out of EU REACH. “Moreover, UK companies sourcing chemical substances and mixtures from the EU either directly or in articles, and that were previously downstream users under EU REACH, may suddenly become importers under UK REACH and may have new registration obligations if not supported by EU suppliers,” Ms Patel adds. Access to only representative (ORs) and responsible person services will be important to secure markets, as will timely access to data, Ms Bullock says. “Many organisations are

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concerned about the practicality of extending existing, or setting up new, data-sharing arrangements in a short timeframe for UK regulations.”

new actives”. UK biocides manufacturers will need to have a legal entity in the EU in order to get the required product authorisations in member states.

It is still very unclear, Ms Bullock adds, how companies will organise themselves to comply with UK product regulatory requirements, for example, and whether new consortia will need to be formed. “This will only start to become clear in the months ahead.”

For these companies too, Steptoe & Johnson advises a review of the existing supply chain for potential impacts – for instance where UK companies are biocidal product authorisation holders, or listed on the EU Article 95 list.

“One of the key challenges for chemical companies is scenario planning and securing resources for the additional work that needs to be done”, according to Ms Cockcroft and Ms Lloyd, “including developing and implementing a relevant post-Brexit business strategy whilst ensuring compliance.” Access to data to support UK REACH is also an area where EU consortia and Siefs are encouraged to actively start preparations if not already done, using services such as ReachCentrum Data Brokerage Platform to facilitate data sharing across jurisdictions. Data that has been submitted for EU REACH may be owned by companies and consortia who have no interest in participating in UK REACH. Such information cannot be transferred via any data transfer there may be between Echa and the UK on the UK’s exit, yet if UK REACH comes into force it requires the submission of robust study summaries and reports. This may be a reasonable expectation where UK companies own the relevant data but could be problematic for UK legal entity co-registrations relying on cost sharing with Sief agreements for data access. These often stipulate data use within an EU REACH context and not for other regulatory jurisdictions. Steptoe & Johnson advises that a review is carried out on the existing supply chains for potential impacts and to determine if new registrations are required (under each regime), or if transfers of existing registrations are necessary and possible. “In all cases of regulatory compliance, restructuring and data access rights (including submission of data to UK authorities) will be key and will need to be secured. This cannot be taken for granted.”

Companies in the UK exporting/importing articles If the UK leaves the EU without a trading deal that maintains close alignment with the single market requirements then companies exporting goods to the EU and importing goods into the UK “will have to navigate customs trade and tariffs, including how these affect online sales”, says the ERM team. “Knowledge of the two sets of legislation, obtaining and maintaining the right knowledge and having the required expertise, is critical.” For UK companies exporting to the EU, ongoing compliance with all EU product legislation “will be essential, as will compliance with all article/product notification requirements”, such as REACH Article 33 and Echa’s new substances of concern in products (Scip) database.

Getting biocides to market – the biocidal products Regulation For companies that buy or sell biocides, Brexit may result in delays in the re-notification process, Ms Cockcroft and Ms Lloyd point out. “On the other hand, it is possible that UK authorities will be able to process biocidal active substance dossiers quicker than the EU.” This could, they say, be advantageous for industry and the UK could become a “test market for innovative

The transitional periods under UK BPR, the law firm says, are very short, “in some cases requiring the submission (not only letters of access) of all relevant data within 90 days from Brexit”. Affected companies should therefore review their data access rights and, where necessary, negotiate additional access rights. Steptoe & Johnson further recommends that companies assess the extent to which the REACH registration of potential coformulants might be affected by Brexit.

Companies in the EU exporting to the UK or importing from the UK Given the relative size of the two markets, chemical companies are anticipating that for some substances, “UK volumes will not be sufficiently large to justify an investment in a UK registration, which could have significant repercussions for UK companies”, the ERM team says. EU companies will also need to conduct analysis to assess exposure to possible supply chain disruption as a result of Brexit, the consultancy adds. For EU regulatory compliance where tonnage volumes are fundamental, EU companies will need to ensure they assess tonnages at EU27 level as well as UK level, and appoint a UK OR as required, it advises. The team at Steptoe & Johnson says that as “trans-channel trade will become international trade” companies need to assess the potential impact of customs on their supply chains with an eye out for preferential origin rules under EU free trade agreements.

Meeting the challenges What role can service providers play in helping companies take on these new hurdles? It starts with preparation and ensuring access to comprehensive information. ERM says it is providing “significant strategic support” for companies including those headquartered outside the EU, by offering supply chain analysis to help assess the potential “size and scope” of their business exposure. It also advises on the necessary steps to achieve compliance from a legal entity perspective. Digital strategies are also important, the consultancy says, as well as “the capabilities of chemical management systems for achieving and maintaining business, regulatory and compliance structures in a post-Brexit environment”. According to Steptoe & Johnson, mitigating the effects of Brexit, such as market access impediments and barriers, “will require an investment of resources, both financially (fees under UK regimes and/or new data access rights) and possibly in terms of personnel (to the extent that outsourcing is not preferable). “Our strength is in mapping and executing cost-effective solutions for our clients to mitigate those effects. This work is focused on strategic advice and global data rights management.”

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No-deal advice The clock is ticking and industry should take the necessary preparedness steps in the event of a no-deal Brexit “as a matter of urgency”, Steptoe & Johnson says. This, ERM adds, includes “considering the various scenarios” in the decision-making process. Where new registrations, notifications or authorisations are required, Ms Bullock recommends clear communication. “Confirm your supplier will continue to supply and has appropriate plans in place. A new supplier, OR or responsible person agreement may be needed to continue operating in the EU and/or the UK, in which case discussions are needed now.” If companies are still unsure of what they need to do, “seek advice so you are not caught out”. Ms Patel, at REACHReady, summarises the short-term to-do list: O

identify products impacted by Brexit (includes substances, mixtures and articles);

consider both EU and non-EU suppliers and customers;

identify place in the supply chain, both pre- and post-Brexit;

track volumes to determine registration obligations; and

engage with suppliers and customers to identify options.

New trade agreement expectations Boris Johnson’s re-election as prime minister in December triggered a new round of questions about regulatory alignment in the new trade deal.

ERM says it is aware that some “experts anticipate that the UK could slowly drift away” from EU legislation. It adds that no matter what happens, it will not change the fact that for UK companies and those located outside the EU and doing business with the trade bloc, “there will continue to be an ongoing need to understand the EU legislative framework”. Ms Bullock expects there will be “gradual divergence and perhaps even more rapid change in some areas”. However, the UK, she adds, “may welcome the opportunity to exercise its voice independently on the world stage, and seek to lead scientific debate and policy making in priority areas”. That could be an “exciting proposition” even if lack of alignment is “perceived burdensome in other ways”. Ms Bullock says she wants to see a continuation of the UK’s “reputation for a strong scientific approach that is pragmatic and avoids unnecessary complexity. A reciprocal arrangement for mutual recognition of registrations or notifications may be one approach.” Steptoe & Johnson largely agrees with this: “Even if the new trading agreement would foresee complete harmonisation, over time considerable divergence between the two regimes is to be expected and appears to be the stated aim of the new UK government”. It warns that having different regimes may mean dissimilar data requirements and potential data sharing/access issues. With different underlying data sets, it is likely that the regulatory authorities would come to “different substantive decisions”, it adds. And finally, while it would be possible to challenge decisions, the reviewing bodies in the UK and EU will be different and may reach “contradictory” positions.

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North America

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What are the latest developments in US state-level chemicals legislation? As individual states across the country continue to enact their own regulations, Amanda Ulrich speaks to service providers about the key trends The challenges for chemical and product suppliers in tracking the patchwork of US state-level chemicals legislation, regulatory changes and voluntary programmes have continued to mount in recent years.

“Although the Lautenberg Chemical Safety Act was supported by industry in the hope that it would cut down on state chemical laws, the level of state activity has not diminished,” says Herb Estreicher, a partner at law firm Keller & Heckman.

Where the federal government has moved more slowly when it comes to chemicals management, individual states have picked up the slack and introduced their own regulations. These can vary across different states and jurisdictions and the sometimes disparate laws can prove testing when it comes to ensuring corporate compliance.

Thomas Lewandowski, a principal scientist at environmental and risk sciences consulting firm Gradient, agrees that the Lautenberg amendments haven’t solved the issue of streamlining state regulations.

In 2016, the Frank R Lautenberg Chemical Safety for the 21st Century Act became law. Among other things, the Act, which amended TSCA, required the EPA to evaluate existing chemicals with “clear and enforceable” deadlines through risk-based chemical assessments. At the time, industry leaders envisioned that the updates to the statute would help reduce the number of state-specific chemical laws, even though regulators and advocacy groups insisted at the time that states would continue to play a “significant role” in managing chemicals of concern in consumer products. Almost four years later, states are still leading the legislative charge.

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“The expectation was that TSCA reauthorisation was going to address this ‘patchwork’ problem, but this doesn’t seem to have been the case,” he says. States continued to introduce and pass a flurry of their own chemical regulations in 2019. Popular state-level legislation involved per- and polyfluoroalkyl substances (PFASs), flame retardants, 1,4-dioxane, chemicals in children’s products and ingredient disclosure mandates, among many others.

Trends in state-level legislation Supply-chain data management company Assent Compliance says it has noticed states being at the frontline of legislation. “State-level trends continue to show efforts per state to drive chemical regulations if they feel the federal-level laws have not

North America

been proactive enough,” says James Calder, vice president of compliance and regulatory programmes at Assent Compliance.

EU’s REACH Regulation are potential indicators for what might happen on a state level.

A good example is the PFAS group of chemicals. According to Safer States, an NGO that tracks chemical legislation across the country, ten different states have now adopted 20 policies that address them. Several states, including New Hampshire, New York, New Jersey and Michigan, have sued manufacturers of the substances over alleged environmental contamination.

Assent Compliance, meanwhile, says of Prop 65: “Not only has it been a major local regulatory driver, but also a global regulatory priority because of California’s purchasing power and the free distribution of many products after production and/or import into the US.”

“The PFAS topic has received a lot of attention due to the various litigation activities occurring throughout the US,” Mr Calder says. “The details around the litigation do show how much business risk is associated with understanding the safety of material/substance in comparison to only product quality and performance. Product performance and quality must now include a balance of hazardous substance risk.” Consulting firm Gradient says it has seen a tendency for state legislatures to use a “list of lists” approach in creating new regulations. In other words, rather than identifying chemicals of concern for one particular product, those laws are simply referencing third-party chemical lists. “The problem is that many of the lists weren’t developed with products in mind and they have many chemicals that are unlikely to be found in the products (for example hormones, cat dander),” Dr Lewandowski says. They may also have imprecise listings using alternate chemical names, for example, and failing to provide chemical abstract service (Cas) registry numbers. All of this makes it hard to determine if a particular chemical is present in a product or not. But Dr Lewandowski says that adding “yet another list” is probably easier from a legislative standpoint. California uses 23 third-party lists in its cleaning product regulation – the Cleaning Product Right to Know Act. New York added another six to its own related legislation – the Household Cleansing Product Information Disclosure Program – before the scheme was struck down in 2019 after litigation in the courts, he says. The state resumed its efforts to put an ingredients disclosure programme in place earlier this year.

The influence of California legislation All three companies that shared their expertise – Assent Compliance, Gradient and Keller & Heckman – say California’s Proposition 65, or the Safe Drinking Water and Toxic Enforcement Act, is one of the most influential state regulations in the US. The law, enacted in 1986, requires businesses to give warnings to Californians about exposure to chemicals known to cause cancer or reproductive toxicity. California, with the largest economy of any US state, is also one of the top economic leaders in the world. If manufacturers don’t comply with Proposition 65, then, they effectively exclude themselves from that significant market. Mr Estreicher says the scheme “remains the single piece of state legislation that concerns most companies”. Along with Prop 65, the law firm says the bans and restrictions that fall under the

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The company’’s Mr Calder describes the state as lying within the US’s ‘import region’, meaning that many manufacturers and sellers must assume that all products sold into the country will have to comply with Prop 65’s warning requirements. “Recent changes to how businesses may use [and] provide these warnings came into effect in August 2018, creating a need for companies to revisit and revise historical compliance programmes and causing a ripple effect throughout the supply chain to address the new regulatory requirement,” he says.

How service providers can help The growing number of differing state regulations, can prove especially challenging for companies. Meanwhile, Mr Calder says the biggest they face in tracking state regulations is actually identifying and interpreting which apply to their products. “Once scoping has been completed, the next big puzzle is to figure out if the company has the right data to make an informed decision about whether they need to change the design of their product, and/or introduce inventory control for products in circulation within the US,” he says. Service providers can help companies make sense of the web of state-level legislation in a variety of ways. Supply-chain data management platforms should use “microbased” data points to prevent “macro-related” risks, involving what the product contains, who produced it and where, and what type of conditions it was produced under, says Mr Calder. “Lastly, in addition to software, service providers should be able to provide the expertise and guidance to help companies understand and navigate this complex regulatory environment.” Meanwhile, Dr Lewandowski from Gradient stresses the importance of having a central database of information. Though some sectors, like the auto industry, are ahead of the curve and already have those databases, Dr Lewandowski says, many companies hold their relevant data (which can include a bill of materials, restricted substances lists, or chemical analyses of products) in different places. “Having a single database of information allows you to identify those products most at risk for regulatory issues and get out in front of potential problems,” he says. Keller & Heckman says “The next few years promise to be an exciting and challenging period in the history of US chemical regulation”.

Experts in Regulatory Compliance Arrow Regulatory Limited has extensive knowledge of chemical legislation, particularly the Biocidal Products Regulation, REACH, CLP and ADR. We offer integrated and cost-effective solutions to assist companies in meeting their regulatory obligations. The world of chemical regulation is constantly developing and leads to changes in how supply chains operate. We are able to assist with initial regulatory compliance plus the necessary updates to technical dossiers, risk assessments, classification, labelling, Safety Data Sheets and transport activities. The company has also actively prepared for UK withdrawal from the EU. Our team of specialists understand the complex communication issues that arise during product development, interaction with regulators and marketing. You can draw on our expertise knowing that we understand your goals and make them happen.

Arrow Regulatory Limited 6th Floor, City Gate East Toll House Hill Nottingham NG1 5FS UNITED KINGDOM

Arrow Regulatory (Ireland) Limited 9 Pembroke Street Upper Dublin 2 D02 KR83 IRELAND

T: +44 (0) 115 9352243

T: +353 (0) 1 653 2165

Biocides Arrow Regulatory's wide experience in supporting active substances and biocidal products under the Biocidal Product Regulation or other, is your guarantee of a quality service.

REACH Arrow Regulatory has extensive experience in supporting clients of all sizes to comply with their REACH requirements.

CLP Arrow Regulatory provides a comprehensive service to help you achieve compliance with the classification, Labelling & Packaging (CLP) Regulation.

Dangerous Goods Arrow Regulatory can offer the experience of a certified DGSA regarding the Classification and transport of dangerous goods.

info@arrowregulatory.com www.arrowregulatory.com

Asia

A SIA

What obligations and challenges will companies face under China’s new and revised chemicals laws? This year, the Chinese government is expected to provide further clarity to industry on the country’s proposed overarching regulation and how it will interplay with the existing regulation, MEP Order 7. Ellen Daliday and Charlotte Niemiec take a look MEP Order 7 – the Measures for Environmental Administration of New Chemical Substances – has been China’s main chemicals regulation since 2010. The regulation, which only controls new substances, is currently being revised, with changes aimed at simplifying the registration procedure and introducing several exemptions expected to come into force within the next 12 months. But alongside these revisions, the Ministry of Ecology and Environment (MEE) is developing a new overarching regulation for new and existing substances. When approved, the Environmental Risk Assessment and Control Regulation for Chemical Substances (Erac) is expected to supersede MEP Order 7. The proposed law draws on the regulatory frameworks of the US and Japan, requiring pre-market approval of new chemicals and the evaluation of certain existing ones that the government considers high risk. And, unlike EU REACH – where it is the responsibility of industry to register all existing substances before they are considered for further action – China’s government will lead this process by compiling an initial list of high risk chemicals that companies will have to register.

Global Service Providers Guide 2020

Tommy Ju, principal consultant at ERM China, says trade associations and larger chemical companies are likely to support the government in its efforts. “Substances will be screened based on their risk and whether they are included on different lists, including restricted or banned substances,” he says. While this could mean that smaller companies would not initially be required to carry out as much work as EU REACH required, they will also potentially not have as much sway over decisions, he adds. And they will be expected to react quickly to decisions made by the authorities in order to ensure compliance.

Technical support The government may invite local companies to provide “technical support”, but this raises important questions relating to transparency and fairness, says Chia-Sui Hsu, business coordinator at Sustainability Support Services (SSS) Europe. “This might be a barrier for non-Chinese companies to be able to comment on the process. But as long as this is done in a transparent way and information can be communicated, we don’t see that there is a problem with the authorities inviting technical support companies to assist,” she says.

Pharmaceutical Registration

CSCL/ISHL Notification

Disinfectant Products Record

HSE Services

K-REACH

Email: regulation@hse.cncic.cn

Tel:+86-10-64421139

www.chemhse.com

Asia

The government will also ask “relevant technical support companies” to help it conduct risk assessments, the draft says, but it does not specify how the government will identify these companies. “I know the MEE will organise an expert committee to conduct the risk assessments. The experts usually come from companies, universities and formal regulators, but this hasn’t been determined yet,” says Selina Xu, managing scientist at Exponent. ERM’s Mr Ju adds that the government is “learning” from Japan and, based on that country’s experience, China is likely to rely on major manufacturers, importers and associations to provide help with risk assessment. Another provision of the law requires companies to submit reports on chemicals and their uses to the government every three years, but the latest draft does not detail how far downstream this requirement will extend. “This is one of the hot topics of discussion,” Mr Ju says, and “the authorities have not given any formal feedback on it yet.” Ms Xu says it may cover any manufacturer using the chemical as a raw material for production, while Ms Hsu from SSS says it’s possible the requirement will extend to manufacturers of articles and products. The government has not yet confirmed a timeline for the adoption and implementation of the law. In September last year, the MEE notified the WTO of a second draft outlining plans for how the government would handle confidential business information (CBI) claims, along with several proposed exemptions – but did not clarify the scope of the regulation with regards to notification.

MEP Order 7 As the government firms up its plans for the new law, it is also close to finalising revisions to MEP Order 7. These are expected to “streamline” the process of registering new chemicals, based on their risk. For example, “under the proposed revisions, MEP Order 7 increases the concern of high-risk substances with persistent and bioaccumulative properties and decreases the notification burden for low risk substances,” says Bryan Zhou, senior regulatory consultant at the Irish branch of consultancy CIRS. But this means “industry will need to follow regulatory updates closely, in particular any additions to the existing chemical inventory. Companies might also need to make adjustments to their strategy in China because the regulation will have a greater focus on substances with persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) properties,” he says. He advises companies to: O

fully understand their compliance obligations under MEP Order 7 and develop a compliance management plan; establish an internal chemical inventory or database and review the regulatory status of each substance; and introduce environmentally-friendly substances into China.

Global Service Providers Guide 2020

CBI protection The revisions to MEP Order 7 keep the existing five-year CBI protection period, but remove any provision for companies to extend it. When the protection period expires, the chemical will be added to the country’s existing chemicals inventory (IECSC) and it will no longer be subject to the regulation, but could be regulated under Erac, when adopted. Some companies have raised concerns that five years is too short a time period for protection, but others have different views, according to Mr Ju. “Some would like to extend the CBI protection period so they can keep their trade secrets. Others would like to make it shorter so they can easily use others’ notifications of substances to manufacture or import them.” Mr Zhou adds that the authorities are looking to “reduce industry burden … because after it is listed on the existing inventory, then MEP Order 7 is no longer required.” “We see similar time limits for CBI protection in South Korea and Taiwan,” Ms Hsu adds. “In Taiwan, the limit is also five years, but it is possible to extend to 15 years for new chemicals and ten years for existing chemicals. In South Korea, it’s possible to extend to 15 years for both. We think if there’s no possibility to extend the CBI protection then industry may find this tricky.”

Letter of commitment In an industry first, the proposed changes would introduce a requirement for companies registering any new substance in China to supply a letter of commitment accepting their legal liability in the event of the chemical causing any damage to the environment or human health. The letter will confirm the authenticity, accuracy and legitimacy of the notification document, says Mr Zhou, and “must be signed by a legal representative of the notifying company.” Mr Ju adds that “this is a new requirement and the draft does not specify a time limit for the liability. The detailed process is still not clear.” But Exponent’s Ms Xu says “the liability will last forever. So if a company’s chemical causes great damage, the company may also be rejected from registering.” “The letter of commitment is something that has been of concern to a lot of people. We have not seen this in other Asian regulations such as those in South Korea or Taiwan,” Ms Hsu says.

Implementation timeline Last month, the government formally approved the revisions to MEP Order 7, but it has still not indicated a timeline for when they will come into force. Mr Zhou and Ms Xu, however, agree that it will be finalised this year. Mr Ju adds that the authorities are looking to get the regulation into force as soon as possible, but the process was delayed while China allowed companies to nominate 1,560 substances to the existing inventory before the new requirements come in fully. Furthermore, the coronavirus outbreak has interrupted progress and Ms Hsu says that, because of this, “the final approval might take a bit longer than the authorities had originally planned because their resources might not be fully focused on it at this time.”

Profile: Acta

GLOBAL OFFICES UK: 26 Cross Street, Manchester, M2 7AQ, UK Tel: +44 (0) 330 223 0610 EU: Place du Luxembourg 2, 1050 Brussels, Belgium China: 1009 Tongguang Tower, No 12 Nongzhanguan Nanli, Beijing, China 100125, Tel: +86 108 453 4538 Acta has affiliates in Shanghai, Nanjing, and Xi’an, China; Seoul, South Korea; Istanbul, Turkey; and Eurasia.

CONTACTS 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

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

SERVICES PROVIDED

OVERVIEW The Acta Group (Acta®) is a leading international consulting firm focusing on chemical product approval, compliance support, business strategy development and implementation, and regulatory defence, providing a full-range of support for the processes of developing, commercialising, and sustaining industrial and specialty chemicals, biocides, cosmetics, metals, food contact chemicals, products of biotechnology, and nanotechnology. Acta professionals are scientists, lawyers, and business and regulatory consultants. This combination and our wealth of experience in and out of laboratories, global chemical companies, and government agencies make 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), the Eurasian Economic Union (EAEU), South and Central America, Asia, the Middle East, and the Pacific Rim. VITAL STATISTICS

2018/19

No of offices

No of countries represented

>25

Staff, group

35+

Staff, chemical service provision

35+

SERVICE AREA BREAKDOWN

Information 10%

Training 5%

Legal 10%

Representation & management 30%

Global Service Providers Guide 2020

Consultancy/advisory 45%

General consulting services We counsel global business entities, trade associations, and industry associations. Our fundamental goals are to solve our clients’ existing problems and minimise future difficulties to assist them in achieving their regulatory and business goals. We take a multi-disciplinary approach in assisting our clients. Attention must be paid to various regulatory and scientific nuances and the interplay of all branches of government and interest groups. Our extensive national, regional, and international expertise on chemicals policy and regulatory matters, combined with our global partnerships, positions us perfectly to manage strategically worldwide needs of our clients and industry with expert judgment, creativity, and efficiency. Acta’s general consulting services cover virtually all jurisdictions and types of chemicals. We offer unparalleled technical, regulatory, scientific, and legal support under a wide range of global chemical programs, including the US Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the EU’s Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation and Biocidal Products Regulation (BPR), South Korean REACH (K-REACH), Turkey REACH (KKDIK), and Eurasia REACH. Our general consulting services cover a wide array of activities to support our clients, including regulatory interpretation, strategic support, and persuasive advocacy for wide-ranging issues. Global product registration and agent services (representative services) Acta offers a range of “hands-on” practical compliance services, with Acta (alone or in concert with trusted global partners) serving as an agent or representative under the relevant regulatory framework. These services include chemical product notification, registration, and technical defence under global chemical programmes, including EU REACH, EU BPR, the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), TSCA, FIFRA, K-REACH, KKDIK, China REACH, and Eurasia REACH. Acta is a global market leader in providing expert, seamless Only Representative (OR) services under EU REACH and similar global programmes. Acta remains heavily engaged in managing post-2018 EU REACH compliance (e.g., dossier evaluation, new registrations) and providing OR services under K-REACH and KKDIK. Acta’s “boots on the ground” in Manchester, UK, are valuable assets to our clients. We are optimally positioned to provide expert representative services, from “day one,” under post-Brexit chemical laws in the UK, including UK REACH. Our clients benefit from our strategic planning, presence in various locations, and assurances of uninterrupted compliance in the UK, Europe, and beyond. Acta’s expert knowledge of KKDIK, the Turkish Classification, Labelling, and Packaging (CLP) Regulation, and the Turkish Safety Data Sheet (SDS) Regulation, coupled with our strong ties to a trusted business partner and OR in Turkey, allows Acta to assist the global chemicals industry in managing suitably compliance under the important KKDIK pre-registration and registration deadlines. Similarly, Acta clients seeking South Korean regulatory support benefit from our in-depth knowledge and ability to provide superior representative services. Acta focuses 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, EU, UK, Switzerland, Turkey, EAEU, Australia and New Zealand, Malaysia, China, Japan, South Korea, Taiwan, Philippines, Singapore, and Indonesia.

Data compensation and competition support services Acta is engaged extensively in worldwide data compensation matters under a wide range of chemical regulatory frameworks, including EU REACH and Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS). Acta’s regulatory and legal personnel understand deeply applicable rules and guidelines, and support clients in managing data sharing, maintaining compliance, and optimizing data compensation. Our activities include developing letter of access costs, managing cost negotiations, and supporting clients in resolving disputes. Many clients are evaluating and pursuing competition-related issues and Acta is well-positioned to assist companies in understanding applicable rules and achieving fair and favourable outcomes. We are actively involved in attempts to resolve competition-related disputes under EU REACH. While amicable resolution is typically beneficial, it is not always possible. Acta provides strategic and practical support for competitionand data-related mediation, arbitration, and litigation. We are the industry experts in managing challenging and contentious data compensation- and competition-related matters, and are heavily engaged in these practice areas. Technical document preparation activities – hazard, exposure, and risk assessment We undertake the appropriate analysis, document preparation, and coordination to support registration and post-registration activities under global chemical regulatory regimes (i.e. chemical substance dossier preparation, exposure assessments, hazard assessments, specific effect assessments). GHS, CLP services Acta offers comprehensive global services, including substance classification-related support, SDS preparation/review, label formulation/ review, and guidance on strategic approaches to GHS adaptations. Tailored training programmes are also available.

CASE STUDY 2: Lead Registrant Support Acta serves as Lead Registrant under EU REACH for an important substance globally, as OR on behalf of a non-EU manufacturer. The joint registration for the substance has multiple co-registrants and numerous issues, including a Lead Registrant dispute, challenging data compensation matters, confidential business information issues, Lead Member collaboration, and substance evaluation. Acta continues to manage successfully the registration for the substance, engaging in various important activities, including strategic planning, advocacy, legal review and negotiation, engagement of external service providers, cost reconciliation, downstream user support, and coordination for substance evaluation. Acta’s clients benefit from our efforts and are able to sell their products uninterruptedly across Europe. STAFF SELECTION Lynn L Bergeson – President Ms Bergeson assists companies and a wide range of trade groups and ad hoc consortia on chemical-specific legislative, scientific, 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. Jane S Vergnes, PhD, DABT –Vice President, Scientific Affairs, Director of Toxicology 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, BPR, FIFRA, and TSCA, including study design, laboratory practices, and data requirements for new chemical introductions.

Regulatory Training The TSCA Tutor™ training platform provides live in-person training at a company’s site, live webinar training, and on-demand online training modules -- all designed to offer expert, efficient, and essential TSCA training. Companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs. Visit our TSCA Tutor web page, www.TSCAtutor.com, for more information.

Karin F Baron, MSPH – Senior Regulatory Consultant Ms Baron has significant experience leading hazard communication, industrial hygiene, and environmental health and safety (EHS) programmes for multi-national chemical companies. Her primary areas of practice include hazard and risk assessment and communication, industrial hygiene and EHS programmes, US Food and Drug Administration (FDA) regulations pertaining to food contact materials, GHS and SDS, and the transport of dangerous goods. She is certified by the Dangerous Goods Advisory Council.

PARTNERS

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 significant 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 tests ensuring Good Laboratory Practices (GLP) at laboratories in the US, EU, and China.

B&C Consortia Management, LLC Bergeson & Campbell, PC ®

CLIENTS Acta’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: Chemical Registration and Regulatory Support Acta assists clients across a wide range of industry sectors with preregistrations, new and existing substance notifications, and registrations in South Korea, China, and Taiwan. Expert resources develop registration and notification strategies for businesses seeking to launch new products or to expand into new regions. Acta support services include robust study summary review and preparation, guidance on testing for data requirements, and OR, Third Party Representative, or agent appointment. Acta advocates, on behalf of its clients, with regulatory bodies against unnecessary, and often costly, animal testing. Acta closely monitors the region for changes, and is equipped to support clients with complex regulatory challenges in a dynamic and ever-changing regulatory environment.

Emma Louise Jackson, CBIOL, MSB – Regulatory Consultant 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 EU laws related to Acta’s practice areas, and he deploys this knowledge to assist Acta clients in achieving and maintaining compliance across multiple regulatory frameworks. A native English/Urdu bilingual, Mr Qureshi is also conversant in Hindi. James E Greenhalgh, MCHEM – Regulatory Assistant Mr Greenhalgh assists 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 GLP. www.chemicalwatch.com/SPG

Profile: Acta

Profile: Apeiron-Team NV

SERVICES PROVIDED Regulatory services We assist in the interpretation of legal texts: REACH, REACH-like legislations including UK, CLP, Biocidal Product Regulation (BPR), EU and national nano legislations, food contact, RoHS, waste legislation, developments in circular economy.

CONTACTS Website

www.apeiron-team.eu

E-mail

info@apeiron-team.eu

Head office

Berten Pilstraat 4, 2640 Mortsel, Belgium

Tel/Fax

+32 3 808 20 67

Contact

Elke Van Asbroeck

Directors

Elke Van Asbroeck, Hiram Moerman, Tine Vandenbrouck

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 toxicologists, chemists 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

2018/19

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% Information 10%

Global Service Providers Guide 2020

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 assist clients in the development of chemicals management systems and product stewardship programmes. Examples of our services: O portfolio management of REACH registrations: fully outsourced management of the REACH registrations including updates and tracking of regulatory position of the registered chemicals. O several audit programmes (eg compliance; system; supply chain; project; due diligence and SCC audit); O set up of monitoring programmes (occupational hygiene); O advice on import/export strategy to ensure business continuity; O position papers and communication with authorities; O scientific advocacy in the pre-authorisation process; O development of Regulatory and Risk Management Options Analysis for individual companies or associations O strategy for comments during evaluation and/or during preauthorisation process; O strategy deployment for authorisation dossiers; and O 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 workshops on REACH (pre)-authorisation, courses on eSDS compliance, understanding REACH and its business impacts, Iuclid for REACH and for biocides, PNECs and DNELs, SVHC in articles, etc.

Other 5%

Representation & management 10%

Scientific services A selection of our services: O REACH registration dossiers from A to Z: Generation and maintenance of registration dossiers including substance ID, hazard assessment, study monitoring, exposure and risk assessment, PBT assessments, dossier updates and follow-up; O REACH authorisation dossiers: strategy development, chemical safety assessment, analysis of alternatives, socio-economic analysis, supply chain communication; O other REACH related topics: support during evaluation, support during BoA, RMOA generation, DU-CSR generation, Annex XV dossier generation, representation of clients in consortia, training on all aspects of REACH; and O 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,â&#x20AC;Ś

Consultancy/advisory 65%

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2009

Apeiron-Team NV was founded

2010

Gradual development of all REACH related aspects from registration to authorisation. Resulting in > 100 registration dossiers and the first authorisation applications.

2013

Addition of biocides related services to our portfolio.

2014

Development of a standard approach for application for authorisation used in several Chromates, TCE and other application dossiers. Submission of various Union authorisations under the BPR. Successful conclusion of a BoA case on additional Persistence testing; Development of an in-house RMOA methodology Successful submission of > 150 registration dossiers for the 2018 deadline.

2018

Development of regulatory support for circular economy based business models.

2019

10 years of Apeiron-Team Managing outsourced REACH registrations for over 400 substances. Development of > 5 authorisation dossiers.

ACCREDITATIONS O O O

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

PARTNERS Burgess Regulatory Services Ltd, eftec, Jongerius Consult; Vander Straeten Consulting Services

CASE STUDY 2: Overcoming regulatory hurdles in circular economy Several companies approached Apeiron regarding the regulatory hurdles to implement circular economy-based business models. While safeguarding the principles of safe chemicals management, strategies are developed to comply in a cost effective way with the chemical regulations. 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. 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.

CLIENTS Our references are situated in several industries and cover the entire supply chain from manufacturing to recycling: O 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 process of authorisation 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 proactive 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 Apeiron has developed a standardized approach to develop authorisation applications. This approach covers single and multiple sites cases and has been used in several successful applications. The approach is structured and strongly project driven allowing a cost and time efficient development of applications. The expectations towards the applicants are clear and agreed in function of resource availability of the applicant. In collaboration with the applicant, the strategy for the application is developed at the start of the project. Guidance is provided to the applicant on the required data including exposure / emission monitoring and socio-economic data. Alternatives are scrutinized and development plans are thoroughly justified on timing and relevance. The application dossiers are subject to a specific QC in order to assure a consistent, complete and transparent application file allowing a correct opinion and decision making by the authorities. In all cases, this has resulted in a granted authorisation period equal to the requested period.

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 and a draft risk assessment covering the complete BPF was generated. Apeiron actively took part in the discussion with authorities and working group meetings at ECHA. The final commission decision is expected in the coming months. STAFF SELECTION Elke Van Asbroeck – ir (Bio-)chemical engineer Polymer chemistry/ waste and recycle O Cost-efficient regulation implementation, import/export strategy O Authorisation process, generation of authorisation dossiers O Advocacy O Circular economy O

Hiram Moerman – ir Chemical engineer O Specialised in process chemistry O Product stewardship/GPS O Authorisation process, generation of authorisation dossiers O RMOa generation O Auditing Dr Katrien Monsieurs – PhD Organic Chemistry O Specialised in organic synthesis O REACH dossiers: registration and authorisation O Substance identification & human toxicology O Read-across O PBT assessments Dr Tine Vandenbrouck – PhD Ecotoxicology O Specialised in mixture effects O REACH dossiers: registration and authorisation O Biocidal product dossiers O Senior exposure assessor O ERT certified toxicologist 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. Our practice focuses on the following services:

CONTACTS

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

Website

www.arcadis.com

E-mail

PSSinfo@arcadis.com

Head office

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

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

Ownership

Public company

Locations

350+

Founded

1888

World-wide regulatory surveillance Includes continuous regulatory monitoring for emerging and existing chemical (eg REACH, GHS) and product regulations (eg WEEE, RoHS, MDR, batteries, waste), and impact assessments for individual products, product lines and portfolios. Data management for product compliance 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. Scientific and regulatory compliance support Includes risk assessment and dossier preparation for registration (incl. nanomaterials) and authorisation under REACH and REACH-like regulations (TSCA); country-specific chemical licensing/ permitting; classification, labelling, and packaging for GHS and national variants; hazard communication, biocides authorisation, plant protection product authorisation (US FIFRA, (EC) 1107/2009), EU Medical Device Regulation, RoHS, and, California Proposition 65 assistance.

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

2018/19

Turnover, group

â&#x201A;Ź3.3bn

Turnover, chemical service provision No of offices

â&#x201A;Ź11m

Consortium management Includes financial management, third party communication and representation (SIEFs, MS CA, Echa), role as Trustee, as well as technical consultant for dossier preparation (eg, product family, union vs. national authorisation, testing strategy, read-across justification, etc). 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. Laboratory services Includes in-house aquatic ecotoxicology, biodegradation, and physicochemical testing according to international guidelines (OECD, OCSPP, JMAFF) in compliance with GLP.

350

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

70 27,000+

1888

Parent company, Heidemij, formed in the Netherlands

70+

1998

Global company becomes Arcadis

2002

Establishment of a product stewardship Centre of Excellence (CoE) in North America

2006

Arcadis Belgium becomes a product stewardship CoE

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

2017

Arcadis acquires E2 ManageTech, the preeminent enterprise technology solutions firm providing IT and business services for the EHS information market in the USA

SERVICE AREA BREAKDOWN

IT & software 10%

Training 5%

Laboratory 11% Information 4% Representation & management 15%

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Consultancy/advisory 55%

ACCREDITATIONS 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.

Global Service Providers Guide 2020

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: Applications for authorisation under REACH Arcadis has assisted several companies in the pharmaceutical sector to compile applications for authorisation. Several dossiers for 1-3 uses and 1-2 substances were submitted. Support included scoping of uses, comprehensive data gathering within the companies and in-house preparation of the Analysis of Alternatives, Socio- Economic Analysis and the Chemical Safety Report. Arcadis further provided support in the identification of exemptions and overall strategy development including strategy regarding joint or separate submissions. Arcadis is also supporting in answering questions from the committees and in communication with Echa. CASE STUDY 2: Authorisation dossier for a biocidal product for the treatment of articles Arcadis has supported the preparation of an application for authorisation of a biocidal product for the treatment of articles under PT2. The support included developing a testing strategy for leaching and efficacy, human health and environmental risk assessment as well as definition of claims for the treated articles. Support also includes all communication with the competent authorities as well as adaptation of the dossier. CASE STUDY 3: CA Proposition 65 consulting and compliance support Arcadis assisted a security products company in evaluating the compliance of their products with California’s Proposition 65 (Prop 65) requirements. Support included reviewing their portfolio of products, identifying product categories based on composition and toxicologicalconsiderations, developing an analytical test plan for high-priority products, coordinating analytical testing, developing exposure estimates, and comparing exposure estimates to Safe Harbor Levels (SHLs). Arcadis also develops provisional SHLs for substances that have not been assigned a SHL by California regulatory authorities and tracks Prop 65 trends, such as those related to bisphenol A (BPA), phthalates, lead, and per- and polyalkyl substances (eg, PFOAs, PFOSs).

identified across 24 data sources. At a small number of locations, lowlevel groundwater detections of the PPP were observed. At each of these locations (approximately 100 sites located on Belgium, Czech Republic, France, Slovakia, Slovenia, and Portugal) field surveys were conducted as part of positive environmental stewardship efforts being undertaken by the client. The objective of the surveys was to better understand the agricultural setting and environmental factors that might have contributed to the groundwater detections observed. Surveys across all countries were conducted using an Arcadis developed mobile application that captured all pertinent data. STAFF SELECTION Norm Forsberg, PhD – Toxicology and product stewardship Norm has 11 years of experience as a toxicologist and risk assessor. He has designed and performed toxicology-based projects for a wide range of industrial clients and provided technical review for projects in which the critical evaluation of toxicological data is key. He routinely applies toxicological and risk assessment principles to support clients facing challenges related to compliance with California’s Proposition 65, REACH, and TSCA. Andy Newcombe – Agrochemical product stewardship Andy has more than 29 years of international experience in the field of agrochemical research and the fate of agrochemicals in the environment. He has vast experience in the management and oversight of numerous contract laboratory facilities, analytical data evaluation, project direction, technical report preparation, cost control, and subcontractor management. His background includes successful negotiation with European and North American regulators on the design and interpretation of higher-tier environmental safety studies for plant protection products. He also represents agrochemical industry clients on environmental safety issues associated with their products. Anja Liedtke, PhD – Ecotoxicological testing Anja heads the ecotoxicology laboratory at Arcadis Switzerland. She has 11 years of experience in conducting GLP studies for clients from the pharma, agrochemical, chemical and cosmetic industries. She specializes in tailor-made study designs based on the product properties to meeting her clients’ needs. Special emphasis is given to animal welfare, 3R strategies, and alternatives to animal experiments.

CASE STUDY 4: Product stewardship organizational redesign and supporting tool selection

Ortwin Meeuws, MSc – Chemistry and product stewardship Ortwin has more than 20 years of experience in implementing, monitoring and negotiating international technical regulations. His key profession areas include product, waste and chemical regulations. Having previously worked for the Flemish Government as well as for industry, he is uniquely positioned to fully understand the impact of complex regulations on all actors in the regulatory process.

Arcadis supported a medical device company after divestiture to design the strategy and approach for a future-proof and proactive product stewardship organization with efficient processes and reliable tools to enable market access. We prepared a detailed business plan, reviewed existing processes, identified potential weaknesses, and supported the selection of software solutions for regulatory tracking and restricted substances management.

Karina Urmann, PhD – Chemical regulatory affairs expert Karina heads the Product Stewardship Solutions department at Arcadis Switzerland. She has 12 years of regulatory and product stewardship experience with chemical and pharmaceutical companies. She specialises in European legislations such as REACH, CLP and BPR and the corresponding Swiss legislation supporting clients with compliance internally and for their products.

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 monitoring data was conducted for the PPP across 17 European countries. The data search was conducted by performing online database searches and contacting regulatory agencies, authorities, and organisations that may collect these data. The data collected were cleaned, duplications removed, processed, and compiled into a single data structure to facilitate detailed statistical analysis. More than 280,000 individual analytical results for the PPP were

Tina Armstrong, Ph.D., Product stewardship & regulatory affairs Tina has 20 years of regulatory and product stewardship experience with multinational automotive, chemicals, and consumer goods companies. She specializes in product stewardship programmatic gap assessments, merger integrations, and the build-out of product stewardship programs and processes for clients. Tina also supports product compliance under a wide variety of North American federal and state regulations including US TSCA, California Proposition 65, CPSA, CPSIA, PPPA, CCCR, FHSA, and OSHA’s Hazard Communication Standard, and is well versed in APAC chemical regulations.

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Profile: Arcadis

Profile: Arcerion GmbH

arcerion

SERVICE AREA BREAKDOWN Training IT & software 5% 5%

REACH | CLP | Seveso | Biocides

Laboratory 10%

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

Information 10%

Consultancy/advisory 40%

Representation & management 30%

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

OVERVIEW 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. VITAL STATISTICS

2018/19

Turnover, group

Turnover, chemical service provision

No of offices No of countries represented

3 Global

Staff, group

Staff, chemical service provision

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

Global Service Providers Guide 2020

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

2014

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

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 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. PARTNERS 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. 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 publicly. 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 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.. STAFF SELECTION 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. Dr Florian Wrage – Director Florian holds a degree in environmental technology. His area of expertise includes 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 includes 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 Authorisation/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

2018/19

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

IT & software 5%

Training 5%

Representation & management 15%

Global Service Providers Guide 2020

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.

20132020

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

ACCREDITATIONS Consultancy/advisory 75%

Certified Material Health Assessor (Cradle to Cradle)

PARTNERS PietConsulting ECTX-Consulting ROSC Toxicological Consulting REACHlaw Vander Straeten Consulting Services ERMC (Dr Mike Holland) EBRC Consulting CLIENTS Industrial clients and consortia related to the following chemical substances: O metals including: Cu, Ni, Mo, Pb, Zn, Hg, V, Co, Fe, Se, Sb, Sr, Mg, Bi, Te, Ti, etc; O organic compounds: chlorinated flame retardants, organic acids, plasticisers, amines, , plant protection products; O complex materials: Cu slags, Ti slags; O other inorganic substances: Ca, B, NaOH, KOH, sulphur dioxiderelated substances (SO2, sulphites, thiosulphates, dithionites), lime, nitric acid, phosphoric acid; and O several biocide consortia such as Sodium chloride (Active chlorine generated from NaCl by electrolysis) consortium, Permethrin and in situ peracetic acid consortium. 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 availa-ble, 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, Ter-peneTech Ltd. “IMOA has worked for the last decade with the environ-mental scientists working at ARCHEConsulting, and they have proved for IMOA/MoCon to be a very wise invest-ment. We can therefore highly recommend ARCHE with regard to their technical expertise and knowledge on envi-ronmental 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 con-sultancy 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 Regula-tions (BPD/BPR) and we can only recommend to others the training we received on several aspects of risk assess-ments (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 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. STAFF SELECTION 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). 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 Vanden Bosch – Expert Science Manager An Vanden Bosch graduated in 2004 as Master in Bio-Engineering, with a specialization in gene biotechnology, at the Catholic University of Leuven. She obtained her PhD in Medical Sciences in 2009. From 2010 till 2013, she worked as a Registration Specialist in industry, responsible for the development and registration of plant protection products. In 2014, she started working as consultant for ARCHE Consulting. At that time, she also obtained a certification as European Registered Toxicologist (ERT). Her expertise is situated in the broad field of plant protection products and biocides. Within these fields, she mainly deals with environmental exposure assessments and ecotoxico-logical risk assessments, as well as general regulatory matters.

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Profile: ARCHE Consulting

Profile: Artemisa

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

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

Directors

Ms Bojana Zgonec

Ownership

Private company

Locations

Slovenia, Slovakia, Poland

Founded

2018

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

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Information Representation & 2% Training 2% management 1%

Consultancy/advisory 95%

Biocide products regulatory services in Eastern EU and beyond We offer the following services: O preparation and submission of applications following EU transitional measures or BPR rules in local language and according to national requirements; O IUCLID dossier preparation; O SPC translation services into multiple languages; O R4BP submissions and project management; O post submission work/ product stewardship; O facilitation of communication with local authorities in local language; O strategic advice taking national specific rules into consideration; and O project management in cases of multiple submissions into multiple countries. Medical devices We offer the following services: O understanding the data requirements and procedures to be followed in order to place medical devices on the markets; O take different national requirements into consideration in cases where relevant; O help you solve borderline cases in case of any doubts; and O facilitate communications with the authorities in the pre- and post- submission phase. Poison centre notifications We offer the following services: O consultancy based on the most current information available; O compliance with national requirements where applicable; O facilitation of communication in national language; and O preparation and submission of a Poison Center Notification (PCN) dossier via European Chemicals Agency (ECHA) portal. Detergents O identification of the status of your detergents and surfactants in the light of the EU legislative framework and your obligations resulting from it; O preparation, translation/adaptation or review of the labelling for your detergents to be compliant with the national requirements and EU rules; and O representation of your company in national associations, serving as a liaison between your company and the local community. SDS services O SDS adaptation to specific national requirements and in the national language for a specific country; O 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 O SDS extension to Extended Data Sheets (eSDS) to comply with your substance Chemical Safety report (CSR).

Global Service Providers Guide 2020

Translation and Proofreading Support O Translations of technical texts from the following expert areas: Agriculture, Chemistry, Regulatory, Security in the workplace, Business, Environmental, Healthcare; and O proofreading of general and technical texts, labels, MSDS-es, SPC and PAR documents. Business Seminars O Training in regulatory matters; O internal trainings upon request. Strategic Advice O Preliminary assessment of your portfolio or individual products taking the EU status of your substance as well as data protection rules into consideration; O study Generation support by commissioning and supervising generation of studies; and O 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

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 helps 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 also takes 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

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 ten 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.

With experience and large network of local partners we were able to minimize the extent of data and documentation (including local testing) for the client. With that we have confirmed our knowhow and ability to optimize 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. 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 six 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.

www.chemicalwatch.com/SPG

Profile: Artemisa

Profile: Assent Compliance

74 Staff, chemical service provision

As a privately held company, Assent does not report on this.

SERVICE AREA BREAKDOWN

CONTACTS

Training 7%

Website

https://www.assentcompliance.com/

E-mail

info@assentcompliance.com

Head office

525 Coventry Road Ottawa, ON, K1K 2C5 Canada

IT & software 35%

Tel

1 866 964 6931

Contact

info@assentcompliance.com

Directors

Andrew Waitman, Chief Executive Officer Russell Frederick, Chief Financial Officer Dave Curley, Chief Revenue Officer Matt Whitteker, Vice President, Growth Patrick Ryan, Vice President, Sales Jean-François Pouliotte, Vice President, Customer Success James Calder, Vice President, Compliance & Regulatory Programs Marc Harrison, Vice President, Corporate Development Travis Miller, General Counsel & Director of Assent Compliance USA Ltd Keira Torkko, Vice President, Employee Experience Jonathan Hughes, Director, Strategic Relationships

Ownership

Privately Held

Locations

Ottawa, Canada; Ohio, USA; Amsterdam, Netherlands; Penang, Malaysia; Eldoret, Kenya

Founded

2010

Other Consultancy/advisory 1% 15%

Representation & management 32%

Information 10%

GLOBAL OFFICES Ottawa, Canada; Ohio, USA; Amsterdam, Netherlands; Penang, Malaysia; Eldoret, Kenya SERVICES PROVIDED Regulatory Assessment Services The Assent Compliance Regulatory team provides insight into clients’ product compliance, vendor management and corporate social responsibility requirements and how to meet them. Compliance Planning & Corporate Policy Assent’s team of experts supports clients’ compliance program planning and execution to meet best practices and legal requirements. Supply Chain Data Collection The Assent Compliance Platform automates data collection, validation and analysis while providing support and education for suppliers. Data Quality Assessment Assent supports both automated and manual review of data submissions for quality and accuracy.

OVERVIEW Assent Compliance is the global leader in supply chain data management. Combining leading-edge technologies with extensive supply chain expertise, Assent provides cloud-based SaaS solutions that identify and assess third-party risks, educate stakeholders on regulatory and data program requirements, and increase transparency between businesses. The Assent Compliance Platform is a centralized third-party risk assessment platform that leverages automated supplier engagement and logic-driven data validation to provide actionable analytics on information related to product compliance, corporate social responsibility and vendor management. Assent supports product compliance regulations that include, but are not limited to, the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH); the EU Restriction of Hazardous Substances (RoHS); the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65); and the EU Waste Framework Directive (WFD).

Compliance Reporting Using our supply chain data management software, Assent’s team assists in the completion of reports necessary for compliance and support responses to customer data requests.

VITAL STATISTICS

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2010

Assent Compliance was incorporated in 2010.

2014

Andrew Waitman joined as CEO with the goal of rapidly accelerating the company’s growth.

2016

Assent closed its Series A financing round for $20 million CAD.

2017

Assent’s U.S. office relocated from New York to Columbus, Ohio.

2017

Assent closed its Series B round for $40 million CAD.

2018/19

2018

Turnover, group

As a privately held company, Assent does not report on this.

Assent closed its Series C funding round for more than $100 million USD with Warburg Pincus.

2019

Turnover, chemical service provision

As a privately held company, Assent does not report on this.

Assent opened two new offices: one in Amsterdam, Netherlands, and a second in Penang, Malaysia.

2019, Narwhal List

Assent was highlighted as a young Canadian company with the potential to become a “unicorn” — valued at $1 billion or more.

No of offices

No of countries represented

Staff, group Global Service Providers Guide 2020

600

2019, Deloitte Win

Assent was recognized on both the Technology Fast 500™ and the Canada Technology Fast 50™ for the company’s remarkable growth over the previous four years.

2020, Narwhal List

Assent was highlighted as a young Canadian company with the potential to become a “unicorn” — valued at $1 billion or more.

PARTNERS PTC, Lorax Compliance, riskmethods, ECD Compliance and BlueCircle Advisors. CLIENTS Assent has over 500 clients in industries such as aerospace and defense, automotive and manufacturing, and include a number of Fortune 500 businesses. Clients include ASM International, Ashcroft Inc., ESCATEC Sdn. Bhd., DMI Companies Inc., Terumo Medical, Kaba Ilco Corp., Plexus Corp., Woodward Inc. and GE Appliances. TESTIMONIALS “Collaborating with Assent has been of great value for us. Their continued dedication to customer education and relevant online content keeps us informed about the latest news affecting the sector, and now, in most cases, I know about my customers’ upcoming compliance needs before they do.” Benjamin Khor, Corporate Regulatory Compliance Manager, ESCATEC CASE STUDY 1: Woodward Inc. A designer, manufacturer and service provider of control solutions used in aerospace and industrial markets. O Annual revenue of over $2 billion USD. O Offices/facilities in 17 countries and more than 9,000 employees. O With Assent, can handle 10 times the number of compliance inquiries with a similar amount of staff (went from managing 60 products to 860+ and 28,000 parts). CASE STUDY 2: GE Appliances A designer and manufacturer of household appliances. O Approximately $7 billion USD in annual revenue and 12,000 employees. O In the year following deployment, saved over $300,000 USD, engaged 350 suppliers and saved 1,000 working hours. CASE STUDY 3: Plexus Corp. An electronics manufacturer that builds final assemblies. O Over 19,000 employees, 4,295 suppliers and 216,181 parts. O More than 4,295 suppliers supported and surveyed, and all supply chain data centralized on one platform. STAFF SELECTION James Calder Vice President, Compliance & Regulatory Programs James contributes to data management, verification, assessment, supply chain training/engagement, mitigation and due diligence strategy at Assent Compliance. With more than 12 years of compliance experience, he leads Assent’s team of regulatory and compliance experts, advising on areas such as materials and substance management, responsible sourcing and corporate social responsibility. James has previously worked with companies such as Nortel, Rakuten Kobo and Intertek. In addition, he has authored many publications, and is a member of several industry groups, including the IEC TC111 Group Mirror Committee, IPC-175X, IAEG, SCCE and AIAG.

Raj Takhar Subject Matter Expert, Materials Management & Chemical Reporting Raj helps companies meet their product compliance challenges in an ever-changing regulatory landscape. He specializes in product compliance, chemical reporting and program implementation in Europe. Raj spent 20 years working in product compliance and systems development with Rolls-Royce and Hewlett Packard. He is currently researching the impact of evolving chemical regulations on the aerospace and defense industry. Valerie Kuntz Subject Matter Expert, Materials Management Valerie specializes in RoHS and REACH implementation processes at large companies, and in extended producer responsibility and conflict minerals processes. She is committed to developing and improving declaration standards, and led the working group for the International Aerospace Environmental Group’s Declarable Substances List pilot project. Before joining Assent, Valerie spent 20 years at Intel, starting in materials and eventually becoming the program manager in charge of its global materials compliance program. Bruce Jarnot Senior Manager, Product Compliance Bruce is a board-certified toxicologist with a background in global product compliance regulations, materials management, and environmental health and safety. Over his 30 years in global product compliance, food and beverage regulations, U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) standards, and other health and safety standards, Bruce has promoted product safety and compliance through his work with large organizations, including Whirlpool, Exxon Mobil, the American Petroleum Institute and the U.S. Air Force. Steven Andrews Subject Matter Expert, Environmental Stewardship & Policy Steven Andrews helps companies understand environmental regulations and how they are enforced. He is an internationally recognized expert, with more than 17 years of experience in EU policy development focusing on sustainability, product, waste and recycling legislation. As the former Deputy Head of the Resources & Waste Division at the UK Department for Environment, Food & Rural Affairs, he led teams responsible for developing and enforcing policy around the RoHS and Waste Electrical and Electronic Equipment (WEEE) directives, as well as broader environmental legislation. Neil Smith Manager, Compliance & Regulatory Programs Neil helps companies manage their product compliance and sustainability programs with a focus on environmental health and safety (EHS). He is an energetic, effective communicator who thrives on collaborating with companies to solve their challenges. Before joining Assent, Neil was the Global Product Compliance and Sustainability Manager with Isola Group, running its EHS program, and leading worldwide regulatory and customer-driven compliance programs. Travis Miller General Counsel & Director of Assent Compliance USA Ltd. Travis is an international trade and compliance attorney who specializes in ITAR/EAR/sanctions, global anti-corruption and anti-slavery, codes of conduct, environmental health and safety, product stewardship and corporate social responsibility. Travis manages Assent’s worldwide legal activities, advises the Board of Directors on legal matters, and oversees corporate compliance, governance initiatives and other commercial transactions. Before coming to Assent, he served in various high-level counsel positions with companies such as Microchip Technology, Foresite Group and St. Jude Medical (Abbott).

www.chemicalwatch.com/SPG

Profile: Assent Compliance

Profile: bibra toxicology advice & consulting

SERVICE AREA BREAKDOWN IT & software 1% Training Information 1% 3% Representation & management 10%

CONTACTS Website

www.bibra-information.co.uk

E-mail

info@bibra.co.uk

Head office

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

Tel

+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 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

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 exceptional 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) phase-in registration deadline, and continuing with dossier updates and responses to Echa Evaluation decisions. VITAL STATISTICS

2018/19

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 2020

Data searching, gap analysis and development of testing strategies We perform searches for data in line with the relevant regulatory requirements (eg 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. 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 cost effective 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

2005

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

2010

Relocated to new, larger offices in Wallington, Surrey

ACCREDITATIONS 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. PARTNERS Enviresearch Ltd Linmark Consulting Gmbh REACHWise TSG Consulting wca environment Ltd CLIENTS Our several hundred clients span across a variety of industries; a selection of which is listed: O O O O O O

REACH Biocides and Plant Protection Products Pharmaceuticals and Medical Devices E-cigarettes and other nicotine delivery systems Food and Food-contact materials Consumer Products (including cosmetics)

TESTIMONALS “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 scientific 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 ten 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 readacross 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.

CASE STUDY 2: Urgent request for help with chemical safety report 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. CASE STUDY 3: REACH Evaluation 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. We are currently involved in updating Iuclid dossiers to help clients upgrade their dossiers in line with Echa Evaluation decisions. STAFF SELECTION Richard Young – Managing Director and Principal Toxicologist Richard has been at Bibra for over 17 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 12 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 44 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 and 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 contributed to 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. www.chemicalwatch.com/SPG

Profile: bibra toxicology advice & consulting

Profile: BIG vzw

GLOBAL OFFICES Belgium CONTACTS SERVICES PROVIDED

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

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. OR-services BIG has expanded its OR-services for UK (post-Brexit), Turkey (KKDIK), China, Japan, South-Korea (K-REACH) and Taiwan. CLP Classification and labelling of substances and mixtures in compliance with Regulation (EU) No 1272/2008 and amendments (CLP). Performing Classification and Labelling Notifications and product registrations as stipulated in Art 45. Audits 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 scenarios.

OVERVIEW 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. VITAL STATISTICS

2018/19

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% Consultancy/advisory 40%

Information 30% Representation & management 10%

Global Service Providers Guide 2020

Screening and authoring of (e)SDS’es BIG provides a full service for authoring your (e)SDSs based on data evaluated by our experts and using an in-house developed SDS-system. We can also screen (e)SDSs coming from your suppliers on their accuracy. PCN BIG performs Poison Centre Notifications for mixtures that are classified for human health or physical hazards in Europe. BIG can assist companies to prepare their submission dossiers and submit them through the ECHA-submission portal. EMRES BIG is as emergency response centre 24/7 available to give adequate advice in case of incidents involving hazardous materials. Our commanders are trained to answer all calls in English, Dutch, French and German, other languages are available through a three-way-call (caller – BIG Commander – Interpreter). Time and accuracy are of essence when dealing with Hazmat incidents! Biocides BIG provides support and registration under the Biocidal Products Regulation, Regulation (EU) 528/2012 (BPR). Transport Shipping dangerous goods worldwide is not something to be taken lightly. Shippers, packers, loaders and transporters must stay current in transport regulations, which change at least every two years. The requirements regarding classification, packaging, marking, labelling and documentation can be very complex. BIG can help you ship your dangerous goods so that there are no delays or rejections at airports, customs or ports. 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 1979

BIG was founded as a cooperative project

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

1995

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

2003

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

2008

Offering REACH services as consultant and OR

2013

Submission of first REACH registration dossier as Lead Registrant

2019

BIG also offers OR–services for UK (post-Brexit), Turkey, China, Japan, South-Korea and Taiwan

2020

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

ACCREDITATIONS ISO 9001 : 2015 Quality Certificate 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.

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 ten 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. Frank Pelgroms, BSc – Sr consultant Frank obtained a degree as Professional Bachelor in Environmental Chemistry in 1995. He gained experience by working in different international chemical companies and joined BIG in 2007 as Dangerous Goods Safety Advisor (ADR/ADN/RID/IMDG/IATA). He now has more than 13 years of experience and is in charge of performing audits to evaluate legal compliance. He is also an excellent trainer with a feeling for the needs of the trainees. He provides training not only in transport of dangerous goods but also in CLP, REACH and SDS-authoring. He is currently obtaining an MSc in Safety Management while also training to become official Hazmat-advisor for the fire departments. Marleen Vermeulen, MSc – consultant Marleen graduated as a Master in Biology. She joined BIG in September 2013 after gathering over seven 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.

PARTNERS BIG has partners in different fields of expertise in order to offer the best possible solution for our 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. Ruth Stoffelen, PhD – regulatory affairs & quality manager Ruth obtained a PhD in Applied Biological Sciences and joined BIG in 2000. In 2004, she introduced the quality system ISO 9001 at BIG and since then she has been our Quality Manager. In her 20 years at BIG she has become an expert in regulatory affairs concerning dangerous goods in Europe and is specialised in CLP-labelling and Poison Centre Notifications.

www.chemicalwatch.com/SPG

Profile: BIG vzw

Profile: BioGenius GmbH

80 ®

SERVICES PROVIDED Analytical services and physico-chemical data The GLP laboratories of BioGenius are capable of providing tailor made analytical solutions for a variety of biocidal and plant protection products. With our extensive GLP-facilities BioGenius also provides flexible solutions for a broad range of physico-chemical test parameter: O analytical method development; O method validation (SANCO); O 5-Batch analysis for technical equivalence (e.g. Art. 95); O accelerated storage stability studies; O ambient storage stability studies; O application tests for solid, liquid and spray products; O safety data packages; O active ingredient residues; and O analysis of impurities and byproducts. Efficacy data for insecticides and repellents (PT 18 & PT 19) BioGenius is one of the leading European efficacy test institutes for biocidal insecticide and repellent applications. With our broad range of efficacy test protocols against crawling and flying insects, BioGenius fulfills all requirements of national and international product authorizations according to the BPR: O field tests; O laboratory tests; and O simulated use test (semi field). Data packages for different other approaches, such as: O dose response tests for actives; O screening tests for claim support; and O testing for product development. All required insect pest species are bred at BioGenius.

CONTACTS Website

www.biogenius.de

E-mail

info@biogenius.de

Head office

Technologie Park, Campus 1 Friedrich-Ebert-Straße 75 51429 Bergisch Gladbach Germany

Tel

+ 49 2204 83077 23

Fax

+ 49 2204 83077 11

Contact

Alexander Brux

Directors

Mike Bublitz

Ownership

Private company

Locations

Germany

Founded

2004

OVERVIEW Since 2005 BioGenus is supporting its customers with an in-deep competence in providing services and data packages for the international registration of biocides, plant protection products and several other product segments. With our team and with our state-of-the-art facility of analytical and efficacy test laboratories in Germany, BioGenius is a strong partner of the global chemical industry. For us, competence means recognising your needs as a customer and being aware of our own limits of performance. The competence of our employees is characterised above all by their motivation to identify themselves with your goals and to use their knowledge and skills to achieve them. At least we define competence as the creative combination of information and expertise in order to provide you as our customer with the best possible benefit to achieve your goals. VITAL STATISTICS

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Consultancy/advisory 10%

Laboratory 90%

Global Service Providers Guide 2020

Technical Consulting There are many guidelines and regulations which need to be followed during registration processes especially for biocides. However, these documents and the mentioned methods cannot be applied to each product and each application. Therefore, a practical and technical evaluation is always required and mandatory for the required technical data packages of efficacy, shelf life and physico-chemical data. In addition, tests may need to be adjusted for products which are not covered by the method descriptions. We as BioGenius define this kind of support as “Technical Consulting”. PARTNERS Our extensive network of partners consists of consultants, laboratories and authorities. This network enables us to fully support you in the implementation of your projects. Because where we cannot help, we have a reliable partner at hand. CLIENTS With more than 600 customers worldwide, we at BioGenius GmbH have an extensive spectrum of experience. Our range of activities extends from biocides to plant protection actives and products.

Profile: BioGenius GmbH

EFFICACY INSECTS

ANALYTICS

DEVELOPMENT

Your Competent Test Institute.

„We deﬁne competence as the creative combination of information and expertise in order to provide you as our customer with the best possible beneﬁt to achieve your goals”

Mike Bublitz - Managing Director

www.chemicalwatch.com/SPG

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

GLOBAL OFFICES

Directors

Damien Carson Tom Hargreaves

Edinburgh, Scotland, Cardiff, Wales, UK Chabrillan, France

Ownership

Private limited company

SERVICES PROVIDED

Locations

UK, France

Consultancy/advisory 80%

Scientific consultancy regulatory testing design and study monitoring; O intelligent testing strategies; O ecotoxicology and environmental fate; O environmental hazard and risk assessment; O toxicology; O human health hazard and risk assessment; and O compilation of dossiers and expert reports. O

Founded

2006

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 France, 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

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2020

Regulatory affairs O regulatory affairs for chemicals, human medicinal products, veterinary medicinal products, plant protection products and consumer products; O project management; O product defence; O consortium and task force management; and O only representation of non-EU chemical companies under REACH. Biocides (BPR) Blue Frog Scientific provides a comprehensive range of services to the EU biocides sector. O strategic planning; O execution of technical and regulatory strategies (e.g. data-gap analysis, study monitoring, pre-submission meetings); O development of the biocidal product family concept; O hazard and risk assessment for relevant Product Types; O technical Dossier compilation and Draft Assessment Report compilation; O project management; and O advocacy and product defence. Due to the ever-changing requirements under the BPR, and challenges being faced by both industry and regulatory authorities under the review programme, our Clients are turning to us as their partner of choice when it comes to technical challenges such as risk assessment, efficacy, endocrine disruption and disinfection by-products. We can also offer effective management of dossiers through the evaluation stage, and final processes through to approval, utilising our dossier managers to advocate for our Clients in front of Member States and Working Groups.

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: O monomers, process chemicals, coatings and catalysts; O oilfield chemicals and petroleum products; O fragrances and flavourings; O pharmaceutical intermediates; O substances of unknown or variable composition, complex reaction products or biological origin (UVCB); and O 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. O Our services include: O provision of a consortium bank account; O accounts payable and accounts receivable; O VAT and tax accounting; O purchase contract management; O teleconferencing facilities; and O data storage and management via the secure Blue Frog Scientific extranet. Plant Protection Products (PPPs) O Blue Frog Scientific and associates offer a full dossier service for registering plant protection products throughout Europe. O Our range of services provides cost effective solutions to support placing your products on the European market. Our areas of support for plant protection products include: O Conducting risk assessments at the EU level; O EU active substance and product dossier regulatory submission and project management; O EU active substance and product dossier regulatory submission and project management; O over 100 years worth of staff experience working within the plant protection sector with Blue Frog Scientific being established since 2010; and O effective study contracting and monitoring with much of the team having significant direct laboratory experience. 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: O HMPs: AIDS, chronic kidney disease, ataxia, an.-inflammatory, hypertension, diabetes; O VMPs: antibiotics, parasiticides, coccidiostats, antipyretics; O all classes of cattle, swine, sheep, poultry; O oral drenches, injectables, pour-ons, in feed, in drinking water; and O 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

2019

Formation of Blue frog Scientific in France

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

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Profile: Blue Frog Scientific

Profile: Cambridge Environmental Assessments

GLOBAL OFFICES UK and Republic of Ireland SERVICES PROVIDED CONTACTS Website

Our services cover: www.cea.adas.co.uk

O O

E-mail

enquiries@cea-res.co.uk

Head office

Cambridge Environmental Assessments, Battlegate Road, Boxworth Cambridge CB23 4NN, UK

O O O O O

Agrochemicals biocides; veterinary medicines; industrial and speciality chemicals; foods and food contact materials; cosmetics; pharmaceuticals; environmental fate and exposure, including novel field fate studies; ecotoxicology and risk assessment, including novel laboratory and outdoor (mesocosm) aquatic ecotoxicity studies; toxicology and human health risk assessment; software development; and training.

Tel

+44 (0)1954 268298

Contact

Adrian Terry

Directors

Managing Director: Adrian Terry

Ownership

Private

Locations

UK (Cambridge, Nottingham, Wolverhampton), Republic of Ireland (Dublin)

Founded

2001

Agrochemicals We provide specialist regulatory support and consultancy to agrochemical industry clients and their associations seeking to register and steward their plant protection products. This encompasses all aspects of the process including: advocacy, exposure modelling, environmental fate, field fate studies, spatial analysis & statistics, ecotoxicology, aquatic ecotoxicity testing (lab and mesocosm studies), toxicology, risk assessment, dossier section preparation, software development, training and product stewardship. In particular we have a well-earned reputation for providing higher tier, non-standard support for challenging products in an increasingly challenging regulatory environment.

O O

OVERVIEW Cambridge Environmental Assessments (CEA), part of RSK ADAS, provides technical and strategic expertise and dossier support for chemical registrations. This encompasses agrochemicals (plant protection products/pesticides), biocides, veterinary and human pharmaceuticals, food additives, novel foods, cosmetics and general chemicals. The team specialises in higher tier approaches to chemical risk assessment, including the design and conduct of higher tier studies tailored to address specific issues in the risk assessment. Our team of 30 people are based in the UK and Ireland, comprising specialists in environmental fate and behavior; field fate and stewardship; exposure and spatial modelling; aquatic ecotoxicity testing; ecotoxicology and risk assessment; toxicology and human health risk assessment; and regulatory affairs. VITAL STATISTICS

2018/19

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

Training 5%

Representation & management 5%

Global Service Providers Guide 2020

Veterinary medicines Specialising in the environmental safety section of the dossier, our veterinary medicine specialists can provide non-clinical environmental safety support for actives throughout the entire regulatory process. Industrial and speciality chemicals We provide REACH and chemical regulatory support to a range of industries, including chemical manufacturers and importers. We specialise in providing chemical regulatory support to clients seeking regulatory compliance for new substances, difficult to identify substances, or those substances where properties or uses require a non-standard approach to toxicology or ecotoxicology testing, alternative testing approaches, non-standard exposure modelling and evaluations.

SERVICE AREA BREAKDOWN

Laboratory 30%

Biocides CEA provides specialist regulatory support and consultancy to industry clients seeking approval/Annex I inclusion and Article 95 support of their active substances and authorisation of their biocidal products, including biocidal product families. We have a wide range of experience with various product types and can offer expert guidance on the requirements of EU No 528/2012, the Biocidal Products Regulation (BPR). A thorough understanding of a substanceâ&#x20AC;&#x2122;s properties, use patterns and exposure pathways are necessary to demonstrate safety to human health and the environment. Due to our multidisciplinary expertise and building on our track record of higher tier environmental risk assessment, CEA provides a full dossier preparation and support service under the BPR and support clients throughout the entire regulatory process.

Consultancy/advisory 60%

Foods and food contact materials We have a wealth of expertise working in the food industry, carrying out hazard and risk assessments for novel foods, food additives, enzymes and food contact materials. We also support regulatory submissions and dossier preparation under the varying regulations.

Contaminated land and water We have extensive knowledge and expertise in the area of contaminated land and water and are able to provide support and advice related to the potential adverse effects of chemicals in environmental media. We can support clients by deriving bespoke â&#x20AC;&#x2DC;safeâ&#x20AC;&#x2122; levels of contaminants in soil and water, conducting exposure modelling and performing corresponding risk assessments. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2001

Formation of CEA, part of ADAS UK Ltd

2005

Field fate unit established

2007

GIS/spatial modelling capability acquired; REACH consultancy services launched

2009

Upgrades to mesocosm and laboratory facilities initiated

2013

Development of toxicology services

2016

CEA becomes part of RSK ADAS Ltd

2018

CEA Ireland office established

Alan Lawrence As Head of Regulatory Risk Assessment, Alan provides technical, strategic and regulatory leadership to risk assessment and ecotoxicology functions across CEA. Alan specialises in higher tier risk assessments for non-target organisms, designing laboratory and field programmes, and liaising with Member State authorities. He has also conducted research projects for the UK Government into aspects of risk assessment for non-target arthropods, birds and mammals, and the use of statistics in ecotoxicology field studies. Claire McMillan Claire is Head of the Chemical Regulatory and Toxicology team. Claire is an environmental risk assessor specialising in exposure assessments for both general chemicals under REACH and veterinary medicines. Her experience under REACH includes working on a wide range of substance types for commercial clients and industry bodies. Claire also conducts Phase II ERAs for veterinary medicine products.

ACCREDITATIONS GLP certified EUROTOX registered toxicologists SETAC Europe Partner PARTNERS CEA is a business unit within ADAS, which is a part of the RSK group of companies. CLIENTS We work with clients encompassing agrochemical, biocide, veterinary and human pharmaceutical, food additive, novel food, cosmetic and general chemical companies from around the globe. We also provide specialist policy advice and research to government clients and consultancy to water companies and their associations. STAFF Adrian Terry Initially from an organic chemistry, molecular biology and natural product discovery background, Adrian has been involved specifically in the agrochemical industry since 1990. For the last 25 years this involvement has been in the Environmental Chemistry area, including environmental fate studies, environmental risk assessment and product regulatory advocacy (in the areas of environmental fate and risk assessment). Adrian is currently Head of CEA, providing specialist support to client organisations in the area of environmental chemistry and risk assessment for agrochemicals, biocides, veterinary pharmaceuticals and industrial chemicals. Greg Hughes As Head of the Environmental Exposure team, Greg leads a team of environmental modellers and field fate specialists in the design and conduct of higher tier chemical fate and exposure modelling as well as field fate studies to refine model inputs or provide higher tier evidence of product safety, predominantly for the agrochemical industry. Greg is an environmental modeller that specialises in the definition, development and implementation of higher tier spatial/probabilistic/catchment based approaches in the refinement of environmental risk assessments and risk communication, particularly for groundwater.

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Profile: Cambridge Environmental Assessments

Profile: Cardno ChemRisk

O O O O O

CONTACTS

Website

http://cardnochemrisk.com/

Head office

235 Pine Street, Suite 2300 San Francisco, CA 94104, USA

Contact

Andrew Maier andrew.maier@cardno.com +1 513 520 2943 Marisa Kreider marisa.kreider@cardno.com +1 412 694 7055

Locations

90+

Founded

1945

OVERVIEW Cardno ChemRisk offers scientific consulting services, specialising in using risk assessment methods to characterise and provide improved understanding of potential impacts from exposures to chemicals. Our scientists have conducted hundreds of assessments to understand the potential human health risks posed by various industrial chemicals, consumer products, pharmaceuticals, and food ingredients. These assessments are developed in the context of various risk management strategies for contaminated sites, facility emissions, product uses, and occupational scenarios. Because Cardno ChemRisk scientists have pioneered and helped popularize many of the approaches used in the risk assessment field, both in the US and abroad, we are confident that few other firms can equal our ability to confront the multi-layered issues that arise when humans are exposed to chemical agents. SERVICE AREA BREAKDOWN

Other 20%

Training 10%

Consultancy/advisory 30%

Legal 40%

SERVICES PROVIDED Occupational health and safety Cardno ChemRisk occupational health and safety professionals, many of whom are board certified industrial hygienists (CIHs), specialise in evaluating health risks to workers and communities resulting from exposure to chemical, physical, and biological hazards. We have helped clients navigate compliance, legal, and reputational business risks, and have facilitated the development of world-class Environment, Health and Safety (EHS) programs. Our work extends to diverse sectors, including energy, pharmaceutical, technology, healthcare, and food and beverage industries. O Exposure assessment; O industrial hygiene support;

Global Service Providers Guide 2020

occupational toxicology; chemical hazard and risk assessment; ehs program development; risk communication and training; regulatory compliance; and emergency response risk management and plan development.

Regulatory support We have a large team of toxicologists, many of whom are boardcertified, who have extensive experience providing clients with critical information about their products, to aid companies in decision making and help to ensure that their chemicals or products align with US and International regulatory standards. O GHS-based regulations; O food contact; O medical devices regulation; O US HCS; O other; O REACH; O global chemical notifications; O CLP; O new TSCA/LCSA; O Biocidal Products Regulation; O EU cosmetics Regulation; O agrochemical registrations; and O COSHH. Product quality Cardno ChemRisk scientists have assisted companies with better understanding potential human health and environmental risks associated with their products, the life cycle, potential contamination events, and other aspects related to product integrity. In this context, we have evaluated a wide range of food and beverages, and consumer products, including cosmetics, children’s toys, household cleaners, flame retardants, and fabric treatments. O Consumer product safety; O medical and pharmaceuticals; O personal care; O electrical and electronics; O toys/children’s products; O cleaning products; and O food. Contaminated sites Our scientists have pioneered and helped popularise many of the approaches used in the risk assessment field both in the US and abroad, and have conducted over 500 risk assessments for sites regulated by state, regional, and federal environmental agencies. O Site-based risk assessment; O environmental monitoring; O environmental fate & degradation. CORPORATE DEVELOPMENTS & ACHIEVEMENTS O O O

More than 500 papers and book chapters published; over 1,000 papers presented at scientific conferences; our publications have received multiple “best paper” awards by scientific organisations and peer-reviewed journals; we are recognised as world authority on human health and environmental risk assessment; we have pioneered original research on a variety of chemicals and environmental pollutants, helping establish regulatory guidelines; and our staff are often recognised for their technical excellence at scientific conferences and organisations.

ACCREDITATIONS 16 CIHs, 2 CSP, 9 DABT, 1 QEP, 1 CHMM

PARTNERS Cardno ChemRisk has experience partnering with various organizations, such as laboratories, non-profits, government entities, and trade associations. CLIENTS Cardno ChemRisk provides services to a variety of clients, including chemical, oil and gas, pharmaceutical, medical device, and consumer product industries TESTIMONIALS References can be provided upon request. CASE STUDY 1: OEL Development We have worked with many industries, including chemical manufacturers, and pharmaceutical and food producers, to develop occupational exposure limits (OELs) for specific substances. We evaluate existing OELs, if available, and conduct a comprehensive literature and data analysis to provide accurate and comprehensive OEL derivations. Overall, we have derived OELs for hundreds of chemicals. Additionally, we provide customized risk assessment trainings for our clients. CASE STUDY 2: Chemical Carryover during Food Transportation We were contacted regarding unexplained odor coming from a food product. Upon investigating further, it was determined that the odor was the result of a chemical carryover from the shipping container. Using risk assessment principles, we helped the client determine what materials are appropriate to transport in bulk in large shipping containers and determine if there were any chemical carryover concerns that they had to address. CASE STUDY 3: Lubricant Proposition 65 Risk Assessment We were asked to perform a risk assessment of lubricant products for potential Proposition 65 compliance. We conducted a risk assessment for 16 chemicals and derived acceptable exposure levels. Our team then calculated the cumulative exposure assessment representative of typical consumer use of various lubricant products. CASE STUDY 4: Consumer Product Ingredient Safety Evaluation We were asked to evaluate safety of the active ingredients found in sunscreen. For this project, we evaluated the safety of active ingredients and metabolites by reviewing and critically evaluating toxicity literature, identifying critical end points of concern, preparing chemical safety profiles based on available literature and client internal data, and identifying data gaps in available literature. Additionally, we performed read across analyses where applicable, and threshold of toxicological concern (TTC) modeling to evaluate the carcinogenicity of selected active ingredients. Lastly, we developed and managed toxicity and clinical testing for the client.

CASE STUDY 6: Contaminated Sites Risk Assessment Service for Cost Allocation We were asked to review the baseline risk assessment to understand the clientâ&#x20AC;&#x2122;s responsibility in the cost allocation process during a Superfund sediment site remediation. The responsible parties at the site were associated with either mercury or PCBs. To address the clientâ&#x20AC;&#x2122;s needs, we reviewed baseline risk assessment and identified areas where the risk assessment was biased towards the chemical for which the client was responsible. STAFF SELECTION Marisa Kreider, PhD, DABT, Principal Marisa Kreider is a board certified toxicology with 13 years of experience in human health risk assessment consulting and specific expertise in product stewardship and toxicology support. She has managed a variety of project types, including reviewing of toxicological literature for a variety of chemical types; designing, managing and interpreting toxicity studies; conducting or critiquing dose response assessments for chemicals or particulate; and conducting quantitative or qualitative risk assessments of consumer products. Andrew Maier, MS, PhD, CIH, DABT, Principal Andrew Maier has over 25 years of professional experience in the areas of environmental health, occupational hygiene, and toxicology. He has led numerous projects and has co-authored toxicological reviews, technical reports and human health risk assessment documents for several hundred individual substances. Dr. Maier has served as a Toxicology Fellow at NIOSH in support of exposure limit method development and is the Publications Coordinator and past-Chair of the Workplace Environmental Exposure Levels (WEEL) has been a leader in occupational and pharmaceutical risk assessment methods. Ken Unice, MS, Principal Ken Unice has 20 years of quantitative human health risk, exposure assessment, and environmental modelling experience. His risk assessment expertise is in the areas of environmental modelling, biokinetic modeling, indoor air modeling, occupational exposure assessment, environmental fate and transport analysis, and computer programming database design. Mr Unice has co-authored 50 peerreviewed journal articles and more than 100 conference abstracts. He has provided extensive exposure assessment support for chemical assessments performed under TSCA and REACH. Rachel Zisook, MS, CIH, Supervising Health Scientist Rachel Zisook is a board certified industrial hygienist with ten years of varied professional experience in exposure assessment, industrial hygiene, data analysis, and human health risk assessment. Ms. Zisook has been involved in assessing risk to workers, communities, and consumers exposed to a variety of chemicals, such as asbestos, silica, metals, polycyclic aromatic hydrocarbons (PAHs), volatile organic hydrocarbons (VOCs), diacetyl, polychlorinated biphenyls (PCBs), particulate matter, pharmaceutical and personal care products (PPCPs), and perfluorinated compounds (PFCs), and bioaerosols.

CASE STUDY 5: Tire and Road Wear Particles Our multi-disciplinary team of scientists has been a product stewardship and sustainability consultant to the tire industry for more than 15 years. An important focus of our research has been on tire and road wear particles (TRWP) generated by the necessary friction at the surface of the tire and road. Our team has assisted the industry address human and environmental health risk questions about their products through applied research efforts.

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Profile: Cardno ChemRisk

Profile: CEHTRA

GLOBAL OFFICES

Website

www.cehtra.com

Belgium – Waterloo France – Bordeaux, Lyon, Paris Germany – Hamburg Spain – Madrid Luxembourg United Kingdom – Nottingham India – Kerala Canada – Toronto

E-mail

contact@cehtra.com

SERVICES PROVIDED

Head office

15 rue Aristide Briand, 33150, Cenon, Bordeaux, France

Tel

+33 557775610

Fax

+33 557775620

Contact

Nathalie HANON Faizan SAHIGARA

Directors

Peter JENKINSON – France, UK and India Nathalie HANON – Spain, Germany Philippe ADRIAN – Belgium, Luxembourg Jason NUGENT – Canada

Regulatory dossier services CEHTRA provides clients with bespoke services for regulatory dossiers for the following markets: Biocides, Chemicals, Cos-metics, Pharmaceuticals, Plant Protection, Food and Packag-ing and Medical Devices. Our services include CADDY dossi-ers, 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 soft-ware 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).

CONTACTS

Ownership

Private company

Locations

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

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.

2001

Founded 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

2018/19

No of offices

No of countries represented Staff, group

8 60

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

Global Service Providers Guide 2020

Consultancy/advisory 75%

Consortia management: REACH & BIOCIDES We offer a complete service that can either be used as a standalone 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. 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. Global notification. At CEHTRA we have developed our own internal tools designed to provide the best worldwide, personalized and optimised strategy for a minimum cost. Our expert practitioners have collectively decades of experience and are able to hone in on the most up to date regulatory requirements for the designated target country. We prepare the master dossier on which all other submissions are based. When required, our partners, chosen for their geographic proximity, language, and culture have the skills to prepare your submission 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

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 Available on request TESTIMONIALS Available on request STAFF SELECTION Peter JENKINSON − PhD, GT – CEO CEHTRA and Manager of UK Office Peter Jenkinson has a PhD in reproductive toxicology and over 30 years of 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.

Cyril DUROU, PhD – Senior Ecotoxicologist Cyril holds a PhD in Ecotoxicology and has participated during four years in research programmes such as the national ecotoxicology programme managed by the Ministry of Ecology and Sustainable Development. In 2007, Cyril Durou joined CEHTRA as an ecotoxicologist. He was first in charge of the realisation of ecotoxicological profiles for chemicals, environmental hazard classification and reviewing of safety data sheets. Presently Cyril Durou is involved in the preparation of regulatory dossiers (Biocides, REACH), from data-gap analysis, to test strategy designing and monitoring of ecotoxicological lab studies. Stephane PIERRE, PhD – REACH Authorisation 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 on new bacterial enzyme mechanism. He qualified as a European Registered Toxicologists (ERT) in 2016. He holds expertise in several toxicological problematics (Exposure scenario, data evaluation, data gap analysis, study monitoring, classification, DNELs calculation, etc), and in socioeconomic analysis. In CEHTRA he manages the REACH authorization team. Jason NUGENT, MSc – Manager of Canada office 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 of 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.

Nathalie HANON, MSc – Manager of Spain office Nathalie holds an engineering degree in natural sciences from the Gembloux Agricultural University (Belgium). She has over 20 years of experience in regulatory affairs, eight 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 is Manager of our Spain office and leads our Biocides group. Philippe ADRIAN, PhD – Manager of Belgium and Luxembourg offices Philippe Adrian has a PhD in soil science and over 20 years of 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.

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Profile: CEHTRA

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

GLOBAL OFFICES

Directors

James Foster

Ownership

Public limited company

251 Ballardvale Street Wilmington, MA 01887 United States

Locations

Global locations and offices

SERVICES PROVIDED

Founded

1947

Laboratory 95%

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 and North America, we are well-positioned to help optimise the discovery and development of our clientsâ&#x20AC;&#x2122; drugs, chemicals, agrochemicals, biocides, foods/feeds, additives, novel foods 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 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

2018/19

Turnover, group

Turnover, chemical service provision

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

Global Service Providers Guide 2020

24 8 16,000 -

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. 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 development 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. To date, we have commenced nearly 40 of these complex studies globally.

Inhalation toxicology Charles River has conducted hundreds of studies via the inhalation route, ranging from acute to chronic including studies with the fibre and other difficult substances. By partnering with our team of inhalation toxicologists and aerosol specialists, you can leverage their expertise at all stages of your programme development. 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 With a portfolio which includes both acute and reprotoxicity studies in avian species, Charles River offers a comprehensive range of aquatic, avian and terrestrial biodegradation and ecotoxicology testing services to assess the environmental risk of chemical, pharmaceutical, biocide and agrochemical products. We design studies to meet specific data requirements that consider the properties of the test item and its potential routes of environmental exposure. Our scientists are skilled in the handling of difficult test items (eg, 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 Charles River has over 25 years of 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 disruptors Charles River offers custom endocrine disruptor studies and consultancy 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, a specialized team from a range of disciplines, can support your needs at every stage, from data gathering through evaluation, interpretation and ED assessment, to discussing an alternative mode of action. 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. 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, Science & Regulatory Affairs O 40+ years’ experience in nonclinical toxicology; and O experienced in project development, acute to chronic in vivo toxicology, DART, genotoxicity, structure-activity assessments, ecotoxicity and physical chemistry. Head, Regulatory Affairs O Joined Charles River in 2010; O 20 years’ experience in agrochemical, biocides and chemical regulatory affairs; and O leads a team of more than 20 regulatory affairs experts, which provides support for the registration of chemicals, biocides, agrochemicals and pharmaceutical products Head, Environmental Fate and Metabolism O Joined Charles River in 1994; and O 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, Discovery Environmental Sciences and Ecotoxicology O 25+ years’ experience; O specializes in aquatic toxicity (short and long-term), biodegradation and terrestrial toxicity; and O extensive experience in the conduct and management of standard regulatory and custom-designed studies to support compound development in chemical, agrochemical and pharmaceutical industry sectors, including difficult substances (eg mixtures, poorly soluble, unstable etc.) from the industrial chemical sector

www.chemicalwatch.com/SPG

Profile: Charles River

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 (eg GHS, transport, national regulations). CHEMDOX® regulatory calculators provide automatically computed classification suggestions

OVERVIEW The CHEMDOX® company provides an outstanding software solution for the chemical industry: O classify chemicals according to numerous regulations; O generate high-quality safety-related documents in the most efficient way; O 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

2018/19

No of offices

No of countries represented

Europe, Americas

Staff, group

50+

Staff, chemical service provision

20+

SERVICE AREA BREAKDOWN Training 20%

Poison Centers Notifications Create Poison Centers Notifications super efficiently with CHEMDOX. Your entire product portfolio including product data is already available on your installation and can therefore be converted into a notification with just a few clicks. Regulatory coverage Cover global regulatory requirements on a best practice level and up-todate for all major markets in e.g. Europe, Asia, Americas. 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. 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 O application; O state-of-the-art technology makes CHEMDOX® future-proof; and O freedom of choice regarding hardware, operating system, and installation scenario. O

Training, support and professional services Updates and support

IT & software 80%

Global Service Providers Guide 2020

At least quarterly, CHEMDOX® updates ensure that the software is up-todate 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 (eg development with the CHEMDOX® API, system integration, etc.) especially tailored to your needs. 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 O Configuration of CHEMDOX®; O connection of your ERP system to CHEMDOX®; O data transfer or migration from other programs; O implementation of interfaces with other systems; and O custom development of special software modules. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1999

UCS – unique computing solutions gmbh

2011

CHEMDOX GmbH

2016

CHEMDOX Inc.

PARTNERS O O

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: O government agencies; O substance producers; O formulators; O industrial users (eg automotive); O consulting firms; and O distribution companies etc. TESTIMONIALS 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 2 A consulting firm has to replace the software solution for their main service: Safety Data Sheet (SDS) authoring. O migration of 25.000+ products to CHEMDOX®; O comprehensive regulatory and language support; O respect customer’s corporate identity when authoring SDS; and O strong focus on accuracy and efficiency. CASE STUDY 3 A multinational company wants to avoid differences in product information or documentation due to multiple software installations in their subsidiaries. O centralisation of product and regulatory information, as well as documentation in CHEMDOX®; O working remains decentralised taking into account official languages, national legal terminology, as well as national regulations and national GHS-implementations; O web-application with the perfect usability of a desktop application but without the need for a local client installation; O multilingual user interface including regional specifics (e.g. date, time or number formats); O fine grained permission settings, versioning, change history, statutory retention; O quality improvements and efficiency gains due to collaboration across the subsidiaries; O 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 O 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.

CASE STUDY 1 A major player in the automotive industry has to implement a chemical management solution due to compliance reasons. O manage and check SDS and regulatory information provided by suppliers for plausibility; O automatically track the regulatory status of substances in use O (classification calculators); O comply with Global Automotive Declarable Substance List (GADSL); and O integrate with SAP® for substance volume tracking and VOC reporting.

www.chemicalwatch.com/SPG

Profile: CHEMDOX

Profile: Chementors Ltd

GLOBAL OFFICES Austria (Head Office), USA SERVICES PROVIDED Where does CHEMDOX® help? The CHEMDOX® software supports experts in all tasks regarding hazardous materials management:

CONTACTS 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

2018/19

No of offices

No of countries represented

Europe, Americas

Staff, group

50+

Staff, chemical service provision

20+

SERVICE AREA BREAKDOWN

Legal 5%

Training 5%

Information 5%

Representation & management 20%

Global Service Providers Guide 2020

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. 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 O application; O state-of-the-art technology makes CHEMDOX® future-proof; and O freedom of choice regarding hardware, operating system, and installation scenario. O

Training, support and professional services Updates and support

IT & software 10% Laboratory 5%

Regulatory coverage Cover global regulatory requirements on a best practice level and up-todate for all major markets in e.g. Europe, Asia, Americas.

Consultancy/advisory 50%

At least quarterly, CHEMDOX® updates ensure that the software is up-todate and in accordance with regulatory changes. Our team of experts provides continuous support via e-mail or on the phone.

UCS – unique computing solutions gmbh

2011

CHEMDOX GmbH

2016

CHEMDOX Inc.

PARTNERS O O

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

www.chemicalwatch.com/SPG

Profile: Chementors Ltd

Profile: Chemical Check GmbH

SERVICES PROVIDED Safety data sheets and chemicals management Services are offered from individual orders to comprehensive product portfolios. We count over 1,200,000 documents online. O Authoring – A core field is the authoring of safety data sheets with a focus on Europe using our own IT structure. We rely on our own databases since 30 years including validity and plausibility checks of classification and labelling under CLP and a continuous development and improvement of our IT structure and systems. Authoring of international SDS considering the building block approaches of the different GHS regions completes the service for a couple of years. O National particularities/restrictions – Implemented in the authoring process and our chemicals management is the consideration of national particularities and restrictions which may have an impact on marketability of products in the trade regions. O Update services – Automatic update services on a daily basis or after a specified period consider legislative amendments as well as updated raw material information. O Administration services/report options – For larger product portfolios administration of documents and data is done in our hazardous management program with various functionalities for our clients. It includes amongst others a history function for a document version control as well as various report options for documents, hazardous chemicals or dangerous goods registries or monitoring of storage parameters. O SQL-Databases/web services – Structured databases for interaction with ERP- or logistic systems or other client specific web services and applications may be provided.

CONTACTS Website

www.chemical-check.de

E-mail

info@chemical-check.de

Head office

Chemical Check Platz 1-7 32839 Steinheim Germany

Tel

+49 5233 94 17 0

Fax

+49 5233 94 17 90

Contact

Larissa Budde

Directors

Karen Schnurbusch Larissa Budde

Ownership

Karen Schnurbusch

Locations

Germany

Founded

1990

24/7 Emergency response phone number Our 24/7 Emergency response phone number is available 365 days a year. Services: O Carriers road/railway, air and sea; O complies to the US-directives (§49 CFR 172.604); O may be entered into the safety data sheets as emergency call number of the company; O up to 12 responders per shift such as doctors, chemists, skilled chemical workers; O medical references for treatment of injured persons; O information for fire brigade and auxiliary staff; and O instructions for the proper disposal after an incident.

OVERVIEW Acting instead of reacting – source out your responsibility For 30 years our team of experts have analysed, in close consultation with our clients, which services fit the products and company structure best in the fields of: O hazardous substances and chemicals management; O dangerous goods/transportation and documents; O occupational health and safety/workplace safety; O 24/7 Emergency response phone number; O product notifications; and O IT-solutions/ SQL-databases to ensure legal compliance and simplify marketability. Our compliance solutions and consultancy services cover the whole range of consumer, professional and industrial activities, product types and applications. VITAL STATISTICS

2018/19

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Equipment 1% Other 1%

Training 1% IT & software 20% Information 1% Laboratory 1% Representation & management 10%

Global Service Providers Guide 2020

Consultancy/advi sory 65%

Product notifications Product notifications of chemical products, cosmetics and biocides are an important building block in marketability of products in Europe and affect the whole supply chain. We perform about 10,000 notifications per year: O Article 45, Regulation (EC) No 1272/2008 (CLP); O national product registries; O notifications for detergents/washing and cleaning products; O cosmetics; and O biocides – national notifications Dangerous goods/transport documents The tasks of our External Dangerous Goods Safety Advisors are O regular inspections O preparation of legally required reports O employee training Consultancy services are provided for O packaging and loading O completion of transport documents, as IMO declarations O Training courses for all modes of transport Especially regarding the IMO declarations there always arise problems, as the shipping companies demand additional information differing from the transport regulations. Our External Dangerous Goods Safety Advisors care for large enterprises with > 3,000 employees as well as SMEs.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

STAFF SELECTION

2000

Expansion of company building, seven employees

2005

Development of a hazardous chemicals management “Sichdat online” as online administration tool for clients

2007

Moving to new company building, 25 employees

Karen Schnurbusch, founder, owner and manager Regulatory expert in all fields of chemicals management. She started the business in 1988 when hazardous substances legislation as we know it today was still at the beginning.

2007

Extension of product notification business to all European countries

2010

First client databases

2012

Expansion of company building, 40 employees

2015

Development of an online order and data capturing portal for digital placing of orders and recipe data

2017

New version “Sichdat online” with improved functions, with 1,200,000 documents online

2019

Developing of program structure to support new European PCN notification format

Larissa Budde, manager A team member for 20 years, regulatory expert in chemicals management and product notifications. Our team of experts Our experts mainly have a chemical, biological or food technology background. Starting in our team means continuous training and education for up to three years by our senior staff and internal and external training courses to assure expert level for our consultancy services.

CLIENTS Our clients represent the whole supply chain of chemical products covering: O national and international companies; O large enterprises and SMEs; O manufacturers, formulators, distributors; O re-Branding/ Private label business; O consumer, professional, industrial use; O mixtures and substances; and O liquids, solids, aerosols. Examples of product types covered: O adhesives; O colouring agents; O construction materials; O detergents; O fragrance products; and O lubricating agents. CASE STUDY 1 Full service chemicals management > 1,000 products including: O Compilation of safety data sheets and label; O daily update service; O SQL-database, customized content; O providing the 24/7 emergency number; O automatic check and performing product notifications where necessary; O additional documents for washing and cleaning agents; O about 50,000 documents online; O provision of an External Dangerous Goods Safety Advisor; and O provision of an External Safety Officer covering all subsidiaries for risk assessment. CASE STUDY 2 Providing a SQL-database for interaction with ERP- and logistic system for product data, > 15,000 products O Customised parameter (UN, VOC, storage classes etc.) O Plausibility/validity check of supplier data CASE STUDY 3 Providing of 24/7 emergency phone number for the use in > 5,000 safety data sheets and for single transportations.

www.chemicalwatch.com/SPG

Profile: Chemical Check GmbH

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 (elif@chemleg.com) Mr Gökhan Ardıç (gokhan@chemleg.com) Mr Mehmet Yolcu (mehmet@chemleg.com)

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-Turkey REACH), 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; O only representative service for KKDIK (Turkey REACH), Turkey CLP Regulation and Turkey BPR; O KKDIK (Turkey REACH) compliance services; O Turkey BPR Compliance Service; O SDS/MSDS authoring services; O SDS certification services for Turkish SDS; O preparation of “label” and “technical information form” for general chemicals; O CLP compliance (Turkey CLP-SEA and EU CLP) and GHS compliance services; O Turkish detergent regulation compliance services; O non-medical veterinary products registration services; O training and consultancy services; O CHEMLEG is partner with TELEMATIC for providing EPY SDS authoring software; O technical translation services; and O training institution for “chemical assessment expert”. Global Service Providers Guide 2020

Consultancy/advisory 30%

Information 10% Representation & management 35%

SERVICES PROVIDED Only representative (OR) service KKDIK (Turkey REACH) regulation; O Turkey BPR regulation; O Turkey CLP regulation. O

KKDIK compliance services O 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. CHEMLEG services; O to be done pre-registration for KKDIK; O join and follow-up all activities in the pre-SIEF and SIEF; O following up consortium activities; O determination of chemical characterization of the substances; O data management and data-gap analysis; O translation and compilation of KKDIK registration dossiers including the uses, robust study summaries, CSR, CSA, risk assessment report etc. (started as of the beginning of 2020); O translations of technical documents/test reports in preparation of the registration dossier; O uploading/submission of the registration dossier to KKS in Turkish by the chemical assessment experts; O establishing of the substance inventory list under annex 17; O communication with the supply chain; and O training institution for “chemical assessment expert”. Turkish biocidal product Regulation compliance services Companies, which market their biocidal products in Turkey, should have biocidal product license for their products. O determination of the product’s scope; O preparation of the BP license dossier; O management of the licensing process; O technical evaluation and suitability assessment for the physicochemical analysis and efficacy test methods; O management of the analyses/efficacy test procedures; and O assessment and translation of toxicologic, eco-toxicologic tests, risk assessment reports. Turkish CLP Regulation Compliance Services O classification of substances/mixtures supplied to the market; O labelling and packaging of harmful substances/ mix-tures; O notification of hazardous substances to C&L (SEA) inventory through KKS; O follow up the updated information of the substances; and O 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. O preparation of safety data sheets; O checking the safety data sheets compliance with the relevant regulation; O 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, regu-latory and technical support on EPY. ACCREDITATIONS O O O

Member of Istanbul chamber of commerce; SDS authorized certificate; and 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 UK, USA, Norway, Italy, Germany, France, Bulgaria, Belgium, Netherlands, Japan, China, Russia 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 UK, 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. 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 utilisation 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.

Gökhan ARDIÇ He is chemist and health and safety expert. He has a 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 al-most 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 uni-versity. 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 and 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. Haydar Hazer He has worked for the Chemicals Management Department, Turkish Republic MoEU for 23 years. He worked for establishment of “Chemicals Inventory System” and “Chemicals Registration System (KKS)” as well as working for the harmonization of CLP Regulation and REACH Regulation for Turkey. He has been working KKDIK (Turkey REACH) and Turkey CLP Regulation since their harmonisation process start up for Turkey. He attended many national CARACAL and REACH meetings, seminars and trainings as the representative of MoEU in Turkey. CHEMLEG’s other members Other members of CHEMLEG are environmental and chemical engineers. All members have SDS authorised 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.

www.chemicalwatch.com/SPG

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 Qsars. 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 2020

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: O OEL/OEB/ ASL evaluation + PDE; O ERA (environmental risk assessment); O in silico evaluation (DEREK, SARAH, METEOR); O extractables and leachables toxicological evaluation; and O quantification/qualification of impurities. 2) GMP: O DMF preparation in CTD format (module 3, section 3.2.S) for the European registration, US and Canada; O OQS (overall quality summary 2.3P and 2.3.S); and O preliminary evaluation of all documentation for the dossier and DMF preparation. 3) GLP activity: O from candidate profiling to preclinical development.

Medical devices O Strategic/regulatory consultancy as per new EU Reg 745/2017; O MD class identification; O biological evaluations; O human health risk assessment; O technical dossier preparation; O quality system application; and O liiason with regulatory bodies.

CASE STUDY 2: REACH dossier work

Cosmetics O General regulatory support for cosmetic products; O competent person designation; O data evaluation, data gap analysis, read-across methodology, in silico method application, testing programme design, and study monitoring/coordination; O PIF (product information file) or PSR (product safety report); and O 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 eight 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 ten 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 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.

www.chemicalwatch.com/SPG

Profile: Chemsafe

101

Profile: Chemservice

102

SERVICE AREA BREAKDOWN

Other 5%

CONTACTS Training 5%

Website

www.chemservice-group.com

E-mail

contact@chemservice-group.com

Head office

Chemservice GmbH Herrnsheimer Hauptstr. 1b, 67550 Worms, Germany Chemservice SA 13c, Fausermillen, 6689 Mertert, Luxembourg Chemservice Asia Co Ltd Technical Innovation Building B-201, 202, 15, Jongga-ro, Jung-gu, 44412 Ulsan, Korea

Tel

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

Fax

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

Contact

Karl-Heinz Reis (Germany) Dr Dominik Kirf (Luxembourg) Jae-Seong Choi (Korea)

Directors

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

Ownership

Privately owned group of companies

Locations

Germany, Luxembourg, Korea, Switzerland, Spain, UK, USA

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 also in the fields of consortia and LoA management, representation of interests and socio-economic evaluation, as well as health and safety, 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 1,000 years of regulatory affairs experience. Our business philosophy? Dedication to find the best solutions to suit your needs! VITAL STATISTICS

2019

Turnover, group (w/o affiliated companies)

~ €10m

Turnover, chemical service provision

~ €10m

No of offices (w/o affiliated companies) No of countries represented

9 7

Staff, group (w/o affiliated companies)

ca. 60

Staff, chemical service provision

ca. 50

Global Service Providers Guide 2020

Information 15%

IT & software 10%

Consultancy/advisory 45%

Representation & management 20%

GLOBAL OFFICES Chemservice GmbH, Worms, Germany Chemservice SA, Mertert, Luxembourg Chemservice Asia Co Ltd, Ulsan, Korea Chemservice Schweiz GmbH, Morschach, Switzerland Chemservice Iberia, Castellón, Spain Chemservice UK Ltd, Maidstone, United Kingdom Chemservice Americas LLC, Helena (MT), USA Consortia Management GmbH, Worms, Germany Consortia Asia Co Ltd, Seoul, Korea 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, Taiwan-REACH and KKDIK. Trough our various legal entities, we also offer regulatory consultancy for the Swiss, South American and US market; being as well prepared for any developments on UK chemicals law (UK-REACH). 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, REACH-IT and Iuclid assistance, C&L notification, safety data sheet and label creation as well as support on EH&S issues. In addition, we provide REACH authorisation and restriction services (including SEA), advocacy and product stewardship consulting. Consortia and Letter of Access management For more than ten years Consortia Management GmbH provides independent secretarial, fiduciary and financial services (including trustee account management) in the field of national and international chemicals legislation (especially REACH) and biocide regulations. We support consortia and lead registrants of chemical substances and biocidal products in an efficient and competent manner, implementing the data generation and cost sharing required by the regulations. With our online LoA Shop (www.reach-loa.com) we offer efficient Letter of Access management for all parties who need data access rights for certain substances in order to fulfill their registration obligations. Combining expertise & competence: Your partner for managing consortia.

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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

CASE STUDY 2: REACH-Code-Model â&#x20AC;&#x201C; a unique feature of Chemservice 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 â&#x20AC;&#x201C; the REACH-Code-Model. Many companies with multistage non-EU supply chains have already signed up to this unique feature of Chemservice. A web-based application will be accessible soon. Furthermore, the tool is available for K-REACH and KKDIK.

2007

Start-up in Luxembourg

2008

Opening of Chemservice office in Germany Development of REACH-Code-Model

2009

Launch of Consortia Management GmbH in Germany

2010

Opening of Chemservice Asia office in Korea

2011

Launch of Chemservice EHNS GmbH in Germany Launch of Joint Venture ChemCehtra in France

2016

Chemservice acquired a two-digit share of CEHTRA

2017

Ten years Chemservice

CASE STUDY 3: REACH dossier work

2018

Launch of Chemservice Schweiz GmbH in Switzerland Launch of Consortia Asia Co Ltd in Korea Acquisition and merger of REACh ChemAdvice GmbH into Chemservice GmbH

2019

Establishment of three new Chemservice entities: Chemservice Iberia, Spain Chemservice UK, United Kingdom Chemservice Americas, USA Acquisition and merger of Chemservice EHNS GmbH into Chemservice GmbH

We are experienced in the preparation and submission of circa 1,000 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 2,500 C&L notifications.

2020

Extension of Chemservice offices in Germany and Luxembourg

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. CLIENTS

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 circa 100 small volume substance registrations, 50 substance registrations and circa 100 exemption confirmations. We act as OR, with around 3,000 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 secretarial and financial services as well as LoA and data access management to K-REACH registrants.

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. CASE STUDY 1: Global inventory strategy and registration We have significant experience in global inventory registrations and conducted around 200 notifications to the Turkish inventory, 400 nominations to the inventory in Taiwan, 75 notifications to the Thai inventory and circa 1,000 inventory nominations in Eurasia (e.g. Russia). 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), Korea (KECL), New Zealand (NZIOC), Philippines (PICCS) and USA (TSCA).

www.chemicalwatch.com/SPG

Profile: Chemservice

103

Profile: Chemwatch

104

SERVICE AREA BREAKDOWN

Training 10%

CONTACTS Website

www.chemwatch.net

E-mail

sales@chemwatch.net

Head office

1227 Glen Huntly Road, Glen Huntly VIC 3163 Australia

Tel

+6139573 3100

Contact

Sales Team

Directors

Bernie Bialkower

Ownership

Private Company

Locations

United States, United Kingdom, Australia, China, New Zealand, Japan, India, Italy, The Netherlands, Malaysia, Mongolia, Singapore, South Korea, Turkey, and Qatar.

Founded

1993

IT & software 50%

For over 25 years, Chemwatch have been pioneering the latest advancements in chemical and SDS management to thousands of clients globally. Chemwatch is a one-stop-shop to assist you in meeting your workplace health and safety needs, providing: O The world’s largest SDS library – over four million SDS added monthly; O AI technology to continuously update SDS and safety documents; O chemical management systems for all user levels; O SDS authoring and labels to comply with local and global regulations; O regulatory and health and safety documentation and databases; O assets management, including use of barcoding and RFID technologies; O customisable chemical approvals processes; O visualisation of your chemical stores and hazard identification; O reports and documentation, including for emergency responders; and O mobile device access to chemical safety and assets management apps. We enjoy working with our clients to help them comply with regulatory requirements and reach their chemical safety goals, pairing the latest technology with personalised service and support from our team of experts, including WHS professionals, toxicologists and medical doctors, chemists, IT specialists, and scientists. 2018/19

Turnover, group

$30+ million

Turnover, chemical service provision

$30+ million

No of offices No of countries represented

21 Global

Staff, group

300+

Staff, chemical service provision

300+

Global Service Providers Guide 2020

Information 30%

GLOBAL OFFICES

OVERVIEW

VITAL STATISTICS

Consultancy/advisory 10%

United States: coe@chemwatch.net ; 615-467-0383 United Kingdom: paul@chemwatch.net ; +447869138940 Australia: sales@chemwatch.net ; +613 9573 3100 China: info@nrcchem.com ; +86 138 1603 6076 New Zealand: pgtse@chemie-tech.com Japan: japan@chemwatch.net ; +81-95-827-6634 India: info@axionsoftware.net Italy: renato@chemwatch.net ; +39 3332168669 The Netherlands: geoffrey.devlaam@itis.nl Malaysia: monwee@chemcareasia.com ; +60 3 8022 8632 Mongolia: info@chemwatch.mn ; +976 88001556 Singapore: info@chemcareasia.com ; +65 6848 9048 South Korea: chemtopia@chemtopia.net ; +822 826 9100 Turkey: aynur@chemwatch.net ; +90 545 628 0073 Qatar: m.naser@ieco-ps.com.qa ; +974 44 472 485 Norway, Finland, Sweden: mos@reachnroll.com; +358 449881850 Russia: yulia@reachnroll.com; +7 926 118 00 19 SERVICES PROVIDED Chemical and SDS Management Chemwatch maintains a database of over 60 million continuously updated SDS from around the globe – over four million SDS are added monthly. Clients can access additional chemical safety documentation such as health monographs, summary SDS, environmental and toxicological reports and more. Assets Management and Chemical Approvals Chemwatch chemical management systems offer chemical approval workflows, and the ability to manage both chemical and non-chemical assets, using barcoding and RFID technology. SDS Authoring and Updating Chemwatch has a team of professional chemists authoring over 2000 SDS weekly for clients. Clients wishing to author SDS themselves for their own products can access SDS authoring software with thousands of pre-classified substances and functionality designed for beginner or expert users. Chemwatch also continuously updates the database of 60+ million original supplier SDS. Chemical Stores Visualisation and Hazard Identification With Chemwatch you can create Heat Maps of your chemical stores to quickly identify your holdings and any potential issues. You can view 2D or 3D maps of your sites, and take a tour through your chemical storage areas. Chemical holdings are colour-coded for easy hazard identification, allowing for ongoing assessment of your chemical stores, emergency planning, and effective communication with first responders.

Profile: Chemwatch

105 Heat Maps You can now visualise your chemical inventory with Heat Maps. Mapping out your sites in 2D and 3D, you can now ‘fly over’ your sites, and even complete ‘walk-throughs’ of your buildings, enabling you to view you inventory in real-time, right down to each shelf your chemicals are stored on. Your inventory is calculated and then colour-coded based on the level of hazard posed by your stock holding. Heat Maps helps you to plan chemical containment and emergency procedures (including mapping your fire mitigation measures), plus evaluate the effects of your storage areas on surrounding environs. RFID Complete instantaneous stocktakes and audits with RFID technology. With improvements made to liquids and chemicals in metal containers, you can now use RFID tags on your products to quickly find containers of interest or even complete a stocktake of an entire room in a matter of moments. GoGal Ensure you stay on top of regulatory changes. Powered by our Galleria Chemica global regulatory database containing thousands of lists from 90+ countries, GoGal enables you to select just your chemicals and lists of interest to quickly keep track of currently regulations. Data Analytics Take your chemicals management to the next level with our Data Analytics tool. This powerful new feature enables you to quickly create a range of charts based on your Manifest data. A large library of charts is available to select from and can be customised with different colours, styles and layouts. Giving you an overall view of your chemical safety activities, Data Analytics can help you quick identify your chemical safety measures, including changes you’ve made to reduce hazardous materials on site, reduce chemical exposure to staff, and measure ongoing usage and ordering requirements for your chemicals. GoSDS Create SDS quickly and as needed with GoSDS. Simply enter your supplier and substance details, and you’ll receive a compliant SDS in a matter of minutes! ACCREDITATIONS O O O

ISO 9001:2015 accredited Registered Training Organisation Certified through the Turk Accreditation Institute for Turkish SDS Preparation

CLIENTS Over 5,000 clients globally, including Research Institutions, Local and Federal Government Departments, Universities and Educational Providers, Hospitals, Chemical Manufacturers and Suppliers. PARTNERS NRCC Technical Service Co., Ltd – an affiliate company of National Registration Center for Chemicals (NRCC), the Chinese Government Department responsible for manag-ing Hazardous Substances in China. STAFF SELECTION 300+ staff

www.chemicalwatch.com/SPG

Profile: China National Chemical Information Center

106

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

Contact

+86 10 64428331

GLOBAL OFFICES

Directors

Lisa Zhong 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

SERVICES PROVIDED

Locations

Beijing, China

Founded

1959

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. O CNCIC provide services including: O regulation consulting and LA-OR service; O Affirmative of Inventories of Existing Chemical Substances; O data evaluation and data gap analysis; O strategies of tests, waiver statements, QSAR; O test arrangements and monitoring; O chemical risk assessment; O SDS and labelling; O organisation and submission the notification dossier; O following-up and informing of the notification process; O communicating with the authorities; and O maintenance after notification.

Information 14%

Representation & management 9%

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: O new chemical substance notification; O globally harmonized system of classification and labelling (GHS); O hazardous chemical substance registration; O pesticide registration; O cosmetic declaration and new raw material registration; O food related products registration; O disinfectant products registration; O pharmaceutical registration; O Asia-REACH like services; and O HSE services VITAL STATISTICS Turnover, group

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

2018/19 -

Turnover, chemical service provision

No of offices

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

Consultancy/advisory 60%

1 400 45

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

Global Service Providers Guide 2020

Food related product compliance and notification service CNCIC provides notification services according to the food related regulations, including: O regulatory compliance evaluation; O test arrangement and monitoring; O prepare the declaration dossier; O attend the technical review meeting on behalf of clients; O communication with authority and assist clients to solve the potential problems.

TESTIMONIALS

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

STAFF SELECTION

Pharmaceuticals registration CNCIC provides pharmaceuticals registration services including: O review technical documents; O technical support; O studies placement and monitoring (non-clinic studies, clinical studies phase I to IV; bioequivalence tests etc); O organisation and submission the registration dossier; and O following-up and informing of the registration process. Asia-REACH like services CNCIC provides Asia REACH like registration services including: O K-REACH; O CSCL/ISHL services; and O Taiwan TCSCA/OSHA. HSE services CNCIC provides HSE services including: O standardization for Chemical Industry; O energy Conservation and Emission Reduction; O establishment, Application and Evaluation of HSE System; O EMRC Evaluation of Emergency Response; O Hazard Process Device HAZOP Analysis; and O HSE Training and 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.

“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!”

Minyan Liang Minyan Liang is a senior engineer with 15 years of experience in Asia chemical regulation consulting services. She has been 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, disinfectants notification, food contact material declaration. She has participated in more than 150 new substances general notification and supervise more than 1000 substances tests. She has extensive experiences in China 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 15 years’ experience in chemical regulatory consulting services. He has successfully achieved more than 1000 registration certificates for simplified notification and more than 200 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 15 years of experience in China and overseas pesticides registration. She has led more than 200 pesticide registration projects, and Led more than 30 new ingredient registration, she has extensive experience in domestic and foreign pesticide registration regulations. And she leads a specialised and professional team for agricultural chemicals compliance services.

ACCREDITATIONS 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.

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Profile: China National Chemical Information Center

107

Profile: CIRS

108

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.

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

Global chemical notification EU REACH only representative, EU REACH registration, SCIP dossier preparation and notification, 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.

Tel

+353 (1) 477 3710 (Ireland) +86 571 8720 6574 (China)

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)

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 substance notification (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

2007

Founded

VITAL STATISTICS

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

320

Staff, chemical service provision

Approx. 55%

SERVICE AREA BREAKDOWN Other Training 5% 5% IT & software 5% Laboratory 15%

Consultancy/advisory 45%

Information 10% Representation & management 15%

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. 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). CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007

Foundation, Hangzhou, China

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

2019

Milestone of the 100,000th SDS authoring (Global) Milestone of the 3,000th K-REACH pre-registration Milestone of the 10,000th China Cosmetics Registration Host ‘HCF&SMCR 2019’ Conference in China Acquire full CNAS/CMA testing qualifications of FCM products covering EU, USA, China and so on.

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

Global Service Providers Guide 2020

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 600 international corporates are using our services to fulfil their product regulatory obligations in EU, China, South Korea and other target Countries/Regions. 55% 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 Michael Chang, PhD – technical director of R&D centre, CIRS HQs More than ten years of product compliance experience. Participate in the translation of “Risk Assessment of Chemicals An Introduction”, introducing the concept of chemical risk assessment into China; Proficient in various chemical risk assessment software and models, such as EPA-SUITE, EUSES, ECETOC-TRA, CHESAR, etc. Pay close attention to the implementation of dangerous goods rules and GHS in China, and help a number of international top 500 enterprises to conduct compliance audit, which is highly recognized by customers. Queenier Yang – team leader/senior scientist, CIRS HQs Ten years experiences on EU REACH, K-REACH, US TSCA, Canada DSL/ NDSL, Australia NICNAS, etc. Her team completed more than 2000 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.

Cathy Yu – food sector manager/senior consultant, CIRS HQs Cathy Yu’s major in university was food science and engineering, she is very familiar with food industry, and has extensive experience in China food and food related laws and regulations. She is always invited to give the training to foreign food and food supplements companies in international regulatory conference. She works in CIRS Group for more than 7 years and leads the Food Business Division to assist global well known food companies. Charles Chang – deputy GM/Senior Consultant, CIRS Nanjing Ten years of experiences on global chemical regulation consulting and software solution. He has solid knowledge on Hazardous Substances Free, Full Material Declaration and Supply Chain Transparency. Green Product Management system(GPM) and Chemical Safety Management system(CSM) developed by his team have been well adopted by many OEMs, importers and retailers around the world. Eric Xiong – chemical Sector Manager, CIRS HQs More than ten years experiences on in product stewardship and regulatory compliance for chemical industry. His team has provided solutions for hundreds of enterprises to achieve chemical regulatory compliance in EU, China, Korea, Taiwan and other AP Countries/regions, acquired hundreds of certificates for typical notification under China REACH, act as lead registrants under EU REACH and K-REACH. Eric Xiong also addressed speeches regarding how to achieve compliance for REACH-Like chemical regulations in dozens of professional seminars, workshops and conferences. Bryan Zhou – deputy GM/senior consultant, CIRS Ireland Six 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 Ten 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. Since 2013, more than 100 medical device registrations have been completed by his team in China.

Bruce Wang –team leader/senior scientist, CIRS HQs Mr. Wang has more than nine years of experience in chemical regulations registration. He has conducted a deep research on chemical registration in China Mainland and in China-Taiwan. More than 180 typical notifications of new substances have been completed by his dedicated team as well as more than 1600 simplified notifications under MEP Order No 7 in China. He has a store of experiences in chemical risk assessment, GHS standards and identification of chemical hazards, and has provided policy recommendations to authorities of chemical management on many occasions. Cloris Pan – GHS team leader/senior scientist, CIRS HQs Graduated from Tsinghua University of China and University of Sheffield of UK. She has more than seven years experiences and plenty of indepth research on global GHS consulting service along with hazardous chemical managements in Asia Pacific. Since 2013, more than 30,000 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 eight 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.

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Profile: CIRS

109

Profile: CIS Center

110

GLOBAL OFFICES Russia SERVICES PROVIDED

CONTACTS Website

www.ciscenter.org

E-mail

info@ciscenter.org

Head office

Lyusinovskaya ul, 36/1 Moscow, Russia

Tel

+7 495 128 95 45

Contact

Natalia Druzhinina

Directors

Igor Ayzenberg

Ownership

Non-profit organisation

Locations

Russia

Founded

2008

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: consulting and development of regulatory strategy; O chemicals state registration under the Decision of the Customs Union Commission of May 28, 2010 No. 299; and O in-depth consulting on technical regulation of EAEU “On the safety of chemical products” (TR EAEU 041/2017). 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. Testing of chemicals Via laboratory network we organize testing of chemicals for the purposes of: O identification of chemicals, O toxicology and ecotoxicology assessment, O exposure assessment, etc. CIS Center has already successfully implemented QSAR method. Moreover, our specialists were the first to use it in Russia.

OVERVIEW Coordinating Informational Center of CIS Member States on approximation of regulatory practices (CIS Center) is an expert organisation in the field of chemical 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 such as APEC Chemical Dialogue, UN GHS Sub-Committee, SAICM and OECD Chemicals Committee gives us an opportunity 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 representatives of government, industry and the scientific community, acting as a platform for constructive dialogue on topical issues of chemical regulation. VITAL STATISTICS

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

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 2020

Hazard classification and labelling 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: O classification of chemicals and mixture (the series of standards); O labelling of chemicals. General requirements; O dangerous goods. Classification and marking; and O marking of cargoes. CIS Center will help you to choose correct classification code and handling marks and to prepare the proper label. Risk assessment and risk management CIS Center conducts risk assessment to reduce negative impact of chemicals on human health and the environment. Our activities in risk management area are aligned with Global Product Strategy (GPS) initiative SDS for Russia and other countries 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. Russian SDS should be compiled in Russian and undergo verification and registration. We provide our clients with the best level of service in these sphere. Many years of experience working with Russian SDS allows us to develop SDS taking into account features of the national legislation of the country where the chemical products will be handled. Our specialists can develop SDS for any type of chemical products (petrochemical, household chemicals, paint and varnish, pesticides, agrochemicals, etc.).

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: O classification, labelling and SDS development under the Russian national standards; O compliance with the requirements of the technical regulations of EAEU “On the safety of chemical products” (TR EAEU 041/2017); and chemical risk assessment and management etc. 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. Environmental Product Declarations We provide assistance on voluntary environmental declaration to exporting companies also in terms of participation in green public procurements. We provide our clients with the full service including life-cycle assessment and EPD registration. In 2018 CIS Center became a hub of the International EPD System®. Other 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. 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 of Russia and EAEU; and Organisation of the international conference on actual issues of chemicals regulation with focus on TR EAEU 041/2017 that was held in Astana, Kazakhstan.

CLIENTS CIS Center assists a broad range of companies of the chemical and petrochemical industry. We work with both large international companies and SMEs. PARTNERS ASTM International, ChemAdvisor, CRAD Cevre Risk Analiz Den. Ve Egitim Hiz AS, EPD International AB. CASE STUDY 1: Inventory development as the first step for the formation of Register of chemical substances and mixtures of the Union Within inventory development a company has the right to submit data on chemical substances (as such or within a mixture) for inclusion in the Register, thereby declaring them as existing in the customs territory of the Union. After the entry into force of the TR EAEU 041/2017, you must notify (long and expensive procedure) all chemical substances that are not in the Register before it being released to the Union market (even as part of the mixture). In Russia, data may be submitted only by the resident of Russia (Russian legal entity). A foreign company that does not have a branch in Russia need to appoint a Russian representative for data submission. CASE STUDY 2: Russian SDS Russian SDS creation is not obligatory until 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 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.

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Profile: CIS Center

111

Profile: CRAD

112

SERVICE AREA BREAKDOWN Training 15%

CONTACTS Website

www.crad.com.tr

E-mail

info@crad.com.tr

Head office

CRAD A.Ş. Atakent Mh.Turkler Cd.Gokturk Sk.No:8 Umraniye, Istanbul Turkey

Tel

+90 216 335 4600/ +90 216 335 4606

Contact

Melih Babayigit

Directors

Melih Babayigit, Managing Director-Founding Partner

Ownership

Private Joint Stock Company

Locations

Turkey

Founded

2008

IT & software 15% Information 5% Representation & management 25%

SERVICES PROVIDED

OVERVIEW CRAD is the leading consultant company in Turkey, providing chemical regulatory compliance consultancy for the global chemical industry. With a well-equipped team of consultants and with their knowledge of local regulations as well as of global and EU chemical products regulations, CRAD can provide services within a wide context. Our multidisciplinary service portfolio allows our clients to have a better understanding of the compliance process, with similarities and differences between regulations in Turkey and EU. Serving more than 500 global chemical manufacturers worldwide for their compliance to Turkish Chemical Control Regulations such as Turkish CLP, the KKDIK which is the Turkish implementation of the EU REACH regulation. CRAD, acting as OR and registrant for product and substance registration schemes supports your compliance for the products placed on the Turkish market without any concerns on CBI for the exporters that they may need to share with their local distributor. Thanks to our strategic partners around the globe CRAD is also capable of providing its clients global information with a local twist. Providing services related to Biocidal Product Regulation and Turkish compliant SDS authoring are another core service of ours. Aiming to be a one-stop compliance solution centre, we always aim to enlarge our portfolio of services. As of 2020 CRAD serves with a team of 17 consultant who are experienced in their field of service. A team of hazard communication experts serves our clients in SDS and label compliance for products placed on the market in Turkey and the EU. CRAD is also the first institution for training Chemical Assessment Experts (KDU) approved by Turkish Ministry of Environment. VITAL STATISTICS

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2020

Consultancy/advisory 40%

KKDIK (Turkish REACH) Compliance and OR services CRAD is ready to support you in KKDIK compliance with our team who have an extensive EU REACH regulation experience and expertise as well fluent both in English & Turkish. We do act as an OR for KKDIK preregistrations and registrations and provide KKDIK Compliance support in the below listed main context but not limited to; O OR Services O registration strategy consultancy- scope identification; O submission of pre-registrations-registration dossier; O SIEF Communication & follow up; O communication with DU; O consortium Management & data brokerage; O data management and data-gap analysis; O compilation of registration LR/JR dossiers; O conducting/compiling robust study summaries, CSR, CSA; O technical translation; O services that are obliged to be conducted by cCAE-KDU in accordance with KKDİK Provisions; O as an MoEU Accredited cCAE Training Institute providing KKDIK and CAE training and bespoke training for your team; O other applications and inquiry to MoEU such as authorization, PPORD etc; O full KKDIK compliance assessment; and O third Party Representative & Trustee services for CBI concerns. SEA (Turkish CLP) compliance and OR services UN GHS and EU CLP are implemented in Turkey by the Turkish SEA Regulation. Services provided to comply with SEA regulation are as below and more; O Acting as OR in accordance with article 41 of SEA; O classification of substances/mixtures placed on the Turkish Market; O SEA Compliant Turkish Label support; O C&L notification of substances to SEA C&L inventory; O follow up and report services for ATP’s applied to SEA Regulation; and O alternative name application for confidentiality. SDS Compliance services in accordance with Turkish SDS Regulation & KKDIK Annex II Turkish SDS provisions are unique when compared with EU SDS provisions. A compliant SDS should be compiled in accordance with the Turkish SDS regulation, in Turkish and by certified SDS compilers. After 31.12.2023 a SDS or e-SDS where applicable should be compiled by a cCAE. With a team of experts which all are certified SDS expert/ cCAE CRAD can compile Turkish SDS in accordance with Turkish SDS regulation as of today and KKDIK Annex II after 2023. O SDS Compilation in accordance with Turkish SDS regulation; O certified SDS Compiler review services; O consultancy support for enhancing the phrase library and format in accordance with Turkish SDS regulation; O bespoke SDS Compliance services for enterprises; O regular trainings for certified SDS compilers; O regular and Bespoke trainings on Turkish SDS compliance; and O submission of SDS to the SDS notification system of the MoEU.

Biocidal product regulation (Turkish BPR) compliance Compliance to Turkish BPR is essential to export and place on the Turkish market of Biocidal Products. As a procedure which is complex and challenging for the importers and CBI sensitive for the manufacturers of Biocidal Products OR & Trustee services become critical for CBI safe compliance to Turkish BPR. CRAD acts as a Registrant and Consultant for safeguarding your CBI while complying with BPR. O BPR Compliance Support and Consultancy; O acting as representative/ registrant; O label compliance in accordance with TR BPR; O compilation of Provisional application & registration dossier; O generation of compliant SDS & Label in according to Turkish SDS regulation/SEA Regulation with specific conditions that apply for BP; O consultancy on frame formulation structure; O strategy setup, organisation & consultancy for local testing; O compilation of active substance dossier; O bridging communication with Competent Authority; and O efficient bespoke compliance solutions. Bespoke reporting on compliance for chemical products & articles Many global companies are in the aim of expanding their range of products placed on the Turkish and neighbourhood markets. It becomes challenging when they fall in incompliance after they initiate the marketing activity. It is always time and cost wise to be aware of regulation to comply with before initiating your activities or expanding your product portfolio in a market that you are already on. Having an accurate advice in the form of a report prevents and protects you from after coming regulatory burden and penalties. CRAD Provides you bespoke, to the target reports before you initiate your activity, change your supply chain or expand your portfolio for the Turkish and neighbourhood markets. IT compliance & communication solutions IT Tools are essential components for compliance which are widely used by all stakeholders starting from Competent Authorities to Industry and the Downstream users. Regulations bring quite a workload related to obligatory communication up and down the supply chain and with the authorities and co-registrants. With our co-operators we do provide IT solutions for; O hazard Classification & SDS Compilation; O communication IT solutions for DU; O SIEF and Consortium management tools; O M2M submission & notification tools; O data brokerage systems; O IT solutions for SDS Distribution and PCN; and O labelling Software. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2008

CRAD established & staff certified as SDS author by TSE

2008

Market leader in REACH compliance services in Turkey

2009

CRAD launched services for Turkish regulatory compliance

2012

CRAD enlarged its offices to 420 sqm at its owned HQ .

2013

CRAD launched services to comply with Turkish SEA (CLP)

2014

CRAD started providing certified SDS author trainings

2015

Turkish SDS authored by CRAD exceeded 30,000 More than 3,000 substances notified to the Turkish C&L Inventory representing over 300 global chemical companies.

2017

CRAD is accredited by MoEU as the first cCAE training center

2019

All 17 service staff are accredited as cCAE-KDU per the provisions of KKDİK Annex 18- One and only among all KKDİK service providers

ACCREDITATIONS Approved Institute of training for cCAE by MoEU Certified SDS author (all team) Turquality and TSE certified consultant company 17 consultants are granted as cCAE under KKDİK Member of REACH discussion group at Turkish CA

CLIENTS Due to our confidentiality policy and the nature our business, we do not release the identity of our customers publicly. We do serve a portfolio of clients starting from multinational top listed global chemical industry actors to SME’s who are in the search of trustworthiness, expertise, stability and cost efficiency for their compliance process. As a reader of this profile you will soon be our client if you are not already. TESTIMONIALS The best of testimonials would be your own decision to select your consultant and OR taking the below listed questions in mind while making your preference: O Can I visit the premises of our OR with giving a short notice or no notice at all? O Is your OR a Legal Entity nothing more than a registered company at a shared lease office? O Is the consultant team of my OR transparent enough to me which I can become acquainted with every member of the team that I work with or they just declare as ‘’we are a team of consultants’’? O Does the consultant/OR who serves you have the risk of policy change as being owned/directed by an association whose board of directors that can change from time to time and even include directors from one of your competitors? O Are the consultants who serves you capable of fluent communication in Turkish for Competent Authority and DU’s and English with you? O Is your OR in Turkey a sub-branch of a non-Turkish consultant who can decide to cease the business in case of lack of business in future? O Is your OR financially independent – self sustained-and have the financial sources for a long-term service? Your replies to the above questions will lead you to the best testimonial that you can depend on. STAFF SELECTION CRAD team You can see the bio of our consultants on our web site transparently. For further information we are looking forward for your e-mail, phone call or even a visit for your convenience. Why to prefer working with CRAD: As a reply to the questions noted in the testimonials; we can define CRAD as below which we await your visit to eyewitness the truth. O We always welcome our clients to visit us to have a face to face meeting so that they can solidly meet the consultants they work with. O CRAD own’s its offices and not like post box Legal Entity or a company registered as a Lessee of a leased office service provider. O We are happy to give the bio of all our team members on our website as a Consultancy Service Provider in Turkey having the highest capacity and expertise with our number of team members. O We are a private owned Joint Stock Company by founding Partners Melih Babayigit and Nur Babayiğit. We are not owned by an association thus our directors don’t change depending on the association and organisation based on General Assembly. O All consultants at CRAD are Fluent in English at a proficiency level so you can easily communicate in English both written and spoken. They are as well experienced in the Technical Terminology of EU and Global regulations. O CRAD is a Consultancy Support and OR Service provider established in Turkey in 2007. Serving in a wide portfolio of services, existence of CRAD is not dependent to the level of income earned from a particular service area like KKDİK. By bearing this in mind, we are not like a ‘’Liaison office of a Global Consultant’’ which is established just for KKDIK only. Thus our existence in the long run is not dependent to KKDİK number of clients like some others. O CRAD, having its own offices and without any debts to any financial institution, and capable of long term running with owned equity. This enables us to invest on improvement and to resist the fast changing financial conditions. www.chemicalwatch.com/SPG

Profile: CRAD

113

Profile: CSB Online

114

SERVICE AREA BREAKDOWN Training 1% IT & software 20%

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

Our fields of expertise include:

Locations

Germany

Founded

1996

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.

Representation & management 4%

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

2018/19 -

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2020

Consultancy/advisory 66%

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: O Management of authorisation processes O Downstream-user consulting;and O 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: O Preparation of the mixture notification O Generation and management of UFIs O Submission through ECHA submission portal O 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: O approval of active substances; O application for national authorisation and/or mutual recognition of biocidal products; O application for Union authorisation of biocidal products; O application according Art 95; O application for technical equivalence; and O 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)

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

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.

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Profile: CSB Online

115

Profile: Danish Technology Institute

116

SERVICE AREA BREAKDOWN Other 22%

Consultancy/advisory 30%

CONTACTS Training 14%

Website

www.dti.dk/biocides

E-mail

mkl@dti.dk

Head office

Gregersensvej 3, DK-2630 Taastrup Denmark

Tel

+4572202337

GLOBAL OFFICES

Contact

Morten Klamer, Project Manager

Denmark

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%

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 Turnover, group Turnover, chemical service provision

2018/19 €151m €31m

No of offices

No of countries represented

Staff, group Staff, chemical service provision

Global Service Providers Guide 2020

1074 50

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. 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 claimed 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 – Business 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: DHI

118

GLOBAL OFFICES Australia, Austria, 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

https://tox.dhi.dk/en/ and www.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 Department

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 globally, currently with intense activity in the EU and Korea. We offer our customers a one-stop solution for regulatory services worldwide: O Guidance and strategic counselling on chemicals legislation and registration tasks; O Preparation of registration dossiers, safety assessments and testing strategies integrating use of QSAR and read-across; O Support to decisions on substances of very high concern. O Application for authorisation, analysis of alternatives and SEA. DHI offers to facilitate consortia, third party representation and only representative (OR) services in the UK, Korea and China. 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. Provider of chemicals management systems and regulatory data including worldwide lists on classification, substance names, exposure limits, CAS numbers, phrase modules with 4,500+ phrases in more than 40 languages.

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. We use our expert knowledge to support both industry and authorities across the world in assessing and managing the risks of chemical substances and products. VITAL STATISTICS

2018/19

Turnover, group

€110m

Turnover, chemical service provision

€3.7m

No of offices

No of countries represented Staff, group

26 1,100

Staff, chemical service provision

SERVICE AREA BREAKDOWN

IT & software 20%

Global Service Providers Guide 2020

Medical devices, pharmaceuticals and cosmetics DHI supports industry in achieving compliance with the regulation: O Documentation of biocompatibility and toxicological safety of medical devices according to the ISO 10993 standards; O Biological Evaluation Report according to ISO 10993-1 and US FDA guidelines; and O Preparation of cosmetic dossiers and safety assessments (CPSR). 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.

Training 1%

Representation & management 4%

Biocides and pesticides DHI offers regulatory and documentation assistance to industry and authorities: O consortia management for BPR authorisation; O preparation of dossiers on biocidal active substances, biocidal products and biocidal product families; O preparation of dossiers on active substances and plant protection products; O exposure and risk assessment O data search, data gap analyses, testing strategy O toxicological and ecotoxicological evaluations; and O phrasing of claims, notifications and expert reports.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS Consultancy/advisory 66%

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

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

STAFF SELECTION

2005

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

2013

Offices in 30 countries around the world

2018

DHI becomes DHI A/S, fully owned by the foundation DHI Fonden

Jens Tørsløv, PhD – Head of Department 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 the Department of Environment and Toxicology 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.

ACCREDITATIONS DHI works in accordance with the quality management system standard: O ISO 9001 as certified by Bureau Veritas. PARTNERS Consultancy: KIST-Europe (Korea), TsafeG (Korea). DHI has a wide network of EU and non-EU partners in order to supplement our expertise, for instance within the area of socio-economy CLIENTS DHI Environment and Toxicology provides regulatory compliance services to a large number of industries and industrial organisations within chemicals and the metal industry, pharmaceuticals and medico. We have a strong foothold in Korea together with our Korean partners, KIST and TsafeG Ltd. 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 DHI assisted 15 companies with formation of the ECA Consortium – a non-profit association dedicated to support the use of ECA (Electro Chemical Activation) technology. DHI facilitated the communication between the European regulatory bodies (EU Commission and ECHA – the European Chemicals Agency), the ECA Consortium and member state authorities. We conducted a 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.

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.

CASE STUDY 2: Registration in Korea (K-REACH) DHI has a successful partnership with the Korean Institute of Science and Technology (KIST) and TsafeG Ltd. We offer Korean speaking specialists in K-REACH and a partner with good connections to the Korean authorities. Our services include OR representation in Seoul, Consortium Management and preparation of K-REACH registration dossiers via our Korean partner TsafeG. Further services include compliance with the Korean BPR legislation.

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Profile: DHI

119

Profile: EBRC Consulting

120

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: O data gathering, literature searches, and evaluation; O data gap analysis, closing of data gaps, and study monitoring; O chemical safety assessment (CSA) and report (CSR); O PBT and vPvB assessment; O technical dossier (Iuclid 6); O identification of known uses; O development of exposure scenarios for HH and ENV; O risk characterisation; O classification and labelling; O safety data sheets; O consortium and Sief management; and O 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

2018/19

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 2020

Agrochemicals Active substance approval and national product registration. EU notification of active substances governed under regulation (EC) No 1107/2009: O support of existing substances in the context of the renewal O programme of the EU (AIR); O support of new active substances; O completeness checks, validation of existing studies, literature surveys; and O 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: O aII dossiers (dRRs) for registration and re-registration of plant protection products, label extensions and formulation changes; O 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 O 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. O active substances (Inclusion into the BPR list of approved substances [Reg (EU) No 528/2012]) O biocidal products (registration/authorisation in EU member states) O task force/consortia management; and O 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: O statistical (re-)evaluation of data; O implementation of EU-models and/or scenarios (eg as given in OECD emission scenario documents); O ready-to-use spreadsheet solutions for various applications (eg substance specification); O probabilistic exposure assessments; O derivation of species sensitivity distributions; and O 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: O importing and (re-)structuring of data; O online generation status update reports; and O 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

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.

On behalf of Eurometeaux, 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. 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

121

Profile: ERBC S.r.l.

122

SERVICE AREA BREAKDOWN

CONTACTS Laboratory 100%

Website

www.erbc-group.com

E-mail

info@erbc-group.com

Head office

ERBC Group – Chemin de Montifault, 18800 Baugy, France

Tel

+33 / +39 06 91095263

GLOBAL OFFICES

Fax

+33 / +39 06 9122233

ERBC SAS. – Chemin de Montifault, 18800 Baugy, France ERBC SrL. – Via Tito Speri 12/14, 00071 Pomezia (Rome), Italy

Directors

Serge Richard (CEO), Christophe Priou (COO), Frank Visser (CCO)

SERVICES PROVIDED

Ownership

Privately owned

Locations

France (HQ) and Italy

Founded

2019

OVERVIEW Stemming from the merger of two reference CRO’s in pharmacology and toxicology (CERB and RTC), ERBC is a European leader in nonclinical studies. It offers to healthcare and chemical professionals a comprehensive range of experimental capabilities, preclinical models, regulatory pre-IND package and consultancy services to de-risk innovation and improve R&D productivity. Based in Baugy, near Paris (France) and in Pomezia, near Rome (Italy), ERBC provides all services from preclinical proof-of-concept to market of any type of drug candidate or chemical compound. Each project is managed by a study director, relying on a multi-disciplinary team of experts, notably in general, genetic and reproductive toxicolo-gy, carcinogenicity, pharmacology and safety pharmacology, non-clinical cardiology, electrophysiology and pathophysiology, also benefit-ing from a world class academic and private network. Every year, study reports from our two centers are successfully used in support of market authorization of new product approval submis-sions around the world, including the European (EMA, Echa), US (FDA and EPA) and Japanese (MHLW and MAFF) regulatory authorities. Investment in outstanding scientific and technical manpower, high-tech equipment and facilities are crucial cornerstones of our sound and organic growth. The quality and reliability of our performance is reflected by the many ongoing and long-lasting collaborations we maintain with leading international pharmaceutical and chemical companies. ERBC is deeply engaged in animal ethics and welfare. ERBC supports the Basel Declaration, respects the 3R’s concept and continually improves its tools and procedures to maximise the balance between the benefit for health and the animal well-being. VITAL STATISTICS No of offices Staff, group

2017/18 9 1074

Genetic, in chemico and in vitro toxicology General toxicology, carcinogenicity Reproductive toxicology and Juvenile toxicology Preclinical proof-of-concept and early safety Safety pharmacology and general pharmacology (in vitro and in vivo) Analytical support (PK/PD & metabolism, analytical chemistry, bioanalysis, immunology, pathology) Infrastructure and team include: O Animal facilities: dedicated facilities for each species (rodents, non-rodents including non-human primates) with surgical suites and histopathological laboratories; O analytical laboratories (small and large molecules) for GLP and nonGLP analyses; O secured data center; O project coordination and management; O full study reporting including SEND; and O a multi-disciplinary team of experts: toxicologists, pathologists, pharmacologists, biologists, pharmacists, chemists, veterinarians and engineers. To maintain its leadership, ERBC is continually investing in highly trained scientists and state-of-the-art technologies. The company has also established, and continues to set up, strategic scientific and technological partnerships both with academia and industry. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1972

Foundation of Italian facilities (RTC)

1973

Foundation of French facilities (CERB)

1987

First GLP certification

2012

AAALAC accreditation

2014

Start of cooperation between CERB and RTC

2019

Foundation of ERBC, merging CERB and RTC

ACCREDITATIONS AAALAC GLP FDA approved ISO 14001:2004 BS OHSAS 18001:2007 EcoVadis PARTNERS We collaborate with partner laboratories for eco-toxicology, physicochemical properties, inhalation studies and regulatory support.

Global Service Providers Guide 2020

TESTIMONALS

STAFF SELECTION

Testimonials can be provided upon request.

Pascal Champeroux – Chief Scientific Officer, Senior Expert in Pharmacology (cardiovascular) and Safety Pharmacology Silvana Venturella – Associate Scientific Director, Head Business Unit In Vivo Toxicology Serena Cinelli – Associate Scientific Director, Head Business Unit Genetic and In Vitro Toxicology Rosaria Cicalese – Expert in Reproductive toxicity Studies, Senior Study Director Cristina Longobardi – Expert in Industrial Toxicology, Senior Study Director Francesca Calfapietra – Head & Expert, Analytical Chemistry Department Jean-Michel Raimbault – Head & Expert, Analytical Chemistry Marie-Laure Sola – Expert General Toxicology Christine Laigot – Senior Expert General Pharmacology Armelle Bouchard – Senior Expert Alternative In Vitro Toxicology and Cell Cultures Vincent Maleysson – Senior Expert, CNS stereotaxy Sébastien Judé – Senior Expert Cadiology

CLIENTS We serve a wide range of clients, from SME’s to global corporations, consortia and industry associations worldwide. Confidentiality agreements preclude the possibility of naming them. CASE STUDY ERBC works hand in hand with academic and industrial partners during the early stages of drug development to demonstrate the pre-clinical proof-of-concept of the test compound, ultimately aiming to convert it into a drug candidate. ERBC performs a range of in vivo assays and offers numerous animal models of human diseases covering almost all therapeutic areas. At ERBC, we consider this initial step of in vivo proof-of-concept studies as essential to minimize risks of late attrition during clinical trials reminding that the lack of efficacy in the clinic is one of first cause of late attrition during drug development. ERBC offers the clear ad-vantage to run these pivotal studies under GLP (Good Laboratory Practice). Very often, the development of New Chemical Entities (NCE) must be stopped following abnormal toxicity, safety margin issue, mutagenicity, cardiovascular or neurological adverse effects. To detect these deleterious events as early as possible, ERBC conducts exploratory safety programs combining in vitro and in vivo toxicity assays (in rodent and non-rodent species) and predictive biomarkers. To optimise the costs and timing, the administrative work is minimised as much as possible, the experimental procedures are described in standard study plans, and all details specific to each study will be described in an information study sheet Low costs are also achieved through reduction of animal number while sensitivity is maintained by using low variability model, appropriate statistical designs (biostatisticians in the team) and application of very powerful approach such as the probabilistic method. In the same way, a summary report including the results of each test in each model, the interpretation of results and a description of the experimental methods are issued just after the end of the ultimate experimental phase (less than two weeks after the last experimentation). With over 200 validated methods and models, a facilitated access to patient samples and a world class academic and industrial network, ERBC is uniquely positioned to establish the preclinical proof-of-concept of any therapies. Thus, by performing in vitro functional assays and custom-designed assays and assessing the therapeutic effect of the test compound in relevant animal models, ERBC converts next-generation therapeutics into validated drug candidates across almost all therapeutic areas and indications (except infectious diseases). In addition, the company also conducts exploratory programs that allow early detection of deleterious adverse effect and toxicity induced by new chemical entities. Together, these translational studies contribute to clarify the mecha-nism of action of the drug candidate and obviously, to improve risk-taking and decision making. To establish the toxicological profile of new compounds or to extend the known profiles of existing one (new indications, new formulations, new routes of administration…), ERBC offers a full range of services covering from exploratory programs to fully GLP-compliant toxicology studies. The latter range from acute to chronic toxicity – with different species and multiple routes of administration – to specialty toxicology. These data support human clinical trials and marketing authorization approval around the world. Today, the company is a leading innovator in the discipline. ERBC scientists develop advanced tools, assays and models that contribute to reduce the use of animals and improve data predictivity and partici-pate in interdisciplinary working groups that shape the future of toxicology.

www.chemicalwatch.com/SPG

Profile: ERBC S.r.l.

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Profile: Eurofins

124

GLOBAL OFFICES Eurofins is located globally in 47 countries. Our main testing facilities for chemical / REACH services are located in Germany, UK, China and the USA. CONTACTS Website

www.eurofins.com

E-mail

erssinfo@eurofins.com

Head office

Brussels, Belgium

Tel

+44 (0)1332 864800

Contact

Brad Dayton

Directors

Gilles Martin, Chief Executive Officer

Locations

800 locations worldwide

Founded

1987

SERVICES PROVIDED For the chemical, agrochemical, pharmaceutical, veterinary medicine, biocides, cosmetics and food industry Eurofins offers a broad scope of biological safety studies, which meet international regulatory requirements and includes the following services. Toxicology for chemicals, agrochemicals, biocides and food additives In co-operation with our AAALAC-accredited partner laboratories, all relevant toxicology services for chemicals, agrochemicals and biocides are provided. This includes the classical in vivo studies from acute to repeated dose and teratogenicity studies. Emphasis is placed 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: O O O

OVERVIEW

With more than €3.7bn annual revenues in 2018 and over 45,000 staff in more than 800 laboratories across 47 countries*, Eurofins is a global leader in the pharmaceutical, food and environmental testing market and offers 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 saw the addition of a highly complementary business to the existing Eurofins services in terms of capabilities/capacities and particularly geography. This makes Eurofins the only global solution provider capable of providing a full suite of services for clients in the Chemical industry to perform required research services for government regulatory approvals in North America, Europe, Asia and Latin America. We are able to offer support during the registration process for a huge variety of chemicals across many industry sectors. In vivo toxicology services are offered in cooperation with BSL BIOSERVICE Scientific Laboratories Munich GmbH. *reported in 2019 VITAL STATISTICS

2018/19

Turnover, group

€3.7bn

No of offices

800

No of countries represented

Staff, group

>45,000

SERVICE AREA BREAKDOWN Consultancy/advisory 10%

O O O O O O O O

irritation/corrosion (in vitro/ in vivo); sensitisation (in vitro /in vivo); dermal absorption (in vitro/in vivo); OECD 427 / 428 genetic toxicity (in vitro/in vivo); acute toxicity; repeated dose toxicity; reproductive and developmental toxicity (DART); toxicokinetics, ADME; carcinogenicity; neurotoxicity; endocrine disruptor testing; and mode of action studies.

Avian Safety Studies With one of the largest and most respected avian safety 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. 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 with a full complement of ground and surface water monitoring, dislodgeable foliar residues, magnitude of residue analyses, as well as worker and domestic exposure studies.

Laboratory 90%

Global Service Providers Guide 2020

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.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

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 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 offer the majority of anticipated studies related to Endocrine Disruptor screening and testing. 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 O mutagenicity, clastogenicity, carcinogenicity; O skin and eye irritation/corrosion – several models; O dermal absorption; O photo-induced toxicity; O reproductive toxicity (embryonic stem cell test); and O 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 in 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. All angles are considered, substance properties as well as the interdependency of many studies required e.g. for REACH, cosmetics and agrochemicals. Our experienced team of regulatory experts can support you through the agrochemical registration process starting with data gap analysis through to 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.

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. Dr. Martin Traub, Scientific Manager, EAS EcoChem Head of program management and central services. Martin has worked at EAS Group since 2008 and was previously responsible for environmental fate, metabolism and analytical chemistry (European region) 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. Vincent Dreze, BU Manager Eurofins Agroscience 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.

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Profile: Eurofins

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Profile: Exponent International Limited

126

SERVICES PROVIDED REACH and Persistent Organic Pollutants (POPs) 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 regulatory strategy and advice, nanomaterials testing, data evaluation, read-across and intelligent testing strategies, followed by study placement and monitoring. We prepare and submit registration dossiers and chemical safety reports including exposure assessments and risk characterisation. Our expertise also includes dossier and substance evaluation, updates of registrations, restrictions, applications for authorisation and article notifications. Exponent has significant experience in SIEF and consortia management and we can also act as your only representative registrant or third party representative in both the EU and UK. Our consultants have expertise in assessing the implications of the EU POPs Regulation for your business, including their relationship to REACH.

CONTACTS Website

www.exponent.com

E-mail

jreddy@uk.exponent.com

Head office

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

Contact

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

Directors

Julian Reddy

Ownership

Wholly owned subsidiary of Exponent Inc.

Locations

Harrogate, Derby, London and Edinburgh, UK; Dublin, Ireland and 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 Turnover, group

2018/19 Est US$ 22m

Turnover, chemical service provision

Est US$ 5m

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 OFFICES Global head office (Exponent Inc): 149 Commonwealth Drive, Menlo Park, CA 94025, US. Plus numerous other offices in the US, UK, Ireland, Switzerland and China. Global Service Providers Guide 2020

Global chemical notifications and the Stockholm Convention (POPs) 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, Russia (EAEU), Taiwan and Turkey and can call upon the experience of our US colleagues for TSCA notifications. Exponent also has expertise in providing regulatory support for substances being considered for inclusion in the Stockholm Convention and its implementation. 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 online channels to a global market. Services provided include ‘hot line’ regulatory consultancy, provision of cosmetic product safety reports, ingredient safety reports, toxicity risk assessments, product formula and labelling reviews, product information auditing, help with ingredient selection, advice for new product development and investigation of production issues. We also can review candles, household fragrances and air fresheners for compliance in the UK, EU and USA. 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 or UK and act as the responsible person. For this service the Exponent company name and address is printed on the product label. As an international company with offices in both the UK and the Republic of Ireland, Exponent can provide both a UK and an EU address assuring continuity of compliance for our clients with a single English language product information file. 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.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

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.

1967

Parent company Exponent Inc formed.

CASE STUDY 2: Global regulatory support

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.

2018

Regulatory staff recruited to our Asian offices in Shanghai and Hong Kong.

2019

Dublin, Ireland office opened.

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.

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 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 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. 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 in the REACH registration 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.

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 requirements for a number of regulatory regimes can be reused effectively 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 (where we have staff in Shanghai) 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 19 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. Mr Iain Brunning – Head of Cosmetics Mr Brunning leads Exponent’s Cosmetics business and is an experienced consultant with over 30 years’ experience working in cosmetics regulations and FMCG retail.

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Profile: Exponent International Limited

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Profile: Fieldfisher LLP

128

GLOBAL OFFICES Amsterdam, Barcelona, Beijing, Belfast (x2), 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

Directors

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

Ownership

Limited Liability Partnership

Locations

Founded

1835

SERVICES PROVIDED

OVERVIEW Fieldfisher is a full service European law firm comprising over 720 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

No of offices

No of countries represented

Staff, group

1550

Staff, chemical service provision

Biocides The biocides team is the longest established in the EU. We provide 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. We offer expert advice on the national member state regulations of biocidal active substances/product type combinations during the review programme. Its expertise encompasses all EU member states. We also provide support in making biocidal product authorisation applications in the member states. We have broad experience in providing expert advice on data sharing/compensation agreements, as such or in the context of distribution/purchasing or other arrangements. We have an in-depth knowledge of the free rider and EU competition law issues at stake. We guide 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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Training Consultancy/advisory 5% 10% Representation & management 10% IT & software 5%

Global Service Providers Guide 2020

Agrochemicals/fertilisers We have established a reputation of excellence for more than two decades, advising major pesticide manufacturers on the European reregistration programme laid down by Regulation 1107/2009, including the renewal programmes under the so-called AIR regulations, as well as follow-up re-registration activity. 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. We address these issues at both an EU-wide and member state level and are particularly 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.

SERVICE AREA BREAKDOWN

Legal 70%

Chemicals With more than 20 years of experience, EU chemical law – compliance and litigation – is a core area of expertise. 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 companies or for groups of companies (industry associations, task forces or consortia).

2007

Fieldfisher’s office and EU Regulatory practice established in Brussels

2010

Interim Order from the President of the EU General Court won to suspend an Echa decision regarding the REACH candidate list – the first of its kind.

2011

First ever appeal filed before the Echa Board of Appeal and successful obtaining reversal of the Echa decision thereby maintaining client details as confidential.

20122015

Ground breaking annulment actions filed 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).

20162020

Management of about 40 consortia under REACH, BPR and pesticides renewals and acts as financial trustee and legal secretary.

ACCREDITATIONS The Legal 500 Claudio Mereu’s practice at Fieldfisher is notably adept in the EU chemical regulatory sphere; recent work includes REACH, biocide and pesticide matters. (2019) Chambers & Partners Clients praise the firm for having “an excellent team with accumulated expertise.” (2020) 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: Taminco BVBA, Belgium, and performance additives Italy SpA, Italy On 29 January 2020, Echa’s Board of Appeal annulled an Echa decision which requested an additional combined developmental neurotoxicity study and neurotoxicity study in rats as part of the substance evaluation of zinc bis dimethyldithiocarbamate (Ziram) (case A-008-2018). Ziram is registered under the REACH regulation at a tonnage band of 100-1000 tonnes per annum, covering the manufacture, formulation and industrial use as a vulcanisation agent in rubber and latex production in the EU. As part of the process for evaluating Ziram under REACH with respect to identified concerns for developmental neurotoxicity and parkinsonian disorders, Echa requested further information from the appellants in the form of a combined developmental neurotoxicity study and neurotoxicity study in rats. The appellants contested the decision on five grounds, including Echa’s failure to meet the required legal standard for requesting information for substance evaluation under Article 46 of REACH. They argued that Echa had failed to satisfy any of the criteria established by the BoA in its three-tier test for requesting information under substance evaluation: Echa must firstly show that the substance presents a potential risk to the environment or to human health; it must also demonstrate that the potential risk needs to be clarified; and it must show that the requested information has a realistic possibility of leading to improved risk management measures. With respect to the “potential risk” in relation to parkinsonian disorders, the BoA found that the epidemiological and mEchanistic studies relied on by Echa demonstrated little or no evidence of a link between parkinsonian disorders and exposure to Ziram. Consequently, Echa had not presented sufficient evidence to demonstrate a potential risk, and the request for further information was unjustified. The BoA therefore annulled Echa’s decision insofar as it related to the neurotoxicity study. Regarding the concern for developmental neurotoxicity, the BoA took into consideration its annulment of the first part of the combined study.

Accordingly, if it were to uphold the request for the second part of the study, this would entail an amendment of Echa’s decision and the adoption of its own decision ordering the Appellants to perform the developmental neurotoxicity study. However, in examining the available evidence concerning this part of Echa’s decision, the BoA concluded that it did not provide sufficient information for it to be able to decide whether the requested developmental neurotoxicity study, when performed without the neurotoxicity study, would provide additional information to that already in the Appellants’ dossier, and that it was therefore unable to replace Echa’s decision with its own decision requesting such study. The BoA therefore annulled Echa’s decision in its entirety and remitted it to Echa for further action regarding the developmental neurotoxicity study. It should also be noted that the BoA rejected the Appellants’ initial claim that Echa had failed to identify a ‘real risk’ of parkinsonian disorders caused by exposure to Ziram, considering that this threshold was too high in light of REACH’s human health and environmental protection aims. The BoA confirmed that Echa’s obligation under the three-tier test is to establish a ‘potential risk’ – albeit not a purely hypothetical one – and not an ‘actual risk’, and then proceeded to examine whether a ‘potential risk’ had been established, as claimed by Echa. The BoA’s decision clearly sharpens the standard of precision that Echa must meet when seeking to justify a request for further information at substance evaluation with the demonstration of a potential risk. Furthermore, with regard to Echa’s conclusions in the contested decision that certain studies in the Appellants’ dossier “cannot be used to negate” the parkinsonian disorder concern, the BoA recalled that the burden of proof under the substance evaluation process rests on Echa to demonstrate that a request for information is necessary, and not on a registrant to prove that there is no concern. STAFF SELECTION Claudio Mereu – Joint Managing Partner, EU Regulatory partner, Belgium Koen Van Maldegem – EU Regulatory Partner, Belgium Peter Sellar – EU Regulatory Partner, Belgium

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Profile: Fieldfisher LLP

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Profile: FoBiG

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SERVICES PROVIDED REACH registration FoBiG provides full-scale scientific support to meet industry’s REACH obligations: O 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) covering all endpoints (physico- chemical properties, human health, environmental fate and ecotoxicity); O classification and labelling according to CLP Regulation; O PBT/vPvB assessments; and O (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

REACH authorisation Together with our partner RPA Ltd, FoBiG prepares complete dossiers for submitting applications for authorisation with: O CSRs according to authorisation requirements, including a refined exposure assessment to demonstrate implementation of suitable RMMs/OCs and acceptable remaining risks; O analysis of alternatives; O socio-economic analysis; O complete application for authorisation dossier (Iuclid 6); O support for communication with Echa during the process (eg in TIS, telephone information sessions); and O post-submission services (eg communication with Echa and Rac/ Seac on submitted dossiers, trialogue meetings). Up to now FoBiG was/is involved in preparing initial applications for authorisations as well as review reports for 16 substances and numerous uses for single companies, small and large consortia.

OVERVIEW FoBiG is a privately owned consultancy specialising in toxicological and ecotoxicological risk assessment, with now more than 27 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, including review reports. 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

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).

2018/19 €1m

No of offices

No of countries represented

Europe-wide

Staff, group

Staff, chemical service provision

Pharmaceuticals and medical devices Scientific services for pharmaceutical companies and for manufacture of medical devices include: O derivation of PDE (permitted daily exposure) according to EMA guidelines for residual substances (eg for use in cleaning validation); and O assessment of impurities, including application of TTC (threshold of toxicological concern) approaches.

SERVICE AREA BREAKDOWN Training Other Information 2% 1% 5% Representation & management 2%

Consultancy/advisory 90%

Global Service Providers Guide 2020

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.

Occupational toxicology (Company-specific) occupational exposure limits (OELs) for threshold and non-threshold substances (the latter based on an analysis of exposure-risk-relationships) 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 dose-response 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 F. Kalberlah, K. Schneider, M. Hassauer.

2009

New company partner Jan Oltmanns.

2018

F. Kalberlah and M. 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 REACH 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 O

O O

Chemical and pharmaceutical companies (from multinational to small- and medium-sized); EU institutions (eg Efsa, several Directorates General (DG) of the European Commission); (German) federal and other authorities (eg BfR, Baua, UBA); and 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: O category formation/grouping based on structural relationship; O read-across from metabolites to parent compounds or vice versa; and O 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.

Experience from authorisation projects clearly shows that CSRs from registration dossiers need to be improved. 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. FoBiG drafted the first authorisation review report CSR for which RAC/SEAC recommended a review period of 12 years. 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 Echa will increase the numbers and the scope of their dossier evaluations. Increasingly, CSRs will be targeted by evaluations. Consequently, updating various parts of registration dossiers (regarding data requirements, exposure assessment, risk characterization) might become necessary. 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). With regard to substance evaluation, companies with Corap-listed substances should adopt a proactive position, communicate with the competent authority, and try to reduce existing concerns. 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 Jan Oltmanns, MSc, PgDip Key areas: Exposure assessment (workers, consumers, environment). Ulrike Schuhmacher-Wolz, PhD, ERT, Fachtoxikologin DGPT Key areas: reproductive toxicology and endocrine disruptors Karin Heine, PhD, ERT, Fachtoxikologin DGPT Key areas: in vitro toxicology, 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

CASE STUDY 2: Application for authorisation: refined CSR For non-threshold substances such as carcinogens key to a successful application for authorisation is: O use of exposure-risk relationships, which are scientifically sound and O acceptable to RAC; O documentation of implementation of suitable measures to reduce emission and exposure; and O refinement of the exposure assessment to derive realistic exposure estimates to demonstrate minimisation of risks and to conclude on low remaining risks associated with the use for which authorisation is sought.

www.chemicalwatch.com/SPG

Profile: FoBiG

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Profile: GBK GmbH Global Regulatory Compliance

132

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: O free market incentives for responsible handling of dangerous substances and goods are created by purchasing certified commodities; O as consumer interest in finished goods increases, companies have the opportunity to comply with the proper standards; O simplified and fast customer clearance; and O reinforcement of sales network.

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

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.

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

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

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 2020

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: O access to a professional emergency call centre (24 hours /7 days/365 days per year); O emergency telephone number in 190 languages; O fulfilment of your legal obligations; O realisation of all airline and shipping company requirements; O medical advice in case of poisoning; O additional service in the USA: waste management; O fulfilment of regional requirements on an emergency service; and O comprehensive support in case of accidents with chemicals. Your benefits O you provide us with the required information – we’ll take care of the rest; O we take on your legal responsibilities; O you assume the responsibility to an external service provider; and O 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 O substance/product registration in Europe, USA and Japan, China, Korea and Australia (other countries on request); and O consulting services in connection with the registration. Your benefits O compliance together with reduced costs; O legal responsibilities met by an external adviser; service with more than 30 years of professional experience; and O excellent price/performance ratio Dangerous goods safety advisor/dangerous goods services Due to major accidents occurring during the transport of dangerous goods, the German implemented a responsible person in each legal 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: O taking over the responsibility of safety adviser for all modes of transport (road, rail, barge, sea); O classification/labelling of substances and preparations including evaluation of suitable packaging; O ongoing consultation for your organisation; O development of process-oriented checklists; O regular training to ensure your employees always act in compliance with all applicable regulations; O periodical audits guarantee to detect possible weak areas; and O providing an IATA/DOT/IMDG compliant 24/7 emergency telephone number. Your benefits: O we take on your legal responsibilities; O reduction of internal fixed costs; O fully experienced advisers offering high quality services; O legal and organisational consulting regarding EHS; and O 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) O Asian-Pacific and Chinese chemical legislation; O United States and Canadian hazard communication; O MSDS/SDS Authoring expert training; O training for dangerous goods safety advisers; and O 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: O clearly reducing operating costs thru optimizing and completely switch the process to electronical document management also now for dangerous goods; O 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 O 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, Hangzhou, China

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-/logistic-law 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

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Profile: GPC

134

GLOBAL OFFICES Sweden, with affiliates in India, South Korea, Ireland, United Kingdom, Turkey, Taiwan and Russia. CONTACTS Website

SERVICES PROVIDED gpcgateway.com

E-mail

info@gpcregulatory.com

Head office

IDEON Science Park, Beta 5, Scheelevägen 17, 223 70 LUND Sweden

Tel

+46 46 2114615

Ownership

GPC Holding, Sweden.

Locations

Sweden, India, South Korea, Ireland, United Kingdom, Turkey, Russia and Thailand.

Founded

2008

OVERVIEW Global Product Compliance (GPC) specialises in Global Regulatory Compliance Solutions across sectors globally. SSS Europe, a familiar name in chemical regulatory and compliance services now formally belongs under the umbrella of GPC Holding Sweden. Since 2008, we have emerged as one of the leading names among global regulatory compliance service providers with representation services in Europe, Asia and Middle East for respective chemical 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 172 companies opting to switch over to us from other service providers, for better and cost effective services. Our extensive experience in regulatory compliance support services started with EU REACH but our large client base has motivated us to venture into every new regulation that has emerged over the past few years like Cosmetics Regulations (EU, India and the USA), Korea and Turkey REACH, and the regulations in the UK, Russia, Australia, Taiwan, Japan, China, US, Canada etc. GPC is also actively contributing towards the finalization of India’s chemical regulation and policy. Indian Ministry of Commerce has commissioned GPC for several studies and reports which have contributed significantly to the upcoming Indian Chemical (Management and Safety) rules. SERVICE AREA BREAKDOWN Training 10% Legal 10%

IT & software 10%

Consultancy/advisory 50%

Laboratory 10% Representation & management 10%

Global Service Providers Guide 2020

Our specialized regulatory areas are: Indian Chemical (Management and Safety) Rules; O EU-REACH; O UK-REACH; O Eurasia REACH; O Turkey REACH; O Korea-REACH; O Taiwan Regulation; and O Cosmetics Regulation (EU, India, USA). O

Within the above regulations, we comprehensively deal with a broad range of services such as (but not limited to): O Registrations & Notifications (pre and late pre-registration/prenotification); O global regulatory compliance and status assessment; O substance and dossier evaluation process management; O lead registration activity, technical dossier preparation; O contract study management & monitoring; O compliance verification and certificates; O REACH & CLP compliant SDS and Extended SDS (e-SDS); and O SDS translations in over 30 languages. Global Chemical Regulation Service portfolio: O Manages a portfolio of over 9000 substances for its clients; O client base of over 1000 clients. O registered over 1200 substances for our clients; O lead registration & consortia management experience with over 400 substances; O over 9000 pre-registrations and notifications within chemical and cosmetic regulations, globally; O translated SDS in over 30 languages with combined authoring of over 4200 REACH and CLP compliant SDSs and over 320 e-SDSs. O extensive network of OECD-GLP certified CROs to manage toxicological, eco-toxicological, environmental and phys-chem studies; and O developed and deployed a fully automated compliance certificates management system called ‘Supply Chain Communication Portal’ for seamless regulatory communication and due diligence – between supplier, buyer and OR. The portal is used by over 4000 users. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2010

35 REACH registrations successfully completed.

2010

Delivered 1,500 REACH and CLP compliant SDS.

2011

Mandated as lead registrant for 50 substances.

2012

Mandated as lead registrant for over 60 additional substances.

2013

Registered over 225 chemicals by the 2013 EU -REACH deadline.

2014

Over 20 companies switched over from other ORs.

2015

Group company is accredited as a certified inspection body.

2016

GPC established an affiliate in S. Korea to offer services pertaining to K-REACH compliance.

2016

Collaboration with Lund University, Sweden; in the area of Toxicology.

2017

Successfully added over 400 new substances to its portfolio, via pre-registrations and notifications.

2018

Completed registrations for all the requests received well within the last EU REACH Registration deadline of May 2018.

2018

Successfully completed requested registrations within the first Korea REACH registrations deadline of June 2018.

2018

Business affiliates in the UK and Ireland.

2019

Collaboration with DTU, Denmark, in the field of Ecotoxicology and Environmental Fate.

2019

Initiated Eurasia and Turkey REACH services.

2019

Signed MOU with Chemtopia, South Korea, National Institute of Industrial Engineering (NITIE) and Centre for Cellular and Molecular Biology (CCMB), India.

2020

Business Affiliate in Turkey.

2020

Business Affiliate in Taiwan.

2020

Business Affiliate in Russia.

CASE STUDY 3: Automation of Compliance Process Management

Centre for Cellular & Molecular Biology (CSIR-CCMB) Danish Technical University, DTU Chemtopia, South Korea Confederation of Indian industry (CII), India China International Electronic Commerce Center (CIECC), China Tisamax Technical Co Ltd (Tisamax), Taiwan Randis ChemWise (Shanghai) Co Ltd, China Associated with Ricardo’s CareChem24 chemical emergency helpline

To further streamline our clients’ compliance management process, GPC has developed an in-house fully automated end-to-end software solution called ‘Compliance Process Management Portal’ which gives our clients, access to three main components: O Compliance Initiation: Here clients can request services and ask for preregistrations, registrations, and notifications. They also have their personalized compliance dashboard wherein they can maintain, manage and update their complete compliance-related information and can request further services (everything mentioned above under the services provided section and more). O Consortia Management: This section provides clients with an endto-end solution of the lead registration process, including requesting and managing all informationnrelated to consortia management. For example, Syndication, LoA, administration of agreements and assignments, documentation and archiving, etc. O Supply Chain Communication: It is a compliance certificates management system called for seamless regulatory communication and due diligence – between supplier, buyer, and the OR. Currently, the portal handles requests from ~4000 users. Indeed, as part of our mutual reliance growth cycle, all the above is freeto-use for our clients.

CLIENTS

CASE STUDY 4: Emphasis on Research and Development (R&D)

GPC has over 1000 clients in the industrial and specialty chemical and petrochemical industry, as well as the following industries: agrochemical, food color, cosmetic, electrical and electronics, automotive industry, leather, garment and apparel, plastic, rubber, steel, writing instruments and polymers.

On the service quality criteria, 88% of our client companies have rated the compliance assistance services being offered by GPC as very good.

Capacity building is integral to the success of an organisation, especially in our regulatory compliance field, where ‘change is a constant’ – where each year we see newer regulations being imposed. To sustain in this changing environment, we strongly believe that our knowledge is our strength. Thus, for effective training and development of our work force, we have engaged in strategic tie-ups with esteemed research institutions like the Technical University of Denmark (DTU), Denmark; Lund University, Sweden; Council for Scientific and Industrial Research (CSIR)–- Centre for Cellular and Molecular Biology (CCMB), and National Institute of Industrial Engineering (NITIE), India.

CASE STUDY 1: Sustainable Growth

CASE STUDY 5: Contribution to Indian Chemical Policy

Predecessor of GPC was set up in the year 2008, with a view to provide Regulatory compliance services to chemical exporters, exporting to Europe. We started off with the European regulation REACH and gradually moved on to other regulations like the K-REACH, Turkey REACH, UK REACH, Taiwan Regulation etc. Today we are catering to clients from over 35 countries in Europe, Asia, Middle-East and South-East Asia, with about 99% customer retention (Client loyalty). Our prompt and excellent, yet cost-effective services have helped us garner over 1000 clients across the globe. We have also had over 172 companies opting to switch-over to us from other service providers, for better and costeffective services. With each new regulation, we have also extensively invested in skill development and capacity building. Thus, GPC has been steadily growing, both, in terms of its technical knowledge and expertise.

The vast experience that we have gained while working on EU’s REACH Regulation for Indian companies, has helped us to understand the Indian Chemical Industry and its trends. We have been closely working with the relevant Government Ministries in India, in finalizing the draft Indian Chemical regulation – Indian Chemical (Management & Safety) Rules. In this context, several background studies and papers have been submitted by us, on request from the Indian Ministry of Commerce. GPC is part of the technical committee responsible for drafting these regulations.

PARTNERS

TESTIMONIALS

CASE STUDY 2: Mutual Reliance We believe and acknowledge the fact that our clients have played an important role in our growth and vice versa. It was primarily their plan of expansion to newer regions and product sectors, which encouraged us to learn and explore newer and upcoming regulations, solely to help our clients comply with newer regulations and help them expand their businesses. Over the years, GPC has diversified its services by developing capacities and competencies and has evolved with the changing regulatory landscapes. As a result, today, we work within the chemicals, cosmetics, pharmaceuticals, agro-chemicals, textiles & garments, leather, electronic components and auto components sectors in over ten countries, and EU and Eurasia as regions.

STAFF SELECTION Mr Shisher Kumra, Executive Director Mr Shrirang Bhoot, Chief Technical Officer Dr Martina Holst, Head of Laboratory, Sweden Dr Zsuzsanna Szepesi, Sr Toxicologist Dr Anders Bergqvist, Sr Toxicologist Mr Mangesh Barbate, Evaluation Process Manager Dr Vaibhav Diwan, Business Development Manager Dr Yashwant B, Eco-toxicologist Dr Shweta Deoskar, Senior Chemist Dr Shweta Dalwee, Lab Manager, India Dr Vaibhav Gujar, Analytical Chemist Ms Ketki Kulkarni, Regulatory Expert Mr Keith Yongho Jung, South Korean Regulation Executive Ms Priyanka Manapure, UK REACH Coordinator Ms Ahra Jung, South Korea Business Co-Ordinator Dr Chia-Sui Hsu, South East Asia Business Co-Ordinator Mr Mirac Mert Pelister, Business Contact – Turkey Ms Elena Kondryukona, Eurasia Business Co-Ordinator

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Profile: GPC

135

Profile: H2 Compliance

136

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

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 Beth Bidstrup

Ownership

Part of the Landbell group of Companies

Locations

6 (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 supports 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 OR. 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, PCN, 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

2018/19

Turnover, group

Not declared

Turnover, chemical service provision

Not declared

No of offices

No of countries represented

>20

Staff, group

300

Staff, chemical service provision

SERVICE AREA BREAKDOWN

IT & software 10%

Training 5%

Laboratory 5% Information 10%

Representation & management 25%

Global Service Providers Guide 2020

Consultancy/advisory 45%

Authorisation The authorisation process involves the progressive replacement of certain 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. 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 OR (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 no-deal brexit. element1™ software A centralised management platform is 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 Echa, H2 Compliance is engaging with clients and preparing their data accumulation in advance of the Jan 2021 deadlines. Our new software platform allows a client to manage, and most importantly, maintain their technical, data management and financial activities. 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, such as Korea, China, Japan, Switzerland and Turkey which trigger ongoing obligations while many emerging regulations require careful observation and preparation. With offices in the US, we are able to provide support with North American obligations. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006

Company established, opened Dublin Office

2007

Cork office opened

2009

USA office opened

2011

Recognised by Irish Small Firms Association

2012

Deloitte Technology Award for company growth

2016

H2 Compliance acquired by The Landbell Group, Germany

2017

Poland office opened

2018

UK office opened

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.

ACCREDITATIONS

CASE STUDY 3: Biocides support – a systems approach

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

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.

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, and metals sectors. PARTNERS Redstone USA (KMK) Safebridge Consultants Inc USA (Industrial Hygiene) SCC (Biocides) ATTO Partners (software) 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

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 of 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 of 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 of 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.

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Profile: H2 Compliance

137

Profile: I+K AG, Compliance-Footprint AG

138

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

CONTACTS Website

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

SERVICES PROVIDED

E-mail

weggimann@i-k.ch, hdiener@i-k.ch, cbastian@compliance-footprint.com

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 mobile cockpit App. Safin.net, Trade.net, cfp.net: O 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; O integrated solutions to achieve regulatory compliance and positive market impact at low operational cost; O intelligent data processing capabilities: O expert system functionality to facilitate GHS/CLP, Transport, HSand storage/warehouse classification; O regulatory control to identify substance import/export restrictions; O assistance to compose, to translate and to deliver SDSs; O capability to allow for XML based SDS transfer; O integration to deliver customised labels, including communication via QR code; O enabling data interface to enterprise systems, eg SAP; and O enabling data interface to chemical registration systems, eg to facilitate biocide registration in accordance with the Swiss biocide VBP directives; O compliance certification, in partnership with compliance footprint AG.

Head office

Hadlaubstrasse 154 CH-8006 Zurich Switzerland

Tel

+41 79 404 17 33, +41 44 364 22 33, +41 44 381 11 85

Fax

+41 44 363 22 36

Contact

Dr Walter Eggimann Dr Heinz Diener Dr Claude Bastian

Directors

See Contact and E-mail

Ownership

Four board members

Locations

Switzerland

Founded

1993

OVERVIEW Twenty-five years of dedication in delivering regulatory solutions to businesses, worldwide and local. I+K AG, in partnership with ComplianceFootprint 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

PARTNERS 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.

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

global

Staff, group

Staff, chemical service provision

Training Consultancy/advisory 5% 5%

Global Service Providers Guide 2020

I+K AG holds beyond ten 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

SERVICE AREA BREAKDOWN

IT & software 40%

CASE STUDY 1

Representation & management 50%

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.

Profile: I+K AG, Compliance-Footprint AG

139

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 â&#x20AC;&#x2DC;the big fiveâ&#x20AC;&#x2122;: 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, eg via QR code, iv) to conduct regular safe use training, aligned with the chemical portfolio, v) to control risk assessment and corrective steps.

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Profile: INERIS

140

SERVICE AREA BREAKDOWN Equipment 5% Training 5%

CONTACTS Website

www.ineris.fr

E-mail

prestaweb.dsc@ineris.fr Laboratory 45%

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

2018/19 66mâ&#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 2020

Representation & management 8% Information 5%

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

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 (eg 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

Consultancy/advisory 30%

GLOBAL OFFICES

OVERVIEW

VITAL STATISTICS

Other 2%

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: O acute tests (OECD 402, 403, 423, 425 and 436); O repeated dose 14-day preliminary tests (range finding assays); O repeated dose 28-day toxicity tests (OECD 407 and 412); O repeated dose 90-day toxicity test (OECD 408 and 413); and O 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: O 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); O 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); O sediment tests: Chironomids (OECD 218 and 219), Hyalella azteca (ISO 16303) and Myriophyllum (OECD 239, ISO 16191) toxicity tests; and O 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. 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): O 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; O 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; O realisation, at the same geographical site, of required physicochemistry, in vivo toxicity and ecotoxicity experimental assays; O 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 O 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

141

Profile: Intersolia

142

GLOBAL OFFICES Sweden – Stockholm United Kingdom – Manchester Germany – Ratingen Denmark – Copenhagen Serbia – Belgrade

CONTACTS Website

www.intersolia.com

E-mail

info@intersolia.com

Head office

Gamletullsgatan 12, 302 27 Halmstad Sweden

Tel

+46 35 16 20 00 Germany +49 2102 305950 United Kingdom +44 161 7131710 Denmark +45 88532453 Serbia +381 62220006

Contact

info@intersolia.com

Directors

Daniel Persson, Owner

Ownership

Privately owned

Locations

Sweden, Germany, United Kingdom, Denmark and Serbia.

Founded

1999

SERVICES PROVIDED iChemistry Our chemical management solution enables organizations to ensure compliance according to occupational health and safety legislation. iChemistry is a one-stop shop to identify hazards, digitalisation of safety data sheets (SDS), risk assessments, mitigate exposures to hazardous substances and identify environmentally friendly substitutes. O Minimisation of time-consuming tasks; O enhancement of workplace safety, legal compliance, and audit success rate; and O availability of up to date digital SDS on different devices. iPublisher iPublisher – Our solution for suppliers to create, publish and distribute safety data sheets (SDS) that comply with national and international law, such as REACH and CLP. O Publish your SDS in 32 languages/markets with one click; O create safety data sheets based on recipes; O access to full history of safety data sheets; O automatic calculation and classification of your content; and O support for national and international legislation such as REACH and CLP.

OVERVIEW Intersolia has been working since 1999 to support organizations in their work on health, safety and the environment, with a focus on chemicals. We provide web-based business support for chemical management. We also offer a broad range of consultancy services to help companies achieve chemical sustainability and to ensure businesses comply with both national and international legislation (for example CLP, REACH, RoHS, pesticides, medicines and foodstuffs). Intersolia currently have a staff of a total of 130 persons, 25 of whom are consultants, with offices in Sweden, Germany, Denmark, the United Kingdom and Serbia. We have over 750 customers in both the private and public sectors. Our customers consist of both large and small companies and operate within various branches of industry. VITAL STATISTICS

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

130

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 5% Consultancy/advisory 20%

IT & software 75%

Global Service Providers Guide 2020

iDistributor Our solution for distributors to automate the distribution of safety data sheets with no manual effort. Through central management, you get full control over the process and you can, in a simple way, make sure that the customers always have the latest safety data sheets. SDS Service Integrated SDS service with +25 full time employees solely focused on collecting and updating safety data sheets for our customers in over 50 geographical markets. ISO certified in accordance with ISO 45001:2018, ISO 9001:2015 and ISO 14001:2015. Chemical Management Services Intersolia’s multidisciplinary team of scientists and regulatory specialists have a long experience of assisting companies with chemical management services. We help our clients to identify which legal requirements they are affected by and how to comply with those requirements. Intersolia's consultants work with both national and EU legislation as well as global health, environmental and safety legislation. Examples of services are presented below. REACH and CLP/GHS Intersolia offer our clients strategic, legal and technical support in order to comply with the REACH and CLP-regulations. We provide services such as REACH-registrations, Only Representative services, Authorisation services and services related to REACH and articles. We also provide SDS services including creation of exposure scenarios and notification of chemicals. Biocides Intersolia’s specialists assist our clients in identifying their current status and compliance requirements according to BPR and national transitional rules. We provide strategic advice and help our clients with compiling regulatory submissions, including preparation of assessment reports (PAR), dossiers (IUCLID), biocidal product characteristics (SPC) and submissions (R4BP). We work with both national and union authorisation applications.

Profile: Intersolia

143 Specific strategic investigations Upon requests from customers Intersolia’s consultancy team execute strategic investigations and gap analysis work regarding supply chain management, prevalence, management and substitution analysis of specific risk-associated chemicals such as PFAS, management of certain high-risk products such as fire-fighting foams etc. Training To get the most out of our solutions we offer introductory, individual and open trainings for our users. Intersolia’s EHS experts also offer trainings in Risk assessment, REACH, Chemical handling, Chemical legislation, Substitution, Safety data sheets and Exposure scenarios. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1999

Formation of Intersolia

2000

Intersolia launches iChemistry

2008

Opening of Serbia office

2008

Opening of UK office

2015

Opening of German office

2017

Opening of Danish office

2019

Intersolia launches iPublisher

2019

Intersolia launches iDistributor

ACCREDITATIONS SDS service with Quality Endorsed Company – Accredited to ISO 45001:2018, ISO 9001:2015 and ISO 14001:2015. PARTNERS Chemical Safety Environment, Notisum CLIENTS Our global customer base incorporates manufacturers, distributors and retailers across several industry sectors in both the private and public sectors. TESTIMONIALS References can be provided upon request. CASE STUDY 1: REACH OR-services Intersolia’s consultancy team has provided expert support for an extensive GAP-analysis work with regard to legal requirements for a US producer of a medical device being exported to the EU as a chemical mixture, and in the EU, being manufactured to its final device. Intersolia provides the OR-service for the company with regard to the compliance duties with respect to the REACH-regulation and executed the necessary REACH-registration of substances within the chemical mixture. CASE STUDY 2: Public product procurement of high-risk chemical products Intersolia’s consultancy team have supported different Swedish Authorities in developing legally compliant product procurement specifications, aiming for a procurement process that results in more sustainable and chemically acceptable products as well as increasing the overall transparency of the procurement process for all involved stake holders.

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Profile: Kelley Drye & Warren

144

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

Fax

202.342.8451

Contact

Joseph Green

Directors

Joseph Green

Ownership

Law firm

Locations

Washington, D.C.; New York, NY; Los Angeles, CA; Houston, 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, DC; Los Angeles, California; Austin and Houston, Texas; Chicago, Illinois; Stamford, Connecticut; and Parsippany, New Jersey. Outside of the US, 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 US 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.

Global Service Providers Guide 2020

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. California Proposition 65 presents an array of challenges not only to businesses located in the state, but to any business that manufactures or distributes products that may be sold in California, including through the internet. 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

2018/19

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

Legal 100%

GLOBAL OFFICES New York; Washington D.C.; Los Angeles; Houston, 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 REACH, CLP, RoHS Emergency Planning and Community Right-to-Know Act (EPCRA) Toxic Release Inventory (TRI) Program Clean Water Act Resource Conservation and Recovery Act (RCRA) Spill Prevention, Control and Countermeasure (SPCC) Litigation: Environmental Remediation Contamination Cleanup Transactional: Purchase and Sale of Contaminated Property

CASE STUDY 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. 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. 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. 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 Joseph Green – Special Counsel (DC) Laura Van der Meer – Partner (Brussels) Wayne D’Angelo – Partner (DC) William Guerry – Partner (DC) Andrew Homer – Special Counsel (Los Angeles)

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Profile: Kelley Drye & Warren

145

Profile: KFT Chemieservice GmbH

146

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: O only representative services pursuant to Article 8 (REACH); O registrations according to article 10/11 and 18/19; and O 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.de/kft-academy www.kft.de/kft-chemdoc24

E-mail

mail@kft.de

Head office

Im Leuschnerpark 3, 64347 Griesheim, Germany

Tel

+49 6155 8981 – 400

Fax

+49 6155 8981 – 500

Contact

Marcus Rosenberger, Stefan Palla

Directors

Marcus Rosenberger, Managing Director Stefan Palla, Managing Director

Ownership

Wholly owned subsidiary of Infraserv GmbH & Co. Höchst KG

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:

2018/19

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

Legal 1%

Training 12%

Other 8%

IT & software 1%

Consultancy/advisory 40%

Laboratory 2%

Information 24% Representation & management 12%

Global Service Providers Guide 2020

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 (WRMG) 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 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

2018

ISO-Certification DIN EN ISO 9001:2015

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 O perform a safety evaluation before the product is placed on the market and create the required safety report; O create and maintain a product information file at your request; O support you with the CPNP-notification required for authorities; O advise you and ensure sound legal protection for all tricky legal questions related to the Cosmetics Regulation; and O protect and strengthen your brand and the success of your company in the long term. 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.

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

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Profile: KFT Chemieservice GmbH

147

Profile: knoell

148

SERVICE AREA BREAKDOWN IT & software Training 1% 5% Laboratory 5% Information 7%

CONTACTS 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 Michael Cleuvers

Directors

Felix Knoell Dr Runar Eberhardt 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, Taiwan, Brazil

Founded

1996

Representation & management 20%

GLOBAL OFFICES

OVERVIEW We are a full service provider in global regulatory affairs, offering any necessary regulatory and technical service for the notification, registration, and/or authorisation of industrial and specialty chemicals, crop protection products (conventional agrochemicals, biocontrol agents, (bio-) fertilisers and biostimulants), biocides, pharmaceuticals, veterinary medicine and medical devices. Additionally we offer a wide range of services in the field of product safety (eg preparation of (extended) safety data sheets, classification and labelling of substances and mixtures) as well as chemical regulatory compliance and product compliance. We will work with you to ensure that your products are in compliance with the latest developments, not only in Europe (EU and non-EU), 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 your business needs. VITAL STATISTICS

2018/19

Turnover, group

> €60m

Turnover, chemical service provision

> €20m

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

Global Service Providers Guide 2020

Consultancy/advisory 62%

20 14 approx. 600 >180

knoell Germany GmbH, Mannheim, Germany knoell Germany GmbH, Berlin, Germany knoell Germany GmbH, Leverkusen, Germany knoell Germany GmbH, Münster, 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 knoell Medical Devices, LLC, Nashville, TN, US Knoell Brazil Consultoria Ltda., Sao Paulo, Brazil SERVICES PROVIDED Global registration of industrial and specialty chemicals Dossier preparation and submission: Iuclid 6 files for REACH/UK REACh and Switzerland, TSCA registration including PMN support, registration dossiers for Canada, Korea, China, Taiwan, Japan, Turkey, the EAEU 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, training courses. 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, training courses.

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 (eg model coupling, bee studies), assessment of endocrine disrupting properties, IUCLID-dossiers, CADDY-dossiers and dossier submission (R4BP3). Regulatory support, communication with authorities, post-submission, training courses, 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: support 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 (eg 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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

2010

Opening of a new office in Wageningen (NL)

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 400 REACH dossiers and more than 100 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 BV)

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

2019

Opening of a new office in Sao Paulo, Brazil and Nashville, TN, US

2019

Successful submission of > 1.000 pre-registrations for K-REACh

ACCREDITATIONS Qualified Cefic – partner. CLIENTS We deliver flexible services to globally acting companies as well as to small- and medium-sized enterprises. We also take care of big consortia and task forces. We work on- and off-site to support our customers’ specific local needs. PARTNERS SCAS Japan, SCAS Europe, Domo Salute, Biotek Agriculture, Cekindo, Mourão Henrique Consultores Associados, CRAD 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.” Additional testimonials can be provided on request.

1996

Foundation, Mannheim, Germany

2002

Office in Leverkusen, Germany

2007

Foundation of Dr Knoell Consult Switzerland GmbH, Basel

2009

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

STAFF SELECTION

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)

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

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Profile: knoell

149

Profile: Lisam Systems

150

SERVICE AREA BREAKDOWN Training 5% Enabling full compliance.

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)

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,

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

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 five continents. VITAL STATISTICS

2018/19

Turnover, group

€34m

Turnover, chemical service provision

€19m

No of offices

No of countries represented

Staff, group

330

Staff, chemical service provision

170

Global Service Providers Guide 2020

Information 10%

SERVICES PROVIDED Regulatory advisory services Lisam Telegis is the main regulatory expertise department of Lisam Systems, partner of the chemical industry in regulations on health, safety and environment for more than 20 years. With pragmatic knowledge and experience they will guide you in making strategic decisions and bring support in the following areas: O safety data sheets: issue of quality SDSs in compliance with REACH O and other regulations specific to your activities; O exposure scenarios authoring: preparation and translation of exposure O scenarios in the latest standard format; O consultancy and regulatory studies: compliance projects on REACH, worldwide GHS, CLP, (e)SDS, dangerous goods transport, notifications of hazardous substances, biocides … including preparation of chemicals’ dossiers; O poison centre notifications (Annex VIII to CLP) ; O regulatory monitoring and watch, general and on-demand; O 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; O 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; O REACH registration: data collection, data gap analysis, dossiers preparation and submission (around 200 dossiers submitted), regulatory advice on dossier evaluation; O REACH only representative: REACH obligations for non-EU O manufacturers; and O 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:SDS and label 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; O 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 databases, 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 our own provider, WikiChemia, for the monitoring and fast integration of global regulatory content;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 inventory and document generation tool based on the SDSCOM xml format. Training, services and support Our services are proposed in several languages: O regulatory training and consulting: REACH, GHS, CLP, Iuclid, (e)SDS, Poison Centre Notifications, biocidal products regulations…; O introduction and extended trainings on ExESS applications; O regional trainings: EU, US, China, Japan; O technical trainings: API, ERP integration, customisation…; O a helpdesk answering you on the phone or via email; and O 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 1500 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; O some subsidiaries using the same tool, but with different approach; O some subsidiaries sharing a centralised database whilst others use O independent ones without synergy; and O SDS and labels layouts all different, no efficient working way. Achievements: O unification of the software’s patchwork under Lisam ExESS®; O central unique database for all subsidiaries; O limited migration of data: interface ExESS® with ERP/lab software; O work done by one is benefiting to all; and O one corporate standard for all compliance documents. O

CASE STUDY 2: Global regulatory success stories Lisam Telegis has been supporting successfully global actors in cosmetics, detergents, fine chemicals, industrial and specialty gases etc with their: O ingredients, raw materials and products compliancy under REACH O under other regional regulations; O early regulatory qualification processes; O preparation and submission of inquiries as well as individual and joint O REACH registration dossiers; and O 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 Telegis After working in industry then in continued training, Françoise has created and 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

151

Profile: Makersite GmbH

152

GLOBAL OFFICES UK, Germany, Norway, India CONTACTS

SERVICES PROVIDED

Website

makersite.io

E-mail

team@makersite.de

Head office

Munich, Germany

Tel

leia.ruffini@makersite.de

Ownership

Private

Locations

Munich, Berlin, London, Zurich, Bergen

Founded

2018

Makersite offers the following fully integrated solutions. All data including proprietary 3rd party data is included in our subscriptions.

OVERVIEW Makersite is an award-winning software and data company that develops next-generation product data management tools for manufacturing companies worldwide. We help companies accelerate their product development process so they can make better products, faster. Our platform combines artificial intelligence (AI), graph technology, and pre-integrated data to create 'digital twins' of products and their supply chains. Product teams can then collaborate and instantly understand how changes in external variables (e.g. supply shortages, price fluctuations, regulations) or product designs (e.g. different manufacturing processes, materials) impact their product’s performance and their bottom line. Customers can further improve the accuracy of insights by adding their own supply chain information. With over 30 integrated “apps” across areas of product compliance, sustainability and costing, Makersite is the only platform in the world that can help understand a product across all these criteria, simultaneously and in real-time. VITAL STATISTICS

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

Makersite Compliance: to manage quality and regulatory requirements, faster. Compliance teams can use Makersite to harmonize Material Master Data across the organization to support timely and accurate compliance management. Product requirements including requirements for testing, quality and certification, and hazard communication can also be managed in an integrated manner. Makersite can help identify and mitigate compliance risks as an early warning system providing interactive and regionalized visualizations. EHS chemical incident monitoring and substance tracking for compliance against COMAH, SEVESO, etc. are also possible. Teams can also track compliance status against REACH, RoHs, Prop65, etc. as well as custom lists and future regulation and collaborate with suppliers with integrated surveys or standard exchange formats. Makersite offers flexible reporting including BI integration for centralized dashboards. Makersite Sustainability: for more sustainable products, faster. Sustainability teams can use the integrated Life Cycle Analysis functionality to understand drivers of the product's environmental footprint orders of magnitude faster than traditional software. Makersite also enables engineering teams to Design for Environment and Circularity with material lookups and AI-powered improvement suggestions, scenario analysis, and decision support functionality. Makersite Costing: to calculate and optimize costs across your product's lifecycle, faster. Makersite helps procurement teams implement their purchasing strategies by enabling them to should-cost purchased parts. Teams can quickly identify cost drivers and create a basis for supplier discussions. Makersite centralizes cost data for the business and simplifies product costing for everyone. This enables engineering teams to design for cost and compares design alternatives, even of early designs. Makersite offers the following fully integrated solutions. All data including proprietary 3rd party data is included in our subscriptions. Makersite 360° combines the best of all our products and provides a centralized product data management system that can integrate, harmonize and gap-fill data from multiple systems. Together with our scenario analysis and decision support tools, this reduces friction between departments and helps to arrive at solutions faster. Makersite 360° also supports change and configuration management to reduce costly errors and rework by understanding the impacts of changes in real- time. Implementation and other services can be provided through us or our partners. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

IT & software 50%

Information 50%

2018

Founded in Munich Launched the platform with product sustainability and costing applications

2019

Top 10 startups in Europe by Innovation Radar Launched compliance applications and integrated over 100 data providers

CLIENTS References can be provided upon request.

Global Service Providers Guide 2020

Profile: Makersite GmbH

153

CASE STUDY 1: Detecting restricted chemicals and analyzinganalyzsing potential alternatives Makersite worked with a major US chemical association to fully automate the process of assessing health risks from chemical products based on the REACH methodology. Further to that, a Multi-criteria Decision Analysis (MCDA) approach was used to find safer substitutes and analyze them across financial and non-financial criteria. Stewardship teams can perform these analyses in seconds instead of hours with improved accuracy because of the standardized, automated process. Engineering teams can understand the chemical risks associated with their choices and assess what could be a better alternative with visual reports and reliable data. CASE STUDY 2: Powering Supplier Collaboration for the HPDC Makersite powers the supply chain data collection functionality for the Health Product Declaration Collaborativeâ&#x20AC;&#x2122;s platform â&#x20AC;&#x201C; the HPD Builder. Manufacturers can request material declarations from their suppliers who can use their Bills of Materials to generate HPD compliant reports and submit them to their customers. This allows manufacturers to improve supplier collaboration and provide better information to their stakeholders while protecting the intellectual property of suppliers. The automated checking against live data sources detects irregularities and restricted substances as they enter the system to accelerate the verification process. Manufacturers can now automatically assess compliance in minutes and pinpoint problematic components and substances that need to be discussed with suppliers. CASE STUDY 3: Complete compliance and sustainability analyses in minutes Makersite is helping a leading electronic manufacturer to drive more sustainable, compliant and cost-effective decisions. The platform accepts Full Material Declarations (FMD) and using an AI-supported engine together with their productâ&#x20AC;&#x2122;s Bill of Materials, it generates complete supply chain models including supplier and manufacturing data. This fully automated process allows our customer to assess compliance against multiple regulations and internal standards, perform complete and in-depth Life Cycle Assessments with unprecedented accuracy, and estimate the cost of design changes in minutes instead of months.

www.chemicalwatch.com/SPG

Profile: National Chemical Emergency Centre (NCEC)

154

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

CONTACTS Website

www.the-ncec.com

E-mail

ncec@ricardo.com

Head office

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

Tel

+44 (0) 1235 753654

Contact

+44 (0) 1235 753656

Directors

ncec@ricardo.com

Ownership

Jonathan Gibbard

Locations

Founded

1973

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: O 24-hour multilingual emergency response advice delivered by trained chemists; O rapid and reliable response to support emergency services and businesses around the world; O chemical handling and regulatory compliance support; O REACH consultancy, poison centre notification and CLP support (including SDS authoring); and O crisis management services to help our customers deal with all types of incidents, crisis and business continuity disruptions. VITAL STATISTICS

2018/19

Turnover, group

£384m

Turnover, chemical service provision

£7.0m

No of offices

No of countries represented

Staff, group

3000

Staff, chemical service provision

SERVICE AREA BREAKDOWN

IT & software 20%

Consultancy/advisory 75%

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 Global Service Providers Guide 2020

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: O measuring your crisis readiness capability to identify and address gaps and development opportunities; O review and support the development of crisis response and business continuity plans and procedures, including business impact assessments; O bespoke training programmes to achieve your needs, focusing on developing the people’s non-technical skills (making decisions under pressure, crisis leadership, etc.); and O full suite of exercising capabilities from coaching walk throughs to fully fledged simulation exercises to test the procedures and further develop the people. Software O 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 O ChemeDox® – document management system, with functionality for COSHH compliance and distribution.

Training 1%

Representation & management 4%

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

Training NCEC provides online and on-location bespoke training courses to teach critical skills for operating across the chemical supply chain, including: O securing regulatory compliance and handling chemical emergencies; O bespoke hazmat and chemical spill response training; O chemical hazard awareness; O COSHH assessments; and O first aid for chemical exposure.

ACCREDITATIONS

CASE STUDY 1: BASF – exceeding best practice guidelines

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 O BS EN ISO 9001: 2008 Quality Management; O ISO 14001: 2004 Environmental Management; and O ISO 27001 Information Security Management.

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 ten-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.

Training O Training courses are accredited by the Royal Society of Chemistry. 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. 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. 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 NCEC and wider network.” Brian Galsworthy, Fire Safety Advisor & Incident Manager Specialist, AstraZeneca Plc

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.

www.chemicalwatch.com/SPG

Profile: National Chemical Emergency Centre (NCEC)

155

Profile: Nexreg

156

SERVICE AREA BREAKDOWN

Training 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

Tel

+1 519-488-5126

Consultancy/advisory 75%

SERVICES PROVIDED O

Fax

519-488-5217

Contact

info@nexreg.com

O O O O

Ownership

Private

Locations

1 Location

O O O O

Founded

Other 5%

2005

O O

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

OVERVIEW

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

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.

2005

VITAL STATISTICS No of offices Staff, group

Global Service Providers Guide 2020

2018/18 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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眀眀眀⸀渀攀砀爀攀最⸀挀漀洀

Profile: Ramboll Environment and Health

158

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

+44 20 7808 1420

Contact

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

Directors

Ramboll Group companies are owned by the Ramboll Foundation

Ownership

Private Company

Locations

300 offices worldwide

Founded

1945

SERVICES PROVIDED Risk management, strategic support and global regulatory compliance (e.g. 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 15,500 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

2018/19

Turnover, group

DKK 14.2 billion (unaudited)

Turnover, chemical service provision

No of offices

300

No of countries represented Staff, group

35 16,500

Staff, chemical service provision

SERVICE AREA BREAKDOWN Representation & management 10%

Laboratory 5%

Consultancy/advisory 85%

Global Service Providers Guide 2020

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. Product stewardship, substitution and troubleshooting We have tremendous breadth and depth of expertise as well as extensive hands-on process experience, covering: O toxicology and toxicokinetics; O epidemiology; O exposure modelling, measurement and reconstruction; O risk assessment and mitigation; O ecotoxicology; O environmental fate; O chemistry; O occupational health; O regulatory affairs; O supply chain and stakeholder management; O product vigilance; and O 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 2014

Ramboll acquires ENVIRON.

2016

Ramboll acquires specialist consultancy BiPRO

2019

Ramboll acquires OBG

CLIENTS

CASE STUDY 5: Comprehensive exposure assessment

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.

When residual levels of a contaminant were unexpectedly found in a key product for a food packaging producer, we could show that consumer exposure from handling the packaging and ingesting the packaged foods was safe. We updated systems to avoid a similar occurrence in future.

TESTIMONIALS “We are working with Ramboll in a constructive and successful manner on various REACH projects, covering the entire processes (ie preparation of technical dossiers, ex-posure 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 seam-less integration into our team and systems creates an un-precedented collaboration that enables high quality, cost effective and timely solutions. Our dossiers have been consistently ahead of schedule and have been fully satis-factory when reviewed by the competent authorities. Ramboll’s professionalism, expertise, and organisational excellence has and continues to contribute to our compli-ance 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. 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 Ramboll has prepared over 75 applications for authorisation for a broad range of clients across the pharmaceutical, biotech, aerospace, automotive, engineering and chemical sectors, amongst others. We provide extensive support to comply with authorisations, including worker and environmental monitoring. CASE STUDY 3: Risk Management Option Analysis (RMOA) We provided the technical support necessary 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 actively engaged with stakeholders to inform policy development.

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. CASE STUDY 7: Product Stewardship Our comprehensive emissions and exposure model characterised releases of a SVHC across Europe, providing a firm basis for discussions regarding risk management options. CASE STUDY 8: Endocrine Disruption We assess potential endocrine disrupting properties of a substance using a weight of evidence approach to assess all available and relevant data. We presented the evidence to authorities to inform policy making. STAFF SELECTION Ramboll’s product regulatory services involves over 100 experts. They include: 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 of 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 of 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 of expertise evaluating health effects from chemical exposures in the workplace and community. Juliana Ding – Managing Director, Asia 20 years of experience in environmental and health consultancy, including regulatory advice, product stewardship and supply chain management.

CASE STUDY 4: Assured global compliance of new product We advised a company launching a new consumer product worldwide on regulatory obligations in 50 countries, considering chemical notification, packaging and labelling requirements and optimising the formulation and market claims.

www.chemicalwatch.com/SPG

Profile: Ramboll Environment and Health

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Profile: REACH Global Services S.A.

160

SERVICE AREA BREAKDOWN Training Other 6% Consultancy/advisory Laboratory 3% 5% 3% 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

+32 (2) 234 77 78/ +32 (2) 234 79 11

Fax

Dr Yaprak Yuzak Kucukvar

Contact

Global Offices Managing Director Mr A Ecmel Yorganci

Directors

Chairman of the Board Ahmet F Bitlis

Ownership

Private company owned by Chemicals and Chemical Products Exporters’ Association

Locations

Headquarters: Brussels, Belgium; Offices: Istanbul, Turkey

Founded

2008

Representation & management 80%

GLOBAL OFFICES RGS SA Brussels, Belgium RGS Istanbul Liaison Office Istanbul, Turkey REACH Global Danışmanlık AŞ 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 costeffective 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’ 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

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2020

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: O inquiry dossier submission; O registration dossier submission; O Sief/consortia representation; O specialised tonnage tracking IT system and certification for compliance of the downstream user (DU)/importer; O general consultancy services for EU based companies impacting substance registration dossiers, and interactions with regard to the authorities’ requests and inspections; and O 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’ experienced team of consultants assists manufacturers to compile cosmetic product information files (PIFs) to comply with the legal requirements. Our cosmetics compliance services cover: O EU legal representation (responsible person); O preparation and verification of PIF; O cosmetic product safety report parts A&B (CPSR); O formulation and claims review; O review and guidance on borderline cases; O review and guidance on necessary corrections on labelling; O cosmetic product notification; O scientific and laboratory services (mandatory and claim tests); and O 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. 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. Pre-registration deadline: 31/12/2020

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. 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. 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 legislation 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 12-year-long experience in EU REACH and Turkish KKDIK regulation extended its activities in Korea, China, Japan, Taiwan

2018

Completed 11 years of REACH registration period with 2000+ pre/registration for over 450 manufacturers

2019

Pre-registered and notified 4250+ substances under KKDIK as OR/TPR, and SEA as Trustee Preliminary preparations of SIEF/Consortia establishment for Turkey in direct communication with the EU REACH Consortia Extending activities in UK, and Eurasia.

ACCREDIATIONS 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. Standardisation and certification ISO 9001-2015 Quality Management Systems ISO 10002-2018 Quality Management – Customer Satisfaction ISOIEC 27001-2013 Information Security Management The General Data Protection Regulation 2016/679 – Kisisel Verileri Koruma Kanunu 2016/6698 CLIENTS 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.

www.chemicalwatch.com/SPG

Profile: REACH Global Services S.A.

161

Profile: REACHLaw

162

GLOBAL OFFICES Helsinki, Brussels, London, Istanbul, Moscow and New Delhi CONTACTS

SERVICES PROVIDED

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 9 412 3055 / +358 9 412 3049

Contact

Mr Frederik Johanson, Partner, Sales

Directors

Mr Jouni Honkavaara, CEO, Partner Mr Frederik Johanson, Partner Mr Mathias Berner, COB, Partner

Ownership

Private company

Locations

Finland, Belgium, UK, Turkey, Russia, India

Founded

2006

Advocacy and REACH authorisation support services REACHLaw provides a range of services relating to substances of very high concern (SVHCs). These include technical and legal support in providing input in public consultations for entries proposed for inclusion on the Candidate List, restriction proposals and recommendations for entries to be included on the Authorisation List. We prepare applications for authorisation for our clients to enable them to continue their use of substances listed on Annex XIV. We assist our clients at every step in the process from strategy development to the collection, compilation, analysis of the information needed for the application to its documentation in the format of the four reports to be submitted to Echa. Post submission, we also assist with preparing responses to questions from the Echa committees, responding to input from alternatives providers and commenting on the draft committee opinions. We approached to date more than 20 prepared applications for 26 uses that includes individual and joint applications, consortia for upstream and downstream applicants.

OVERVIEW As a leading expert in registration, authorisation and notification of chemical substances, inside and outside the EU, REACHLaw provides chemical regulatory compliance and product safety solutions to fit each customer and their needs. We help companies 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, K-REACH and GHS, “Eurasia REACH” and many more. Furthermore, REACHLaw is also committed to supporting companies with their sustainable growth and, as part of EU’s action plan for a Circular Economy, we also help companies to comply with SCIP notification and End-of-Waste criteria obligations, as required by the revised Waste Framework Directive (WFD). REACHLaw is able to serve its clients in the following languages: English, Finnish, French, German, Spanish, Italian, Swedish, Hindi, Russian, Ukrainian, Hungarian and Turkish. VITAL STATISTICS

2017/18

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

60+

Staff, group

30+

Staff, chemical service provision

25+

SERVICE AREA BREAKDOWN Training 5% Legal 20%

Global Service Providers Guide 2020

SCIP Notification and Strategy Consulting Services REACHLaw supports suppliers of articles containing SVHCs on the candidate list to comply with SCIP (Substances of Concern In articles as such or in complex objects [Products]) notification requirements by helping them to prepare and submit their notifications to the SCIP database as is required as of the 5th January 2021. Furthermore, we provide strategic advice for companies from determining the impacts of the SCIP notification on their business and supply chain to implementing their strategy with concrete actions to successfully comply with SCIP notification requirements. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 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. Brussels and New Delhi offices opened

2010

300+ REACH registrations submitted. REACHLaw launched global compliance services outside the EU.

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.

2013

REACHLaw supported several hundred REACH registrations, numerous authorisation projects, lead registrant cases.

2014

Delivering several REACH lead registrations and a large number of authorisation projects.

Consultancy/advisory 30%

IT & software 10% Laboratory 5% Information 5%

Global Chemical Regulatory Compliance Services REACHLaw provides a comprehensive range of chemical regulatory compliance services to help companies in adapting to the changing regulatory requirements and provides full support with inquiry/preregistration, registration and authorisation of their chemical substances placed within and outside the EU. Through our offices in Helsinki, London, Istanbul, Moscow and New Delhi, and our global partner network, we serve our clients as both their Only Representative and service provider. To date REACHLaw has prepared: +3,000 EU REACH registrations, +1,000 CLP notifications, 20 authorisation applications, +5,000 KKDIK preregistrations, +10,000 inventory notifications in Russia, +500 K-REACH notifications and many more.

Representation & management 25%

2015

Providing IT management solutions especially related to supply chain compliance and risk management.

TESTIMONIALS

2016

Supporting several companies with advocacy projects. Working on different authorisation cases and registrations

2016

The European Defence Agency (EDA) commissioned REACHLaw to carry out a study to examine the impact of the EU’s chemicals regulations – mainly REACH and CLP- on the defence sector.

2017

Supporting several REACH registrations. Working on EU country specific product notifications.

“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.

2018

Preparing many REACH 2018 Lead registrations and coregistrations. Supporting several companies with their 2019 Applications for Authorisation and KKDIK pre-registrations.

2019

Preparing several large-scale joint Applications for Authorisation. Supporting EU 27 and UK companies in maintaining access to the EU/EEA market as well as the UK market. Preparing large number of KKDIK and K-REACH preregistrations. REACHLaw Moscow office is established. Prepared thousands of “Eurasia REACH” notifications in Russia.

2020

Supporting the industry with their notifications in Russia and Turkey KKDIK pre-registrations. Helping article suppliers with SCIP notifications. Helping UK and EU companies to address Brexit related impacts. REACHLaw YouTube channel – REACHLAW TALKS- was launched.

ACCREDITATIONS 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. PARTNERS REACHLaw collaborates with several industry associations and has partners in all of the key areas globally CLIENTS

CASE STUDY 1: Authorisation MOCA was added to the Authorisation list in 2013 and had the sunset date in November 2017. Currently, all downstream users of MOCA in the EU are covered by a single upstream authorisation application. To gain more control, several downstream users of MOCA established the MOCA Authorisation Consortium with the help of REACHLaw, to apply for a new Authorisation to cover the use of MOCA beyond the end of the review period of the upstream application. REACHLaw is providing Consortium Management and Technical as well as Trustee services for the Consortium with the aim of developing a fit-for-purpose Authorisation to allow the continued use of MOCA. The Joint Downstream User Application for Authorisation will be submitted during 2020. CASE STUDY 2: Global regulatory compliance – One-stop-shop A North American chemicals manufacturer is placing chemicals on all the following markets: EU, UK, Turkey and Russia. Through REACHLaw, we have supported them as their EU Only Representative since 2010. With the entry into force of the Turkey KKDIK regulation in 2017, REACHLaw has also been their Only Representative in Turkey though REACHLaw’s Turkey office in Istanbul. In late 2019 “Eurasia REACH” inventory notification came into play for substances placed in the Eurasian (including Russia) market and REACHLaw could, again, natively support this Client as their nominated representative to perform such notifications. Furthermore, access to the UK market will be a current topic during 2020 and beyond and REACHLaw is supporting the Client in keeping access to the UK market through our London office functioning as a UK REACH Only representative. STAFF SELECTION Tim Becker, MA (Law) – Senior legal advisor Bernadette Quinn PhD (Chemistry) – Head of authorisation practice Sini Suomela (MSc in Organic Chemistry) – Head of OR and registration practice

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. We have served +700 customers from +60 countries.

www.chemicalwatch.com/SPG

Profile: REACHLaw

163

Profile: Risk & Policy Analysts Ltd (RPA)

164

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

Matthew Lambert

Directors

Meg Postle Teresa Fenn Matthew Lambert

Ownership

Employee owned

Locations

Founded

1990

Consultancy/advisory 95%

GLOBAL OFFICES RPA: UK; 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 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 multinational staff routinely undertakes detailed analysis and consultation with industry and regulators in most European languages. VITAL STATISTICS

2018/19

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 2020

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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1992

1998

2000 2004 2009 2012 2013 2014 2015 2016 2017 2018 2019

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. RPA wins major framework contract for the UK authorities on chemical risk management leading to numerous risk reduction strategies under the existing substances Regulation. OECD publishes guidance documents on SEA and chemical risk management prepared by RPA. RPA wins major framework contract for the European Commission on chemicals. RPA contracted by industry clients to support applications for authorisation under REACH with a focus on SEA work. RPA completes three studies for DG Environment reviewing the first years of REACH implementation. RPA leads the market in supporting seven applications for authorisation of SVHCs under REACH. RPA clients obtain the first granted REACH authorisations. RPA supports the submission of another nine applications for authorisation. RPA leads the EC fitness check for chemicals legislation (excluding REACH). RPA supports DG Employment in major revisions of the CMD and RPA clients submit first ever Authorisation review reports. RPA Europe established as an EU legal entity to ensure continuity of services within the EU post-Brexit RPA selected to lead a team of consultants in providing technical services to the Aerospace & Defence Chromates Reauthorisation Consortium (ADCR). This team is also supported by Fieldfisher, FoBiG and Bureau Veritas.

PARTNERS RPA works with FoBiG, Ökopol, Bureau Veritas, Triskelion, Milieu, DHI, RIVM, ARCHE Consulting, 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 (AoA) and socio-economic analysis (SEA) support services RPA has been providing REACH Authorisation support to several consortia of manufacturers and users of SVHC substances. This 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 mid-2019, RPA has been providing technical consultant support to a large chemical consortium for the purposes of drafting applications for authorisation for numerous clients working within the aerospace and defence sector. CASE STUDY 2: Work conducted to support the European Environment Agency program HBM4EU RPA Ltd has recently completed work to support the European Environment Agency program HBM4EU. This work included performing a mapping of the legislative frameworks relevant to a list of prioritised substances, as well as producing policy briefs for policy makers and other stakeholders highlighting the potential hazards of the prioritised substances, analysing the work undertaken to date by HBM4EU and possible areas of policy that HBM could play a role in. This study builds on and updates the work completed by Risk & Policy Analysts Ltd (RPA) for the EEA in 2017 under Negotiated Procedure No EEA/IEA/17/001, which required the production of individual policy briefs for the 1st list of HBM4EU Priority Substance Groups.

CASE STUDY 3: Study on Occupational Exposure Limit Values (OELVs) RPA Ltd. has recently completed work for DG Employment of the European Commission on assessing the socio-economic impacts of potential revisions of potential revisions to OELs under the Carcinogens and Mutagens Directive (CMD) 2004/37/EC for two substances. This work included performing a socio-economic analysis of a range of possible OELVs to assess the costs and benefits of the proposed OELVs. This study followed on from three previous OELVs studies performed by RPA Ltd. for DG Employment. 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. Tom Persich – Principal 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 almost 10 years of expertise in preparing core AoA and SEA arguments at sector level for downstream users. He also continues to undertake extensive supply chain mapping activities to assess the potential vulnerability of downstream user groups to the loss of key substances. Daniel Vencovsky – Principal Consultant, Policy Daniel has extensive experience in the field of impact assessment and evaluation of EU policies and regulation including in EU chemical policies and regulations. He has been project manager for the studies on OELVs performed by RPA Ltd. for the European Commission. Daniel has expertise in performing socio-economic assessments, impact assessments and also stakeholder consultation. Max La Vedrine – Senior Consultant Max has worked on REACH applications for authorisation where he has attended client meetings and PSIS meetings, conducted site visits, performed literature reviews, and developed client’s analysis of alternatives, socio-economic analysis and chemical safety reports. Max has supported clients by creating substance databases, mapping their regulatory status and conducting supply chain mapping. Max has also conducted extensive literature reviews, organised and helped to run workshops, and conducted stakeholder engagement. Max has worked on several studies looking at the impact of chemical legislation, this includes the DG Environment regulatory fitness of the legislative framework governing the risk management of chemicals (excluding REACH), in particular the CLP Regulation and related legislation, including BPR, PPPR, CMD, CAD, toys, cosmetics and ELV. Russell Norman – Senior Consultant Russell has over 25 years’ experience as an industrial chemist working within manufacturing. Areas of expertise include proprietary surfactantbased cleaning, re-odourising and biocidal products, sold across global markets in compliance with a variety regulatory regimes and controls. As an industrial chemist he focused on sustainable chemistry attaining professional Practitioner membership of the Institute of Environmental Management and Assessment (IEMA). The main focus of Russell’s work is identification and compilation of information for the purposes of applications for authorisation. Marco Camboni – Director (RPA Europe) Marco specialises in the evaluation of the European chemical 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 is a Director of RPA’s sister company RPA Europe. www.chemicalwatch.com/SPG

Profile: Risk & Policy Analysts Ltd (RPA)

165

Profile: Royal HaskoningDHV

166

GLOBAL OFFICES HaskoningDHV Nederland BV: Jonkerbosplein 52, 6534AB Nijmegen, The Netherlands Haskoning UK Ltd: Rightwell House, Bretton, Peterborough, PE3 8DW, UK CONTACTS

SERVICES PROVIDED

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, ADR). 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 a global independent, international engineering and project management consultancy with 135 years of experience. Backed by the expertise and experience of over 5,800 colleagues, our professionals combine global expertise with local knowledge. They 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 Turnover, group

2018/19 €615m

No of offices No of countries represented Staff, group

(Extended) Safety data sheets Royal HaskoningDHV provides a full safety data sheet service including the preparation of the Annex to the SDS (eSDS) for substances and mixtures. With our dedicated SDS system we provide a total solution for SDS management. Our consultants are experienced with different types of SDS software and can also support you in your own SDS software. Based on information from REACH dossiers, CSRs and/or existing exposure scenarios we can prepare informative annexes with exposure information for your supply chain. This is accompanied with sound advice on risk management for your workers and the environment, also in the form of Workplace Instruction Cards. In addition we perform poison centre notifications at local and EU level, depending on the clients preference. 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 and risks of substances and their safe use up and down the supply chain as the key issue for the near future. 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 and Verhey 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.

5818

Staff, chemical service provision

50-100

SERVICE AREA BREAKDOWN Training Legal 5% 5% IT & software 15% Laboratory 5% Information 10% Representation & management 10%

Global Service Providers Guide 2020

Consultancy/advisory 50%

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.

ACCREDITATIONS ISO 9001 / ISO 14001 / ISO 45001 / OHSAS 18001 / Anti-corruption Compliance Certification (ETHIC Intelligence) PARTNERS ChemCon Conferences, EPPA SA, Lisam Systems, Doruksistem 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 For different types of substances we prepared applications for authorisation in collaboration with EPPA SA. The applications varied in scope from those that cover the entire supply chain, to those that are single site uses or even future uses. The hazard for which the substances were prioritized varied from carcinogenicity to endocrine disruption. The sectors of use were coatings, plastics, pharmaceutical and diagnostics. We determined the required scope of the applications taking into account the exemptions in the legislation. Details on exposure and emission conditions were determined in site visits throughout Europe. Risk assessment was generally done using exposure modelling tools and measurement data. For one application we guided the client to a zero emission scenario and assisted the companies on the elimination of emission. We looked at potential emissions from every angle and improved containment and waste treatment. Consequently, we demonstrated that emissions to water, air and soil were zero using a range of emission calculation tools. The applications for authorisation were supported by socio-economic analyses, analyses of alternatives and where applicable substitution plans. Other project activities included generating or updating Iuclid substance dossiers, official meetings with Echa (PSIS and Trialogue) and meetings with Member States and EC to explain the cases. These efforts combined resulted in a favourable review by SEAC and RAC in all dossiers, with proposed review periods ranging from 7 to 12 years. One proposed review period of 12 year included no additional conditions. For the carcinogenic substances the European Commission decided on a review period of seven and four years for different uses. As a follow-up we continue to collaborate with our clients to demonstrate that conditions imposed in the authorisation are being met. CASE STUDY 2: Implementation of KKDIK in Turkey For the Turkish government, we have worked on strengthening the capacity of the governmental institutions and establishment of an institutional structure and legal framework for the Turkish KKDIK law. We have performed an impact analysis for 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 KKDIK. The latest project contains a training program in which potential trainers are trained in Chemical Safety Assessment and the use of a Turkish Chesar tool that is going to be released in 2021. All projects combined aim to make the implementation of KKDIK smoother in Turkey.

CASE STUDY 3: Annex to the SDS The increasing demand for extended Safety Data Sheets (eSDS), for both substances and mixtures, has led to a solid project portfolio in which we gained extensive experience generating informative Exposure Scenarios. We use our expert knowledge of exposure and risk assessment to translate the overwhelming amount of information from the Chemical Safety Report into clear and readable Exposure Scenarios. These contain practical information relevant for safe use of the product throughout the supply chain. In case of mixtures, we first analyse and decide on the lead substances for the product. Per case we determine what type of Annex is most suitable to the users needs, resulting in ESs, SUMIs or a tailor-made Annexes to the SDS. Alternatively, use information can be incorporated in the main body of the SDS. All SDSes and Annexes are authored in our ExESS SDS system and can be made available in all EU languages. STAFF SELECTION 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. 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 of 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. www.chemicalwatch.com/SPG

Profile: Royal HaskoningDHV

167

Profile: SCC

168

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 +49 671 298 46-100

Contact

Dr Thomas Roth (Chemicals / REACH, Consumer Products, Cosmetics, Feed & Food Additives)

Directors

Dr Friedbert Pistel, Owner and President Florian Pistel, President Dr Monika Hofer (Regulatory Science, Pharma PreClinical) Dr Bernd Brielbeck (Agrochemicals and Biorationals) Dr Thomas Roth (Chemicals / REACH, Consumer Products, Cosmetics, Feed 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, medical devices and pharmaceuticals (pre-clinical). VITAL STATISTICS

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.

Consultancy/advisory 68%

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 (as technical consultant, consortium manager and legal advisor through SCC Legal).

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

130

Staff, chemical service provision SERVICE AREA BREAKDOWN

Legal IT & software 10% 2%

Training Other 3% 0%

Information 3% Representation & management 14%

Global Service Providers Guide 2020

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 150 inquiry dossiers. Beyond Europe, SCC notified new and existing substances in many international markets, eg China, Japan, Korea, Australia, and Canada. SCC also operates a wellestablished network with competent authorities in the EU and abroad and is recognised as a competent and reliable partner both by authorities (eg Echa) and industry organisations (eg Cefic). For all types of substances and across all industry sectors, SCC can provide you with: O development of registration & testing strategies for chemicals and polymers, as well as organising and monitoring of the studies; O preparation of inquiry and registration dossiers and submission to competent authorities; O literature search, data review and identification of data gaps; O development of grouping/category approaches (read-across); O estimation of substance properties and data generation via QSAR prediction tools, eg QSAR Toolbox, EPI Suite, ECOSAR; O human health and environmental risk assessments, incl. exposure modelling (eg EUSES, Risk of Derm, ConsExpo, EasyTRA, ART, Stoffenmanager); O preparation of the annex to extended Safety Data Sheets (eSDS); O C&L support (CLH dossier acc. to Annex XV, RAC evaluation); O defence support for chemicals under authority evaluation or scrutiny (EU: CoRAP, SVHC, compliance checks, restriction, authorization procedure); scientific/regulatory support at EU expert meetings; O Only representative support and trustee service for supply chains (non-EU, EU); O joint submission and consortia support/management; and O poison center notifications

Conformity assessments of medical devices SCC has a profound knowledge of quality- and admission- relevant standards and regulations. We assist in issues dealing with the new European medical device regulation MDR (EU) 2017/745 as well as other international regulations and in preparation or updating your technical files. In addition, SCC is experienced in risk management (ISO 14971), biological evaluation (study selection and evaluation in line with ISO 10993-1), and clinical evaluation (MEDDEV 2.7/1 rev. 4) as well as qualification and validation.

2004

Liaison Office Japan founded

2007

Feed and Food Additives group

2014

Office Berlin founded

2018

SCC Japan founded

2019

Medical Devices business unit SCC Legal founded 30 years of regulatory expertise

Authorisation of feed 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 (eg for plastics, for active and intelligent materials) and a variety of directives for further products categories (eg printing inks).

ACCREDITATIONS

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 (eg for cosmetics or detergents) and applicable national regulations is the basis to meet all challenges, eg the animal testing ban for cosmetics. 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 A skilled team of multi-discipline experts at our Regulatory Science business unit provides its profound expertise in the fields of: O data gap analyses, study monitoring and dossier preparation; O exposure modelling and risk assessments for human health and environment; O conceptual work on higher-tier approaches (eg in silico (eco) toxicology, population modelling); O assessment of potential endocrine disruption incl. MoA analysis, AOP O concepts and WoE approaches; O preparation of expert statements and position papers by certified experts; O classification and labelling support (CLH dossier preparation and defence during RAC process); and O 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 Agrochemicals and Biorationals and Regulatory Science business units established

1996

Chemical and Consumer Products business unit Biocides business unit

2000

GLP archive certification

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 Dr Roth has a PhD in food chemistry and is a certified expert for toxicology. He has been with SCC for ten years and is head of Chemicals/ REACH, Consumer Products, Cosmetics & 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 more than 15 years and her focus is on Joint Submission, 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 and on cosmetics. Dr Alexander Theis Dr Theis has a PhD in Chemistry and has more than one decade of experience in medical device industry. He is an expert for medical device conformity assessments and related documentation. www.chemicalwatch.com/SPG

Profile: SCC

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Profile: Sphera Solutions

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SERVICES PROVIDED Sphera provides cradle to cradle product stewardship solutions 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. Our comprehensive chemical management and product compliance 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, Sphera supports your company’s compliance programme with these powerful information management capabilities:

CONTACTS 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)

Chemical management Ensure universal access to Safety Data Sheets, manage the approval, physical arrival and departure of chemicals on site and easily report on all of your chemical data. Our chemical management solutions, including on-site inventory services, offer integrated regulatory data and chemical approval functionality. With access to 1 million unique product profiles, global capabilities, automated SDS updates and compliant reporting and labeling tools, you can ensure worker safety and compliance.

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

2018/19

No of offices

No of countries represented

Global

Staff, group

1000+

Staff, chemical service provision

150

SERVICE AREA BREAKDOWN Training 5%

Consultancy/advisory 20%

IT & software 40% Information 35%

GLOBAL OFFICES 24 Greville Street, London, EC1N 8SS, UK 400 Ste-Croix Avenue, St-Laurent, Quebec, Canada, H4N 3L4 Oranjesingel 34, 6511 NV Nijmegen, The Netherlands Global Service Providers Guide 2020

Product compliance Our SDS Authoring solution aAutomates 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 ac-cess to global markets. This includes a powerful rule-based document generation engine with the ability to produce ex-tended SDS and exposure scenarios with translated ESCOM Phrases. The solution also has functionality to allows 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 Tthe solution allows for GHS by Design, a unique functionality that allows SDS authors to configure user-defined GHS implemen-tations for any area, country or region with no official GHS regulatory support. Documentation and labels: Simplifies the process of design-ing, producing and printing labels for GHS, transport and con-sumer goods regulations. Product declarations and compliance analysis 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. Sphera also offers a product compliance solution for SAP® EHS: As an official SAP® partner, 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 Sphera provides a modular prepackaged 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

decision justifications. Yara was also able to streamline work processes by automating distribution of SDSs.

1989

Atrion International is founded

1991

Dolphin Software is founded

CASE STUDY 3: Tikkurila

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

Challenge: Generate worldclass safety documentation and labelling in multiple languages. Meet increasingly tight regulatory requirements and rising customer expectations. Drive operational efficiency to support international growth strategies. Results: Standardised 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.

2017

Sphera acquires Rivo Software

CASE STUDY 4: Siemens Healthcare

2017

Verdantix – Green Quadrant Leader

2017

Verdantix – Market Leader, Chemical & Hazardous Waste Management

2017

Environmental Leader – Project of the Year

2018

Sphera acquires SparesFinder

2018

Sphera acquires Petrotechnics

2019

Sphera acquires SIteHawk

2019

Sphera acquires ThinkStep

2019

Verdantix – #1 Provider, Chemical Management

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.

2019

Verdantix – Sustainability and Product Stewardship Excellence

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

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 multiorganisation task forces in establishing industry best practices for regulatory compliance. 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 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. www.chemicalwatch.com/SPG

Profile: Sphera Solutions

171

Profile: Staphyt

172

SERVICES PROVIDED Areas of expertise: Plant Protection Products Fertilisers and Biostimulants Biocides Chemical substances (REACh)

CONTACTS Website

www.staphyt.com/regulatory

O O

E-mail

contact@staphyt.com

Head office

57, avenue du Président Edouard Herriot 69002 Lyon France

O O O O O O

regulatory advice and strategy; data gap analysis; field and laboratory study monitoring (GLP and/or GEP); dossier preparation for active substances and products; technical equivalence; risk assessments for humans, animals, consumers, environment; modelling; CLP classification, SDS and labelling; poison control centre declarations; expert statements, literature search on chemical substances regulatory support in all European countries; technical and regulatory training; update service Regulatory Watch (newsletter by subscription); and support with issues relating to the UK’s exit from the EU (Brexit).

Tel

+33 (0)3 21 21 45 21 +44 (0)1937 587962

Contact

Manda Vince

Directors

Regulatory Business Director: Manda Vince

Ownership

Staphyt

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Locations

France, UK, Austria, Poland, Czech Republic, Italy, Hungary, Brazil, Australasia.

1989

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

O O O O O O

OVERVIEW Our large Regulatory Affairs department provides comprehensive technical expertise, multiple language skills and in-depth regulatory knowledge throughout Europe and in other countries. Our mission is to help our clients to meet all aspects of their chemical and biological regulatory obligations, to achieve authorisation for the production, import or sale of their new or existing substances or products. We will also keep you informed about regulations that apply to your activities. In collaboration with our extensive Staphyt Agrosciences field teams, we can, if required, offer complete management of your crop related projects. VITAL STATISTICS

2018/19

No of offices

No of countries represented Staff, group

>40 >400

Staff, chemical service provision

>50

Training 10%

Consultancy/advisory 80%

Global Service Providers Guide 2020

GLP, GEP, Research Tax Credit accreditation and training. PARTNERS In addition to our in-house teams, we also work with a network of third parties (laboratories and local external consultants) on many continents providing local regulatory and scientific expertise. This network supports us in preparing and submitting dossiers throughout Europe and beyond and extends our language skills and close relationships with regulatory authorities. CLIENTS From SMEs to multinationals, our clients are chemical and biological product manufacturers, formulators, importers or distributors. They specialise in biocides, chemicals, plant protection and plant nutrition products. CASE STUDY 1

SERVICE AREA BREAKDOWN

Representation & management 10%

ACCREDITATIONS

Biocides Sector Thanks to its extensive experience in the preparation of dossiers for active substances, products and product families under most PTs, the Staphyt team managed and submitted in parallel nine single product dossiers and three product family dossiers for the same deadline. We have prepared all dossier sections including all risk assessments. Tailored strategies for Human Risk Assessment were advised to our clients. Specific refinements were developed, including dermal absorption studies monitored by our toxicologists. We successfully obtained the BPR authorisation for all products in many EU countries. Prior to this regulatory deadline, our team was in charge of transitional registrations of these products across Europe. More specifically, new products were registered according to national regulations in countries such as the Czech Republic, Greece, Latvia, Romania, Slovakia, Slovenia, Switzerland, Poland, Denmark, Lithuania and Belgium. In the framework of the renewal of some authorisation dossiers, we are currently dealing with the update on BPF regulation, taking into account the change of our clients’ products.

CASE STUDY 2

STAFF SELECTION

Crop Protection Sector A dRR for the renewal of authorisation of a product in different Member States across the EU was prepared. This product was used on a wide range of crops, which involved a complex environmental risk assessment. As a first step, our 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 iden tified 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.

Manda Vince – Regulatory Affairs Director Prior to joining Staphyt, Manda spent 5 years at another leading European consultancy, where she led a team delivering work for major plant protection clients and managed client relationships. With over 26 years’ experience in UK Government, Manda previously held several senior leadership positions in strategic and delivery roles. These involved negotiating major contracts, managing relationships with other Government departments, and managing business change and improvement. Manda also spent several years at the UK Chemical Regulations Directorate, where she led the evaluation of several dossiers for new active substances from the regulator’s perspective.

CASE STUDY 3 Crop Protection Sector One of the active substance data-matching programmes for protected study dossiers that our team 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. Members of our team 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.

Aurély Béghin – Deputy Regulatory Affairs Director With over 11 years’ experience in consultancy, Aurély has held several senior leadership positions in biocides business development, in regulatory and scientific teams’ management. These roles involved supporting clients in their strategic projects, managing business change and building team expertise. Previously, Aurély spent seven years in the chemicals industry, where she led product development, from R&D to commercial availability, managed regulatory matters and the relationships with marketing and commercial departments, as well as supporting the group merger processes. Our large, highly qualified and experienced team has expertise in all areas. Our experts are drawn from regulatory authorities, industry, grower organisations or testing facilities and from other consultancies, providing Staphyt Regulatory Affairs with a varied and comprehensive offering to our clients.

CASE STUDY 4 Combined Field and Regulatory Services for Crops Our large regulatory team works with our extensive Agrosciences field teams to provide clients with full management of their projects from beginning to end, if the client wishes. Clients can benefit from our large field trial sites coverage. Our team 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 5 Chemicals – REACH Our experts have prepared many lead registration dossiers under REACH, including UVCB registrations. Our experts worked closely with Echa to confirm substance identity, prior to submitting a successful Inquiry dossier. To upgrade the Inquiry dossier to a new substance lead registration, our technical specialists completed a detailed data gap analysis to identify end-points where additional data would be required. Following completion of a targeted literature search, the project manager provided the client with a strategy for addressing remaining data gaps, which included commissioning new testing, alongside securing access to read across ‘source’ data. The PM managed the laboratory appointed to conduct the new testing, drawing in technical specialist support where necessary. The PM negotiated read across letters of access to the additional source studies. The Iuclid dataset, accompanying read across justification (in accordance with the RAAF), and CSR, including exposure assessment, was then prepared by specialists across a range of disciplines, including toxicologists, ecotoxicologists, environmental fate and physchem specialists, and human health/environment risk assessors. The dossier was prepared quickly, to enable the client to place the substance on the EU market quickly, and submitted as an ‘only representative’ registration. www.chemicalwatch.com/SPG

Profile: Staphyt

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Profile: TEAM Mastery s.r.l.

174

SERVICES PROVIDED REACH services REACH registration dossier TEAM mastery has a long experience in the preparation of REACH registration dossiers, both as lead registrant and joiner. This activity includes any type of update of existing dossiers: tonnage band increase, update from Iuclid 5 to 6, response to specific requests from Echa, 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

READ across justification TEAM mastery is leader in the READ across justifications, in compliance with the latest Echa standard requests. We have submitted many successful dossiers containing READ across justification to waive demanding in vivo tests. READ across is performed in combination with QSAR modelling and in vitro testing, when necessary. Testing & in vitro strategy development, QSAR modelling An integrated testing strategy is the first step for cost optimisation and building rationale for waiving. The expertise in QSAR modelling has been often successful in discussion with the national authorities and scientific working groups. Assessment & characterisation of nanomaterials TEAM mastery offers assistance in the registration of nanomaterials following the analytical evaluation and (eco)toxycological assessment. Consortia management Experience in consortia management. We can provide legal advice, agreement documents, meeting location, cost calculation, managing of LoAs.

OVERVIEW TEAM mastery is a leading service provider in the area of Chemical Regulatory Affairs, covering all aspects of REACH, Biocide Product Regulation, Medical Devices, Plant Protection Products etc. The staff is highly motivated with specific expertise in chemistry, toxicology, 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. Our approach is focused in the most advanced and innovative solutions, that combine the scientific approach with regulatory needs to gain the highest benefit for the Industry and the downstream users.

Authorisation dossiers TEAM mastery has the expertise to develop complete authorisation dossiers with analysis of alternatives and socio-economic analysis. PPORD dossier TEAM mastery can assist in the preparation of PPORD dossiers. Test monitoring In case new tests are required, TEAM mastery will be responsible of selecting the most appropriate lab, review the protocol, audit the lab and check the results.

VITAL STATISTICS

2018/19

Turnover, group

2 million

Turnover, chemical service provision

2 million

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Legal Information 2%

CSA-CSR TEAM mastery can offer the possibility of preparing a new CSR, adding new uses or preparing a downstream user dedicated CSR. Evaluation process Echa is now evaluating all substances. In some cases, there are pending decisions to include a substance as a candidate SVHC. TEAM mastery can support the registrants in the dialogue with Echa during this process. CLP/GHS services Data collection and assessment of classification and labelling; O CLP notification; O SDS compilation; O extended safety data sheets; O exposure scenarios scaling and translation; O UFI submissions; O CLH dossier; and O Supply chain communication. O

Training Other 5% 1%

Representation & management 15% Consultancy/advisory 75%

Global Service Providers Guide 2020

Exposure modelling Exposure modelling can be performed with most of the recognised official tools like EUSES, Ecetoc TRA, EASY TRA, ART, CONS EXPO, RISKofDERM.

BPR services O Full dossier preparation for active substance and products; O technical equivalence; O testing strategy development; O management of Biocidal Product Family (BPF); O management of Biocidal Product Family (BPF) In situ generated active substances; O study monitoring; O risk assessment;

O O O O

endocrine disruptor properties evaluation; evaluation of co-formulants ED properties; finalisation and discussion with national and EU authorities; and Post-submission support.

PPP services O Full dossier preparation for active substances and products; O testing strategy development; O study monitoring; O risk assessment; O finalisation and discussion with national and EU authorities; and O post-submission support. PHARMA services O Medical devices; O human health risk assessment; O environmental risk assessment; O determination of the PDE (permitted daily exposure); and O assessment of mutagenic impurities. FEED and FOOD registration O Dossier preparation; O risk assessment; O test monitoring; and O assistance to customer for Efsa calls for data. EU cosmetic directive O Regulatory compliance support; O product notifications; O cosmetics ingredient profiles; O product information files; O clinical studies: design and monitoring; O cosmetic product safety reports; and O product labelling review and support. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

CLIENTS We are working for about 500 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 hundreds of lead dossiers, many of them with a full study plan ordered and monitored. UVCBs and difficult substances are the main specialisation area. With the increase number of Echa compliance check, many dossiers need to be re-evaluated, discussed and improved from the first submission of 2010. TEAM mastery was able to improve the exposure scenarios, READ across justifications, and the overall quality of the existing dossiers. TEAM mastery is now working on the update of registration dossier for nanomaterials and on endocrine disruptors properties assessment. CASE STUDY 2: Task Force Hypochlorite During 2017 and 2018 TEAM mastery organised together with CENTRO REACH and Mérieux NutriSciences Italia- Chelab the biggest Italian Task Force for the National Authorisation of biocidal products based on active chlorine generated from sodium hypochlorite. Several Family dossiers, covering product type (PT) applications from 1 – 5, have been submitted including approximately 600 products belonging to more than 50 members. Moreover several mutual recognition authorisations have been submitted around Europe.

2008

Foundation of REACH mastery

2010

About 120 successful registrations for the 2010 deadline

STAFF SELECTION

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

Dr 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 only a minor proposal. The co-operation with many specialists within international companies and universities let her specialise in consortia management and dossier preparation.

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 dossiers

2018

Technical management and dossiers implementation of the biggest Italian Task Force for the National Authorisation of Sodium Hypochlorite

2018

New company name as TEAM mastery

2019

Acquisition of bigger premises

PARTNERS O O O

CENTRO REACH Srl Kahlberg Consulting Srl Research projects in collaboration with: Department of Pharmacological and Biomolecular Sciences, University of Milan Department of Earth and Environmental Sciences, University of Milano-Bicocca, Milan; Department of Science and high Technology, University of Insubria. Strong partnership with CAAT Europe (Centre of Alternative to Animal Testing).

Dr Costanza Rovida – ERT– REACH regulatory specialist Graduated in chemistry, after fifteen years experience, in the field of analytical chemistry, she is now responsible for the management of individual projects and global customer assistance. She is also part of CAAT-Europe team and participant in an integrated EU project: the EU-ToxRisk focused on integrated development of alternative toxicological methods to animal testing. Dr Stefano Tortelli – Biocides regulatory specialist Graduated in chemistry, he developed experience in project management and human resources, before dedicating to the regulatory field. Dr Silvia Lazzari – PPP regulatory specialist Graduated in chemistry, she developed experience as consultant for health and safety and quality assurance. She joined TEAM mastery as regulatory specialist for the REACH division and, after five years of experience, she joined the PPP regulatory division.

www.chemicalwatch.com/SPG

Profile: TEAM Mastery s.r.l.

175

Profile: Triskelion B.V.

176

GLOBAL OFFICES TRISKELION Headquarters: Zeist, The Netherlands First Dutch Innovations Headquarters: Delft, The Netherlands Sales representatives: Japan, USA, Canada

CONTACTS Website

www.triskelion.nl

E-mail

info@triskelion.nl

Head office

Reactorweg 47A, PO Box 40237, 3504 AA Utrecht, The Netherlands

Tel

+31 6 5280 3578

Contact

Paul Stoffels

Ownership

Private company

Locations

Zeist, The Netherlands

Founded

TNO, 1932; TNO TRISKELION, 2011; TRISKELION, a First Dutch Innovations company, 2017; DUCARES B.V. | trading as TRISKELION, 2020.

SERVICES PROVIDED

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 specialise in multidisciplinary projects in which our consultative skills, broad expert knowledge and per-sonal 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, totalling 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

2018/19

No of offices

No of countries represented

Staff, group

100

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training, 5%

Consultancy/advisory, 20%

Representation & management, 10% Laboratory, 65%

Global Service Providers Guide 2020

Registration Services & Risk Assessment Looking for a CRO that knows the market and can help you remain 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 â&#x20AC;&#x201C; 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 additional studies need to be performed, we set up and monitor this to include in your dossier(s). Food Contact Materials Do you want to make sure that your Food Contact Material (FCM) is compliant with relevant legislation? We provide the expertise and capabilities to test and evaluate your FCMs. Our labs are internationally renowned and accepted. We offer full support with EU and FDA regulation of FCMs, as well as petitioning of new substances. We have ample experience with migration testing, modelling and compliance statements. Our state-of-the-art analytical laboratory equipment enables the detection of NIAS (NonIntentionally Added Substances) and oligomers at very low levels. We can advice on requirements, procedures, and strategies for your FCMs to be compliant. 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, analyse 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

CASE STUDY 1: REACH registration

1932

Foundation of TNO, The Netherlands Organisation for Applied Scientific Research

1946

Creation of the Central Organic Chemistry Institute in Zeist

1963

First study on food packaging materials

2001

First submission of Food Contact Notifications to FDA

2004

Completion of five-year HPV chemicals programs on various chemical groups, including organotins

2006

Participation in REACH implementation projects (data requirements, exposure assessments)

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. First petitioning for authorization of food contact materials under the EU Plastics Regulation.

While the last registration deadline is behind us, the work for compliance with REACH legislation is far from finished. Echa and member state authorities are ramping up the assessment of registration dossiers and prioritization of substances for further regulatory action (eg compliance checks, substance evaluations, restrictions, authorisations). Thanks to the massive amount of experience we 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 authorisation. We can also assist you in creating successful applications for authorisation.

2012

Extensive application of our exposure experience to the evaluation of risk management options for SVHCs

2013

REACH 2013 dossiers submitted on time!

2015

Expanded presence in areas beyond the EU

2017

First Dutch acquires TNO Companies, including TRISKELION

2018

Timely submission of all REACH registration dossiers

2019

Successful petitioning of a bio-based polymer as a food contact material in the EU

2020

Merger TRISKELION & DUCARES in order to complement each other in regard to food safety testing, analysis, consultancy and several other research areas. Our Knowledge is your strength!

ACCREDITATIONS In compliance with GLP (analytical chemistry); ISO 9001 certified; some analytical services under ISO 17025 (L546). 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 (such 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 inconducting 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

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. 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. Our 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.

www.chemicalwatch.com/SPG

Profile: Triskelion B.V.

177

Profile: TÜV SÜD Industrie Service GmbH

178

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.tuvsud.com/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 26,000 people in 60 countries in ca. 1000 locations

Founded

1866

OVERVIEW 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

2018/19

Turnover, group

€2,600m

No of offices

1000

No of countries represented Staff, group

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: O O O

introductory training courses to gain an overview of REACH and CLP; seminars on selected topics of REACH; workshops to create solutions under the guidance of an experienced expert; and in-house consulting for the ad-hoc solution of characteristic problems.

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

26,000

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 Singapore-based PSB Group

2007

Establishing REACH services. Founder member of the “BUSINESSEUROPE REACH Implementation Network”.

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. In-house training and seminars

Training 5%

Laboratory 5% Information 10%

Representation & management 35%

Consultancy/advisory 35%

ACCREDITATIONS GLP

Global Service Providers Guide 2020

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 almost 20 years’ professional experience. Ing. Rupert Scherer Rupert Scherer is an engineer and certified REACH multiplicator with 16 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.

www.chemicalwatch.com/SPG

Profile: TÜV SÜD Industrie Service GmbH

179

Profile: UL

180

SERVICES PROVIDED

CONTACTS Website

msc.ul.com

E-mail

ul.mscinfo@ul.com

Head office

333 Pfingsten Rd, Northbrook, IL 60062, United States

Tel

North America (US): +1 800 572 6501 Europe (UK): +44 115 965 1888

Directors

Mette W. Pedersen

Ownership

UL, LLC

Locations

Global

Founded

1894

OVERVIEW We help customers manage a product through its entire lifecycle. From material selection and product manufacturing to meeting retailer specific requirements and disposal – and every life stage in between – UL provides innovative solutions to meet the health, safety and environmental (EHS) requirements of the dynamic demands of the global marketplace today. For more than 30 years our customers have relied on us to meet the chemical compliance requirements of government, non-government, retailers and consumer organisations. In order to accomplish this, we constantly monitor and analyse the regulatory landscape to assess and interpret the implications to the supply chain. With best-in-class software solutions, the most robust regulatory data, backed by a team of global regulatory experts, customers can proactively manage their supply chain with transparency and confidence by making informed and strategic business decisions. VITAL STATISTICS

2018/19

No of offices

160

No of countries represented

113

Staff, group

14,500

Staff, chemical service provision

820

SERVICE AREA BREAKDOWN Training 5%

IT & software 60%

Consultancy/advisory 15%

Information 20%

GLOBAL OFFICES Brussels, Belgium; Ballerup, Denmark; Krefeld, Germany; Cabiate, Italy; Nottingham, UK; Northbrook, Illinois; Overland Park, Kansas; Latham, New York; Pittsburgh, Pennsylvania; Shanghai, China; Tokyo, Japan; Seoul, South Korea; São Paulo, Brazil and Melbourne, Australia

Global Service Providers Guide 2020

SDS authoring and chemical data management software Whether you require SDS authoring, raw material introduction, report creation, or distribution and workflow management, you can leverage UL’s industry-leading expertise, technology and data for an integrated compliance solution to meet your exact needs. UL’s market-leading hazard communication compliance solutions allows you to easily manage your EHS initiatives and regulatory compliance obligations with: O software options for every size of business and budget; O platforms that are configurable and flexible, and can be integrated with other business systems (such as SAP); O compliance data acquired by industry experts monitoring over 6,200 regulatory lists; and O solutions supported by an experienced, global network of scientists, consultants and regulatory experts. Global market access and advisory services It doesn’t matter if you are a small business that needs compliance knowledge to grow, or a large corporation that needs surge capacity for the latest regulatory deadline, UL has the expertise and experienced staff to provide the advisory services you need. Our team of 60+ world-class regulatory experts provide support services to assist with: O product development and product launch; O verifying and maintaining product compliance; O training staff on global regulations and best practices; O regulatory data and information; O technical and industry specific issues; O hazard communication & risk assessments; O product or component registration/notification (such as REACH and TSCA); O site audit and process reviews; O developing processes to support your company’s growth; and O chemical policy development. Sustainable product design We provide formulators, engineers and R&D experts with the technical and compliance information they need to develop products quicker and with the regulatory insights to successfully enter the marketplace. From the selection of the first raw materials, through a complex manufacturing process, to its proper disposal at end of use, UL provides customers around the globe with the information and the resources to make informed and sustainable decisions. Predictive toxicology software Leveraging a curated database of 70 million structures and over 80,000 chemicals with more than 800,000 labeled hazard endpoints, our innovative software utilizes an advanced algorithm, machine learning, and analysis of millions of chemical combinations to predict chemical hazards similar to the reproducibility accuracy of animal testing. UL’s Cheminformatics is a computational toxicology Read Across Structure Activity Relationship (RASAR) software that quickly and accurately assesses chemicals for GHS hazard classification, as well as suggested hazard endpoints and weighting. Supply chain compliance By facilitating the secure data exchange throughout the most complex product supply chains, UL is the trusted third party for providing risk mitigation and data transparency. Whether it is securing the makeup of raw materials, the proprietary formulation from the leading manufacturers, or providing retailers with the critical data necessary to comply with local or national regulations, we can help you manage your compliance needs with confidence. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2012

UL Prospector® (formerly Innovadex & IDES) becomes the world’s trusted materials and ingredients search engine

2013

UL acquires supply chain software specialist The WERCS

2016

UL acquires leading chemical EH&S regulatory compliance provider Safeware Quasar

2017

UL acquires ChemADVISOR, a recognized world leader in chemical regulatory compliance and data solutions

2017

UL partners with Johns Hopkins researchers to develop the revolutionary machine learning software Cheminformatics

2018

UL launches powerful search tool UL Product iQ™, which verifies UL certifications for products and components

2019

UL launches Navigator™, an online compliance knowledge base for over 50 countries

2019

UL launches LOLI® Illuminator, a first-of-its-kind software tool enabling online access to industry-leading LOLI data

ACCREDITATIONS ISO 27001 (Latham, New York) CLIENTS More than 14,000 customers worldwide use various UL product compliance products and services across industries such as: Adhesives, automotive, plastics, consumer products, flavour and fragrance, life sciences, paints and coatings, consumer electronics, building products, petrochemical, pharma, retail, and specialty chemicals. CASE STUDY 1: UL’s Global Regulatory Support Assists Large Global Manufacturer A large manufacturer ships and handles a variety of chemical products including oils, lubricants, cleaners and paints to support their robust global operations, and had a need to author a significant number of SDSs and labels in an expedited timeline due to regulatory changes. As with many companies who are not specifically chemical manufacturers, they did not have the expertise or personnel to author compliant SDSs for all of the chemical-containing products that they were using, selling, or transporting. With limited time, resources and technical expertise, they required comprehensive global SDS and labelling support – in multiple languages – to ensure that they met their hazard communication compliance obligations. By leveraging UL’s powerful, sophisticated software, integrated with the world-class expertise of our global Regulatory Services team, we delivered quality and compliant SDSs and label text in all of the required languages to meet the aggressive timelines. This combination of expert regulatory support and efficient turnaround time was crucial in allowing the manufacturer to fulfil their hazard communication compliance obligations while continuing to focus on their core manufacturing expertise. Benefits: O Accurate SDSs and labels created quickly and efficiently; O documents created for multiple regions simultaneously UL-approved GHS-compliant SDS template; O powerful software backed by SAP implementation; and O global regulatory expertise from a safety company. CASE STUDY 2: Supply Chain Compliance Due to increasing regulatory demands, a leading retailer was looking for a solution to bridge the gap between the chemical data provided by manufactures and the data required to assure the correct handling, transportation, storage and disposal of the chemical containing products on their store shelves. UL provides an online presence for manufacturers to enter required data as part of a standardized process to distribute products through retailers. Utilising automated algorithms and advanced logic, the software then determines the data points necessary for the retailer to correctly handle, transport, store and dispose of the chemical-containing products on their shelves. With advanced access to data beginning at procurement, retailers can manage their entire supply chain before products arrive on the dock – allowing for proactive regulatory compliance management. Today, UL serves over 50+ major leading retailers and assists more than 14,000 manufacturers transfer critical data necessary to place products on retail shelves.

Benefits: O A trusted third-party solution that facilitates the secure transfer of product composition data from manufactures and allows retailers to meet product compliance needs without disclosing confidential information; and O retailers can convert legacy SDSs to region-specific GHS standards. CASE STUDY 3: Compliance Software That Goes Beyond SDS Authoring A leading global adhesives company required SDS documents and several additional regulatory documents for commercial reasons, including the Declaration of Performance document (DOP). A DOP is a key part of the Construction Products Regulation (CPR), which provides information on the performance of construction products. Each construction product covered by a European harmonised standard, or for which a European Technical Assessment has been issued, requires this document and they must follow defined formats with standardised language, similar to an SDS. This company was able to leverage the power of UL’s flexible software to create a template and seamlessly author compliant DOPs for all of their construction products in addition, to the compliant SDS documents. Benefits: O compliant documents for multiple commercial applications created quickly; O all documents available internally through the user friendly web viewer; O no need to purchase additional software or services, saving resources; and O solving additional compliance needs with UL software and data.. STAFF SELECTION Karen Lintz – Director of Regulatory Services With nearly 30 years of experience in regulatory affairs, Karen is the Managing Director of UL’s Regulatory Assurance & Data Insights Group, where she leads a global team of over 60 regulatory specialists and industry experts who deliver exceptional regulatory services in over 30 languages all over world. Karen has a rich understanding of EHS, environmental compliance, toxicology, and hazardous materials, and is an esteemed authority on regulatory requirements, risk assessments, and occupational health concerns. Craig Rowlands PhD, DABT – Senior Toxicologist UL’s Dr. Craig Rowlands is an industry leader with expert knowledge in scientifically sound product safety assessments that enhance product sustainability and reduce environmental, health & safety risks of chemicals. He has a successful record helping organizations achieve their sustainability performance goals through collaborating, partnering and impacting internal R&D programs, government agencies, regulatory authorities, technical-and trade-associations, non-governmental organizations, and universities. Craig has published over 85 articles in scientific journals, book chapters and developed numerous hazard and risk assessment reports. Dr. Rowlands regularly presents technical seminars at conferences, symposia and trade association meetings, and currently serves on the US EPA Science Advisory Committee on Chemicals. Andrew Brooks PhD, DGSA – Regulatory Affairs Manager Andrew joined UL in 2012 as a Chemical Regulatory Consultant, coming from the chemical industry. Predominantly focusing on EU chemicals legislation REACH, CLP, and preceding European Directives, he assisted many companies with differing product portfolios during the transition to GHS, providing support and insights into the methodology and requirements for industry, enabling businesses to adapt and succeed with compliance. Andrew provides ongoing support and consultation to a wide range of companies, and is a qualified Dangerous Goods Safety Adviser. Stacie Abraham – Regulatory Program Manager for Innovation & Client Solutions With over 35 years of combined regulatory and chemistry experience, Stacie engages directly with chemical companies to evaluate compliance needs and create innovative, efficient compliance programs to solve complex supply chain challenges. Stacie has expertise in global chemical control regulations for all industry sectors as well as GHS and toxicology data analysis. She is also an expert on U.S. TSCA, and has presented extensively on this regulation at conferences all over the world. www.chemicalwatch.com/SPG

Profile: UL

181

Profile: UMCO GmbH

182

SERVICE AREA BREAKDOWN Other Training 5% Legal 5% 5% Information 5%

CONTACTS Website

www.umco.de

E-mail

umco@umco.de

Head office

UMCO GmbH, Georg-Wilhelm-Straße 187, 21107 Hamburg, Germany

Tel

Representation & management 5%

+49 (0)40 / 555 546 300 +49 (0)40 / 555 546 357

Contact

Jan Mönster

Directors

Anika Biehl Peter Duschek Ulf Ch Inzelmann

Ownership

See directors

Locations

Germany

Founded

1982

GLOBAL OFFICES Germany: Hamburg, Cologne SERVICES PROVIDED

Chemical Compliance Consulting As a consultancy firm with offices in Hamburg and Cologne, we have over 38 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: O global chemicals management; O SHE-management; O dangerous goods management; O regulatory compliance and audits; O digital efficiency solutions; and O emergency management.

No of offices No of countries represented

2018/19 2 1

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2020

Global chemicals management determination of the status of all the chemical products used or traded by your company with regard to their worldwide marketability; O auditing and advising regarding chemicals management at company or corporate level and the integration of responsibilities and documentation into management systems; O determination of classification and labelling in accordance with European and international chemical and dangerous goods legislation; O 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; O 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; O notification of hazardous mixtures acc. Article 45 of CLP regulation O 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); O customised interfaces to generate the automatic import and export of data in standard XML format into/from UMCO SDS software UHCS; O 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; O automated export of data to print direct CLP/GHS labels; O company-internal hazardous chemical management; O compliance service for restricted / banned substances in mixtures / O articles; and O data maintenance for hazardous substances, raw materials and products in the SAP EHS system of our customer. REACH management Registration management for co-registrants: O support in joint registration: communication regarding substance O sameness and letter of access (LoA); O compilation of dossiers and submission to the European Chemicals Agency (Echa); and O only representative (OR) for non-EU manufacturers according to Article 8 of the REACH Regulation. Comprehensive support for lead registrants: O communication with co-registrants and preparation of contractual arrangements for data and cost sharing; and O dossier management: collection and evaluation of information for technical dossier and chemical safety report. O

OVERVIEW

VITAL STATISTICS

Consultancy/advisory 75%

Communication in the supply chain: O strategies for the communication with suppliers and customers; O integration of registration information in the eSDS; O support regarding the identification of uses (use mapping); O implementation of exposure scenarios in daily practice; and O consultation regarding substances of very high concern (SVHC). Strategic consulting: O consultation and evaluation of organisations and structures in order to O ensure REACH compliance; O support related to participation and argumentation in public consultations and other communications with authorities; and O application for authorisation: consultancy, planning and support. Biocides management (Biocidal Product Regulation (EU) No 528/2012) Strategic consulting: O consultation and evaluation of organisations and structures O in order to ensure BPR compliance; and O advising regarding borderline and dual use products Active substance approval and biocidal product authorisation: O definition of the appropriate strategy; O

O O

O O O

preparation of dossiers according to national legislation, in case the transitional period for actives is applicable; conduction of literature research, data evaluation and data gap analysis; identity, technical equivalence and physical-chemical parameters; toxicology and human exposure, environmental fate and ecotoxicological evaluation; monitoring of studies; communication with authorities and laboratories; and preparation and submission of dossiers

Safety health environment management O provision of a SHE manager/officer; O provision of external company advisors/officers for the fields of occupational safety, emission protection, water pollution control, waste, hazardous incidents, fire protection; O carrying out of approval procedures; O advice on storage of dangerous materials; O explosion protection consultation; O preparing operating instructions and risk assessments; O compiling safety reports and further hazardous incident documentations such as safety management systems and corporate alarm and hazard control plans; O training and instruction (executives, contract workers, employees); O management systems: ISO 14001, 18001 (OHSAS), 45001, 50001; O compliance organisation; O compliance checks (HSE legal compliance); O conducting internal audits; and O fire protection. Dangerous goods O provision of an external Dangerous Goods Safety Advisor (DGSA); O establishment of a company individualised dangerous goods O organisation and analyses for optimising procedures; O inventory and dangerous goods audit; O dangerous goods consulting; O checklists, working and operating instructions; O verification of correct classification and labelling; O instruction and training courses; O preparing and checking of documents; O information about legislative changes; and O project organisation.

Training O training, workshops and seminars in all services provided O in-house seminars; and O working and process instructions CORPORATE DEVELOPMENTS & ACHIEVEMENTS 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.

2016

Customised online training for employees about occupational safety and related areas. These trainings can be adapted to suit the needs of individual company requirements.

PARTNERS Global Chemical Consultant Network O eg NCEC O eg REACH24H 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 O

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 O

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 O O O O

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.

Emergency services O Emergency telephone number for EC SDS (all European Poison Centres); and O GlobalChem24 – 24 hour emergency number for chemicals transport and SDS worldwide (together with the NCEC).

www.chemicalwatch.com/SPG

Profile: UMCO GmbH

183

Profile: Veeva

184

SERVICES PROVIDED Manage risk and simplify product compliance by using Veeva’s regulatory and quality management software for the Chemical industry. Expanding product portfolios, M&A activities and increasing global regulatory demands are stretching quality and regulatory departments. Whatever chemical business you are in, Veeva simplifies and unifies your compliance activities in a single, easy to use cloud solution.

CONTACTS Website

https://www.industries.veeva.com/chemical

E-mail

info@industries.veeva.com

Head office

4280 Hacienda Drive Pleasanton, CA 94588 United States

Tel

+1 866 243 2055

Contact

David Karpay, +1 866 243 2055 Maximilian Krahn, +49 69 5060 6857 Charles Di Nicola, +33 1 8652 5994

Directors

Andrew Douglass – Strategy Director, Chemical Shawn Steurer- Strategy Director, Regulatory Paul Gilfrin – Director of Sales, Veeva Chemical, Europe Kent Potts – Director of Sales, Veeva Chemical, North America

CORPORATE DEVELOPMENTS & ACHIEVEMENTS Founded in 2007, Veeva Systems, is a global provider of cloud-based software solutions. We help quality, regulatory and commercial teams in the chemical, cosmetics, consumer goods, and life science industries unify disconnected processes, documents and data. In doing so, we help our customers eliminate inefficiencies so they can bring innovative, high quality products to market faster without compromising compliance. Read our story, find the latest news and view awards presented to Veeva.

Ownership

Public (NYSE: VEEV)

Locations

Headquartered in the San Francisco Bay Area, with 18 offices throughout North America, Europe, Asia, and Latin America.

Founded

2007

VITAL STATISTICS Turnover, group

PARTNERS Verisk 3E, Labvantage, AWS, Salesforce, Zoom, Microsoft CLIENTS Veeva serves 800+ customers around the world and across the chemical, cosmetics, consumer goods and life science industries, including DSM, Syngenta, Bayer Crop Science, Parfums Christian Dior, Reckitt Benckiser, Unilever, Merck and Pfizer. TESTIMONIALS

2018/19 862.2M USD

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

2500+

Staff, chemical service provision

SERVICE AREA BREAKDOWN

"Veeva helps us to overcome challenges in Regulatory and Quality Assurance of BASF’s Crop Protection and Seed & Trait business. Veeva Vault provides a foundation for our digital transformation with great potential within our Agricultural Solution business, but also beyond." - Rainer Becht-Mattern, Head of IS Business Architecture R&D, Crop Protection at BASF “Veeva Vault Platform helped us transform and speed up our regulatory processes. It streamlines product submissions and establishes a single source of truth across all stakeholders. It provides us with the needed visibility and helps us increase our productivity.” - Dr. Landry Le Chevanton, Head of RAQM/Operations at DSM “The new system allows us to centralize the end-to-end process of registering genetically-modified products, as all of the applications are unified on one platform. Users can now seamlessly exchange information, and re-use content.” - Shanna Chriscoe, Business Lead at Syngenta CASE STUDY 1

IT & software 100%

From Weeks to Seconds: How Syngenta Modernized and Optimized Its Regulatory Function By Moving to the Cloud https://www.industries.veeva.com/resources/syngenta-case-study

CASE STUDY 2 GLOBAL OFFICES European Headquarters 131 Av Charles de Gaulle 92200 Neuilly sur Seine FRANCE Phone: +33 1 8652 5994 Offices: Pleasanton, Philadelphia, Toronto, Columbus, Oxford, Paris, Barcelona, Frankfurt, Budapest, Shanghai, Beijing, Seoul, Tokyo, Osaka, Mumbai, Singapore, Sao Paulo, Sydney

Global Service Providers Guide 2020

Learn how Veeva helps DSM to streamline product submissions and to establish a single source of truth across all stakeholders https://www.industries.veeva.com/resources/customer-success-dsm

Profile: Veeva

185

CASE STUDY 3 Learn why dietary supplement producer New Chapter Inc. chose Veeva QualityOne to modernize their quality document systems to drive day-today business decisions, workflows and personnel timelines. https://www.industries.veeva.com/resources/customer-interview-newchapter STAFF SELECTION Andrew Douglass, Strategy Director, Chemical Andrew is responsible for the Chemical market strategy for Veeva software. He has more than 20 yearsâ&#x20AC;&#x2122; experience in R&D and marketing within the chemical, biotechnology and consumer goods industries and has a B.Sc. and Ph.D. Chemistry from the University of Southampton, England. Shawn Steurer, Strategy Director, Regulatory Shawn Steuer is an expert in regulatory affairs, familiar with both the consultant and industry perspective. The biologist with a focus on biochemicals began his career in the area of toxicological safety and now brings nearly 15 years of regulatory experience. He has worked in many different areas such as biocidal products, EU-REACH, CLP, TSCA, plant protection products, pharmacovigilance and toxicological safety. He has also been in charge of the quality assurance for dossier quality for plant protection and biocidal products. His objective today is to bring together suppliers, manufacturers and consultants from the Chemical industry and support them in all regulatory and quality management challenges.

www.chemicalwatch.com/SPG

Profile: VelocityEHS

186 provider of leading EHS solutions, including:

GLOBAL OFFICES

MSDSonline® | ChemTel®

United States, Canada, United Kingdom, Australia SERVICES PROVIDED

CONTACTS Website

www.EHS.com

E-mail

Velocity@ehs.com

Head office

222 Merchandise Mart Plaza, Suite 1750, Chicago, IL 60654 USA

Tel

1.888.362.2007 1.312.881.2000

Contact

www.EHS.com | 1.888.362.2007 | 1.312.881.2000

Locations

United States, Canada, United Kingdom, Australia

Founded

2001

SDS/chemical management VelocityEHS’ award-winning MSDSonline cloud and mobile SDS/ chemical management solution, trusted by more customers than any other provider’s solution in the industry, delivers the easiest-to-use tools for centralised SDS management and employee right-to-know access (online and offline), as well as container-level product management, secondary workplace labeling (GHS and more), reporting, regulatory list cross-referencing, chemical data archiving, and innovative sharing of critical inventory information with first responders. Its multi-language capabilities and ease-of-use empower workers ― wherever they are ― to be active participants in assuring the success of their company’s chemical management, environment, safety, health and sustainability programs.

OVERVIEW VelocityEHS—trusted by more than 18,000 customers worldwide and millions of end-users—offers a comprehensive cloud-based environment, health and safety (EHS) software platform and suite of services to help companies reach their EHS goals faster. VelocityEHS solutions range from incident management to industrial hygiene to ergonomics to chemical management. Popular VelocityEHS brands include MSDSonline® for chemical management, Humantech® for ergonomics, and ChemTel® for chemical emergency response services. Customers benefit from VelocityEHS solutions’ ease-of-use, quick implementations, affordability, and unparalleled customer support. Recognised by the EHS industry’s top independent analysts, including Verdantix in its 2019 Green Quadrant Analysis, VelocityEHS is the global leader in EHS software solutions. VITAL STATISTICS

2018/19

No of offices

SERVICE AREA BREAKDOWN Training Consultancy/advisory 6% 11% Information 11% Laboratory 2%

IT & software 70%

Global Service Providers Guide 2020

Authoring & regulatory consulting services VelocityEHS has certified experts on-hand to help companies classify chemicals, as well as author, translate and review chemical-product documents, such as safety data sheets, ingredient disclosure documents, a variety of labels, and more. Its team is available to assist companies with meeting global chemical management compliance requirements such as those related to OSHA HCS, EU CLP, WHMIS, the other 65+ GHS-aligned Hazard Communication Standards, as well as individual corporate product stewardship and sustainability goals. The team’s work ranges from preparing hybrid SDSs and Classified Business Information/ trade secret claims to performing ingredient substitution assessments and creating custom container labels. All projects are handled with the greatest attention to detail and in line with industry best practices. Emergency response services VelocityEHS’ Emergency Response Services – powered by ChemTel – give customers access to a 24-hour toll-free number that connects to a globally recognized call center, which is available to provide support in more than 200 languages. Through this service, customers receive unlimited use of the 24-hour hotline for: O hazardous materials shipping papers and manifests, in order to meet DOT, FAA, IMDG, IATA and other global hazmat shipping requirements; O SDSs in order to meet OSHA, WHMIS, and other hazard communication regulatory requirements; O chemical exposure support; O escalated chemical incident reporting; O SDS back-up access by phone, email and fax from the industry leading VelocityEHS | MSDSonline database; and O lithium battery shipping support. Chemical management services VelocityEHS offers a range of services that complement its MSDSonline cloud and mobile system and help further streamline customers’ chemical management tasks. Whether customers are looking for ways to fast-track a transition from paper to electronic SDS management or confirm an accurate accounting of their physical chemical inventory, VelocityEHS can help. A sampling of services includes: O on-site chemical inventory audit; O SDS online library build; O SDS library back up; and O SDS indexing — where VelocityEHS inputs desired data from SDSs, such as but not limited, to GHS pictograms, hazard statements, ingredients, PPE, and target organs, into customers’ MSDSonline account to facilitate the generation of secondary workplace container labels and a variety of useful inventory reports.

Industrial hygiene VelocityEHS’ Industrial Hygiene solutions—including Sample & Equipment Management, IH Program Management, Medical Surveillance, and Respirator Fit Test—work together or independently to help automate and streamline IH workflows. VelocityEHS IH solutions help both Certified Industrial Hygienists and EHS professionals new to IH succeed through a comprehensive cloud software system that makes it easy to assess and control workplace stressors with tools that simplify sampling and data entry, drive IH program management and enhance the visibility of workplace risks. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2015

Best New SDS Management – OH&S New Product of the Year

2016

Best New Product – Environmental Protection

20162019

Best SDS Management Product – ISHN Readers’ Choice Award

2017 & 2019

Industry Leader – Verdantix Green Quadrant Analysis

2017

Most Recommended – NAEM EHS & Sustainability Software Ratings and Report

2017

Best EHS & MSDS Software Product – ASSP Safety 2017 Attendee Choice Award

ACCREDITATIONS O O

Company: SOC 2 and GDPR compliant Staff accreditations include, but not limited to: Toxicologist, Chemical Engineer, Chemist, Certified Industrial Hygienist (CIH), Project Management Professional (PMP), Certified Professional Ergonomist (CPE), Certified Dangerous Goods Professional (CDGP), Certified Safety Professional (CSP), Safety Data Sheet Registered Professional (SDSRP), Bachelor's and Master's degree in Biotechnology, Environmental Law, Master's in Public Health, Master's in Ergonomics and Kinesiology

PARTNERS NSC, VPPPA, ASSP, AIHA, NAEM TESTIMONIALS “MSDSonline is so easy to use” – IKEA North America Services, LLC “Very well done, from sales to implementation” – A healthcare customer “Flexible, convenient, easy to use and explain to the employees. Great time saver over the old paper system that we had. I am very happy with the experience; from building the file to the roll out to the employees.” – Cope Plastics, Inc. “Everybody in the company can look something up very quickly and easily. It’s become part of our culture of emergency preparedness and response” – Jim Kamon, MAG Automotive “I have found MSDSonline to be a great resource and I was glad that my predecessor had selected you folks. With the GHS change, MSDSonline was way ahead of other companies in providing information and training.” – Eastern Pennsylvania Electronics Manufacturer “[The MSDSonline HQ Account] has made it really easy for anyone to access what onsite chemicals we have, and in what departments. Especially in a multiple location environment, this thing is extremely efficient. It saves time for our administrators; they can check anything they need to check, location by location. I access it remotely, and so do many of our line managers — on their iPads or iPhones.” – Ron Odell, Cactus Feeders.

CASE STUDY 1 VelocityEHS’ MSDSonline solutions simplified SDS/chemical management for New Life Chemical & Equipment, an industry leader in sustainable chemical recycling with customers around the world. With nearly 1,000 different chemicals at any given time in more than 100,000 square feet of warehouse space, New Life needed an easier way to manage and access a large amount of safety data sheets and chemical inventory information—especially in the face of changes to hazard communication requirements brought on by GHS alignment. Additionally, after a small warehouse fire, the company identified a need for a smoother process to provide critical safety information to first responders. VelocityEHS’ MSDSonline cloud-based and mobile SDS/ chemical inventory management system was the perfect solution. It gave New Life the ability to easily maintain its library of SDSs and chemical inventory information online, obtain new and updated documents from its industry-leading SDS database, and quickly generate GHS-aligned workplace container labels. Plus, the system’s unique, built-in first responder sharing tool provided an efficient way for the company to share its potentially lifesaving hazardous chemical inventory information with local emergency responders, making New Life better equipped to handle chemical-related incidents. CASE STUDY 2 Primetals Technologies—a joint venture between Mitsubishi and Siemens that provides metals industry processing equipment and solutions— turned to VelocityEHS and its MSDSonline SDS/chemical inventory management solutions to more efficiently manage chemical hazards and ever-evolving compliance requirements. As a manufacturing industry leader with a global reach, multiple facilities across locations, and nearly 1,000 chemicals on-hand that require safety data sheets, Primetals needed a solution it could rely on to meet hazard communication requirements and keep its employees safe, all while simplifying dayto-day chemical management tasks. In addition to the ability to easily access and manage SDSs and chemical inventory details, VelocityEHS’ MSDSonline cloud-based and mobile system allowed Primetals to more efficiently create secondary workplace container labels and reduce its environmental footprint through the selection of safer chemical substitutions—the latter of which it achieved by comparing its own product inventory information with that of alternatives from the system’s expansive database—an important asset to helping advance the company’s ongoing commitment to sustainability. Primetals also found benefit in using VelocityEHS because it offered other easy-to-use EHS solutions, including tools for managing OSHA recordkeeping compliance and employee on-demand training on a variety of workplace topics. CASE STUDY 3 VelocityEHS’ Authoring and Regulatory Consulting Services teams help companies with a broad range of complex compliance needs. A sampling of just some of the common as well as more unique challenges it resolves for its customers includes: helping businesses of all sizes by providing Regulatory Consulting support, expedited SDS Authoring projects, and free WHO Hand Sanitizer SDSs in response to the global COVID-19 pandemic; helping multiple small businesses understand and meet global e-commerce documentation requirements for shipping products via a popular online marketplace; helping multiple large consumer and industrial product manufacturers classify product ingredients according to GHS; helping a food manufacturer prepare custom documentation to clarify confusion among its distribution network about what product-related information is and isn’t required for OSHA HazCom (versus FDA compliance); and helping a leading global car cleaning product manufacturer stay on top of compliance by creating newly required Ingredient Disclosure Documents for its California market.

www.chemicalwatch.com/SPG

Profile: VelocityEHS

187

Profile: Verisk 3E

188

GLOBAL OFFICES Carlsbad, CA, US: Verisk 3E’s headquarters Bethesda, MD, US Canton, OH, US Montreal, QC, Canada Copenhagen, Denmark Frankfurt, Germany Markdorf, Germany Siegen, Germany Sofia, Bulgaria Beijing, China Tokyo, Japan

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 (Germany): +49 322 21099383; APAC (China): +86 4001209384 (Japan): +81 365512850

Ownership

Owned by public company, Verisk Analytics

Locations

US, Canada, Europe, Asia

Founded

1988

SERVICES PROVIDED

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

2018/19

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

475

Staff, chemical service provision

80%

SERVICE AREA BREAKDOWN

IT & software 30%

Consultancy/advisory 15%

Information 55%

Global Service Providers Guide 2020

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. Tools for scanning the horizon for emerging regulations. 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, dangerous goods content and vendor SDS data for authoring SDSs and labels and managing EHS compliance activities. Integrates with any third party platform including advanced/specialized integration with SAP EHS and S/4HANA for product compliance. Product marketability and chemical compliance Access to comprehensive, up-to-date substance lists and regulatory content used to support decisions related to securing the right to market, sell and ship products in intended markets. Notification, registration and reporting Global chemical registration, notification and reporting – consulting support for new chemical notification, chemical registration and reporting, including REACH and REACH-like requirements. EU Poison Centre Notifications – solutions and services to help companies meet both current and upcoming notification obligations. 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 and 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. 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 – a full spectrum of services that address the challenges of bringing a product to market and managing compliance from a global perspective. 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

2010

Acquired by Verisk Analytics

2014

Expanded global presence with office in Tokyo

2017

Rebranded: 3E Company became Verisk 3E

2018

Expanded global presence with office in Beijing

2019

Acquisition and Strategic Software Development Alliance: SAP’s Content as a Service (CaaS) business, which included the Environmental Health and Safety Regulatory Content (ERC) and Environmental Health and Safety Regulatory Documentation (ERD) teams and data assets

2002 – 2020

Long-time and frequent industry award recipient: www. verisk3e.com/about-verisk-3e/awards-recognition

PARTNERS Airsweb, ASD, BIOVIA, Cority, Dotmatics, Enablon, Flashpoint, Gensuite, Intelex, Jaggaer, Kelaroo, Links-AS, Logic1, Logical Data Solutions, Reliance Label Solutions, SAI Global, SAP, 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. TESTIMONIALS "Verisk 3E allows us to make the world a safer place by giving us clarity and the ability to be compliant in the regions of the world where Valvoline decides to serve. SAP is our core platform that we are using for financials and supply chain, but we also use it as a key portion of our regulatory compliance program. The content that Verisk 3E provides matches very nicely with the functionality that SAP provides and allows us to stay current with the regulations that are coming along as well as allowing Valvoline to expand almost seamlessly into the regions that we wish to do business in." Global ERP Services Manager, Valvoline

CASE STUDY 1: CHS Cultivates Chemical and Workplace Safety with Verisk 3E Solutions Industry: Agronomy, Agriculture, Energy, Food, Food Ingredients, Oil and Gas, Lubricants Challenges: O Lack of access to updated, compliant SDSs in all locations O Inefficient chemical management and inventory tracking O Highly manual processes for meeting SARA reporting requirements Solutions: 3E Protect SDS and chemical management; 3E Optimize integrated content solutions Results: O Saving 15 minutes per SDS by eliminating manual review and data extraction processes O Elimination of manual processes including SDS obtainment and SDS filtering and indexing O Streamlined SARA reporting O Standardization of processes resulting in cost savings O Ease of integration with third party applications CASE STUDY 2: Global Chemistry Company Industry: Chemicals for Automotive, Paints, Plastics, Electronics, Construction, Energy and Telecommunications Challenge: The global chemistry company needed to standardize the way it managed hazardous substances. The business required a globally compliant approach to meet international regulations to be able to sell its products across the world with compliant hazard communication documentation. Solution: 3E ERD cloud-based SDS and label authoring services from Verisk 3E Results: O Simplified processes for classifying dangerous goods O Updated, globally compliant SDSs and labels for approximately 5,000 chemical products in 39 languages O Reduced risk of noncompliance with a flexible cloud solution, maintaining consistent data maintenance practices across the company’s diverse business and products O Improved chemical safety and compliance throughout the product lifecycle, from development to distribution O Reduced time to market STAFF SELECTION Ulrike Weissbach, Product Expert Ulrike Weissbach is a PhD chemist and is responsible for the coordination of a worldwide network of experts relating to product safety regulations. She has more than 15 years’ experience in the area of product development of content solutions for SAP EHS. Her role is to conduct analysis of legislative requirements according to European and global product safety regulations and GHS worldwide. Diana Schramm, Manager, Base Component Library & Content Update Diana Schramm provides her subject matter expertise to Verisk 3E clients in the area of chemical classifications based on GHS regulations worldwide, Poison Centre Notification requirements, supply chain communication and raw material information management as it relates to the authoring of compliant SDSs. She is a lean six sigma yellow belt. Scott Stephens, Manager, Regulatory Research Scott Stephens oversees a team of analysts responsible for tracking EHS regulatory developments in the Europe, Middle East and Africa (EMEA) region. His duties include keeping a large set of regulatory databases up to date, expanding regulatory coverage to meet client needs, fielding client questions concerning EMEA EHS regulations, producing regulatory guidance and providing regulatory support for product development initiatives. Besides English, he is proficient in seven languages.

www.chemicalwatch.com/SPG

Profile: Verisk 3E

189

Niche firm profiles

190

CONTACTS

Website

www.anthesisgroup.com

E-mail

contact@anthesisgroup.com

Head office

The Future Centre, 9 Newtec Place, Magdalen Road, Oxford, OX4 1RE, UK

+30 2109901150 / +30 2109901151

Tel/Fax

+44 (0)1865 250 818

+30 2109901150 / +30 2109901151

Contact

Helen Kean

Contact

Panos Drougas

Ownership

Private company

Ownership

Private

Locations

UK, Europe, N. America, China, Philippines

Founded

2007

Founded

1994

Website

www.3s-chem.gr

E-mail

info@3s-chem.gr

Head office

133, El. Venizelou Str, 16343 Athens, Greece

Tel/Fax Fax

OVERVIEW 3S–SafelyServingScience is a distinctive company providing specialised advice and guidance at each-stage-of-chemicals-lifecycle. Our mission is to effectively guide and support SMEs to achieve a sound management of hazardous chemicals throughout their life cycle. Our +27 years 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 (best price guaranteed) solutions. Aiming to provide high value-added services, we practice the modern project management principles, supported by the latest cloud technologies. We are passionate about quality and effectiveness, which define everything we do to create value for our customers and look forward to offering you the best possible customer experience! SERVICES PROVIDED Here are the out-of-the-box core services we offer to our EU/International customers*: O authoring multilingual SDSs and labels; O classification & labelling studies; O Iuclid Cloud services (REACH, PCN, C&L notifications, biocides); O creation and maintenance of cloud-based chemical inventory; O Chemical storage system according to chemical compatibilities; O Seveso III (notification/safety report); O UN transport classification (ADR-IMDG/IATA-DGR); O HazWastes classification (WFD Annex III); O emergency Response (Plans and Level-1 service)/risk assessments of chemical hazards/Business conduct policies (EH&S); and O SQAS.org (preparation for assessment) *For customers based in Greece and Cyprus, please visit our website

CONTACTS Website

www.altox.dk

E-mail

altox@altox.dk

Head office

Tonsbakken 16-18, DK-2740 Skovlunde, Denmark

Tel/Fax

+45 3834 7798

Contact

Pernille Hjaltalin

Ownership

Private limited company

Locations

Denmark

Founded

1991

OVERVIEW 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: O REACH and CLP requirements of chemicals and articles (C&L, SDS, Echa registrations and communication); O toxicological end ecotoxicological evaluations and reviews; O biocides (BPR); O cosmetics (safety assessment, product information file, labels, CPNP etc); O product safety; O Safety of toys and child care articles; O other registration services (eco labelling, national product registers, poison centres); O general HSE counselling (on-site handling, storage, ATEX etc); and O Scandinavian regulations (eg MAL codes and order on carcinogenic substances) 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.

OVERVIEW Anthesis provides policy and regulatory consultancy in the field of chemical regulation and has done so since 1994 under the name of Caleb. Since 2014 Caleb has been part of the Anthesis Group. 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 clients’ internal resources in order to maximise the value of its contribution. The company has a considerable track record in sustainable chemicals management globally and supports clients with sustainable procurement as well as within the circular economy agenda. SERVICES PROVIDED Consortium and Sief management; O REACH – dossier development for registration, evaluation and authorisation / restrictions; O OR and TPR services for EEA and for UK Brexit (if required); O CLP compliance management; O SDS authoring and management; O product compliance under REACH, RoHS and Extended Producer Responsibility; O sustainability strategy development and implementation; O sustainable procurement; O chemical management including supply chain mapping, design & implementation; and O environmental due diligence. O

CLIENTS Anthesis 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 also supports more than ten REACH consortia as managers, technical and regulatory advisors.

CONTACTS Website

www.arrowregulatory.com

E-mail

info@arrowregulatory.com

Head office

6th Floor, City Gate East, Tollhouse Hill, Nottingham, NG1 5FS, UK

Tel/Fax

01159 352243

Contact

Dr Sara Kirkham / Dr Carlo Poncipe / Dr Virginia Gretton

Ownership

Limited Company

Locations

UK, Ireland, Austria

Founded

May 2016, October 2017, March 2020

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 90 person-years of experience in regulatory compliance during which time we have prepared over 65 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. SERVICES PROVIDED Arrow Regulatory Services: O REACH registration and authorisation; O preparation of vulnerability reports for REACH; O biocides; product authorisation and active substance Union list inclusion; O human and environmental risk assessment; O SIEF and consortium management services; O data gap analysis, data evaluation (reliability and acceptance), data-sharing and cost compensation; O project management and study monitoring; O worldwide product compliance; O EU OR and biocide EU representative functions via the Irish office; O dangerous goods consultancy; O CLP, GHS, and labelling advice; O efficacy consultancy; and O Preparation of safety data sheets (SDSs). CLIENTS Manufacturers, importers or downstream users of industrial chemicals, biocides. Veterinary drugs, plant protection products or cosmetic ingredients.

Global Service Providers Guide 2020

CONTACTS

Niche firm profiles

191

CONTACTS

Website

www.asseso.eu

Website

www.coracle.global

E-mail

info@asseso.eu

E-mail

info@coracle.global

Head office

Frohsinnstraße 28, 63739 Aschaffenburg, Germany

Tel/Fax

+44(0)1484 866777

Tel/Fax

+49 6021 15086-0

Contact

Claire Clarke

Contact

Stefan Oehrlein

Ownership

Private Limited Company

Ownership

Corporation

Locations

Germany

Founded

2015

Founded

2018 (2008)

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 work with a holistic approach and consist 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. SERVICES PROVIDED O Compliance check, product specifications; O development and implementation of tailor-made product compliance management systems; O inventory of legal provisions/effective product data management; O REACH registration process (strategy, dossier, SIEF and consortia, OR service); O safety data sheets (SDS); O classification, labelling and notification of substances and mixtures; O poison centres notification/UFI; O notification and information obligations due to REACH, CLP/GHS, WEEE, RoHS, food contact etc; O CE conformity; O risk assessment; and O client-specific workshops and trainings. 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, eg toys, interior decoration, electrical or chemical products. Company sizes range from small size companies to global corporations.

CONTACTS Website

www.chem-academy.com

E-mail

info@chem-academy.com

Head office

Bahnhofsplatz 2, D-16321 Bernau bei Berlin, Germany

Tel/Fax

+49 3338 75157 0 / +49 3338 75157 10

Contact

Dr Bjoern Nehls

Ownership

Private company

Locations

Germany, Switzerland

Founded

2003

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 are 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.

OVERVIEW Experts in colour chemistry, regulatory affairs and project management, we specialise in COMPLEX SUBSTANCE IDENTIFICATION, ANALYTICAL INTERPRETATION AND PROBLEM SOLVING. Our analysis goes beyond the simple fail/pass parameters to provide detailed interpretation and suggest solutions to problems. We use the expertise and facilities of a number of laboratories complimented by other partners with a background in colour chemistry, research and development and colour synthesis. SERVICES PROVIDED O Complex analytical Interpretation; O substance Identification; O Iuclid dossier preparation; O REACH/BPR; O process development; O product stewardship; O batch testing; O purity analysis/screening; O SDS reviews and authoring; and O supplier audits.

CONTACTS Website

www.stoffenmanager.com; www.cosanta.nl

E-mail

info@cosanta.nl

Head office

Stationsplein Noord-Oost 202, Gebouw 144, 1117 CJ Schiphol, The Netherlands

Tel/Fax

+31 20 792 00 13

Contact

Albert Hollander, Erika Ustailieva, Henri Heussen

Ownership

Private Limited Company

Locations

The Netherlands, Germany, Austria, Belgium, Finland, Denmark, Sweden, UK, Poland, Spain, France, Italy, Portugal.

Founded

2014

OVERVIEW Cosanta BV 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 owner and developer of the online platform Stoffenmanager®. 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 7000 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 37,000 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.

www.chemicalwatch.com/SPG

Niche firm profiles

192 ®

CONTACTS

912749-niehauscorp-C796-05-03-12-C ART SIZE:2.779x2.216 ILLUST-VECTOR COLOR:CMYK ARTIST:Paul(PC)

Website

www.csregulatory.com

Website

www.e3strategicpartners.com

E-mail

helpline@csregulatory.com

E-mail

info@e3strategicpartners.com

Head office

The Old Courthouse, St Peters Churchyard, Derby, DE1 1NN, UK

Head office

Tel/Fax

+44 1332380692 / +44 1332380692

6724 Perimeter Loop Road, #236 Dublin, Ohio 43017

Contact

Steven Green, Craig Deegan

Tel/Fax

Ownership

Privately owned

(513) 225-5923 (513) 345-8294

Locations

UK and Republic of Ireland with a global network of expert technical providers

Contact

Dr. Carol Clinton, P.E., LEED AP

Ownership

Private

Founded

2007

Locations

Dublin, Ohio; Berkley, Michigan USA

Founded

2012

OVERVIEW 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. With offices in the UK and Republic of Ireland, CS Regulatory is ideally placed to assist with all aspects of EU REACH and CLP and the likely onset of UK REACH, including Only Representative function in both the EU and UK, working with both EU and UK manufacturers and current DUs in each jurisdiction. With a network of strategic partnerships throughout the globe we can assist with worldwide notification of chemicals, production of associated chemical safety documents, liaison with authorities, advice on testing strategies and project management of data packages and acquisition of existing data. SERVICES PROVIDED O REACH and CLP (EU and UK); O worldwide notification of chemicals; O representation of clients within Europe and UK; O production of SDS, classification and labelling, hazard assessments (CSA/ES); O liaison with authorities and product defence; O advice on testing strategies, including administrating and project management of data packages; O acquisition of existing data; O DGSA services; and O compliance audit services. CLIENTS A broad range of clients, from niche suppliers to global multinationals with customers throughout the world.

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 specialty marketers in the consumer chemical product, automotive, pigment, adhesive and sealant manufacturing industries; mining, education, utility and other sectors.

CONTACTS

CONTACTS Website

dangerousgoods.com

E-mail

larry@dangerousgoods.com

Head office

14606 Sheraton St, Houston, TX 77039, USA

Tel/Fax

(281) 821-0859

Contact

Larry Snellings

Ownership

Privately owned

Locations

USA

Founded

1980

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: O on-site safety inspections; O spill response clean up and disposal; O review and preparation of SDS; O hazard classification of products; O design and prototype for UN spec packages; and O 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: O Handling Hazardous Materials; O packaging; O forklift Operational Safety; and O custom training designed for specific needs.

Global Service Providers Guide 2020

Website

www.espheres.com

E-mail

Philip.capel@espheres.com

Head office

Pères Blancs 4, 1040 Etterbeek, Brussels, Belgium

Tel/Fax

+ 32 (0)2 740 43 36/ + 32 (0) 473581473

Contact

Philip Capel

Ownership

Private

Locations

Belgium, Finland, Germany

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 implements SAP Poison Centre Notification software. Expertise in product safety, SVT, PCN, Vendor SDS management, waste management, IDMP and recipe management, global label management; dangerous goods, conflict minerals. Outsourced EHS regulatory content update (3E ERC, Sphera CE) 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. CLIENTS (petro)chemicals, pharmaceuticals, paint, mining and minerals, steel and alloys, pulp and paper, polymers, electronic, semiconductor, cosmetic, automotive industry.

CONTACTS

CONTACTS Website

www.eurideastranslation.com

Website

www.infotox.pt

E-mail

translation@eurideastranslation.com

E-mail

info@infotox.pt

Head office

Square de Meeûs 35, 1000 Brussels, Belgium

Head office

Tel

+32 (0)2 669 7701 / +32 (0)2 808 4406 / +49 1522 1306186

INFOTOX, Lda, Rua de Moscavide 6D, Parque das Nações, 1990-160, Lisbon, Portugal

+32 (0)2 627 5655

Tel/Fax

+ 351 218 063 659

Fax

Kristina Bitvai

Elsa Casimiro

Contact

Private company

Ownership

Belgium, Germany, Hungary

Portugal and UK

Locations

2007

2004

Founded

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.

CONTACTS Website E-mail

www.produsebiocide.ro; www.chemicalcompliance.eu; office@produsebiocide.ro; office@chemicalcompliance.euoffice

OVERVIEW Originally, founded in 2004, INFOTOX is a specialist consulting company providing chemical regulation compliance, 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: O dossier data gap analysis; O Iuclid dossier preparation for BPR and REACH; O electronic submissions and updates (CPNP, R4BP and REACH-IT); O toxicological reviews and expert support (including Qsar); O design of testing programmes (efficacy tests and (eco)toxicity); O safety data sheets production, review, and translation; O reviewing and updating marketing/efficacy claims and product label; O guidance on setting up a post-market surveillance programme; O BPR specific services: transitional period biocidal product registrations in EU/UK; product assessment report (PAR); consortia for biocidal products; Article 95 listing of active substances; O poison centre notifications in EU/UK; O REACH specific services: only representative services; production of chemical safety reports (CSR); and O 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.

Head office

37 Salva St, 1st District, Bucharest, Romania

Tel

+40 721 039 610

WeChat

+4 031 105 38 00

CONTACTS

Contact

Mioara Simona ILIE

Website

www.kerona.ie

Ownership

Private company

E-mail

info@kerona.ie

Locations

Romania, Central & Eastern Europe, Moldavia

Head office

Founded

2011

14 Thomas Hand Street, Skerries, Co Dublin K34 A375, Ireland

Tel/Fax

+353 (0)1 8495284

Contact

Dr Irene McGrath

Ownership

Private Company

Locations

Ireland and Spain

Founded

2014

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 and 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 and other 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 development & market strategy; business representation; Chemical Compliance support services for marketing and sales teams. CLIENTS 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/or other EU States.

OVERVIEW 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. SERVICES PROVIDED 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 SMEs from the biocides, chemicals, plant protection, cosmetics, plant biostimulant and biopesticide sectors.

www.chemicalwatch.com/SPG

Niche firm profiles

193

Niche firm profiles

194

CONTACTS

CONTACTS www.LKC-ltd.com

Website

www.chinaoci.com(English Web Site)

E-mail

LKC@lkc-ltd.com

E-mail

david.chang@chinaoci.com

Head office

Postfach 167, Hauptstrasse, Fuellinsdorf, Switzerland

Head office

Tel/Fax

+41 61 906 8503 / +41 61 906 8509

Room 2006, MOMA Towers, Chaoyang North Street No.199, Chaoyang District, Beijing (100026), China

Contact

Mr Matthew Kane & Dr David Kane

Tel

+86-10-68091928 EXTN 8008

Ownership

Private company

WeChat

13910863852

Locations

Switzerland, UK

Contact

David Chang, Cissy Zhou, Wendy Sun

Founded

2001

Ownership

Licensed company

Locations

China Beijing, Shanghai, Guangzhou

Founded

2006-06

Website

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.

OVERVIEW OCI (北京正智远东化工) is a legal regulatory services provider, to provide consultation and services in compliances with product aspects of chemicals, novel food & additives, cosmetic new ingredients & marketing products, and fertilizer & pet food or additives. Aspiration in decade delivery, heritage out century reputation. SERVICES PROVIDED Compliance assessments varies in products/supply chains/regions; O pre-staged RA proposal/data gap analysis; O China and ASEAN chemical registration focus; O global policy and regulation news edition and presentation; O site RA support and emergence team backup; and O strong petition capability of Food-Cosmetics-Feed new additives O

CLIENTS DSM, Sasol, Solvay, Arkema, KANEKA, Meiwa, KAO, etc.

CONTACTS Website

www.pfagroup.eu

E-mail

info@pfagroup.eu

Head office

Saxon House, John Roberts Business Park, Pean Hill, Whitstable, Kent, CT5 3BJ, UK

Tel/Fax

+44 (0)1227 470901 and +44 (0)1227 765117

Contact

Dr Oliver Warwick

Ownership

Limited company

Website

www.mediator.as

Locations

E-mail

info@mediator.as

Founded

Originally founded in 1995. Founded as a limited company in 2006

Head office

Mediator A/S, Centervej 2 E, DK-6000 Kolding

Tel/Fax

+45 75 54 08 24

Contact

Jens Haugaard

Ownership

Jens Haugaard

Locations

Denmark

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.

Founded

2011

CONTACTS

OVERVIEW Mediator A/S is a consultant company where all consultants are specialised in working on 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.

SERVICES PROVIDED Peter Fisk Associates Limited, works in collaboration with PFA-Brussels SPRL on REACH and other regulatory work including: O 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; O secretariat services, including consortium management and joint submission O communications; O 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; O provision of only representative (OR) services for non-UK exporters; O 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); O 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 O 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.

Global Service Providers Guide 2020

CONTACTS Website

www.pfagroup.eu

E-mail

info@pfagroup.eu

Head office

Rue Abbé Cuypers 3, 1040 Etterbeek, Brussels, Belgium

Tel/Fax

[+32] 02 741 2444

Contact

Dr Oliver Warwick

Ownership

SPRL

Locations

Belgium

Founded

2016

OVERVIEW 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: O 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; O secretariat services, including consortium management and joint submission communications; O 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; O provision of only representative (OR) services for non-EU exporters; O 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); O 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 O 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 Website

www.reachnroll.com

E-mail

info@reachnroll.com

Head office

Turku, Finland

Tel/Fax

+358 44 981850

Contact

Maria O'Shea

Ownership

Independent

Locations

Finland

Founded

2020

OVERVIEW New on the scene we are here to help you to REACH and Roll…. We offer friendly and fully comprehensive service. We provide regulatory advice and practical technical support to companies need ingto comply with EU Chemical Product Regulations. We are also proud to be the official Nordic & Russian Local Agent for CHEMWATCH Chemicals Safety Management Software. SERVICES PROVIDED O BPR Biocide Product Authorisation; O REACH Compliance advice; O REACH Registration support; O REACH Authorisation support; O Only Representative and Responsible Person EU legal entity for Non EU companies; O scientific tools: IUCLID, Chesar, etc; O Chemical Risk Assessments / Chemical Safety Reports, Exposure Modelling,Exposure Scenario; O alternative test strategies, QSAR Modelling; O CLP/GHS Classification and Labelling, UFI code & Poison Centre Notifications; O Safety Data Sheets Authoring and translations (EU & Global); O EU Cosmetic Product Notifications; O on behalf of our clients we liaise with consortiums, test facilities, and authorities; O Product Stewardship Management, Restricted substances list, SVHC declarations; and O offering CHEMWATCH Chemicals Management Cloud Software solutions (SaaS). CLIENTS Nordic countries EU/EEA, UK, Russia, America, Australia, India

CONTACTS Website

www.reachready.co.uk

E-mail

enquiries@reachready.co.uk

Head office

Kings Buildings, Smith Square, London SW1P 3JJ

Tel/Fax

+44 (0) 20 7901 1444

Contact

Rachel Nabudde

Ownership

REACHReady is a wholly owned subsidiary of the Chemical Industries Association

Founded

2006

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 O Helpdesk; O consultancy; O training; and O matchmaker. CLIENTS O Chemical manufacturers; O formulators; O downstream users of chemicals; O article manufacturers; O retailers; and O service providers.

CONTACTS Website

www.reachspektrum.eu

E-mail

info@reachspektrum.eu

Head office

Rubeška 393/7 190 00 Prague Czech Republic

Tel/Fax

+420 739 463 410

Contact

Jan Holomek, CEO

Ownership

Private Company

Locations

Prague, Czech Republic

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; and the Ministry of Environment of the Czech Republic.

www.chemicalwatch.com/SPG

Niche firm profiles

195

Niche firm profiles

196

CONTACTS Website

www.reachwise.com

E-mail

info@reachwise.com

Head office

22, St Albans Avenue, London W4 5JP, UK

Tel/Fax

+44 (0)20 87470873

Contact Ownership

CONTACTS Website

www.scas-eu.be

E-mail

scaseurope07@scas-eu.be

Head office

SCAS Europe (Sumika Chemical Analysis Service), Leonardo da Vincilaan 19A Bus6 (MC Square Offices) B-1831 Diegem, Belgium

Peter Douben

Tel

+32 (0) 2 719 0475

Private company

Fax

+32 (0) 2 719 0480

Locations

UK, Netherlands, Germany

Contact

Dr Rick Stanton

Founded

2007

Ownership

Sumika Chemical Analysis Service, Tokyo, Japan

Locations

For parent company: Japan, China, Singapore, Taiwan, South Korea

Founded

Parent company 1972; SCAS Europe 2007

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.

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.

CONTACTS Website

www.selerant.com

E-mail

sales-ehs@selerant.com

Head office

Selerant srl Via Leonardo da Vinci, 19 20060 Cassina de’ Pecchi, Milan, Italy Phone + (39) 02 786203 Fax + (39) 02 95341389

Tel/Fax Contact

Giuseppe Mallozzi

Website

rovaltainresearch.com

Ownership

Private Company

E-mail

contact@rovaltainresearch.com

Locations

Head office

2 rue René Truhaut – 26300 Alixan

Australia, China, France, Germany, India, Italy, Serbia, Ukraine, United States

Tel/Fax

+33 4 82 48 00 31

Founded

1990

Contact

Martin Lawniczak

Ownership

Private

Locations

France

Founded

2014

OVERVIEW Founded in 1990 in Italy, Selerant is a leading global provider of regulatory compliance and Safety Data Sheets Authoring software Solutions. Additionally, Selerant provides formulabased 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 regions.

CONTACTS

OVERVIEW Rovaltain Research Company (RRCo) is a global expert service and CRO for ecotoxicology and environmental fate. We are a company that specialises in providing a distinctive blend of innovative and classical approaches to evaluating the potential risks of chemical and biological substances. We offer a range of services from GLP studies concerning environmental fate, physicalchemistry and ecotoxicology to applied research. We also offer more conventional tests following ISO, ASTM, OECD and CIPAC guidelines. SERVICES PROVIDED O Ecotoxicology: Acute and chronic tests from series 2xx. Tests can be realised according to OECD/ISO guidelines or adapted on client’s requests O Phys-chem properties & environmental fate: Relevant physical-chemical properties and regulatory studies on biodegradability and bioaccumulation O Analytical and bioanalytical chemistry: LC-HRMS, LC-MS/MS, GC-MS/MS, IC, HPLCUV, HPLC-14C detection, UV, IR… O Studies in mesocosm: We offer the possibility to work in climatic chambers with BSL2 to handle potentially dangerous substances or organisms. O Efficacy trials – mini-field: efficacy of pure substances or formulated products in order to optimize the selection of the PPP candidates for a type approval and/or for a marketing authorization. O Stability and storage studies: Stability tests can be realised according to CIPAC guidelines. O Endocrine disruptors: RRCo performs in-vivo studies according to OECD guidelines 229, 230, 231, 234, 240, 241… CLIENTS O Industries; and O research institutes.

Global Service Providers Guide 2020

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, and provides SDS generation in more than 20 languages. Hazex SDS Authoring Solution helps you to create and manage: O Worldwide GHS regulations, O SDS distribution, O Transport classification, O Hazard labelling, O UFI management and EU Poison Centres notification, O Exposure Scenarios, O EU Cosmetic Regulation and PIF, O 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 Selerant has global customer base and provides EHS solutions across a wide range of industries serving local specialist producers, developers and manufacturers to multinational giants.

CONTACTS CONTACTS

Website

www.toxfocus.com

Website

www.siam-it.com

E-mail

barbara.vogt@toxfocus.com

E-mail

sales@siam-it.com

Head office

8967 Hunters Way, Highlands Ranch, CO 80129, USA

Head office

Ortega y Gasset 17 bajo, 26007 LogroĂąo, Spain

Tel/Fax

+1 501 351 4389

Tel

+34 941 28 67 49

Contact

Barbara Vogt, PhD, DABT

Ownership

Private company

Ownership

Private company

Locations

Europe and North America.

Locations

Founded

2007

Founded

2008

OVERVIEW SIAM develops software for the classification and management of safety data sheets under CLP and GHS regulation. Provides a highly versatile software platform for preparing multilingual SDS and chemical products labelling. Our CHEMETER and SDSAREA can offer much time saved, with features suited to the current and evolving safety regulations in over 60 countries. The software is built up in a modular fashion to suit your exact needs at a given time.

OVERVIEW Tox Focus LLC provides the toxicologic and scientific content for REACH, cosmetics Regulation, and other regulatory programmes, drawing upon 30 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 O Chemical data management: a solid substance database is available and constantly under review; O SDS authoring software CHEMETER: it generates compliant and multilingual SDS for more than 60 countries; O label editor: an innovative tool for designing CLP and GHS labels; O SDS efficient management and distribution: SDSAREA takes care of sending SDS to your customers notifying them in compliance with REACH regulation; O updated software: new features are constantly developed, and legislative updates implemented; O integration with your system and possibility of automation of the issuing and sending of updated SDS process; and O further documents: extended SDS (e-SDS), dangerous goods documents and sector specific paperwork.

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 Wide variety of clients from small size to global international companies are operating now with our software to make their SDS and LABELS. Today we have a well-established international presence through our world-wide sales network. Our clients are companies manufacturing and distributing all kinds of chemical products in many sectors, such as: cleaning, paints and coatings, rubber, detergents, adhesives and sealants, flavours, fragrances, water treatment etc.

CONTACTS

CLIENTS The Redstone Group/Trinity Consultants, 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.toxicon.it

E-mail

info@toxicon.it

Head office

Via Robolini 1, 27100 Pavia, Italy

Tel/Fax

+39 0382 1938015 / +39 0382 1938026

Contact

Raffaella Butera, MD

Ownership

Private company

Locations

Italy 2010

Website

www.sweco.fi

E-mail

sds@sweco.fi

Head office

Finland

Tel/Fax

+358 207 393 000

Contact

Eeva Punta, +358 400 298 465

Founded

Ownership

Public company

Locations

Finland, Sweden, Belgium, Germany

Founded

1898

OVERVIEW Toxicon provides a wide range of expert advice services in regulatory fields and in the areas of toxicology, pharmacology, occupational medicine and consumer safety for companies, institutions and general public. 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, food technologists, economists and lawyers. We believe that complex problems can be solved with success and quality only through teamwork.

OVERVIEW Sweco plans and designs the built environment and industry of the future. We offer our customers the right expertise for every need. Sweco is Europeâ&#x20AC;&#x2122;s leading engineering and architecture consultancy with 17,000 employees and net sales EUR 1.9 billion. There are more than 30 experts in the compliance team. SERVICES PROVIDED O Chemical safety; O REACH; O Safety Data Sheets (SDS), CLP, Exposure Scenarios (ES); O Biocides, BPR; O toxicological and ecotoxicological risk assessments; O cosmetics safety assessments; O medical device compliance; O food safety; O contact material safety; O legal advice; and O regulative services. CLIENTS O Industry; O brand owners; O retail; and O public organisations.

SERVICES PROVIDED O Overall services: guidance on regulatory interpretation, compliance support, auditing. O REACH: data sharing, consortia management. Data gap analysis, testing strategy. Dossier preparation including CSA/CSR. PPORD. SDS and e-SDS. Compliance check with ES, scaling, CSR-DU development. ES for mixtures. Applications for authorisation including SEA. Notification to SCIP database. O CLP/GHS: hazard assessment, C&L, notification to Echa C&L inventory, to member states bodies and to PCN Portal for emergency health response on mixtures. O BPR Regulation: data sharing agreements, dossier for active substances approval and biocidal products authorisation at national and UE level. O Cosmetic products: safety assessment, product information file, notification. O Medicines and medical devices: CTD, genotoxic impurities, PDE assessment, environmental risk assessment, provisional OELs for APIs and other chemicals. Leachables and extractables assessment. O Occupational medicine: risk assessment and management (CAD, CMD). O Toxicological risk assessment: documents, expert advice and consultancy. O Other: training for companies, universities and institutions. CLIENTS Toxicon assists large companies and SMEs. Moreover, Toxicon works in partnership with institutions, industries and associations for R&D and compliance projects.

www.chemicalwatch.com/SPG

Niche firm profiles

197

Niche firm profiles

198

CONTACTS Website

www.vrs-regulatory.net

E-mail

jobs@vrs-regulatory.net

Head office

Vantage House, 26a Northenden Road, Sale, M33 3BR, UK

Tel/Fax

+44 (0)161 976 2825 +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 O Chemical regulatory affairs recruitment consultancy; O we recruit for permanent, temporary/interim roles and provide consultants for projects; O advice to employers on salaries, skills availability, recruitment methods; and O 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.

CONTACTS Website

www.wsp.com

E-mail

REACH@wsp.com

Head office

70 Chancery Lane, London, UK

Tel/Fax

+44 20 3116 6072

Contact

Alan Ritchie/ Dr Stephen Bounds

Ownership

Private Company

Locations

UK, Europe, worldwide

Founded

8 April 1987

OVERVIEW WSP is one of the worldâ&#x20AC;&#x2122;s leading professional services consulting firms, working across the chemical industry and their downstream users to identify, manage and mitigate current and future risks and liabilities. Companies benefit from opportunities presented through regulatory and environmental compliance, EHS improvements, and sustainability aspirations. SERVICES PROVIDED Our experts possess a rich understanding of the chemicals sectors which we combine with our multidisciplinary services to support clients throughout the life cycle of their assets, processes and projects. At each stage from planning, design, build, through to operation our sector-specific solutions are designed with a sustainable future in mind and delivered by a worldwide network of EHS, product stewardship and engineering experts to support the most complex projects and share best practice. We actively engage with our clients to help identify and provide solutions to the challenges they face. For instance, our Product Stewardship team offers a turn-key chemical regulation and compliance service. Clients benefit from easier access to market, increased reputation, and reduced reporting obligations. Services include: O EU REACH and worldwide registration and authorisation dossier preparation and submission; O only representative services, strictly controlled conditions and REACH audits and training; O safety data sheet and exposure scenario preparation and management; O CLP harmonised poison centre notification management; O support with EU cosmetic regulations & EU Biocide product regulations; O support with non-EU chemical regimes (Brexit, K-REACH, TSCA); and O Study Monitoring Services for regulatory guideline studies placed at Analytical and Contract Research Laboratories. CLIENTS WSP supports a wide range of companies across the chemical industry. Company sizes range from single site SMEs to large multinational corporations covering all aspects of the supply chain. Specialising in helping companies respond to their business challenges and effectively manage compliance allows WSP to remain at the cutting edge of knowledge in the chemical industry.

Global Service Providers Guide 2020

Intelligence to transform product safety Our new membership gives you and your colleagues unlimited use of our new class-leading platform, featuring:

News and insight

Resources

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Cardno ENTRIX South America, Canada CE.way: Cosmetics Regulatory and Testing Solutions 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 2020

10-25 50-100 10-25 25-50 25-50 2-5 5-10 50-100 100-500 5-10 2-5 2-5 1 10-25 5-10 100-500 5-10 10-25 10-25 10-25 25-50 5-10 10-25 10-25 2-5 10-25 1 50-100 2-5 2-5 5-10 100-500 1 50-100 50-100 2-5 50-100 10-25 5-10

e e e e e i e e e e m m

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1,000-2,000 2-5

25-50 2-5

m m

e e e i e

2,000-5,000 25-50 1,000-2,000 25-50

Europe, Colombia, Africa Europe, N. America, China, Philippines UK, Austria, Poland, Czech Republic, Hungary, Australasia, Brazil

Other(s)

UK UK

Germany, Netherlands, USA

Equipment

Cambridge Environmental Assessments Cambridge Environmental Assessments part of RSK ADAS ltd Cardno ChemRisk

Training

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 10-25 5-10 100-500 5-10 10-25 50-100 10-25 25-50 10-25 25-50 25-50 500-1000 10-25 1 1,000-2,000 2-5 2-5 100-500 100-500 2,000-5,000 1 5,000 plus 5,000 plus 500-1000 50-100 10-25 10-25

U.S. UK

e e

Information services

Belgium The Netherlands Belgium, Switzerland, North America Germany Belgium Sweden UK UK Ireland Slovenia Slovakia, Poland Hong Kong China, USA Canada United States, Amsterdam, Kenya, Malaysia Germany Croatia France UK India No Turkey Hungary UK Switzerland, USA UK USA China USA UK Belgium Nederland Germany France Japan, Thailand, USA Belgium UK Republic of Ireland Belgium UK UK Republic of Ireland United Kingdom Republic of Ireland Finland USA USA Austria Denmark China, Hong Kong, France, Germany, USA Denmark UK UK Germany USA Italy Germany

Belgium

25-50 2-5 25-50 50-100 2-5 2-5 2-5 5-10 1 1 1 1 1 2-5 2-5 25-50 2-5 1 10-25 100-500 5-10 50-100

m m m g i

IT & software solutions

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 Auxilife Scientific Services Pvt. Ltd 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 BioDetection Systems bv BioGenius GmbH BioQuanta Bird & Bird LLP Blue Frog Scientific Limited Boeije Consulting Bond Dickinson Bootman Chemical Safety Bootman Chemical Safety Ltd. 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 C.S.B. GmbH CAAT-Europe

UK, Belgium, China

Global staff 25-50 50-100 2-5 5,000 plus 25-50 25-50 25-50 100-500 2-5 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 100-500 100-500

Laboratory services

Alan Best Alberi EcoTech Alchemy Compliance Ltd. Alemare Solutions Limited 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 Group APC

San Francisco, CA, USA USA Slovenia

Other locations USA

Chemical staff 2-5 10-25 2-5

Headquarters Germany UK Greece Belgium USA USA UK India Canada USA UK Switzerland UK USA UK United Kingdom Germany Belgium Denmark UK USA The Netherlands China USA UK UK

Legal services

Pagr

Representation/management

Organisation 1cc GmbH 24-7 Response 3S-SafelyServingScience Accenture Acta Actio Software Corporation Active Steward Advinus Therapeutics Limited Aegis Regulatory Inc Aequor, Inc. AG-HERA AGREXIS AG

Consultancy/advisory

A-Z LISTING

200

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

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Cardno ENTRIX     CE.way: Cosmetics Regulatory and Testing  Solutions 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

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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.aequorinc.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.biodetectionsystems.nl   www.biogenius.de www.bioquanta.net www.twobirds.com www.bluefrogscientific.com www.boeijeconsulting.com        www.bonddickinson.com www.bootmanchem.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.csb-online.de        www.biologie.uni-konstanz.de/leist/ caat-europe/ www.cea-res.co.uk           www.cea.adas.co.uk 

201

A-Z LISTING COSHH US HCS

CAD

CMD

Medical devices Regulation



                      

Cambridge Environmental Assessments Cambridge Environmental Assessments part of RSK ADAS ltd Cardno ChemRisk

                 

                                                                                                                                   

Toy Safety Directive

        

                                

                                    



                

       

RoHS

Food contact

           

Agrochemical registrations

      

EU cosmetics Regulation

      

                                           

Biocidal products Regulation

REACH Global chemical notifications

Food (contact) Occupational

Medical devices

Cleaning products

Textiles & apparel

Construction

Toys/children's products

Electrical and electronics

Veterinary medicine

Personal care (inc. cosmetics)

Biocides

Biotechnology

Aerospace, automotive & engineering 

New TSCA/LCSA

     



GHS-based regulations

        



Regulatory expertise

CLP



Medical & pharmaceuticals

Organisation 1cc GmbH 24-7 Response 3S-SafelyServingScience Accenture Acta Actio Software Corporation Active Steward Advinus Therapeutics Limited Aegis Regulatory Inc Aequor, Inc. AG-HERA AGREXIS AG Alan Best Alberi EcoTech Alchemy Compliance Ltd. Alemare Solutions Limited 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 Group APC

Industrial chemicals Agrochemicals

Focus of activities

  cardnochemrisk.com/ www.cardnoentrix.com www.ceway.eu

www.chemicalwatch.com/SPG



 



 

Centro Reach Srl CERM CFCS CGI Charles River CHD Global Chem-Academy ChemADVISOR, Inc. ChemAdvocacy S.A. ChemAlert CHEMDOX Chementors Ltd Chemest Ltd. ChemHaz Solutions Chemical Check GmbH Chemical Compliance Chemical Consultant Chemical Regulatory Affairs - Israel Chemical Safety Consulting CHEMLEG ChemPharmaServe Ltd Chemphex ChemRegs (UK) Ltd ChemSafe Chemservice Chemservice EHNS GmbH Chemtopia Co., Ltd.

 

Italy USA Germany Canada USA Turkey Switzerland USA Luxembourg Australia Austria Finland Finland Ireland Germany DE USA Israel Germany Turkey UK Finland UK Italy Germany, Luxembourg, Korea Germany South Korea

chemtrac® CHEMTREC Chemwatch CHESSOL B.V. China National Chemical Information Center Co., Ltd. ChIR - Chemical Innovation and Regulation Chris Braun Consultancy Chymeia ApS CIDP Cindax BV CIRS CIS Center Citoxlab CJV Consulting Ltd

UK USA Australia The Netherlands China

Clariant Compliance & Risks Compliance Footprint AG Compliance Services International compliance2business Consortia Management GmbH CONUSBAT Regulatory Services Coracle Cosanta

Italy Ireland Switzerland USA Italy Germany Germany UK The Netherlands

Cosmetic Design Laboratories

Belgium, Germany, Spain, UK, India, Canada, Luxemberg

Italy USA, France UK, Netherlands, France, Hungary Germany Belgium, Singapore

USA China, Vietnam

Germany

Switzerland, Spain, UK, USA

EU, USA, Canada, China, Thailand, Japan, Vienam, Malaysia Italy, USA, Japan, China USA, Brazil, China US, Europe, Asia Belgium, France, Italy USA

Global Service Providers Guide 2020

The Netherlands, Germany, Austria, Belgium, Finland, Denmark, Sweden, UK, Poland, Spain, France, Italy, Portugal.

50-100 5-10 2-5 1 50-100 1 1 1 1 5-10 2-5 1 2-5 10-25 50-100

10-25 5-10 2-5 1 25-50 1 1 1 1 5-10 2-5 1 2-5 10-25 50-100

5-10 50-100

2-5 25-50

m g e e e e

25-50 50-100 100-500 5-10 100-500

25-50 50-100 100-500 2-5 25-50

50-100 1 5-10 10-25 2-5 50-100 50-100 100-500 1

e e g e e

e e g e e e i e

m i

e e e m e g e

g e m g

i g e m g i g e e e e e i e e e e e m e m e a a g a a m m e e e i i m g g g e e e i m e m g i g e e e e e i g e e e

e g m m e e e

m e

g e g e

i i e m i e g a m e e

m m

e m i e e e e e i e e e e g e m m e e e e

5,000 plus 50-100 5-10 10-25 1 10-25 Globally 5-10 10-25

100-500 50-100 5-10 10-25 1 10-25 5-10 5-10 5-10

i i i m g g m i g

2-5

10-25

i g e

25-50 5-10 100-500 100-500 100-500 5-10 10-25 1 100-500 2-5 10-25 2-5 50-100

5-10 5-10 100-500 25-50 25-50 5-10 10-25 1 25-50 1 2-5 2-5 50-100

g g i m g e g m g e e i m m e g e e g g g g g m e

g g

e e

e m i

e e e e g e e g m g e a i e e a i g m e

e e e a e g e g i g e

i e e m

g m

Other(s)

Equipment

Training

e a e

2-5 2-5 5-10 100-500 100-500 5-10 5-10 50-100 5-10

i i m g e i

Information services

2-5 5-10 5-10 5,000 plus 5,000 plus 5-10 10-25 50-100 5-10

5,000 plus 1 Denmark 10-25 Brazil, Romania, India, Singapore 100-500 Cloud based chemical information service provider2-5 Ireland, USA，South Korea 100-500 50-100 Hungary 1,000-2,000 1

USA, UK global offices UK

g m e

IT & software solutions

Chemical Global staff staff 500-1000 25-50 50-100 25-50

Spain, Italy, UK

Turkey Representatives in EU, UK, USA, Japan, Korea Crowell & Moring USA CS Regulatory Ltd UK Republic of Ireland CTT China Currenta GmbH & Co. OHG Germany Cyprotex UK USA Danger and Safety srl Italy dangerousgoods.com USA Europe - China DanGoods Training & Consultancy UK Danish Technological Institute Denmark  Datalab USA David Ryberg Norway de ViB fabriek Netherlands Decernis 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%



CRAD

Portugal The Netherlands Denmark Mauritius Netherlands China Russia France UK

Other locations

Laboratory services

Headquarters UK France

Legal services

Pagr

Representation/management

Organisation Cefas CEHTRA

Consultancy/advisory

A-Z LISTING

202

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

Chemservice EHNS GmbH Chemtopia Co., Ltd. chemtrac® CHEMTREC Chemwatch CHESSOL B.V. China National Chemical Information Center Co., Ltd. ChIR - Chemical Innovation and Regulation Chris Braun Consultancy Chymeia ApS CIDP Cindax BV 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

               

 

     

   

    

        

 

        



      

   

      

CRAD

      



                       

   

   

 

COSHH US HCS

CAD

             www.chemtracglobal.com www.chemtrec.com              www.chemwatch.net www.chessol.nl     www.chemhse.com/english     

     

         

       

  www.emmcchir.org

www.almego.com www.cidp-cro.com www.cindax.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.com 

www.cosmeticdesignlaboratories. co.uk www.crad.com.tr

           

Crowell & Moring          CS Regulatory Ltd       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             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.centroreach.it www.Cermonline.com www.cfcs-consult.com 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.chemhazsolutions.com www.chemical-check.de www.pl-chemical-compliannce.de www.chem-consult.com 0 www.chemicalsafetyconsulting.com www.chemleg.com www.chempharmaserve.com www.chemphex.com www.chemregs.co.uk www.chemsafe-consulting.com www.chemservice-group.com www.chemservice-ehns.com www.chemtopia.net

   

        

CMD

             



       

      

        



  

      

  

 

     

                     

203

A-Z LISTING

Medical devices Regulation

                

                                                           

                 





                  

                                                

Cosmetic Design Laboratories

 

            

      

Toy Safety Directive

                         

RoHS

   

Food contact

   

  



                                                              

Agrochemical registrations

            

     



EU cosmetics Regulation

 

            

CLP

   

                                                                                                                                                                                 



Biocidal products Regulation

REACH Global chemical notifications

Food (contact) Occupational

Medical devices

Cleaning products

   

     

     





Further information www.cefas.co.uk                                www.cehtra.com

                            





Textiles & apparel

Construction

Aerospace, automotive & engineering

Toys/children's products

Electrical and electronics

Veterinary medicine

Personal care (inc. cosmetics)

    

New TSCA/LCSA

     

Biocides

Biotechnology

     

Regulatory expertise

GHS-based regulations

Medical & pharmaceuticals

Organisation Cefas CEHTRA

Industrial chemicals Agrochemicals

Focus of activities

www.crowell.com   www.csregulatory.com 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

www.chemicalwatch.com/SPG



Chemical staff 10-25 10-25 100-500 100-500

5-10 10-25 100-500 1,000-2,000 5-10 2-5 25-50 2-5 1 1 1 1

2-5 10-25 10-25 10-25 2-5 2-5 25-50 2-5 1 1 1 1

Austria, Germany, France 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

i i g m e g g i m m m m

50-100 2-5 100-500 1 25-50 2-5 5-10 50-100 2-5 5-10

g m m a e a e e e a a e m i m m e e e i g e e e e m a m m e e i g e e e

25-50 10-25

m e m

g e e a

5-10 25-50 5-10 100-500 5-10 1 2-5 10-25 2-5 100-500 1 1 10-25 500-1,000 10-25 10-25 2-5 2-5 10-25 25-50 5-10

e g e m

m e e

80+ globally UK France Spain India China USA

Canada UK USA Denmark UK Belgium Turkey USA Germany India Italy Germany Canada USA United States USA South Africa Germany Canada Belgium USA The Netherlands UK

EcoMundo Economics for the Environment Consultancy Ltd. (eftec) EcoOnline ECT Oekotoxikologie GmbH Edif ERA Edupalli Ramakrishna EggCentris EHS Strategies, Inc EHSCareers.com, Inc elc group Elements Advisory Elemica Emveo Enhesa Enthone BV Envigo Enviresearch Enviresearch Ltd Environmental Assessments EnviroPlanning AB epos Software & Service AG EPP EquiTox ERBC ERM eSpheres ETC EUPHOR Eupoc Eurideas Language Experts Euro Safety and Health Eurofins

France UK

Canada, Korea, USA (New-Jersey) Belgium

Norway Germany UK India Belgium USA USA UK Belgium USA Belgium Belgium The Netherlands USA UK United Kingdom Germany Sweden Germany UK France France UK Belgium Slovakia USA Germany Belgium UK Belgium

Sweden, Finland, Denmark, Switzerland

Hong Kong Belgium 26 offices worldwide

25-50 10-25

50-100 25-50 100-500 500-1000 5-10 1 5-10 Czech Republic, India, Romania 50-100 2-5 Europe, Asia 100-500 France, Germany, UK 1 USA, China, Japan, Canada 100-500 2,000-5,000 Offices in 14 countries worldwide 2,000-5,000 10-25 Portugal 10-25 Sweden 2-5 5-10 25-50 25-50 5-10 Italy 1,000-2,000  Worldwide offices 5,000 plus Finland, Germany 10-25 10-25 50-100 1 Hungary, Germany 10-25 2-5 Germany, UK, Switzerland, Denmark, Asia, USA, 5,000 plus  UK, China, India & Australia Eurofins Air Toxics USA Denmark, Germany, France, China 5,000 plus Eurofins Product Testing A/S Denmark Europe, China, USA 5,000 plus Euromines Belgium 5-10 Eversheds LLP UK Europe, Middle East, Asia 2,000-5,000 Exitss Belgium 10-25 Exponent International Limited UK USA, Ireland, London, Switzerland, China 500-1,000  f_OXYDE GmbH Austria 5-10 Fanwood Chemical, Inc USA Germany 2-5 Fera Science Ltd England England, UK 100-500 Fieldfisher LLP UK Belgium, France, Germany, Italy, Spain 500-1000  Flashpoint srl Italy 10-25 FoBiG Germany 10-25  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%

m g g

g g e i

i g

g e e e

g i g e e e e g a e a g a e e m m g a e e e e a g g e e e g e e g

m i m

e m

m e m

i i m e i g

e a e a e m i g m e

g m g m g i m g

m e e e e m

m m g

a m

100-500 10-25 5-10 10-25 1 10-25 2-5 1,000-2,000

m e g e g g i m e e e e m g i e e e m m g e e m

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

g e

g m m m g e m m

m m m g e g e e e e a e

e e e e

e g

e e m e g a

Other(s)

Equipment

Training

Information services

IT & software solutions

Global staff 50-100 1,000-2,000 5,000 plus 100-500

Other locations Germany, Thailand, Chile

Global Service Providers Guide 2020

Laboratory services

Headquarters USA USA UK United Kingdom

Legal services

Pagr

Representation/management

Organisation Decernis LLC Defense Logistics Agency DEKRA DEKRA Process Safety

Consultancy/advisory

A-Z LISTING

204

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

Dell Tech Laboratories Ltd. Delphic HSE Solutions Limited Dentons DHI DIPHEX Ltd Distefano Law Office DORUKSISTEM DougMar Consultants DR MACH Chemical Compliance & Competence Dr Prerna Shinde Dr. Andrea Volpato Dr. Philipp Langenbach GmbH DR-Software DXC Technology E3 Strategic Partners, LLC EAG Laboratories Eagle Environmental EBRC Consulting ECD Compliance ECETOC Ecolab Ecomatters BV EcoMole Ltd. EcoMundo Economics for the Environment Consultancy Ltd. (eftec) EcoOnline ECT Oekotoxikologie GmbH Edif ERA Edupalli Ramakrishna EggCentris EHS Strategies, Inc EHSCareers.com, Inc elc group Elements Advisory Elemica Emveo Enhesa Enthone BV Envigo Enviresearch Enviresearch Ltd Environmental Assessments EnviroPlanning AB epos Software & Service AG EPP EquiTox ERBC ERM eSpheres ETC EUPHOR Eupoc Eurideas Language Experts Euro Safety and Health Eurofins

Further information                             decernis.com www.dla.mil                                     www.dekra-process-safety.co.uk www.dekra-uk.co.uk/en/process                 safety-overview/ www.delltech.com              www.delphichse.com              www.dentons.com                                            tox.dhi.dk/en/ www.diphex.com                                   www.distefanolawoffice.com www.doruksistem.com.tr                       dougmarconsultants.com     www.mach-chemguide.com            www.andreavolpato.it                 www.dr-langenbach.de          www.dr-software.com dxc.technology                                              www.e3strategicpartners.com www.eag.com                           www.eagleenv.co.za EBRC Consulting                    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                          

                                                                                     

                                                            

         

 

       

                                        

   

         

                                        

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               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.ecoonline.com www.ect.de  www.edifgroup.com    www.bhu.ac.in  www.EggCentris.com  www.ehsstrategies.com www.ehscareers.com www.elc-group.com  www.elements-advisory.be    www.elemica.com  www.emveo.be         www.enhesa.com/ enthone.com www.envigo.com  www.enviresearch.com   www.enviresearch.com/  www.enas-online.com     

 



       

       

                              

     

     

     

         

                                 

                          

205

A-Z LISTING COSHH US HCS

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

Food (contact) Occupational

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 Decernis LLC Defense Logistics Agency DEKRA DEKRA Process Safety

Industrial chemicals Agrochemicals

Focus of activities

www.gefahrstoff.com www.eppltd.com www.equitox.eu www.erbc-group.com/ www.erm.com 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.chemicalwatch.com/SPG



GlobalMSDS GLTaC, Inc. Golder Associates Gradient GreenSoft Technology, Inc Grow Smart Chemical Compliance 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 Hunton & Williams I+K AG, Compliance-Footprint AG

UK USA France USA USA Romania Ireland USA China Japan Israel Canada UK UK UK Germany Belgium Switzerland

ibacon GmbH ICB Pharma IDRG (International Development of Regulatory Globalization) IES Ltd IFF China imds professional GmbH & Co. KG INERIS INFOTOX INSCX exchange International Cosmetics & Chemical Services Ltd Intersolia Intertek IOM IPO O/Pszczyna iPoint-systems gmbh

Germany Poland Germany

Italy, Cyprus, Slovenia, Spain, Poland

Australia, Canada, Chile, New Zealand, UK

India, South Korea, Ireland, UK, Taiwan, Turkey and Russia

Taiwan, Japan, China, Spain USA, UK, Poland

Bangladesh, China, Hong Kong, USA, India USA

1 100-500 1 1 2-5 25-50 5-10

m m

e g e i g 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 i e e e e e

5-10 10-25 5,000 plus 100-500 50-100 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 5,000 plus 2-5

10-25 50-100 50-100 2-5 10-25 10-25 50-100 2-5 10-25 2-5 2-5 2-5 25-50 100-500 1,000-2,000 2-5

100-500 50-100 2-5

100-500 25-50 2-5

e e i

m e

2-5 50-100 5-10 1,000-2,000 5-10 2-5 5-10 10-25 5,000 plus 10-25 50-100 25-50

e g g g m g m g

2-5 2-5 1 2-5 50-100 1 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 1 25-50 1 50-100 50-100 10-25

g e e g e e e e m e e e e m e m m g g e g g i i m m e e e e i g g e g m e e e m m m e e e i e g a a a e e m g e e a e g g m e e m e m i i e e m i i g e e a a g i a a m e m

i e m m

g g g i e

i i g e a a a a 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 a m e e e e m e i i e

i i m e m m i

e m i

g g g e g i e e i e e a e e i g g e m e m m e e e e m g m e

Other(s)

Equipment

Training

Information services

Chemical staff 5-10 5-10 25-50 50-100 1 10-25

IT & software solutions

Global staff 25-50 5-10 100-500 50-100 1 25-50 100-500 2-5 5,000 plus 1 1 2-5 50-100

50-100 5,000 plus France Italy Spain Brazil 25-50 1,000-2,000  UK 5-10 USA, Turkey 5-10 UK 5-10 Germany, United Kingdom, Denmark, Serbia 100-500  110+ 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 The Netherlands 1 K J Bray & Associates UK 1 K&L Gates LLP Belgium 1,000-2,000 KAELTIA Compliance Services Spain 5-10 Kalium solutions inc. Canada Canada 5-10 Kathrin Lanz Germany 10-25 Keller and Heckman LLP USA Belgium, France, China 100-500 Kelley Drye & Warren USA Brussels 100-500  Kerona Scientific Ltd Ireland Spain 5-10 KFT Chemieservice GmbH Germany 10-25  Knoell Germany 100-500  Konica Minolta Business Expert, Inc Japan 2,000-5,000 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 LEORAT NATHALIE CONSULTING France 1 LG CNS South Korea Asia, South America, Europe, USA, Middle East 5,000 plus LGC UK 1,000-2,000 Linge Agroconsultancy The Netherlands 10-25 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 2020

Switzerland China Germany France Portugal UK USA Sweden UK UK Poland Germany

Other locations

Laboratory services

Headquarters USA US Germany Germany France Germany USA The Netherlands USA Canada Hungary UK Sweden

Legal services

Pagr

Representation/management

Organisation 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 Global Product Compliance

Consultancy/advisory

A-Z LISTING

206

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

      

                                     

  

              

                         

Further information www.foresitesystems.com  www.formulatorus.com              www.item.fraunhofer.de/en.html www.gabconsulting.de   

  www.gbk-ingelheim.com www.gensuite.com www.gentrochema.nl       www.ghd.com www.ghstc.com   www.REACHexpert.eu         www.gilliesassociates.co.uk                            www.gpcgateway.com                       

           

    

      

   

              

   

   

         



        

    



                                              

   

              

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   

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www.globalmsds.co.uk www.gltac.com 0 www.gradientcorp.com www.greensofttech.com 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.idrgplantprotection.eu

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www.ies-ltd.ch

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Jaehak Jung   Japag Regulatory Consultancy Japan Chemical Safety Institute  Jean Warshaw, Esq.   Jones Day        Jongerius Consult BV       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   Krogerus Attorneys Ltd.                Kumi Consulting Ltd    KV Consulting Services BVBA          LAUS          LEORAT NATHALIE CONSULTING       LG CNS LGC        Linge Agroconsultancy    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

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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

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207

A-Z LISTING COSHH US HCS

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

Food (contact) Occupational

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

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.krogerus.com       www.kumi.consulting www.kvconsultings.com    www.laus.group      0  www.lgcns.com  www.lgc.co.uk  www.lingeagroconsultancy.nl 

www.chemicalwatch.com/SPG

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LKC Switzerland Ltd Logic SDS Logscale Ltd Loufakis Chemicals SA LSR Associates Makersite GmbH Manatt, Phelps & Phillips, LLP MB Research Laboratories Mediator A/S Mercer Miami Chemical Micromeritics Analytical Services MSDS Europe MSDSWriter LLC National Chemical Emergency Centre (NCEC) National Physical Laboratory (NPL) Neuralog, LP Nexreg Compliance Inc. NimkarTek Technical Services Pvt. Ltd NOACK Laboratorien GmbH Noerr LLP NORMACHEM S.r.l NovaTox NRM Solutions

Switzerland United Kingdom Finland Greece UK Germany USA USA Denmark USA USA USA Hungary USA UK UK USA Canada India Germany Germany Italy Canada Trinidad & Tobago

OCI ONLY CORE CHEM, UNIPESSOAL LDA PACA GmbH

China Portugal Germany

USA, Canada, UK, France, Germany, Romania, India, Turkey, Brazil UK, Ireland France Bulgaria, Servia, Macedonia USA, Japan Munich, Berlin, London, Bergen

Asia-Pacific, EMEA, Americas

France, Germany, Poland, Italy, Spain

5-10 2-5 2-5 25-50 1,000-2,000 10-25 100-500 25-50 10-25 100-500 10-25 10-25 10-25 2-5

500-1000 25-50 10-25 Sri Lanka, Bangladesh 10-25 50-100 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 Portugal 10-25 5-10

Canada

Pace Regulatory Services USA Paul Illing Consultancy Services Ltd UK PeerAspect USA France Pengin Oy Finland Penman Consulting Belgium UK, The Netherlands Pera Technology UK Peter Fisk Associates UK Belgium PFA-Brussels Belgium UK pIEt Consulting BVBA Belgium Pinnacle Associates UK Pirjo Heikkilä Finland Polgar ACRO Hungary Belarus, Kazakhstan, Moldova, Russia, Ukraine Pöyry Finland Oy Finland Primetra Global Regulatory Consultants Canada Proactima AS Norway ProductIP The Netherlands China, Hong Kong, Germany, UK Prosacon GmbH Germany PwC The Netherlands Global presence Quality Technical Services LLC China USA Ramboll Environment and Health UK 130 in 35 countries  REACH Advice GmbH Germany REACh ChemConsult GmbH Germany Reach Chemical BV The Netherlands REACH Global Services S.A. Belgium Turkey  REACH Monitor Spain REACH n Roll Oy Finland Reach Registration Services UK REACH24H Consulting Group China Ireland, USA ReachCentrum SA Belgium EU, Taiwan, Vietnam, S.Korea, China, USA REACHECK Solutions GmbH Germany REACHLaw Finland Belgium, UK, Turkey, Russia, India  REACHLINKED China REACHReady UK ReachSpektrum Czech Republic REACHwise UK The Netherlands, Germany Redebel Regulatory Affairs S.C.R.L. Belgium Redeker Sellner Dahs Rechtsanwälte Germany Belgium ReFaC UK RegTox Solutions Inc. Canada Canada, US REGULATORING Consultancy Sole Venture Hungary REGULATORING Consultancy SV Hungary Regulatus 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 2020

2,000-5,000 1 10-25 1 5-10 100-500 25-50 10-25 1 2-5 1 10-25 2,000-5,000 1 100-500 25-50 5-10 2,000-5,000 10-25 5,000 plus 1 2-5 1 10-25 10-25 2-5 10-25 100-500 10-25 5-10 25-50 5-10 5-10 10-25 2-5 50-100 100-500 2-5 1 1 1 1

m g i g g e a e

5-10 2-5 2-5 2-5 25-50 5-10 25-50 2-5 5-10 2-5 5-10 1 10-25 2-5 25-50 100-500 10-25 5-10 10-25 50-100 10-25 10-25 2-5 1

m e i e i

5-10 10-25 2-5

m e i g

100-500 1 5-10 1 5-10 10-25 10-25 10-25 1 2-5 1 5-10 10-25 1 10-25 25-50 5-10 25-50 10-25 50-100 1 2-5 1 10-25 2-5 2-5 2-5 50-100 10-25 2-5 25-50 5-10 2-5 10-25 2-5 50-100 5-10 2-5 1 1 1 1

m m e

m e g e e e e m g e e i i m m m e e m e m 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 m i e e a e e m m e g e e

e e e g

e i m

m m i m m m m i m m m i m e m i m m i m m e m g g m e g g g i i m m g m m m m m

e g

e e e e

e e

a a e

a a

i g e e g g m e e e

g e e e i e g e g m e g g e m

e g e

e g

e e

a a

a e

e e e e e g e e g e e a e e e

g e e e e e e e e e i e e g e g a a g e g e e e

m g e e

e e e

e g

Other(s)

Equipment

Training

Chemical staff 2-5 5-10 100-500

Information services

Global staff 2-5 10-25 100-500

IT & software solutions

Other locations United Kingdom, Malta

Laboratory services

Headquarters Switzerland Finland Belgium

Legal services

Pagr

Representation/management

Organisation Linmark Consulting GmbH Linnunmaa Oy Lisam Systems

Consultancy/advisory

A-Z LISTING

208

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

Further information www.linmarkconsulting.com                               www.linnunmaa.fi                                        www.lisam.com

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OCI ONLY CORE CHEM, UNIPESSOAL LDA PACA GmbH

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www.LKC-ltd.com            www.logicsds.com logscale.fi/en/         www.loufakis.gr    www.lsr-associates.com                 makersite.io www.Manatt.com    www.mbresearch.com       www.mediator.as            www.mercer.com www.miamichemical.com www.particletesting.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.noack-lab.com      www.noerr.com                     www.normachem.it www.novatox.ca       www.nrmsolutions.org/       

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Pace Regulatory Services                 Paul Illing Consultancy Services Ltd     PeerAspect             Pengin Oy         Penman Consulting   Pera Technology  Peter Fisk Associates    PFA-Brussels    pIEt Consulting BVBA    Pinnacle Associates    Pirjo Heikkilä  Polgar ACRO      Pöyry Finland Oy     Primetra Global Regulatory Consultants               Proactima AS     ProductIP   Prosacon GmbH           PwC  Quality Technical Services LLC    Ramboll Environment and Health                 REACH Advice GmbH   REACh ChemConsult GmbH         Reach Chemical BV  REACH Global Services S.A.            REACH Monitor        REACH n Roll Oy                 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     RegTox Solutions Inc.          REGULATORING Consultancy Sole Venture   REGULATORING Consultancy SV     Regulatus       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

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 www.chinaoci.com www.onlycorechem.com   www.paca.de/sicherheitsdatenblatterstellen www.pacelabs.com/regulatory   www.peeraspect.com www.pengin.fi www.penmanconsulting.com www.peratechnology.com www.pfagroup.eu www.pfagroup.eu www.pietconsulting.eu www.pinnacleassoc.com

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209

A-Z LISTING COSHH US HCS

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

Food (contact) Occupational

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 Linmark Consulting GmbH Linnunmaa Oy Lisam Systems

Industrial chemicals Agrochemicals

Focus of activities

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www.polgar-acro.eu www.poyry.com 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.reach-advice.com www.reach-chemconsult.com/ www.reacheu.nl www.reach-gs.eu www.reachmonitor.org www.reachnroll.com 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.com www.redebel.com www.redeker.de www.refac.eu www.regtoxsolutions.com www.regulatoring.com/ www.regulatoring.com

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USA Germany UK

Risk Control Services Ltd Riskchem Rivendell International REACHUP REGULATORY NETWORK ITALY – RNI SRL RoHS Ready LLC Roisin McEneany ROSC bvba Rovaltain Research Company Royal HaskoningDHV RTC, Research Toxicology Centre S.p.A. SAFENANO Safety Data Services SAP AG SAP Japan Co, Ltd SATRA Technology SCAS Europe SCC Science & Environnement Scitegrity Selcia Ltd. Selerant SenzaGen ServiREACH, S.A. SFS Chemical Safety SGS SGS Agriculture, Food and Life ShawCor SHES Chemical Consulting Co., Ltd Shridhar Rajappanavar Siam S.L.

UK South Africa Ireland Italia USA Ireland Belgium France The Netherlands Italy UK UK Germany Japan UK Japan Germany Switzerland United Kingdom UK Italy Sweden Spain USA China Switzerland Canada South Korea India Spain

SIEF-IT SiteHawk Sitmae Reach Services BV Smithers Viscient SOCOTEC - Health and Product Safety Agency SOCOTEC Environment

Poland USA The Netherlands USA France France

spectra Consult GmbH SpetsInterProject Oy Sphera Solutions Spinnaker Coating, LLC Staphyt Regulatory

Germany Finland USA USA France

Star Wang Stefanie Merenyi Steptoe & Johnson LLP Stewardship Solutions Ltd Subvise Surface Science Western Sustainability Consult Sustainability Support Services (Europe) AB SustChem Engineering Ltd Sweco Industry Ltd Syska Voskian Consulting TEAM mastery Ted Simon LLC TEI Analytical, Inc Telematic srl Tenviro TERRA-The Electronics Reuse & Recycling Alliance Tetra Tech The Chemical Compliance Coach

China Germany USA UK Germany Canada Belgium Sweden Greece Finland USA Italy USA USA Italy Sweden USA USA The Netherlands

Belgium UK

USA, Spain and Japan ONLY ITALY PREMISE (MILAN, COMO, ROME) Canada

100 offices worldwide Singapore

China China, Singapore, South Korea, Taiwan Japan France

USA, India, China, Germany, France, Serbia Sweden, US

More than 140 countries

Spain, U.S.A., Denmark, Switzerland, Norwey, Island, Estonia, Latvia, Lithuania, Finland, Greece, Cyprus, Holland, Belgium, India, Israel, Italy, Czech Republic, Potugal, UK, Ireland, Romania, Serbia

UK France

Russia Ukraine Worldwide UK, Austria, Poland, Italy, Czech Republic, Hungary, Australasia, Brazil

Belgium

India, South Korea, Ireland Finland Denmark

The Netherlands USA Germany, Canada, UK Spain

The Compliance Map Ltd. UK US, Australia The Economics Interface Limited UK The Isosceles Group 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 2020

500-1,000 25-50 10-25

1 2-5 10-25 5-10 1 1 1 25-50 5,000 plus 100-500 100-500 1 5,000 plus 1,000-2,000 100-500 1,000-2,000 100-500 5-10

1 1 10-25 5-10 1 1 1 10-25 50-100 50-100 25-50 1

50-100 100-500 10-25 10-25 25-50

50-100 50-100 5-10 10-25 25-50

5,000 plus 2,000-5,000 10-25 2,000-5,000 25-50

5,000 plus 2-5 10-25 50-100 25-50

5-10 25-50 2-5 100-500 5-10 5,000 plus

5-10 25-50 2-5

i e

5-10 5-10

m g m g

2-5 5-10 1,000-2,000 2-5 100-500

2-5 2-5 100-500 2-5 50-100

m e i i g g i e a m e a e a a m e e

500-1000 1 100-500 5-10 2-5 10-25 5-10 25-50 5-10 100-500 2-5 10-25 1 5-10 10-25 1 2-5 5,000 plus 2-5

50-100 1 25-50 5-10 2-5 10-25 1 25-50 5-10 25-50 2-5 10-25 1 5-10 5-10 1 2-5 25-50 2-5

25-50 1 10-25

10-25 1 10-25

e e

m m

m m g i m m i g e i e m m i

e e e e

m g e g g

m e e e e e e e m g e e i m e m e m m e a a e a m e e e e g m e e m e e e i e g m e i e g e g g i i

m m e

e e

e i e

e i m

i i i

i i

g m e

m m g e e m m

g e m

g m i m m m m m e e g

e e e e e e g

g a e

e a

g g m i e m e g e m i e

e a e

m m

e g g

e e g e e e m e e e e i e

Other(s)

500-1,000 25-50 25-50

5-10 5-10 25-50 25-50 5-10

Equipment

Training

Information services

Chemical Global staff staff 1 1

IT & software solutions

Other locations

Laboratory services

Headquarters UK

Legal services

Pagr

Representation/management

Organisation Renfrey Regulatory and Compliance Consultancy Ltd Ricerca Biosciences, LLC RimaOne Risk & Policy Analysts Ltd (RPA)

Consultancy/advisory

A-Z LISTING

210

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spectra Consult GmbH SpetsInterProject Oy Sphera Solutions Spinnaker Coating, LLC Staphyt Regulatory

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SIEF-IT SiteHawk Sitmae Reach Services BV Smithers Viscient SOCOTEC - Health and Product Safety Agency SOCOTEC Environment

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www.ROSconsortium.eu rovaltainresearch.com www.royalhaskoningdhv.com www.rtc.it www.safenano.org

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                                                                                                                                   

www.ricerca.com www.rimaone.com   www.rpaltd.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.selcia.com            www.selerant.com www.senzagen.com www.servireach.com                www.chemicalsafety.com 0 www.sgs.com/en/agriculture-food  www.shawcor.com         www.cae.com www.siam-it.com      

                                               

Further information www.rrandcc.com

www.rcsinfo.com     www.riskchem.co.za  www.rivendell.ie                   www.reachup.it www.rohsready.org      

www.sief-it.com www.sitehawk.com www.sitmaereachservices.com www.smithersviscient.com       www.socotec.com/en/        www.socotec.com/fr/activites/ environnement-securite/offre-santeet-risques-produits www.spectra-consult.de/ www.spetsinterproject.com         www.sphera.com www.spinps.com www.staphyt.com/regulatory  

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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.sweco.fi      www.sysvoskconsulting.com www.team-mastery.eu    www.tedsimon-toxicology.com www.teianalytical.com www.epyplus.com www.tenviro.eu www.jointerra.org/ www.tetratech.com www.thechemicalcompliancecoach.  com        www.thecompliancemap.com www.theeconomicsinterface.com      www.theisogroup.com

                      

                                

                    

            

The Compliance Map Ltd.                    The Economics Interface Limited               The Isosceles Group                    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

211

A-Z LISTING

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                                                                                                                            

COSHH US HCS

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

Food (contact) Occupational

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 Renfrey Regulatory and Compliance Consultancy Ltd Ricerca Biosciences, LLC RimaOne Risk & Policy Analysts Ltd (RPA)

Industrial chemicals Agrochemicals

Focus of activities

www.chemicalwatch.com/SPG

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The Windsor Consulting Group, Inc.

USA

TJS Technical Services Inc. TO21 Co. Ltd. Tox Focus LLC toXcel Toxicon Toxi-Coop Toxicological Research Centre Ltd. Toxikon ToxMinds ToxServices ToxSolve LLC ToxStrategies TraceGains Trade Wind B.V. Tradebe UK TRASYS Triskelion Triskelion B.V. TSGE Consulting TUV Rheinland TUV Rheinland Hong Kong Ltd TÜV Rheinland LGA Products GmbH

Canada South Korea USA UK Italy Hungary USA Belgium USA USA USA USA The Netherlands UK Belgium The Netherlands The Netherlands UK USA Hong Kong Germany

TUV Rheinland of North America TÜV SÜD Industrie Service GmbH

USA Germany

TUV SUD Japan UetlibergPartners GmbH UL UMCO GmbH Universit Bordeaux Segalen Vanta Bioscience Veeva Systems

Japan Switerland USA Germany France India United States

VelocityEHS 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

USA USA USA USA Belgium Spain Germany UK USA UK USA USA UK Switzerland UK

UK, Germany, Belgium

France, Belgium, UK, China, Germany, Japan

Canada, France, United Kingdom, Germany, Spain, Hungary, China, South Korea, Japan, India, Singapore, Brasil, Australia

US, Canada, Europe, Asia

Scotland, Italy

United States

e e g e

2-5

e e e

e g

1 25-50 1 10-25 5-10 25-50 5-10 10-25 10-25 1 5-10 25-50 5-10 500-1000 50-100 100-500 100-500 50-100 10-25 100-500 500-1000

m i m i g e e m m m m

e e a a

1,000-2,000 50-100

g e i e e g g e e e e

100-500 2-5 5,000 plus 50-100 500-1,000 25-50 2,000-5,000

2-5 2-5 100-500 25-50 100-500 10-25 100-500

e m e a a m g i e m e e e e e e e g e e e m m

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

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 e a m e e e m e e e i g 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

5,000 plus 10-25 50-100 5-10

50-100 10-25 50-100 2-5

m e e e e m i g g e e e e

m e g g e m g i

g e a i e g e e a m m e e g a m g m e e i e m e m e i e e e e g e

a e a e e

e e e e a a

e e

g e e g g

e e e

Other(s)

Equipment

Training

5-10

m m m m

Information services

Chemical staff 1 10-25 5-10 2-5

2-5 50-100 1 USA 25-50 5-10 Switzerland, USA 50-100 Belgium 100-500 India, Germany 10-25 15 25-50 1 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 Japan, USA, Canada (sales offices) 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 Japan, Singapore, China, India 2,000-5,000

WSP UK Ltd UK Wordwide XCellR8 UK Yordas Group 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 2020

Global staff 50-100 10-25 5-10 2-5

IT & software solutions

Other locations Germany, China, Japan, Brazil, Chile The Netherlands

Laboratory services

Headquarters USA USA USA The Netherlands

Legal services

Pagr

Representation/management

Organisation The Martec Group The Redstone Group The Sapphire Group the SDS factory | de ViB fabriek

Consultancy/advisory

A-Z LISTING

212

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

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 ToxStrategies TraceGains Trade Wind B.V. Tradebe UK TRASYS Triskelion Triskelion B.V. TSGE Consulting TUV Rheinland TUV Rheinland Hong Kong Ltd TÜV Rheinland LGA Products GmbH

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                      

               

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         

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                         

          

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                        

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TUV Rheinland of North America TÜV SÜD Industrie Service GmbH

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TUV SUD Japan UetlibergPartners GmbH UL UMCO GmbH Universit Bordeaux Segalen Vanta Bioscience Veeva Systems

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  ehs.com        www.verdantlaw.com        www.Verisk3E.com www.vidaris.com         www.ehs.vito.be/ www.vivotecnia.com    www.vonroll.com www.vrs-regulatory.net       www.WEtrainConsulting.com www.wca-consulting.com  

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www.tuv.com/en/usa/home.jsp www.tuev-sued.de/technical_ installations/reach www.tuv-sud.jp www.uetlibergpartners.com www.ul-scs.com      www.umco.de www.u-bordeaux2.fr www.vantabio.com www.industries.veeva.com/chemical   

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213

A-Z LISTING COSHH US HCS

CAD

Further information 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.toxstrategies.com www.tracegains.com     www.twnl.nl www.tradebe.co.uk www.trasys.be triskelion.nl    www.triskelion.nl    www.tsgeurope.com www.tuv.com/us/green-solutions www.chn.tuv.com www.tuv.com

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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

Food (contact) Occupational

Medical devices

Cleaning products

Textiles & apparel

Construction

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REACH Global chemical notifications

Aerospace, automotive & engineering

Toys/children's products

Electrical and electronics

Veterinary medicine

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Biocides

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Biotechnology

Medical & pharmaceuticals

Regulatory expertise

Industrial chemicals Agrochemicals

Organisation The Martec Group The Redstone Group The Sapphire Group the SDS factory | de ViB fabriek

Personal care (inc. cosmetics)

Focus of activities

www.wileyrein.com www.wyesideconsulting.com www.reachwilmer.com www.womblebonddickinson.com/uk/ sectors/manufacturing/chemicals WSP UK Ltd www.wsp.com                  XCellR8 www.x-cellr8.com                  Yordas Group                              www.yordasgroup.com Zanos Ltd www.zanos.co.uk     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

Endocrine Disruptors A topic to consider

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