Global Service Providers Guide 2021 by Enhesa Product

Global Service Providers Guide 2021 The guide to global chemicals management and control services

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Foreword

Foreword It is my pleasure to welcome you to the eleventh edition of our annual Chemical Watch Global Service Providers Guide. As the leading provider of independent product safety intelligence and insight, Chemical Watch now connects the largest community of product safety and regulatory professionals across the globe. Our membership today consists of more than 68,000 individuals from more than 17,000 organisations, and we are helping them to transform product safety management and unlock the full value of regulatory compliance within their business. We know regulatory developments continue to drive huge activity in chemicals management and control across the globe. As a result the workload of regulatory professionals continues to increase, as the job of maintaining compliance across product lines and throughout supply chains expands. At the same time, organisations are working hard to move beyond compliance, to transform business practices and ensure a more sustainable future. In order to continue supporting our members, Chemical Watch has continued to grow, in coverage and in our ability to be that one-stop shop for timely, business critical information, and a trusted voice delivering that all-important perspective on what is coming down the pipeline. To this end, and as many of our members will already know, Chemical Watch was acquired by Enhesa – the market leading

global EHS compliance content & intelligence platform – at the end of last year. This represents a hugely exciting opportunity for us and our members. By working together, Chemical Watch and Enhesa can now help you to identify, understand and meet more of your product and EHS operational compliance needs, helping you to transform your compliance management with the support of these two leading global brands. The Global Service Providers Guide presents the results of our annual survey. With an average of 800 responses each year, we are able to present the most comprehensive picture of key drivers and industry trends for the chemicals management and control sector. As our flagship annual publication, it offers a great introduction to the ways we support our members with a 360° view of chemicals management and control. For those readers already familiar with us and to those opening the guide for the first time, I hope you enjoy reading through the eight specially commissioned articles, and find the directory listings of 90 service provider profiles useful. As always, if you have any questions or feedback on the guide, please don’t hesitate to get in touch. Henry Tipping Publishing manager

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Contents Introduction.........................................................................5 Global regulatory and non-regulatory drivers.............7 Service providers outlook.............................................. 18 Careers and salary trends............................................. 33 What are the key factors driving US chemicals management activity?............................................ 40 How is the market for laboratory testing services shaping up?.............................................. 47 What will shape Asia’s busiest jurisdictions for chemicals management in 2021?...................... 51 What developments can industry expect in the EU’s chemicals strategy for sustainability in the near future?.................................................... 55 What will shape the approach of business to chemicals management this year?..................... 60

Contents

C.S.B. GmbH...................................................................110 Danish Technology Institute.......................................112 EBRC Consulting...........................................................114 ERBC.................................................................................116 ERM..................................................................................118 Eurofins............................................................................120 Fieldfisher LLP...............................................................122 FoBiG................................................................................124 GBK GmbH Global Regulatory Compliance...........126 Global Product Compliance.......................................128 H2 Compliance..............................................................130 INERIS..............................................................................132 Intertek.............................................................................134 Kahlberg Consulting.....................................................136 Kelley Drye & Warren....................................................138

Profiles.................................................................66 Acta.....................................................................................66 Apeiron-Team NV............................................................ 68 Arcadis...............................................................................70 Arcerion GmbH................................................................ 72 ARCHE Consulting.......................................................... 74 Arrow Regulatory Ltd..................................................... 76 Artemisa d.o.o.................................................................. 78 BIG vzw.............................................................................. 80 BioGenius GmbH............................................................ 82 Blue Frog Scientific Limited.......................................... 84 Cardno ChemRisk........................................................... 86 Charles River.................................................................... 88 CHEMDOX......................................................................... 90 Chemical Check GmbH................................................. 92 CHEMLEG......................................................................... 94 ChemSafe......................................................................... 96 Chemservice.................................................................... 98 China National Chemical Information Center Co., Ltd........................................................100 CIRS..................................................................................102 CIS Centre ......................................................................104 Concept Life Sciences.................................................106 CRAD................................................................................108 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 Chief operating officer Stuart Foxon stuart.foxon@chemicalwatch.com Chief commercial officer Richard Butterworth richard.butterworth@chemicalwatch.com Chief customer officer Emma Chynoweth emma.chynoweth@chemicalwatch.com Consulting editor Geraint Roberts geraint.roberts@chemicalwatch.com Global marketing manager Ryan McErlean ryan.mcerlean@chemicalwatch.com

KFT Chemieservice GmbH.........................................140 Knoell................................................................................142 Lisam Systems..............................................................144 National Chemical Emergency Centre (NCEC).....146 Ramboll............................................................................148 REACH Global Services S.A........................................150 Reach Only Representative Ltd.................................152 REACHLaw.....................................................................154 Risk & Policy Analysts Ltd (RPA)...............................156 SCC...................................................................................158 Sphera Solutions...........................................................160 Staphyt Regulatory.......................................................162 TEAM mastery...............................................................164 TOXIT & S-IN Soluzioni Informatiche Srl.................166 ToxServices LLC............................................................168

Niche Profiles.................................................. 186 3S-SafelyServingScience............................................186 Anthesis Group..............................................................186 Cambridge Environmental Assessments ..............186 ChemFORWARD...........................................................186 Chem-Academy.............................................................187 ChemManage................................................................187 Compliance for Chemicals.........................................187 Coracle.............................................................................187 CS Regulatory Ltd.........................................................188 Delphic HSE....................................................................188 eSpheres..........................................................................188 Eurideas Language Experts.......................................188 Euro Safety and Health................................................189 INFOTOX..........................................................................189 Kerona Scientific Ltd....................................................189 LKC Switzerland Ltd.....................................................189 Mediator A/S..................................................................190 Peter Fisk Associates...................................................190 OCI ....................................................................................190 PFA-Brussels..................................................................190 REACHReady.................................................................191 REACHwise.....................................................................191 REGARTIS.......................................................................191 Rovaltain Research Company...................................191 SCAS Europe..................................................................192 Selerant............................................................................192 Sweco Industry Ltd.......................................................192 Tox Focus LLC...............................................................192 Toxicon............................................................................193 WSP UK Ltd....................................................................193

Triskelion.........................................................................170 TÜV SÜD Industrie Service GmbH............................172 UL ....................................................................................174 UMCO GmbH.................................................................176 Veeva Systems..............................................................178 VelocityEHS....................................................................180 Verisk 3E..........................................................................182 Yordas Group.................................................................184 Global managing editor Kate Lowe kate.lowe@chemicalwatch.com Global sales manager Louise Osborne louise.osborne@chemicalwatch.com Chief analyst Nhat Nguyen nhat.nguyen@chemicalwatch.com Event director Judy Jackson judy.jackson@chemicalwatch.com Publishing manager Henry Tipping henry.tipping@chemicalwatch.com Deputy editor Nick Hazlewood nick.hazlewood@chemicalwatch.com Production Francesca Cotton francesca.cotton@chemicalwatch.com Writers Elaine Burridge, Kathryn Carlson, Emma Davies, Kate Lowe, Leigh Stringer, Vanessa Zainzinger Sub editors Claudia Ward, Martina Chamberlain 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 Claire Houston-Holland claire.houston-holland@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 Copyright and Database Rights © 2021 CW Research Ltd. All rights reserved Photo credits: Adobe stock.

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Introduction A 360° view of chemicals management and control The eleventh Chemical Watch survey of the chemicals management industry finds a marked shift in the factors driving market activity, while prospects for employment are improving after a tough 12 months. During the three months from December 2020 to February 2021, Chemical Watch took the opportunity to survey its chemicals management community across the globe in order to uncover the key factors driving activity in the market, as well as track changes in employment and spot emerging trends. Respondents to this year’s survey – the eleventh that Chemical Watch has undertaken – include chemicals companies and their downstream customers, service providers, regulatory professionals and more. The aim is to provide a 360° view of the state of today’s chemicals management industry, supported by a series of articles examining key regulatory and non-regulatory drivers, recruitment trends and demand for professional services, as well as regional reports on the US, EU and Asia. Our commentary starts on page 7. While Covid-19 had less impact than might have been expected on the pace of regulatory activity during 2020, it nevertheless made its presence felt in the chemicals management sector in a variety of ways, both as a driver of activity, specifically in the market for cleaning products, and as an obstacle to activity, seen most strikingly in its impact on recruitment in the sector. Hence it is a topic to which we frequently turn in the accompanying articles to this year’s Guide. After a challenging 12 months, the mood in the market is as positive as ever, with expectations of increased recruitment and investment in information and training, software tools and consultancy services that can help teams manage an increasing workload with the guidance and support they need.

Market drivers This year’s survey sees the EU’s REACH Regulation maintain its pole position as the regulatory driver most often cited by survey respondents as a leading factor in activity. Some 87% of respondents – up a little from 84% in 2020 – cited “any aspect of REACH” as having a significant impact on chemicals management. However, whereas in the 2020 Chemical Watch survey, various aspects of REACH featured in four of the five top regulatory drivers identified by respondents, year’s survey sees the EU chemicals strategy for sustainability take second place, followed by Brexit in third place, “any aspect of US regulation” in fourth and EU CLP in fifth. Looking at the top market drivers by sector, whereas in 2020 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, in this year’s survey both the chemicals and life sciences, and service providers placed Brexit at the top of their lists.Meanwhile those working in the consumer products sector picked the EU chemicals strategy for sustainability and manufacturers picked SVHC obligations under REACH. Turning to non-regulatory drivers, the Covid-19 pandemic outstrips all other factors in this year’s survey, cited by 77% of

respondents as either a negative or positive driver. Next comes economic growth cited by 49% and customer and supply chain demand cited by 48%. For more see page 11. How are the shifts in both the regulatory and non-regulatory drivers reflected in the services customers require? As we report on page 21, the latest figures show a dramatic increase in demand for representation and management, with the share of respondents’ total spend on such services up from 10% in 2019 to 37% in 2020. Meanwhile “IT and software” continued its rise – this year reaching 12% of total spend, taking it into second place. Looking at the next five years, that increase in demand for representation and management services continues, with 77% of respondents citing help with business process outsourcing as a key requirement, while 65% are seeking help with the management of Siefs and other consortia and 63% cite CLP notification as a driver. A further 71% cite regulatory interpretation as a driver of external services, and 67% regulatory information management.

Employment trends Turning to employment within the chemicals management sector there is little doubt that the coronavirus has taken its toll, with recruitment plans heavily affected in 2020. The latest survey records a significant drop in the number of respondents that saw an increase in staffing levels in 2020 (28.5%) when compared to 2019 (41.4%). This is considerable change in circumstances for a sector that saw one of its strongest periods of growth in 2019. Thankfully, however, existing jobs were less affected, with staffing levels remaining static during the course of 2020, according to 62.9% of respondents to this year’s survey (. Signalling better times ahead, when asked about prospects for the next 12 months, 59.1% of respondents said they expected no change in employee numbers, while a further 37.2% predict an increase. Interestingly, the number of participants expecting staffing levels to drop has shrunk from 11.4% to just 3.7% in this survey. Despite the challenges that Covid-19 brought to the workplace in 2020, there has been little change in job satisfaction levels: as with previous surveys more than half of respondents said they felt satisfied in their work. Those reporting dissatisfaction with their jobs accounted for 11% of responses in the 2020 survey, versus 10% in 2019 and 13% in 2018. The highest salaries in this year’s survey were reported by regulators, some earning up to €100,000, followed by product safety/stewardship, regulatory affairs and environment, health and safety (EHS) management, all of which command average salaries of about €72,000-76,000. Those working in occupational hygiene were receiving the lowest salary, averaging about €51,000, unchanged on the previous year’s survey. For more on this year’s findings turn to page 33.

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What are the key regulatory and non-regulatory developments driving chemicals management and control activities? Regulatory developments continue to drive chemicals management activity across the globe, but non-regulatory drivers including the negative impact of coronavirus Covid-19, have made their impact felt too. Elaine Burridge reports. Europe’s REACH Regulation continues to dominate the chemicals management workload of manufacturers, importers and users of chemicals. The Regulation’s position as the top business driver remained unchallenged in Chemical Watch’s annual survey of its chemicals management community, although professionals’ attention is also drawn to other regulatory regimes around the world, such as K-REACH in South Korea, TSCA and California Proposition 65 in the US, MEE Order 12 in China and Turkey’s KKDIK. “We do see a shift in requests from the EU to the rest of the world,” says Gijs Manneveld, senior manager for international affairs at German regulatory consulting company SCC. “Companies are increasingly trying to monetise the regulatory investments in the EU and want to re-use the experience and data available in the EU to open markets internationally.” Strategic and regulatory consulting, as well as substance/ product registrations of industrial chemicals in several AsiaPacific countries and the only representative (OR) service for South Korea, have been most in demand at knoell. Canada’s WSP saw higher demand for OR services last year, driven by Brexit and companies wanting to ensure they would remain compliant in both UK and European jurisdictions. The same is true for Finland’s REACHLaw. Ingrid Sekki, the company’s chief marketing and business development officer, says 2020 was an “extraordinary” year, with several regulatory deadlines to be met in regions where its offices are based, specifically pre-registration under Turkey’s KKDIK, Eurasia REACH inventory notification and actions related to REACH and Brexit. Multinational consultancy H2 Compliance notes that broader appreciation of global chemical regulatory requirements is driving industry towards a more holistic approach to ensure market access. “Companies ask for a single point of contact to explore their obligations and execute them internationally, avoiding duplication of effort and content generated under EU REACH,” observes Kevin Hoban, chief operations officer at the company.

Dossier updates REACH dossier updates are a key focus too. Helen Kean, regional director of sustainable chemistry, EMEA and AsiaPacific, at consultancy Anthesis, says clients are beginning to review their dossiers in light of the Cefic/Echa dossier quality improvement programme. “More registration dossiers are

being scrutinised by Echa, and with substance grouping, more substances are coming into scope,” she says. Cefic said in April 2020 that 165 companies had joined its voluntary initiative to help members systematically review and update data in their previously submitted REACH registration dossiers. Compliance checks carried out by Echa in 2020 resulted in 88% of REACH dossiers needing more information. Dutch service provider Triskelion also cites high demand for REACH dossier updates, as well as for new REACH dossiers for substances formerly covered by other legislation. In addition, SCC’s Mr Manneveld says clients have needed help with Echa’s substances of concern in products (Scip) database. Launched in October 2020, Echa set a deadline of 5 January 2021 for companies to notify the agency about any substances of very high concern (SVHCs) above 0.1% in their articles. As of 11 January 2021, there had been more than five million notifications to the Scip database. IT systems providers Chemical Check and Lisam Systems say that other primary drivers of chemicals management work include CLP and poison centre notifications. And specialist consultant LKC adds advice on plant protection products and biocides into the mix, noting that biological control of pests, biostimulants and nanoparticles sit at the top of the company’s business agenda. Françoise Saint-Romain, managing partner and senior regulatory affairs consultant at Lisam Telegis, the French arm of Lisam Systems, says they have seen increasing requests relating to compliance procedures on products, for example customers needing assistance as to what steps they need to take to ensure a product complies with local legislation, what evidence must be collected and how to follow the various compliance steps required. REACHLaw sees the same trend. Ms Sekki reports growing demand for regulatory services related to sectors such as electronics, automotive, food contact materials, batteries, plastics and textiles. She says: “I believe this demand will continue growing as these sectors are at the core of the EU’s green transition for making sustainable products the norm in the region.”

Major regulatory drivers The vast majority – 87% – of respondents to the Chemical Watch survey put REACH as the top regulatory driver of their workload for 2020 [Figure 1]; the regulation also features in six out of the top eight drivers.

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Global regulations

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Figure 1: Leading regulatory drivers for survey participants

Chemicals Management regulations

National transposition of GHS on classification, labelling and inventory notification regulations

Sectors

Links between chemicals management and other major regulations/policies

Occupational hygiene UN Environment Programme (Unep)

REACH (any) US (any) Brexit EU REACH SVHC obligations EU REACH registration EU REACH dossier updates EU REACH evaluation related activities EU REACH Annex XVII Restrictions South Korea (K-REACH) US: TSCA New Substance Notifications China - existing chemicals US: California Proposition 65 Turkey EU REACH authorisation activities US: TSCA risk evaluations Nanomaterials risk assessment – Revised REACH information requirements for nanoforms Russia Canada Chemicals Management Program India US: California Safer Consumer Products Regulation Japan Other EAEU Australia Brazil Other US state legislation (Washington, Vermont etc) Taiwan Mexico EDC risk assessment Vietnam Other Asia chemicals regulations Thailand New Zealand Rest of LATAM Regulations Malaysia Argentina Israel Philippines Colombia Indonesia EU CLP regulation EU CLP Annex VIII Poison Centre Notification Implementation of GHS in other countries US: HazCom 2012 (GHS) Standard Canada Workplace Hazardous Materials Information System (WHMIS) EU Biocidal product regulation (BPR) Packaging regulations Food contact material regulations RoHS regulations Cosmetics regulations Medical devices regulations WEEE Regulations South Korea (K-BPR) Pharmaceutical regulations Toy Safety regulations US Fifra antimicrobials regulation Agrochemical regulations Veterinary product regulations EU chemicals strategy for sustainability Sustainable development goals Circular economy Global strategies for plastics/plastics pollution Microplastics EU Waste Framework Directive and Scip Database European strategy for plastics Long term 'environmentally neutral' ambitions Other Extended Producer Responsibility/Take-back regulations EU Chemical Agents Directive (CAD) and Carcinogens and Mutagens Directive (CMD) US UK Canada Japan Australia POPs (Implementation of the Stockholm Convention on Persistent Organic Pollutants) International Maritime Dangerous Goods (IMDG) Code International Carriage of Dangerous Goods by Road (ADR) Pic (Prior informed consent implementation of the Rotterdam Convention) Mercury (implementation of the Minamata Convention)

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Global regulations

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Figure 2: Leading regulatory drivers by sector Chemicals, life sciences and similar

Consumer products

Brexit

EU chemicals strategy for sustainability

EU CLP regulation

Sustainable development goals

EU Biocidal product regulation (BPR)

EU CLP regulation

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Implementation of GHS in other countries

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EU CLP Annex VIII Poison Centre Notification

EU REACH registration

Cosmetics regulations

EU REACH dossier updates

Packaging regulations

EU Chemical Agents Directive (CAD) and Carcinogens and Mutagens Directive (CMD)

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South Korea (K-REACH) EU Biocidal product regulation (BPR)

EU REACH registration EU REACH SVHC obligations

Food contact material regulations All manufacturing

Service providers, including laboratories, consultants, lawyers, etc

EU REACH SVHC obligations

Brexit

EU CLP regulation

EU chemicals strategy for sustainability

Sustainable development goals

EU REACH SVHC obligations

EU chemicals strategy for sustainability

EU CLP regulation

RoHS regulations

EU Biocidal product regulation (BPR)

EU Waste Framework Directive and Scip Database

EU CLP Annex VIII Poison Centre Notification

Brexit

EU REACH dossier updates

EU REACH Annex XVII Restrictions

Circular economy

Packaging regulations

RoHS regulations

Circular economy

Microplastics EU Chemical Agents Directive (CAD) and Carcinogens and Mutagens Directive (CMD)

Perhaps unsurprisingly, given the UK’s exit from the EU on 31 December 2020, more than half of respondents place Brexit in second place, with any US regulation featuring third. Over half of survey participants also indicate EU CLP as a major driver, as well as sustainability goals. Looking back at previous polls, the top results are little changed, with the notable exception of Brexit. Indeed, when analysing the results by sector [Figure 2], Brexit is top of the list for both professionals working within the chemicals and life sciences sector – and for service providers. Meanwhile it ranks fourth for professionals working within the consumer products and cosmetics sector. Anthesis saw a last-minute rush by some UK-based REACH registrants to ensure business continuity. UK REACH entered into law on 1 January 2021, although the deadline for submitting all data to comply with the Regulation extends to between 2023 and 2027, says Dr Kean. “The challenge that lies ahead will be ensuring that a UK-REACH registrant has legitimate access to the data it needs,” she says. Interestingly for 2020, and continuing the trend in the previous survey, sustainability features highly among all the sector groups, whether it is because of the EU’s chemical strategy for

sustainability or the UN’s sustainable development goals. This marks quite a shift for the consumer products and cosmetics sector which has placed California Proposition 65 as the top driver during the previous two years. Survey respondents once again included the circular economy, although it was not ranked very highly in the all manufacturing and service providers sectors.

The Covid-19 effect A significant impact from the coronavirus pandemic relates to the spike in demand for sanitisers. Many services companies, such as LKC, ChemSafe, SCC and WSP, report an increase in requests from clients for support with biocidal product registrations and authorisations as they sought to place sanitisers on the market. “We witnessed a scramble at the beginning of Covid-19 from many food and beverage manufacturers pivoting to change formulations and make hand sanitisers and remain in compliance,” says Bernie Henn, supplier development manager at Verisk 3E. “This increased demand for our expert safety data sheet (SDS) and label authoring services among this sector. As a public service to help companies keep workers and communities

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safe, we provided free access to SDSs for cleaning products approved for use against Covid-19.” However, Matthew Kane, chief operating officer at Swissbased LKC, says that although demand for services relating to disinfectant products rose, the ability to respond was “offset by uncertainty in the marketplace, delays to projects because of interrupted services, as well as delays to timelines and disruptions within supply chains”.

Non-regulatory drivers Negative impacts from the Covid-19 health crisis were rated by more than half of poll participants as the top non-regulatory driver in 2020 [Figure 3], followed by economic performance and customer/supply chain demands, then governmental policies/ spending. Figure 3: Leading non-regulatory drivers for survey participants Negative impacts of COVID-19 54%

supply chain demands, which was placed top in the prior two years and now slips to third. Economic growth is in second place, one step up from the third position it held in the previous two surveys. Consumer awareness, supply chain requirements and government policies are at the head of many agendas. Italy’s ChemSafe says a consumer push for safe products, along with regulatory complexity and the interaction between regulations, both within the EU and with other countries such as the US and China, are strong drivers of its work with clients. The company adds that it is also developing its offering in the food/feed area where the need for toxicological expertise is growing. Verisk 3E’s Mr Henn says supply chain requirements are the main drivers of its business in addition to product safety, and chemical and workplace safety. “Companies turn to us to ensure sustainability, supply chain responsibility and corporate social responsibility,” he says, noting that NGO pressure is forcing manufacturers, distributors and retailers to eliminate toxic chemicals in their products and packaging, and work towards developing safer chemicals policies. “We are seeing more companies developing a restricted substances list and priority chemicals list while committing to continuous improvement. This is driving investment in product safety and compliance solutions,” Mr Henn adds.

Economic performance 49% Customer and supply chain demands 48%

Downsizing of in-house chemical management and control teams, which has dropped down the list in the past three years, is now sitting in ninth place compared with tenth in 2020. It took first and second place respectively in the 2017 and 2018 editions of the Service Providers Guide.

Governmental policies/spending 31% Redistribution of regulatory compliance responsibilities within organisations 26% Consumer concerns on products/services provided by organisations

While most companies expect no impact from the pandemic on four key business aspects, 30% believe the pace of regulatory developments will however increase, while 27% and 26% respectively forecast a rise in the use of external service providers and the enforcement of regulations.

26% Positive impacts of COVID-19 23% NGO pressure

Looking at which activities have been most affected by Covid-19 [Figure 4], nearly half of those surveyed – 45% – say that dealing with supply chain issues will increase.

22% Downsizing of in-house chemical management and control teams 19%

Figure 4: Activities most impacted by COVID-19

Merger and acquisition activity 16%

The same

Increasing

Decreasing

Non-statutory ‘voluntary’ corporate initiatives/CSR 15%

Managing chemicals compliance of existing products/business

Relocation of the organisations to different countries/regions

17%

78%

14% Outsourcing of business support functions (by client organisations)

Tracking/managing chemicals regulatory changes

12%

19%

76%

Investors pressure

Managing changing chemical inventories

11%

21%

73%

Increased commercialisation/better management of service provider… 8%

Supporting new product registrations

Insurance factors

24%

67%

10%

Supporting new product development

Other

23%

62%

20%

40%

60%

Dealing with supply chain issues 45%

48%

% of participants

The key difference with last year’s responses is, unsurprisingly, the ranking of Covid-19 in pole position, replacing customer/

15%

% of participants

100%

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Global regulations

The green agenda Political developments such as the EU’s chemicals strategy for sustainability and the European Green Deal, an action plan to boost the efficient use of resources by moving to a clean, circular economy and restore biodiversity, have spurred significant interest in services relating to environmental and social governance. Anthesis says interest has come from businesses that are positioning to be at the front of the queue for investments – from both the private and government sectors – as well as future proofing for the longer term. Anthesis’s Dr Kean says the firm is also seeing a ramp-up of interest among clients in net-zero and science-based targetrelated activity, driven by consumer pressure, supply chain demands, brand enhancement and competitive advantage. Mr Hoban of H2 Compliance adds they are now starting to see companies actively approaching the need to remove more hazardous materials from supply chains. He says substances such as titanium dioxide that was previously considered “reasonably innocuous”, but which has been classified (in

February 2020) by the European Commission as a category 2 carcinogen in inhalable powder form, “have focused the minds of many companies”. There has also been a notable shift towards software solutions that centralise information, identify drivers and offer nimble project management, says Mr Hoban. The circular economy, including substances from recycling, nanomaterials and new energy technologies are key market trends identified by German consultancy Chemservice. Likewise, digitalisation, supply chain management and ethical standards are the big issues flagged by German service provider Chemical Check. Certainly, as knoell puts it, chemical companies are being asked to manage more products, navigate more regulations and do so more transparently. The expanding maze of global and increasingly complex chemical and product regulations will undoubtedly continue to drive chemicals management activity across all sectors both today and in the future.

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Service provider outlook

OUTLOO K

What is the outlook for chemicals regulatory and management services this year? Elaine Burridge examines the findings of the latest Chemical Watch service provider survey to reveal key trends for the next 12 months. Service providers are unanimously positive in their outlook as they continue to see rising demand for their services and an ongoing trend for companies to outsource their regulatory compliance needs. This is no doubt down to the increasing number and growing complexity of regulations around the world, but is also being driven by newer industry trends, such as sustainability, which is bringing its own set of compliance requirements. Regulations in Europe are constantly being revised, for example on poison centre requirements, notifications to Echa’s substances of concern in products (Scip) database and REACH dossier updates to name but a few. Outside the EU, countries such as Turkey, Russia, South Korea and China are among many where regulatory regimes are being established or upgraded. And then there is the implementation of various editions of the UN’s Globally Harmonized System (GHS) for classification and labelling of chemicals in various countries including Australia, South Africa and Chile, and an increasing number of requests worldwide for safety data sheet (SDS) services. Overall, service providers predict that outsourcing will continue. They are definitely more upbeat than last year when their mood was more mixed, with many feeling that the trend had peaked. So, what has changed this year? Service providers say it is becoming less and less cost effective for companies to retain all the necessary scientific and expert knowledge in house – a trend exacerbated by Covid-19.

Global Service Providers Guide 2021

Michael Cleuvers, director, products and markets at service provider knoell, says companies have already adapted their business models to outsource chemical management work. “Outsourcing and downsizing have already proven to be useful instruments to help organisations deal with the new business environment, especially now with Covid-19 continuing to affect business.” The outbreak of coronavirus in China in late 2019 and its subsequent spread around the world has created extra work in the area of biocides regulations and workplace safety, a trend that Verisk 3E expects to remain in place for the next 12 months. “The global pandemic increased focus on chemical and workplace safety, ushering in changes to regulations on biocides, rapid retooling of manufacturing to produce sanitisers and disinfectant products and a strong focus on protecting workers and consumers from Covid-19,” says Bernie Henn, Verisk 3E’s supplier development manager. “The emphasis on work safety will continue, with many companies turning to us for expert SDS and label authoring services to comply with hazard communication requirements.” However, on a more cautionary note, Matthew Kane, chief operating officer at Swiss-based LKC, believes service providers will continue to be challenged this year by the remote working practices imposed to combat the spread of coronavirus, which will have economic impacts for 2021 and beyond. In addition, the management of project delays as timelines slip across most sectors will affect virtually all supply chains.

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Consequently, legal and regulatory services will see the strongest growth in demand this year as industry looks to cope with the implications of unpredictable delays to their project planning, he says.

Brexit triggers growth The European political landscape also shifted on 1 January as a consequence of Brexit with the UK now having its own chemical regime. Canadian service provider WSP anticipates seeing the strongest growth in demand for its services this year for UK REACH only representative (OR) services, for both UK and EU companies. Many UK firms , several of which are small- and medium-sized enterprises (SMEs) with no resources or expertise for regulatory work, will have new or additional obligations, as well as the need to comply with EU REACH for exports to the region. This, says Jenny Butcher, principal consultant, REACH and product stewardship at WSP, will probably lead to an increase in outsourcing and may also lead to higher demand for regulatory professionals in the short term. Service providers SCC in Germany and Triskelion in the Netherlands cite increasing workloads related to the biocidal products Regulation (BPR) and plant protection products Regulation (PPPR). SCC’s senior manager international affairs Gijs Manneveld is expecting a steady growth in demand for international regulatory support for disinfectants given the increased focus of regulators worldwide on the safety of these products during the course of the Covid-19 pandemic. He adds that there is also increasing interest from companies, especially in the EU, to apply their experience with BPR, PPP and REACH to similar regulations in other world regions. Triskelion says it sees “the strongest growth in BPR and PPPR registration support, which we will be targeting specifically to grow in 2021.” Over the coming years, it says demand for BPR and PPPR dossier services will slowly shift towards higher tier assessments. Consolidation underway within the PPP sector will also occur within the biocides industry over the coming years and the portfolio of EU conventional biocidal active substances will continue to decrease, which will simultaneously increase the need for dossiers for novel sustainable active substances in the EU, the Dutch firm adds.

New requirements Other areas of growing demand are new requirements for assessing endocrine disrupting chemicals and nanomaterials, as well as ever-growing data requirements and an increasing focus on legislation such as food contact materials (FCMs), which will continue in 2021 and beyond, according to Triskelion. The company is forecasting steady growth in demand [?] for its services in the years ahead, starting with a 25% rise already this year. Top of the agenda at LKC for 2021 and beyond are regulatory services for nanoparticles, biostimulants and biochemical developments in Europe as the region’s biotechnology sector appears to be ahead of the curve, says Mr Kane. “One would hope that such a trend can result in an increase in requirements for technical and regulatory services to cover these growing sectors,” he comments.

Italian regulatory affairs consultancy Chemsafe sees most demand for its expertise in regulatory toxicology, ranging from chemicals to medical, including pharmaceutical and medical devices, to cosmetics and food. Chemsafe’s managing director Antonio Conto says REACH dossier updates, authorisation dossiers for products under the BPR, and the EU’s sustainability strategy will also drive more consultancy work. Product-related regulations will continue growing too in 2021, says Ingrid Sekki, chief marketing and business development officer at Finland’s REACHLaw, who mentions plastics, textiles, FCMs, electronics, automotive and batteries as areas where companies need assistance. Continuing a trend that started in 2019, Ms Sekki says service providers will increasingly join forces to meet demand for REACH-like registrations and representation services in different markets, particularly those where they do not have offices or local partners. “Furthermore, software providers and chemical regulatory service providers will continue creating alliances to complement each other’s offering to better serve their clients who may need regulatory advice but also an IT solution to gather all substance data for notification or supply chain communication purposes, for example.”

Chemical Watch survey results According to the results of Chemical Watch’s survey, topping the list of services retained by service providers in terms of value [Figure 5] is representation and management with 37.5%, displacing laboratory services which slips to third place this year with just 13.1%. Likewise, consultancy services which ranked second last year and accounted for 20.8% of companies’ spend in 2019, drops to 9.1% this year. IT & software moves up one to second place with 16.7% versus 10.6% previously. Spending on training also falls significantly in this year’s poll, from 5.3% to just 1.2%. Figure 5: Services retained by respondents organisation, by value Training 1.2% Information 11.9%

Equipment 2.3% Consultancy 9.1%

IT & software 16.7%

Laboratory 13.1%

Representation & management 37.4% Legal 8.1%

There are major year-on-year changes in spending [Figure 6] in the areas of representation and management, also laboratory: the former rising from 10% in the previous survey to 37% and the latter plunging from 43% to 13%. Investment in IT & software and equipment also rises, but drops for consultancy services.

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Service provider outlook

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Figure 6: Changes in proportion of spending on external services Consultancy

Representation & management

Legal

Laboratory

IT & software

Information

Training

Equipment

% of participants

Equipment added

100% 90% 80% 70%

16%

50%

40%

7% 13%

13%

60%

10%

7% 4%

8% 3% 7%

12%

18%

30%

13%

14%

47%

28%

5% 3%

27%

25%

24%

20%

19% 7% 6%

27%

3% 4%

35%

12%

2% 1%

5% 5%

12%

11%

12% 17%

14%

43%

21%

17%

20% 10%

12%

14% 33%

27%

30% 19%

10%

5% 10%

6% 5%

11%

17%

18%

17%

21%

2011

2012

2013

2014

2015

2016

2017

2018

2019

The volume of work completed on average by in-house teams in 2020 shows a decline versus 2019 for the majority of survey respondents [Figure 7], possibly a reflection of rising workloads and more need to outsource, which is in line with service providers’ aforementioned comments. There is a slight change in views this year with regard to a shift in companies’ approach to internal chemicals management and control over the last five years [Figure 8]. Those firms where the level of integration has remained the same slides to 47% from 51% in 2019 – while the percentage of general management that has taken more responsibility rises four percentage points to 18%.

37%

0% 2010

13%

2020

Looking at frequency of service retention [Figure 9], 29-47% of poll participants use outside assistance occasionally, rather than frequently (5-30%) or permanently (4-19%). Meanwhile, satisfaction levels [Figure 10] have risen to their highest-level ever at 77.9% and those that are dissatisfied are at their lowest since 2013-2014 with just 1.5%. Respondents that are neither satisfied nor dissatisfied are also at their lowest point (20.6%) since 2011. Figure 8: Integration changes at survey respondents organisation over the last 5 years

Figure 7: Percentage of work performed by in-house teams 80-100%

40-60%

60-80%

20-40%

0-20%

35% 47%

% 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%

42.2%

18%

60% 50% 26.7% 25.3% 40% 30%

12.7% 15.2%

20% 10.4% 10% 0%

11.8%

14.9% 11.8%

25.3% 31.4%

8.3%

27.9%

8.2%

6.9%

5.9%

3.8%

4.8%

7.6%

7.4%

6.9%

29.9% 25.6% 25.3% 23.3% 27.3%

30.5%

8.4% 5.5% 9.0% 10.4% 11.4% 3.7% 8.5% 6.5% 4.7% 5.2% 5.1% 5.5% 14.7% 12.3% 8.6% 9.5% 8.0% 7.3%

Level of integration has remained the same General management have taken more responsibilities from separate compliance divisions Separate compliance divisions have taken more responsibilities from general management

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

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Service provider outlook

Figure 9: Frequency of services retained by participants Permanent

Frequent

Occasional

Expertise of key staff 78%

IT & software solutions 19%

22%

Proven experience on similar projects

34%

76%

Information services

In-depth knowledge of country specific regulations 30%

14%

35%

63%

Consultancy/advisory 13%

Availability 55%

46%

27%

Comprehensiveness/accuracy of proposal

Laboratory 11%

54%

39%

30%

Appropriate accreditation/certification

Legal services

52%

12%

Figure 11: Choice factors when provisioning external services

54%

Ability to operate on a global scale

Representation & management 19%

43% Contract price

29%

40%

Training

Recommendation from peers

47%

27%

32%

Other services

ISO9001 or equivalent (quality management)

30%

5% 5%

30%

Equipment 4%

ISO14001 or equivalent (environmental management) 37%

13%

26% Independence of supplier organisation

100%

% of respondents

Dissatisfied

Neither

21%

Satisfied

Figure 10: Change in overall satisfaction levels for respondents % of participants 100% 90%

25% Inhouse equipment/software Proximity to your office 9%

3.1% 2.4% 2.1% 1.5% 1.5% 3.2% 3.1% 3.8% 3.8% 3.6% 1.5%

Large size of supplier organisation 7%

19.3%

80%

24.9% 27.0% 26.1% 26.1% 26.1% 28.9% 29.0% 30.3% 30.7%

20.6%

20%

40%

60%

80%

100%

% of participants

70%

Figure 12: Relationship factors when provisioning external services

60% 50%

Service level agreements in place 40% 30%

77.6%

72.7% 70.9% 72.4% 72.4% 70.7% 68%

77.9% 67.2% 65.9% 65.7%

46% Strict adherence to project protocols 45%

20%

Building long-term relationships with individual staff

10%

41%

0% 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

Expertise and proven experience remain the most important factors when choosing an external service provider [Figure 11]. The large size of an organisation and proximity to the office are regarded as negligible considerations. The first most important relationship factor for survey participants [Figure 12] is having service level agreements in place followed very closely by a strict adherence to project protocols. This is a swap in importance from last year. Building long-term relationships with members of staff remains in third place, unchanged from both 2019 and 2018.

Regularly reviewing (and at times changing) suppliers 28% Suppliers keeping costs as low as possible 27% Regular face-to-face meetings 19% Paying more to get better value 12% Use of penalty clauses 5%

10%

20%

30%

% of participants

Global Service Providers Guide 2021

40%

50%

Service provider outlook

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Over the next 12 months, respondents to the Chemical Watch survey expect the biggest increases in demand for external services [Figure 13] in information and training, at 65% and 63% respectively, which is very little changed on the prior year. IT & software retains third position with exactly the same percentage (56%) as before, with consultancy/advisory down four percentage points at 51%. Excluding the ‘Other’ category, the majority of respondents are anticipating steady demand for legal (66%), equipment (64%) and representation & management (61%), a slight shift from 2019. Looking at demand five years ahead, the ranking slightly alters [Figure 14]. Information remains a top priority at 68% with all services next at 65% and training at 64%. Most service providers expect demand to remain stable for equipment (65%), legal (54%) and representation and management (51%). Drilling down into the specifics of which types of services will be required during the next five years [Figure 15], most forecast increases in the areas of consultancy and advisory services, representation and management, information, laboratory, IT solutions and training.

33%

IT & software 56%

41%

Consultancy/advisory 51%

41%

Laboratory 48%

45%

Representation & management 32%

61%

Legal services 31%

66%

Equipment 26%

64%

31%

68%

Training 32%

64%

Consultancy/advisory 29%

62%

IT & software 40%

57%

Laboratory 44%

50%

Representation & management

12%

Training 63%

51%

64%

65%

10%

Other(s)

Information 34%

27%

65% Information

25%

65%

All services

Equipment

All services 41%

Decrease

33%

Decrease

50%

Static

Legal services

Figure 13: Anticipated need for external sector services in the next 12 months Static

Increase

41%

Within the consultancy and advisory services category, a large share of respondents want help with regulatory interpretation (71%) and product compliance (60%) – their rankings unchanged on last year’s poll – with environmental risk assessment next (57%). With regard to supply chain communication, which slips to fourth from last year’s third place, responses are equally split (49%) between those predicting an increase and those expecting stable demand.

Increase

Figure 14: Anticipated need for external sector services in the next 5 years

10%

86%

% of participants

100%

On a par with responses in 2019, all topics within representation and management are predicted to see a rise in demand. At the top is business process outsourcing (77%), second is Sief/ consortia management (65%) and CLP notification is third (63%). For the information sector, most support is needed for regulatory databases, news and global insights, which makes its debut this year, and regulatory/policy tracking. Environmental monitoring will be the most-requested laboratory service, with ecotoxicology next and physical and analytical chemistry and exposure testing sharing third position. In the IT solutions sector, demand for regulatory information management will see the biggest increase during the next five years (67%), but the majority are anticipating steady demand for laboratory information management (75%) and consortia/ registration management (71%). Looking at the legal/training/other sectors, most respondents expect no change in the level of customer requests for services, for example on insurance, press relations, logistics and emergency response, among others. Higher demand will be seen though for training courses and webinars.

Other(s) 10%

88%

% of participants

100%

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Service provider outlook

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

REACH Applications for Authorisation

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

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

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

Figure 15: Anticipated need for specific external sector services (by service area) for survey participants over the next 5 years Increase

Static

Environmental risk assessment

57%

39%

Chemical safety assessment

57%

41%

Registration strategies

54%

Supply chain communications

49%

Product stewardship

47% 43%

47%

Safer alternatives assessment

42%

51%

Corporate strategy/strategic planning

42%

55%

Data management

42%

56%

Workplace risk assessment (exposure)

42%

53%

Consumer product safety

39%

56%

Health & safety

39%

58%

Health effects assessment

38%

58%

Product safety testing

37%

57%

Assessment of data quality

36%

60%

Testing strategies

35%

60%

Hazard & exposure modelling

34%

Safety of nanomaterials

33%

Occupational hygiene

32%

SVHC advisory services

28%

Data-gap analysis (Qsar)

26%

Chemical transport/warehousing advice

25%

64%

12%

55%

61%

64%

72%

10%

65%

74%

19%

77%

Management (Sief, consortium etc)

65%

CLP notification

63%

Dossier preparation

60%

GHS notification

60%

Registration services

54%

41%

44%

55%

Regulatory/policy tracking

41%

58%

Global news and insights

2% 0%

39%

61%

Regulatory database

Chemical hazard database

50%

49%

(Material) safety data sheets

49%

50%

Managed regulatory content

46%

53%

Environmental monitoring

49%

48%

Ecotoxicology

48%

52%

Physical & analytical chemistry

46%

51%

Exposure testing

46%

50%

Environmental fate & degradation

45%

55%

Human health toxicology

42%

55%

Alternative approaches to testing

42%

55%

SVHC testing

37%

57%

Product testing

34%

61%

2% 6%

66%

31%

Monitoring processes (on-site)

52%

47%

(Material) safety data sheets

33%

67%

Regulatory information management Supply chain communications

43%

56%

EH&S

42%

58%

Inventory management

39%

61%

Supply chain management

38%

62%

31%

Bespoke/in-house training

39%

60%

Training courses/webinars

75%

24%

Laboratory information management

71%

28%

Consortia/registration management

Legal/training/other sectors

49%

Representation (OR, 3rd party etc)

IT solutions

49%

Business process outsourcing (BPO)

Laboratory

43%

Ecolabelling

Product Inspection (on-site)

Information

2% 2%

37%

60%

Product compliance

Representation & management

27%

71%

Regulatory interpretation

Consultancy/ advisory

Decrease

61%

Legal representation (as lawyers)

27%

71%

Emergency response

25%

73%

Lobbying/advocacy

24%

72%

Logistics

23%

76%

Public relations

21%

77%

CPD/CES certified training

19%

Insurance

12% 0%

73%

85% % of participants

100%

www.chemicalwatch.com/SPG

Service provider outlook

Industry trends The primary industry trends driving service providers’ workloads are globalisation and sustainability. Depending on where their core business is located, companies cite all world regions as offering the greatest demand for services, although there is probably more bias towards Europe and Asia. While SCC expects the greatest demand for services in the EU, it nevertheless notices a steady trend and rising requests for international regulatory support, going hand in hand with the increasing number of EU trade deals. Mr Manneveld adds that SCC’s biggest focus in the years ahead will be the impact of chemicals on the environment. “With the EU Green Deal, political climate and consumer interest in environmentally friendly solutions, our customers will need more and more support with alternative assessments, as well as environmental risk and exposure assessments,”he says. Germany’s Chemservice expects that the EU’s Chemicals Strategy on Sustainability will stimulate more work on advocacy and product stewardship. H2 Compliance describes product stewardship as a “hot trend” right now, pointing to the EU Green Deal, Scip requirements and the development of chemical recycling technologies as key examples. “There is an increasing focus on the interconnectedness of waste, chemicals and the environment, which we expect to continue to grow,” says H2 Compliance’s chief operations officer Kevin Hoban. However, Frans Lemaire, product manager at multinational regulatory compliance firm Lisam Systems, believes it is a little early for green chemistry to have a real impact on the service provider sector – maybe in 2022, he says. Nevertheless, he notes that awareness about chemicals and their potential hazards is growing globally. “Consumers are increasingly asking for ‘right-to-know’ information and, as a result, companies are transferring this pressure to their own suppliers,” Lemaire says, adding that customers will be looking for more and more automation in their chemical management systems and will need support for data collection and generating legal documents. German service provider Chemical Check agrees, saying customers will increasingly focus on digital formats in the next

Global Service Providers Guide 2021

five years. The company, which serves the European market, says rising legal requirements and taking over companies’ chemical management liabilities is driving its workload, and predicts the strongest growth for services related to product notifications. The adoption of artificial intelligence, machine learning and blockchain technologies is adding another dimension to the digital trend, spurring companies, including service providers, to expand their capabilities. But, H2 Compliance says that while the biggest opportunities for service providers stem from the global adoption of chemical control laws and GHS, increased digitisation, sustainable products and the circular economy, they also present significant challenges around business and service complexity and software expectations. “Service providers need to develop game-changing service delivery models to integrate with clients for data solutions and build partnerships and networks to offer clients a ‘crystal ball’ and be a single point of contact,” it says. The point about having a single contact or provider is also raised by Verisk 3E and SCC. The former says clients are generally seeking a single provider with integrated data, tools, expertise and services, while SCC adds that customers are less willing to work with multiple providers covering different compliance parts of the product value chain. “Service providers will need to find a way to scale their services to be able to compete on the market,” Mr Manneveld says. Germany’s Chemservice believes smaller service providers might not be able to address the current complexity of regulatory issues, particularly because clients are looking for global solutions, not local ones. “You need to have a critical mass and be able to support globally in different areas of the world,” it says. Customers’ needs will continue to grow in the years ahead and service providers will be challenged to keep up to date with the emerging regulatory landscape around the world, as well as on the minutiae of being compliant in a variety of different markets. As Dr Cleuvers at knoell puts it, being flexible and having sufficient capacity to handle the growth in demand will be key requisites for businesses in the future.

Service provider outlook

Global Service Providers Guide 2021

Careers and salary

CA REERS AN D S AL A RY

What are the prospects for professionals working in chemicals management and control in 2021? After a year of great uncertainty across the globe, what can the annual Chemical Watch careers survey tell us about opportunities for chemicals management and regulatory professionals? Elaine Burridge reports. As businesses grappled with the impact of the Covid-19 pandemic in early 2020, many sectors saw a rapid fall in recruitment activity – not least the chemicals management industry. Wayne Brophy, managing director of UK-based recruitment agency CAST UK says demand almost ceased in the second quarter of 2020 as a result of the pandemic, although it picked up in both the third and fourth quarters. Meanwhile the switch to remote working for many has had an impact on the requirements of employers he adds: “One issue we are seeing is to do with onboarding remote workers. With it being so difficult, we are seeing less demand for trainee managers and a significant demand for skilled and experienced hires,” he says. Founder and CEO of global executive search specialist Chemical Search, Stephen Mothersole, says demand for staff “hit a brick wall” in March and most clients stopped or indefinitely delayed recruitment until the future became clearer and the fate of their own businesses was secure. He says recruitment was viewed as a distraction and shelved even for those companies working with laboratory reagents and products associated with testing, where demand soared as a direct result of the pandemic. In the UK, the Covid-19 impact has been exacerbated by Brexit, not least the issues associated with the country’s decoupling from EU REACH after 31 December 2020. Apart from the decline in demand, filling roles during the pandemic has been equally difficult. “Candidates have understandably been more risk averse to moving [to a new]

employer and the process of interviewing candidates has been hampered by the necessity to remain remote,” Mr Mothersole says. “Most clients are happy to use remote interviewing to a point, but want and need that final face-to-face meeting, especially for more senior appointments. Hence the recruitment process has been extended, in some cases by months.” According to John Sherratt, regulatory affairs business manager at UK-based recruitment specialist VRS Regulatory, while recruitment slowed down last year, underlying demand for people with skills in chemical management stayed fairly constant. Nonetheless, he notes there were more direct replacements than examples of strategic recruitment. Meanwhile, demand for skills in biocides and the EU biocidal products Regulation (BPR) increased due to the large number of products entering the market either for human hygiene purposes, or for disinfecting surfaces, materials, equipment and furniture as a result of the pandemic. Mr Sherratt also points to ongoing high demand for agrochemical registration/risk assessment skills, an area where development programmes are often long term and thus not affected by the pandemic. Turning to 2021, he reports that there has been huge pent-up demand since January with very high volumes of roles available across all sectors – a development which is outstripping the supply of qualified people. Most in demand now, according to Mr Mothersole, are specialist R&D skills associated with new product development, especially in fine chemicals related to biotechnology and bio-related chemicals production. Also, regulatory skills in dealing with www.chemicalwatch.com/SPG

Careers and salary

Global Service Providers Guide 2021

the registration of new products, mainly as a result of REACH decoupling in the UK, and toxicologists. Consulting and market intelligence skills associated with the market tracking of traditional chemicals are currently the least in demand roles. These have been affected by a decreased demand from chemicals manufacturing clients during the pandemic. This will probably improve slowly as the economy gets back on its feet, Mr Mothersole says. At UK-based NES Fircroft, an engineering and technical recruitment specialist, Neil Mellin, director, oil, gas & chemicals, says skills in commercial, sales, business development and account management have been in demand to support future business growth.

Survey results The latest Chemical Watch survey explores the trends and issues highlighted by recruitment professionals in more detail. Unlike last year, there is more of a gender bias. This year 54.3% of respondents were male, compared with an almost equal split previously. The majority of respondents – 35.7% – [Figure 16] categorise themselves as specialists or technicians, while the next biggest group at 25% are project or team managers. Figure 16: Job titles of survey participants Director/associate /partner 12.9%

Key industry trends Looking at key trends in the job market, CAST UK’s Mr Brophy is seeing more clients wanting experienced hires and candidates with data and analytical skills. However, people seem much more cautious about changing employers, he says. As such prospective employees are carrying out significantly more due diligence on the hiring company to ensure they would be going to a stable business. Prospective employees are carrying out much more research on social media, looking at a company’s Glassdoor profile and searching other channels to get a sense of the brand and what it is like to work there. “We are also seeing significant numbers of candidates being ‘bought back’ by their existing employer,” Mr Brophy says as existing employers act to retain their staff. The push towards sustainability is a key trend in the jobs market. Mr Mellin says companies are realigning their focus around sustainability and the circular economy and diversifying their portfolios, for example through new applications in functional polymers and additives. “Circular solutions and ways of developing circular economies are key, with sustainability high on companies’ agendas, which is also impacting on climate change initiatives where Sweden and Finland are leading the way,” he says. During the past 12 months, Mr Mellin has also seen rising demand within the specialty chemicals sector, where there has been an increased focus on sustainability and new technologies, and where companies are increasingly looking at the environmental impact of the products they manufacture. “We expect that demand for commercial professionals will continue into 2021 and beyond as companies continue to invest in decarbonisation to reduce their carbon footprint and focus on ethical products. Substantial [job] opportunities will emerge through the circular economy and bio-based polymers,” he says. Nevertheless, against a forecast of rising demand for suitably qualified and experienced people in chemicals management and control, Mr Brophy says sourcing candidates with the right skills is taking longer and with baby boomers retiring, people are less convinced about pursuing a career in manufacturing. He adds that perceptions about salary and benefits, the working environment, plus the nature of working in the manufacturing sector, can be negative. He says that this “resulting shortage of talent will only increase demand for employees in the long term. Chemicals producers should look to enhance their employer branding, benefits and workforce engagement in general, as well as look to recruit diversely, also recruiting, developing and retaining female employees to expand the talent pool available to them.”

Junior/graduate trainee 5.4%

Officer (government/agency

Specialist/ technician

bodies) 1.3%

35.7%

Project/team manager 25%

Senior manager 19.6%

Most participants to the poll say staffing levels remained static during the past 12 months (62.9%) [Figure 17], which is up on the 55% recorded in the 2020 guide, but there is a significant drop this time on those who see an increase, 28.5% versus 41.4% previously. Figure 17: Staffing trends Increase

Static

Decrease

% of participants 100% 90%

8.6%

3.7%

80% 70% 60%

59.1% 62.9%

50% 40% 30% 20% 10%

28.5%

37.2%

0% Last 12 months

Next 12 months

For the coming 12 months, 59.1% expect no change in employee numbers, while 37.2% predict an increase, which is slightly more than the 34.1% of respondents in last year’s guide. Interestingly, the number of participants expecting staffing levels to drop has shrunk from 11.4% to just 3.7% in this survey. When asked about job security, the majority of survey respondents (70.51%) say little has changed from a year ago, www.chemicalwatch.com/SPG

Careers and salary

both when considering all roles as well as their own, 70.51% and 67.57% respectively [Figure 18]. But fewer respondents say they feel more secure compared with last year’s findings, probably because of the pandemic. Looking back each year to 2012, the number of participants feeling more secure is at a low of 17% [Figure 19]. Figure 18: Job security for survey participants Less secure

Similarly secure

More secure

Responses on job prospects globally in 2020 [Figure 20] show a significant change versus 2019, with only 45% saying they were good, the lowest level recorded since 2012, although 48% say they were stable, up from 37%.

% of participants 100% 90%

12.90%

12.61%

70.51%

67.57%

In terms of career progression [Figure 21], the highest proportion (60.6%) of respondents feel that opportunities are good in the wider jobs market. However, this drops significantly to just 36% when talking about their own companies with the majority (41.9%) saying they are neither good nor bad. But it is noteworthy that more respondents feel progression prospects are poorer in their own company than in the wider jobs market (22.1% versus 4.6%). Overall, the number of respondents who feel that career opportunities are poor in their own companies has declined from 24% in 2018 to 22% in 2020.

80% 70% 60% 50% 40% 30%

There has been little change in job satisfaction levels, as with previous surveys more than half of respondents said they felt satisfied in their work. Those reporting dissatisfaction with their jobs accounted for 11% of responses in the 2020 survey, versus 10% in 2019 and 13% in 2018.

20% 10%

19.82%

16.59%

0% Across all roles

chemicals industry underpins so many industries. Job security in the UK could however be affected if companies offshore new product introductions and manufacturing to Europe or elsewhere, due to the problems caused by the decoupling from EU REACH. While roles may not be physically shifted to Europe, he says it is likely that many new positions in chemicals management will be created in Europe or elsewhere, rather than in the UK, which may affect promotion opportunities and salary progression for those not able to relocate.

In own role

Figure 20: Job prospects globally and in participants country Poor

Figure 19: Year-on-year job security for survey participants

Similarly secure

90%

More secure

70%

100% 15%

10%

13%

12%

13%

54.1%

60%

40%

70%

30%

60% 68%

68%

64%

67%

71%

66%

68%

71%

20%

44.6%

35.6%

10%

40%

30%

Globally

20% 10%

47.9%

50%

80%

50%

10.4%

80%

% of participants

90%

% of participants 7.5%

Less secure

13%

Good

100%

Across all roles

12%

Stable

20%

23%

21%

20%

2012

2013

2014

2015

2016

2017

2018

2019

17%

0% 2020

Commenting on job security, Mr Mothersole says chemicals management jobs are more secure than other sectors since the

Global Service Providers Guide 2021

In your country

Remuneration The highest salaries in this year’s survey were reported by regulators, some earning up to €100,000, followed by product safety/stewardship, regulatory affairs and environment, health and safety (EHS) management, all of which command average salaries of about €72,000-76,000. Those working in occupational hygiene were receiving the lowest salary, averaging about €51,000, unchanged on the previous year’s survey.

Careers and salary

www.chemicalwatch.com/SPG

Figure 21: Career progression Stable

Poor

Good

% of participants 100% 90%

4.6% 22.1%

80%

34.9%

70% 60%

41.9%

40%

20%

60.6% 36%

10% 0% Your organisation

The US is the world region paying the best salaries, with Europe next. In the latest Chemical Watch survey, salaries still favour men, with their earnings averaging €67,988 compared with women, who are averaging €63,896. The 56-60 age group earn the highest average salaries, followed by those aged 61-65. The spread of salaries across all the ages ranges from €36,680 to €91,391 , slightly wider than last year.

50%

30%

pay of €55,603, while service providers, including consultants, laboratories and lawyers came second bottom with average pay of €56,327. One year ago, the highest salaries were to be found in government and agencies, followed by consumer products, cosmetics and similar.

Wider jobs market

By organisation, the top annual salaries are to be found in the engineering, automotive and aerospace industries, where they average €89,600, followed by government agencies at €86,085, then chemicals and life sciences at €76,543. The worst-paying sector is consumer products and cosmetics with average

Recruitment agencies believe the outlook in chemicals management and control is very positive. Prospects remain excellent, says Mr Sherratt, pointing to the growing volume and complexity of the work, as well as its rising profile and importance as regulatory functions become increasingly integrated into business operations. “There is upward pressure on salaries and professional development and continuous learning is as strong as ever,” he says. Mr Mothersole also points to the resurgence of interest in STEM (science, technology, engineering and maths) subjects at university in the UK, noting that the chemicals industry has always suffered from a lack of earlier-stage talent from university, which has led to deficits of talent in middle management. He says: “This may be about to change with a resurgence of interest in STEM subjects at university, but the effect on chemicals management roles will be some years off.”

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Careers and salary

North America

CH E M IC ALS M ANAGE ME N T I N T HE U S

What are the key factors driving US chemicals management activity? While Covid-19 proved a significant driver of activity in the US in 2020, changes to hazcom regulations, heightened TSCA activity, the drive for transparency and state level actions are set to shape the next 12 months. Chemical Watch’s Global Managing Editor, Kate Lowe reports. “I don’t think there is doubt in anyone’s mind that a lot will be done differently under a Biden administration, including TSCA,” Steve Owens, a partner with law firm Squire Patton Boggs and former EPA assistant administrator told Chemical Watch in the run up to last November’s US election. Three months in, the new administration has so far lived up to the expectations that it will bring significant change in its wake – not least for chemicals management. Already tasked with laying out risk management proposals for several substances under TSCA this year, and continuing evaluations for more than 20 others, the US EPA must also now incorporate the priorities of the Biden administration that has called for a review of all EPA actions over the last four years, including: OO

But that’s not to say that TSCA wasn’t a significant area for chemicals management activity in 2020 – far from it.

Key drivers in 2020 Jeff Hafer, senior scientist, regulatory affairs at service provider knoell USA describes pre-manufacture notices (PMNs) and polymer exemptions for new chemicals under TSCA as “the stars of the show” when considering key regulatory drivers. Following the 2016 signing into law of the Frank R Lautenberg Chemical Safety for the 21st Century Act, which reformed TSCA, the process for PMNs changed and the EPA was obliged to make one of the following alternate affirmative determinations on all new chemicals and significant new uses of them: OO

the 2017 rule laying out the TSCA risk evaluation process; five recently completed rules restricting persistent, bioaccumulative and toxic substances (PBTs); and the TSCA evaluation of methylene chloride – and a 2019 ban on the substance’s use in consumer paint removers.

The expectation of heightened TSCA activity in 2021 is clearly reflected in the results of the latest Chemical Watch chemicals management survey, which saw a higher proportion of respondents identifying TSCA-related regulatory developments as key regulatory drivers than in the 2020 survey. While the same proportion of respondents in 2020 and 2021- 55% – identified any US chemicals management activity as a key regulatory driver, the number that identified TSCA risk evaluations as a key regulatory driver rose from 24% to 28% in the latest survey, and the number that similarly identified TSCA new substance notifications rose from 28% to 31%.

Global Service Providers Guide 2021

the new chemical or significant new use presents an unreasonable risk; available information is insufficient or the new chemical or significant new use may present an unreasonable risk or it has substantial production and exposure; or the new chemical or significant new use is not likely to present an unreasonable risk.

The additional complexity that these changes have brought has ensured PMNs have stayed high on the chemicals management activity list. Exactly how this was going to work, “wasn’t anticipated in the language of the Lautenberg Act.” says Mr Hafer. “In enacting it, the things that have fallen out, such as the concept of insufficient information being the only thing needed to stop a PMN review, and the fact that they [industry] have to produce a ‘not likely to present an unreasonable risk’ finding that’s defensible, has really upped the bar for these notifications,” he adds. “People weren’t expecting that and a lot of clients don’t know what to do”.

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Meanwhile, Mr Hafer says, the expertise required to manage this greater level of complexity has been in decline: “There really has been a change both at the EPA and in the industry with people retiring. There’s been a huge loss of experience and knowledge about these things and understandably new folks coming in not having the history, not having the background, they are just perplexed as to what’s going on.” Other areas that continued to be big drivers of activity in 2020 included California’s longstanding law, Proposition 65, which requires businesses to provide warnings, typically in the form of labels or signs, for exposures to chemicals that cause cancer or reproductive harm. Says Bernie Henn, supplier development manager at global intelligent compliance solutions provider Verisk 3E, “Prop 65 has been a strong force because it’s been enforced. And we’ve worked a lot with that in our services, as well as our supply chain compliance, gathering that data.”

Impact of Covid-19 But one of the biggest drivers of new chemicals management activity in 2020 was without question, Covid-19. Mike Harvey, president of safety data sheet (SDS) and label services company Nexreg Compliance describes the rush to meet the sudden market demand for consumer products: “During those first few months of the pandemic we were getting calls every day with people looking for advice on selling hand sanitisers and disinfectants specifically. Up until that point we typically only had a few requests for those products during a year.” “Coupled with that we also saw an increase in SDS requests for those products. Many companies were taking advantage of US and Canada interim policies for hand sanitisers in order to get them to market because of the increased demand – so we saw companies eager to get those SDSs out as soon as possible,” he adds. Lynn Bergeson, owner and managing partner of specialist law firm Bergeson and Campbell says in 2020 the firm saw double digit increases in work falling under the Federal Insecticide, Fungicide, and Rodenticide Act (Fifra): “There was an astonishing explosion of innovation, of wanting to repurpose chemicals that were approved for uses as antimicrobials and biocides, and the latest applications that could be utilised to address Covid-19 – the whole EPA ‘List N’ opportunity [disinfectants effective against Covid-19].” Bernalyn McGaughey, president and CEO of regulatory consultancy Compliance Services International also reports experiencing a “flood of companies wanting to register products on the antimicrobial market” as a result of Covid-19. “So we’ve had a lot of work to do there”. Meanwhile, Karen Lintz, UL’s managing director of regulatory assurance and data insights, says that the pandemic expedited existing trends in the market – in particular, the need for faster information: “What the pandemic did was it accelerated drivers that were already there, for example supply chain transparency, but also the need to get to market as quickly as possible.” She adds: “Companies are needing information sooner when they are doing new product development, they need it delivered to them in a way that is easy for them to consume, easy for them to understand and works with their systems.” “Companies are needing information sooner when they are doing new product development, they need it delivered to them in a way that is easy for them to consume, easy for them to understand and works with their systems.”

Key drivers in 2021 Turning to the key drivers of chemicals management activity in 2021, it is clear the impact of the pandemic is set to continue.

Global Service Providers Guide 2021

“I don’t see that abating at all,” says Ms Bergeson. “Even if the pandemic is brought under control in quarter four 2021, the fact that people are just really, really mindful of the next pandemic, or variations on a theme of Covid-19, has sparked a lot of innovation in this space.” Ms Lintz agrees: “Cleaning products, disinfecting products, certainly will continue to be important even as we see the pandemic is beginning to abate. That is something consumers will continue to be very sensitised to now and that is going to drive new research into those types of products and then new requirements regarding how you determine if they are suitable for use, do they work as intended.” Meanwhile manufacturers producing those kinds of products will need support, says Ms Lintz. “Are they meeting the very specific labelling requirements for those kinds of products, are they communicating the use correctly in the right sector? That for me is still going to be a very important area and that will require more information in the supply chain...Brand trust, that trust of the claims on the label, has it been verified, has it been tested, by an independent party – those are things which will continue to be important.”

Heightened TSCA activity Beyond the pandemic, there is little doubt that the impact of heightened TSCA activity driven in part by a new administration with fresh priorities, will be clearly felt by product stewardship professionals this year. Most recently, on 25 March, Michal Freedhoff, acting assistant administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP) revealed at Chemical Watch’s Key Regulatory Updates conference that the EPA will revise its new chemicals review approach under TSCA to “better align” the decisionmaking process with the law’s requirements. Her announcement confirmed expectations that the Biden-Harris EPA will be taking a close look at new chemical reviews and plans to resume an Obama-era trend of issuing consent orders on a larger proportion of pre-manufacture notice (PMN) reviews. “Starting today and in the coming weeks and months, EPA will be revising its review efforts for new chemicals to restore the important gatekeeper role that this part of TSCA plays in ensuring the safety of new chemicals before they first enter commerce,” Dr Freedhoff said at the event. Interviewed before the plans were revealed, knoell USA’s Mr Hafer said it was expected that the EPA was, “going to become much more prescriptive and clear about what makes a satisfactory notification with sufficient information. “What is going to come out of that is if you don’t provide a very robust package with sufficient information, it’s just going to be rejected.” With regard to existing chemicals, TSCA risk management proposals for several substances are due this year as the EPA continues its evaluations for more than 20 others – all the while incorporating the new priorities of the Biden administration. “New policies are going to emerge which will have a substantive impact on risk evaluation for industrial chemicals and agrichemicals because of exposure to marginalised environmental justice populations. That is something that businesses and trade associations are mindful of, and anybody in the space needs to be mindful of, and should comport their operations accordingly,” says Ms Bergeson. “Because the administration is as forward thinking as it is, that is an area where businesses need to be a little more committed,

North America

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anticipating how these changes are going to be driving their business operations,” she adds. “Any workplan chemical should be the subject of intense review internally now – whether you are part of a risk evaluation process or not.

State-level legislation While California’s Proposition 65 was cited as a key regulatory driver by a slightly lower percentage of respondents in this year’s Chemical Watch survey (from 36% to 31%), it remains the “grandfather of state initiatives” says knoell’s Mr Hafer – and one that has always been a challenge. That looks set to continue in 2021 with proposals announced in January by California’s Office of Environmental Health Hazard Assessment (Oehha) to limit the use of ‘short-form’ warning labels on consumer products under Proposition 65. Current regulations allow businesses to use a simplified message consisting of the warning symbol, language indicating the endpoint of the exposure – such as “cancer” or “reproductive harm” – as well as the web address for the scheme. Oehha said this was intended to only be used for small products or containers with insufficient space for the longer warning, but that it had been used on a wide range of consumer products with more than enough label space. The proposal was met by a call in March for its withdrawal from a coalition of more than 100 industry groups who believe it will “inject confusion into the market and impose substantial financial burdens and additional litigation risks on businesses at a time when they can least afford it”. Another state level development that could drive additional activity this year is California’s Cleaning Product Right to Know Act. The final measure’s online disclosure requirements took effect on 1 January 2020 – and the labelling mandates on 1 January 2021. Mr Harvey at Nexreg Compliance says that “not all industry members are aware of requirements until they are audited – especially smaller, but sometimes medium-sized, companies. We’ve been trying to spread the word about the Cleaning Product Right to Know Act and about how clients proactively need to meet these requirements. We now expect an uptick in terms of service demand for 2021.” Another area that has seen an upturn in state-level activity in 2020 and could see more in 2021 is the restriction of per- and polyfluoroalkyl substances (PFASs). Ms Bergeson says that PFASs “could be much more a consideration at the state level because of contamination hotspots that will drive the agenda there. Less so in states that are not PFAS-challenged.”

Hazcom regulations The last week of December 2020 saw Health Canada publish a draft regulation updating its Hazardous Products Regulations (HPR) that govern the classification, labelling and preparation of SDSs for hazardous products. The update will see the country’s Workplace Hazardous Materials Information System (WHMIS) move to the seventh revised edition of the UN’s Globally Harmonized System (GHS) of classification and labelling of chemicals from GHS 5 – and usher in requirements, including for companies to update their SDSs. While organisations will have time to complete this work, says Nexreg Compliance’s Mr Harvey: “We like to spread the word and get companies on this early so they are not caught off guard in 2023.” The message does appear to be getting out: this year’s Chemical Watch survey saw WHMIS cited by 14% of respondents as a key regulatory driver – up from 9% in 2020.

Next up is the US. Six weeks after Health Canada published its draft regulation, the US Occupational Safety and Health Administration (Osha) also proposed changes to its Hazard Communication Standard (HCS) that would see it conform with GHS 7. The two countries created the US-Canada Regulatory Cooperation Council (RCC) in 2011 to reduce “unnecessary” regulatory differences. Last March, the RCC laid out plans for the US and Canada to coordinate efforts on the implementation of GHS and interpreting SDS and labelling requirements. Verisk 3E’s Bernie Henn describes the SDS updates that will be required in both Canada and the US as a result of the move to GHS 7 as “the biggest thing that I see” with regard to the key drivers of chemicals management activity in 2021. “That is a major change so companies that have been perhaps a little bit complacent – or perhaps those smaller companies where there is just the inability to get to that higher level of compliance – we’re going to see a strong need for a company like Verisk 3E to help them through and and renew closer to that goal of 100% compliance.” Mr Henn’s comments on the significance of the changes are clearly echoed by the Chemical Watch survey which saw 23% of respondents cite the hazcom standard as a key regulatory driver in 2021, up from 16% in 2020: the biggest jump of any US related activity uncovered in the results. With this in mind, and other developments regarding workplace protection, Ms Bergeson is also expecting to see an uptick in Osha work: “The Department of Labor can be expected to be reinvigorated by this administration.” Meanwhile Covid-19 and the challenges the pandemic is creating for employees returning to the workplace means not only should companies be expecting a greater focus on Osha compliance, but also on meeting standards that address the invisible threat to the workplace from the virus says Ms Bergeson: “I would expect renewed work in that area both in the enforcement area, and also in innovation, PPE and ways of ensuring workers and working environments are safe.” The findings of the Chemical Watch survey this year again underline this message with some 32% of respondents citing occupational health as a key regulatory driver over next 12 months. The result makes occupational health the top regulatory driver of chemicals management activity in 2021 with respondents placing it even higher than TSCA activities.

Push for transparency Other key drivers of chemicals management activity expected to feature consistently this year include the push for more transparency. “We will continue to see pressure from consumers, manufacturers or retailers, for more transparency in the supply chain,” says UL’s Karen Lintz: “The flexibility of the supply chain is key and paramount in many ways and certainly the pandemic has really brought this into sharp focus for everybody – we’ve all experienced the empty shelves and the challenges for manufacturers around finding new suppliers for the things that they need. But even with all of that, they still need to meet the compliance requirements and the regulations,” she adds. “Consumers want to know what is in a product, is it going to work, is it good for me and my family, and suppliers, retailers and manufacturers must respond to that – so transparency, data collection and data sharing will continue to be a very prominent part of regulatory work going forward.” Helping to drive that push for transparency are the activities of NGOs. Says Mr Henn: “Our strong base in retail is telling us that the Mind the Store campaign matters, being publicly shamed with an F grade on an NGO’s rating is very important to them. Because the consumer has visibility of that through the internet.” www.chemicalwatch.com/SPG

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Laboratory testing

LA B ORATO RY TES T I N G

How is the market for laboratory testing services shaping up? Chemicals policy developments, regulatory changes, the Covid-19 pandemic and a more ‘risk averse’ culture are all playing their part in driving demand for more testing services, says Emma Davies. Demand for lab testing services looks set to continue its rise for the foreseeable future. In Europe, this rise is fuelled partly by Echa’s drive to ensure REACH registration dossiers are upto-date and in compliance. Increased testing is also anticipated as a result of proposals in the EU’s new chemicals strategy for sustainability. Meanwhile, a raft of rules and regulations coming into force in China this year is also expected to push up demand for testing. The European Commission’s chemical strategy is part of the EU’s zero pollution ambition – a key commitment of the European Green Deal. It sets the EU on a course to a sustainable and circular economy by 2050. The strategy includes a plan to accelerate the development and uptake of methods to generate information on endocrine disrupting chemicals (EDCs). It also proposes new hazard classes and (EDCs) in the EU’s classification, labelling and packaging (CLP) Regulation – and for chemicals with environmental mobility, persistence, bioaccumulation and toxicity. The Commission has vowed to take a “zero tolerance” approach to non-compliance in regulations. Last year it adopted new EU-wide deadlines meaning that industry must add any new relevant information to their REACH registration dossiers “without undue delay”. It has set deadlines of up to 12 months to update dossiers, for example when a substance’s classification and labelling changes. In China, MEE Order 12 Provisions for the Environmental Management of New Chemical Substances came into effect on 1 January, with new registration types and data requirements for chemical substances. The final technical guidelines for the environmental risk assessment of chemical substances are expected soon. These will be essential for

industry to prepare new chemical substance registration dossier and environmental risk assessment reports. “There’s now a different mindset towards industrial chemicals in China, with new guidance in place, so the testing will change for that too,” predicts Jeannette Paulussen, head of regulatory affairs at Charles River, a global contract research organisation. In particular, complying with this new guidance will initially involve more ecotoxicity testing, she says.

Environment testing surge Half of respondents to Chemical Watch’s chemicals management survey looking into key regulatory drivers and sector trends, predict that the need for external lab services will continue to grow over the next five years. For lab testing companies, the highest expected increase is for environmental testing and ecotoxicology. Antonio Conto, managing director at Italian regulatory affairs company Chemsafe, has already noted a marked increase in demand in tests for reproductive toxicity and environmental toxicity, which he attributes largely to Echa’s focus on updating REACH dossiers, as well as the EU chemicals strategy. Charles River, which provides a wide range of laboratory services, has seen similar increases in environmental toxicology studies. The increase mainly covers more complex methods such as measuring bioconcentration and longterm and/or reproductive toxicity, according to Dr Paulussen. Meanwhile, testing required under REACH is also pushing up the number of higher-tier toxicity studies in rodents, including 90-day toxicity tests, developmental toxicity studies and extended-one generation reproductive toxicity studies (Eogrts), Dr Paulussen says.

www.chemicalwatch.com/SPG

Laboratory testing

In some respects, the move to more higher-tier studies can be thought of as redistributing efforts, suggests Kevin Scase, director of chemistry at Charles River’s site in Den Bosch, the Netherlands. “In the past we perhaps had more, smaller studies on more compounds and for every compound we would need to develop a method. Now we have bigger studies, but maybe only on one compound and maybe the method already exists because of previous testing,” he says. The increased number of toxicology tests also drives up analytical chemical tests. “They go hand in hand so we see an increase in demand for chemistry because there is an increase in demand for toxicology or ecotoxicology,” he says. One growth area at Charles River is in silico work, including models using quantitative structure-activity relationships (Qsars). “In the past, we used the models mostly for pharmaceuticals, but we now see that there’s also an increase in chemicals and agrochemicals,” says Dr Paulussen. Eurofins Regulatory Science Services (ERSS), a division of Eurofins, provides global product development and technical support services to help companies meet regulatory needs. Demand has been such that ERSS has set up a REACH “competency centre” offering “one-stop-shop” solutions to help chemical companies meet requirements. Partly as a result of the EU’s chemicals strategy, which focuses on safety and sustainability by design, “much of the chemical manufacturing supply chain is requiring biodegradation data for products”, says Christoph Grondal, head of business development and strategy at ERSS (Europe). It has already seen a “commensurate growth” in voluntary biodegradation testing. ERSS has also observed two “major changes in study requests driven by Echa” over the past year, he says. Firstly, it too is seeing requests for environmental safety and higher tier toxicology data tests to be completed in accordance with REACH requirements. Secondly, data for assessing the biodegradability of complex mixtures using a simple measure of total organic carbon is increasingly being “rejected” by Echa, adds Dr Grondal. Instead, ERSS is seeing requests for “high-end” analytical tests to be carried out on substances of unknown or variable composition, complex reaction products or of biological materials (UVCBs) and compounds with low water solubility. As a result, ERSS expects a “strong increase” in environmental safety studies with analysis tailored to specific test substances, he says.

Testing for EDCs For a while now, Charles River has been carrying out more tests to detect potential endocrine disrupting chemicals, particularly since the Commission adopted criteria and guidance for EDCs in plant protection and biocidal products in 2018. With the chemicals strategy bringing a renewed focus on EDCs, the company is keeping a close eye on the regulatory situation. Both ERSS and Charles River are switched on to EU proposals to register polymers under REACH. Dr Grondal describes the increased scrutiny of polymers as an “exciting emerging area for developing further capacity and capabilities”. “There is a lot of discussion going on in industry,” says Dr Paulussen. In June 2020, consultancy groups Wood and Peter Fisk Associates (PFA) compiled a report for the Commission detailing “scientific and technical support” for developing criteria to identify and group

Global Service Providers Guide 2021

polymers for REACH registration. The Wood-PFA report “sets the stage for increased testing across a variety of needs including aquatic toxicology, environmental fate and biodegradability and physical and product chemistry,” says Dr Grondal. Where possible, most contract research organisations carry out non-animal tests, particularly for skin and eye irritation, skin sensitisation and for testing for EDCs. “We invest heavily in alternatives. At this moment, for instance at our facility in Den Bosch we are rebuilding our entire canteen into a new in vitro laboratory,” says Dr Scase. Charles River is involved in discussing and commenting on draft alternative test guidelines at OECD level. It also co-funds and takes part in a consortium for a new Dutch alternative testing project called the Virtual Human Platform for safety assessment, which envisages a future in which animals will not be needed to assess the safety of chemicals and is led by Juliette Legler at Utrecht University.

Impact of Covid-19 The Covid-19 pandemic has generally pushed more work towards testing companies. For example, Chemsafe is now doing more testing in the biocides and pharmaceutical sectors. The increase in work in this area can be expected to continue for at least the next two to three years, says Dr Conto. Charles River has also been involved in tests for Covid-19. “Being such a big company, we are still able to manage all of the testing alongside everything else,” says Dr Scase. “We are able to maintain our required output and meet the expectations from our clients so that’s something we are very proud of ... We are expanding our teams, we are expanding our space and we are expanding our equipment to meet the demand at the moment.” He considers that clients see the company as “a very trustworthy partner that is very stable and reliable, even in this moment of time”. Meanwhile, ERSS has seen “increased registration activity” for disinfectants fuelling demand for product chemistry testing, says Dr Grondal. “Cautious contingency planning and a novel pre-emptive contract tracing programme allowed ERSS staff to continue providing timely service throughout the Covid-19 pandemic,” he says. “Whilst we believe that the recent Covid-19 pandemic has delayed some testing programmes, we are seeing these scheduled in 2021 through 2022.” ERSS benefited from being part of the Eurofins group, he adds. Eurofins was able to draw on its scientific experience to develop a range of SARSCoV-2 tests and set up an initiative called SAFER@WORK. The initiative includes testing for the virus in wastewater and on all types of surfaces in the workplace. It also tests worn masks – and employees where necessary. Covid-19 has thrust science into the public arena at a time when society is becoming more aware of health risks posed by certain groups of chemicals. As consumers become more sensitive to “green” products and ingredient lists, companies are increasingly testing voluntarily to support marketing claims and to differentiate products, says Dr Grondal. “Society as a whole is moving towards accepting less and less risk,” says Dr Scase. “This means that there is an increase in safety testing and subsequently more analytical support and more chemistry requirements.”

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Asia

CH EM IC AL S M ANAGE ME N T I N A S I A

What will shape Asia’s busiest jurisdictions for chemicals management in 2021? Updated legislation and the introduction of new regulations are bringing fresh obligations for companies operating in the jurisdictions of South Korea and China. Vanessa Zainzinger reports. A wave of changes has been rippling through Asia’s chemicals management landscape and it shows no signs of slowing. New legislation and standards, overhauls of existing rules and regulations are bringing new obligations for companies. Nowhere is this regulatory activity more prevalent than in South Korea. A third of respondents to the annual Chemical Watch chemicals management survey named the region’s K-REACH law as a key regulatory driver for the year ahead, making it the top driver in Asia. Implementation of South Korea’s flagship law reaches a milestone this year, when the first registration deadline for substances used in volumes of 1,000 tonnes or more a year will arrive on 31 December. More than 17,000 substances have already been pre-registered under the law, with hundreds more being added even after the pre-registration deadline in June 2019. K-REACH makes joint registration mandatory and, although optional, most companies will have now joined the country’s substance information exchange forum, known as CICO, to find co-registrants. Businesses can choose a lead registrant (LR) using the election function on the CICO platform. After this, the consortium can proceed with full registration of the substance and the LR can send letters of access (LoAs) to other registrants at the end of the process. Bryan Zhou, senior regulatory consultant at product safety and chemical management consulting firm Chemical Inspection and Regulation Service (CIRS) is seeing many lead registrants working on their dossiers now. “As far as we know, most consortia are working on collecting exposure scenario information to develop chemical safety reports and prepare registration dossiers. Our K-REACH team is very busy with handling different projects for clients now,” he says.

For substances manufactured or imported at 10 tonnes or more per year, the submission of a chemical safety report (CSR) is required as part of the registration process. The CSR documents the information on risks associated with the substances as well as descriptions of how to handle and control them. It is the key source from which a registrant provides information to all users of chemicals through the exposure scenarios. Ingrid Sekki, chief marketing officer at regulatory compliance consulting firm REACHLaw has seen few requests for help with K-REACH registrations so far, but expects a rush later in the year. “Companies will generally react closer to the registration deadline. Later this year, the requests for K-REACH will no doubt be coming in,” she says. Currently, her clients are mostly requesting help with Bureau of Indian Standards (BIS) licences for chemicals which are under a mandatory certification scheme.

New GHS standard But the law is not the only regulatory driver in South Korea this year. The country implemented a GHS standard from 16 January, that introduced an official classification and use category, and the obligation to provide safety data sheets (SDSs) for hazardous chemical products. This is keeping Mr Zhou at CIRS busy. He advises companies to ensure they update their existing SDSs in time. The grace period for updating an existing SDS and complying with the SDS submission obligation is mainly based on the annual tonnage band. For hazardous chemical products, companies in the supply chain also need to negotiate which company will submit the SDS to South Korea’s Ministry of Employment and Labour (MoEL). This must be done by either a local Korean importer or a foreign manufacturer (via an only representative). For SDS submission, the full composition is required.

www.chemicalwatch.com/SPG

Asia

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Mr Zhou notes that if a company needs to apply for confidential business information (CBI) protection, it will also have to submit its application to the MoEL for approval. Finally, for foreign companies that need to appoint a local OR, Mr Zhou notes it will take about seven working days to receive OR approval from the authorities. Meanwhile, regulatory consultant, SCC (Scientific Consulting Company) has seen an increase in questions surrounding the Consumer Chemical Products and Biocide Safety Management Act (K-BPR). The biocides legislation will continue to be a focus throughout the year, says Gijs Manneveld, SCC manager for international business. The K-BPR, which came into force on 1 January 2019, requires companies to obtain approval for substances and products before they can manufacture or import them. Companies need to pre-report substances in order for them to be designated “existing” and to gain a grace period for submission of a full application for approval. One and a half years before the end of the respective grace period, approval dossiers have to be submitted to the Ministry of Environment (MoE). The first of these dossier deadlines – for disinfectants, algicides, rodenticides, insecticides and repellents – is 30 June 2021. Mr Manneveld flags a second driving force behind the uptick in questions around the K-BPR – Covid-19. Due to the pandemic, there has been a significant increase in demand for regulatory support related to the sale of disinfectants which are in scope of the biocides law, he says. This trend goes beyond South Korea, with Asian companies asking for help to bring their disinfectants to the European market, he adds. However, the main driver for specific services in 2021 “will remain upcoming regulatory deadlines or changes in legislation requiring companies to act, such as K-REACH, K-BPR and the latest regulatory changes in China,” Mr Manneveld says.

Focus on China China’s regulations followed hot on the heels of South Korea in the Chemical Watch survey, with 31% of respondents naming them as a key driver. This is hardly surprising: China kicked off 2021 at a rapid pace with a raft of rules and regulations coming into force – and more is expected as the year rolls on. The MEE Order 12 Provisions for the Environmental Management of New Chemical Substances replaced MEP Order 7 and officially came into effect on 1 January with new registration types and data requirements for new chemical substances. The Regulation governs all new chemicals in the country and will work in tandem with the overarching Regulations for the Environmental Management of Toxic and Hazardous Substances when the latter is finalised. Like MEP Order 7, the MEE Order 12 requires new chemical substance notifications, but strengthens the management of persistent, bioaccumulative and toxic (PBT) new chemicals and reduces requirements for some polymers of low concern.

Companies eyeing new chemical registrations in China are most concerned about the notification of polymers, says Piyatida Pukclai, regulatory policy director for Asia-Pacific at knoell. Polymer registration is always of crucial concern for the chemical industry and the final rules for compounds are not yet entirely clear. Draft guidelines propose to exclude certain types of polymers from the filing, qualifying them instead for “simplified registrations” or “regular registrations” depending on the annual volumes requested by the registrants. The final technical guidelines for the environmental risk assessment of chemical substances were published in January 2021. The guidelines are essential for industry to prepare new chemical substance registration dossier and environmental risk assessment reports. For most substances, the key point is to identify whether they have PBT properties. This is the biggest departure from MEP Order 7, says Dr Pukclai. Registration, approval and risk management of PBT substances are challenging and costly, as is their identification, she says. Data requirements differ based on the PBT properties of a substance. High hazard chemicals above the 10 tonne band can be subject to time-consuming 90day toxicity, toxicokinetic and carcinogenicity tests. Service providers are also flagging new standards that limit the volume of volatile organic compounds (VOCs) as a priority for their clients in 2021. China’s State Administration for Market Regulation (SAMR) and the Standardisation Administration of China (SAC) approved five new standards last year that limit the volume of VOCs and other substances that can be used in coatings, adhesives, printing inks and cleaning agents. The standards for marine coatings and interior floors were approved on 31 December 2019 and came into force on 1 July 2020. The remaining standards were approved on 4 March 2020. All came into force on 1 December 2020 with the exception of the standard for printing inks which will come into force on 1 March 2021. “Most companies are only now learning about these standards since they are really new,” says Mr Zhou from CIRS. “It’s important to learn about the system, as the standards differ by industry. Most of all, companies which are involved in industries of coatings, adhesives, ink and cleaning agents have to pay attention,” Mr Zhou says. Once the standards are in effect, downstream users can request testing reports when purchasing chemical products from their suppliers. If the products are imported from overseas, importers need to make sure all products are compliant under China VOC standards and may request the testing reports from foreign manufacturers, Mr Zhou says. The next year looks set to be a busy one for regulatory developments across Asia, with rapidly changing demands on companies driving what support they need to stay compliant, says Dr Pukclai from knoell. “Chemical companies are being asked to manage more products, navigate more regulations, and do it more transparently,” she concludes.

www.chemicalwatch.com/SPG

Asia

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EU chemicals strategy for sustainability

EU CH EM IC AL S S T RAT E GY FO R SU STA I NA B ILIT Y

What developments can industry expect in the EU’s chemicals strategy for sustainability in the near future? Several of the strategy’s aims are set to be completed by the end of 2021, including a proposal to introduce new hazard classes under CLP, says Europe reporter Kathryn Carlson In October last year, the European Commission unveiled its chemicals strategy for sustainability, the biggest update to EU chemicals regulation since the rollout of REACH in 2007. The strategy lays out more than 50 actions to be implemented by 2024, including: OO

the introduction of generic risk assessment for hazardous chemicals; extra controls on consumer products; and targeted actions on substances of concern such as endocrine disrupting chemicals (EDCs) and per- and polyfluoroalkyl substances (PFASs).

Several of the strategy’s aims are set to be completed by the end of this year. One of the most significant actions to come is a proposal to introduce new hazard classes under CLP, giving the Commission the mandate to initiate harmonised classifications. Originally set to be completed by the end of 2021, the Commission has now pushed back its projected schedule for this revision, with a draft proposal now set for 2022. A Commission source told Chemical Watch recently that the timeline could still change, particularly during the upcoming inception impact assessment (IIA) roadmap for the revision. The new hazard categories will apply across all legislation pertaining to chemical controls and will cover: OO

Categorisation of EDCs has proved controversial, with industry advocating continued controls under REACH rather than CLP, and for hazard categories under CLP to remain aligned with the UN’s Globally Harmonized System (GHS) of classification and labelling of chemicals. The Commission has said it may apply the approach used for carcinogenic, mutagenic and reprotoxic substances (CMRs) – with categories for ‘known’, ‘presumed’ and ‘suspected’ substances – to EDCs under CLP. The proposal will affect anyone who manufactures or uses substances that will fall into the new hazard categories. For EDCs, especially for suspected EDCs, the exact substances a potential hazard classification could cover may not yet be known.

Roadmap to prioritise substances of concern for REACH restrictions The chemicals strategy also proposes a roadmap that will categorise ‘substances of concern’ for restriction under REACH. These will cover: OO

CMRs;

EDCs;

PBT and vPvB substances;

immunotoxicants;

neurotoxicants;

substances toxic to specific organs; and

respiratory sensitisers.

endocrine disrupting chemicals (EDCs); persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances; and persistent, mobile and toxic (PMT) substances.

Group restrictions may also be proposed.

www.chemicalwatch.com/SPG

EU chemicals strategy for sustainability

The roadmap is expected in 2021, setting out which restrictions the Commission plans to introduce, and the restrictions will be adopted through the comitology process. As this is not subject to approval by the EU institutions, updates can be passed more quickly.

Update to information requirements for the identification of EDCs The Commission and EU member states have stepped up efforts in recent years to combat EDCs, with France and Belgium unveiling national action plans. The Commission is now proposing EU-wide measures for the identification of the substances, which would introduce new data requirements identifying EDCs in registered substances. The updated information requirements for chemical registration are set to be rolled out across many major pieces of legislation. In the annex to the chemicals strategy (also known as its action plan), which outlines key dates for the implementation of specific actions, the Commission says that in 2021, data requirements will be included in the annexes of the biocidal products Regulation (BPR) and the plant protection products Regulation (PPP). In 2022, the data requirements are set to be introduced in REACH, the food contact materials Regulation and the cosmetics Regulation. For REACH, the updates will be introduced through the comitology process. Initially, the new information requirements will affect actors in the biocides and pesticides sectors. From 2022 the requirements will affect the majority of manufacturers and users of hazardous chemicals. As with many issues concerning EDCs, particularly suspected EDCs, the exact scope of any future identification is not yet known. Industry has warned that lab availability could be an issue, as registrants including SMEs attempt to meet increased information requirements. Cefic has pressed for low-tonnage producers to be exempt from EDC-specific testing.

Legal requirements on substances of concern in products The sustainable products initiative, part of the European Green Deal that also includes the chemicals strategy, will broaden the scope of the 2009 Ecodesign Directive, applying broad sustainability requirements – including chemical restrictions – to a large range of products. The initiative’s roadmap also proposes information requirements, digital ‘product passports’, and the tracking of hazardous substances in the manufacturing process. According to the Commission’s action plan for the implementation of the chemicals strategy, legal requirements for substances of concern in products, including PFASs, will be introduced under the sustainable products initiative in 2021–22. A public consultation was launched on the future Directive on 17 March, with the legal text expected to be adopted in the fourth quarter. Sustainability requirements are set to affect anyone who uses substances of concern in product manufacturing. Information requirements, including a digital ‘product passport’, will affect merchants, including online retailers.

Global Service Providers Guide 2021

Creation of ‘essential use’ and ‘safe and sustainable-by-design’ criteria The concept of ‘essential use’ of hazardous chemicals is a cornerstone of the new chemicals strategy. The Commission aims to restrict chemicals in future based on whether their use is considered ‘essential’ to society. Commission officials have said the definition could be decided by a chemical’s hazard properties and potential for substitution. Under the strategy’s action plan, the creation of essential use criteria is scheduled for 2021–22. The process for determining criteria will be drawn up this year, officials said. If the Commission follows through on the strategy’s aims, the criteria will eventually apply to authorisations and restrictions for a wide range of hazardous substances, especially those used in consumer products. The concept will ultimately affect all manufacturers and users of hazardous chemicals. In its first stages, the Commission has identified consumer products as a priority, including food contact materials (FCMs), toys, childcare articles, cosmetics, detergents, furniture and textiles, so actors in these sectors are likely to be the earliest affected. As for ‘safe and sustainable-by-design’ criteria, which will factor into a wide range of chemicals legislation in the coming years, the Commission says it will draw up the criteria in 2022. Industry has called for the criteria to include a harmonised hazard assessment methodology and measures to aid full disclosure of ingredients along the supply chain. Discussions have already begun, and as of 2021 the Commission aims to establish key performance indicators (KPIs) to map the transition towards production of these chemicals, any skills mismatches and competence gaps, and to roll out financial support for their development, commercialisation, and uptake of substances, materials and products that are ‘safe and sustainable-by-design’.

Creation of ‘one substance, one assessment’ process and mixture assessment factors under REACH The Commission action plan says a ‘one substance, one assessment’ process, which will coordinate risk assessment of chemicals across all chemicals legislation, will be established “as of 2021”. Under ‘one substance, one assessment’, each chemical registered under a variety of chemicals legislation would be subject to one overall hazard assessment procedure, with the data shared between regulatory agencies, although a Commission official said that different assessments could be needed to satisfy the requirements of different pieces of chemicals legislation. Officials have said that various agencies could work together on risk assessment for the process – for instance, with Echa assessing general exposure and the European Food Safety Authority (Efsa) assessing dietary exposure to certain substances. The strategy’s action plan said the process will be established using a public authorities coordination tool (PACT), an expert group and a Commission coordination mechanism. The Commission will also work on introducing a mixture assessment factor (MAF) under REACH. This would take the combination effects of different chemicals into account in the risk assessment process.

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EU chemicals strategy for sustainability

The action plan states that one or more MAFs will be introduced into Annex 1 of REACH in 2022 using the comitology process. An impact assessment is expected to be launched in 2021. The hope is that ‘one substance, one assessment’ will eventually involve all the EU agencies that assess chemicals – Echa, Efsa and the European Medicines Agency (EMA). Industry supports the idea, with Cefic saying the process could result in big efficiency gains in registration.

Introducing the MAF concept to REACH could raise the risk profile of many mixtures, meaning that more would be considered of significant risk. Registrants could also need to update their dossiers to take this into account. The planned 2021 impact assessment will reveal more about which sectors are set to be affected the most heavily.

Key developments By the end of 2021 OO

Roadmap to prioritise substances of concern for REACH restrictions

Updates to information requirements for EDC identification in the BPR and PPP

Process for determining ‘essential use’ criteria drawn up

‘One substance, one assessment’ process drawn up

Discussions on the development of safe and sustainable-by-design criteria for chemicals

Impact assessment for MAFs under REACH

Public consultation, adoption of updated ecodesign Directive

Commission to set up a ‘high level roundtable’ of stakeholders to monitor the impact of the strategy’s actions and promote efficiency of chemicals legislation Commission to establish key performance indicators (KPIs) to measure the industrial transition to production of safe and sustainable chemicals

Developments by substance OO

Proposal to amend hazard classes under CLP – EDCs, PBTs and vPvBs, and persistent and mobile substances – 2022 Creation of a roadmap to prioritise substances of concern for REACH restrictions – CMRs, EDCs, PBT and vPvB substances, immunotoxicants, neurotoxicants, substances toxic to specific organs, respiratory sensitisers – 2021 Update to information requirements for the identification of endocrine disruptors – all substances covered by REACH, the BPR, the PPP, the FCM Regulation, or the cosmetics Regulation – 2021-22 Legal requirements on substances of concern in products – all substances in products covered by updated ecodesign Directive – 2021-22 Creation of ‘essential use’ criteria – all hazardous chemicals – 2021-22 Creation of the ‘one substance, one assessment’ process and mixture assessment factors under REACH – all substances subject to risk assessment, and all substances covered by REACH – as of 2021

Global Service Providers Guide 2021

SERVICES

y REACH and chemical safety y Biocides y Agrochemicals y Cosmetics y Medical Devices y Food and Nutraceuticals y Food Contact Material y Pharma y Safety y Regulatory Affairs y Pre-clinical development y “In silico” evaluations y Ecolabel y Legal Affairs y Consortia / Task Forces

CHEMSAFE S.r.l. | Registered office: Via Ribes, 5 - 10010 Colleretto Giacosa (TO) - Italy | Tel: +39 0125 538888 Operational seat: Via Lugnacco, 4 - 10010 Parella (TO) - Italy | Tel: +39 0125 669035 | Fax: +39 0125 538475 Email: chemsafe@chemsafe-consulting.com | www.chemsafe-consulting.com

Global business outlook

G LOBAL O U T LO O K 2 02 1

What will shape the approach of business to chemicals management this year? The chaos brought by the Covid-19 pandemic in 2020 did little to slow the ambitions of companies, countries and regions to improve the management and safety of chemicals in products. Business editor, Leigh Stringer, asks what companies can expect this year

Key points Europe: The EU’s chemical strategy for sustainability: Businesses will want to pay close attention to how the EU addresses grouping, where regulatory measures could be applied to classes of chemicals as opposed to one substance at a time, and the concept of ‘essential uses’. North America: Businesses will need to identify if they are using any of the high priority substances subject to the next round of risk evaluation by the US EPA, while keeping a close eye on state level legislation. Substances under the microscope: The PFAS chemical group will remain in the spotlight this year around the world, alongside phthalates, halogenated flame retardants and bisphenols. Investors: As the issue of chemicals management gains momentum, more investors are turning their focus to the risks associated with the manufacturing and use of hazardous chemicals.

Europe The EU is moving forward with its green deal ambitions. The strategy is made of several action plans, including the ambitious chemicals strategy for sustainability. Businesses will want to take note of all aspects of the strategy, as the implications are far and wide. But the areas that are likely to significantly impact all companies are the approaches being considered to grouping where regulatory measures could be applied to classes of chemicals as opposed to one substance at a time, and the concept of ‘essential uses’. On the latter, the European Commission aims to ensure consumer products do not contain chemicals that cause cancers, gene mutations, affect the reproductive or the endocrine system, or are persistent and bioaccumulative.

Grouping For substances identified under these classifications, the EU plans to adopt restrictions for all uses and through grouping, instead of regulating them one by one. This approach will probably see many more substances regulated at a much faster pace, increasing the need for companies to get a strong grasp of the chemicals in their products and manufacturing processes to ensure compliance. Without this information, the risk of non-compliance could increase if blanket regulatory measures are applied to whole groups of substances. One example of this is a proposal by Germany, the Netherlands, Norway, Sweden and Denmark to group all per- and polyfluoroalkyl substances (PFASs) into one REACH Annex XV restriction dossier. This could result in a dossier covering a class Global Service Providers Guide 2021

of several thousand compounds, and ultimately their use in a large number of applications. As this develops, companies should make it a priority to work with their suppliers and product designers to understand if their product portfolios, or manufacturing processes, contain or use any of these chemicals. This will enable them to plan for any regulatory measures imposed if a PFAS restriction – or for any other chemical classes in the future – is adopted under REACH.

Essential use The strategy also seeks to define criteria for ‘essential use’ to ensure that the most harmful chemicals are only allowed if their use is necessary for health, safety or is critical for the functioning of society, and if there are no alternatives that are acceptable from the standpoint of the environment and health. These criteria will guide the application of essential uses in all relevant EU legislation for both generic and specific risk assessments. For companies, how essential use is defined will have significant implications on the use of chemicals and their applications. The end result could determine the future of certain products, companies and industries. The details on the decision-making process for determining essential use criteria will be released this year.

Enforcement A number of EU actions are set to address the lack of enforcement of chemicals legislation across member states. The chemicals strategy sets a ‘zero tolerance’ crackdown on non-compliance, with the Commission considering how to strengthen the enforcement of REACH at the EU’s borders, as well as to promote cooperation with online market platforms. For example, the EU market surveillance Regulation, which entered into force this year, and the proposed Digital Services Act, both aim to address the issue of products being sold into the EU that do not comply with EU legislation. This enforcement drive will not only impact EU companies, but also those located outside the region who have a market presence in the EU. Non-compliant products are set to come under the spotlight in a much bigger way. Other key EU action plans that will have implications for industry and their use of chemicals include the sustainable products initiative, which, among other things, aims to address the presence of harmful chemicals in products such as electronics, textiles, furniture and building materials. There are also sector specific plans for textiles, with the EU sustainable textiles initiative, which, among other things, aims to tackle hazardous chemicals. And for electronics, the review of the Directive on the restriction of hazardous substances (RoHS) in electrical and electronic equipment is scheduled for completion in June. As these developments progress, companies will need to comply with the obligations set out under Echa’s substances of

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Chemical Check GmbH Chemical Check Platz 1–7 D-32839 Steinheim / Germany Tel. +49 (0) 52 33 / 94 17 - 0 www.chemical-check.com

Global business outlook

concern in products (Scip) database, which entered into force on 5 January. The obligation requires suppliers to communicate to Echa information related to articles containing candidate list substances above 0.1%. In March, Echa announced that more than 7.5m notifications from around 3,600 companies had been submitted since Scip obligations entered into force. The EU’s ambitions will probably have a sweeping effect across other countries and regions. Many multinationals already bring their global operations in line with EU chemicals legislation, such as REACH and RoHS. The new chemicals strategy is likely to have a similar impact and could set a new standard for how chemicals are managed around the world, and up and down supply chains.

Key dates 2021: Details released on the decision-making process for determining ‘essential use’ criteria. 2021: A public consultation on the proposed Sustainable Products Initiative expected in the coming months. Commission adoption is anticipated in the fourth quarter of this year. 2021: Review of RoHS Directive to be complete by July. 2021: A public consultation on the strategy for sustainable expected in the coming weeks, with adoption of the strategy expected by 30 September. 2025: Five member states will prepare a PFAS REACH restriction proposal over the coming two years. If adopted, Echa says entry into force of this restriction is expected in 2025.

North America The US EPA continues to carry out risk evaluations on high priority substances designated under TSCA. The first ten have been completed and the agency has moved on to the next 20, which consist of chlorinated solvents, halogenated flame retardants and phthalates. The agency has issued test orders to obtain additional data on nine of the 20 substances, and may call for more information on others and their uses. It will be important for business to identify if they are using any of these designated substances, and if so, understand their uses. In doing so, they will be able to contribute to the TSCA risk evaluation process. Industry feedback will probably help shape the end result of any regulatory measures deemed necessary.

State-level legislation While TSCA risk evaluations play out, businesses will also be advised to keep a close eye on what’s happening at the state level. Many US states have adopted policies or laws that place regulatory requirements on industry, with Washington, California and New York setting the standard. All three have, in the last year or two, introduced laws that call for more disclosure of chemicals in certain applications, such as children’s products, cleaning products or menstrual products. Becoming familiar with these disclosure requirements will prepare companies for the level of disclosure other states may require in the future. For example, since 2 January New York’s Household Cleansing Product Information Program has required large cleaning Global Service Providers Guide 2021

product manufacturers to post specific information about their products and the ingredients they contain on their websites. The Washington State Department of Ecology (ECY) is in phase three of its Safer Products for Washington programme, with roughly two years to consider regulations and study alternatives to reduce the use of substances of concern in 11 consumer product categories. The department has until June 2022 to determine what regulatory actions are needed. It must also consider whether safer alternatives are available. Companies associated with the 11 categories should evaluate possible outcomes of the process and prepare for the different scenarios. Regulatory actions the department may take to “increase transparency and reduce the use” of certain substances include notification or ingredient disclosure requirements, as well as restrictions or prohibitions when feasible alternatives are available. In the Golden State, California’s Department of Toxic Substances Control (DTSC) has proposed to name plant fibre-based food packaging containing PFASs a priority product under the state’s Safer Consumer Products (SCP) programme. If adopted, the designation would require manufacturers of plant-based food packaging treated with PFASs to conduct an alternatives analysis to determine if safer options exist. At the end of the process, the state could also determine if further regulations are in order. The action in California comes as restrictions on the use of PFASs in food packaging continued to expand. The US states of Washington and Maine have taken action on PFASs in food packaging, and New York’s governor recently signed a bill to ban the full substance class. Several food chains and grocery stores have also committed to phasing out or reducing PFASs in at least some of their packaging materials, including McDonald’s, Amazon, Sweetgreen, Taco Bell, Ahold Delhaize and Trader Joe’s. This trend will probably continue this year, with no let up from NGOs and regulatory authorities who continue their focus on the controversial chemical class and the most common applications. In addition, a general drive in the US for companies to adopt strong policies on a number of chemicals and hazard classes, and to publicly share progress, is to continue in 2021 and beyond.

Key dates June 2022: Washington to determine what regulatory actions, if any, are needed for the eleven consumer products categories. 31 December 2022: Ban on selling or distributing food packaging with intentionally added PFASs enters into force in New York.

Asia, the Middle East and Africa Companies selling into China, or those who have manufacturing operations in the country, will be anticipating its long-awaited overarching chemicals law. The law is still in draft form, and the government has not indicated a timeline for next steps. However, the draft Regulation is similar to TSCA in the US, or Japan’s Chemical Substances Control Law (CSCL), in that it would require pre-market approval of new substances and risk evaluation of certain existing substances.

Global business outlook

A raft of national chemicals regulations are at various stages in the Middle East and Africa. Israel’s Ministry for Environmental Protection has published a draft law that would establish a national inventory of industrial chemicals, and set out processes for risk assessment and management, with the aim of finding “less dangerous substitutes for industrial chemicals used in making everyday products”. The ministry has proposed the law will enter into force on 1 March 2023, but it will give manufacturers and importers until 1 September 2024 to register chemicals. Although some way off, the law will set the foundations for the authorities to impose regulatory measures on chemicals in products so companies operating in the country should get to grips with what’s required and carry out due diligence. Saudi Arabia’s government is expected to approve a technical regulation restricting certain substances – those covered under the EU’s RoHS Directive – in electronics and electrical equipment. The regulation is identical to its regional counterpart, originally published in 2018, which is still under consideration by to: member countries of the Gulf Cooperation Council (GCC) trade bloc. Ghana’s EPA is drafting a bill that would require companies to register all industrial and consumer chemicals in the country, and would give the agency authority to ban chemicals that pose “unnecessary harm”. And Nigeria’s government expects to develop a “comprehensive national legal framework” for managing chemicals and waste by 2022.

Key dates 2023: Israel’s proposed law could enter into force with manufacturers and importers potentially being given until September 2024 to register chemicals. 2022: Nigeria expected to develop chemicals framework.

Substances under the microscope Chemical group PFASs, as mentioned, will remain in the spotlight this year around the world, but other well-known classes of chemicals will continue to share the limelight, including phthalates, halogenated flame retardants and bisphenols. Some downstream users of the substances have taken steps to get ahead of any potential regulatory measures. For example, UK headquartered multinational home improvement company, Kingfisher, pledged to remove by 2025 phthalates, the PFAS sub class known as perfluorinated compounds (PFCs), and halogenated flame retardants (HFCs) from its own-brand products. Setting the same phase out deadline, US restaurant chain Taco Bell committed to phasing out PFASs, phthalates and bisphenol A (BPA) from its consumer facing packaging. Those representing manufacturers of the substances have opposed blanket phase outs set by downstream companies. The American Chemistry Council (ACC), for example, said it understands that retailers and brands must respond to their customers’ needs and concerns, but initiatives to ban, restrict or otherwise limit entire classes of chemicals, based on concerns about specific, discrete uses of elements within that class, are misguided. Despite this, the pressure from consumers, NGOs and regulatory authorities is driving companies to consider and act on these, and other substance groups. Global Service Providers Guide 2021

We’re also seeing further pressure on certain hazard classes. For example, the EU’s chemicals strategy will see the European Commission propose to establish legally binding hazard identification of endocrine disruptors. This will be based on the definition set by the WHO and will apply across all legislation. It also plans to ensure that endocrine disruptors are banned in consumer products as soon as they are identified, allowing their use only where it is proven to be essential for society. At the member state level, France recently published a draft decree that will require anyone placing consumer products on the national market to declare those containing suspected endocrine disrupting chemicals (EDCs). The requirement will come into effect on 1 January 2022. This hazard class approach is also being taken up by unlikely stakeholders. To fit its chemicals of concern strategy, DSM’s coatings and resins business is developing a phase out timeline for EDCs, respiratory sensitisers and “other chemicals of high concern” (CoHCs).

Key dates 2022: France to require companies to declare consumer products that contain suspected EDCs. 2025: Phase out deadline for certain chemicals set by Taco Bell, Kingfisher and DSM.

One to watch: investors While NGOs and consumers have historically piled the pressure on industry to act on chemicals of concern, the investment community is going to be one to watch this year. As the issue of chemicals management gains momentum, more investors are turning their focus to the risks associated with the manufacturing and use of hazardous chemicals. There has been a drive by some corporate ratings agencies to integrate chemicals into their evaluating criteria. For example, in 2017 the Dow Jones Sustainability Indices (DJSI), which evaluates the sustainability performance of the largest 2,500 companies listed on the Dow Jones Global Total Stock Market Index, began asking companies for more data on the chemicals used in their products. Since then, disclosure around chemicals has improved, but investors say they still lack the level of information they need to make effective decisions. Investors want data on production, use and disposal of chemicals, but also a better understanding of whether a company’s products and supply chain are exposed to risk through CoHCs. Companies who are not prepared to offer this level of detail could see investment opportunities pass them by. Some investment firms have offered examples where they divested in a company following information of poor chemicals management. NGOs, such as the US Mind the Store, Clean Production Action and Sweden-based ChemSec, understand that the investment community holds a lot of power with the ability to create waves of change. All three organisations have developed rankings and tools to help guide investor decisions that consider a company’s efforts to manage chemicals. And all three will continue to scrutinise the operations and products of companies throughout 2021 and beyond.

Key dates 2021: second iteration of the ChemScore rankings to be published later in the year.

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· Engineering Circular Economy Contact: www.h2compliance.com · info@h2compliance.com Ireland: +353-21-4868120 · USA: +1- 518-512-3553

Profile: Acta

SERVICES PROVIDED

Information 10%

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

Legal 10%

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.

No of offices

2019/20 4

No of countries represented

>25

Staff, group

35+

Staff, chemical service provision

35+

SERVICE AREA BREAKDOWN 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.

Global Service Providers Guide 2021

Consultancy/advisory 45%

Representation & management 30%

OVERVIEW

VITAL STATISTICS

Training 5%

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 strategically manage the 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 programmes, including the US Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (Fifra), EU 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 UK REACH, 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 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 have in-depth understanding of 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. 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 compensationand 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. 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. PARTNERS 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.

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 successfully manage 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, 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. 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 multinational 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. 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. 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. Edith G. Nagy – Regulatory Consultant Ms Nagy assists clients with EHS compliance, with a focus on pesticides, biocides, and product stewardship. Ms. Nagy’s international experience and extensive language skills (English, Romanian, Hungarian, German, Spanish, French, and Italian) are valuable assets to clients pursuing and maintaining commercialization in multiple global markets Karen L. Lorusso – Regulatory Consultant Ms Lorusso is a highly-experienced product safety professional assisting clients with global hazard communication and regulatory compliance projects including classification and labeling of substances and mixtures, and preparing and submitting dossiers to support REACH, UK REACH, K-REACH and other chemical regulatory programs. www.chemicalwatch.com/SPG

Profile: Acta

Profile: Apeiron-Team NV

SERVICES PROVIDED We assist our clients with the following: REACH, CLP, biocides regulations, UK chemicals legislation, EU and national nano legislations, food contact, RoHS, waste legislation, sustainability goals a.o. developments in circular economy. 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.

CONTACTS Web site

www.apeiron-team.eu

E-mail

info@apeiron-team.eu

Head office

Berten Pilstraat 4, 2640 Mortsel, Belgium

Tel

+32 3 808 20 67

Contact

Elke Van Asbroeck

Directors

Elke Van Asbroeck, Hiram Moerman, Tine Vandenbrouck

Ownership

Private company

Locations

Mortsel (Antwerp), Belgium

Founded

2009

Sustainability OO Sustainable recycling OO Alternatives assessment OO Set up of circular business models

OVERVIEW Our mission is to guide our clients to sustainable, future-proof business operations. Regulatory compliance is our point of departure. From there we go the extra mile to drive long-term improvement for human health and the environment, with added value for society. We do this by means of incremental improvements or, even better, by a step change. We are a highly motivated, multidisciplinary group of experts: (eco) toxicologists, chemists and engineers with industrial experience. As a team, together with a limited number of sub-contractors with niche knowledge, we turn your project into a success. We provide specific expertise, while being able to act flexibly and maintain our client focus. VITAL STATISTICS

2019/20

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%

REACH and CLP OO Set-up REACH import/export strategy OO REACH registration dossiers from A to Z: substance ID, hazard assessment, study monitoring, exposure and risk assessment, evaluation of PBT properties, integration of nano data OO Substance portfolio management: fully outsourced management of REACH registrations including updates and tracking of regulatory position of registered chemicals OO REACH authorisation dossiers: strategy development, chemical safety assessment, analysis of alternatives, socio-economic analysis, supply chain communication OO Other REACH topics: support during evaluation, support during Board of Appeal (BoA) cases, generation for individual companies associations, DU-CSR generation, Annex XV dossier generation, representation of clients in consortia, position papers, set up of monitoring programmes (occupational hygiene), communication with authorities Biocides Transitional regulation and BPR related services: authorisation strategy development, transitional notifications/registrations, BPR biocidal products dossier generation including biocidal product family concept integration, data gap analysis, study monitoring, risk assessment, PAR generation, follow-up with authorities, technical equivalence dossier preparation, Article 95 listing. UK chemicals legislation Brexit related chemical legislation: strategy definition, UK REACH, GB CLP, GB BPR, only representative services. Due diligence OO Audit programmes: compliance, system, supply chain, project, due diligence and SCC audit OO Merger and acquisition support OO Prepare and support during enforcement inspections Out-of-the-Box Solutions Expect the unexpected!

Other 5%

CORPORATE DEVELOPMENTS & ACHIEVEMENTS Information 10%

Representation & management 10%

Global Service Providers Guide 2021

Consultancy/advisory 65%

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 inhouse RMOA methodology. Successful submission of > 150 registration dossiers for the 2018 deadline.

2018

Development of regulatory support for circular economy based business models.

2019

Ten years of Apeiron-Team. Managing outsourced REACH registrations for over 400 substances. Development of more than five authorisation dossiers.

ACCREDITATIONS OO OO

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

PARTNERS Burgess Regulatory Services Ltd, eftec, Jongerius Consult; Vander Straeten Consulting Services; VIB fabriek CLIENTS Our references are situated in several industries and cover the entire supply chain from manufacturing to recycling: OO petrochemical industry, fine chemicals, toll manufacturing, food industry, polymer industry, refinery, tyre industry, pharma industry, textile industry retail. TESTIMONIALS “Apeiron-Team are professional and experienced, driven and engaged. With their expertise they translate the tangle of the REACH legislation into practical, concrete guidelines and actions” – BP Chembel “Apeiron-Team is a no-nonsense company delivering their services on time, in full and in budget” – Monument Chemical “For us, Apeiron-Team distinguish themselves from other excellent consultants because they are able to think further in the benefit of the company together with us. We consider them as one of us” – Christeyns “During the 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 standardised approach to developing 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 scrutinised 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 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 2: Overcoming regulatory hurdles in the circular economy

Business models in the circular economy are often not considered in the legislation. Apeiron-Team supports its customers in discussions with the 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 its client and together with its 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 PBT case won by the appellant and the first in which the BoA decided in favour of the appellant in a case of scientific uncertainty. Explorative science with unclear interpretation as requested by the member state was avoided in favour of scientifically proven testing methods. The case showed that a close collaboration of technical-scientific and legal support results in a strong defence of substances. CASE STUDY 4: Union authorisation of a biocidal product family A Union authorisation dossier for a biocidal product application was prepared based on the biocidal product family (BPF) concept. This was within product type 4. The composed biocidal product family, and its meta-SPCs, was evaluated in detail together with the client to ensure that the different criteria of a BPF were fulfilled. 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 and new info was integrated into Iuclid and a draft risk assessment covering the complete BPF was generated. Apeiron actively defended the dossier with the authorities and during working group meetings at Echa. The final commission decision for one of the first submitted Union dossiers was received in the spring of 2020. STAFF SELECTION Elke Van Asbroeck – (Bio-)chemical engineer OO Polymer science OO Regulatory business strategy OO Sustainable chemicals management OO Circular economy OO Due diligence Hiram Moerman – Chemical engineer OO Previously in polymer industry OO REACH authorisation OO Alternative assessment OO Risk management option analysis OO Sustainable chemicals management OO Circular economy Dr Katrien Monsieurs – Chemist and Human Toxicologist (PhD) OO Specialised in organic synthesis OO Risk assessments OO Read-across justifications OO Endocrine disruptors and nanomaterials OO Persistence, bioaccumulation, mobility Tine Vandenbrouck (ERT) – Ecotoxicologist and risk assessor (PhD) OO Biocidal product strategies OO Registration and authorisation OO Exposure estimation and modelling OO UK chemicals legislation OO Specialised in mixture effects

Several companies have approached us on the regulatory hurdles to implementing circular economy-based business models. While safeguarding the principles of safe chemicals management, strategies are developed with the clients to comply in a cost-effective way with the chemical regulations in a cost-effective manner. www.chemicalwatch.com/SPG

Profile: Apeiron-Team NV

Profile: Arcadis

70 Product stewardship programs and audit services Includes compliance program development and implementation, auditing, due diligence and post-merger integration assistance. World-wide regulatory surveillance Includes continuous regulatory monitoring for emerging and existing chemical (eg, REACH, GHS, BPR) and product regulations (eg, WEEE, RoHS, MDR, batteries, waste), and impact assessments for individual products, product lines and portfolios.

CONTACTS 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

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 (including nanomaterials) and authorisation under REACH and REACHlike regulations (China-REACH, UK-REACH, etc); 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. 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 v national authorisation, testing strategy, read-across justification, etc).

OVERVIEW Arcadis works 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 and safety and sustainability into the design and delivery of solutions across the globe. VITAL STATISTICS

2019/20

Turnover, group

€3.5bn

Turnover, chemical service provision

€11m

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

1888

Parent company, Heidemij, formed in the Netherlands

1998

Global company becomes Arcadis

70+

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

Laboratory 10% Consultancy/advisory 60%

Representation & management 10%

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

Global Service Providers Guide 2021

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Training 5%

Information 5%

Laboratory services Includes in-house aquatic ecotoxicology, biodegradation, and physicochemical testing according to international guidelines (OECD, OCSPP, JMAFF) in compliance with GLP, to support dossier preparation, ecolabeling and claims.

28,000+

SERVICE AREA BREAKDOWN

IT & software 10%

Agrochemical fate and exposure Includes conduct of environmental and consumer safety field studies, aquatic and terrestrial modelling, risk assessment, spatial data analysis, environmental stewardship, and registration support for plant protection products.

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 has supported companies in answering questions from the committees and in communication with ECHA. For all dossiers reviewed by ECHA and the committees, feedback was very positive.

CASE STUDY 2: Authorisation dossiers for biocidal products

STAFF SELECTION

Arcadis has supported the preparation of multiple applications for authorisation of biocidal products (eg, for the treatment of articles under PT2 and hand disinfection under PT 1). The support included developing a testing strategy, human health and environmental risk assessment as well as definition of claims. Support also includes all communication with the competent authorities as well as adaptation of the dossier.

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.

CASE STUDY 3: California Proposition 65 consulting and compliance support Arcadis has assisted multiple clients 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 toxicological considerations, developing analytical test plans for the 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, PFOA, PFOS). CASE STUDY 4: Product stewardship organisational redesign and supporting tool selection Arcadis has supported multiple global companies with defining or re-defining a strategy and approach for a future-proof and proactive product stewardship organization with efficient processes and reliable tools to enable market access. We have prepared detailed business plans, reviewed existing processes, identified potential weaknesses, and supported the selection of software solutions. Arcadis has also provided support for implementation of the strategy including management of change, process development, and training. CASE STUDY 5: Enhancing product sustainability and supporting environmental product claims Arcadis has developed several tools to aid companies in a variety of industries including consumer goods, pharmaceuticals, and medical devices with sustainable material selection based on human health and environmental hazards. These tools have aided our clients in developing products and production processes with more sustainable profiles. Arcadis has also collaborated with clients to develop bespoke guidance on environmental labeling claims such as ‘natural’, ‘plant-derived,’ and ‘bio-based,’ considering global regulation of such claims, product attributes, and industry and third-party certification guidance. CASE STUDY 6: 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 EU, a search for publicly available groundwater monitoring data was conducted across 17 countries by performing online database searches and contacting regulatory agencies, authorities, and organisations. The data collected were cleaned, processed, and compiled into a single data structure to facilitate detailed statistical analysis. At approximately 100 sites with low-level PPP concentrations located in Belgium, Czech Republic, France, Slovakia, Slovenia, and Portugal, field surveys were conducted 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 pertinent data.

Tina Armstrong, PhD – Product stewardship & regulatory affairs Tina has more than 20 years of regulatory and product stewardship experience with multinational automotive, chemical, and consumer goods companies. She specialises in product stewardship programmatic gap assessments 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 and OSHA’s Hazard Communication Standard, and is well versed in global chemical regulations. 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 specialises in tailor-made study designs based on the product properties to meet her clients’ needs. Special emphasis is given to animal welfare, 3R strategies, and alternatives to animal experiments. Maaike Bilau, PhD – Sr. Product Stewardship Consultant Maaike has more than 15 years of experience in human health risk assessment of hazardous chemicals. She supports multinational companies with the development and implementation of product compliance strategies. She partners with clients and guides them when strategic decisions need to be taken. Karina Urmann, PhD – Chemical regulatory affairs expert Karina has 13 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. Andy Newcombe – Agrochemical product stewardship Andy has more than 30 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. Alain Vassart, PhD – Senior product stewardship consultant / project manager Alain has more than 20 years of experience in the chemical and recycling industry. He was an active member of the EU Copper Task Force (plant protection), participated in the VRA on copper and was past chairman of the copper compounds REACH consortium. Alain has actively contributed to the development of EBRA (European Battery Recycling Association – www.ebra-recycling.org), currently taking the role of Secretary General. He is managing several REACH consortia including the administrative and financial side.

www.chemicalwatch.com/SPG

Profile: Arcadis

Profile: Arcerion GmbH

arcerion

GLOBAL OFFICES München, Germany Hamburg, Germany

REACH | CLP | Seveso | Biocides

SERVICES PROVIDED

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

Consultancy/advisory OO Regulatory support & interpretation (REACH, CLP, Biocides, Seveso). OO Product compliance assessment and implementation (including certificates of compliance). OO Environmental risk and health effects assessments. OO Hazard and exposure modelling. OO SVHC advisory/REACH authorisation. OO Data management/Data-gap analysis. OO Reducing of animal testing/Qsar, read-across. OO Brexit implications on suppliers of chemicals. OO Chemical transport/warehousing advice. Representation and management OO REACH registration services (including inquiries, notifications, Sief representation, completion of data requirements). OO Dossier preparation and submission (Iuclid files). OO CLP implementation (including authoring of eMSDS, CSA/CSR). OO Only representative of non-EU manufacturer (REACH article 8). OO Third party representation (REACH article 4). OO Supply chain management and communication. OO Consortium and letter of access (LoA) management. OO Sief representation and management. OO 24/7 emergency phone services. OO Management of downstream user obligations (REACH articles 31–38). OO Preparation of applications pursuant Seveso-III directive.

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 supports our clients in their regulatory duties, to enable them to maintain secure market access for their products. Our objective is to facilitate the most efficient and costeffective 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.

Information/IT solutions OO (Material) safety data sheets/product labels. OO Supply chain management. OO Exposure scenario/chemical safety assessment management. OO Consortia/registration management. OO Regulatory information management. OO Chemical inventory management.

VITAL STATISTICS

2019/20

No of offices

No of countries represented

Global

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training IT & software 5% 5%

Representation & management 30%

Global Service Providers Guide 2021

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

2018

Preparation and submission of more than 200 REACH registration dossiers

ACCREDITATIONS

Laboratory 10% Information 10%

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Consultancy/advisory 40%

Certified Expert pursuant to 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

STAFF SELECTION

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

Dr Michael Piber – Director Michael holds a degree in organic chemistry and was a faculty member of the LMU University, Munich, lecturing 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 NorthAmerican 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.

CLIENTS Arcerion serves more than 100 clients in Europe, North America, Africa, Australia and Asia, across multiple industry sectors including industrial, 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 Client situation: 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 comply with REACH for exported goods to his European customers, without disclosing the identity of all raw materials to his European customers. Arcerion solution: 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 workflow. 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.

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 researched the fate of fluorinated chemicals in the environment. Florian leads the Arcerion Hamburg office, focusing 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 Qsar. Over the course of his career, Hakim has managed the preparation of more than 200 chemical registrations in the EU, Korea and the US. 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 of 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.

www.chemicalwatch.com/SPG

Profile: Arcerion GmbH

Profile: ARCHE Consulting

SERVICES PROVIDED REACH and Chemical Strategy for Sustainability (CSS) REACH entered into force in 2007. Since then almost 23,000 substances have been registered in the EU, and REACH-like regulations have been rolled out internationally. Currently, as the focus is shifting from registration to evaluation and enforcement, companies will have to check if they comply with all the conditions as stipulated in the REACH registration files to ensure they do not face sudden interruption in their supply chain. In addition, the new Chemical Strategy for Sustainability (CSS) rolled out within the EU Green Deal will shift the boundaries in which we do business today and in the future. Companies that want to secure market access are faced with complex challenges that may impact every segment of their product supply chain. This surpasses the traditional way business units are organised and deal with these issues. Recognising the need to provide a proactive holistic approach, ARCHE Consulting developed together with Deloitte a unique platform for chemical regulatory compliance that is able to cope with any challenge chemical regulations may pose.

CONTACTS 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

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 working with two other renowned and experienced service providers. For more information visit our dedicated website www.rosconsortium.eu

OVERVIEW Several key services are provided by ARCHE Consulting including 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, ARCHE experts have been involved in the preparation of many guidance documents (eg for Echa) on these topics. Other key services provided 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

2019/20

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

Global Service Providers Guide 2021

Consultancy/advisory 75%

Biocides and agrochemicals ARCHE Consulting offers a one-stop-shop for the registration of your biocides and Agrochemicals 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 agrochemicals. Offered services include: OO consortia management for biocidal product; OO effect and exposure assessment for active substances and products; OO data gap identification and designing higher-tier studies; OO exposure modelling (FOCUS suite of models, Euses, Consexpo, EASE); OO higher-tier exposure scenario development; OO CLP; OO dossier preparation, submission and follow-up; OO client representation in meetings with regulatory authorities; OO product stewardship; and OO training Iuclid for biocides. Cradle to Cradle certification® As an authorised 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: OO material health; OO material reutilisation; OO renewable energy and carbon management; OO water stewardship; and OO 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.

20132021

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

ACCREDITATIONS

Certified Material Health Assessor (Cradle to Cradle)

PARTNERS

Deloitte PietConsulting ECTX-Consulting ROSC Toxicological Consulting REACHlaw Vander Straeten Consulting Services ERMC (Dr Mike Holland) EBRC Consulting RPA FieldFisher CLIENTS Industrial clients and consortia related to the following chemical substances: OO metals including: Cu, Ni, Mo, Pb, Zn, Hg, V, Co, Fe, Se, Sb, Sr, Mg, Bi, Te, Ti, etc; OO organic compounds: chlorinated flame retardants, organic acids; OO plasticisers, amines, , plant protection products; OO complex materials: Cu slags, Ti slags; OO other inorganic substances: Ca, B, NaOH, KOH, sulphur dioxiderelated substances (SO2, sulphites, thiosulphates, dithionites), lime, nitric acid, phosphoric acid; and OO 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 available, knowledgeable, thorough and were instrumental in guiding our responses and submissions to help insure the successful outcome. We look forward to maintaining an ongoing relationship for our future regulatory requirements with ARCHE Consulting.” OO Antoine Birron, Director, TerpeneTech Ltd. “IMOA has worked for the last decade with the environmental scientists working at ARCHE Consulting, and they have proved for IMOA/MoCon to be a very wise investment. We can therefore highly recommend ARCHE with regard to their technical expertise and knowledge on environmental issues (aquatic and terrestrial), organisation of research projects, and data interpretation.” OO Sandra Carey, International Molybdenum Association (IMOA) “ARCHE Consulting has proven to be a very valuable consultancy partner for DeLaval over the past few years. DeLaval was able to benefit from the in-depth knowledge of the ARCHE scientists on the European biocidal Regulations (BPD/BPR) and we can only recommend to others the training we received on several aspects of risk assessments (both human and environmental).” OO 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: Consortium support We supported many Industrial clients and consortia related to the following chemical substances (non-exhaustive list): OO metals including: Cu, Ni, Mo, Pb, Zn, Hg, V, Co, Fe, Se, Sb, Sr, Mg, Bi, Te, Ti, etc; OO organic compounds: chlorinated flame retardants, organic acids, plasticisers, amines, agrochemicals, gertilizers; OO complex materials: Cu slags, Ti slags;

other inorganic substances: Ca, B, NaOH, KOH, sulphur dioxiderelated substances (SO2, sulphites, thiosulphates, dithionites), lime, nitric acid, phosphoric acid; and several Biocide consortia such as Sodium chloride (Active chlorine generated from NaCl by electrolysis) consortium, Permethrin and in situ peracetic acid consortium.

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 ecotox-icological risk assessments, as well as general regulatory matters.

www.chemicalwatch.com/SPG

Profile: ARCHE Consulting

Profile: Arrow Regulatory Ltd

SERVICE AREA BREAKDOWN Information 2%

CONTACTS Website

www.arrowregulatory.com

E-mail

info@arrowregulatory.com

Head office

6th Floor East West Building 2 Tollhouse Hill Nottingham, NG1 5FS, UK

Tel

01159352243

Contact

Dr Sara Kirkham/Dr Carlo Poncipe/Dr Virginia Gretton

Directors

Representation & management 48%

Limited Company

Locations

UK, Ireland, Austria

Founded

May 2016 (UK), Oct 2017 (IE), Mar 2020 (AT)

Nottingham, UK Dublin, Ireland Innsbruck, Austria SERVICES PROVIDED Biocides Arrow Regulatory’s wide experience in supporting active substances and biocidal products under the EU and GB Biocidal Product Regulations and globally, is your guarantee of a quality service.

OVERVIEW Arrow Regulatory has extensive knowledge of chemical legislation, particularly in the EU Biocidal Products Regulation, REACH, CLP and ADR, as well as the equivalent GB regulations. 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 companyspecific enquiry. Our aim is to provide a high level of service to all clients, irrespective of their size. VITAL STATISTICS Turnover, group

2019/20 -

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

Staff, chemical service provision

Chemicals (REACH & CLP) With offices in the UK, Republic of Ireland and Austria, Arrow Regulatory is well placed to assist with all aspects of EU/GB REACH. Arrow Regulatory provides a comprehensive service to help you achieve compliance with the classification, Labelling & Packaging (CLP) Regulations for the EU and GB. Consortium Management (REACH & Biocides) At Arrow Regulatory, we have a long history of Consortium Management not only under the BPR for both active substance approval and product authorisation, but also in REACH. EU & GB Only Representative With offices in the UK, Republic of Ireland and Austria, Arrow Regulatory is well placed to assist with all aspects of EU/GB REACH and CLP. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2016

Formation of Arrow Regulatory Limited in Nottingham, UK

2016 -2021

Team expands from 4 to 11 consultants

2017

Formation of Arrow Regulatory (Ireland) Limited in Dublin, Ireland

2020

Formation of Arrow Regulatory GmbH in Innsbruck, Austria

PARTNERS Available on Request CLIENTS Manufacturers, importers or downstream users of industrial chemicals, biocides. Veterinary drugs, plant protection products or cosmetic ingredients. STAFF SELECTION

Global Service Providers Guide 2021

Consultancy/advisory 48%

GLOBAL OFFICES

Dr Sara Kirkham Dr Carlo Poncipe Dr Virginia Gretton Elicia Hodgson Dr Joanna Ganatsiou (Austria)

Ownership

Training 2%

Profile: Arrow Regulatory Ltd

77 Sara Kirkham, PhD Sara has over 20 years of Regulatory experience in biocides registration. Involved in the preparation of over 30 active substance dossiers for Union approval and biocidal product submissions through the BPD/BPR process and under National schemes. Working on consortium management, regulatory strategies for biocides, designing testing programmes and providing tailored regulatory advice, in addition to the preparation of dossiers and risk assessments. Involvement on behalf of industry with development of new guidance under the BPR on disinfection by-products, in situ generation systems and PT 11 and PT 12 efficacy. Carlo Poncipe, PhD Carlo has 20 years of Regulatory experience in both biocides and industrial chemical registration. Since 2008 he has focused on all aspects of the REACH regulation, acting as Technical and Administrative manager to several consortia as well as preparing lead registration dossiers and chemical safety reports and providing support to co-registrants. Virginia Gretton, PhD Virginia is an experienced regulatory expert with interests in REACH, CLP and Dangerous Goods gained over nearly 15 years. Responsible for all aspects of preparation and submission of REACH lead dossiers for multiple clients. Involved with provision of detailed advice to clients involved in defence of their REACH dossiers. Specialist in CLP/transport classification and preparation of complex Safety Data.

www.chemicalwatch.com/SPG

Profile: Artemisa d.o.o.

SERVICES PROVIDED Plant protection services in Eastern EU and beyond We offer the following services: OO preparation of national submission dossiers for zonal, MR, renewal and other procedures; preparation of documentation in local languages adjusted to national requirements including label and SDS preparation; OO submission of dossiers; OO post submission work/ product stewardship (communication with national enforcement bodies on as need basis, compliance with annual reporting duties, national electronic registers, etc); OO facilitation of communication with local authorities in local language; OO strategic advice given, taking national specific rules into consideration; and OO project management in cases of multiple submissions into multiple countries. Areas of expertise: OO plant protection products; OO fertilisers and supplementary soil substances; OO adjuvants; and OO biopesticides.

CONTACTS Website

www.artemisa.si

E-mail

registrations@artemisa.si

Head office

Artemisa d.o.o., Opekarniška 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 the chemical industry to comply with 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

2019/20

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Information 2% Training

Representation & management 1%

Consultancy/advisory 95%

Global Service Providers Guide 2021

Biocidal products regulatory services in Eastern EU and beyond We offer the following services: OO preparation and submission of applications following EU transitional measures or BPR rules in local language and according to national requirements; OO SPC (summaries of product characteristics) translation services into multiple languages; OO R4BP3 submissions and project management; OO post submission work/ product stewardship; OO facilitation of communication with local authorities in local language; OO strategic advice taking national specific rules into consideration; and OO project management in cases of multiple submissions into multiple countries. Medical devices We offer the following services: OO understanding the data requirements and procedures to be followed in order to place medical devices on the markets; OO take different national requirements into consideration in cases where relevant; OO help you solve borderline cases in case of any doubts; and OO facilitate communications with the authorities in the pre- and post- submission phase. Poison centre notifications We offer the following services: OO consultancy based on the most current information available; OO compliance with national requirements where applicable; OO facilitation of communication in the relevant national language; and OO preparation and submission of a poison centre notification (PCN) dossier via the Echa portal. Detergents We offer the following services: OO identification of the status of your detergents and surfactants in the light of the EU legislative framework and your obligations resulting from it; OO preparation, translation/adaptation or review of the labelling for your detergents to be compliant with the national requirements and EU rules; and OO representation of your company in national associations, serving as a liaison between your company and the local community.

SDS services We offer the following services: OO SDS adaptation to specific national requirements and in the national language of a specific country; OO SDS updating, reformatting or editing to accommodate changes in legislation (REACH, CLP, ADR …), classification changes of the product, product composition, company specific information; and OO SDS extension to extended safety data sheets (eSDS) to comply with your substance chemical safety report (CSR). Translation and proofreading support We offer the following services: OO translations of technical texts in the following expert areas: agriculture, chemistry, regulatory, security in the workplace, business, environmental, healthcare; and OO proofreading of general and technical texts, labels, MSDS-es, SPC and PAR documents. Business seminars We offer the following services: OO Training in regulatory matters; and OO internal trainings upon request. Strategic advice We offer the following services: OO preliminary assessment of your portfolio or individual products taking the EU status of your substance as well as data protection rules into consideration; and OO advice on the data requirements in place in different countries of the region we cover, with all the nuanced differences and local specifics that need to be taken into consideration for the successful registration of your products. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2018

Company establishment

2018

Branch offices establishment in Poland and Slovakia

CLIENTS Our clients are typically multinational as well as generic companies, who originate in the western EU countries. Artemisa helps them place their products on the market in eastern EU countries and countries outside the EU, by preparing all the 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 an Article43 PPP application in a very challenging eastern EU country. Thanks to our reliable local partners and good contacts with the authority, Artemisa team was able to deliver the submission in time. Our ability to act quickly and flexibly is contributing to the success in achieving complete registrations in different eastern EU geographies. CASE STUDY 2: Data package preparation for multiple EU countries With our experience and a large network of local partners we were able to minimise the extent of data and documentation (including local testing) for the client. With that we have confirmed our knowhow and ability to optimise data packages for multiple markets and regions wherever possible. Additionally, we have the ability to handle the entire registration process on behalf of a 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 the BPR our client had a very short timeline to prepare and submit high quality national versions of a 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 being fluent in Eastern European languages, and having a thorough regulatory knowledge, all national SPC versions were prepared by the required deadline. In this way we contributed to the success in obtaining authorisations in a timely manner. In addition we prepared national versions of product labels and SDSs assuring a high compliance of all elements of the approved SPC and content of the authorisation decision. 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 (2009-2018). Before moving into a regulatory consultancy role in 2006 she gained experience as a registration manager, working for Bayer CropScience and Pinus TKI d.d. Over the last 20 years Bojana has gained extensive experience in regulatory affairs and business development in Eastern Europe. Her career 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 a basic understanding of Russian. Liana Skok – Principal Expert Liana started her career as a PPP registration manager in 1995 with Ciba. She continued her carrier in Novartis and Syngenta as the 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 Liana has been with Artemisa in the 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 the regulatory authorities. She also prepares submissions (zonal and national) for Eastern European and Balkan countries. Liana is fluent in Slovenian, English, German, Croatian and Serbian and has a basic understanding of Macedonian. Viktor Prachar – Principal Expert Viktor joined the Centre for Chemical Substances and Preparations in 2001 where he was head of the Biocides Unit at the national competent authority for biocides. For ten years Viktor was national representative at the EU CA meetings and the Standing Committee for Biocidal Products. Viktor is an Associated Professor at the Slovak University of Technology. In 2014 he moved to regulatory consultancy and joined TSGE. Viktor has been with Artemisa since June 2018 in the position of principal regulatory expert for BP and PPP Slovakia and Czech Republic. The combination of Viktor’s extensive experience covering the areas of science, work in regulatory bodies and consultancy within the private sector is ideal for properly understanding the needs of clients, thorough interpreting the requirements of the authorities and a facilitation of discussions between the private sector and national/EU bodies. Viktor is fluent in Slovak, English, German and Czech.

www.chemicalwatch.com/SPG

Profile: Artemisa d.o.o.

Profile: BIG vzw

GLOBAL OFFICES Belgium SERVICES PROVIDED CONTACTS Website

www.big.be

E-mail

info@big.be

Head office

Technische Schoolstraat 43A 2440 Geel Belgium

Tel

+32 14 58 45 47

Fax

+32 14 58 35 16

Contact

Zita Snellinx

Directors

Paul Martens – Chairman Es Goossens – General Manager

Ownership

Non-profit

Locations

Belgium

Founded

1979

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 Article 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 Scenario’s. Screening and authoring of (e)SDS’es BIG provides a full service for authoring your (e)SDS’es based on data evaluated by our experts and using an in-house developed SDS-system. We can also screen (e)SDS’es coming from your suppliers on their accuracy

OVERVIEW

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.

BIG is an independent information and emergency call centre for dangerous goods (substances, mixtures and articles). Information is gathered on physicochemical 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

2019/20

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 35% Representation & management 5%

Global Service Providers Guide 2021

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. 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 four 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 becoming also the first 24/7 available emergency center 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

2021

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

ACCREDITATIONS ISO 9001 : 2015 Quality Certificate CLIENTS Our clients also include multinational and SME companies in Europe and more global, but always with an interest in the EU market and from diverse sectors. Besides industry, BIG also counts emergency services, governmental and inspection services, healthcare and academia among its clients. PARTNERS BIG has partners in different areas of expertise, in order to offer the best possible solution for our clients. TESTIMONIALS

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 has a master’s degree in biology. She joined BIG in September 2013 after gaining seven years’ 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 regarding environmental regulations. She is responsible for implementing environmental legislation in the BIG database, and 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. Maries Verachtert, MSc – Chemical Safety Advisor/ Biocides Consultant Maries graduated as a Master in Biomedical Sciences. She joined BIG in May 2017. Previously she worked for more than 7 years as QHSE Manager and Dangerous Goods Safety Advisor (ADR/ADN) at the largest inland terminal in the Benelux. At BIG, she has built up knowledge in the field of chemical regulations with a focus on pesticides. Her main field of expertise encompasses BPR, specifically registrations of biocidal product in Benelux and other EU countries.

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. She joined BIG in 2002 and has more than 12 years’ experience as a consultant, active on REACH since its beginning. She is currently coordinator of the REACH team at BIG, responsible for specific REACH implementations and updates in the BIG database. She is also 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

SERVICE AREA BREAKDOWN Consultancy/advisory 10%

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

Laboratory 90%

SERVICES PROVIDED Analytical services and physico-chemical data

OVERVIEW Since 2005, BioGenus has been supporting its customers with an indepth 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 state-of-the-art facility comprising analytical and efficacy testing 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

2019/20

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

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 parameters: OO analytical method development; OO method validation (SANCO); OO five-batch analysis for technical equivalence (e.g. Art. 95); OO accelerated storage stability studies; OO ambient storage stability studies; OO application tests for solid, liquid and spray products; OO safety data packages; OO active ingredient residues; and OO analysis of impurities and byproducts. Efficacy data for insecticides and repellents (PT 18 & PT 19) OO BioGenius is one of the leading European efficacy testing institutes for biocidal, insecticide and repellent applications. With our broad range of efficacy testing protocols against crawling and flying insects, BioGenius fulfills all requirements of national and international product authorisations according to the BPR: OO field tests; OO laboratory tests; and OO simulated use test (semi-ﬁeld). Data packages for different other approaches, such as: OO dose response tests for actives; OO screening tests for claim support; and OO testing for product development. All required insect pest species are bred at BioGenius. Technical Consulting There are many guidelines and regulations which need to be followed during registration processes, especially for biocides. However, these documents and the aforementioned methods cannot be applied to each product and each application. Therefore, a practical and technical evaluation is always required, and is 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.

Global Service Providers Guide 2021

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 Limited

SERVICE AREA BREAKDOWN Representation & management 20%

CONTACTS Website

www.bluefrogscientific.com

E-mail

info@bluefrogscientific.com

Head office

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

Tel

+44 (0) 131 523 1412

Contact

Damien Carson

Directors

Damien Carson Tom Hargreaves

Ownership

Private limited company

Locations

UK, France

Founded

2006

GLOBAL OFFICES Edinburgh, Scotland; Cardiff, Wales, UK Chabrillan, France SERVICES PROVIDED

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 Frog’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

2019/20

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2021

Consultancy/adviso 80%

Scientific consultancy OO Regulatory testing design and study monitoring OO Intelligent testing strategies OO Ecotoxicology and environmental fate OO Environmental hazard and risk assessment OO Toxicology OO Human health hazard and risk assessment OO Compilation of dossiers and expert reports Regulatory affairs OO Regulatory affairs for chemicals, human medicinal products, veterinary medicinal products, plant protection products and consumer products OO Project management OO Product defence OO Consortium and task force management OO Only representation of non-EU chemical companies under REACH Biocides (BPR) Blue Frog Scientific provides a comprehensive range of services to the EU biocides sector, including: OO strategic planning; OO execution of technical and regulatory strategies (e.g. data-gap analysis, study monitoring, pre-submission meetings); OO development of the biocidal product family concept; OO hazard and risk assessment for relevant Product Types; OO technical Dossier compilation and Draft Assessment Report compilation; OO project management; and OO 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 byproducts. We can also offer effective management of dossiers throughout 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: OO monomers, process chemicals, coatings and catalysts; OO oilfield chemicals and petroleum products; OO fragrances and flavourings; OO pharmaceutical intermediates; OO substances of unknown or variable composition, complex reaction products or biological origin (UVCB); and OO transported isolated intermediates (Article 18). We also provide only representative services in accordance with Article 8 of REACH for non-EU companies that manufacture or formulate chemical substances and mixtures. Consortium/Sief management Blue Frog Scientific has developed a model for managing the financial and administrative challenges of consortia and task forces. We are currently managing consortia and Siefs under REACH as well as other groups of companies collectively working on research and development projects. Our services include: OO provision of a consortium bank account; OO accounts payable and accounts receivable; OO VAT and tax accounting; OO purchase contract management; OO teleconferencing facilities; and OO data storage and management via the secure Blue Frog Scientific extranet. Plant protection products (PPPs) Blue Frog Scientific and associates offer a full dossier service for registering plant protection products throughout Europe. Our range of services provides cost-effective solutions to support placing your products on the European market. Our areas of support for plant protection products include: OO Conducting risk assessments at the EU level; OO EU active substance and product dossier regulatory submission and project management; OO more than 100 years worth of staff experience working within the plant protection sector with Blue Frog Scientific being established since 2010; and OO 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: OO HMPs: AIDS, chronic kidney disease, ataxia, an.-inflammatory, hypertension, diabetes; OO VMPs: antibiotics, parasiticides, coccidiostats, antipyretics; OO all classes of cattle, swine, sheep, poultry; OO oral drenches, injectables, pour-ons, in feed, in drinking water; and OO product defence, particularly for two ‘priority list’ substances.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006

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

2007

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

2008

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

2010

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

2010

Development of agrochemical consulting services.

20112018

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

2016

Development of biocides consulting services

2018

Formation of Blue Frog Scientific in Republic of Ireland

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.

www.chemicalwatch.com/SPG

Profile: Blue Frog Scientific Limited

Profile: Cardno ChemRisk

SERVICES PROVIDED

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 popularise 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% Consultancy/advisory 30% Training 10%

Legal 40%

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) programmes. Our work extends to diverse sectors, including energy, pharmaceutical, technology, healthcare, and food and beverage industries. Services include: OO Exposure assessment; OO industrial hygiene support; OO occupational toxicology; OO chemical hazard and risk assessment; OO ehs program development; OO risk communication and training; OO regulatory compliance; and OO 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, available to aid companies in decision-making and helping to ensure their chemicals or products align with US and international regulatory standards. We provide support for: OO REACH; OO TSCA; OO COSHH; OO GHS-based regulations; OO US HCS;•CLP; OO global chemical notifications; OO food contact; OO medical devices regulation; OO biocidal products regulation; OO EU cosmetics regulation; OO agrochemical registrations; and OO others Product quality Cardno ChemRisk scientists have assisted companies to better understand 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. Product areas include: OO consumer product safety; OO medical and pharmaceuticals; OO personal care; OO electrical and electronics; OO toys/children’s products; OO cleaning products; and OO 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. Risk assessments include: OO site-based risk assessment; OO environmental monitoring; and OO environmental fate and degradation

Global Service Providers Guide 2021

CORPORATE DEVELOPMENTS & ACHIEVEMENTS OO OO OO

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 the 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. 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 AND CLIENTS Cardno ChemRisk has experience partnering with various organizations, such as laboratories, non-profits, government entities, and trade associations. TESTIMONIALS References can be provided upon request. CASE STUDY 1: Tyre and Road Wear Particles Our multi-disciplinary team of scientists has been a product stewardship and sustainability consultant to the tyre industry for more than 15 years. An important focus of our research has been on Tyre and Road Wear Particles (TRWP) generated by the necessary friction at the surface of the tyre and road. Our team has helped the industry address human and environmental health risk questions about their products through applied research efforts. CASE STUDY 2: 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 3: Chemical Carryover during Food Transportation We were contacted regarding unexplained odour coming from a food product. Upon investigating further, we determined that the odour 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 they had to address. CASE STUDY 4: Consumer Product Ingredient Safety Evaluation We were asked to evaluate the safety of active ingredients found in sunscreen. For this project, we assessed 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 5: Chemical Hazard Classifications for EU and US Regulations Cardno ChemRisk has worked with many companies to evaluate proposed hazard classifications for chemical substances under various international, EU and US regulations. For example, we evaluated reproductive, developmental and lactation hazard potential for an alcoholbased consumer product, and mutagenicity and carcinogenicity hazard classification requirements for certain industrial solvents under GHS and REACH. Detailed analyses were used to support comments to regulators that can impact final classification requirements and provide robust science rationales on chemical hazards for outreach to the public health community. CASE STUDY 6: European Medical Device Regulatory Support Our scientists have provided technical support to a consortium of 14 medical device companies addressing regulatory challenges regarding the classification of the carcinogenic and reproductive hazard potential of cobalt in the EU. We presented our findings to the notified bodies designated for the EU medical devices, to help them respond to upcoming regulatory guidelines. STAFF SELECTION Marisa Kreider, PhD, DABT, Principal Dr Kreider is a board certified toxicologist 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 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 Dr Andrew Maier has more than 25 years of professional experience in the areas of environmental health, occupational hygiene and toxicology. He has led numerous projects and has coauthored 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). He has been a leader in occupational and pharmaceutical risk assessment methods. Ken Unice, MS, Principal Mr 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 Ms 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), perfluorinated compounds (PFCs) and bioaerosols.

www.chemicalwatch.com/SPG

Profile: Cardno ChemRisk

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 1875 614555

Contact

Koen Mondt

Directors

James Foster

Ownership

Public limited company

251 Ballardvale Street Wilmington, MA 01887 United States

Locations

Global locations and offices

SERVICES PROVIDED

Founded

1947

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

Laboratory 95%

GLOBAL OFFICES

OVERVIEW Charles River is the market-leading provider of contract testing services to the pharmaceutical, chemical and agrochemical industry, and has been providing high quality research models and laboratory animal support expertise since 1947. Our unique safety assessment portfolio spans the entire research and development process, allowing for flexible, customised approaches to support both single study and broad based programmes. With facilities in Europe and North America, we are well positioned to help optimise the discovery and development of our clients’ drugs, devices, 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 carcino-genicity 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

2019/20

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group Staff, chemical service provision

Global Service Providers Guide 2021

17,000 -

Regulatory support Charles River can advise and assist in many ways, including designing a registration strategy for REACH that suits the needs of a substance and/or portfolio. We partner with clients across the whole 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 decades 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 characterise 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, medical device 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 more than 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 OO OO

40+ years’ experience in nonclinical toxicology Experienced in project development, acute to chronic in vivo toxicology, DART, genotoxicity, structure-activity assessments, ecotoxicity and physical chemistry.

Head, Regulatory Affairs OO OO

Joined Charles River in 2010 25 years’ experience in agrochemical, biocides and chemical regulatory affairs Leads a team of more than 25 regulatory affairs experts, which provides support for the registration of chemicals, biocides, agrochemicals and pharmaceutical products

Senior Director, Laboratory Sciences – Biosciences OO OO

Joined Charles River in 1994 Oversees the scientific disciplines which investigate the nature and magnitude of residue in the environment, crops and animals. 25+ years expertise in the design and conduct of studies intended to characterize the fate of chemicals in the environment and to study the nature of metabolites and metabolic pathways using a range of chromatographic and spectroscopic techniques.

Head, Discovery Environmental Sciences and Ecotoxicology OO OO OO

Joined Charles River in 1991 25+ years’ experience Specializes in aquatic toxicity (short and long-term), biodegradation and terrestrial toxicity. 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? CHEMDOX® software supports experts in all tasks regarding hazardous materials management, including:

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, US

Founded

2011

SDS authoring software Generate SDSs efficiently and ‘translate’ your SDSs into more than 50 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. Through frequent interaction with all CHEMDOX® users, a wide variety of applications and use cases have been developed, and we are constantly adding new ones. Even special use cases – such as private labelling – are handled efficiently. Classification calculators Improve regulatory compliance when classifying chemicals according to different regulation types (eg GHS, transport, national regulations). CHEMDOX® regulatory calculators provide automatically computed classification suggestions.

OVERVIEW CHEMDOX® provides an outstanding software solution for the chemical industry, including on: OO classifying chemicals according to numerous regulations; OO generating high-quality safety-related documents in the most efficient way; and OO assuring regulatory compliance. What our clients like about us? 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 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. CHEMDOX® is a 100% subsidiary of UCS – unique computing solutions gmbh – developing high-quality software since 1999. VITAL STATISTICS

2019/20

No of offices

No of countries represented

Europe, Americas

Staff, group

50+

Staff, chemical service provision

20+

SERVICE AREA BREAKDOWN Training 20%

Poison centre notifications Create poison centre 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 Meet global regulatory requirements on a best-practice level – current and up to date for all major markets in Europe, the Asia-Pacific region and the Americas. Chemical management software With CHEMDOX® software, including its legal content and substance database, managing your chemicals is easy and efficient. Track your substances to stay up to date and compliant. With these tools, 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 SDSs automatically with no manual effort. System integration and data exchange 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 OO All benefits of a web-application with the perfect usability of a desktop application OO State-of-the-art technology makes CHEMDOX® future-proof OO Freedom of choice regarding hardware, operating system, and installation scenario Training, support and professional services Updates and support

IT & software 80%

Global Service Providers Guide 2021

Create multilingual hazard labels with our flexible label editor or integrate CHEMDOX® with your existing solution. 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 training for users, as well as technical training (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 and SaaS For your comfort, CHEMDOX® can also be installed on our servers and is accessible via an internet connection. By adding the CHEMDOX®️ Hosting service to your rental plan, you easily get an SaaS solution. Configuration and customisation options OO Installation, implementation and configuration support for the CHEMDOX® software OO Connection of your ERP system to CHEMDOX® OO Data transfer or migration from other programs OO Implementation of interfaces to other systems OO Development of special software modules OO Document template configuration CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1999

UCS – unique computing solutions gmbh

2011

CHEMDOX GmbH

2016

CHEMDOX Inc.

PARTNERS OO OO

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

CASE STUDY 2 A consulting firm had to replace the software solution for their main service: SDS authoring. In this case we: OO enabled the migration of 25,000+ products to CHEMDOX®; OO gave comprehensive regulatory and language support; OO respected the customer’s corporate identity when authoring SDSs; and OO ensured a strong focus on accuracy and efficiency. CASE STUDY 3 A multinational company wanted to avoid differences in product information or documentation due to multiple software installations in their subsidiaries. In this case we: OO ensured the centralisation of product and regulatory information, as well as documentation in CHEMDOX®; OO ensured that working remains decentralised, taking into account official languages, national legal terminology, as well as national regulations and national GHS-implementations; OO set up a web-application with the perfect usability of a desktop application, but without the need for a local client installation; OO built a multilingual user interface including regional specifics (eg date, time or number formats); OO ensured fine grained permission settings, versioning, change history, statutory retention; OO made quality improvements and efficiency gains due to collaboration across the subsidiaries; OO enabled interfacing with multiple IT systems: OO keeping ERP system and CHEMDOX® in sync; OO generating labels in a high through-put production environment OO with variable data like batch numbers, individual barcodes, etc; and OO distributed technical information and technical datasheets generated with CHEMDOX® to different systems.

CLIENTS

STAFF SELECTION

CHEMDOX® clients range from medium-sized companies to multinationals across all industries and the chemical supply chain. They include: OO authorities; OO substance producers; OO formulators; OO industrial users (e.g. automotive); OO regulatory consultants; and OO distributors, etc.

CHEMDOX® Team The CHEMDOX® staff includes professional, qualified, and skilled experts from the areas of chemistry, law, and software engineering. We work as a team to constantly improve CHEMDOX® and our outstanding customer support.

TESTIMONIALS We work very closely with our customers, appreciate their input, and strive for a durable, long-term partnership. Find out for yourself: We would be happy to connect you with one of our customers.

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 had to implement a chemical management solution for compliance reasons. In this case we: OO managed and checked SDSs and regulatory information provided by suppliers for plausibility; OO automatically tracked the regulatory status of substances in use (classification calculators); OO complied with the Global Automotive Declarable Substance List (GADSL); and OO integrated with SAP® for substance volume tracking and VOC reporting.

www.chemicalwatch.com/SPG

Profile: CHEMDOX

Profile: Chemical Check GmbH

SERVICE AREA BREAKDOWN Equipment Other Training 1% 1% 1% IT & software 20% Information 1%

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

Laboratory 1% Representation & management 10%

SERVICES PROVIDED

OVERVIEW Acting instead of reacting – source out your responsibility Since 30 years our team of experts analyses in close consultation with our clients which services fit the products and company structure best in the fields of: OO hazardous substances and chemicals management; OO dangerous Goods/ Transportation and documents; OO occupational health and safety/ Workplace safety; OO 24/7 Emergency response phone number; OO product notifications; and OO 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 No of offices No of countries represented

Consultancy/advisory 65%

2019/20 2 1

Staff, group

Staff, chemical service provision

Safety data sheets and chemicals management Services are offered from individual orders to comprehensive product portfolios. We count over 1,200,000 documents online. OO 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. OO 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. OO Update services – Automatic update services on a daily basis or after a specified period consider legislative amendments as well as updated raw material information. OO 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. OO SQL-Databases/web services – Structured databases for interaction with ERP- or logistic systems or other client specific web services and applications may be provided. 24/7 Emergency response phone number Our 24/7 Emergency response phone number is available 365 days a year. Services: OO is available for road, rail, air and sea carriers; OO complies to the US-directives (§49 CFR 172.604); OO may be entered into the safety data sheets as emergency call number of the company; OO up to 12 responders per shift such as doctors, chemists, skilled chemical workers; OO medical references for treatment of injured persons; OO information for fire brigade and auxiliary staff; and OO instructions for the proper disposal after an incident. 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: OO Article 45, Regulation (EC) No 1272/2008 (CLP); OO national product registries; OO notifications for detergents/washing and cleaning products; OO cosmetics; and OO biocides – national notifications

Global Service Providers Guide 2021

Dangerous goods/transport documents The tasks of our External Dangerous Goods Safety Advisors are OO regular inspections OO preparation of legally required reports OO employee training Consultancy services are provided for OO packaging and loading OO completion of transport documents, as IMO declarations OO 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 more than 3,000 employees as well as SMEs.

CASE STUDY 1 Full service chemicals management > 1,000 products including: OO compilation of safety data sheets and label; OO daily update service; OO SQL-database, customized content; OO provision of a 24/7 emergency number; OO automatic check and performing product notifications where needed; OO additional documents for washing and cleaning agents; OO around 50,000 documents online; OO provision of an External Dangerous Goods Safety Advisor; and OO provision of an External Safety Officer covering all subsidiaries for risk assessment. CASE STUDY 2

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 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

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

CLIENTS Our clients represent the whole supply chain of chemical products covering: OO national and international companies; OO large enterprises and SMEs; OO manufacturers, formulators, distributors; OO re-branding/ private label business; OO consumer, professional, industrial use; OO mixtures and substances; and OO liquids, solids, aerosols. Examples of product types covered: OO adhesives; OO colouring agents; OO construction materials; OO detergents; OO fragrance products; and OO lubricating agents.

Providing a SQL-database for interaction with ERP- and logistic system for product data, with more than 15,000 products. OO Customised parameter (UN, VOC, storage classes etc.) OO Plausibility/validity check of supplier data CASE STUDY 3 Providing of 24/7 emergency phone number for the use in more than 5,000 safety data sheets and for single transportations. STAFF SELECTION Karen Schnurbusch, founder, owner and manager Regulatory expert in all fields of chemicals management. Karen started the business in 1988, at the start of hazardous substances legislation as we know it today. Larissa Budde, manager A team member for 20 years, Larissa is a regulatory expert in chemicals management and product notifications. Our team of experts Our experts mainly have a chemical, biological or food technology background. Our staff enjoy continuous training and education for up to three years from our senior staff, and from internal and external training courses, to assure expert consultancy services for our clients.

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 firms working in the chemical industry. Our staff have many years of professional experience working with technical chemicals information and legislation. Our experienced consultants provide chemical regulatory support for companies, to help give them a competitive advantage in global market, by providing accurate, efficient and high quality services. CHEMLEG offers high quality consultancy services, at competitive prices. Our chemical regulatory consultants understand chemicals legislation and chemistry, with experience in chemistry and biochemistry. Our consultants guide customers towards the most efficient path to ensure compliance with chemical regulations. Staff qualifications include Chemical Assessment Expert (CAE for KKDIK-Turkey REACH expert), which is obligatory for the relevant Turkish regulations. CHEMLEG provides services globally and locally, working with trade and university associations, technical universities and laboratories. Our core service areas are: OO only representative service for KKDIK (Turkey REACH), Turkey CLP Regulation and Turkey BPR; OO KKDIK (Turkey REACH) compliance services; OO Turkey BPR Compliance Service; OO SDS/MSDS authoring services; OO SDS certification services for Turkish SDS; OO preparation of “label” and “technical information form” for general chemicals; OO CLP compliance (Turkey CLP-SEA and EU CLP) and GHS compliance services; OO Turkish detergent regulation compliance services; OO training and consultancy services; OO CHEMLEG is partner with TELEMATIC for providing EPY SDS authoring software; OO technical translation services; and OO training institution for “chemical assessment expert” authorised by MoEU.

Global Service Providers Guide 2021

Consultancy/advisory 30%

Information 10% Representation & management 35%

SERVICES PROVIDED Only representative (OR) service OO KKDIK (Turkey REACH) regulation OO Turkey BPR regulation OO Turkey CLP regulation KKDIK compliance services 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: OO providing administrative management for the data owner; OO to be done pre-registration; OO join and follow-up all activities in the pre-SIEF and SIEF; OO following up consortium activities; OO determination of chemical characterization of the substances; OO data management and data-gap analysis for Turkey REACH; OO translation and compilation of EU REACH dossiers, including the uses, robust study summaries, CSR, CSA, risk assessment report etc., for creation of KKDIK registration dossiers (as from the start of 2020); OO translations of technical documents/test reports in preparation of the KKDIK registration dossier; OO uploading/submission of the registration dossier to KKS in Turkish by the chemical assessment experts; OO establishing of the substance inventory list under annex-17; and OO 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. CHEMLEG services: OO determination of the product’s scope; OO preparation of the BP license dossier for all product types; OO management of the licensing process; OO technical evaluation and suitability assessment for the physicochemical analysis and efficacy test methods; OO management of the analyses/efficacy test procedures; and OO assessment and translation of toxicologic, eco-toxicologic tests, risk assessment reports; Turkish CLP Regulation compliance services OO Classification of substances/mixtures supplied to the market OO Labelling and packaging of harmful substances/ mixtures OO Notification of hazardous substances to C&L (SEA) inventory through KKS OO Follow up the updated information of the substances OO Determination of label and packaging dimensions of hazardous substances and mixtures.

Turkey SDS Regulation and label compliance services Safety data sheets should be prepared in accordance with the Turkey SDS regulation/ KKDIK Annex-II by certified persons. In this context CHEMLEG authorise SDS and check/ review SDSs prepared by the supplier and certificate them. CHEMLEG sales EPY SDS authoring software including technical and regulatory support. OO preparation of safety data sheets; OO checking the safety data sheets compliance with the relevant regulation; OO certification of safety data sheets after review. SDS software CHEMLEG has a partnership with TELEMATIC for providing safety data sheet and label software to the Turkish market. EPY is a modular, integrated software suite developed specifically to help chemical companies comply with the regulations governing chemical products. In addition to full compliance with the Turkey and European regulation, the possibility of creating SDS and hazard labels has now been added for the Chinese, the USA and Canadian markets. We as CHEMLEG also provide training, regulatory and technical support on EPY. ACCREDITATIONS OO OO OO OO

Member of Istanbul chamber of commerce; SDS authorized certificate; Chemical assessment expert certificate; Training institution for “chemical assessment expert” authorised by MoEU.

PARTNERS TELEMATIC (Italy) for EPY SDS authoring software. CLIENTS CHEMLEG’s clients are companies working in the chemical industry and associated industries around the world, such as the UK, US, Norway, Italy, Germany, France, Bulgaria, Belgium, Netherlands, Japan, China, Russia, and more. Our clients span manufacturers, importers and downstream users in raw materials, biocides, paints and coatings, cosmetics, cleaning products, the petrochemicals industry, etc. CHEMLEG also works with consultancy companies in the UK, Finland, Italy, China, US and Germany, to help clients comply with Turkish chemical control regulations. CHEMLEG does not disclose client names, but they may be revealed upon request, if clients consent. STAFF SELECTION Elif Koç Elif is master’s degree of chemist. She is the responsible person for management of the OR process of regulatory compliance for KKDIK and biocides departments. She has CAE certificate expert. In order to enable companies to manage their internal KKDIK compliance process, she delivers KKDIK training within Technical University. Also, she delivers KKS utilization training for the companies. She worked as a research assistant at Istanbul Technical University for the scientific and technological research council of Turkey projects for years. She worked R&D departments as analytical method development & validation specialist for active substance and impurities. Then she moved to consultancy company as biocide department team leader. She managed lots of international companies’ biocidal products requirements for Turkey. She is experienced to manage physical and chemical properties of the product, analyses methods, toxicologicalecotoxicological profile. She carried out the first submission in Turkey for a biocidal product to be used for the purpose of R&D and managed all the process. Also, she is experienced in chemical technical advice on KKDIK substance characterization thanks to her technical background. She has more than ten years experienced in the chemical industry as a researcher and regulatory specialist.

Gökhan ARDIÇ Gökhan is chemist and health and safety expert, with a master’s degree from Marmara University. He has more than eight years of experiences with chemical regulatory services, especially safety data sheet authoring. He has a CAE certificate, and has compiled almost 10,000 SDSs in many different languages. He is also authorised to author Turkish safety data sheets, and is an expert on the classification, labelling and packaging (Turkey SEA/EU CLP) regulation. He gives training on safe usage and storage of chemicals, is the responsible person for CHEMLEG’s SDS authoring software, and provides technical and regulatory support for companies using this software. His specialities include: SDS authoring (including e-SDS with exposure scenarios); product safety; chemicals management; assessing toxicological and ecotoxicological test results from CSR; chemical labelling; technical and regulatory support. Mehmet Yolcu Mehmet is a chemist with a master’s degree and is a health and safety expert. He is trainer for chemical assessment expert. He has more than eight years of experience as a chemical regulatory consultant, especially with Turkish CLP/CICR and the EU REACH regulation for Turkish exporters. He has carried out thousands of C&L, CICR and SDS notifications for companies. In addition, he has delivered group and individual training on KKDIK, CLP, SDS and EU REACH regulations. He managed the project scope and processes for the EU REACH, Turkish CLP, CICR and Turkish SDS regulations for companies. He provides support for Turkish-based companies on their responsibilities under EU CLP and EU REACH when exporting products to EU member states. He can also interpret provisions of new or updated chemical regulations. Haydar Hazer Haydar has worked for the chemicals management department of the MoEU for twenty-three years. He helped establish the Chemicals Inventory System and Chemicals Registration System (KKS), and worked on harmonising the CLP and REACH Regulations for Turkey. He has been working on KKDIK and Turkey’s CLP Regulation since their harmonisation process began inTurkey. He ha sattended many national CARACAL and REACH meetings, as well as seminars and trainings as the representative of the MoEU. CHEMLEG’s other members As at the beginning of 2021, CHEMLEG has 17 members of staff, and regularly expands its team. CHEMLEG’s staff are chemists and chemical engineers. All team members have chemical assessment expert certificates. They have experience ranging from three to seven years within the field of chemical regulatory consultancy, including EU REACH, KKDIK, SDS authoring and biocidal products. They are also very experienced in interpreting toxicological and ecotoxicological tests. They are competent managers of chemicals regulation and provide accurate consultancy to all clients.

www.chemicalwatch.com/SPG

Profile: Chemleg

Profile: Chemsafe

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 to comply with international and national chemical and medical control legislation. Along almost 20 years Chemsafe has develop a unique expertise in Regulatory Toxicology provided to customer of different fields: from chemical including Biocides and Agro up to pharma, medical devices and food/feed. The company is organized in 5 Business Units as follows:

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

August 6, 2001

BU CHEMICAL

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

2019/20

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%

Consultancy/advisory 50%

Chemsafe provides its clients with strategic & technical support to comply with REACH and CLP/GHS as well as SDS and eSDS 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 study monitoring, CSA/CSR preparation, Human and Environmental Exposure Scenarios (ES), Risk Assessment (RA) and application of alternative strategies to testing such Read-Across approach and QSARS. SIEF/Consortia management as well as OR appointment for non-EU company is offered. UK OR service and UK REACH registrations are offered in partnership with a UK company. Biocides and Agrochemicals services are manged by the BU Chemical. Our specialized team can prepare and submit Technical Dossiers for authorisation of active substances and for registration of formulated products. We coordinate the regulatory strategy with the National and/ or International authorities as well as the preparation of the technical equivalence data for active substances. 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 in 2011. Cosmetics OO General regulatory consultancy and RP designation. OO Data evaluation, data gap analysis, read-across methodology, in silico method application, testing programme design, and study monitoring/coordination. OO PIF (product information file) or PSR (Product Safety Report). OO Administrative activity, including robust study summaries and substance information sheet (SIS) with ingredient evaluation. BU PHARMA 1) Safety OO OEL/OEB/ ASL for occupational evaluation OO PDE from cross-contamination evaluation OO ERA (Environmental Risk assessment) OO in silico with DEREK, SARAH, METEOR, ZENETH OO Extractables and Leachables toxicological evaluation OO Quantification/qualification of impurities. 2) GMP OO DMF preparation in CTD format (module 3, section 3.2.S) for the European registration, US and Canada. OO Internationals AUDITS for active substances, intermediates. OO Preliminary evaluation of all documentation for the dossier and DMF preparation. 3) GLP activity OO From candidate profiling to preclinical development. Study monitor and CROs selection. BU MEDICAL DEVICE

Representation & management 20%

OO OO OO

GLOBAL OFFICES Chemsafe Srl, Colleretto Giacosa (TO), Italy and Operative Office in Quagliuzzo (TO), ITALY

Global Service Providers Guide 2021

OO OO OO OO

Strategic/regulatory consultancy as per new EU Reg. n. 745/2017. MD class identification. Biological evaluation. Human health risk assessment. Technical dossier preparation; Quality system application Liason with regulatory bodies.

BU FOOD/FEED We advise our clients on legal and technical aspect. In particular: OO Consultancy OO Novel Foods OO Food Contact Materials (FCM) OO Nutraceuticals and Functional Foods OO Food additives, Enzymes and Flavouring OO Food supplements OO GRAS (Generally Recognized as Safe) OO Study Monitoring (toxicological, clinical) BU TRAINING Training ‘onsite’. Webinars and specific technical/regulatory courses are available on demand.

CASE STUDY 1: REACH testing programme Working 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. CASE STUDY 2: REACH dossier work More that 1,400 Reach dossiers completed, including lead registrant and joint submission; including some for UVCB substances. Our team has also completed a significant number of CSRs and hundreds of SDS and e-SDS STAFF SELECTION Dr Antonio Conto – Managing Director

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Biology Degree, European Registered Toxicologist (ERT). Founder of Chemsafe, >30 years of experience as Toxicologist

2001

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

20072008

REACH and OR services offered.

2009

Biocides and agrochemicals group creation.

2010

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

2011

Petrochemicals derivatives, waste, cosmetics and pharmaceuticals consortia management Staff increased to 12 people First biocides product dossier for two actives submitted and authorised

Dr. Francesca Fasano – Head of BU Chemical

2012

Pharma Business service created Staff increased to 14 people

Dr. Federica Carra, Head Quality System

2015

Operative offices moved to Parella (TO)-Italy and organisation in Business Units (BU)

Chemical-Pharmaceutical Technology Degree Qualified Person for Pharma companies Implementation of the ISO 9001-2015 in Chemsafe activities

2017

New Business development Manager

Dr. Camilla Conto, Deputy Head of BU FOOD/FEED

2018

ISO 9001:2015 Certification acquired BU Medical Devices created, 20 employees

Chemical-Pharmaceutical Technology Degree Master in food Legislation and Safety (London)

2019

BU Food/Feed created Acquisition of ILC Srl, a company active in GMP activities for pharma companies worldwide

Dr. Emanuela Fino, CFO

2020

Dr. Paolo Rossi, BDM Chemical Area Biotechnologist. Ten years of experience in the Business Development Management activities at international level Dr. Iavello Alessandra – Head of BU Medical Device Medical Biotechnologist, 8 years of experience Industrial Chemist and Chemist, 12 years of experience. Dr. Marco Rodda – Head of BU Pharma Biologist, European Registered Toxicologist (ERT), 10 years of experience

30 years of experience

New operative Offices open in Quagliuzzo (TO)-Italy New partnership with China, Brazil. 26 employees

ACCREDITATIONS Chemsafe is a full member of ORO, the EU Only Representatives Organisationand the Industrial Union of Turin and Federchimica, Italy PARTNERS ChemSafe is 100% privately owned. CLIENTS Our clients are manufacturers and importers in the market sectors: chemicals, pharmaceuticals, agrochemicals, biocides, cosmetics, food, feed, medical devices, nanomaterials and petrochemicals worldwide TESTIMONIALS Any companies requiring testimonials or references will be provided with them upon individual written request.

www.chemicalwatch.com/SPG

Profile: Chemsafe

Profile: Chemservice

SERVICE AREA BREAKDOWN Training 5%

CONTACTS Website

www.chemservice-group.com

E-mail

contact@chemservice-group.com

IT & software 10%

Head office

Chemservice GmbH Herrnsheimer Hauptstr. 1b, 67550 Worms, Germany Chemservice SA 13, 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, Managing Director Iberia Lara Dickens, Managing Director UK Christy Leeper, Managing Director Americas Jae-Seong Choi, Branch Manager Korea

Ownership

Privately owned group of companies

Locations

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

Founded

2007

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, beyond the bounds of chemical regulations. Adding up our collective professional experience, 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

2019/20

Turnover, group (w/o non-integrated affiliated companies)

~ €10m

Turnover, chemical service provision

~ €10m

No of countries represented

10 8

Staff, group (w/o non-integrated affiliated companies)

ca. 70

Staff, chemical service provision

ca. 60

Global Service Providers Guide 2021

Information 15%

Consultancy/advisory 45%

Representation & management 20%

GLOBAL OFFICES

OVERVIEW

No of offices (w/o non-integrated affiliated companies)

Other 5%

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 ChemAdvocacy Turkey, Istanbul, Turkey 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 ensure product safety, producer liability and consumer and environmental protection to regulate the marketing of chemical substances. As well as inventory notifications, we conduct registrations of biocides, cosmetics and food contact materials. With our offices and regional partners, we help you to comply with international chemical regulations such as REACH, K-REACH, UK REACH and KKDIK. Through our various legal entities, we also offer regulatory consultancy for the Swiss, South American and US markets. REACH and GHS/CLP We provide 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 environmental health and safety (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 10 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 letter of access (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 fulfil their registration obligations.

Via our legal entities Consortia Asia Co Ltd and ChemAdvocacy Turkey, we also offer consortia, LoA and data management services for K-REACH and KKDIK. 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 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 of Chemservice

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

2020

Extension of Chemservice offices in Germany and Luxembourg Merger of Chemservice EHNS GmbH into Chemservice GmbH

2021

‘Chemservice OR-Trustee’, the fully automated and web‐based successor of the well‐established REACH‐Code‐Model system, goes online for REACH, UK REACH and KKDIK. Launch of ChemAdvocacy Turkey

ACCREDITATIONS We are a founding 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. PARTNERS With our global network of experienced partners, we ensure that you get the best support to comply with chemicals legislation around the world. Our partners are located in Argentina, Belgium, Brazil, Canada, China, Colombia, France, India, Japan, Mexico and Taiwan, among others.

CLIENTS 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 original equipment manufacturers (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 completed around 200 notifications to the Turkish inventory, 400 nominations to the inventory in Taiwan, 75 notifications to the Thai inventory and around 1,500 inventory nominations in Eurasia (for example, Russia). We have supplied global inventory strategies for new substances and conducted notifications to chemical inventories, for example, Australia (AICS), Canada (DSL), China (IECSC), Korea (KECL), New Zealand (NZIOC), Philippines (PICCS) and the US (TSCA). CASE STUDY 2: ‘Chemservice OR-Trustee’ – a unique compliance solution for supply chains The REACH regulation does not distinguish between direct and indirect imports into the EU, which makes trade outside the EU with subsequent import into the EU more difficult. This is especially true when multiple companies are involved along a non-EU supply chain that formulate substances into mixtures with secret compositions. In such multi-level non-EU supply chains, manufacturers of substances usually do not know via which channels and in which products and quantities their substances are imported into the EU. The components that make up their products and who their suppliers and customers are represent confidential business information (CBI) that is closely guarded by distributors or formulators. Thus, neither non-EU manufacturers (represented by only representatives) nor importers can meet their REACH obligations without disclosing CBI and risking loss of their business. To address this, Chemservice developed a software-based solution in 2008 – the ‘REACH-Code-Model’. In 2021, this system was replaced by its fully automated and web-based successor ‘Chemservice OR-Trustee’, available for REACH, and for UK REACH and KKDIK. Many leading companies in the chemical industry globally benefit from this unique compliance solution from Chemservice. For further information, please see https://chemservice-group.com/ourservices/compliance-in-the-supply-chain/or-trustee. CASE STUDY 3: REACH dossier work We are experienced in the preparation and submission of around 1,250 tier 1, 2 and 3 REACH dossiers, including member and lead dossiers. Moreover, a significant number of new substance registrations (nonphase-ins), inquiry dossiers, product and process oriented research and development (PPORD) notifications, chemical safety reports and extended safety data sheets were successfully completed. On behalf of our clients, we have conducted more than 3,000 classification and labelling notifications. CASE STUDY 4: Korean REACH Chemservice Asia has made many new substance notifications to the Korean Inventory under the TCCA legislation. Our K-REACH experience is based on around 120 small volume substance registrations, 50 substance registrations and approximately 150 exemption confirmations. We act as OR, with around 3,500 substances contracted, and have considerable experience in managing K-REACH consortia and CICOs. 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.

www.chemicalwatch.com/SPG

Profile: Chemservice

Profile: China National Chemical Information Center

100

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

SERVICES PROVIDED

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

Lisa Zhong

Directors

Yubin Jie Victor Lu

Ownership

China state owned company

Locations

Beijing, China

Founded

1959

Market Consulting CNCIC provides clients with a full range of tailored market consulting services, such as in-depth analysis of market opportunities and risks from various angles of the industrial chain to assist clients in investment decision-making, market development and strategic planning. Strategy Consulting Based on its comprehensive market consulting experience to get in-depth insight into the market environment, competitive environment, policy environment and technological environment, CNCIC Consulting can provide businesses with the most viable strategic consulting services, help them enhance their core competitiveness, and become winners in the increasingly complex domestic and international competition. CNCIC Consulting has long worked with national and provincial chemical parks, and provided them with a tailored 'one-stop' consulting service based on their development environment and current situation, as well as their existing problems and development goals. Investment Consulting CNCIC upholds the concept of professionalism, authority, objectivity and foresight, explores investment opportunities, evaluates investment risks and formulates investment plans for enterprises, thus supporting their investment decisions.

OVERVIEW China National Chemical Information Center Co, Ltd (CNCIC), former Intelligence Institute of the Ministry of Chemical Industry, has become a leading consulting, research and information service institution for China's chemical industry since its founding in 1959. CNCIC Consulting has a highly-professional and well-experienced consulting team, combined with its scientific and rigorous methodology, global professional database resources and multi-field expert advisory group, providing authoritative, professional, objective and rigorous consulting services related to strategy, marketing, investment, product compliance, environmental and energy management, safety management, and chemical and material standards formulation for value enhancement. VITAL STATISTICS

Healthcare Consulting With rich and professional experience in pharmaceutical industry, CNCIC are committed to research in pharmaceutical, medical instrument and other important biomedical sectors and have a thorough understanding of relevant policies and regulations in China, trends of international medical technology, professional physicians and the pharmaceutical market dynamics.

2019/20

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

400

Staff, chemical service provision

200

SERVICE AREA BREAKDOWN Laboratory 10%

Other 2%

Information 9%

Environmental and Energy Management Consulting By using innovative and scientific technologies to provide integrated solutions, CNCIC is committed to helping chemical enterprises improve the efficiency of their energy use and management.

Representation & management 9% Consultancy/advisory 70%

Global Service Providers Guide 2021

Regulatory Compliance Consulting CNCIC has long been tracking relevant domestic and overseas regulations and policies regarding industrial chemicals, agricultural and household products, cosmetics, food related products, and pharmaceutical products, among others. With highly qualified experts, CNCIC is committed to providing professional, reliable and efficient technical consulting and compliance services to help clients control compliance risks. Services include: OO industrial chemical registration and notification such as EU-REACH and REACH-like regulations (EU, the US, China, Taiwan, Korea, Japan); OO biocides, pesticides registration; OO disinfectants registration; OO global GHS compliance; OO cosmetics and new ingredients registration and filing; OO food contact materials registration and notification; OO health food declaration; OO pharmaceutical registration; OO fertiliser registration and filling; OO 24-hour emergency service agent; OO local Only Representative; OO testing services; and OO customised regulation services.

Safety Consulting CNCIC provides on-site hidden danger investigation and identification, safety management consulting and auditing, safety management training, safety information and intelligence services for chemical enterprises and institutions to help them establish/improve safety management systems and thus improve their safety performance. Establishment of Chemical Standards CNCIC has been involved in the management and operation of the Secretariat of the Chemical Standardisation Branch of the China Standardisation Association, the Secretariat of the CSTM/FC05, the safety production management work group of the Standardisation Working Committee of China Petroleum and Chemical Industry Association, the Standardisation Working Committee of China Chemical Industry Information Association and other chemical standardisation organisations. By the end of 2018, CNCIC has led the drafting and revision of 599 standards, including various national, industry and group standards. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1959

Intelligence Institute of China Ministry of Chemical Industry (IICMC) 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

IICMC 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.

2020

Established Shanghai Branch.

ACCREDITATIONS ISO 9001 Quality Management System Information System Integration and Service Qualification CMMI Software Certification Information Security Service Qualification Certificate

CASE STUDY 2 One Japanese client planned to sell new pesticides to China, but they were not clear how to complete the registration. CNCIC suggested that the client register the new AI and formula at the same time. CNCIC also helped the client control the registration budget, formulate a thorough registration plan, start the risk assessment procedure in advance, test in optimised test labs, prepare a complete registration dossier, and helped the client successfully obtain the registration certificates of new AI and formula. With CNCIC support, the client successfully entered the Chinese market. STAFF SELECTION Peter Huang CNCIC Consulting CEO, previously worked in bio-pharmaceutical teams of well-known management consulting companies and held the post of Asia Pacific Vice President in a foreign chemical consulting company. He has acquired over 15 years’ experience in chemical consulting business, sponsored hundreds of chemical consulting projects and also assumed the position of project manager in major consulting projects. Peter Huang has rich experience in project management and execution. He has profound knowledge of various sectors in the chemical industry and can accurately perceive market dynamics and development trends of chemical sectors and propose unique insights. Victor Lu CNCIC Consulting General Manager, Mr Lu joined CNCIC and started consulting research work in 1996. He has more than 20 years of experience in petrochemical and chemical consulting research, and has provided professional industrial consulting services to domestic and foreign enterprises for many years. Mr Lu has led relevant teams in CNCIC Consulting to complete several hundred consulting projects regarding market analysis, industrial research and industrial planning. He also established the CNCIC Research Institute of Industrial Economics. The scope of research includes trending petroleum/chemical products, new material, coal, gas and salt chemicals, biochemicals, pesticides, organofluorine and organosilicon sectors, as well as energy, industrial and economic analyses.

TESTIMONIALS “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!” CASE STUDY 1 A chemical company plans to produce and sell chemical A in China, but they have queries about the specific market of the product. What should be done to comply with the regulations? The client came to CNCIC hoping to get answers to these questions and support to establish appropriate market strategies to successfully enter the market. CNCIC Consulting, with years of in-depth research into the Chinese chemical market, along with scientific and thorough investigations by its expert team, understands the current market, and its prospects. CNCIC can predict market opportunities and risks, provide a basis for investment decisions, and provide clients with market access suggestions. At the same time, CNCIC can manage the regulations involved in the production and marketing of the product. Based on its senior technical capabilities and good laboratory resources, CNCIC helped the client carry out registration work, for example hazardous chemicals and new chemical substance registrations. In the absence of any test data, CNCIC help the client obtain a level 2 general registration certificate of new chemical substances within ten months, and helped the client smoothly enter the Chinese market.

www.chemicalwatch.com/SPG

Profile: China National Chemical Information Center

101

Profile: CIRS

102

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

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

Ownership

Private company

Locations

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

Founded

2007

VITAL STATISTICS

Global chemical notification EU REACH only representative, EU REACH registration, China New Chemical Substance Notification, China Hazardous Chemical Registration, K-REACH/K-BPR and Kosha Registration, Taiwan TCSCA and Osha registration, chemical notification in other Regions: Japan, Philippines, US and Australia etc. Food and food-related product service in China Health food registration and filing, infant formula milk powder registration, food for special medical purpose (FSMP) registration. New food raw material registration, new food additive registration. Pre-packaged food regulatory compliance, formula review on prepackaged food, label review and translation for pre-packaged food. Regulatory compliance on food contact materials and articles (FCMs), new food contact resin and additive registration (FCN). Cosmetics and ingredients registration in China CFDA registration, new cosmetic ingredient registration, toxicology safety assessment, formula and label review, the customs clearance assistance, regulatory compliance testing. Medical devices registration in China Medical devices registration (recording), clinical trial, quality management system (QMS) consulting, compliance analysis and project assessment.

2019/20

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

400

Staff, chemical service provision

Approx. 45%

SERVICE AREA BREAKDOWN Training 5%

Other 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.

2020

CIRS UK Ltd. established

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 US – 3100 Clarendon Blvd., Arlington, VA 22201 CIRS UK LTD – Widegate Studio, 23 Widegate Street, London, E1 7HX

Global Service Providers Guide 2021

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, Export Access CLIENTS CIRS has worked with more than 4,000 clients and partners across many industries, including chemicals, cosmetics, biocides, agrochemicals, food, medical devices and consumer goods. Its services are used by 70% of Chinese chemical companies, including for global GHS, China REACH, EU REACH, K-REACH etc. Over 600 international corporations 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 us for more than five years and 80% 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. Worked on 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. Closely follows the implementation of dangerous goods rules and GHS in China, and has helped a number of international – in the top 500 – enterprises to conduct compliance audits, which are highly valued 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 2,000 registration dossiers, including 100+ LR dossiers. By expert use of Qsar and read-across instead of testing, she also succeeds in gaining compliance with K-REACH and DSL/NDSL for the chemical industry.

Cathy Yu – food sector manager/senior consultant, CIRS HQs Cathy Yu’s major in university was food science and engineering. She knows the food industry well, and has extensive experience in China of its food-related laws and regulations. She is often invited to advise foreign food and food supplements companies at international regulatory conferences. She has worked for the CIRS Group for more than seven years and leads the Food Business Division to assist globally well-known food companies. Charles Chang – deputy GM/Senior Consultant, CIRS Nanjing Ten years of experiences on global chemical regulation consulting and software solutions. He has solid knowledge on hazardous substances, full material declaration and supply chain transparency. The Green Product Management system(GPM) and Chemical Safety Management system(CSM), developed by his team. have been adopted by many OEMs, importers and retailers around the world. Eric Xiong – chemical Sector Manager, CIRS HQs More than ten years’ experiences in product stewardship and regulatory compliance for the chemical industry. His team has provided solutions for hundreds of enterprises to achieve compliance in the EU, China, South Korea, Taiwan and other AP countries/regions, acquired hundreds of certificates for typical notification under China REACH, acted as lead registrant under EU REACH and K-REACH. Eric Xiong has also delivered talks on achieving compliance in REACH-like chemical regulations in dozens of professional seminars, workshops and conferences. Bryan Zhou – deputy GM/senior consultant, CIRS Ireland Six years practical experience on global chemical regulation including in the EU, China, South Korea and other Asian countries. His team has expertise and exceptional knowledge of EU REACH registration and OR transfer service, global GHS and how EU companies can fulfil their obligations under K-REACH. Edwin Wen – GM/Senior consultant, CIRS Beijing Ten years’ experience of our China medical device regulatory service. He leads a dedicated team to help global medical device companies to develop regulatory compliance procedures for medical device productsand formulate solutions for regulatory approval, clinical trials, quality assurance and gaining a manufacturing or distribution licence 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 looked at this in depth in mainland China and in Taiwan. More than 180 typical notifications of new substances have been completed by his dedicated team as well as more than 1,600 simplified notifications under MEP Order No 7 in China. He has a wealth of experience in chemical risk assessment, GHS standards and identification of chemical hazards, and has provided policy recommendations to chemical management authorities on many occasions. Cloris Pan – GHS team leader/senior scientist, CIRS HQs Graduate of Tsinghua University of China and University of Sheffield UK. She has more than seven years’ experiences with plenty of in depth work on global GHS along with hazardous chemical management in Asia Pacific. Since 2013, more than 30,000 SDSs have been authored by her team as well as more than 50 tailored training sessions for industry and China’s government. April Guo– personal care sector manager/senior consultant, CIRS HQs April Guo has worked for the CIRS Group for more than eight years and leads the personal care team to help globally well-known cosmetic companies and ingredient suppliers in regulatory compliance for thousands of products each year. She is frequently invited to give advice to foreign cosmetic companies at international regulatory conferences.

www.chemicalwatch.com/SPG

Profile: CIRS

103

Profile: CIS Center

104

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: OO consulting and development of regulatory strategy; OO chemicals state registration under the Decision of the Customs Union Commission of May 28, 2010 No. 299; and OO in-depth consulting on technical regulation of EAEU “On the safety of chemical products” (TR EAEU 041/2017), including notification and state registration. 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.

OVERVIEW CIS Coordinating and Information Center for 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 safe management of chemicals throughout the whole product life cycle, with focus on environmental and safety aspects. Our participation in international fora such as APEC Chemical Dialogue, UN GHS Sub-Committee, SAICM and the 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 held an annual chemical conference, training seminars and discussion events with representatives from government, industry and the scientific community, to enable constructive dialogue on topical issues in chemical regulation. VITAL STATISTICS

2019/20

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Other 20%

Training 5%

Consultancy/advisory 50%

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

Global Service Providers Guide 2021

Testing of chemicals Via laboratory network we organise testing of chemicals for the purposes of: OO identification of chemicals under TR EAEU 041; OO toxicology and ecotoxicology assessment; and OO exposure assessment, etc. CIS Center has already successfully implemented QSAR method. Moreover, our specialists were the first to use it in Russia. 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: OO classification of chemicals and mixture (the series of standards); OO labelling of chemicals. General requirements; OO dangerous goods. Classification and marking; and OO marking of cargoes. CIS Center will help you 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. 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: OO classification, labelling and SDS development under the Russian national standards; OO compliance with the requirements of the technical regulations of EAEU “On the safety of chemical products” (TR EAEU 041/2017); and chemical risk assessment and management etc.

Proficiency Testing Programs (PTP) CIS Center has a licence to provide proficiency-testing programs to a wide range of products according to Russian and interstate standards (GOST R / GOST). CIS Center is the only organisation 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, putting Russian laboratories on the world stage. Also in 2018, CIS Center signed an Agreement with IIS (Institute for Interlaboratory Studies, the subdivision of SGS) to organise different interlaboratory crosschecking programmes under the IIS (SGS) logo in Russia and the 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®. More information on http://epdrussia.org. 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 organise different interlaboratory crosschecking programmes under the IIS (SGS) logo in the territory of Russia and the EAEU. Organisation of the international conference on actual issues of chemicals regulation with focus on TR EAEU 041/2017, held in Astana, Kazakhstan.

2020

Implementation of QR-codes in Russian SDS to increase document security and simplify access to basic information on product hazards

PARTNERS ASTM International, ChemAdvisor, CRAD Cevre Risk Analiz Den. Ve Egitim Hiz AS, EPD International AB. CLIENTS CIS Center assists a broad range of companies in the chemical and petrochemical industry. We work with both large international companies and SMEs. 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 (standalone or within a mixture) for inclusion in the Register, thereby declaring them as existing in the customs territory of the Union. Since the entry into force of the TR EAEU 041/2017, you must notify all chemical substances that are not in the Register (a long and expensive procedure) before they can be released to the Union market (even as part of the mixture). In Russia, data may be submitted only by a Russian resident (Russian legal entity). A foreign company that does not have a branch in Russia must appoint a Russian representative for data submission. CASE STUDY 2: Russian SDS Russian SDS creation is not obligatory until the technical EAEU regulation “On the Safety of Chemical Products” enters into force. However, the reality is that customs may have specific requirements and usually demand to see this document at the customs border. In the course of our work, 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 money due to the delay at customs. Such companies are usually aware of Russian SDSs, 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 is 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 SDSs and labels in advance, which will save time and money by avoiding delays at customs. STAFF SELECTION CIS Center team CIS Center is a team of experienced professionals working in the field of chemicals management throughout a product’s life cycle. Our specialists are directly involved in development of Russian national and interstate standards, and always possess up-to-date information on national and international chemicals control legislation.

www.chemicalwatch.com/SPG

Profile: CIS Center

105

Profile: Concept Life Sciences

106

CONTACTS Website

www.conceptlifesciences.com

E-mail

info@conceptlifesciences.com

Head office

Registered Office: Heritage House, Church Road, Egham, Surrey, TW20 9QD Head Office: Frith Knoll Road, Chapel-en-le-Frith, High Peak, Derbyshire, SK23 0PG United Kingdom

Tel

01298 816700

Contact

John McManus, Business Development Manager

Directors

Dr Mark Carnegie-Brown

Ownership

Concept Life Sciences Integrated Discovery & Development Services Ltd is owned by Spectris plc

Locations

Concept Life Sciences (IDDS) Ltd has locations across the UK. Spectris plc operates globally. See www. spectris.com for further details.

Founded

Concept Life Sciences IDDS Ltd was founded in February 1989. The company was purchased by Spectris plc in January 2018.

OVERVIEW Concept Life Sciences is a knowledge-based, science-led contract research organisation providing a wide range of innovative and integrated solutions to clients in the agrochemical, petrochemical, chemical, cosmetics and consumer products sectors. Concept Life Sciences has a proven track record in delivery of world class solutions focused on synthetic chemistry, analytical chemistry (GLP), ADMET services and investigative and exploratory toxicology, including assessment of nongenotoxic carcinogens, endocrine disruptors. Concept Life Sciences is also experienced in providing support to the crop protection, chemicals and consumer products sectors. SERVICE AREA BREAKDOWN

Consultancy/advisory 30%

Laboratory 70%

Metabolites & standards Highly skilled chemists are able to quickly produce complex analytical standards, metabolites and impurities, as required for testing across a number of sectors. This synthetic expertise is supported by extensive cutting-edge analytical instrumentation from our dedicated analytical scientists. Process chemistry Concept Life Sciences develops scalable, innovative, safe, economical and robust processes for synthesis intermediates, target molecules and active ingredients (AIs). Fit for purpose solutions are designed to meet your urgent needs for the delivery of complex molecules on time and in full. Our highly skilled process PR&D team enables clients to overcome complex challenges by connecting science and providing results. Analytical Concept Life Sciences provides an unrivalled breadth of analytical solutions, instrumentation/techniques and applications to the agrochemicals, biocides, food and feed sectors, including pesticides. Physico-chemical properties As part of Concept’s analytical capabilities, we provide services for physico-chemical testing, storage stability and method validation. Our highly skilled team has decades of experience designing and delivering studies tailored to customers’ specific requirements. We offer a wide range of studies to meet client requirements, suitable for worldwide submission according to Good Laboratory Practice (GLP) standards and OECD principles. To attain regulatory compliance, we can confidently satisfy all regulatory requirements, including: OO REACH testing OO Biocides OO SANCO requirements 5 batch studies Concept Life Sciences offers complete purity profiling and characterisation for 5 batch analysis and preliminary analysis studies to GLP or non-GLP requirements for worldwide registrations. This includes optional impurity pre-screening work. Toxicology Concept Life Sciences is a leading provider of predictive, mechanistic and investigative pharmacology and toxicology solutions to the chemical, agrochemical and consumer product industries. Human relevance toxicology Concept Life Sciences offers world-leading expertise in conducting mechanistic investigations to evaluate the human relevance of rodent liver non-genotoxic carcinogenesis. We generate data used to support submissions to multiple regulatory agencies, including the European Chemicals Agency (ECHA) and the Environmental Protection Agency (EPA). Endocrine disruption Concept Life Sciences provides tailored mechanistic investigations to expertly evaluate the potential of chemicals to disrupt endocrine signalling. Assays include both the OECD Tier 2 endocrine disruption and bespoke thyroid assays. Neurosciences Concept Life Sciences have strong capability and experience in supporting neurosciences investigations and can assist with both in-vitro and in-vivo assessment of mechanisms.

GLOBAL OFFICES

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

See www.spectris.com

20192020

SERVICES PROVIDED Concept Life Sciences IDDS Ltd provides the following services: Industrial and consumer product chemistry Concept Life Sciences has one of the largest, most skilled and experienced chemistry groups in the UK, with over 25 years’ experience in the synthesis of novel organic compounds. Discovery chemistry Concept Life Sciences collaborates closely with you to understand the competitive landscape, providing you with data, scientific insight and interpretation to accurately inform the next stage of design success. Global Service Providers Guide 2021

Amplify Analytics is a partnership between Concept Life Sciences and its Spectris company colleagues, Malvern Panalytical, world leading suppliers of analytical instrumentation. Together, we offer flexible and scalable services which solve key challenges, reduce risks, and accelerate progress. Amplify Analytics offers a range of instrumentation and services, which extends from supplying access to specific analytical capabilities such as a method validation or transfer, to providing a fully integrated programmes of work.

2020

Accreditation at CLS Sandwich site Further expansion into our scale up and GMP manufacturing area.

2021

Concept continue to investigate how our strong history of support in mechanistic toxicology can be expanded. Endocrine disruption platforms have been developed and expanded and we look to use our skill sets to broaden across into neurosciences and ecotox mechanism support.

ACCREDITATIONS OO

GLP accredited at Concept Life Sciences’ Bradford, Dundee & Sandwich sites. ISO9001; 2015 at Bradford site

PARTNERS Concept Life Sciences conducts the majority of work in-house. However, approved partners are used for some services, including in vivo toxicology. CLIENTS Concept Life Sciences works with a wide range of clients in the UK and globally in the agrochemical, chemical and consumer products arena. Clients range from global suppliers to small scale chemical specialists. CASE STUDY 1: Analytical Services OO

REACH projects completed across technical and formulated product packages 5 batch studies following BPR, EU and global regulations

CASE STUDY 2: Non-Genotoxic Carcinogens Since 2001, we have worked collaboratively with clients to design and perform mechanistic investigations to understand the human relevance of rodent toxicological findings. Our adept scientists have recognised expertise in investigating rodent toxicology and its relevance to humans. By understanding the pathways that define the sensitivity of cells to chemicals, we evaluate the actual hazard to man. As an example, chronic activation of the nuclear hormone receptors CAR/PXR or PPARα in lifetime rodent carcinogenesis studies can lead to the development of liver tumours. Phenobarbital (PB) is one such molecule. Chronic exposure to PB does not cause liver cancer in humans as the mechanism is unique to rats and mice and is not considered to be relevant for humans. Demonstration that rodent liver tumours observed in chronic studies develop via a phenobarbital (PB)-like mechanism can lead to a non-carcinogenic classification. Using this approach, it is possible to prevent or reduce a carcinogenic classification. CASE STUDY 3: Endocrine disruption Concept Life Sciences are experts in regulatory studies for investigative mechanistic toxicology. Our specialist team of scientists offer a suite of endocrine disruptor assays which can be used to compare results across species and interrogate different mechanisms of thyroid hormone modulation, to evaluate the relevance of in vivo toxicology findings. We have delivered these packages for a range of clients across a range of assays including TPO, DIO, NIS, aromatase and cross species comparative induction of UGT gene expression.

STAFF SELECTION Dr Caroline German, Technical Director, Analytical Services Caroline joined Concept Life Sciences in 2015, on the acquisition of Agenda1 Analytical Services, of which she was a co-founder in 2006. She is currently Technical Director, Analytical services based at the Bradford site. Prior to Agenda1, Caroline spent eight years as a research scientist / project manager at Nektar Therapeutics, leading generics product development from lab scale to first in man using a novel SCF technology. She has a PhD in crystallisation chemistry, and more than 20 years’ experience in the field of materials characterisation. Her area of specialisation is powder properties and performance, including method development, method transfer and validation for a diverse range of techniques including X-ray diffraction, particle size analysis, specific surface area analysis, thermal methods (DSC / TGA / ITC / DVS) and elemental analysis (ICP, XRF, SEM-EDX). Caroline has led projects including: quantitative X-Ray diffraction method development and validation focussing on phase purity, stoichiometry and crystallinity; project management of transfer / validation of 18 release test methods for an inhalable product, product release and physical / chemical stability; investigations into the polymorphic form and stability of finished products, including oral suspensions, tablets and capsules. Dr David Leese, VP Chemistry Services David has over 15 years CRO experience serving the pharmaceutical industry and was appointed Group Head of Chemistry in 2015. Prior to that he was a laboratory-based scientist who progressed through the company with a proven track record of working on and leading projects for large pharma, biotech and academic clients across an extensive range of chemical series. This included overall project management of +20 scientists for a global pharmaceutical company and organisational lead on the steering committee used to maximise efficiencies for the multi-year collaboration. Dave has a particular interest in nucleosides and nucleotides and is co-author on a number of publications in this area. David has an MBA, a PhD in nucleophilic catalysis, he is a STEM ambassador, a member of the SCI Fi-ne Chemicals Group and a Fellow of the Royal Society of Chemistry (FRSC). Dr Graeme Clark, VP Bioanalysis & DMPK Graeme leads the Bioanalytical and DMPK teams that support investigative toxicology & DMPK programs, as well as standalone regulatory bioanalytical functions (Discovery to Clinical Study support). Graeme has a proven track record of increasing productivity and implementing novel and emerging technologies. His particular expertise is in bioanalysis, metabolism and pharmacokinetics of small molecules, industrial chemicals, mixtures, oligos, peptides and biotherapeutics, as well as ‘in vitro to in vivo’ extrapolation and analytical read-across approaches for REACH. Graeme has over 21 years’ experience in bioanalytical, DMPK, biomarker and biotransformation sciences. He has worked in academia, biotech, large pharma and contract research. He was previously Head of Analytical Sciences at Cyprotex. Prior to that he was Associate Research Fellow at Pfizer. Graeme is a Fellow of the Royal Society of Chemistry (FRSC), a Fellow of the Royal Society of Biology (FRSB), a Chartered Chemist (CChem) and Chartered Scientist (CSci). Dr Tilly Bingham, VP Science 19 years’ experience working in pharma R&D in ‘large pharma’ (Organon, Schering-Plough, Merck MSD), Biotech (RedxPharma) and the CRO industry. Matilda’s early career was spent working in CNS therapeutic areas where her research focussed on design strategies for getting small molecule therapeutics across the bloodbrain barrier. More recently as Head of Research and Operations at RedxPharma she headed the group that discovered and developed oncology and fibrosis clinical and preclinical candidates including theporcupine inhibitor RXC004 (oncology), RXC006 (fibrosis) and BTK inhibitor LOXO-305 (oncology). Matilda joined Concept Life Sciences in 2018 and was made VP Science in 2020, to develop and drive science strategy across the group. www.chemicalwatch.com/SPG

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Profile: CRAD

108

SERVICE AREA BREAKDOWN Training 15%

CONTACTS IT & software 15%

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

Information 5% Representation & management 25%

SERVICES PROVIDED

OVERVIEW CRAD is the leading consultancy in Turkey, providing advice on chemical regulatory compliance to 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, and the similarities and differences between regulations in Turkey and the EU. We serve more than 500 global chemical manufacturers worldwide in their compliance withTurkish chemical control Regulations such as Turkish CLP and the KKDIK, which is the 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 allaying any CBI concerns for exporters regarding sharing information with their local distributor. Thanks to our strategic partners around the globe, CRAD can also provide its clients global information with a local twist. Another core service covers the biocidal products Regulation and authoring Turkish compliant SDSs. Aiming to be a one-stop compliance solution centre, we always aim to enlarge our portfolio of services. Since 2020 we have a team of 17 consultants, experienced in their fields. 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 was also the first institution approved for training chemical assessment experts (KDU) by the Turkish Ministry of the Environment (MoEU). VITAL STATISTICS

2019/20

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2021

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: OO OR Services OO registration strategy consultancy- scope identification; OO submission of pre-registrations-registration dossier; OO SIEF Communication & follow up; OO communication with DU; OO consortium Management & data brokerage; OO data management and data-gap analysis; OO compilation of registration LR/JR dossiers; OO conducting/compiling robust study summaries, CSR, CSA; OO technical translation; OO services that are obliged to be conducted by cCAE-KDU in accordance with KKDİK Provisions; OO as an MoEU Accredited cCAE Training Institute providing KKDIK and CAE training and bespoke training for your team; OO other applications and inquiry to MoEU such as authorization, PPORD etc; OO full KKDIK compliance assessment; and OO 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 SEA Regulation. Our services include: OO acting as an OR in accordance with Article 41 of SEA; OO classification of substances/mixtures placed on the Turkish market; OO SEA-compliant Turkish label support; OO C&L notification of substances to SEA C&L inventory; OO follow up and reporting for ATPs applied to SEA Regulation; and OO alternative name application for confidentiality. SDS Compliance services in accordance with Turkish SDS Regulation & KKDIK Annex II Turkish SDS provisions are distinctive compared with those in the EU. A compliant SDS must be compiled in accordance with the country's SDS Regulation, in Turkish and by a certified compiler. After 31 December 2023 a SDS or e-SDS should be compiled by a cCAE. Our team of experts are all certified SDS expert/ cCAE and can compile Turkish SDSs in accordance with the SDS Regulation currently and KKDIK Annex II after 2023. Our activities include: OO SDS Compilation in accordance with Turkish SDS regulation; OO certified SDS Compiler review services; OO consultancy support for enhancing the phrase library and format in accordance with Turkish SDS regulation; OO bespoke SDS Compliance services for enterprises; OO regular trainings for certified SDS compilers; OO regular and Bespoke trainings on Turkish SDS compliance; and OO submission of SDS to the SDS notification system of the MoEU.

Biocidal product regulation (Turkish BPR) compliance Compliance with the Turkish BPR is essential in order to export and place biocidal products on the Turkish market. As a procedure which is complex and challenging for importers with CBI issues for manufacturers, OR & trustee services are critical for safe compliance. CRAD acts as a registrant and consultant, safeguarding your CBI at the same time as ensuring compliance. Our activities include: OO BPR Compliance Support and Consultancy; OO acting as representative/ registrant; OO label compliance in accordance with TR BPR; OO compilation of Provisional application & registration dossier; OO generation of compliant SDS & Label in according to Turkish SDS regulation/SEA Regulation with specific conditions that apply for BP; OO consultancy on frame formulation structure; OO strategy setup, organisation & consultancy for local testing; OO compilation of active substance dossier; OO bridging communication with Competent Authority; and OO efficient bespoke compliance solutions; Bespoke reporting on compliance for chemical products & articles Many global companies aim to expand their product range on the Turkish and neighbouring markets. It saves time and money to be aware of regulatory obligations before placing new products on the market. Accurate advice in the form of a report saves you from belated regulatory burdens and penalties. CRAD can provide you with targeted reports before you initiate your activity, change your supply chain or expand your portfolio. IT compliance & communication solutions IT tools are essential for compliance and widely used by all stakeholders from competent authorities to industry and downstream users. There is quite a workload related to obligatory communication up and down the supply chain and with authorities and co-registrants. With our cooperators we do provide IT solutions for: OO hazard Classification & SDS Compilation; OO communication IT solutions for DU; OO SIEF and Consortium management tools; OO M2M submission & notification tools; OO data brokerage systems; OO IT solutions for SDS Distribution and PCN; and OO 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 as per the provisions of KKDİK Annex 18 – unique among KKDİK service providers

2020

>500 Legal Entities are represented as OR under the scope of KKDİK. >50 K pre-registrations submitted. KKDİK MBDF Consortia platform has been established covering +500 substances.

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 make public the identity of our customers. We serve a portfolio of clients from multinational top ranking global chemical industry actors to SMEs who are seeking trustworthiness, expertise, reliability and cost efficiency for their compliance process. As a reader of this profile, I am sure you will choose our services if you have not done so already. TESTIMONIALS The best testimonial would be you selecting us as your consultant or OR, bearing these questions in mind when making your decision: OO Can I visit the premises of our OR with giving a short notice or no notice at all? OO Is your OR a Legal Entity nothing more than a registered company at a shared lease office? OO 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’’? OO 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? OO Are the consultants who serves you capable of fluent communication in Turkish for Competent Authority and DU’s and English with you? OO 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? OO 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 The biographies of our consultants can be found on our website. For further information, please e-mail, phone or visit us at your convenience. Why work with CRAD: Some of the reasons, for you to discover. 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. OO We always welcome our clients for face-to-face meetings so they can meet the consultants they work with. OO CRAD owns its offices. We are not a post box legal entity or a company registered as a lessee of an office letting agency. OO We are happy to give the biography of all our team members on our website. As a consultancy in Turkey we have high levels of capacity and expertise. OO We are a privately owned joint stock company by founding partners Melih Babayigit and Nur Babayiğit. We are not owned by an association, so our directors don’t change because of other influences. OO All consultants at CRAD are proficient in English so you can easily communicate with us. They are experienced in the technical terminology of EU and Global regulations. OO CRAD is a consultancy support and OR service provider, established in Turkey in 2007. With a wide portfolio of services, we are not dependent on a particular service area like KKDİK. So we are not like a 'liaison office of a global consultant’’ which is set up just for that legislation. This makes us more resilient. OO CRAD, with its own offices and without any debts to any financial institution, is capable of long-term running with owned equity. This enables us to invest in improvement and to cope with fast changing financial conditions.

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Profile: C.S.B Gmbh

110

SERVICES PROVIDED Brexit The UK’s exit from the EU changed the processes for all companies doing business with the UK. We are able to provide all the services required to maintain your business with the UK and still comply with EU and UK chemical legislation.

CONTACTS Website

www.csb-compliance.com

E-mail

info@csb-compliance.com

Head office

Düsseldorfer Str 113, 47809 Krefeld, Germany

Tel

+49 2151 652086 0

Fax

+49 2151 652086 9

Contact

Lars Dobbertin

Directors

Lars Dobbertin

Ownership

Privately owned company

Locations

Germany

Founded

1996

REACH We actively support our clients since 2007 in all questions and services regarding the REACH Regulation. Our wide expertise and diverse skills enable us to provide expert services for all requirements and challenges companies are facing. Our fields of expertise include: Only representative services Serving as OR for a wide variety of worldwide customers, we leverage our knowledge and experience to support companies in efficient supply chain management. With our interdisciplinary team we fully comply with the legal requirements for ORs. Administrative services We actively manage Siefs (data sharing, agreements) and consortia for our clients, eg. Iodine REACH Consortium, where we also take part in the Steering and Technical Committee. Management and organisational services Together with our clients we analyse their products/product portfolios to be able to determine actual needs, action plans and strategies for compliance. 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.

OVERVIEW For more than 25 Years, CSB Compliance has been a leading, familyowned, global consulting business for chemical compliance solutions, including safety data sheets and services for GHS/CLP, REACH or BPR. We have the expertise and knowledge to make chemical compliance a part of your business plan. You care about your business; we care about chemical regulations. VITAL STATISTICS

2019/20

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Consultancy/advisory 25%

Information 45%

Representation & management 30%

GLOBAL OFFICES US and UK

Global Service Providers Guide 2021

Scientific expert services We offer a wide range of scientific services and experience related to REACH registrations. As part of the data gap analysis at the beginning of each project, we develop – jointly with our client – an individual testing strategy including alternative methods, read-across or Qsar, act as study monitor for newly generated tests and evaluate study reports for all relevant endpoints (phys-chem, toxicological or ecotoxicological). Based on these results, we prepare the complete Iuclid 6 dossier and, if required, 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, interalia: OO management of authorisation processes; OO downstream-user consulting; and OO preparation of downstream-user CSR. GHS/CLP With our experienced and well-established team, we offer professional services for all regulatory needs concerning the “Globally Harmonized System”. For Europe, the most important ones include:

Safety data sheets We are able to prepare SDSs for all European and EEA countries, the US, Canada, Australia, most South-American and most Asian countries (including Japan, China, Korea, Taiwan and Thailand). For the European market, we also prepare extended safety data sheets (eSDS). Our Safety Data Sheet Services in overview: OO classification and labelling of substances or mixtures according to GHS; OO transport classification and labelling of dangerous goods according to the TDG-rules; OO preparation of a label draft according the applicable law; OO ongoing maintenance of SDSs; and OO preparation of compliant SDS documents. Product notifications in acc. Annex VIII CLP We can handle harmonized product notifications in their entirety, including the preparation of the UFI, for you. OO Preparation of the formula notification OO Generation and management of UFIs OO Submission through ECHA submission portal OO Ongoing management of formulas BPR With the long-time involvement of our staff in the biocides legislation we offer several services to fulfil the requirements of the BPR: OO approval of active substances; OO application for national authorisation and/or mutual recognition of biocidal products; OO application for Union authorisation of biocidal products; OO application according to Art 95; OO application for technical equivalence; and OO chemical similarity service. KKDIK The Turkish equivalent of the European REACH regulation came into force in the end of 2017. We check for you whether your substances need to be registered and ensure your marketability. We can help you in all questions regarding KKDIK, cCSA and Only Representatives for Turkey. 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

C.S.B. GmbH founded by Heinz Dobbertin

2007

REACH department established

2012

Biocides department established

2017

Lars Dobbertin appointed as General manager

2017

Expanding to US with Chicago office

2019

Acquisition of ReFaC Ltd. (UK)

2020

CSB Compliance – Establishment of a common brand focussing on optimising and expanding global services.

PARTNERS OO OO OO

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

CLIENTS We serve clients varying from small- to large-sized chemical manufacturers, formulators and traders worldwide. Our clients are active in most industry sectors, including specialty chemicals, detergents, pharmaceuticals, biocides, veterinary products, food additives, and more. CASE STUDY 1: Biocidal active substance We helped one client work out a strategic and scientific approach to apply for a new innovative active substance. As part of this project, we helped the client understand the requirements and necessities under the biocidal products Regulation for their specific substance and envisioned product. We then completed a full fledged data gap analysis and plan to present to the competent authority to start the application process. CASE STUDY 2: REACH authorization project For a larger international client we are currently managing the REACH authorisation of several substances within one product line. The success of the authorisation is crucial for our client’s production sites and ongoing European business. As part of the project we developed a strategic approach which fits the product 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 both authorities and industry. Complying with the ever increasing regulatory requirements is becoming an issue for many companies. As part of our SDS maintenance service, we make sure that our clients’ SDSs are compliant according to GHS/CLP and also national rules. We actively manage our clients’ product portfolios, ranging from 10 to 3,000+ products. Through our maintenance service we make sure that all SDS are up to date with the latest regulatory requirements. And we support our clients in managing their suppliers and customers, communicating directly – or through our client – with those parties. Our flexibility means we can offer holistic approaches to SDS management, or work out tailor made solutions according to the clients’ needs.

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

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Profile: C.S.B Gmbh

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Profile: Danish Technology Institute

112

SERVICE AREA BREAKDOWN Other 22% Consultancy/advisory 30%

CONTACTS Website

www.dti.dk/biocides

E-mail

mkl@dti.dk

Head office

Gregersensvej 3, DK-2630 Taastrup

Tel

+4572201139

Contact

Jonas Stenbæk

Directors

President Juan Ferré; Vice President Mette Glavind, Building and Construction; Vice President Sune Dowler Nygaard, Environmental Technology

Ownership

Self-owned and not-for-profit Institute

Locations

Denmark

Founded

1906

Training 14%

Laboratory 34%

GLOBAL OFFICES Denmark SERVICES PROVIDED Disinfectants and other biocides DTI offers physical and chemical testing of biocides and microbiological efficacy testing. Physico- chemical testing is performed in compliance with OECD, CIPAC methods or other validated methods. Efficacy testing is performed according to the required EN-norms given by BPR. Physico-chemical properties For the introduction of biocidal products on the market, we provide data required for authorization in accordance with BPR. Physico-chemical testing is performed in compliance with OECD and OPPTS guidelines, CIPAC methods or other methods referred to by BPR.

OVERVIEW The Danish Technological Institute (DTI) offers consultancy and services for aspects of 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 (BPR). 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 bio-films are tested in various systems. And the efficacy of building materials, such as paint systems and wood preservatives, are tested both in laboratory and field testing. Leaching testing (laboratory and field) and environmental risk assessment are performed for PT 6 to 10. The laboratories are accredited according to EN ISO/IEC 17025 by DANAK. The DTI also offers support in the preparation of BPR dossiers (Iuclid, R4PB). Studies of plant protection products (PPPs) are conducted in our laboratories in compliance with OECD and 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 geo-referenced sensor data.

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 DAD, ELSD or fluorescence detectors, ICP-OES and ICP-MS, and IC. All instrumentation is considered suitable for analytical methods according to BPR.

VITAL STATISTICS

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. We also offer proficiency testing of wood preservatives and paint systems, e.g. EN 330, EN 252 and TS 12037.

Turnover, group Turnover, chemical service provision

2019/20 €151m €31m

No of offices

No of countries represented

Staff, group Staff, chemical service provision

Global Service Providers Guide 2021

1,074 50

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 its physical, chemical and technical properties. Efficacy testing, product type 1-4 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 1500, EN 13624, EN 1650, EN 14348, EN 13697, EN 16615 and EN 17272.

Treated articles and biofilm Testing of the antimicrobial effect of other biocidal products, eg, treated articles and efficacy against biofilm in various systems according to relevant EN standards, ASTM standard tests or customised methods. Advice on choice of relevant test methods to fulfil the requirement within BPR and other legislation. Customisation of analytical methods according to the specific need of the customer and interpretation of results from performed tests. Possible tests for treated articles and efficacy against biofilm, eg, ISO 22196, ASTM E2149-13a and ASTM E2799 (MBEC assay).

CLIENTS

Environmental risk assessment and fate For almost 20 years, DTI has performed laboratory and semi-field leaching tests and risk assessment. The NT Build 509 semi-field standard (now TS 16663) was developed at DTI for wood preservatives but has shown its relevance for product type 6-10. Other methods include TS 15119-1, TS 15119-2 and EN 16105.

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.

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 provide assistance in preparation, submission of dossiers for product authorisation 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 or other validated methods. Our laboratory performs analysis of accredited biocidal and PPP products, eg, fungicides, herbicides and insecticides. Field trials DTI offers independent testing of pesticides, biostimulants, liquid fertiliser and other technologies in the field. Since 2008, we have been GEP certified, and have experience with many types of trials at both small plot and large scale. We can advise on choice of design, analytical methods and statistics. In our OnFarmPlus concept we use geo-referenced sensor data and advanced geo-statistics in order to maximise the power and validity of conclusions. 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

2019

Accredited to the new version of ISO 17025:2017

ACCREDITATIONS EN ISO/IEC 17025

A range of small- and medium-sized SMEs as well as large companies in Europe. TESTIMONIALS Specific references can be provided for potential clients on request. STAFF SELECTION

Helle Stendahl Andersen, MSc – Senior Consultant Helle has more than 15 years of experience with microbiology and is the Danish representative in the European standardization committee for chemical disinfectants and antiseptics (CEN/TC 216). She has more than eight 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. Jonas Stenbæk – Head of Section Jonas has a background as a microbiologist (PhD) and has experience in efficacy testing of paint systems, wood preservatives and other building materials eg. En 152, EN 113, EN 330. He is manager of a section within wood protection at DTI and working on environmentally friendly ant-microbial technologies for coating and wood preservation (PT6-8). He also handles the management of two tropical test sites in Malaysia for accelerated degradation and decay testing as well as physical and chemical UV degradation of coating surfaces. Berit Lindegaard – Business Manager Berit has a M.sc. in building engineering with expertise in material science. She has more than 20 years of experiences in development of coatings for wood protection and development of non- or low toxic anti-microbial coating technologies for wood protection. She is expert in field and lab testing of wood protection products (PT6-10) eg. TS 15119, NT Build 509, EN 16105, EN927-3, EN330 and environmental risk assessment based on these tests. Berit is working with environment legislation BPR (Biocidal Product Regulation) and writing applications for approval of wood protection products and biocides

PARTNERS Various projects in corporation with all major universities in Europe as well as larger companies and medium-sized enterprises (SMEs).

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Profile: Danish Technology Institute

113

Profile: EBRC Consulting

114

SERVICES PROVIDED Industrial chemicals – REACH EBRC offers comprehensive scientific, regulatory and administrative support on industrial chemicals, including: OO data gathering, literature searches, and evaluation; OO data gap analysis, closing of data gaps, and study monitoring; OO chemical safety assessment (CSA) and report (CSR); OO generation of “read-across assessment framework” (RAAF) documents OO PBT and vPvB assessment; OO technical dossier (Iuclid 6); OO identification of known uses; OO development of exposure scenarios for HH and ENV; OO risk characterisation; OO classification and labelling; OO safety data sheets; OO (Q)SAR calculation and reporting (QMRF, QPRF) OO consortium and Sief management; and OO preparation of CLH dossiers.

CONTACTS 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

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

2019/20

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

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

Consultancy/advisory 75%

GLOBAL OFFICES EBRC Consulting GmbH Raffaelstraße 4 30177 Hannover Germany

Global Service Providers Guide 2021

Agrochemicals Active substance approval and national product registration. EU notification of active substances governed under regulation (EC) No 1107/2009: OO support of existing substances in the context of the renewal OO programme of the EU (AIR); OO support of new active substances; OO completeness checks, validation of existing studies, literature surveys; and OO full dossier preparation including risk assessments, literature search report, submission and defence of dossiers in the review and evaluation process. Product registration dossiers for national authorisations in EU member states including zonal dossiers: OO aII dossiers (dRRs) for registration and re-registration of plant protection products, label extensions and formulation changes; OO services include compilation of all required documents, conduct of exposure and risk assessments, biological dossiers, advice in closing data gaps, the supervision of experimental studies, as well as submission of the application to competent authorities and attendant contacts/services during the registration process; and OO previous experience (among others) includes herbicides, fungicides, insecticides, rodenticides, nematicides and growth regulators. Biocides EBRC provides experienced support for all key phases of the evaluation and registration process of biocides. Dossier preparation and defence in the regulatory process both for active substances and biocidal products are our primary services. OO active substances (Inclusion into the BPR list of approved substances (Reg. (EU) No 528/2012)); OO biocidal products (registration/authorisation in EU member states); OO task force/consortia management; and OO evaluation of substances – as specified for industrial chemicals and agrochemicals above. Special services EBRC has in-house experienced scientific support for a wide range of statistical services: OO statistical (re-)evaluation of data; OO implementation of EU-models and/or scenarios (eg as given in OECD emission scenario documents); OO ready-to-use spreadsheet solutions for various applications (eg substance specification); OO probabilistic exposure assessments; OO derivation of species sensitivity distributions; and OO Bayesian approaches for (occupational) exposure assessments. Based on long-term involvement in major EU risk assessment projects, EBRC is very familiar with handling extensive databases, including: OO importing and (re-)structuring of data; OO online generation status update reports; and OO provision of web-interfaces for data-entry and analysis.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

STAFF SELECTION

1993

Foundation of EBRC (initial staffing: six people)

2016

Continual growth, leading to a current staff count of 58

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.

CLIENTS A wide range of companies producing agrochemicals, biocides and industrial chemicals and/or formulated products. CASE STUDY 1: MEASE On behalf of EUROMETAUX, EBRC developed a tool for the estimation and assessment of occupational exposure (MEASE) which combines approaches from the EASE expert system, from the TRA tool and from the health risk assessment guidance for metals (HERAG). It represents a widely-used first tier screening tool for occupational inhalation and dermal exposure to metals and inorganic substances. CASE STUDY 2: HERAG (Health Risk Assessment Guidance) With its extensive background in metals risk assessments, EBRC was contracted from 2005–2007 by the European metals industry to compile a guidance document for the human health risk assessment of metals and inorganic metal compounds. The Health Risk Assessment Guidance (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 REACH Regulation (EC) 1907/2006. 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.

Arne Burzlaff – Senior Registration Manager Industrial Chemicals Dr Arne Burzlaff graduated as a chemist (2000) and obtained a PhD in technical chemistry/biotechnology (2005). He worked for the German Federal Institute for occupational safety and health, Division for Chemicals and Biocides Regulation (2005–2007), on dossier evaluation for biocides, collaboration in EU working groups and scoping issues on borderline cases among legal frameworks. Since 2007, he has been working at EBRC as senior scientist/toxicologist. In this position he has been compiling REACH registration dossiers, with a focus on human health hazard assessment and risk characterisation, and initiation and monitoring of experimental studies on industrial chemicals. Andreas Büsing – Senior Registration Manager Agrochemicals Andreas Büsing graduated as a biochemist at the University of Hannover (1984). After years of experience in biochemical analytics with specific emphasis on the development and validation of immunoassays, he has been working at EBRC as registration manager for agrochemicals since 1999. His main responsibilities at EBRC include the co-ordination and supervision of dossiers for product registration and active substance approval under Regulation (EC) No 1107/2009, with focus on ecotoxicological risk assessments, data gap analysis and monitoring of experimental studies on active substances and plant protection products. Silke Burger – Senior Registration Manager Biocides Dr Silke Burger graduated as a biologist (2000) and obtained a PhD in molecular biology/toxicology (2004). Since 2006 she has been working at EBRC as registration manager for biocides. In this position she has been compiling dossiers in support of active substances approval according to Directive 98/8/EC and BPR (Reg. (EU) No 528/2012) and registration of biocidal products with a focus on human and environmental exposure assessments and risk characterisations, and further initiation and monitoring of experimental studies on active substances and biocidal products. Daniel Vetter – Senior Consultant Special Services Daniel Vetter graduated as Dipl-Ing agr at University of Hannover (2003). His main responsibilities at EBRC include the development and implementation of novel statistical techniques in human health risk assessments. He developed MEASE, an assessment tool for occupational exposure providing first tier estimates of inhalation and dermal exposure to metals. As part of his current work, he incorporates probabilistic techniques into the HEC (human equivalent concentrations) approach.

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Profile: EBRC Consulting

115

Profile: ERBC

116

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 2 48230023 / +39 06 91095263

Fax

+33 2 48261187 / +39 06 9122233

Directors

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

Ownership

Privately owned

Locations

France (HQ) and Italy

Founded

2019

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

OVERVIEW Born on 1 November 2019, when CERB (France) acquired the toxicology activities of RTC (Italy). By merging the complementary portfolios of pharmacology and toxicology, a new full service provider was created and renamed ERBC. ERBC is a European leader in non-clinical studies. It offers 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 multidisciplinary team of experts, notably in general, genetic and reproductive toxicology, carcinogenicity, pharmacology and safety pharmacology, non-clinical cardiology, electrophysiology and pathophysiology, also benefiting from a world class academic and private network. Every year, study reports from our two centres are successfully used in support of the market authorisation of new product approval submissions 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 3Rs 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

2019/20 2 250

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: OO animal facilities: dedicated facilities for each species (rodents, nonrodents including non-human primates) with surgical suites and histopathological laboratories; OO analytical laboratories (small and large molecules) for GLP and nonGLP analyses; OO secured data center; OO project coordination and management; OO full study reporting including SEND; and OO 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

CERB acquires RTC; Foundation of ERBC

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 2021

CLIENTS

STAFF SELECTION

We serve a wide range of clients, from SMEs to global corporations, consortia and industry associations worldwide. Confidentiality agreements preclude the possibility of naming them.

Pascal Champeroux

TESTIMONALS

Silvana Venturella

Testimonials can be provided upon request. 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 a 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 minimising the risks of late attrition during clinical trials, remembering that the lack of clinic efficacy is one of main causes of late attrition during drug development. ERBC offers the clear advantage 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 issues, mutagenicity, cardiovascular or neurological adverse effects. To detect these deleterious events as early as possible, ERBC conducts exploratory safety programmes combining in vitro and in vivo toxicity assays (in rodent and non-rodent species) and predictive biomarkers. To optimise 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 a reduction of animal numbers while sensitivity is maintained by using low variability models, appropriate statistical designs (biostatisticians in the team) and the application of very powerful approaches 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 final experimental phase (less than two weeks after the last experimentation). With more than 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 a 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 programmes that allow early detection of deleterious adverse effect and toxicity induced by new chemical entities. Together, these translational studies contribute to clarify the mechanism of action of a drug candidate and, obviously, improve risk-taking and decision making. To establish the toxicological profile of new compounds, or to extend the known profiles of an existing one (new indications, new formulations, new routes of administration …), ERBC offers a full range of services from exploratory programmes to fully GLP-compliant toxicology studies. The latter range from acute and chronic toxicity – with different species and multiple routes of administration – to specialty toxicology. These data support human clinical trials and marketing authorisation 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 a reduction in the use of animals and improve data predictivity and they participate in interdisciplinary working groups that shape the future of toxicology.

Chief Scientific Officer, Senior Expert in Pharmacology (Cardiovascular) and Safety Pharmacology Associate Scientific Director, In Vivo Toxicology Serena Cinelli Associate Scientific Director, 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 and Expert, Analytical Chemistry Department Jean-Michel Raimbault Head and 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

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Profile: ERBC

117

Profile: ERM

118 Strategy & Systems OO Product stewardship programme development OO Information management / IT enterprise sustainability systems OO Substitution of hazardous chemicals OO Auditing OO Post-merger integration OO Product due diligence OO Data Management with ChemDataSharing

CONTACTS Website

www.erm.com

E-mail

simon.aumonier@erm.com

Head office

2nd Floor Exchequer Court, 33 St Mary Axe, London, C3A 8AA, United Kingdom

Tel

+44 1865 384916

Contact

Simon Aumônier, Director of Product Services & Regulatory Affairs, EMEA

Directors

>550 Partners globally

Ownership

Private limited company

Locations

140

Founded

1971

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

2019/20

Turnover, group

$700m

Turnover, chemical service provision No of offices

$40m 160

No of countries represented Staff, group

40 > 5,500

Staff, chemical service provision

>200

GLOBAL OFFICES We support our clients in all countries globally.

Global registration of biocidal actives and products OO Regulatory support for active substances and biocidal products OO Compilation and submitting active dossiers for a wide range of product types OO Routine submission of national registrations OO Study design & monitoring Global registration of agrochemicals OO Preparation, submission and regulatory support of dossiers and national draft registration reports ; OO Track record of successful approvals and national authorisations OO Study design & monitoring Regulatory support OO New market entry planning OO Ad-hoc regulatory support OO Legal registers (product compliance) OO Horizon scanning for new regulations Hazard communication including safety data sheet (SDS) authoring Data collection /management, data entry/ review, classification support for chemical products and dangerous goods, safety data sheet and label authoring, SDS and label review and improvement. Audit & Field Monitoring Studies OO Supplier audits (TfS) & supplier risk assessment OO Compliance audits & preparedness checks OO Groundwater monitoring / eFate modelling OO Wastewater monitoring / mass flow calculation Lifecycle assessment and product sustainability OO Carbon footprinting and emission inventories OO Lifecycle management (LCM) also to ISO14040 OO Design for environment (DfE) OO Environmental product declarations (EPDs) OO Lifecycle analysis (LCA)

SERVICE AREA BREAKDOWN Training 10%

IT & software 20%

CORPORATE DEVELOPMENTS & ACHIEVEMENTS Consultancy/advisory 60%

Representation & management 10%

Global registration and authorisation of chemicals OO Training/ impact assessments OO Preparation of lead and member registration dossiers OO New chemical notifications; OO Chemical safety assessments OO CLP notifications OO Study design & monitoring OO Socio-economic analyses (SEA) OO Analyses of alternatives (AoA) OO Training OO Preparation of applications for authorization OO Sief management

2016

OO OO

2017

SERVICES PROVIDED 2018

ERM Wins 10th REACH authorization project with all completed projects receiving maximum review period (12 years) OO

Global Service Providers Guide 2021

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

Extension of service portfolio to cover food contact support services Development of Data Brokerage & Data Management activities through ReachCentrum, an ERM Group company

2020

Launch of the SustainAbility Institute by ERM, a Global think tank & advisory who inspire and enable business to lead the way to a sustainable economy

ACCREDITATIONS ISO 9001 and ISO 14001 PARTNERS Partner of ACC, Sphera, SAP, Lisam, Enablon CLIENTS In the past five years we have worked for more than 70% of the Global Fortune 100 and more than 50% of the Global Fortune 500 companies. TESTIMONIALS “Our company has a long history with JSC (an ERM group company). I have found the entire team to be extremely knowledgeable and professional in all engagements. Specifically, JSC’s expertise on biocidal products has been second to none across the industry. I highly recommend their services and assistance with biocidal active substance dossiers, biocidal products registrations and guidance on efficacy testing. The technical depth and quick response we have experienced on every request has helped us navigate challenging and ever-changing global biocidal products regulations.” Senior Regulatory Specialist, Milliken Chemical. CASE STUDY : Roche Product Design for Sustainability Summary: In 2020 Roche, who has been ranked for 11 consecutive years as one of the most sustainable healthcare companies in the Dow Jones Sustainability Index, amplified its commitment to sustainability by establishing a big ambition: improve product stewardship performance by 50% in 10 years. ERM worked in close partnership with the Roche team to articulate specific objectives for the program and co-create a Product Stewardship Performance tool aligned with Roche’s business and environmental goals, which its product development teams will use to evaluate and improve product design and performance at each stage of the product lifecycle. Benefits: The tool encourages product design with fewer toxic substances, lower resource demand, and supports the recycling or reuse of medical and pharmaceutical device components and packaging, among other Circular Economy goals. CASE STUDY 2: DuPont Sustainability and Emerging Chemical Issues Summary: Scientists learn more every day about the 45,000+ chemicals on the global market. As the public and regulatory agencies learn of those findings, they call for action. ERM is working with clients at the cutting edge of chemical sustainability. A team of ERM authors dug deeply into the data and published a book on this topic, entitled Emerging Contaminants: Anticipating Developments (CRC Press 2020). We are proud to work with global innovation leaders like DuPont, which recently acknowledged ERM’s engagement in a press release. Benefits: “To date, DuPont has achieved the following milestones... Engaging with ERM, an accredited third-party expert and leading global provider of EHS and sustainability related services, to review our management of substances of current and emerging concern to further improve our processes and protocols.”

STAFF SELECTION Linda-Jean Cockcroft, Partner Product Stewardship, EMEA Expert in regulatory business strategic advisory services as well as compliance and product sustainability, covering EU legislation as well as the EU Green Deal, the EU Taxonomy, Sustainability and the Circular Economy and related corporate reporting obligations. Dr Jo Lloyd, Partner Product Stewardship, EMEA An experienced Product Stewardship professional with 20+ years of expertise in EU REACH registration and authorisation challenges and more recently in UK REACH. She is also routinely involved in the assessment of gaps in product stewardship and chemicals management programs as a part of global diligence investigations and in supporting companies to optimise their programs and providing the tools to fill these gaps globally. Ruaa Ahmad, Principal Consultant, EMEA Sustainable chemistry advisor with experience in safer chemicals and alternatives assessment, emission reduction and process optimisation. She is also experienced in EU REACH, helping clients to understand requirements, substance identity, data gaps, study needs and chemical risk assessment. She has provided trainings for clients and conducted REACH-focused audits. Richard Elsmore, Partner, EMEA He has worked in technical, regulatory and business management positions and has been involved with a number of industry bodies on the implementation of the EU legislation and in the area of efficacy testing and claim support. He sits on the BSi Technical Committee on disinfectant standards (CH/216). Kathleen Sellers, PE Technical Director, North America Assists clients in building and auditing global product sustainability programmes and fulfilling specific regulatory requirements for chemical registration and reporting, hazard communication, and other product compliance requirements. Recently published her fourth book, Product Stewardship, Life Cycle Analysis and the Environment (CRC Press). Dr Beth Dederick, Partner, North America 15+ years of environmental consulting experience focused on supporting the chemical, oil and gas, and manufacturing industries’ compliance with North American product stewardship regulations. Led global compliance programs for clients with target markets in North America, Asia Pacific, Latin America, Europe, the Middle East, and Africa. Serves as the Vice President for the Society for Chemical Hazard Communication. Bonnie MacCulloch, Partner, North America 15+ years of environmental consulting experience, supporting clients in the crop protection, chemical, and manufacturing industries to meet global compliance in environmental, health, and safety impacts. She is an active member in the Biological Products Industry Alliance, CropLife America, the Product Stewardship Society, and Women in Agriculture. Maryann Sanders, Technical Director, North America An experienced Product Stewardship professional with 25+ years of expertise in regulatory affairs, toxicology and microbiology. She has experience in regulatory submission, auditing, training, and addressing unique client challenges. Dr Ken Liu, Team Leader ERM Taiwan, Asia Pacific MSc chemistry and organic synthesis, PhD Material science & engineering and polymer application, with more than 6 years’ experience in the new chemical materials development and national regulatory implementation for the government. Tommy Ju, Team Leader ERM China, Asia Pacific MS of applied chemistry, with more than 20 years’ experience in the chemical sector, competent product stewardship service for chemical substance management, site safety, dangerous goods transportation and emergency response in Asia Pacific.

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Profile: ERM

119

Profile: Eurofins

120

GLOBAL OFFICES Eurofins has office in 50 countries. Our main testing facilities for chemical/REACH services are located in Germany, UK, Asia and the US.

CONTACTS Website

www.eurofins.com

E-mail

info-munich@eurofins.com

Head office

Brussels, Belgium

Tel

+49 89 899 650 0

Contact

Iris Pfisterer

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 testing All relevant toxicology services for chemicals, agrochemicals, biocides and novel food are provided in cooperation with our AAALAC-accredited partner laboratories. This includes the classic studies from acute to repeated dose and teratogenicity studies. Emphasis is placed on in vitro testing with regard to the 3Rs strategy for refinement, replacement and reduction of animal studies. We have established a large range of in vitro assays for many endpoints. Our services include: OO OO

OVERVIEW

With more than €4.5bn annual revenues in 2019 and over 50,000 staff in more than 800 laboratories across 50 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, agro-chemical, 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. *reported in 2019 VITAL STATISTICS

2019/20

Turnover, group

€4.5bn

No of offices

800

No of countries represented

Staff, group

>50,000

SERVICE AREA BREAKDOWN Consultancy/advisory 10%

Laboratory 90%

Global Service Providers Guide 2021

OO OO OO OO OO OO OO OO OO

irritation/corrosion; sensitisation; dermal absorption; genetic toxicity; 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 Aquatoxicology 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, honeybees 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 We provide 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 Our experts have 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. We offer biodegradation screening and testing (OECD 301, 310, 314, 303 etc.) and environmental fate testing (OECD 307, 308, 309, 106). All these studies can be performed, including metabolite identification. Residue analysis Providing unparalleled method development know-how in the challenging discipline of residue chemistry, Eurofins can offer a full complement of ground and surface water monitoring, dislodgeable foliar residues, magnitude of residue analyses, as well as worker and domestic exposure studies.

Radiolabelling and custom synthesis We offer a full range of 14C custom radiolabelling services, the synthesis of unlabelled reference compounds (metabolites and impurities) and analytical chemistry services (including GLP certification if required). Our expert chemists can prepare C-14 labelled molecules of almost any complexity and have a strong background supporting regulatory studies acquired over many years in the life science and chemical industries.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

REACH services We provide the studies required for all tonnage levels according to Annex VII-X of REACH. Based on the large variety of chemicals tested for the previous REACH deadlines, we can effectively support you with any registration obligations, for example, for NONS or also for global registrations. Services include REACH product chemistry testing for all tonnage bands, environmental testing (terrestrial, fate, aquatic short and long term, endocrine disruptors), human safety testing (local tolerance, acute, repeated-dose and reproductive toxicology), 14C and special synthesis for REACH study conduct. 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 can provide histopathology services to evaluate the potential of chemicals to affect endocrine-sensitive tissues in fish, amphibians and frogs. In vitro safety testing for chemicals and cosmetics Eurofins is a leader in safety testing without the use of animals and is deeply committed to the principles of the 3 R´s of Replacement, Reduction and Refinement. With a set of alternative in vitro test methods we are able to provide the full service to assess necessary toxicological data under GLP-compliance or not. 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. 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 Helge Gehrke, Head of in vitro Pharmacology and Toxicology, Munich, Germany Dr Gehrke has more than 10 years of experience working in scientific institutes and the contract research industry, and drives the development of new in vitro assays within Eurofins. Dr. Philip Allingham, Chief Operations and Compliance Officer in vivo Toxicology Dr Allingham is a 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, Niefern, Germany 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). Marian Ponte, General Manager, Hercules USA Beginning her career as a bench chemist, Marian draws from her experience to continually improve on processes, methods and technologies and master the new challenges we face in the analytical world. 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: Fieldfisher LLP

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GLOBAL OFFICES Amsterdam, Barcelona, Beijing, Belfast (x2), Birmingham, Bologna, Brussels, Dublin, 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 7861 4000

Fax

+44 (0)20 7488 0084

Contact

Claudio Mereu

Directors

Claudio Mereu, Partner

Ownership

Limited Liability Partnership

Locations

Founded

1835

SERVICES PROVIDED

OVERVIEW Fieldfisher is a full service European law firm with over 720 lawyers (300 partners). The EU Regulatory Group advises international clients on domestic and EU law on large and complex multi-jurisdictional 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. Our lawyers advise and represent clients on matters arising out of a variety of EU products legislation, including chemicals (REACH), pesticides, biocides, cosmetics, medical devices, general product safety and ecodesign requirements and, more broadly, EU marketaccess legislation. We address related data protection, competition and other business law issues that arise when, for example, drafting and negotiating commercial agreements or setting up and running REACH consortia and task forces. VITAL STATISTICS

2019/20

No of offices

No of countries represented

Staff, group

1700

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training Consultancy/advisory 5% 10% Representation & management 10% IT & software 5% Legal 70%

Global Service Providers Guide 2021

Chemicals We have more than 20 years of experience in EU chemical law – compliance and litigation. We provide a broad spectrum of chemicalsrelated advice and deal with the most significant REACH implementation and compliance issues relevant for companies or for groups of companies (industry associations, task forces or consortia). We advise clients in the field of product regulation, on issues pertaining to the classification, packaging and labelling of chemical substances and preparations, safety data sheets, marketing and use restrictions, workplace regulations, and product liability related issues, as well as questions relating to the free movement of goods and parallel imports. We represent chemical companies before the European institutions, member state authorities, scientific committees, Echa Board of Appeal, and the European and national courts. Agrochemicals/fertilisers We advise major pesticide manufacturers on the European re-registration 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 including: initial notifications of pesticide active substances; joint and individual company dossier preparation and submission, including zonal applications and mutual recognition across jurisdictions; and 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. Biocides 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. We also provide support in making biocidal product authorisation applications in the member states. We advise 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/producttype combinations through the EU review programme for existing active substances, including counselling and representation before the European Commission and Echa.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 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; successfully obtaining reversal of the Echa decision.

20122015

Ground breaking annulment actions filed before the European General Court against commission regulations adopted under REACH

20162021

Management of about 40 consortia under REACH, BPR and pesticides renewals

ACCREDITATIONS The Legal 500 ‘A team of experts with an excellent knowledge of environmental and chemical law. The team is always looking to find a positive solution without becoming aggressive towards authorities and with the interest of the client as top priority‘. (2020) Chambers & Partners “An excellent team with accumulated expertise. The lawyers are “excellent and operate as a team.” (2020) CLIENTS Major chemical/pesticides/biocides, medical devices and pharma companies, small innovative companies. Industry associations, task forces and consortia: more than15 years’ experience in consortia and task force management. CASE STUDY: Centro REACH S.r.l. – Case A-005-2019 On 15 December 2020, in Case A-005-2019, Echa’s Board of Appeal (BoA) annulled an Echa decision rejecting an application by the appellants, represented by Centro Reach (the ‘appellants’ representative’), to refer to the studies on vertebrate animals contained in the registration dossiers for numerous dyes (the ‘substances’). Between November 2012 and March 2018, the appellants’ representative took part in data- and cost-sharing negotiations with REACH & Colours Kft, representing itself as lead registrant for some of the substances in question, and also the lead registrants for the remaining substances and the data owners for all of the substances. In March 2018, the appellants’ representative submitted an application to Echa for the appellants’ permission to refer to the studies on vertebrate animals contained in the registration dossiers for the substances. In December 2019, Echa rejected the application, considering that the appellants’ representative had not justified its refusal to share the information requested from REACH & Colours Kft, and had failed to make every effort to reach an agreement. The appellants contested Echa’s decision on two grounds, including Echa’s commission of a manifest error of assessment of the case. They argued that the information requested by REACH & Colours Kft was not a prerequisite for data- and cost-sharing negotiations, and that Echa was wrong to find that the appellants’ representative, in refusing to provide such information, had failed to make every effort to reach an agreement. Referring to Implementing Regulation 2016/9 and settled precedent, the BoA noted that Echa must grant a potential registrant permission to refer if “the previous registrant fails to comply with the requirements for dataand cost-sharing to be transparent, fair and non-discriminatory”.

As previously established in its Tecnofluid (II) decision (Joined Cases A-014-2018 to A-021- 2018, 23 July 2020), in order to comply with the transparency requirement, at the potential registrant’s request, the previous registrant must provide “clear and comprehensible explanations on”, amongst other factors, “which information is to be shared and on what basis”. As such, pursuant to Article 2(1)(a) and (2) of the Implementing Regulation, the previous registrant must provide the potential registrant with an itemisation of data and costs, if requested. The BoA found that, while identifying which appellant intended to register which substance is an essential element for the conclusion of a data- and cost-sharing agreement, the information requested by REACH & Colours Kft was not a prerequisite for negotiations to start, and the absence of such information was not prohibitive to providing the requested itemisation. According to Article 2(1)(a), data and cost itemisation only concern the nature and cost of information available for registration of a substance, and not the identity or number of potential registrants for this substance. Additionally, it might be impossible for a potential registrant to ascertain at the beginning of negotiations whether it would register a substance, as this could depend on information exchanged during the negotiation process. Furthermore, the BoA noted that the information provided by the applicants’ representative permitted REACH & Colours Kft to verify which appellant was a member of which Sief and therefore a potential registrant of which substance. The BoA therefore concluded that in failing to provide the itemisation of data and costs, REACH & Colours Kft breached its obligation of transparency under Article 2(1)(a) and (2) of the Implementing Regulation. As Echa’s decision did not refer to this breach, the BoA considered that Echa had not examined the parties’ “compliance with objective requirements of transparency, fairness and non-discrimination” during negotiations, instead basing its decision on a subjective analysis of the intentions and behaviour of the parties. Additionally, the BoA found that Echa should not have denied permission to refer based on a failure of the applicants’ representative to provide the information requested by REACH & Colours Kft, as this information was not a prerequisite for providing an itemisation of data and costs. Echa’s decision was therefore annulled. As the BoA did not have the necessary information to adopt a decision granting permission to refer, the case was remitted to Echa for further action. Key Take-Away The BoA’s decision confirms that, in data sharing negotiations under REACH, the communication by the data owner of cost itemization cannot be made subject to first establishing the sameness of the substance and the specific identity of each applicant for each substance. Indeed, applicants may ultimately decide not to register a substance also on the basis of the data costs. Cost itemization therefore must be provided upfront, in a fair, transparent and non-discriminatory way. 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: FoBiG

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

CONTACTS Website

www.fobig.de

E-mail

info@fobig.de

Head office

Klarastraße 63, 79106 Freiburg i Br, Germany

Tel

+49 761 386080

Fax

+49 761 3860820

Contact

Jan Oltmanns

Directors

Jan Oltmanns, General Manager

Ownership

Private company

Locations

Germany

Founded

1992

OVERVIEW FoBiG is a privately owned consultancy specialising in toxicological and ecotoxicological risk assessment, with more than 28 years of experience in exposure assessment and risk characterisation. FoBiG’s REACH experience dates back to 2001 with participation in, among others, Ceficand 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

2019/20

Turnover, group

€1m

Turnover, chemical service provision

€1m

No of offices No of countries represented

1 Europe-wide

Staff, group

Staff, chemical service provision

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

Consultancy/advisory 90%

Global Service Providers Guide 2021

REACH authorisation Together with our partner RPA Ltd, FoBiG prepares complete dossiers for submitting applications for authorisation with: OO CSRs according to authorisation requirements, including a refined exposure assessment to demonstrate implementation of suitable RMMs/OCs and acceptable remaining risks; OO analysis of alternatives; OO socio-economic analysis; OO complete application for authorisation dossier (Iuclid 6); OO support for communication with Echa during the process (eg in PSIS meetings); and OO post-submission services (eg communication with Echa and Rac/ Seac on submitted dossiers, trialogue meetings). Up to now FoBiG was/is involved in preparing initial applications for authorisations as well as review reports for 16 substances and numerous uses for single companies, small and large consortia. REACH dossier and substance evaluation and restrictions FoBiG provides scientific support to companies whose substances are targeted in dossier and substance evaluations and are affected by restriction proposals. Services include problem analysis, dossier refinement and communication with competent authorities/committees. Substance evaluation decisions often require performance of new studies. FoBiG provides support in comparing quotes from CROs and acts as study monitor for all kind of studies (physico-chemical endpoints, environmental fate and ecotoxicity and toxicity studies). Biocidal product authorisation Together with RegisGate partners (see www.regisgate.eu) FoBiG offers full-scale services for authorising biocidal products according to the biocidal products Regulation (BPR) scheme, including data gap analysis, preparation of the Iuclid-based dossier and communication with competent authorities/Echa. FoBiG provides ample experience eg on authorising disinfection products and biocidal products with in situgenerated active substances. Pharmaceuticals and medical devices Scientific services for pharmaceutical companies and for manufacture of medical devices include: OO derivation of PDE (permitted daily exposure) according to EMA guidelines for residual substances (for example for use in cleaning validation); and OO assessment of impurities, including application of TTC (threshold of toxicological concern) approaches. 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 OO

OO OO

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

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

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 (for example 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 characterisation) 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 the agency’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: OO use of exposure-risk relationships, which are scientifically sound and acceptable to RAC; OO documentation of implementation of suitable measures to reduce emission and exposure; and OO refinement of the exposure assessment to derive realistic exposure estimates to demonstrate minimisation of risks and to conclude on low remaining risks associated with the use for which authorisation is sought.

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Profile: GBK GmbH Global Regulatory Compliance

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SERVICES PROVIDED EMTEL® emergency telephone number An emergency telephone number for dangerous goods transportation is mandatory in numerous countries including the US 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 EMTEL® offers 24/7 immediate telephone assistance, if problems occur during transport or handling of dangerous goods/hazardous materials. This comprehensive service ensures assistance in cases of spillage, fire or contamination, and medical advice for toxicological incidents. Our EMTEL® service OO 24/7 access to a professional emergency call centre OO Emergency telephone number in 190 languages OO Fulfilment of your legal obligations OO Realisation of all airline and shipping company requirements•Medical advice in case of poisoning OO Additional waste management service in the US OO Fulfilment of regional requirements on an emergency service OO Comprehensive support in case of accidents with chemicalsYour Your benefits OO You provide us with the required information and we will take care of the rest OO We take on your legal responsibilities OO You assume the responsibility to an external service provider OO It is valid for all deliveries to any destination worldwide

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

Ulrich Mann

Directors

Björn Noll Thomas Jost

Ownership

Private company

Locations

Germany and China

Founded

1986

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

2019/20

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

Legal IT & software 5%

Training 5%

5% Information 5% Representation & management 10%

Consultancy/advisor 70%

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

Global Service Providers Guide 2021

International EHS consulting/ PCN Notification We help you with all issues around REACH, GHS, product registration and authoring of safety data sheets. Article 45 of the classification, labelling and packaging (CLP) regulation introduces European wide product registers. We can create the dossiers and can complete the poison centre notifications (PCN) via ECHA Portal for you. We guide you through the maze of laws and perform product registrations in chemical inventories in Europe, the US and Asia (Japan, China, Korea, Philippines and Australia). We assume all duties associated with registration, including with regard to labelling and material safety data sheets (MSDS). REACH Services OO Substance/product registration in Europe, USA and Japan, China, Korea, Turkey and Australia (other countries on request) OO Consulting services in connection with the registration Your benefits: OO Compliance together with reduced costs OO Legal responsibilities met by an external adviser; service with more than 30 years of professional experience OO Excellent price/performance ratio Dangerous goods safety advisor/dangerous goods services Because major accidents can occur during the transport of dangerous goods, Germany implemented a responsible person – the safety advisor – in each legal entity who takes over the responsibility for all issues concerning the transportation of dangerous goods. Safety advisers quickly became a success story. After its beginnings in Germany in 1989, the European Union then adopted this important role in the Safety Adviser Directive 96/35/EEC on 3 June 1996. Since 2001, safety advisers have been mandatory in all member States signatories to the agreements on International Carriage of Dangerous Goods by Road (ADR) and International Carriage of Dangerous Goods by Rail (RID). All relevant training programmes have been surpassed in the US. The directive offers the option of transferring this activity to an external expert. Service specification OO Taking over the responsibility of safety adviser for all modes of transport (road, rail, barge, sea) OO Classification/labelling of substances and preparations including evaluation of suitable packaging

Ongoing consultation for your organisation Development of process-oriented checklists OO Regular training to ensure your employees always act in compliance with all applicable regulations OO Priodical audits guarantee to detect possible weak areas OO Providing an IATA/DOT/IMDG compliant 24/7 emergency telephone number Your benefits OO We take on your legal responsibilities OO Reduction of internal fixed costs OO Fully experienced advisers offering high quality services OO Legal and organisational consulting regarding EHS OO Fast and reliable responses adapted to your needs OO

ACCREDITATIONS

Trainings, seminars and GBK Online-Trainings 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 this reason many companies rely on the competence and high quality of our courses and seminars. Some training courses (examples) OO Asian-Pacific and Chinese chemical legislation OO United States and Canadian hazard communication OO MSDS/SDS Authoring expert training OO Training for dangerous goods safety advisers; and dangerous goods training TP1 – guideline for hazardous materials transportation The BMVI announced new guidelines regarding the electronical documents for the transport of dangerous goods on road, rail and inland waters. These guidelines are valid since January 1st 2016. Until now it was only allowed in Germany to use an electronical transportdocument when you have a printer on-board with you, anytime ready to print out. GBK offers a reliable solution for this including an GBK-EMTEL Emergency call number in 24/7/365 format. The GBK-EMTEL Emergency must be readable installed on the vehicle when you use the electronical format of the transport document of dangerous goods. For all companies which working with the transport of dangerous goods this new guideline is a great opportunity to optimise your process and to save cost. Our GBK experts will help you to recognise this and to integrate our GBKTP1 Portal into your daily process of transport of dangerous goods. Your benefits: OO Clearly reducing operating costs thru optimizing and completely switch the process to electronical document management also now for dangerous goods OO Future Readiness & Innovation: This national step by step introduction is already a part of the European-union-wide and international targeted solution for usage of electronical transport documents OO The data protection and encryption of the transport documents at the TP-1 Server is based on the latest technology

ISO 9001 PARTNERS NRCC, CIRS, GIZ, BMZ, BVMW, CFP, IKW, VCI, VDSI, VCH,BGI,DLSV. We also have a global network of partners for collaboration, including governmental institutions and local regulatory specialists, to offer our customers global support. CLIENTS More than 1,400 customers, including medium-sized companies from the chemical industry, and 73% of all German DAX-listed companies, in particular in the fields of chemicals, pharmaceuticals and the automotive industry. 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 GmbH in Ingelheim and is engaged with dangerous goods logistics and international chemicals law for over 25 years. As EU hazardous goods officer he has all the necessary qualifications for all modes of transport. 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. Thomas Jost, managing director Thomas Jost is since May 2020, managing director of GBK GmbH in Ingelheim. The certified dangerous goods officer has extensive knowledge, of new substances and product registrations as well as the entire PCN notification process within the EU. 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, law and further EHS fields. They can offer you our services in German, English and Chinese language.

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

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Profile: GBK GmbH Global Regulatory Compliance

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Profile: Global Product Compliance

128

SERVICES PROVIDED Our specialized regulatory areas are: OO Indian Chemicals (Management and Safety) Rules. OO EU-REACH. OO UK-REACH. OO Eurasia REACH. OO Turkey REACH. OO Korea-REACH. OO Taiwan Regulation. OO Agrochemicals (India, EU, Turkey, South America). OO Cosmetics Regulation (EU, India, USA).

CONTACTS Website

gpcgateway.com

E-mail

info@gpcregulatory.com

Head office

IDEON Science Park, Beta 5, Scheelevägen 17, 223 63 LUND Sweden

Tel

+46 46 2114615

Ownership

GPC Holding, Sweden.

Locations

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

Founded

2008

OVERVIEW Global Product Compliance (GPC) Group specializes in Global Regulatory Compliance Solutions across sectors globally. In 2008, we started regulatory compliance services with EU REACH, but our mutual growth ideology and client needs have motivated us to venture into most of the new regulation emerged over the past few years in India, Korea, Turkey, Eurasia, UK, China, Vietnam, Thailand, South America, Australia, Taiwan, Japan, USA, and Canada. Our over 1500+ 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 200 companies opting to switch over to us from other service providers, for better and cost-effective 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. Indian Ministry of Commerce has also commissioned GPC for several studies and reports which have contributed significantly to the upcoming Indian Chemicals (Management and Safety) rules. VITAL STATISTICS

2019/20

A-Z compliance services within the above regulations: OO Registrations & Notifications (pre and late pre-registration/prenotification). OO Global regulatory compliance and status assessment. OO Substance/dossier evaluation process management. OO Lead registration activity, technical dossier preparation. OO Toxicological assessment & Dossier updates. OO Contract study management & monitoring. OO Compliance verification and certificates. OO REACH & CLP compliant SDS and Extended SDS (e-SDS); and SDS translations in over 30 languages. OO BIS, India Compulsory Certification for Chemicals. Global Chemical Regulation Service portfolio: OO 1500+ happy clients with 99% Client Retention. OO Managed portfolio of 14000 + substances (9000+ Europe, 3000+ Turkey, 500+ S. Korea & 300+ Eurasia). OO Registered 1200+ substances + Lead Registration & consortia management of 600+ substances. OO 14000+ pre-registrations and notifications, globally. OO Authoring of 4500+ REACH & CLP compliant SDSs and 350+ e-SDSs. Translated SDS in 30+ languages. OO Extensive network of OECD-GLP certified CROs managing toxicological, eco-toxicological, environmental & Phys-chem studies. OO Developed & deployed a fully automated compliance certificates management system for seamless regulatory communication and due diligence between supplier, buyer, and OR. The portal is used by 5000+ users. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2010

35 EU REACH registrations & 1500 SDS.

Turnover, group

> 5 million Euros

2011/12 Mandated as lead registrant for 110 substances.

Turnover, chemical service provision

> 5 million Euros

2013

No of offices

No of countries represented

>50

Staff, group

100

Registered 225 chemicals – EU-REACH.

2015/16 Group company is accredited as a certified inspection body; Business affiliate S. Korea, Research collaboration, Lund University, Sweden. 2018

Completed all EU REACH final deadline & first deadline Korea REACH Registrations; Business affiliates in the UK & Ireland.

2019

Research Collaboration with DTU, Denmark.

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, Taiwan, and Russia.

2020

Knowledge Partner Outreach collaboration with Cosmed, Cosmetics Association, France.

2020

Contributed to finalization of Indian Chemicals Management and Safety Rules.

2020

Started Bureau of Indian Standards (BIS) Certification Service.

2020

Initiated International Regulatory Internship Program with over 15 interns in Sweden and India.

GLOBAL OFFICES

2021

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

Business Affiliate in China, Japan, Vietnam, Thailand and South America, Iran and Middle East.

2021

Knowledge Partner Outreach collaboration with China National Chemical Information Center (CNCIC).

2021

Launched Global Outreach Awareness Program for Indian Chemicals Management and Safety Rules.

Staff, chemical service provision

SERVICE AREA BREAKDOWN

Legal 10%

Equipment Training 0% 5%

IT & software 15% Laboratory 15%

Global Service Providers Guide 2021

Consultancy/advisory 40%

Representation & management 15%

ACCREDITATIONS Accreditation: AAA, Bisnode, Highest Credit Worthiness. Recognitions as Knowledge Partner: OO Confederation of Indian Industry (CII). OO Indian Chemicals and Management and safety Rules – Technical committee Member, Ministry of Chemicals and Petrochemicals, India. OO Chemexcil: Basic Chemicals, Cosmetics & Dyes Export Promotion Council, India. Memberships (Regulatory Advisory): OO Member of CII National Chemicals Committee. OO IKEM: Innovations and the chemical industries in Sweden. OO SIBC – Sweden India Business Council, Sweden. OO Confederation of Swedish Enterprise, Sweden. OO Sustainable Business Hub, Sweden. OO Indian Chemical Council, India.

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. Consortia Management: this section provides clients with an end-toend solution of the lead registration process, including requesting and managing all information related to consortia management. For example, Syndication, LoA, administration of agreements and assignments, documentation, archiving, etc. 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 5000+ users. Indeed, as part of our mutual reliance growth cycle, all the above is freeto-use for our clients. CASE STUDY 3: Emphasis on Research and Development (R&D)

PARTNERS Organisations: OO Confederation of Indian Industry (CII), India. OO Chemexcil: Basic Chemicals, Cosmetics & Dyes Export Promotion Council, India. OO Indian Chemical Council (ICC), India. OO Cosmed, Cosmetics Association, France. OO China National Chemical Information Center, China. OO All India Printing Ink Manufacturer’s Association, India. OO Gujarat Dyestuffs Manufacturers Association, India. Business partners: Chemtopia Co. Ltd., South Korea; CHD Global Services, Turkey; EnviX Group (South East Asia); CIRS, China. REACH24H, China; Tisamax Technical Co, Ltd, Taiwan; Randis ChemWise (Shanghai) Co., Ltd, China. Research partners: Technical University of Denmark; Lund University, Sweden; National Institute of Industrial Engineering and Centre for Cellular & Molecular Biology (CSIR), India.

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 4: Contribution to Indian Chemical Policy

GPC has over 1500 clients in the industrial and specialty chemical and petrochemical industry, as well as the following industries: agrochemical, food colour, cosmetic, electrical and electronics, automotive industry, leather, garment and apparel, plastic and rubber, steel, writing instruments, polymers etc.

The vast experience that we gained while working on EU’s REACH Regulation for Indian companies has helped us to understand the Indian Chemical Industry and its trends. Therefore, being India’s largest regulatory compliance service provider, we are also actively contributing towards the finalization of India’s chemical regulation and policy (Indian Chemicals (Management and Safety) Rules (CMSR)). Indian Ministry of Commerce has commissioned GPC for several studies and reports which have contributed significantly to the upcoming Indian CMSR. GPC is also the only non-governmental organization that is part of the technical committee responsible for drafting and finalizing the Indian Chemical Regulation. With over a decade of engagement with the Indian Ministries since 2010 the Indian Chemicals Management Safety Rules will likely come into force in 2021.

TESTIMONIALS

STAFF SELECTION

On the service quality criteria, 92% of our client companies have rated the compliance assistance services being offered by GPC as very good.

Business: Shisher Kumra, Executive Director. Dr. Thomas Mueller, Director (Auxilife, GPC Subsidiary). Dr. Jayachandran Nair, CEO, GPC India. Dr. Vaibhav Diwan, Global Business Development Manager

CLIENTS

CASE STUDY 1: Mutual Reliance & Sustainable Growth We believe and acknowledge the fact that our clients have played an important role in our growth and vice versa. Our clients’ plan of expansion to newer regions and product sectors was our primary incentive. It was primarily their plan of expansion to newer regions and product sectors, which encouraged us to learn and explore newer and upcoming regulations. 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, agrochemicals, textiles & garments, leather, electronic components, and auto components sectors with offices in 8 countries and a network of 25+ institutional and business partners globally. CASE STUDY 2: Automation of Compliance Process Management To 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 putting their compliance management needs on autopilot. The compliance management system has three main components:

Consortia Management: Shrirang Bhoot, CTO. Reynold D’Souza, Senior Advisor, Global Reg. Management. Mangesh Barbate, GM (Dossier Management) Chemical Safety Management: Dr Anders Bergqvist, Head, Toxicology. Dr Zsuzsanna Szepesi, Sr. Toxicologist. Dr. Shweta Deoskar, Sr. Expert Substance Sameness Priyanka Manapure, Sr. Manager, Toxicology. Dr. Yashwant B, Sr. Eco-toxicology. Regulatory: Ketki Kulkarni, Sr. Regulatory & Account Manager; Dr Chia-Sui Hsu, Regulatory Manager; Keith Yongho Jung, S. Korean Reg. Executive; Ahra Jung; Mirac Mert Pelister, Elena Kondryukona, Regulatory Advisors (S. Korea; Eurasia & Turkey) Research and Development: Dr. Martina Holst, TFM, Sweden. Swati Gondhalekar, TFM, India.

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Profile: H2 Compliance

130

GLOBAL OFFICES Ireland (Cork and Dublin) USA (NY and DC) 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 and costs 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 the duties of their importers by acting as OR. A complex service which 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, dedicated to successfully introducing our customers’ products onto global markets, including the United Kingdom under its newly adopted UK-REACH. We support our clients to ensure compliance and market access by applying our breadth of knowledge to the business complexities of topics including REACH and REACH-like programmes, GHS implementation worldwide (SDS & labelling), PCN and chemical management software. H2 Compliance has a global footprint with offices across Europe and the US and with a collection of trusted in-country partners. The acquisition by the Landbell Group has further expanded services into the environmental arena and the circular economy – covering WEEE, batteries, packaging, take back programmes as well as software offerings. VITAL STATISTICS

2019/20

Turnover, group

€ 180 million

No of offices

No of countries represented

Staff, group

300+

Staff, chemical service provision

SERVICE AREA BREAKDOWN

IT & software 14%

Training 2%

Laboratory 2%

Information 28%

Consultancy/advisory 42%

Representation & management 12%

Global Service Providers Guide 2021

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. H2 Compliance has built a deep regulatory expertise in this space to optimise a successful outcome. The complex application process requires companies to make 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. UK REACH With the UK’s withdrawal from the EU, companies are faced with preparing a parallel set of REACH-like activities to remain on the market. H2 Compliance, with its UK legal entity can support companies in navigating the complexities that this significant change presents. It is helping clients understand these new requirements, clarifying similarities to and differences from the EU requirements, navigating the transitional period, and determining the impact of the Northern Ireland Protocol to their business. element1™ software For over a decade, H2 Compliance has made available one of the leading platforms for chemical regulatory management. Provided as a SAAS model, it allows central substance management, threshold control, project planning and execution, supported with financial and archive functionality. With the expansion of REACH-like requirements globally, it also allows for efficient reuse of data. As well as bringing efficiency, ultimately, it provides ease of mind for business continuity and audit preparedness. Poison Centre Notifications With the realignment of this activity and centralisation through Echa, H2 Compliance assists companies to meet submission and labelling 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 development of safety data sheets and supporting labels remains a core obligation for those placing hazardous products onto the global marketplace. With our toxicological, industrial hygiene and regulatory knowledge, supported by our international network partners, we build and maintain programmes for our clients’ portfolios of products. We can also author safety data sheets for any global market.

Global chemical regulatory support The chemical regulatory arena is changing rapidly. Companies shipping worldwide need to keep up to date with the evolving 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 South Korea, China, Japan, Switzerland and Turkey, which trigger ongoing obligations, while many emerging regulations require careful watching and preparation for them. With offices in the US, we are able to provide support with North American obligations. Our network of trusted in-country partners also assist us in providing global support to our customers.

CASE STUDY 1: Pharmaceutical and Healthcare Support & Software Solutions H2 Compliance has immense expertise within the pharmaceutical industry, supporting all aspects of REACH, GHS and emerging global regulations. This understanding allows H2 Compliance to become part of the team, working in partnership to identify issues, determine impacts and manage required actions. H2 Compliance is known for its collaborative platform, ‘element1’, which has recently transformed into the next generation of chemical management software, element1™ plus. 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

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006

Company established, Dublin office opened

CASE STUDY 2: Poison Centre Notifications

2012

Deloitte Technology Award for company growth

2016

H2 Compliance acquired by The Landbell Group, Germany

2017

Poland office opened

2018

UK office opened

H2 Compliance delivered a large scale, short-notice poison centre notification programme at the end of 2020. The project involved engagement with multiple poison centres across the EU and entailed the creation of thousands of separate notification dossiers over a two-month period. In close cooperation with the client, the H2 team experience and expertise created a strategy and plan for delivery, and successfully executed the programme for all of the products, which can now be properly maintained and updated to meet Annex VIII requirements over the five-year transition period.

ACCREDITATIONS Approved REACH Ready Gold Member Member of Only Representative Organisation Co-Sponsor of the Green Alley Circular Economy Awards PARTNERS We have a network of trusted partners in geographically diverse locations who assist us in providing global support to our customers. CLIENTS H2 Compliance has over 300 customers across a diverse range of industries. Core clients are from the pharmaceutical industry, medical devices, petroleum, fragrances, polymers and metals sectors. TESTIMONIALS Stewardship Services: “H2 Compliance was carefully selected to allow us to continue to meet the changing needs of our new and existing client base. We based decisions on their ability to provide all required regulatory support within one compliance organisation. With their assistance we have successfully met the REACH and SDS deadlines without issue. I have found the team to be highly flexible with our deadlines, effective with providing accurate information, and most importantly, focused on our needs.” Michael Goluszka, La-Co Industries, USA Dossier services: “H2 Compliance supported us for the construction of Lead Dossiers; which were submitted on time and to budget. The company brings a wealth of experience to this technical area and have a high quality of communication and project management. We have always found communications to have due regard for the confidential nature of the relationships within the consortia environment. We have found the relationship with H2 Compliance to be strong and we are happy to recommend the firm for this type of activity.” Diversified Chemical Industry, USA

CASE STUDY 3: Global Compliance H2 Compliance has developed a service, assisting clients to meet their chemical regulatory requirements around the globe. One such example is for a company that designs and manufactures additives for rubber and plastics, that solves handling and process issues. While the client concentrates on their core business, H2 provides support to ensure chemical regulatory compliance firstly in Europe but more recently, due to a widening of their market, in South Korea, China, Russia and Turkey via local trusted partners in these regions. H2 Compliance effectively acts as a one-stop-shop for chemical regulatory compliance. STAFF SELECTION Kevin Hoban – Chief Operations Officer Co-founder of H2 Compliance. More than 25 years of experience in industry, heads business development, commercial, 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 30 years of experience in the space, Beth is a certified industrial hygienist and leads services delivered to 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. In depth experience of 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

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Profile: INERIS

132

SERVICE AREA BREAKDOWN Equipment 5% Training 5%

CONTACTS Website

www.ineris.fr

E-mail

prestaweb.sci@ineris.fr

Head office

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

Tel

+33(0)3 44 55 63 29 (Patricia ROTUREAU)

Fax

+33(0)3 44 55 66 55

Contact

Patricia ROTUREAU, Business Development Manager

Directors

Anne MORIN, Environment and Impact on Human and Biodiversity Division

Ownership

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

Locations

France

Founded

1990

Laboratory 45%

2019/20 66m€ -

No of offices

4 Global

Staff, group

540

Staff, chemical service provision

250

Global Service Providers Guide 2021

Information 5%

SERVICES PROVIDED

Turnover, chemical service provision No of countries represented

Representation & management 8%

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).

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

Turnover, group

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, the in-house analytical techniques available include: GC-MS; GC with different detectors (FID, TSD, PFPD); LC with UV and fluorimetric detectors; LC-MS-MS; LC-HRMS; IC coupled to amperometric and conductometric detectors; and 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, including: transmission and scanning analytical electron microscopy and X-ray; fluorescence for morphology and composition of materials, particles and aerosols; laser diffraction; and 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°C to 1600°C).

Toxicological testing INERIS provides customised and regulatory in vivo toxicology studies in its GLP-compliant rodent facility of 1000 m². With particular attention towards animal welfare (in compliance with 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 behavioural testing, surgeries and ex vivo analyses. INERIS provides services ranging from hosting a team project, supplying animal housing and equipment, to performing complete studies. INERIS also performs in vivo studies following OECD test guidelines: OO acute tests (OECD 402, 403, 423, 425 and 436); OO repeated dose 14-day preliminary tests (range finding assays); OO repeated dose 28-day toxicity tests (OECD 407 and 412); OO repeated dose 90-day toxicity tests (OECD 408 and 413); and OO developmental and reproductive toxicity tests (OECD 421, 422 and 443). In addition, in vitro research can be provided with a specific expertise in pulmonary toxicology. Ecotoxicological testing INERIS provides experimental assays and expertise in general ecotoxicity of chemicals and environmental matrices. It develops and performs biological assays to characterise the hazards towards the aquatic, benthic and terrestrial environments, as well as expertise on the environmental fate of chemicals. The study design, including test item preparation, test design and analytical phase is adapted to each specific requirement. The following acute and chronic tests are performed routinely, according to European test methods or OECD test guidelines: OO aquatic tests: short and long-term toxicity on invertebrates (Daphnia magna, OECD 202 and 211; Ceriodaphnia dubia, ISO 20665), growth inhibition test on aquatic plants (algae, OECD 201; duckweed, OECD 221), fish lethality test (OECD 203) and activated sludge respiration inhibition test (OECD 209); OO terrestrial tests: deshydrogenase activity of Arthrobacter globiformis (ISO 18187), lethality and reproduction tests on earthworms (OECD 207 and 222), emergence and growth of higher plants (OECD 208), and growth, fertility and reproduction of nematodes (ISO 10872); OO sediment tests: Chironomids (OECD 218 and 219), Hyalella azteca (ISO 16303) and Myriophyllum (OECD 239, ISO 16191) toxicity tests; and OO environmental fate: ready biodegradability (OECD 301) and inherent biodegradability (OECD 302). INERIS has also developed an expertise in the ecotoxicity of emerging substances including nanoparticles (sample preparation, nanoparticles characterisation, etc), ionic liquids and drugs residues. Nanoparticles hazard assessment INERIS has a complete in vivo (rat models) nose-only inhalation system (HCT) to expose animals to nanoparticle aerosols, with associated metrology, TEM and physico-chemical characterisation of nanoparticles. It participates also in the development of standardised technologies and assays for regulatory use in toxicology and ecotoxicology (e.g. 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, such as: 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 of 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 manufactured byproducts containing nanomaterials when subjected to external mechanical (abrasion, use), thermal (combustion, incineration), ultra-violet or chemical aggressions throughout their lifecycle.

Multi-disciplinary approach INERIS's services include various areas of expertise, such as: 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 of 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 the industrial environment. INERIS is compliant with Good Laboratory Practice (GLP) in the areas of: toxicity testing, environmental toxicity studies on aquatic and terrestrial organisms, behavioural studies in water, soil and air, bioaccumulation, analytical and clinical chemistry testing. INERIS is accredited by COFRAC in compliance with NF EN ISO/CEI 17025 (testing and calibration body), 17043 (interlaboratory comparisons ILC), 17065 (certification body), cf. www.cofrac.fr, under n°1-0157, 2-1251, 1-2291, 5-0045. CLIENTS INERIS works with more than 2,000 clients around the world from various industry sectors and disciplines, including chemistry, paints and coatings, cosmetics, food, oil, gas and petrochemicals, automotive and heavy equipment manufacturers, construction, marine, consumer electronics, nanotechnology, etc. CASE STUDY: Accompanying client for a REACH dossier Unique importer of a substance, at a tonnage above 1T/year (Annex VII), then above 10T/year (Annex VIII): OO validation of existing assay reports; in silico (read-across) feasibility evaluation and bibliographic expertise; guidance in providing physicochemical identification data on the substance for Annex VI; OO definition and proposal of assay strategies for the development and validation of physico-chemical analysis methodology to quantify the test item in different media; for toxicology, ecotoxicology and physico-chemical characterisation; OO realisation, at the same geographical site, of required physicochemistry, in vivo toxicity and ecotoxicity experimental assays; OO guidance along the process, on the assay strategy based on obtained results; for example, guidance for mutagenesis in vitro assays, and selection of the necessary follow-up in vivo assay for proposal to Echa; and OO reporting and preparation of all sections of the Iuclid file, including the chemical safety report (when applicable). STAFF SELECTION Patricia ROTUREAU – Business Development Manager patricia.rotureau@ineris.fr

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Profile: INERIS

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Profile: Intertek

134

SERVICES PROVIDED The Health, Environmental & Regulatory Services (HERS) business line provides high-quality, tailored, and integrated solutions through our global network of world-class scientific, engineering, and regulatory experts, empowering companies to mitigate intrinsic risks and identify regulatory requirements in order to make informed decisions relating to their products, processes, and the impact on humans and the environment. Our services include:

CONTACTS Website

www.intertek.com/green/chemicals/

E-mail

green@intertek.com

Head office

33 Cavendish Square, London W1G 0PS, UK

Tel

Head Office: +44 20 7396 3400 HERS locations: Canada: +1 905 542 2900 China: +86 (21) 6073 7735 France: +33 (0)2 79 23 03 46 Germany: +49 711 27311 160 India: +91 8291 049593 Italy: +39 051 0562930 Russia: +46 8750 03 56 Sweden: +46 8750 03 56 UK: +44(0)161 245 8071 US: +1 302-287-3650

Chemicals OO Global Notification & Registration of New Chemicals Support –– –– –– –– OO

Rose Passarella

Directors

André Lacroix, Chief Executive Officer; Ross McCluskey, Chief Financial Officer; Diane Bitzel, Group Chief Information Officer

Ownership

Public

Locations

Intertek is an industry leader with more than 1,000 laboratories and offices in more than 100 countries.

Founded

1996

Risk assessment & management Data gathering activities (Canada CMP; TSCA LCSA; Inventory nominations, updates, and resets)

Hazard Communication (HazCom) Services –– –– ––

Contact

Workplace MSDS and label support Consumer chemical labelling (Canada & US) Dangerous goods transportation regulatory support

Biocides OO Pre-submission regulatory consultations OO Protocol development, study placement, and monitoring OO Dossier support and data review for Biocidal Active Substances OO Liaison with pesticide regulators and submission shepherding OO Technical expertise and dossier preparation (Product Identity and Chemistry, Toxicology, Efficacy, Ecotoxicology and Environmental Fate) OO GLP, GMP, and GCP–compliant Analytical Laboratory Testing Services: Physical & chemical parameters, quality/purity, residues, contaminants, and shelf-life/stability Global Restricted Substances OO RoHS

OVERVIEW

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

2019/20

No of offices

1,000+

No of countries represented Staff, group

100+ 46,000+

Staff, chemical service provision

5,000+

SERVICE AREA BREAKDOWN For Intertek’s Health, Environmental & Regulatory Services (HERS) division: Training 1% Laboratory 6%

Global Chemical Management –– ––

Canadian New Substances Notification Regulations (NSNR) US Toxic Substances Control Act (TSCA) Services Global REACH Program OR & Technical Support (UK, EU, Korea, Eurasia, Turkey, India) Australian Industrial Chemicals Introduction Scheme (AICIS)

Other 8%

Information 5% Consultancy/advisory 54% Representation & management 26%

Supplier engagement, Intertek database solution for supply chain management, dossier preparation and submissions

REACH ––

Product risk assessment, supplier engagement, SVHC Screening

California Proposition 65 ––

Product and material risk assessment, analytical testing, exposure assessment

Cosmetics & Personal Care OO Toxicological Safety Assessments OO Toxicological Profiles of Ingredients OO Registration & Notification of New Cosmetic Ingredients OO Registration & Notification of Domestic/Imported Cosmetic Products OO Labelling Reviews OO Literature Review & Data Collection OO Regulatory Dossiers OO Microbiology & Stability Testing OO Cosmetic Packaging Analysis OO Causality Assessment Food Contact OO Global food contact regulatory compliance (EU, Mercosur, US, China, Japan) OO Preparation and submission of registration dossiers for EU (such as EFSA), US (FCN) and China OO Safety risk assessments OO Design and implementation of global testing strategies for compliance and registration dossiers OO Liaison with government regulatory authorities regarding submission and regulations interpretation OO Supply chain management review documentation and compliance OO OO

Global Service Providers Guide 2021

SCIP Database ––

Supplier engagement, restricted substance control programs, risk assessment, testing, technical file creation

Good Manufacturing Practices (GMP) implementation FDA No Objection Letter submissions for recycled plastics and recycled paper used in food contact applications Customized training

Sustainability OO Life Cycle Assessment (LCA) OO Ingredient Transparency & Health Declarations OO Responsible Sourcing OO Sustainable Claims Support OO Carbon Footprint & Water Footprint OO Corporate Sustainability Reporting OO GHG Emissions Support Services OO Sustainable Building Certification OO Management Systems Certification CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2016

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

2018

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

2020

Intertek introduces CarbonClear certification program, which brings unique clarity on the carbon impact of cradle-to-gate operations across all stages of oil and gas exploration and production.

2020

Intertek expands chemical regulatory services by providing on the ground local support in Russia to meet ongoing demands.

ACCREDITATIONS Ms Joyce Borkhoff – Active member of the Industry Coordinating Group (ICG) for the Canadian Environmental Protection Act (CEPA), Responsible Distribution Canada (RDC), the Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers (ETAD), Cosmetics Alliance Canada, Colour Pigments Manufactures Association (CPMA), and Canadian Paints and Coatings Association (CPCA). Mr Dan Bastien – Former Head Client Services Unit, Environment and Climate Change Canada and Government Representative at the at the ICG for the CEPA. Dr Rose Passarella – Active Member of the American Chemistry Council (ACC), ACC’s Confidential Business Information (CBI), Risk Prioritization and Chemical Data Reporting (CDR) Work Groups to support US Toxic Substances Control Act (TSCA) activities and implementation of the Lautenberg Chemical Safety for the 21st Century Act (LCSA); US Bar of Pennsylvania and New Jersey; founding member of STRIDE (Scientific Technical Research Institute of Delaware); and certified mentor for SCORE. Dr Michael Leise – Board member of Only Representative Organisation (ORO) AISBL, representing credible REACH only representatives active within the European Economic Area. Dr Rainbow Zhang – Member of Council of Chinese Society of Toxicology (CST) and a Committee Member of the Society of Toxicity Testing and Alternative Methods, CST. CASE STUDY 1: A step-wise strategic approach to registration leads to higher success The regulations governing the registration of biocides/sanitizers across the globe are complex and diverse, which requires a thorough understanding of the local legislations, ensuring the biocide/ sanitizer product is well defined, and the claims are substantiated in accordance with these legislations. To support the introduction of a new biocide/sanitizer product in multiple jurisdictions, Intertek’s global team of regulatory and toxicology experts worked together in completing feasibilities assessments for the associated countries to identify roadblocks and develop a global test strategy to support the registrations, prior to submission of the applications to the competent authorities. Avoiding these roadblocks and aligning study placement saved the registrant time and money, as well as ensured that the submitted application successfully completed the full review process and resulted in approvals for sale and use.

CASE STUDY 2: Intertek’s global network of experts helps clients achieve cost-effective registrations worldwide Keeping up with changes in regulatory landscapes and differences in pre-market approval programs for new products, novel ingredients, and unique raw materials is challenging. When you add a need for reliable safety assessments, in conjunction with protecting confidential information, the challenge can seem insurmountable. Recently, Intertek was asked by a chemical company located in North America for help in understanding and complying with the regulations to gain access to new markets in Canada, U.S., Australia, the EU, China, Japan, South Korea and the Philippines. Sending chemicals into these regions requires compliance with the new chemical notification programs in each of the jurisdictions and submission of sensitive product information by the local importer to the government agency for safety/risk assessment and pre-market clearance. Intertek’s global team worked seamlessly with the chemical company to develop and implement a smart global testing plan for each applicable new chemical to ensure that studies run were completed in a way that would maximize their acceptability across as many of these jurisdictions as possible. The new requirements under TSCA for affirmation before a company can proceed to the US marketplace are increasing the scrutiny of the assessments and offered additional challenges to proactively address the requests for additional data and avoid the common extended timeframes using preliminary inhouse screening approaches. Although the North American company agreed to provide the necessary information, they were reluctant to submit confidential information through the local customers. Intertek was able to work with both the client and their customers in each jurisdiction to prepare and submit the robust dossiers, and act as local country agent/only representative in some of these countries, while maintaining the confidentiality of the data and reaching compliance for import/manufacture of the volumes required by the businesses. We protect our customers’ competitive advantage with efficient, economical and timely global market access. STAFF SELECTION Joyce Borkhoff, Vice President, North America Focus: Chemicals, Agri, Biocides, Pesticides | More than 25 years’ experience Matt Quinn, Director, Business Development and Innovation, North America Focus: Global Restricted Substances | More than 15 years’ experience Sabrina Cescolini, Director, Climate Change & Sustainability Services, North America Focus: Sustainability | More than 12 years’ experience Emilie Savides, Regulatory Affairs Specialist, France Focus: Chemicals, Cosmetics & Personal Care | More than 8 years’ experience Dr. Mohamed Kassem, Senior Regulatory Consultant, Germany Focus: Chemicals, Restricted Substances, Sustainability | More than 8 years’ experience Dr. Chris Brennan, Director, Toxicology & Regulatory Services, UK Focus: Biocides, Cosmetics & Personal Care, Pharmaceutical & Healthcare | More than 20 years’ experience Jeremy Ramsden, Director, Regulatory Services, UK Focus: Chemicals | More than 30 years’ experience Alessandra Tagliani, Senior Regulatory Specialist, Italy Focus: Chemicals, Biocides | More than 25 years’ experience Lisalott Gabro, Business Unit Manager, Sweden Focus: Chemicals, Biocides, Cosmetics & Personal Care, Restricted Substances, Recycling, Food Contact | More than 5 years’ experience Dr. Natalia Borisova, Project Leader, Russia Focus: Chemicals, Biocides, Food, Cosmetics & Personal Care | More than 24 years’ experience Dr. Rainbow Zhang, Senior Manager, China Focus: Chemicals, Food Contact, Cosmetics & Personal Care | More than 10 years’ experience Sunanda Kadam, Business Unit Manager, India Focus: Chemicals, Food Contact, Restricted Substances, Sustainability | More than 20 years’ experience www.chemicalwatch.com/SPG

Profile: Intertek

135

Profile: Kahlberg Consulting

136

SERVICES PROVIDED Europe – REACH KAHLBERG

Regulatory and legal advice and registration strategy OO Full REACH registration dossier OO CLH dossier OO Management and logistical support to consortia/lead registrants OO Representation of customers in consortia OO Post-registration assistance and compliance checks assistance OO Study monitoring for eco and toxicological studies OO Analytical characterisation assistance OO Chemical safety report preparation OO Nanomaterials registration

CONSULTING

CONTACTS Website

www.kahlbergconsulting.com

E-mail

info@kahlbergconsulting.com

Head office

KAHLBERG Consulting S.r.l. Via Locatelli 6, 20124 Milan Italy

Tel

+39 02 6700319

Fax

+39 02 67386811

Contact

Dr. Vanessa Alberti

Directors

Michela Kahlberg, CEO

Ownership

Private Company

Locations

Italy, UK

Founded

2008

OVERVIEW Kahlberg Consulting is a leading chemical consulting company based in Milan, Italy, and an expert in REACH, CLP, biocides Turkish and UK chemical regulations. The highly skilled and experienced team provides fast and strategic solutions for all of its clients. The service delivered goes beyond what is expected and it always positively exceeds clients demands. Over the last decade, Kahlberg Consulting has grown and developed into a trustworthy partner for chemical regulations offering a complete and ever- evolving selection of services. VITAL STATISTICS

2019/20

Turnover, group

>1.000.000€

Turnover, chemical service provision No of offices

No of countries represented

>30 (globally)

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 10%

Product Safety OO General assistance on regulatory issues OO Preparation, verification and update of safety data sheets OO Preparation of extended safety data sheets with the exposure scenarios OO Safety data sheets translation into different languages OO Verification of dangerous goods hazard labels OO Verification of exposure scenarios and identification of the conditions that are not covered OO Preparation of downstream user reports and submission to Echa, for unsupported uses OO UFI creation and poison centre notifications (PCN) OO Assistance in chemical risk assessment, in accordance with Title IX of the Italian D.lgs. n. 81/08 OO Strategies for the management of substances listed in the candidate list, Annex XIV or Annex XVII of the REACH Regulation OO CLP requirements for substances and mixtures OO Request of an alternative chemical name in mixtures OO Consultancy for DGSA services (ADR), including the appointment of a Dangerous Goods Safety Advisor (DGSA) and general consultancy on the IMDG and IATA codes OO Auditing Biocides OO Approval of active substances OO Authorisation of biocidal products OO Article 95 submission OO Goal(s) definition and priority setting for an efficient strategy OO Managing and monitoring of laboratory tests OO IUCLID/R4BP OO Data-gap analysis OO Qsar modelling and read-across approach OO Dossier preparation, submission and pre-/post-submission assistance OO Human health and environmental risk assessment OO Communication with regulatory authorities OO Endocrine disruptor testing strategy and assessment OO PMC (Presidi Medico Chirurgici) authorisation according to national Regulation DPR 392/98 OO Biocide approval in other EU member states, according to national legislation in transitional period for active substances under evaluation OO Mutual recognition in other EU member states Turkey – KKDIK OO

IT & software 10%

OO OO OO

Consultancy/advisory 50%

Representation & management 30%

OO OO

OO OO OO OO

GLOBAL OFFICES Italy, UK Global Service Providers Guide 2021

Regulatory and strategic consultancy Only representative (OR) service Pre-registrations Registration strategy Full KKDIK dossier preparation services with CAE approval Management and secretarial support to consortia and/or lead registrants Representation of customers in Siefs and consortia Communication with regulatory authorities Post-registration assistance Technical and scientific translations

Product Safety OO Preparation/review and certification of Safety Data Sheets OO Notifications based on SEA regulation OO Supplier label preparation in Turkish/English OO Technical data sheet Preparation

Biocidal Products Regulation OO Registration and consultancy services Turkey Detergents Regulation OO Consultancy services UK – UK REACH OO OO OO

Registration, evaluation, authorisation and restriction of chemicals Only representative (OR) service Check the compliance of labels and safety data sheets in accordance with legislation in force

In our experience, we have noticed that sometimes clients have to pay a high price for small (avoidable) mistakes. We have provided all of our clients with a list of things to check about their substances within the realm of product safety. We strive to provide our clients with a 360-degree approach that anticipates future problems and supports them in daily tasks. CASE STUDY 3: KKDIK

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Current REACH clients have asked our support for different regulations around the world. We are always interested in growing and learning, therefore we have decided to expand our services to Turkey. Our background within the REACH Regulation is the added value our clients want when they face new challenges. The expertise of over a decade of work is crucial to understand the problems companies could face tomorrow, in two weeks, as well as in five years. Most of the time, the past repeats itself and, having experienced these processes in Europe, we are sure we can better assist our clients in Turkey. It is normal for companies to have doubts and face difficulties when starting a new journey. Over 50 clients rely on our expertise and our ability to have a long-term view to accompany them into new markets.

2008

Kahlberg Consulting is founded

CASE STUDY 4: Qsar for dyes

2018

KKDIK unit is created

2019

UK REACH unit is created

Due to our client’s interest in dyes, we found out during the registration process that the existing Qsar models could not be applied to dyes, since these substances are very large and complex. Therefore, to solve this problem and help our clients, we started a partnership with the Università degli Studi di Milano-Bicocca. From 2013 to 2016, we developed together a new Qsar model specific for dyes. We have contributed to the creation of a database on dyes containing all the structures, the existing data on physicochemical properties and toxicities that is now updated on a yearly base. Within this project, the whole set of substances was grouped based on their structural similarities and chemical reactivity. A cross-validation procedure was carried out during the modelling stage in order to select the best subset of molecular descriptors and choose the best models based on their predictive power. Overall, this model has helped in reducing animal testing and in the development of new molecules.

GB-CLP OO Classification, labelling and packaging of substances and chemicals UK-Biocides OO Request of inclusion in Article 95 UK OO Request of Authorization for biocidal products and active substances in UK UK-PIC – Prior informed consent UK-PPP – Pesticides or Plant Protection Products

PARTNERS Team Mastery srl CLIENTS Kahlberg Consulting started by supporting small- to medium-sized Italian businesses with the European Regulation REACH. However, shortly after the beginning of REACH, Kahlberg Consulting started working with some of the biggest players in the global market. These partnerships have expanded beyond the REACH Regulation and clients keep returning to Kahlberg Consulting for any kind of request/problem. CASE STUDY 1: REACH – Compliance checks According to Article 41 of REACH, Echa can perform compliance checks on any registration dossier at any time. This means that several registrants face compliance checks every year and these processes can be very costly and complex to manage. We have supported many clients, both individually and at consortia level, in the compliance-check process with single substances or categories. What is common to all of these experiences is the invaluable help of an expert consultant who is able to analyse the situation from different angles. When receiving the draft decision from Echa, we have noticed that several strategies can be applied, depending on the case. The best solution lies in the evaluation of the technical concerns, as well as the commercial ones. Within 30 days of receiving the draft, the consultant has to be fast and efficient in preparing a reasonable strategy that suits the client’s needs. An experienced consultant can see behind Echa’s reasoning and decision, and suggests the most suitable solution for its client. Being compliant is the end goal, but we offer solutions that go beyond the mere regulation and take into account the future of the substance and the business. Our varied experience tells us that investing time and resources during the draft process can save time and money in the long term.

STAFF SELECTION

CASE STUDY 2: Product Safety

Irene Simonato, MSc – Regulatory Affairs Officer Bachelor and Master’s degree in Chemistry at the University of Padova. Expert in REACH Regulation. Regulatory affairs officer for Biocides.

Sometimes small changes can make a huge difference. Echa has increased controls on products arriving into Europe and the results have shown that many products were non-compliant. We are aware that many of our local clients could be heavily affected by these controls. Therefore, to anticipate any issues, we advised them to check what is in their warehouse.

Kahlberg Consulting has a very highly skilled and experienced all female team. Michela Kahlberg – CEO After a degree in Economics, 5 years in Research & Marketing in London and in Milan, during 1998 she took the control of the family company ORIGO, representing the Czechoslovakian chemistry in Italy since 1951, enlarging in particular the organic dyes and pigments businesses. During 2008 she started following the REACH Regulation particularly for the organic dyes. Today her companies are leading in different sectors and fields, inside and outside Europe. Elena Campagnoli, PhD – Senior Regulatory Affaris Officer Bachelor degree in Chemistry followed by a PhD in Chemistry at Dublin City University. Over ten years of experience within the REACH Regulation. Vanessa Alberti, MSc – Senior Regulatory Affaris Officer Bachelor and Master’s Degree in Industrial Chemistry at the Università degli Studi of Milano. Product safety expert, over a decade of work within the REACH Regulation.

Elif Dereli Eke, PhD – Regulatory Affairs Specialist Bachelor and Master’s degree in Chemical Engineering at Yıldız Technical University and Bogazici University. PhD in Chemical Engineering at Bogazici University. Previously a post-doctoral research fellow. Regulatory affairs officer for KKDIK. www.chemicalwatch.com/SPG

Profile: Kahlberg Consulting

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Profile: Kelley Drye & Warren

138 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. 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; San Diego, California

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 clients’ 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; Houston, Texas; Chicago, Illinois; Stamford, Connecticut; and Parsippany, New Jersey. 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 of products with antibacterial and anti-viral claims under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is another active practice area, particularly so during the COVID pandemic. Our professionals help navigate the complex product registration requirements of the U.S. EPA and states, as well as provide practical advice on marketing and labelling issues, with an eye towards avoiding pitfalls that can result in onerous enforcement actions.

Global Service Providers Guide 2021

Kelley Drye attorneys provide “Prop 65” compliance assistance and enforcement defense, including evaluation of whether a product requires a warning and, if so, how best to convey that warning. We assist businesses in developing strategic programs to maximize their understanding of the chemicals in their product and throughout the supply chain, while minimizing any potential liabilities. If a plaintiff “bounty hunter” comes calling with a notice of violation, Kelley Drye attorneys have a wealth of experience defending such actions and, when necessary, negotiating a reasonable settlement. Kelley Drye attorneys are involved in a wide variety of other environmental, health and safety matters on behalf of our diverse clientele. We assist clients in navigating the requirements of the Toxic Substances Control Act (TSCA), including chemical prioritisation and risk evaluation/management, reporting, and record-keeping. We provide counsel regarding European (REACH, CLP, RoHS) and international chemical and product safety requirements. Moreover, we assists clients with Emergency Planning and Community Right-to-Know Act (EPCRA) reporting, including the Toxic Release Inventory (TRI) program and “Tier II.” 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.

Represent clients in the retail consumer product and manufacturing sectors in enforcement actions brought by federal and state (California) authorities for alleged violations of the regulations governing the labelling and marketing of antimicrobial products, including products making COVID-related claims.

VITAL STATISTICS

Represent manufacturing industries in addressing regulatory challenges related to chromium, nickel, manganese, copper, cobalt and other metals.

2019/20

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

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.”

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. 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.

Legal 100%

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.

GLOBAL OFFICES New York; Washington DC; Los Angeles, CA; Houston and Austin, TX; Chicago,IL; Stamford, CT; Parsippany, NJ; San Diego, CA. 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)

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.

Spill Prevention, Control and Countermeasure (SPCC)

STAFF SELECTION

Litigation: Environmental Remediation

Joseph Green – Special Counsel (DC) Wayne D’Angelo – Partner (DC) William Guerry – Partner (DC) Andrew Homer – Partner (San Diego)

Contamination Cleanup Transactional: Purchase and Sale of Contaminated Property CORPORATE DEVELOPMENTS & ACHIEVEMENTS Counsel businesses on the sale and marketing of antimicrobial products claiming efficacy against bacteria, viruses and microbes, including the online sale of anti-viral products.

www.chemicalwatch.com/SPG

Profile: Kelley Drye & Warren

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Profile: KFT Chemieservice GmbH

140

SERVICES PROVIDED KFT Chemicals Legislation: 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 using our taskforces, and undertaken numerous registrations for our customers. We offer you: OO only representative services pursuant to Article 8 (REACH); OO registrations according to Articles 10/11 and 18/19; and OO 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. International Regulations on chemical registrations: Many countries, such as South Korea and Turkey, have built up similar regulations to the EU with an obligation to register chemicals prior to marketing. With our local partners in all relevant countries we can enable you to fulfil all legal requirements.

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. Furthermore, we create the necessary information for mixtures based on the methods LCID (lead component identification) and Sumi (safe use of mixture information).

OVERVIEW

Biocide substances With an experienced team we handle registrations of biocide substances, coordinate study generation, prepare the dossiers and do the authority management.

KFT Chemieservice’s 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 for our services. Our responsiveness to individual customer needs is well recognised in the market. VITAL STATISTICS

2019/20

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

Training 12% Legal 1%

Other 8%

IT & software 1%

Consultancy/advisory 40%

Laboratory 2%

Information 24%

Global Service Providers Guide 2021

Representation & management 12%

Cosmetics We check your formulas regarding permissible ingredients or compliance with permissible concentrations and we create the legally required labelling information and obtain approval of finished labels on your behalf. In addition, we carry out product notification, draw up and verify existing safety assessments or complete product information files and finally, we will guide you through the jungle of ‘borderline’ products. KFT product safety: Safety data sheets Generation of safety data sheets (SDSs) worldwide in accordance with GHS. SDSs are generated according to national GHS implementation and supplemented by country-specific requirements. Examples of countries and regions are EU, Switzerland, Canada, US, all of Asia, South America and South Africa. We generate SDSs 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 customers to continuously update safety data sheets pursuant to statutory requirements. The total care service is completed by the latest innovation KFT SDS Control & Care, covering the management of supplier SDSs. For our customers, we also offer creation and servicing for a specified number of SDSs 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 them to eliminate possible deficiencies. We remotely enter the data of the suppliers’ SDS into their IT systems and also update the regulatory content data. Our many years’ experience with SAP EH&S allows us to ensure 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

2020

Wholly owned subsidiary of Infraserv GmbH & Co. Höchst KG

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 OO

OO OO OO

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 productinformation file (PIF). At KFT, we: perform a safety evaluation before the product is placed on the market andcreate the required report; create and maintain a product information file at your request; support you with the CPNP-notification required for the authorities; advise you and ensure sound legal protection for all tricky legal questions related to the cosmetics Regulation; and protect and strengthen your brand and the success of your company in thelong 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 this 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 find the existing data and data gaps, undertake negotiations with data keepers and contract testing labs to close the data gaps. If necessary we support the transfer of the lead registrant role and negotiate with the previous lead. We create the Iuclid file and CSR and take care of submission of the registration to Echa, including all necessary communications. 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 a 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 Chemtrec/GIZ Nord (Security number services) KTR Europe GmbH (China and Korea New Chemical Sub-stance Notification Service) LISAM Deutschland GmbH (ExESS chemical compliance software solution) CRAD (Cevre Risk Analiz Denetim), Turkey CIRS Chemical Inspection & Regulation Service Ltd

www.chemicalwatch.com/SPG

Profile: KFT Chemieservice GmbH

141

Profile: knoell

142

GLOBAL OFFICES Europe Germany I Mannheim, Leverkusen, Berlin, Münster, Schifferstadt United Kingdom I Cardiff, Bristol, Brampton Netherlands I Wageningen, Rotterdam Switzerland I Basel France I Lyon Spain I Madrid Portugal I Lisbon Italy I Milan

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, Italy, China, Thailand, Japan, South Korea, Taiwan, US, Brazil

Founded

1996

Asia China I Shanghai Japan I Tokyo Thailand I Chiang Mai South Korea I Seoul Taiwan I Taipei City Americas US I Garnet Valley (PA), Research Triangle Park (NC), Lebanon (TN) Brazil I Sao Paulo SERVICES PROVIDED

OVERVIEW We are an independent provider of global registration and regulatory compliance services for chemicals, crop protection and nutrition products, biocides, food contact materials and additives, novel food, cosmetics and medical devices as well as animal health-related products. Benefit from our extensive regulatory and scientific expertise. We work with you to ensure that your substances, active agents and products are always in compliance with the latest regulatory requirements, and that you fulfil all your obligations related to their safe handling. Total outsourcing or individual solutions: with sites in Europe, Asia and the Americas and a well-established network of cooperation partners knoell supports you to gain and maintain marketability – globally. VITAL STATISTICS

2019/20

Turnover, group

~ €60m

Turnover, chemical service provision

~ €20m

No of offices

No of countries represented Staff, group

15 ~ 600

Staff, chemical service provision

>180

SERVICE AREA BREAKDOWN IT & software Training 5% 1%

Laboratory 5% Information 7%

Representation & management 20%

Global Service Providers Guide 2021

Consultancy/advisory 62%

For the business areas supported by us we provide solutions for every step of the regulatory process. Total outsourcing or individual solutions, our teams will work with you to develop the best approach to achieve your goals. Strategic & Regulatory Consulting OO Latest information on the regulatory landscape in your target market OO Impact of the applicable regulations on your product portfolio, check of compliance OO Development of appropriate registration and testing strategies, including alternative non-testing approaches such as Qsar, readacross and waiving OO Determination of customer roles under the different legal regimes in the world, analysis of communication within the supply chains Representative Services OO We can act as only representative (OR) in the EU, UK, South Korea, Switzerland, Local Agent in China or TPR in Taiwan OO We assist you as non-EU manufacturer in the REACH registration process by filing the required inquiries pursuant to Article 26 REACH, represent you in the different Substance Information Exchange Fora (SIEF) and consortia, communicate with authorities, SIEF members, consortia, downstream users and other involved parties as well as monitor the entire registration process for you OO We handle sensitive data confidentially, and hence can act as trusted go-between e.g. for consortia members Submission Support & Document Preparation OO Consortium and Task Force Management OO Support with data sharing and Letter of Access negotiations OO Local in-country submission support: interaction with authorities and notified bodies pre- and post-submission (i.e. representing clients at authority meetings, handling submissions, applications and notifications) as well as with CROs and actors within the supply chain OO Preparation of dossiers and electronic submission (e.g. IUCLID, R4BP, CADDY, VNeeS) OO TSCA registration including PMN support OO Preparation of technical reports, study summaries (e.g. OECD format) and Tolerance Petitions OO Declaration of Compliance / Conformity OO Design, risk management and usability documentation OO Expert statements and opinion letters OO Label finalisation Hazard, Risk & Exposure Assessments OO Toxicological and ecotoxicological hazard and risk assessments OO Environmental exposure assessments OO Higher-tier exposure and risk assessments (e.g. model coupling, bee studies) OO Assessment of endocrine disrupting properties OO Assessments using computer based (in silico) models (e.g. Qsar, read-across)

Technical & Scientific Support OO Literature search & evaluation OO Environmental fate of active ingredients and their metabolites OO Biological efficacy of your products OO Thorough data analysis, including gap analysis, check of completeness, technical equivalence, identity and physical-chemical parameter determination Product Safety & Product Stewardship OO Development and management of (extended) Safety Data Sheets OO Poison Centre Notifications OO Classification & labelling under GHS, CLP, Osha HazCom and other schemes OO Workplace safety cards OO Exposure scenarios OO Dangerous goods: transport on road (ADR), rail (RID), inland waterways (ADN), sea (IMDG) and air (Iata/ICAO), Assessment of provided hazard data (classification as well as additional information), deriving the correct transport classification for the transport types of concern Study Management & Monitoring OO Identification of studies needed for registration purposes OO Study concept management: request and quote negotiation with CROs OO Study organisation at CROs OO Technical contact for CROs and clients – from study plan preparation to the experimental phase and the final report OO Inclusion of endpoints and studies into dossiers (incl. summary preparation) Quality Management & Audits OO Medical devices and in vitro diagnostic medical devices (incl. review and/or implementation of global quality management standards (QSR, ISO 13485, MDSAP, internal and supplier audits, support with certification bodies (inspection assistance, including on-site support and response to inspectional findings). OO Animal health products (quality assurance and audits for any stage of the product life cycle: pre-clinical studies, clinical studies, pharmacovigilance or manufacturing). OO Food contact materials (Good Manufacturing Practices (GMP), in accordance with the Regulation (EC) No. 2023/2006) Process Automation OO Working in close collaboration with you, our dedicated team of IT specialists, scientist and regulatory affairs managers will support you in identifying areas where automation might help to increase the efficiency of your day-to-day work. OO We will automate recurring tasks and processes for you and also speed up the way your reports and dossiers are created. We develop .NET-based tools and customised Microsoft Office add-ins (C#) based on your requirements. OO

Product design and development support for medical devices (non-active, active and software) and animal health products (from manufacturing and quality projects to pre-clinical and clinical projects) Biological safety assessments and clinical evaluation of medical devices Clinical trial support and pharmacovigilance for animal health products (pharmaceuticals, immunologicals, feed additives) Workshops & Seminars on topics from all regulatory areas covered by us via our knoell academy

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1996

Foundation, Mannheim, Germany

2002

Office in Leverkusen, Germany

2007 – to date

Continuous global growth by founding new entities (Switzerland, UK, Netherlands, China, Thailand, Spain, Portugal, France, Japan,

South Korea, Brazil, US), opening offices (Germany, Taiwan, Italy) and acquisitions (Cyton Biosciences Ltd, UK, Critical Path Services, LLC, PA, US, Shotwell & Carr, LLC, Carrolton, TX, US, Sitmae Reach Services, NL, Triveritas Ltd, UK) 2009

Launch of knoell academy, dedicated to provide training courses and bespoke in-house seminars, covering all our areas of expertise

2009

knoell contributed to more than 100 dossiers for plant protection products

2010

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

2010

Expanding our portfolio to animal health consulting services – acquisition of Cyton Biosciences Ltd., Bristol, UK

2010

Extending regulatory affair services from Europe to Japan and the Asia/Pacific region

2010

Successful preparation of more than 400 REACH dossiers and more than 100 chemical safety reports

2010

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

2011

1st knoell Symposium on Chemical Control Regulations in Asia and the Americas

2018

Name change: Dr. Knoell Consult GmbH becomes knoell Germany GmbH

2018

knoell joined the new, EU funded LIFE CONCERT REACH project, aiming at improving the usability and acceptance of results from non-testing methods (such as Qsar models and read-across) for registration purposes

2019

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

2020

Successful completion: knoell was tasked with testing the suitability of IUCLID software to handle pesticide and biopesticide dossiers and to fulfil the requirements of the Transparency Regulation coming into force in March 2021 in a pilot project commissioned by the European Food Safety Authority (EFSA) Full reports published by EFSA in the 2nd half of 2020

ACCREDITATIONS Qualified Cefic – partner PARTNERS SCAS Japan, SCAS Europe, Domo Salute, Cekindo, Mourão Henrique Consultores Associados, CRAD, AgriThority 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. 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. STAFF SELECTION Toxicology > 45 toxicologists Global regulatory affairs including consortium management and TPR > 80 specialists Environmental fate and modelling > 70 experts Ecotoxicology > 45 ecotoxicologists www.chemicalwatch.com/SPG

Profile: knoell

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Profile: Lisam Systems

144

SERVICE AREA BREAKDOWN

Enabling full compliance.

Training 5%

CONTACTS Website

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

E-mail

info.eu@lisam.com

Head office

Rue Jean Jaures 5, B-7190 Ecaussinnes, Belgium

Tel

+32 67 49 00 03

Fax

+32 67 49 02 11

Contact

Michel Hemberg

Directors

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

Ownership

Private company

Locations

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

Founded

1999

Representation & management 2%

IT & software 65%

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, speciality chemical, cosmetics, aromas and flavourings, detergents, paints, coverings, coatings, plastics and energy industries. Today, around 1,400 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

Consultancy/advisory 18%

2019/20

Turnover, group

€34m

Turnover, chemical service provision

€19m

No of offices

No of countries represented

Staff, group

330

Staff, chemical service provision

170

Information 10%

GLOBAL OFFICES Belgium, France, Germany, UK, Romania, US, Canada, India, Turkey, Brazil, Lithuania, Singapore, Luxembourg (WikiChemia), China, South Africa, Italy, the Netherlands (CHESSOL), Australia SERVICES PROVIDED Regulatory advisory services Lisam Telegis is the main department of regulatory expertise of Lisam Systems, partner of the chemical industry in regulations on health, safety and environment for more than 20 years. With practical knowledge and experience, we will guide your strategic decision making and bring support in: OO safety data sheets: issue of quality SDSs in compliance with REACH and other regulations specific to your activities; OO exposure scenario authoring: preparation and translation in the latest standard format; OO 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; OO poison centre notifications (Annex VIII to CLP); OO regulatory monitoring, general and customised; OO biocides: declaration of biocidal products and quantities, composition validation, monitoring of studies and environmental fate assessment, request for market authorisation, inclusion on list of authorised active substances, labels; OO hazard assessment by in silico methods: predictive evaluation of substance properties and hazards with computer models, ensuring cost and time savings compared with in vitro and in vivo studies; OO REACH registration: data collection, data gap analysis, dossier preparation and submission (around 300 dossiers submitted), regulatory advice on dossier evaluation; OO REACH only representative: REACH compliance for non-EU manufacturers; and OO REACH third-party representative: Lisam acts on your behalf for data submission, data sharing Our regulatory department also includes IT experts to advise you on the most adequate IT environment, install Lisam Systems’ EH&S modules, train your teams and support you with change requests and incidents. ExESS® EH&S packages ExESS EH&S applications are easy to use and flexible to configure. The system provides a powerful, open strategy for integrating with customer and third-party content. It allows for real-time API integration with a broad range of enterprise systems, and batch integration with built-in integration tools: OO SDS and 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;

Global Service Providers Guide 2021

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’s 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; and more solutions for waste management, risk assessment, detergents, fragrances, cosmetics, gas etc.

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 offered in several languages: OO regulatory training and consulting: REACH, GHS, CLP, Iuclid, (e)SDS, Poison Centre Notifications, biocidal products regulations; OO introduction and extended trainings on ExESS applications; OO regional trainings: EU, US, China, Japan; OO technical trainings: API, ERP integration, customisation; OO a helpdesk answering you on the phone or via email; and OO version patches and updates of ExESS issued three times a year guarantee a system aligned with latest regulatory changes. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1999

Creation of Lisam Systems in Belgium

2002

Acquisition of Belgian company ESI (Protheus Software)

2006

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

2007

Lisam India opens in association with Kalosoft Systems Technologies

2009

Acquisition of Hemmis, reinforcing development team and integrates ExESS software

2009

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

2010

Lisam America opens in Houston, Texas

2012

Lisam UK opens in Hartlepool

2013

Lisam Canada opens in Montréal, Québec

2014

Lisam Deutschland opens in Berlin

2014

Wikichemia, LISAM start-up dedicated to the 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

PARTNERS EIGA, WikiChemia, Emori, JCDB... CLIENTS With premises and partners around the globe, Lisam applications and regulatory advisory services are used by more than 1,500 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: OO multiple tools used for SDS and labels authoring; OO some subsidiaries using the same tool, but with different approach; OO some subsidiaries share a centralised database, while others use their own, lack of synergy; and OO SDS and labels layouts all differ, no efficient work method. Achievements: OO unification of the software’s patchwork under Lisam ExESS®; OO central unique database for all subsidiaries; OO limited migration of data: interface ExESS® with ERP/lab software; OO work done by one is benefiting to all; and OO one corporate standard for all compliance documents. CASE STUDY 2: Global regulatory success stories Lisam Telegis has been supporting successfully global actors in cosmetics, detergents, fine chemicals, industrial and speciality gases etc with: OO ingredients, raw materials and product compliance under REACH; OO under other regional regulations; OO early regulatory qualification processes; OO preparation and submission of inquiries as well as individual and joint OO REACH registration dossiers; and OO creation of thousands of (e)SDSs, meeting different regional GHS implementation. STAFF SELECTION Michel Hemberg, CEO Michel is a founder and majority owner of Lisam Systems. He took over the CEO position in June 2012, managing the global expansion of the company. Michel obtained 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 developed wide regulatory affairs competence over 25 years. She acts 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

145

Profile: National Chemical Emergency Centre (NCEC)

146

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

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

2019/20

Turnover, group

£352m

Turnover, chemical service provision

£8.0m

No of offices

No of countries represented

Staff, group

3000

Staff, chemical service provision

SERVICE AREA BREAKDOWN

IT & software 20%

Training 1%

Representation & management 4%

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 2021

Hazmat Academy A newly launched blended training solution – Hazmat Academy – provides off-the-shelf and bespoke training, delivered either in person, via distance learning or a combination of both. Training covers the following themes: OO emergency response; OO chemical response; OO non-technical skills; OO distance learning modules covering topics such as waste materials, batteries, explosives and illegal drugs; and OO detection, identification and monitoring. Consultancy OO UK and EU REACH support including Only Representative (OR), registration, dossier evaluation and review, authorisation applications and consultancy. OO Classification, labelling and advice on chemical safety legislation and risk management. OO Environmental chemical safety and risk assessments. OO Support with poison centre notifications from understanding your obligations through to completing notifications on your behalf. OO SDS authoring and translation services and management software – keeping your safety data sheets legal and compliant with REACH and GHS. OO Dangerous Goods Safety Advisor (DGSA) services. Crisis Management and Business Continuity Services OO Review and support the development of crisis response and business continuity plans and procedures. OO Bespoke training programmes to achieve your needs, focusing on developing the people’s non-technical skills (making decisions under pressure, crisis leadership, etc). Software OO Chemdata® – provides instant access to clear and concise chemical hazard information on more than 61,000 substances and is used by all UK and most Australian Fire Services, available for desktop computers and mobile devices; and OO ChemeDox® – document management system, with functionality for COSHH compliance and distribution. Training NCEC provides online and on-location bespoke training courses to teach critical skills for operating across the chemical supply chain, including: OO securing regulatory compliance and handling chemical emergencies; OO bespoke hazmat and chemical spill response training; OO chemical hazard awareness; OO COSHH assessments; and OO first aid for chemical exposure.

ACCREDITATIONS Quality assurance Lloyd’s Register Quality Assurance (LRQA) has issued NCEC, as part of Ricardo Energy & Environment, approval for the Environmental and Quality Management System Standards OO BS EN ISO 9001: 2008 Quality Management; OO ISO 14001: 2004 Environmental Management; and OO ISO 27001 Information Security Management. Training OO Training courses are accredited by the Royal Society of Chemistry. 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 1: BASF – exceeding best practice guidelines BASF is one of the world’s leading chemical companies, with more than 112,000 employees working across 350 chemical production sites globally. BASF originally managed its emergency telephone and chemical response requirements internally but decided to appoint a partner after

an internal audit revealed that they were unable to meet the CEFIC best practice guidelines of a 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. 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. 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)

147

Profile: Ramboll

148

GLOBAL OFFICES We support our clients globally having 300 offices worldwide. CONTACTS

SERVICES PROVIDED

Website

www.ramboll.com

E-mail

sbullock@ramboll.com

Head office

Copenhagen, Denmark

Tel

+44 20 7808 1420

Contact

Sue Bullock

Directors

Sue Bullock (UK) Dr Martina Vosteen, Dr Rudolf Wilden (DE) Dr Bob De Mott, Dr Salvatore Giolando (US) Anna Holst (SE) Lisbeth Odsbjerg (DK) Juliana Ding (Asia)

Ownership

Private Company

Locations

300 offices worldwide

Founded

1945

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: OO industrial; OO agricultural; OO biocidal; OO consumer; OO cosmetics; OO medical device; and OO food contact applications. We balance clients’ technical, regulatory and commercial interests with 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 a consortium manager, only representative and responsible person, and is independent from testing facilities.

OVERVIEW Ramboll is a leading engineering and consultancy company employing 16,500 experts. Our presence is global with representation across continental Europe, the UK and the Nordic countries, North America, the 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 – by adding new services, contributing to scientific advances or expanding geographically. VITAL STATISTICS

2019/20

Turnover, group

euro 1,900 m (unaudited)

Turnover, chemical service provision

euro 20 m

No of offices

300

No of countries represented Staff, group

35 16,500

Staff, chemical service provision

1250

Laboratory 5%

Consultancy/advisory 85%

Global Service Providers Guide 2021

Product stewardship, substitution and troubleshooting We have tremendous breadth and depth of expertise as well as extensive hands-on process experience, covering: OO toxicology and toxicokinetics; OO epidemiology; OO exposure modelling, measurement and reconstruction; OO risk assessment and mitigation; OO ecotoxicology; OO environmental fate; OO chemistry; OO occupational health; OO regulatory affairs; OO supply chain and stakeholder management; OO socio-economic analysis; OO product vigilance; and OO advocacy. We are ideally placed to advise clients on problems across the spectrum of product safety and stewardship, including product substitution and sustainable chemistry. We couple internationally recognised expertise and a reputation as a leader in risk management with client-focused solutions. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

SERVICE AREA BREAKDOWN

Representation & management 10%

Global chemical notifications and regulatory compliance support Ramboll evaluates obligations and provides support for regulatory approvals required to market products globally. 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.

2014

Ramboll acquires ENVIRON.

2016

Ramboll acquires specialist consultancy BiPRO

2019

Ramboll acquires OBG

2020

Ramboll launches Health Sciences Spearhead, bundling product safety & stewardship, occupational & building health, risk assessment and & community health, expert services and science for regulatory support

CLIENTS

CASE STUDY 6: Proposal to reclassify as CMR

Clients span all industrial sectors, including industrial and speciality chemicals, pharmaceuticals, petrochemicals, agrochemicals, food and food packaging, cosmetics, medical devices, electronics, manufacturing, aerospace and defence, apparel and consumer products.

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.

TESTIMONIALS

CASE STUDY 7: Product Stewardship

“We are working with Ramboll in a constructive and successful manner on various REACH projects, covering the entire processes (ie preparation of technical dossiers, exposure estimation and hazard and risk assessment)” – Dr Hans Certa, director, Global Product Safety, SASOL. “Ramboll has been, and is, an essential element in the success of our on-going REACH programme. Their seamless integration into our team and systems creates an unprecedented collaboration that enables high quality, cost effective and timely solutions. Our dossiers have been consistently ahead of schedule and fully satisfactory when reviewed by the competent authorities. Ramboll’s professionalism, expertise, and organisational excellence has and continues to contribute to our compliance goals and commercial success.” – James V Hagan, global director, product stewardship and regulatory affairs, Elementis Specialties Inc. “This is just perfect. I will never again be influenced by site arguments in other countries that we should hire local firms to perform risk assessments! If they had agreed to use Ramboll in the first place this whole process would have been so much cleaner and easier. Thank you for all of your hard work on this and in the short timeframe requested” – Michelle T Quinn, associate general counsel, regulatory affairs and general litigation, Catalent Pharma Solutions.

Our comprehensive emissions and exposure model characterised releases of the substance across Europe, providing a firm basis for discussions regarding risk management options.

CASE STUDY 1: REACH registration and evaluation We prepare robust substance dossiers, reliably characterising chemical fate and effects on humans and the aquatic environment and setting out practical exposure scenarios to deliver safe use for the environment, workers and consumers. We have extensive experience of both dossier and substance evaluation, and support through the appeal process. CASE STUDY 2: Application for authorisation under REACH A cross-sector consortium asked us to prepare an upstream application to support the authorisation of chromium trioxide in various critical surface treatments under REACH. It is regarded as the most complex application to date. We continue to support the applicants to implement the authorisation.

CASE STUDY 8: Endocrine Disruption Identification and comprehensive evaluation of all available data using a weight of evidence approach to assess whether a substance had endocrine disrupting properties. Presentation of the evidence to authorities to inform policy making. STAFF SELECTION Sue Bullock – Principal, product safety and stewardship Supporting strategic, regulatory and technical compliance, risk management, advocacy and policy for chemicals in the environment, the workplace and consumer products. Dr Martina Vosteen – Principal, product safety and stewardship 20 years’ experience in risk assessment and product-related regulatory support for chemicals, biocides and consumer products, including RMOA, restriction and authorisation for REACH. Dr Salvatore Giolando – Principal, product safety and stewardship 29 years’ experience directing and providing leadership in product stewardship programmes for chemical products, global supply chains and international product compliance. Dr Robert DeMott – Principal, product safety and stewardship A Board-certified toxicologist with over 25 years’ expertise evaluating health effects from chemical exposures in the workplace and community. Juliana Ding – Managing Director, Asia A Board-certified toxicologist with over 25 years expertise evaluating health effects from chemical exposures in the workplace and community. Dr Rudolf Wilden – Principal, product safety and stewardship 20 years’ experience in supporting our clients in maximizing the value of product-related HSE compliance & stewardship programs.

CASE STUDY 3: Risk Management Option Analysis (RMOA) Technical support to help an industry sector develop and justify to policy makers a more credible and effective RMO for a chemical than inclusion on Annex XIV REACH, and active engagement with stakeholders to inform policy development. CASE STUDY 4: Assured global compliance of new product A company launching a new consumer product worldwide had overlooked product regulations. We advised on regulatory obligations in 50 countries, considering chemical notification, packaging and labelling requirements and optimising the formulation and market claims. CASE STUDY 5: Comprehensive exposure assessment A food packaging producer was concerned when residual levels of a contaminant were unexpectedly found in a key product. We could show that consumer exposure from handling the packaging and ingesting the packaged foods was safe, avoiding regulatory action.

www.chemicalwatch.com/SPG

Profile: Ramboll

149

Profile: REACH Global Services S.A.

150

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

SERVICES PROVIDED

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

Contact

Dr Yaprak Yuzak Kucukvar

Directors

Global Offices Managing Director Mr A Ecmel Yorganci 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

EU REACH compliance services According to Article 8 of the REACH Regulation it is compulsory for nonEU manufacturers, who export chemicals on its own or in preparations to the EU, to appoint an OR for compliance. The EU importer benefits from being a downstream user and RGS acting as an OR fulfils the obligations of the manufacturer. RGS provides a wide range of services to comply with legal requirements. Our Only Representative Services cover: OO inquiry dossier submission; OO registration dossier submission; OO Sief/consortia representation; OO specialised tonnage tracking IT system and certification for compliance of the downstream user (DU)/importer; OO general consultancy services for EU based companies impacting substance registration dossiers, and interactions with regard to the authorities’ requests and inspections; and OO audit and certification services assisting non-EU manufacturers and their EU importers covering compliance evidence.

OVERVIEW Brussels-based REACH Global Services SA (RGS) and its Turkish branch RGS Danışmanlık AŞ are professional regulatory consulting companies advising clients in the chemicals and allied industries to comply with EU and Turkish chemicals legislations. RGS Group’s experienced staff, based in the EU and Turkey consults to a diverse array of chemical companies, both international and Turkish, operating across a range of chemical industry sectors. Through experience, in-depth knowledge and understanding of the regulations and governments’ regulatory processes, associated policies and guidance documents, RGS offers a wide range of cost-effective services ranging from OR services to; company-specific consultancy services, general consultancy on regulatory compliance issues, training on specific EU REACH and cosmetics legislation compliance, audits or due diligence projects, as well as on Turkish chemical by-laws and Turkish-REACH (KKDIK) compliance services.RGS’ 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

2019/20

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 3% Laboratory 3%

Other 6%

Consultancy/advisory 5%

Information 3%

Representation & management 80%

Global Service Providers Guide 2021

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: OO EU legal representation (responsible person); OO preparation and verification of PIF; OO cosmetic product safety report parts A&B (CPSR); OO formulation and claims review; OO review and guidance on borderline cases; OO review and guidance on necessary corrections on labelling; OO cosmetic product notification; OO scientific and laboratory services (mandatory and claim tests); and OO regulatory compliance support. Turkish REACH (KKDIK) only representative services Turkish-REACH abbreviated as KKDIK is published as of 23rd of June 2017. KKDIK is almost a copy paste of the EU REACH Regulation translated into Turkish, but unavoidably there are slight differences to pay attention to, and all implementation, compliance processes are in the Turkish language. 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. SIEF (MBDF) communications have started for exchange of information between potential registrants.Registration deadline: 31/12/2023 Turkish chemical regulations representative services RGS represents international companies putting chemical substances and mixtures into the Turkish market under the Turkish Ministry of Environment and Urbanism (MoEU) database since 2010. According to By-Law on the Classification, Labelling and Packaging of Substances and Mixtures, hazardous substances and hazardous polymers placed on the Turkish market should also be notified to the MoEU regardless of their volume. 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.

2020

Pre-registered more than 10000 substances under KKDIK as OR/TPR for over 300 manufacturers and notified 4000+ substances for SEA. Leads SIEF/Consortia activities within Turkey. Representing companies under UK REACH through strategic partners.

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.

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Profile: REACH Global Services S.A.

151

Profile: Reach Only Representative Ltd

152

EU REACH compliance and OR Services We provide an extensive and comprehensive regulatory advisory service whilst keeping it tailored to the clients needs. We can explain the full process to registration and beyond.

CONTACTS Website

www.rorltd.com

E-mail

info@rorltd.com

Head office

Booths Park 1, Chelford Road Knutsford, WA16 8GS, UK

Tel

+44 (0) 1565 748 111

Contact

Dr Ben Gandhi

Directors

Dr Ben Gandhi Mrs Shirley Gandhi

Ownership

Private limited company

Locations

GB and Republic Of Ireland

Founded

2007

Consultancy for UFI and poison centre notifications Provide a full service for all PCN and CLP requirements Cosmetic safety assessment and responsible person Provide a full service for cosmetics manufacturers wishing to sell into the EU and UK PARTNERS ChemReach Regulatory Consultancy Services Ltd. Reach Trustee Services Ltd. CLIENTS ROR has a blue chip list of global clients where we help to achieve and maintain legislative compliance in REACH and in UK REACH. Our clients range from SMEs to multinational organisations in industrial chemical, petrochemical, pharmaceutical, agrochemical and consumer product sectors. With the confidential nature of our clients’ information, we fully respect and support their preference to remain undisclosed. CASE STUDY 1

OVERVIEW Established in 2007, Reach Only Representative (ROR) was one of the earliest companies to specialise in consultancy for REACH registration and a founder member of Only Representatives Organisation (ORO). ROR is a market leader in the independent provision of only representative (OR) services for REACH and UK REACH. With offices in the UK and Ireland, ROR is in an ideal position to aid clients with European and UK registration, avoiding duplication of effort. Our aim is to assist each client in creating its individual and inclusive strategy for registration, incorporating legal, ethical and financial aspects in the process. VITAL STATISTICS

2019/20

No of offices

No of countries represented

CASE STUDY 2 Completed over 250 REACH lead and joint registration dossiers and so have a full understanding of all the issues that might occur and how to prevent issues occurring. CASE STUDY 3: Worked with our EU REACH clients to ensure that they all became compliant with UK REACH and ensured a smooth transition in a costeffective manner.

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training IT & software 5% 5% Information 5%

Consultancy/advisory 60% Representation & management 25%

SERVICES PROVIDED UK REACH compliance and OR services We provide an extensive and comprehensive regulatory advisory service whilst keeping it tailored to the clients needs. We can explain the full process to registration and beyond. We can help the client understand the impact of the Irish protocol and what needs to be done to meet the regulations. Global Service Providers Guide 2021

Worked with a major polymer recycling company to ensure that their REACH compliance was achieved before Brexit and they had an easy transition after the UK left the EU.

STAFF SELECTION Ben Gandhi – Managing director PhD Industrial chemistry As a founder of ROR, Ben’s wealth of experience in the chemical industry provided the insight to acknowledge both the legal and financial issues facing companies confronted with the challenges of achieving REACH compliance. Ben works closely with every one of our clients to construct a financially sound, tailored approach to compliance of each of their target substances. Shirley Gandhi – Director BSc (Hons) Industrial chemistry With involvement in all aspects of the chemical industry Shirley has expertise in research, production, planning, quality and finance. Since joining ROR as a partner in 2009, she has worked to assist clients in achieving and maintaining compliant registration. Mark Reid – Senior consultant Senior consultant with ROR since its inception in 2007, Mark has a wealth of experience in all aspects of REACH compli-ance including: OO regulatory affairs including chemicals, cosmetics, biocides and food contact materials law; OO global notification in EU and non-EU jurisdictions; OO globally harmonised system expert; OO international transport regulations expert; OO applied chemistry, toxicology and ecotoxicology; OO Qsars and alternative and ethical testing methodologies; OO registration and notification; OO chemical safety assessment; and OO consortium management.

Profile: REACHLaw

154

SERVICE AREA BREAKDOWN Training 5% Legal 20%

CONTACTS

Consultancy/advisory 30%

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

GLOBAL OFFICES

Ownership

Private company

SERVICES PROVIDED

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 into 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 Echa’s committees, responding to input from alternatives providers and commenting on draft committee opinions. We have prepared and are working on more than 30 applications for more than 40 uses that include individual and joint applications, and consortia for upstream and downstream applicants.

IT & software 10% Laboratory 5% Information 5%

Helsinki, Brussels, London, Istanbul, Moscow and New Delhi

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 & CLP, Eurasia REACH, India REACH, K-REACH & GHS, 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 obligations, as required by the revised EU Waste Framework Directive (WFD). REACHLaw can serve its clients in the following languages: English, Finnish, French, German, Spanish, Italian Swedish, Hindi, Russian, Ukrainian, Hungarian, and Turkish. VITAL STATISTICS

Representation & management 25%

2019/20

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

60+

Staff, group

40+

Staff, chemical service provision

30+

Global chemical regulatory compliance services REACHLaw provides a comprehensive range of chemical regulatory compliance services to help companies adapt to changing regulatory requirements and provides full support with notification, inquiry/preregistration, registration, and authorisation of their chemical substances placed within and outside the EU. Through our offices in Helsinki, Brussels, London, Istanbul, Moscow and New Delhi, and our global partner network, we serve our clients as both their only representative and service provider. Our support includes: EU REACH and CLP, UK REACH and CLP, Turkey KKDIK, SEA and GBF, Eurasia REACH, EAEU GOST Standard No 303332007, India REACH, India BIS, K-REACH and GHS and many more. To date REACHLaw has prepared: 3,000+ EU REACH registrations including updates, 100+ lead registrations, 1,000+ CLP notifications, 30+ authorisation applications, 5,000+ Turkey KKDIK pre-registrations, 7 000+ inventory notifications in Russia, 500+ K-REACH notifications, 300+ UK REACH downstream user import notifications, 10+ India BIS applications and many more. 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. Furthermore, we provide strategic advice for companies ranging from determining the impacts of Scip notification on their business and supply chain to implementing their strategy with concrete actions to successfully comply with Scip notification requirements.

Global Service Providers Guide 2021

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

ACCREDITATIONS

2006

Established in Helsinki.

2008

Partnerships with 20+ local partners in Asia, Europe, Latin America, the US and India established. 3,000+ REACH preregistrations submitted.

2009

REACHLaw received internationalisation award from the president of Finland. Brussels and New Delhi offices opened

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.

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.

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

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.

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.

2014

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

TESTIMONIALS

2015

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

2016

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

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 to maintain access to the EU/EEA market as well as to the UK market. Preparing large number of KKDIK pre-registrations. REACHLaw Moscow office was established. REACHLaw London office was established. Prepared thousands of notifications in Russia.

2020

Prepared and submitted thousands of KKDIK pre-registrations. Helped article suppliers with their Scip notification obligations. Helped UK and EU companies to address Brexit related impacts. Helped industry with India BIS applications. REACHLaw YouTube channel – REACHLAW TALKS – launched.

2021

Supporting industry with UK REACH registration requirements and provisional measures: downstream user import notifications, Grandfathering and more. Helping companies with their KKDIK lead registrations. Supporting companies to comply with Scip notification obligations and preparing companies to deal with the upcoming India REACH Regulation.

“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 CASE STUDY 1: 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 is relevant for our client and therefore, REACHLaw is supporting the Client in keeping access to the UK market through our London office functioning as the UK REACH Only representative. CASE STUDY 2: REACH authorisation REACHLaw prepared the first joint downstream user application for functional chrome plating use of chromium trioxide for a consortium of seven SME Finnish job platers. REACHLaw provided both consortium management services and technical consultancy services to the applicants. The application was submitted before the latest application date and applicants received their decision already on 27.10.2017 granting them authorisation to continue their use for seven years. This joint downstream user application of SME companies was a forerunner of downstream user applications that were submitted later. STAFF SELECTION Mr Tim Becker, MA (Law) – Senior Legal Advisor Dr Bernardette Quinn PhD (Chemistry) – Head of Authorisation Practice Sini Suomela (MSc in Organic Chemistry) – Head of OR and Registration practice.

www.chemicalwatch.com/SPG

Profile: REACHLaw

155

Profile: Risk & Policy Analysts Ltd (RPA)

156

SERVICE AREA BREAKDOWN Training 5%

CONTACTS Website

rpaltd.co.uk

E-mail

post@rpaltd.co.uk

Head office

Suite C, 2nd floor, The Atrium, St Georges Street, Norwich, Norfolk, NR3 1AB, UK

Tel

+44 1603 558442

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 and substitution plans.

OVERVIEW Risk & Policy Analysts Ltd (RPA), established in 1990, is an independent employee-owned 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. It is a market leader in the development and application of socio-economic analysis (SEA) to chemical risk management and particularly proud of its reputation for preparing applications for authorisation of SVHCs under REACH for industry clients. RPA offer 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. Following Brexit, it is offering its services under the UK (GB) REACH legislation. RPA has worked with industry clients since 2001 on the implications of the EU regime for chemical risk management. It has done so closely with the European Commission and the European Chemicals Agency (Echa) on the development and implementation of REACH and many other regulations relating to chemical risk management. Company 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, resulting in detailed studies on over 50 high profile chemicals. RPA’s multinational staff routinely work on detailed analysis and consultation with industry and regulators in most European languages. VITAL STATISTICS Turnover, group

2019/20

No of offices

2 Focus on EU-27, EEA, UK and candidate countries

Staff, group

Staff, chemical service provision

Global Service Providers Guide 2021

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

RPA advises industry clients and regulators on the (potential) impacts of regulations and regulatory change.

1998

RPA wins major framework contract for the UK authorities on chemical risk management

2000

OECD publishes guidance documents on SEA and chemical risk management prepared by RPA.

2004

RPA wins major framework contract for the European Commission on chemicals.

2009

RPA contracted support applications for authorisation under REACH with a focus on SEA work.

2012

RPA completes three studies for DG Environment reviewing the first years of REACH implementation.

2013

RPA leads the market in supporting seven applications for authorisation of SVHCs under REACH.

2014

RPA clients obtain the first granted REACH authorisations.

2015

RPA supports the submission of nine applications for authorisation.

2016

RPA leads the EC fitness check for chemicals legislation (excluding REACH).

2017

RPA supports DG Employment in major revisions of the CMD and RPA clients submit first ever authorisation review reports.

2018

RPA Europe established as an EU legal entity to ensure continuity of services within the EU post-Brexit

€3.0M

Turnover, chemical service provision No of countries represented

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.

2019

2020

RPA 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. RPA selected to lead fifth study for DG Employment assessing the socio-economic impacts of potential revisions to occupational exposure limits (OELs). RPA supporting UK DEFRA in UK REACH monitoring.

CASE STUDY 3: Study on Occupational Exposure Limit Values (OELVs) RPA is completing a fifth study for DG Employment on assessing the socio-economic impacts of potential revisions to OELs under the Chemical Agents Directive and the Asbestos at Work Directive. This includes performing socio-economic analysis of a range of possible OELs to assess the costs and benefits. This study follows on from four previous OELs studies performed by RPA.

PARTNERS RPA works with FoBiG, Ökopol, Bureau Veritas, Triskelion, Milieu, DHI, RIVM, ARCHE Consulting, IEH Consulting, ReachCentrum and Anthesis among others. CLIENTS OECD, European Commission (including DG Grow, DG Environment, DG Employment and DG Justice and Consumers). National authorities (eg UK, Germany, Sweden, Denmark, France, Norway and the Netherlands). European Chemicals Agency (Echa), European Food Safety Authority, European Environment Agency, Executive Agency for Small and Mediumsized Enterprises. 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 as, Dow Chemicals, Eli Lilly, Grupa Azoty, Grupa Lotos, H&R Group, Lanxess, Rolls Royce, Nouryon, Spolana. TESTIMONIALS “We would like to express personally how much we appreci-ated your work and your help during the whole authorisation process. Not only the high level of expertise and the extreme-ly 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 chal-lenging work on developing the model for the 2018 registra-tion costs.” – European Commission client. CASE STUDY 1: Provision of analysis of alternative (AoA) and socio-economic analysis (SEA) support services RPA has provided REACH authorisation support to several consortia of manufacturers and users of SVHC substances. This includes preparation of analyses of alternatives, supply chain communication, preparation of socio-economic analyses and substitution plans. We manage services of specialist toxicology and risk assessment consultants. CASE STUDY 2: Work conducted to support the European Environment Agency programme HBM4EU RPA completed work to support the EEA HBM4EU. It performed mapping of legislative frameworks relevant to a list of prioritised substances, and produced policy briefs for policy makers, highlighting potential hazards of the prioritised substances etc. This study updates the work completed by RPA for the EEA in 2017 which required the production of individual policy briefs for the first list of HBM4EU priority substance groups.

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 she guides the preparation of SEAs to support authorisation and restriction activities. David Carlander – Technical Director, Chemicals David has over 23 years of experience from academia, public administration and the private sector. He holds a PhD in clinical chemistry, and a MSc in biotechnology. Over the last 14 years David has been working with risk assessments in the food and chemicals area including nanomaterials. He has been supporting regulatory submissions of food contact materials under EU and US legislation, and given numerous presentations at national and international events, including regular attendance at Echa stakeholder and OECD meetings. 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 over ten years of expertise in preparing AoA and SEA arguments at sector level for downstream users. He has undertaken extensive supply chain mapping activities to assess the potential vulnerability of downstream user groups to the loss of key substances and prepares substitution plans. Max La Vedrine – Senior Consultant Max works on REACH applications for authorisation where he attends client and PSIS meetings, conducts site visits, performs literature reviews and develops client’s analysis of alternatives, socio-economic analysis and chemical safety reports. He conducts extensive literature reviews, organises and helps to run workshops, and conducts stakeholder engagement. Max has worked on several studies looking at the impact of chemical legislation. This includes DG Environment’s regulatory fitness check of the legislative framework governing the risk management of chemicals (excluding REACH). 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 his work is identification and compilation of information for the purposes of applications for authorisation under REACH. 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)

157

Profile: SCC

158

GLOBAL OFFICES Headquarters Bad Kreuznach (Germany), Office Berlin, SCC Japan and SCC UK 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 (Head of Chemicals)

Directors

Florian Pistel (Managing Director) Dr Monika Hofer (Managing Director, Regulatory Science) Dr Martin Weiser (Managing Director, International Business, Pharmaceuticals and Medical Devices) Dr Bernd Brielbeck (Agrochemicals and Biorationals) Dr Thomas Roth (Chemicals) Dr Martina Galler (Biocides)

Ownership

Private company

Locations

Germany, Japan, United Kingdom

Founded

1989

Registration of chemicals – REACH and non-EU regulations SCC provides strategic expert counselling, registration services and lifecycle support for chemicals at international level. We successfully filed more than 600 lead dossiers for phase-in and non-phase-in substances, more than 50 Ppord notifications, hundreds of member dossiers and more than 1,000 CLP notifications. Beyond Europe, we notified new and existing substances in many international markets, such as Turkey, China, Japan, Korea, Australia, Canada and Eurasia. With our new SCC UK office, we also now offer full-scale regulatory support in the United Kingdom. We have well-established relations with competent authorities in the EU and abroad and are 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, we can provide you with: OO development of registration & testing strategies for chemicals and polymers; OO organising and monitoring of studies; OO preparation of inquiry and registration dossiers and submission to competent authorities; OO literature search, data review and identification of data gaps; OO development of grouping/category approaches (read-across); OO estimation of substance properties and data generation via Qsar prediction tools, such as Qsar Toolbox, EPI Suite and Ecosar; OO human health and environmental risk assessments, incl. exposure modelling (such as Euses, Risk of Derm, ConsExpo, EasyTRA, ART and Stoffenmanager); OO safety data sheet (SDS) support, including preparation of the annex to extended eSDS; OO C&L support (CLH dossier according to Annex XV, Rac evaluation); OO defence support for chemicals under authority evaluation or scrutiny (EU:Corap, SVHC, compliance checks, restriction, authorisation procedure); scientific/regulatory support at EU expert meetings; OO only representative support and trustee service for supply chains (non-EU,EU); OO joint submission and consortia support/management; and OO poison centre and Scip notifications.

OVERVIEW SCC – the Scientific Consulting Company, founded in 1989 – has risen to become one of Europe’s largest privately-owned and independent scientific consulting companies. We support global customers with (international) registration and other compliance obligations for chemicals, cosmetics, consumer products, agrochemicals and biorationals, biocides, feed and food additives, food contact materials, medical devices and pharmaceuticals (pre-clinical). VITAL STATISTICS

2019/20

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

130

Staff, chemical service provision

SERVICE AREA BREAKDOWN

IT & software 2% Information 3%

Legal 10%

Training 3%

Other 0%

Representation & management 14% Consultancy/advisory 68%

Global Service Providers Guide 2021

Registration of agrochemicals and biorationals We 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 partner network, 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 taskforce support. Registration of biocides Our biocides experts have successfully submitted and defended dossiers for more than 20 biocidal active substances in nearly all product types (more than 70 active substance dossiers) as well as numerous dossiers for biocidal products and product families in line with BPD 98/8/EC or BPR (Regulation (EU) No 528/2012). We provide regulatory support in Asia-Pacific (eg China, South Korea and Japan) and for the UK. Conformity assessments of medical devices We have a profound knowledge of quality- and admission- relevant standards and regulations. We help with issues related to the new European medical device regulation MDR (EU) 2017/745 and other international regulations as well as preparation or updating your technical files.

We have experience 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. Authorisation of feed additives and food contact materials Extensive knowledge and closely following the relevant EU regulations is the vital basis for our regulatory and scientific support. This allowed us to successfully manage more than 50 (re-)authorisations for feed additives. Our expertise and relationships with authorities and industries enable us to put together the optimal balance of scientific data and expert statements for your products. We professionally guide 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 and national product regulations (such as for plastics, active and intelligent materials) and a variety of directives for other product categories (such as printing inks). Notification of cosmetics and consumer products We have successfully supported the cosmetics and consumer product industry for more than two decades. With in-depth knowledge of the relevant EU regulations (eg for cosmetics or detergents) and applicable national regulations, we help our clients meet all challenges, such as the animal testing ban for cosmetics. We have 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 and certified experts at our Regulatory Science business unit provides its extensive expertise in the fields of: OO data-gap analysis, study monitoring and dossier preparation; OO exposure modelling and risk assessments for human health andenvironment; OO conceptual work on higher-tier approaches (eg in silico (eco) toxicology, population modelling); OO assessment of potential endocrine disruption incl. MoA analysis, AOP concepts and WoE approaches; OO preparation of expert statements and position papers; OO classification and labelling support (CLH dossier preparation and defence during Rac process); and OO 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 and inclusive 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 any time and from any location. We are also your partner for secure archiving of GLP raw data. In 2004, we were successfully certified as the first GLP contract archive in Germany. Since then, we have been regularly inspected by the German GLP monitoring authority and maintained this status. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

2019

Medical Devices business unit SCC Legal founded

2020

SCC UK founded

ACCREDITATIONS GLP archive (since 2004) PARTNERS In cooperation with our global network of CROs, local regulatory experts and scientists, we can offer our clients support in key markets across the world. CLIENTS Small to large (global) companies in the areas of chemicals, agrochemicals and biorationals, biocides, cosmetics and consumer products, feed and food additives, food contact materials, medical devices and pharmaceuticals (pre-clinical). TESTIMONIALS Many of our clients are longstanding, 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 minimise 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, having waived a number of higher-tier tests. STAFF SELECTION Dr Thomas Roth Dr Roth has a PhD in food chemistry and is a certified toxicologist. He has been with SCC for more than ten years, and head of Chemicals, Consumer Products, Cosmetics & Food Additives since 2017. He previously worked for a large chemical multinational, having gained considerable professional experience in the evaluation and registration of consumer products and chemicals worldwide. Isabel Kirbach Ms Kirbach has a master’s degree in chemical engineering. She has been with SCC since 2004. Her focus is on joint submissions, Iuclid and consortia management. Dr Ingo Walter Dr Walter has a PhD in food chemistry and is a certified toxicologist. He has been with SCC since 2008, focusing on risk assessments, C&L and eSDSs.

1989

SCC GmbH founded Agrochemicals, Biorationals and Regulatory Science business units established

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 cosmetics.

1996

Chemical and Consumer Products business unit Biocides business unit

2000

GLP archive certification

2004

Liaison Office Japan founded

2007

Feed and Food Additives group

Dr Martin Weiser With a PhD in pharmacology and versatile leadership experience in the pharmaceutical industry and associations, Dr Weiser joined SCC as CEO in January 2021, taking on responsibility for international business, pharmaceuticals and medical devices.

2014

Office Berlin founded

2018

SCC Japan founded

Ji Yeong Kim Ms Kim has a master’s degree in environmental engineering and experience in both EU and Korean chemicals and biocides regulations. Before joining SCC, she worked for a Korean regulatory consultant and supported Korean companies for EU-REACH. She joined SCC in 2019 and is in charge of K-REACH and K-BPR. www.chemicalwatch.com/SPG

Profile: SCC

159

Profile: Sphera Solutions

160

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 CONTACTS

SERVICES PROVIDED

Website

www.sphera.com

E-mail

operationalexcellence@spherasolutions.com

Head office

130 East Randolph St, Suite 1900, Chicago IL, 60601, USA

Tel

1-514-337-2114 31 (0) 24 329 7424

Contact

Frank Arcadi

Directors

Paul Marushka, President and CEO Bob Hogue, Chief Financial Officer

Ownership

Privately Held

Locations

United States, Canada, Paris France, London UK, Nijmegen The Netherlands, Bangalore India

Founded

2016 (previous division of IHS)

Sphera provides 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: 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 is the leading provider of environmental, social and governance (ESG) performance and risk management software, data and consulting services with a focus on environment, health, safety & sustainability (EHS&S), operational risk management and product stewardship. 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

2019/20

No of offices

No of countries represented

Global

Staff, group

1000+

Staff, chemical service provision

150

SERVICE AREA BREAKDOWN Training 2%

IT & software 50%

Global Service Providers Guide 2021

Consultancy/advisory 18%

Information 30%

Product compliance Our SDS Authoring solution Automates the production of compliant safety data sheets in nearly 50 languages, ensuring your customers and employees will have the information they need to ensure safe use of your products and continued access to global markets. This includes a powerful rule-based document generation engine with the ability to produce extended 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. Further-more the solution allows for GHS by Design, a unique functionality that allows SDS authors to configure user-defined GHS implementations for any area, country or region with no official GHS regulatory support. Documentation and labels: Simplifies the process of designing, producing and printing labels for GHS, transport and consumer goods regulations. Product 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

CASE STUDY 3: Tikkurila

1989

Atrion International is founded

1991

Dolphin Software is founded

2008

IHS acquires Dolphin Software IHS acquires Environmental Software Providers

2009

IHS acquired Environmental Support Solutions

2010

IHS acquires Atrion International IHS acquires Syntex Systems

2011

IHS acquires Dyadem IHS creates Operational Excellence & Risk Management (EHS) Division

2015

Verdantix – Smart Innovators Badge

Challenge: Generate world-class 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 2,000 products from four sites in four 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.

2016

Verdantix – Green Quadrant Leader

CASE STUDY 4: Siemens Healthcare

2016

Sphera Solutions founded from previous IHS EHS Division

2017

Sphera Solutions acquires Rivo Software

2017

Verdantix – Green Quadrant Leader

2017

Verdantix – market leader, chemical & hazardous waste management

2017

Environmental Leader – project of the year

2018

Sphera acquires SparesFinder

2018

Sphera acquires Petrotechnics

2019

Sphera acquires SIteHawk

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

Sphera acquires ThinkStep

2019

Verdantix – #1 provider, chemical management

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 to have transparency and accountability for audits by offering the ability to track back to chemical composition and business decision justifications. Yara was also able to streamline work processes by automating distribution of SDSs.

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, as well as the implementation of regulations in databases and software applications. Trudeau is a recognised industry expert, serving both as a featured speaker at international conferences and leading multi-organisation task forces in establishing industry best practices for regulatory compliance. Carrie Decatur, senior regulatory analyst Carrie is an internationally recognized expert in GHS at the UN and individual country level. She has been with Sphera Solutions for over 10 years. In her role as Senior Regulatory Analyst she is responsible for the analysis and implementation of global chemical regulations into the Sphera Product Stewardship offerings and the web based training program. She is Chair of the Global Regulatory Focus Group, a monthly client-based forum where regulatory updates and new system implementations are discussed. Carrie has worked in the Services group as a consultant where she utilized her SDS authoring and industry experience to assist clients in implementing product compliance software in an efficient and cost effective manner. Prior to joining Sphera, she worked in the chemical manufacturing arena where she was responsible for HSE and quality programs.

www.chemicalwatch.com/SPG

Profile: Sphera Solutions

161

Profile: Staphyt Regulatory

162

SERVICES PROVIDED Areas of expertise: Sectors covered: plant protection products, fertilisers, biostimulants, biocides, chemical substances (REACH & CLP)

CONTACTS Website

www.staphyt.com/regulatory

E-mail

contact@staphyt.com

Head office

57, avenue du Président Edouard Herriot 69002 Lyon France

Tel

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

Contact

Manda Vince

Directors

Regulatory Business Director: Manda Vince

Ownership

Staphyt

Locations

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

OVERVIEW Our large Regulatory Affairs Division provides comprehensive technical expertise, multiple language skills and in depth regulatory knowledge on plant protection products, fertilisers, biostimulants, biocides and REACH, throughout Europe, UK, Brazil/Latin America, Australia/New Zealand and in many 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, marketing and sale of their new or existing substances or products in their target countries. We will also keep you informed of changes in the regulatory landscape as they emerge. We offer complete management of your registration projects, from understanding data requirements, managing contract research organisations (CROs) to generate the data, production of the relevant dossiers and post submission support. If you wish, we can also work in close collaboration with our extensive Staphyt Agrosciences group, laboratory and glasshouse teams, to meet many of your needs, further reducing the number of parties you have to interact with. VITAL STATISTICS

2019/20

No of offices

No of countries represented Staff, group

>40 >400

Staff, chemical service provision

>50

SERVICE AREA BREAKDOWN Training 10%

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 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

ACCREDITATIONS 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) across many continents, providing a comprehensive offering of regulatory and scientific expertise at both the national and European level. This network supports us by extending our language skills and by having consultants who have formed close relationships with regulatory authorities in their own areas. CLIENTS From SMEs to multinationals, our clients are chemical and biological product manufacturers, formulators, importers or distributors. We work with many well known larger clients, well established small to medium companies, and with start ups. They specialise in one or more of the following types of business: biocides, industrial chemicals, plant protection products, adjuvants, fertilisers and biostimulants. TESTIMONIALS

Representation & management 10%

Consultancy/advisory 80%

Global Service Providers Guide 2021

Services: OO regulatory advice and strategy; OO data gap analysis; OO technical equivalence; OO field and laboratory study monitoring (GLP and/or GEP); OO dossier preparation for active substances and products; OO literature search;•task force/consortium management; OO risk assessments for operators, workers and bystanders, birds andmammals, other terrestrial and aquatic organisms, consumers, environment; OO modelling; OO CLP classification, SDS and labelling; OO poison control centre notifications; OO expert statements and Efsa compliant literature searches; OO regulatory support in all European countries, Brazil, Australia and many others; OO technical and regulatory training; OO update service Regulatory Watch (newsletter by subscription); and OO support with issues resulting from the UK’s withdrawal from the EU (Brexit), including UK REACH.

Client 1: “For us working with Staphyt is effortless. As well as open and collaborative communication, their expertise takes the burden of requiring specialists in each area off our shoulders. Working together provides us with space to focus where our internal value lies, confident our partners Staphyt are fully managing technical aspects to meet our particular needs. I would choose Staphyt for the good relationship with the dossier managers in the different projects and follow-up, the experts also try to tackle problems pragmatically and try to think together with the client for the best solution.

The assistance we received on the endocrine disruption was great. We received quick and reliable feedback on the study progress and the options to continue, so we could weigh these off and choose the best solution to proceed with the study.” Client 2: “Working with Staphyt for several years has shown us that we can count on them for project development. Communication is simple and proactive, being able to have specialists with high competence and knowledge, and with a very high commitment to achieve the set objective.” Client 3: “The assistance we received from the ecotoxicology experts on the ED studies for our active substance was great. We received quick and reliable feedback on the study progress and the options to continue, so we could weigh these off and choose the best solution to proceed with the study.” CASE STUDY 1: 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 prepared all dossier sections including all risk assessments. Tailored strategies for human risk assessment were proposed to our clients. Specific refinements were developed, including dermal absorption studies monitored by our toxicologists. We successfully obtained the biocidal product Regulation 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 biocidal product family regulation, taking into account the change of our clients’ products. CASE STUDY 2: Plant Protection Sector A draft Registration Report was prepared for the renewal of authorisation of a product in different Member States across the EU. The 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 subsequently tailored to support the revised rates and timings, in order to gain the maximum number of crops for renewal of the authorisations. In the environmental fate and ecotoxicity sections, problems were identified in surface water and groundwater, including the relevance of metabolites in groundwater. Strategies used for solving the problems included the performance of new environmental fate studies, correcting the application parameters according to the application type for specific crops, and higher tier modelling. These solutions were successful and the product was approved by the zonal Rapporteur Member State. CASE STUDY 3: Plant Protection Sector One of our clients wanted to data match against protected active substance data held by another company. The substance was to be used in insecticide products and there were many complex metabolites and some very challenging environmental issues. We assisted our client in negotiations to secure access to protected vertebrate studies with the primary data holder. We also provided robust justification waiver of the date requirements negotiated on other areas with the EU RMS. We were able to save our client >€1m as they no longer needed to generate all of the data themselves. Our client was therefore able to maintain all their existing national registrations at a cost significantly below what was initially expected.

CASE STUDY 4: Combined Field and Regulatory Services for Crops Our regulatory and agroscience teams worked together to organise out of season field trials in South Africa, Australia and New Zealand, in order to speed up the generation of data needed in the EU to confirm the performance of a new formulation. We were 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 for the client 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’ substance 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 for the additional source substance studies. The Iuclid dataset, accompanying read across justification (in accordance with Echa’s Read-across assessment framework – RAAF) and CSR, including exposure assessment, was then prepared by specialists across a range of disciplines, including toxicologists, ecotoxicologists, environmental fate and physchem specialists, as well as human health/environment risk assessors. Timely dossier preparation enabled the client to place the substance on the EU market quickly, submitted as an ‘only representative’ registration. STAFF SELECTION 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. 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. Manda previously held several senior leadership positions in strategic and delivery roles in UK Government and consultancy. She has experience in negotiating major contracts, managing relationships with clients and other stakeholders, and managing business change and improvement. Manda 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. Aurély Béghin – Deputy Regulatory Affairs Director With over 12 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 7 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. Garth Drury – Principal Consultant Garth Drury joined our team in 2021. With over 30 years experience in the agrochemical business, Garth has previously held senior positions at Bayer, Rotam and Arysta, plus he was President of the European Crop Care Association. Garth’s considerable experience further strengthens the existing Staphyt team and he is available to assist with high level strategic advice and support. www.chemicalwatch.com/SPG

Profile: Staphyt Regulatory

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Profile: TEAM Mastery

164 response to specific requests from Echa, etc. Noteworthy is the activity of updating a dossier to make it compliant with the latest requests from Echa. READ across justification TEAM mastery is leader in read-across justifications, in compliance with the latest Echa standard requests. We have submitted many successful dossiers containing read-across justifications to waive demanding in vivo tests. Read-across is performed in combination with Qsar modelling and in vitro testing, when necessary.

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

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 often been successful in discussion with national authorities and scientific working groups. Assessment and characterisation of nanomaterials TEAM mastery offers assistance in the registration of nanomaterials following an analytical evaluation and (eco)toxicological assessment. Authorisation dossiers TEAM mastery has the expertise to develop complete authorisation dossiers with analysis of alternatives and socio-economic analysis.

OVERVIEW TEAM mastery is a leading service provider in the area of chemical regulatory affairs, covering all aspects of REACH, the biocidal products Regulation, medical devices, plant protection products etc. Our staff are highly motivated with specific expertise in chemistry, toxicology, environmental toxicology and risk assessment. We are committed to assisting customers along the supply chain using our industrial experience, and helping them with the cost efficient implementation of European and global regulations on chemicals. Our approach is focused on the most advanced and innovative solutions, that combine a scientific approach with regulatory needs to gain the highest benefit for industry and the downstream users. VITAL STATISTICS

2019/20

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% 2%

Training 5%

Other 1%

Representation & management 15%

Consultancy/advisory 75%

SERVICES PROVIDED REACH services REACH registration dossier TEAM mastery has 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, Global Service Providers Guide 2021

Consortia management Experience in consortia management. We can provide legal advice, agreement documents, meeting location, cost calculation, managing of letters of access (LoAs). Test monitoring In case new tests are required, TEAM mastery will take care of selecting the most appropriate lab, review the protocol, audit the lab and check the results. CSA-CSR TEAM mastery can offer the possibility of preparing a new CSR, adding new uses or preparing a downstream user dedicated CSR. Exposure modelling is performed with most of the recognised official tools like Euses, Ecetoc TRA, EASY TRA, ART, CONS EXPO, RISKofDERM. 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 registrants in their discussions with Echa during this process. CLP/GHS services OO Data collection and assessment of classification and labelling OO SDS/eSDS compilation OO UFI and PCN submissions OO Scip notification for articles OO Exposure scenarios scaling and translation OO CLH dossier OO Supply chain communication BPR services OO Full dossier preparation for active substance and products OO Technical equivalence OO Testing strategy development OO Management of biocidal product family (BPF) OO Management of biocidal product family (BPF) In situ generated active substances OO Study monitoring OO Risk assessment OO Endocrine disruptor (ED) properties evaluation OO Evaluation of co-formulants ED properties OO Finalization and discussion with national and EU authorities OO Post-submission support OO Compliance procedures post Brexit PPP services OO Full dossier preparation for active substance and products OO Testing strategy development

Study monitoring Risk assessment OO Finalisation and discussion with national and EU authorities OO Post-submission support PHARMA services OO Medical devices OO Human health risk assessment OO Environmental risk assessment OO Determination of the PDE (permitted daily exposure) OO Assessment of mutagenic impurities OO

CASE STUDY 1: REACH compliance check

FEED and FOOD registration OO Dossier preparation OO Risk assessment OO Test monitoring OO Assistance to customer for Efsa calls for data. EU cosmetics directive OO Regulatory compliance support OO Product notification OO Cosmetics ingredient profiles OO Product information files OO Cosmetic product safety reports OO Product labelling review and support CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2008

Foundation of REACH mastery

2010

About 120 successful registrations for the first REACH deadline

2012

Implementation of the BPR division

2014

Preparation and submission of the first application for REACH authorisation

2015

Implementation of the group to comply with the needs of the biocidal products 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

2016

Implementation of the group to comply with the needs of the plant protection products Regulation. Presentation of two dossiers after Article 95 disputes on biocides and two authorisation dossiers

2018

Technical management and dossiers implementation of the biggest Italian taskforce for the national authorisation of sodium hypochlorite

2018

New company name as TEAM mastery

2019

Move into a larger premises

2020

Hire of new staff, in spite of the lockdown

PARTNERS OO OO OO

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 Alternatives to Animal Testing)

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.

The group has proved itself one of the most professionally prepared in the European scenario to manage all different aspects of a REACH dossier. TEAM mastery has prepared hundreds of lead dossiers, many of them with a full study plan ordered and monitored. UVCBs and difficult substances are our main specialisation area. With the increased number of Echa compliance checks, many dossiers need to be reevaluated, 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. CASE STUDY 2: Authorisation of disinfectants During 2020 TEAM mastery, despite the Covid-19 emergency, managed together with CENTRO REACH and Mérieux NutriSciences Italia- Chelab, the submission of a large number of biocidal product dossiers based on ethanol under national regulation DPR 392-98. This was to meet the demand growth of hand and surface disinfectants. The project involved around 40 SME and 80 biocidal products were authorised to fight the pandemic. Meanwhile, strengthened by the experience acquired organising the first Italian taskforce for authorisation of NaClO biocidal products in 2018, TEAM mastery is managing a new one to submit biocidal product families dossiers based on ADBAC-BKC and DDAC for PT3-4 in compliance with the new BPF concept. CASE STUDY 3: Dietary risk assessment TEAM mastery is working together with companies in the food sector to develop and finalise models for the estimation of the dietary risk from the transfer of biocidal active substances into foods – professional uses. CASE STUDY 4: Nanomaterials TEAM mastery provides assistance on the identification and characterisation of nanoforms as well as on the definition of eco(toxicological) testing strategies, including grouping of nanoforms for read-across approaches. TEAM mastery supported several clients in their compliance to the Commission Regulation (EU) 2018/1881 (amending the REACH regulation) on new information requirements for nanoforms of substances. STAFF SELECTION 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, Monica has been working in regulatory and implementation of REACH regulation since 2001, when it was only a minor proposal. The cooperation with many specialists within international companies and universities allowed her to specialise in consortia management and dossier preparation. 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, Stefano developed experience in project management and human resources, before dedicating himself to the regulatory field. Dr. Giovanna Attardi – PPP Regulatory specialist Graduated in Communication Science, she developed experience in Regulatory Area, initially as GLP Quality Assurance manager, then going through the Registration offices of several Companies. She joined TEAM mastery as Regulatory specialist for the PPP and Agro regulatory Division. www.chemicalwatch.com/SPG

Profile: TEAM Mastery

165

Profile: TOXIT & S-IN Soluzioni Informatiche Srl

166

SERVICES PROVIDED Non-testing, in silico methods OO Qsar OO QMRF, QPRF and Iuclid reporting OO Read-across OO Grouping of chemicals OO TTC assessment OO Metabolism and degradation OO Strategy definition for the hazard assessment OO Database search and expert review of experimental toxicological data Main sectors: OO Chemicals (REACH and CLP) OO Pharma and API (nitrosamines, genotoxic impurities) OO Agrochemicals OO Food OO Cosmetics

CONTACTS Website

www.toxit.it/en/

E-mail

info@s-in.it

Head office

Via G. Ferrari, 14 – 36100 Vicenza Italy

Tel

+39 0444 1821160

Fax

+39 0444 1821169

Contact

Lorenza Broccardo, COO

Directors

Luca Sartori, Managing Director. Senior expert in chemometrics, database design, molecular modelling, and data mining.

Ownership

Private Company

Locations

Italy

Founded

1994

OVERVIEW TOXIT is the computational toxicology unit of S-IN Soluzioni Informatiche and offers services of non-testing methods in the regulatory framework. S-IN Soluzioni Informatiche Srl provides data science services applied to chemical, toxicological, ecotoxicological and environmental information, adopting machine learning and artificial intelligence. VITAL STATISTICS

2019/20

Turnover, group

ca €1.7m

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 10%

Consultancy/advisory 35% IT & software 35%

Information 20%

GLOBAL OFFICES S-IN Soluzioni Informatiche S.r.l. – Vicenza (VI), Italy

Global Service Providers Guide 2021

Worldwide consulting TOXIT supports industrial companies and research groups in the hazard and safety assessment of chemicals by providing scientific advice and solutions to meet both customers’ needs and regulatory requirements. Definition of a strategy to characterise the safety profile of substance(s) makes the best use of available information and non-testing in silico methods, based on predictions and computer-aided simulations, to optimise your time and costs. Strategy definition includes: OO analysis of the target substance(s); OO regulatory requirements; OO analysis of the available information and data gaps; OO identification of relevant endpoints/properties; and OO identification of the most appropriate non-testing methodologies and software solutions. For each endpoint/property, the use of multiple and OECD-compliant tools available nowadays on the market is of paramount importance to obtain scientifically robust results. In addition, this allows us to cover tens of endpoints/properties. We also perform in silico evaluations for prioritisation and screening purposes, even before your chemical has been synthesised, at a very early stage in the development process. We offer training services on how non-testing methods can be applied within different regulatory frameworks, as well as on software solutions implementing these methodologies. Focus on REACH In silico methods can be employed to support and/or substitute experimental data. We support our customers in safety assessment of chemicals with a range of solutions and services: OO strategy definition for hazard assessment; OO database search and expert review of experimental toxicological data; OO Qsar predictions; OO read-across predictions; OO grouping of chemicals; and OO regulatory reporting (QPRF, QMRF, Iuclid compilation). Focus on Pharma and API The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. As a result of chemical synthesis or degradation, impurities reside in all drug substances and associated medicinal products. We perform in silico hazard assessment, database search and expert review of existing data, limit derivation for drug impurities, based on regulatory authorities’ recommendations for: OO nitrosamines; and OO genotoxic and non-genotoxic impurities

Focus on European Projects TOXIT participated in several funded projects related to computational toxicology, ADME and toxicity prediction: OO data collection for PNEC evaluation; OO use of REACH registration database to calculate Human Health Effect Factors of USETox® model; OO specific Advice on Exposure Assessment and Hazard/Risk Characterisation for Nanomaterials under REACH; OO COSMOS Integrated In Silico Models for the Prediction of Human Repeated Dose Toxicity of Cosmetic; and OO EFSA’s OpenFoodTox, open source toxicological database on chemicals in food and feed. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1994

Year of foundation

1999

We were particularly focused on Molecular Modelling approach

2004

We expanded our market perspectives to the Chemical Data Management

2009

The Computational Toxicology Unit started its activities with REACH services

2010

In term of governance, S-IN Soluzioni Informatiche upgraded to a capital firm

2017

Registration of TOXIT as a brand of S-IN Soluzioni Informatiche, headed to in-silico approaches

2020

We enlarge market to vertical industry solutions supported by consulting

ACCREDITATIONS Reach Ready Service Provider KNIME Trusted Partner and KNIME Innovation Partner 2020 Member of Federchimica, Italy PARTNERS Leadscope Molecular Networks – Altamira BIOVIA – Dassault Systèmes ACD/Labs Chemessen – MOL-INSTINCTS Database KNIME Sartorius Stedim Data Analytics AB – Umetrics Pharmacelera Gaussian Wave Function

CASE STUDY 3 In silico assessment of chemicals for REACH submissions. STAFF SELECTION Lorenza Broccardo Lorenza is the COO of TOXIT and coordinates the activities and resources of the Unit, to meet customers’ requests in a timely manner and within the agreed deadlines. She is Senior Scientist, holds a degree in Chemistry and specializes in data analysis with the approaches of Multivariate Analysis and Design of experiments, on which she regularly holds courses for clients and academics. Claudia Ileana Cappelli Claudia is TOXIT Unit Supervisor and takes care of the client’s requests and deliveries, framing the needs in the context and proposing the appropriate solutions. She is an expert computational toxicologist, with expertise in development, validation, application, and evaluation of in silico models, such as Qsar and read-across for ecotoxicological, toxicological, environmental, physicochemical properties within regulatory frameworks (e.g., REACH, CLP, Biocides and Cosmetics Regulations, ICH M7, Q3A/Q3B guidelines) and risk assessment, carried out in research projects and consulting activities. Simona Kovarich Simona is Research Scientist and takes care of the in silico chemical safety assessment, and of generating (eco)toxicological and physicochemical data by means of in silico approaches (QSAR, expert systems and read-across) in compliance with the current regulations (e.g., REACH, CLP, ICH M7 guideline, Biocides and Cosmetics regulation). She is also responsible for research activities in the context of funded projects in the field of data mining, chemoinformatics, computational (eco-)toxicology and risk assessment. Andrea Ciacci Andrea is Senior Applications Scientist and supports the team in the assessment of chemical data, providing important information on the substances to address the consulting and services. He holds a degree in Chemistry and Pharmaceutical Technology and long-term previous experience in a pharmaceutical company as Computational Chemist.

CLIENTS Our customers are industries, research centres, consulting companies, regulatory agencies. CASE STUDY 1 Curation of systemic toxicity endpoint study records in the REACH registration database – Framework Contract ECHA/2016/71 CASE STUDY 2 Evaluation of the applicability of existing Qsar models for predicting the genotoxicity of pesticides and similarity analysis related with genotoxicity of pesticides for facilitating of grouping and read across – OC/EFSA/ PRAS/2016/01

www.chemicalwatch.com/SPG

Profile: TOXIT & S-IN Soluzioni Informatiche Srl

167

Profile: ToxServices LLC

168

SERVICES PROVIDED Cosmetics, Personal Care Products, and Consumer Products Services ToxServices LLC provides clients from around the world with expert technical and regulatory support services in formulating, labelling, manufacturing and marketing cosmetics, personal care products and consumer products. Our PhD-level, board-certified toxicologists include Diplomates of the American Board of Toxicology (DABT) and UK/ Eurotox Registered Toxicologists (ERT), ensuring your cosmetics and personal care products are safe and comply with applicable regulatory requirements.

CONTACTS Website

www.toxservices.com

E-mail

info@toxservices.com

Head office

1367 Connecticut Avenue NW, Suite 300 Washington, DC 20036 USA

Tel

+1 202-429-8791

Fax

+1 202-429-8788

Contact

Margaret H Whittaker, PhD, MPH, CBiol, FRSB, ERT, DABT

Ownership

Limited Liability Company

Locations

USA, UK

Founded

2003

Litigation Support / Expert Witness Services ToxServices provides litigation support services in product liability and toxic tort cases: OO critical literature reviews and preparation of white papers assessing biological and technical feasibility of allegations; OO preparation of detailed toxicology reviews, exposure assessments and human health risk assessments; OO assessing potential human health hazards and risks associated with exposure to substances in occupational and non-occupational settings; and OO California Proposition 65-related services, including NSRL and MADL development, exposure assessments and safe harbour determinations.

OVERVIEW ToxServices is a global provider of scientific consulting services designed to resolve complex human health, environmental health and regulatory compliance issues. ToxServices excels at providing toxicology, sustainability, alternatives assessment, and risk assessment consulting services to private and public sector clients. We strive to advance chemical optimisation throughout the supply chain. ToxServices is an authorised third-party profiler/assessor for the US EPA’s Safer Choice programme, GreenScreen® for Safer Chemicals, CleanGredients®, ChemFORWARD, Health Product Declarations (HPDs), and Cradle to Cradle Certified® Products programme. VITAL STATISTICS

2019/20

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 10% Legal 10%

Consultancy/advisory 50% IT & software 20%

Information 10%

GLOBAL OFFICES ToxServices is located in the United States and the United Kingdom, and is headquartered in Washington, D.C. Global Service Providers Guide 2021

Medical Device Biological Evaluation Services ToxServices performs ISO 10993 biological evaluations of medical devices and combination products, including materials characterisation, assessing health risks of extractables and leachables, and evaluating results of biocompatibility assays for submissions intended for the US, the EU and the Asia/Pacific region. Food Additives, Medical Foods, GRAS Determinations, Dietary Supplements, and Food Contact Substances Services ToxServices assesses exposure and health risks associated with food additives, GRAS ingredients, food contact substances, and dietary supplements marketed in the US, Canada, and the EU. We prepare petitions, notifications, and provide advice regarding the regulatory status of food additives, GRAS ingredients, and food packaging substances. Eco-Label / Sustainability Services Manufacturers, designers, retailers, and consumers are now seeking products that are eco-friendly, are formulated with chemicals that are not toxic to human health or the environment, and are designed and produced responsibly. Cradle To Cradle Certified® Products Program As an authorized assessor, ToxServices evaluates products under the Cradle to Cradle Certified® Products Program managed by the Cradle to Cradle Products Innovation Institute. The ultimate goal of the program is to encourage continuous improvement, innovation, and formulation of products that support the circular economy. U.S. EPA Safer Choice Program ToxServices has partnered with the U.S. EPA Safer Choice Program as a third-party profiler to evaluate thousands of cleaning and homecare products for Safer Choice recognition. . Greenscreen For Safer Chemicals ToxServices is an authorized third-party evaluator of Clean Production Action’s (CPA) GreenScreen®, which is a leading Chemical Hazard Assessment tool. CPA’s GreenScreen® supports informed substitution of chemicals and materials. ChemFORWARD ToxServices is a qualified assessor for ChemFORWARD, chemical hazard assessments, which include more than 21 human health and environmental toxicology endpoints and is based on Globally Harmonised System of Classification and Labelling of Chemicals (GHS) and Cradle to Cradle Certified™ hazard methodologies. CleanGredients GreenBlue’s CleanGredients is an online database for green formulations of cleaning ingredients and products. This resource provides an opportunity for manufacturers and producers of cleaning products to showcase their ingredients and products while protecting their intellectual property. ToxServices is a third-party profiler to evaluate products for CleanGredients.

Health Product Declaration ToxServices is a participating partner with the Health Product Declaration Collaborative™ and develops and verifies Health Product Declarations (HPDs) for manufacturers. An HPD provides a full disclosure of product content and associated health concerns for formulations. Alternatives Assessments ToxServices performs Alternatives Assessments following the IC2 Alternatives Assessment Guide. Alternatives assessments are used to assess a chemical’s impact on human health and the environment and find a science-based solution that promotes the selection of less hazardous ingredients through informed substitution. ZDHC MRSL Level 1, 2, And 3 Conformance: ToxFMD Screened Chemistry® ToxServices assesses textile auxiliaries and leather treatment formulations for compliance with ZDHC MRSL Level 1, 2, and 3 requirements. ToxServices’ ToxFMD Screened Chemistry Library ToxServices maintains the ToxFMD Screened Chemistry Library, the world’s largest collection of GreenScreen® for Safer Chemicals (>1,100 GreenScreen assessments) and medical device Tolerable Intakes (>1,500 TIs). CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2003

Company established

2012

Company expanded to Ann Arbor, MI

2013

Company expanded to Oxford, UK

2013

Launched ToxServices’s ToxFMD® Screened Chemistry Program, which is a third-party certification program used to promote safer chemical selection in the textile, apparel, and footwear industries.

PARTNERS Although ToxServices is a privately-owned corporation, we actively work with law firms, CROs, testing laboratories, and certification organizations around the world to serve our client’s needs. CLIENTS ToxServices’ clients include Fortune Global 500 companies, Consumer products companies, Construction and Built environment companies, Cosmetics and personal care products companies, Chemical companies, national, state, and local Government bodies, Non-governmental organizations, Trade industry associations, and Law firms representing plaintiffs or defendants. TESTIMONIALS “Levi Strauss & Co. nominated ToxServices as a third-party assessor and technical advisor for LS&Co.’s Screened Chemistry program. ToxServices’ toxicological capabilities and expertise in hazard assessment methodologies, along with their professional and collaborative work ethic, make them an ideal partner for LS&Co.” – Linda Gallegos, Innovation Manager Levi Strauss & Co. “ToxServices provides our global innovation team with expert consulting services including evaluating the safety and regulatory compliance of our entire line of consumer products. ToxServices staff are reputable, friendly, and integrate seamlessly with our team. They are the secret to the success of our last five major product launches!” – Confidential Client, Vice President of Innovation, North American Online Retailer CASE STUDY 1: Medical Device Biocompatibility Support Services For a major North American medical device manufacturer, ToxServices provides ongoing biocompatibility support services, including: 1) establish tolerable intakes for chemicals identified during extractables and leachables testing; 2) performing quantitative dermal sensitisation risk assessments to assess dermal safety of devices with dermal contact; and 3) designing, managing, and critically evaluating results of biocompatibility testing under various parts of ISO 10993.

CASE STUDY 2: World-Wide Cosmetics Safety and Regulatory Compliance Services For over a decade, ToxServices has provided scientific support services to a US based cosmetics/personal care products company. OO Prepared safety assessments and product information files (PIFs) for >750 cosmetics/personal care products marketed throughout the EU and China, including safety assessments of intentional ingredients and impurities, and evaluation of clinical, safety-in-use, and in vitro test data supporting safety of formulated products. OO Provided reformulation recommendations to replace chemicals of concern (such as preservatives and UV filters) and, as needed, recommended additional efficacy or safety testing on revised formulations. OO Prepared quantitative risk assessments for >1,700 cosmetics raw materials to ensure compliance with the EU Cosmetics Regulation and the Chinese Safety and Technical Standards for Cosmetics. OO Conducted bi-annual training courses to instruct client’s staff in requirements for cosmetics (EU, US, Canada, China, ASEAN, Gulf States). CASE STUDY 3: Cradle to Cradle Certified Assessments Cradle to Cradle Certified® (“C2C”) is a multi attribute ecolabel that has gained traction around the world with the creation of Amazon’s Climate Pledge Friendly Program, which includes recognition of C2C as an approved ecolabel. C2C evaluates products across five categories of human and environmental health: OO Category One: Material Health OO Category Two: Product Circularity OO Category Three: Clean Air and Climate Protection OO Category Four: Water & Soil Stewardship OO Category Five: Social Fairness ToxServices worked with a consumer products manufacturer to quickly and cost-effectively assess products for C2C Certification, including grouping similar products to save on costs, working with overseas suppliers to obtain confidential disclosures, and strategising to achieve higher levels of C2C certification. STAFF SELECTION Margaret H Whittaker, PhD, MPH, CBiol, FRSB, ERT, DABT Margaret Whittaker is the Managing Director and Chief Toxicologist of ToxServices. She manages ToxServices projects for the US EPA Safer Choice Program, Clean Production Action’s GreenScreen for Safer Chemicals, and Cradle to Cradle Certified Program. Dr. Whittaker is one of the pioneers in the field of chemicals alternatives assessments, and is a key contributor to advancing these methods around the world. Dr. Whittaker is a Diplomate of the American Board of Toxicology who earned a Ph.D. in Toxicology from The University of Maryland, Baltimore and an M.P.H. in Environmental Health from The University of Michigan. Dr. Whittaker is a U.K./EuroTox Registered Toxicologist, as well as a Chartered Biologist and Fellow of the U.K. Royal Society of Biology. Jennifer Ator, Ph.D., M.H.S., D.A.B.T. Jennifer Ator is a board-certified Senior Toxicologist, Risk Assessor, and Project Manager who earned her Ph.D. in Toxicology and M.H.S. in Environmental Health Sciences from Johns Hopkins University. Dr. Ator prepares, reviews, and manages quantitative human health risk assessments, exposure assessments, product and ingredient safety assessments, and regulatory compliance evaluations for a diverse range of substances. Dr. Ator advises clients on key technical issues, such as clinical and nonclinical testing strategies, study design and monitoring, and data interpretation; the scientific merit of test data provided by claimants or other parties; regulatory compliance requirements; and comprehensive interpretation of test data and literature. Senior Toxicologists specialize in the assessment of human health and environmental risks posed by chemicals or biologics, including six Diplomates of the American Board of Toxicology (D.A.B.T.) Multi-Lingual Scientists and Engineers fluently speak and write Mandarin, Arabic, French, German, and English, allowing ToxServices to prepare multi-language work product for countries around the world. www.chemicalwatch.com/SPG

Profile: ToxServices LLC

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Profile: Triskelion

170

SERVICES PROVIDED Regulatory Services Are you 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 – 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).

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

The Netherlands

Founded

TNO, 1932; TNO Triskelion, 2011; Triskelion, a First Dutch Innovations company, 2017; Triskelion-Ducares, 2020; an LLCP company, 2020. 2021 Re-branding TRISKELION-DUCARES will continue to operate under TRISKELION

OVERVIEW Your success is our focus. We aim 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 personal commitment, together with our state-of-the-art equipment, contribute to tailor made study designs and dependable project management. TRISKELION is an ambitious Contract Research Organization (CRO) and is active in the chemical, pharmaceutical, food and feed markets. More than 110 employees serve our clients from all over the world. VITAL STATISTICS

2019/20

No of offices

No of countries represented

Staff, group

110

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 5%

Consultancy/advisory 20%

Representation & management 10% Laboratory 65%

GLOBAL OFFICES Triskelion headquarters: Utrecht, The Netherlands Sales representatives: Japan, USA, Canada

Global Service Providers Guide 2021

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 advise 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 prioritisation of substances for further regulatory action (such as compliance checks, substance evaluations, restrictions, authorisations). Thanks to the vast experience we gained in preparing substance registrations since the beginning of REACH, we can help you address 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 evaluate what steps to take going forward. Our experience in analysing socioeconomic 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!

2021

TRISKELION will be the sole brandname used by the company DUCARES BV

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 cooperators. 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 authorisations under BPR? You may consider using biocidal product families in the authorisation 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. Next, 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 product 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 a Nias evaluation and our in-house analytical experts and toxicologists can advise you on your specific case. The aim in such projects is to optimise 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

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Profile: TÜV SÜD Industrie Service GmbH

172

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 EU community. The obligations of an OR, outlined in Article 8 of the REACH Regulation, comprise not only registration but also all those for importers. 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 find that manufacturers often come 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@tuvsud.com

Head office

TÜV SÜD Industrie Service GmbH, Westendstr 199, D-80686 Munich, Germany

Tel

+49 / 89 / 5791-1044

Fax

+49 / 89 / 5791-1174

Contact

Dr Fritz Prechtl

Ownership

TÜV SÜD Holding AG

Locations

TÜV SÜD Group employs more than 26,000 people in 60 countries in ca. 1,000 locations

Founded

1866

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

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. An increasing focus is to support companies in securing their supply chain management in conjunction with chemicals legislations. VITAL STATISTICS

2019/20

Turnover, group

€2,600m

No of offices

1000

No of countries represented Staff, group

60 26,000

Staff, chemical service provision

SERVICE AREA BREAKDOWN

IT & software 10%

Companies affected by REACH or CLP are seeking advice on how to deal with the challenges caused by REACH in a timely effective manner. Desired training events vary depending on participants’ existing knowledge: OO introductory training courses to gain an overview of REACH and CLP; OO seminars on selected topics of REACH; OO workshops to create solutions under the guidance of an experienced expert; and OO in-house consulting for the ad-hoc solution of characteristic problems.

Any other activities concerning REACH and CLP REACH and CLP shift most of the responsibility for the safe handling of chemicals from the regulatory bodies to producers, importers and downstream users and retailers. The relevant requirements and consequences, however, are not clear at first sight. Consequently, we offer all kind of services related to REACH and CLP, from the starting point to implement REACH via testing in our own GLP accredited laboratory to long-term compliance with chemicals regulations. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1866

Established in Mannheim

1926

Introduction of the “TÜV SÜD mark /stamp” in Germany

1960

Establishing chemical services

1990

Conglomeration of TÜVs from the southern part of Germany to form TÜV SÜD and the expansion of business operations into Asia. Best brand of technical services, testing, consulting, training, certification in all industries worldwide – energy producers and providers, nuclear power plants, chemical industry

2006

Expansion of services in Asean by acquiring Singapore-based PSB Group

2007

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

Training 5%

Laboratory 5% Information 10%

Representation & management 35%

Global Service Providers Guide 2021

Consultancy/advisory 35%

ACCREDITATIONS

CASE STUDY 5: SVHC

GLP

A EU-based group with legal entities in several member states was seeking support in making an inventory of SVHCs in articles placed on the market, as well as in implementing a system to comply with the duties to communicate information on them. 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 the case of uncertainty on the presence or concentration of a SVHC. Testing was performed in TÜV SÜD’s own chemical laboratory. As a result of the investigation and consulting, a unified system was implemented across the entire group. The system ensured full compliance with REACH Articles 33 to 36. Furthermore, supply contracts were amended to increase legal certainty, to avoid the risk of lawsuits and reputational damage.

CLIENTS Due to confidentiality we cannot name individual clients. Our clients are active in all industrial and professional sectors in more than 30 countries. 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 under the biocidal products Regulation (BPR). CASE STUDY 1: Consortium management A consortium with representatives from five countries took over registration of a series of substances with registration deadlines between 2010 and 2018. The duty to act as lead registrant was shared among the individual members. The main bodies of the consortium are the steering committee, technical committee and the secretariat. TÜV SÜD provided consortium management to all bodies. Technical REACH consultancy and financial consultancy were part of the services delivered. CASE STUDY 2: Support in REACH implementation An EU manufacturer of articles and substances required support in implementing a REACH process for the entire company. The tasks focused on communication in the supply chain, registration, SVHCs, training and organisation building. A team was formed to give continuous assistance; the core team fully integrated with the client’s activities onsite. 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. All available information that had been gathered was assessed for its adequacy for classification and labelling. Cost of data sharing is one of the crucial issues of negotiations in Siefs. High-quality data will be more costly than data of low quality. Some data gaps were filled by Qsar and read-across. Others had to be filled through 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 offices. This approach guarantees direct contact with the end-client and avoids language barriers where applicable. This means smaller non-EU manufacturers can benefit from OR services although not 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. Javier Castro Javier Castro is a chemist and certified REACH multiplicator with 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

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Profile: UL

174

SERVICES PROVIDED

CONTACTS Website

ul.com | 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

Jill Oakman

Ownership

UL, LLC

Locations

Global

Founded

1894

OVERVIEW We help customers manage a product through its entire lifecycle throughout complex supply chains. 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 organizations, while protecting confidential product information. In order to accomplish this, we constantly monitor and analyze 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

2019/20

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%

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 allow you to manage your EHS initiatives and regulatory compliance obligations with: OO software options for every size of business and budget; OO platforms that are configurable and flexible, and can be integrated with other business systems (such as SAP); OO compliance data acquired by industry experts monitoring over 6,800 regulatory lists; and OO 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+ regulatory experts provide support services to assist with: OO product development and product launch; OO verifying and maintaining product compliance; OO training staff on global regulations and best practices; OO regulatory data and information; OO technical and industry specific issues; OO hazard communication & risk assessments; OO product or component registration/notification (such as REACH and TSCA); OO site audit and process reviews; OO developing processes to support your company’s growth; and OO 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 regulatory insights to successfully enter the marketplace. From 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 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

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; Melbourne, Australia Global Service Providers Guide 2021

2012 2013 2016 2017

UL Prospector® (formerly Innovadex & IDES) becomes the world’s trusted materials and ingredients search engine UL acquires supply chain software specialist The WERCS UL acquires leading chemical EH&S regulatory compliance provider Safeware Quasar UL acquires ChemADVISOR, a recognized world leader in chemical regulatory compliance and data solutions

2017 2018 2019 2019 2020

UL & Johns Hopkins partner to create innovative machine learning software Cheminformatics UL launches search tool UL Product iQ™, for verifying UL certifications of products and components UL launches Navigator™, an online compliance knowledge base for over 50 countries UL launches Illuminator, a first-of-its-kind software tool enabling online access to industry-leading ChemADVISOR data UL integrates regulatory and retailer compliance data into Prospector for early insights in the product development process

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: Supply Chain Transparency And Risk Mitigation For Consumer Electronics A leading global technology company expanding their offerings into Augmented Reality (AR) and Virtual Reality (VR) devices soon discovered that they required information on the products upstream in their supply chain to effectively deliver finished products into the global marketplace, comply with regulations and minimize potential risks. Like most consumer electronics, this company was managing a component inventory of over 400,000 SKUs (stock-keeping units) with high inventory turnover, representing over 7,000 chemicals. And quickly realized they didn’t have expertise to collect and evaluate product data in order to protect their employees, the environment and to effectively transport their products globally. With the overwhelming complexity of regulations and supply chains, this technology company enlisted UL to help them navigate this new frontier. As a trusted third party in securing and protecting confidential component and chemical data, UL was able secure data on all components and their complex Bills of Materials (BoMs), and quickly identify challenges and implement solutions to mitigate them. The powerful combination of software, data management, regulatory compliance knowledge and industry expertise allows UL to manage the full scope of the product stewardship journey – from material sourcing to product disposal. Benefits: OO Supply chain transparency and accurate component data for complex consumer electronics OO Risk mitigation with regulatory compliance and pro-active chemical and material management software OO Seamless creation of BoMs for finished goods – with multilingual support OO Regulatory expertise and support for the handling, transportation, use and disposal of high-tech electronic products CASE STUDY 2: Helping Manufacturers And Retailers Meet Regulatory Requirements Due to increasing regulatory demands and complex global supply chains, retailers and manufacturers were looking for ways to meet compliance and organizational sustainability requirements, while protecting confidential business information (CBI) and enabling commerce. The securing and exchange of chemical data along with regulatory expertise is necessary to assure the proper handling, transportation, storage and disposal of the chemical containing products. UL became the trusted third party to collect, process, protect and provide the data transparency needed between supply chain nodes to mitigate risks surrounding products containing chemicals or substances of concern. UL’s unique capability allows for the collection of essential chemical formulation

data from manufactures while applying critical regulatory insights to advise retailers on product stewardship without slowing down commerce for either party. While safeguarding proprietary product information, UL’s powerful engine allows manufactures to register their products once, but meet the needs of multiple retailers. Today, UL helps more than 9,000 manufacturers and over 55 major, multinational retailers meet product compliance and stewardship needs. Benefits: OO Trusted third party to facilitate secure transfer of product composition data OO Protection of critical CBI OO Automation of GHS compliant SDS and labelling documentation OO Risk mitigation and brand protection CASE STUDY 3: Innovative Data Automation Facilitates Commerce and Regulatory Compliance A global leader in analytical technologies was challenged with improving the management and distribution of their equipment that shipped with limited hazard materials so the purchased items reached the customers as scheduled. With limited internal regulatory resources and constantly changing global regulatory requirements, compliance was an major task. This company needed an adaptable and scalable solution that would address their data migration needs and provide regionally compliant, multilingual documents to meet global regulatory requirements quickly and effectively. By leveraging UL’s innovative suite of software solutions and extensive regulatory expertise, this company was able to improve their current business processes and integrate regulatory data into their existing ERP, meet chemical handling requirements and deliver equipment as promised to customers while improving cash flow. Benefits: OO Generated 130,000 compliant safety documents in weeks vs. months to meet regulatory deadlines OO Product data is now managed, updated and processed in a timely manner OO Hazard communications are compliant and easy to maintain OO Seamless translation of SDSs into multiple languages in minutes 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 Advisory & Data Insights Group, where she leads a team of over 60 regulatory specialists and industry experts who deliver exceptional regulatory solutions all over world. She is has a extensive background in EHS, environment compliance, hazard materials, risk management and is an esteemed authority on regulatory requirements. Craig Rowlands PhD, DABT – Senior Toxicologist Dr. Craig Rowlands is a board certified toxicologist 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 sustainability performance goals through collaborating, partnering and impacting internal R&D programs, government agencies, regulatory authorities. Andrew Brooks PhD, DGSA – Regulatory Affairs Manager Andrew is a chemical regulatory expert, coming from the chemical industry. Predominantly focusing on REACH, CLP, and preceding European Directives, he assisted many companies with differing product portfolios during the transition to GHS, enabling businesses to adapt and succeed with compliance. He is also a qualified Dangerous Goods Safety Adviser. Stacie Abraham – Regulatory Program Manager, Client Solutions With over 35 years of combined regulatory and chemistry experience, Stacie engages directly with diverse industries to evaluate compliance needs and create innovative, efficient compliance solutions to solve complex supply chain challenges. She has expertise in global chemical control regulations for all industry sectors, and is an expert on U.S. TSCA, presenting extensively on this regulation and others at conferences worldwide. www.chemicalwatch.com/SPG

Profile: UL

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Profile: UMCO GmbH

176

GLOBAL OFFICES Germany: Hamburg, Cologne SERVICES PROVIDED

CONTACTS Website

www.umco.de

E-mail

umco@umco.de

Head office

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

Tel

+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

OVERVIEW Chemical Compliance Consulting UMCO has been offering compliance solutions for the distribution and handling of chemicals all over the world through its offices in Hamburg and Cologne for the last 40 years. Our 80 employees look after 1,000 companies in the chemicals, pharmaceuticals, logistics and processing industries worldwide. Through our longstanding consultancy activities, we know exactly what our clients require in their daily operations: expert knowledge, legal certainty and practical relevance. Our service portfolio includes: OO global chemicals management; OO safety-health-environment management; OO dangerous goods management; OO regulatory compliance and audits; OO digital efficiency solutions; OO emergency management; and OO professional seminars and training. VITAL STATISTICS

2019/20

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 5% Legal 5%

Other 5%

Information 5%

integration of registration information in the eSDS; support with identification of uses (use mapping); OO implementation of exposure scenarios in daily practice; and OO consultation on substances of very high concern (SVHC). Strategic consulting: OO consultation and evaluation of organisations and structures aimed at ensuring REACH compliance; and OO support with participation and argumentation in public consultations and other communications with authorities. OO OO

Representation & management 5% Consultancy/advisory 75%

Global Service Providers Guide 2021

Hazardous substances management OO determination of the status of all chemical products used or traded by your company regarding their marketability worldwide; OO auditing and advising on chemicals management at company or corporate level and the integration of responsibilities and documentation into management systems; OO determination of classification and labelling in accordance with European and international chemical and dangerous goods legislation; OO authoring and monitoring SDS and exposure scenarios (for all European regions / languages using UMCO’s UHCS software for SDS); international SDS compilation and monitoring performed in cooperation with our network partners; OO support with worldwide chemicals management, including analysis of national requirements for marketing and use of chemicals and notification/registration in cooperation with our network partners; OO notification of hazardous mixtures according to Article 45 CLP; OO permanent monitoring of substance and product data with regard to legislative amendments or changes to customer recipes, including the updating of all necessary documents (SDS, eSDS, labels); OO customised interfaces to generate the automatic import and export of data in standard XML format into / from UMCO’s UHCS software for SDS; OO web services for customer-specific evaluations e.g. current stock or dangerous goods lists and functions; CLP-compliant online calculation tool; OO automated data export for printing CLP / GHS labels directly; OO consulting and support with in-house hazardous substances management; OO compliance service for restricted / banned substances in mixtures / articles; OO data maintenance for hazardous substances, raw materials and products in the SAP EHS system of our customers; and OO own data warehouse for all types of substance and product-related information, data and documents. REACH management Comprehensive support for lead registrants: OO preparation of all relevant documents for registration, e.g. technical dossier in IUCLID 6, risk and exposure assessments and chemical safety reports; OO study management and monitoring; OO communication with co-registrants and preparation of contractual arrangements for data and cost sharing; and OO REACH registration dossier follow-ups: support during dossier and substance evaluations, incl. dossier updates. Registration management for co-registrants: OO support with joint registration: communications regarding substance sameness and letters of access (LoA); and OO compilation of dossiers and submission to ECHA. Representative services: OO only representative (OR) for non-EU manufacturers according to Article 8 REACH. Communications in the supply chain: OO strategies for communicating with suppliers and customers;

Scip notifications: OO support with preparation and submission of SCIP notifications to the SCIP database. Biocides management (Biocidal Products Regulation (EU) No. 528/2012) Strategic consulting: OO consultation and evaluation of organisations and structures aimed at ensuring BPR compliance; and OO advising on borderline and dual-use products. Active-substance approval and biocidal product authorisation: OO definition of the appropriate strategy; OO literature research, data evaluation and data gap analysis; OO identity, technical equivalence and physico-chemical parameters; OO toxicology and human exposure, environmental fate and ecotoxicological evaluation; OO study management and monitoring; OO communications with authorities and laboratories; OO preparation of technical dossier in IUCLID 6 and submission; and OO preparation of dossiers according to national legislation (transitional period for actives applicable).

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Safety health environment management OO provision of an SHE manager / officer; OO provision of external company advisors / officers for the fields of occupational safety, emissions protection, water pollution control, waste, hazardous incidents, fire safety; OO carrying out of approval procedures; OO advice on storage of dangerous materials; OO explosion protection consultation; OO preparing operating instructions and risk assessments; OO compiling safety reports and further hazardous incident documentation, such as safety management systems and corporate alarm and hazard control plans; OO training and instruction (executives, contract workers, employees); OO management systems: ISO 14001, 45001, 50001; OO compliance organisation; OO compliance checks (HSE legal compliance); OO conducting internal audits and remote audits; and OO fire safety.

Global Chemical Consultant Network OO eg NCEC OO eg REACH24H

Dangerous goods OO provision of an external Dangerous Goods Safety Advisor (DGSA); OO establishment of a customised dangerous goods organisation and analyses to optimise procedures; OO inventory and dangerous goods audits; OO dangerous goods consulting; OO checklists, working and operating instructions; OO verification of correct classification and labelling; OO instruction and training courses; OO preparation and checking of documents; OO information about legislative changes; OO special topics, such as the transport of explosive and radioactive substances, as well as lithium batteries; and OO project organisation. Emergency services OO Emergency telephone number for EC SDS (all European Poison Centres); and OO GlobalChem24: 24-hour emergency number for chemicals transport and SDS worldwide (together with the NCEC).

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 customer ERP systems

2016

Customised online training for employees about occupational safety and related areas. This training can be tailored to company requirements.

2020

Expansion of the offering on training to webinars and online

PARTNERS

CLIENTS Our clients include over 1,000 national and international companies, ranging from the chemicals and pharmaceuticals industries, traders, warehouses and logistics companies to manufacturing industry – all along the chemicals value-added chain. CASE STUDY 1: Chemical product management OO

Compilation of SDSs for different chemical traders and producers of chemical mixtures More than 60,000 SDSs compiled and regularly updated.

CASE STUDY 2: Business process outsourcing OO

Assumption of product stewardship and legal chemical products services for paint companies, including determination of classification and labelling for products in all EU regions and languages Compilation of SDS and CLP / GHS labels

CASE STUDY 3: REACH consortium management OO OO OO

Financial management, management of subcontractors, trustees Registration management, SIEF and LoA management Representation of the consortium in the Eurometaux REACH Forum

STAFF SELECTION We support our customers with an interdisciplinary team of 80 engineers, scientists and legal experts, who are dedicated to ensuring the economic viability, quality, adherence to deadlines and success of customer projects.

Training OO training, workshops and seminars provided across all services; OO in-house seminars; OO online trainings and webinars; and OO working and process instructions.

www.chemicalwatch.com/SPG

Profile: UMCO GmbH

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Profile: Veeva

178

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

North America: +1 866 243 2055 Europe: +34 (936) 282 975

Directors

Andrew Douglass – Strategy Director, Chemical David Maher – Strategy Director, Regulatory Paul Gilfrin – Director of Sales, Veeva Chemical, Europe Kent Potts – Director of Sales, Veeva Chemical, North America

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

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

PARTNERS Verisk 3E, Labvantage, AWS, Salesforce, Zoom, Microsoft CLIENTS

VITAL STATISTICS Turnover, group

Founded in 2007, Veeva Systems, is a global provider of cloud-based software solutions. We help quality, regulatory and commercial teams in the chemical, 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.

Veeva serves 950+ 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.

2019/20 1,104.1M USD

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

4500+

Staff, chemical service provision

SERVICE AREA BREAKDOWN

IT & software 100%

TESTIMONIALS “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 "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 “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 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

GLOBAL OFFICES European Headquarters: 131 Av Charles de Gaulle 92200 Neuilly sur Seine France Offices: Pleasanton, Philadelphia, Toronto, Columbus, Oxford, Paris, Barcelona, Frankfurt, Budapest, Shanghai, Beijing, Seoul, Tokyo, Osaka, Mumbai, Singapore, Sao Paulo, Sydney

Global Service Providers Guide 2021

CASE STUDY 2 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 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

Profile: Veeva

179

STAFF SELECTION Andrew Douglass, Strategy Director, Chemical Andrew is responsible for the Chemical market strategy for Veeva software. He has more than 20 years’ 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. David Maher, Strategy Director, Regulatory David leads Veeva’s Regulatory Strategy practice for the European Chemical Industry. He has a strong profile within regulatory and product compliance operating models, business cases, benefit realization, and overall digital transformation. David holds a MSc in International Business and Politics from Copenhagen Business School where he focused on transnational governance, nonmarket strategy, and regulatory lobbying in the European Union.

www.chemicalwatch.com/SPG

Profile: VelocityEHS

180

SERVICES PROVIDED SDS/chemical management VelocityEHS’ award-winning MSDSonline SDS/chemical management solution is the industry gold standard for cloud and mobile chemical management solutions. Its software is known for delivering the easiestto-use tools for centralised SDS management and employee right-toknow access (online and offline), as well as container-level product management, secondary workplace labelling (GHS and more), reporting, regulatory list cross-referencing, chemical risk assessments, chemical data archiving and innovative sharing of critical inventory information with first responders. Its system’s multi-language capabilities and easeof-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 programmes.

CONTACTS Website

www.EHS.com

E-mail

Velocity@ehs.com

Head office

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

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

OVERVIEW VelocityEHS — one of the largest vendors in the EHS software market — is trusted by more than 19,000 customers and millions of end users worldwide. The company offers a comprehensive cloud-based environment, health and safety (EHS) software platform and suite of services, aimed at helping companies reach their EHS programme goals faster. VelocityEHS’ primary solutions include incident management (safety), environmental compliance, operational risk, industrial hygiene, ergonomics and chemical management. Included within the VelocityEHS family of solutions are MSDSonline® chemical management, Humantech® ergonomics and ChemTel® chemical emergency response services. Customers benefit from VelocityEHS solutions’ ease-of-use, quick implementation, affordability and unparalleled customer support. Recognised by the EHS industry’s top independent analysts, including Verdantix in its 2021 Green Quadrant Analysis, VelocityEHS is the global leader in EHS software solutions and should be on any company's short list for robust chemical management, ergonomics and industrial hygiene solutions. VITAL STATISTICS

2019/20

No of offices

SERVICE AREA BREAKDOWN Training 6%

Consultancy/advisory 11% Information 11% Laboratory 2%

IT & software 70%

GLOBAL OFFICES United States, Canada, United Kingdom, Australia

Global Service Providers Guide 2021

Authoring & regulatory consulting services VelocityEHS is known for having deep domain expertise throughout its product offerings and each is backed by a deep bench of certified professionals. Included are the company’s certified toxicologists and regulatory experts that are 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+ GHSaligned hazard communication standards, as well as individual corporate product stewardship and sustainability goals. The team’s work ranges from preparing hybrid SDSs and certified business information (CBI)/ 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 and regulatory best practices. Emergency response services VelocityEHS’ ChemTel emergency response services provide customer access to a 24-hour toll-free phone line that connects to the globally recognised chemical emergency call centre, providing support in more than 200 languages. Through this service, customers receive unlimited use of the hotline for: OO hazardous materials shipping papers and manifests, in order to meet DOT, FAA, IMDG, Iata and other global hazmat shipping requirements; OO SDSs, in order to meet Section 1 emergency number requirements for Osha HCS, Health Canada WHMIS and other hazard communication standards; OO chemical exposure support; OO escalated chemical incident reporting; OO SDS back-up access by phone, email and fax from the industryleading VelocityEHS | MSDSonline database; and OO lithium battery shipping support. Chemical management services VelocityEHS offers a range of services to complement its MSDSonline software system that enable customers to further streamline critical safety and 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’ services team can help. A sample of services includes: OO emergency response services — 24-hour SDS back-up and exposure support hotline; OO onsite chemical inventory audit; OO building of an SDS online library; OO SDS library back-up; OO 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’ chemical management account to facilitate the generation of secondary workplace container labels and a variety of useful inventory reports.

Industrial hygiene VelocityEHS’ industrial hygiene (IH) solutions – including sample & equipment management, programme management, medical surveillance and respirator fit test – work together or independently to help automate and streamline workflows. VelocityEHS IH solutions help both certified industrial hygienists and EHS professionals new to the field to 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 programme management and enhance the visibility of workplace risks. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2017, 2019 & 2021

Verdantix Green Quadrant Report – industry leader

20162020

ISHN Readers’ Choice Award – best SDS management product

2017

NAEM EHS & Sustainability Software Ratings and Report – most recommended

2017

ASSP Safety Attendee Choice Award – best EHS & MSDS software product

2016

Environmental Protection – best new product

2015

OH&S new product of the Year – best new SDS management

ACCREDITATIONS Company: SOC 2 and GDPR compliant Staff accreditations include: toxicologist, chemical engineer, chemist, CSP, CIH, PMP (project management professionals), CEP (certified ergonomics professionals) Bachelor’s and Master’s degrees in biotechnology, environmental law, MPH (Master’s in public health) PARTNERS NSC, VPPPA, ASSP, AIHA, NAEM TESTIMONIALS “VelocityEHS’ MSDSonline chemical management software is so easy to use” – Ikea – North America “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 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 VelocityEHS’ MSDSonline software to be a great resource and I was glad that my predecessor had selected you folks. With the GHS change, your software was way ahead of other companies in providing information and training.” – Eastern Pennsylvania Electronics Manufacturer “Your [Chemical Management] software 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 from 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. The company’s 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 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 day-to-day chemical management tasks. In addition to the ability to easily access and manage SDSs and chemical inventory details, the company’s 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 it achieved by comparing its own product inventory information with that of alternatives from the system’s expansive database; an important tool in advancing 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 service 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 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

181

Profile: Verisk 3E

182

GLOBAL OFFICES OO OO OO OO OO

CONTACTS

OO OO

Website

www.Verisk3E.com

E-mail

info@Verisk3E.com

Head office

3207 Grey Hawk Court, Carlsbad, CA 92010, USA

Tel

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

OO OO OO OO

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, 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

2019/20

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

525

Staff, chemical service provision

80%

SERVICE AREA BREAKDOWN Consultancy/advisory IT & software

15%

30%

Information 55%

Global Service Providers Guide 2021

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

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 – 2021

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

PARTNERS Airsweb, ASD, BIOVIA, Cority, Dotmatics, ERM, Enablon, Flashpoint, Gensuite, Intelex, ISO Metrix, Jaggaer, Kelaroo, Links-AS, Reliance Label Solutions, SAI Global, SAP, SI PRO, The Chemical Daily, and 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; and 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: OO Lack of access to updated, compliant SDSs in all locations OO Inefficient chemical management and inventory tracking OO Highly manual processes for meeting SARA reporting requirements Solutions: OO 3E Protect SDS and chemical management; OO 3E Optimize integrated content solutions Results: OO Saving 15 minutes per SDS by eliminating manual review and data extraction processes OO Elimination of manual processes including SDS obtainment and SDS filtering and indexing OO Streamlined SARA reporting OO Standardization of processes resulting in cost savings OO Ease of integration with third party applications CASE STUDY 2: Global Food and Flavours Manufacturer Feeds SAP EHS with Integrated Content from Verisk 3E Industry: Food and flavours Challenge: The global food and flavouring manufacturer did not have an efficient method for fulfilling its SDS and labelling requirements. Solution: Verisk 3E Integrated Content for SAP EHS and an array of services Results: The popular manufacturer leverages Verisk 3E North American and European product safety data, physical-chemical, toxicological and ecotoxicological content (PCTEC), Expert Rules, Templates and Phrases to fuel their SAP EHS platform for SDS authoring. They also rely on Verisk 3E to obtain and integrate their vendor raw material SDS data for use in the authoring process. The solution has significantly streamlined their compliance processes as well as increased their level of compliance. STAFF SELECTION Violeta Malinova, PhD; Sr. Regulatory Research Analyst, EMEA Violeta Malinova holds a PhD degree in Macromolecular Chemistry from the University of Ulm, Germany. She worked as a postdoctoral research associate in the University of Basel, Switzerland leading scientific projects in the field of polymer-based nano-formulations. She joined SAP in 2010 working as an EHS content developer and later focusing on EHS regulatory analysis and EHS product development. Now as part of Verisk 3E, Dr. Malinova is responsible for providing and managing EHS and chemical regulatory content in scope as well as evolving the 3E ERC product portfolio. Terry Wells, Sr. TSCA Regulatory Compliance Analyst Terry Wells is responsible for providing TSCA Compliance Services for customers as part of 3E Consulting Services, preparing regulatory compliance plans, and preparing submissions to competent authorities. Ms. Wells also provides training and audit services via web and on‐site as needed. Elizabeth Tanner, Sr. Product Manager Elizabeth Tanner brings a wealth of global chemical compliance experience including integration knowledge with multiple authoring platforms and training authors on GHS. She is responsible for the development of SDS rules and templates and managing the regulatory requirements related to safety data sheets and labels for integration with SAP. She spent more than seven years as a hazard communication specialist with several global companies. Ms. Tanner is a member of SCHC (the Society of Chemical Hazard Communication).

www.chemicalwatch.com/SPG

Profile: Verisk 3E

183

Profile: Yordas Group

184

SERVICE AREA BREAKDOWN

Training 5%

Other 5%

IT & software 15%

CONTACTS Website

www.yordasgroup.com

E-mail

info@yordasgroup.com

Head office

Lancaster Environment Centre, Lancaster University, Lancaster LA1 4YQ, UK

Consultancy/advisory 40% Laboratory 15% Information 5%

Representation & management 15%

Tel

+44 (0) 1524 510278

Fax

+44 (0) 1524 510588

GLOBAL OFFICES

Contact

Malcolm Stewart

The company has offices and representation in the UK, Germany, Turkey, the US, Canada, Japan, China and Chile.

Directors

Jonathan Lutwyche Dr Sandra Meijer Adam Rowntree

SERVICES PROVIDED

Ownership

Privately owned

Locations

UK, Germany, Turkey, Canada.

Founded

2007

OVERVIEW Yordas Group is a leading provider of scientific, environmental and global regulatory and sustainability consulting services. We have international capability with representation in North America, Asia, Latin America and Europe, and commercial activities around the world. With offices in the UK, Germany, Turkey and Canada, Yordas Group is structured to support companies globally. Our collaborative approach is designed to build strong working relationships over time, allowing us to create a customised and integrated service specifically tailored to the needs of each customer. Delivering innovative solutions for business, industry and government, Yordas is a leading international provider of scientific, environmental, human health, global regulatory and sustainability services. Crosscutting themes such as global chemical notifications, product stewardship, hazard communications, and sustainability. We provide value to SMEs and to some of the biggest brands in the world. VITAL STATISTICS No of offices No of countries represented

2019/20 4 Global

Staff, group

Staff, chemical service provision

Regulatory compliance OO Global notifications, including EU REACH, UK REACH, US TSCA, China MEP Order No 7, Korea ARECS (K-REACH), Taiwan TCSCA and OSHA, Japan CSCL and ISHL OO Cosmetics: scoping assessments and responsible UK & EU persons OO Environmental permitting: HOCNF, OSPAR OO Product regulations: toys, detergents, aerosols, RoHS OO Nanomaterials regulatory compliance and safety OO Biocides product regulations (BPR EU, UK, Turkey and South Korea, North and South America) and claim substantiation OO Hazard communication: global safety data sheets, classification and labelling to GHS, CLP and other global classification systems, exposure scenarios and SDS Product Stewardship and Sustainability OO Global regulatory monitoring OO Regulatory and supply chain audits OO SCIP database reporting OO Yordas Hive chemical management software OO Custom data services OO Sustainability strategy and reporting OO Product substitution and ‘green chemistry’ OO Integrated management systems, such as ISO OO Life cycle assessment Scientific expert & analytical services OO Chemical characterisation OO Chemical safety assessment and reporting OO Analysis of nanomaterials OO Hazard and risk assessment of substances and products OO Data acquisition, testing and management OO Assessment of alternative chemicals and substitution strategies. OO Assessment of endocrine disrupting properties OO Systematic review. OO Expert assessments: polymer status, exemption from registration,physchem and (eco)toxicological endpoint OO Read across justification and QSAR toolbox OO Expert witness services and litigation support Training Yordas Insight provides integrated training solutions that are relevant, up-to-date and interactive. Our training delivers knowledge, tools and methodologies that you can apply to your business. Through case studies and interactive learning methodologies, you will be able to use your learning to inform your business risk management and strategy.

Global Service Providers Guide 2021

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007

Founded as The Reach Centre

2017

Rebranded to Yordas Group and formed a Group of Companies

2018

Yordas Digital established

2018

Yordas GmbH (Germany) and Yordas Limited (Canada) established

2020

Yordas Turkey established

ACCREDITATIONS Our training courses are approved by the Royal Society of Chemistry. ISO 9001:2015 Quality management ISO 14001:2015 Environmental management standard ISO 27001:2013 Information security management standard CLIENTS Our global customer base includes manufacturers, distributors and retailers across a broad variety of industry sectors, along with trade associations and government bodies. CASE STUDY 1: GRMS²: Regulatory radar for the automotive industry Yordas was contracted to develop, populate and maintain the GRMS² (Global Regulatory Monitoring System of Chemical Substances) tool on behalf of ACEA (the European Automobile Manufacturers Association). Our industry-focused GRMS² solution covers the majority of chemical regulatory management needs for the automotive industry, including global regulatory impact assessments for the sector. In this project, we were able to combine our extensive regulatory knowledge with our software development capabilities and make use of the chemical substance data and updates from our in-house database Yordas Hive. GRMS² contains hundreds of fact sheets. Scripted by experts at Yordas Group, these provide key information on new and existing global legislation impacting the automotive sector, including their impact on the manufacture, import, and after-sales of both articles and process chemicals. yordasgroup.com/case-studies/grms2 CASE STUDY 2: Managing REACH registrations for a Japanese Multinational For a strategic client who has contracted Yordas to act as only representative since 2008, Yordas originally submitted over 80 preregistrations and during the 8 year registration period culminating in REACH2018, converted over these to ~45 full registrations, including 9 leads. Work completed by Yordas included: OO regulatory impact assessments and compliance strategies; sameness and substance characterisation; OO literature search and data gap analysis; OO development of integrated testing and assessment strategies; OO commissioning, management and interpretation of endpoint studies; OO exposure and risk assessment; and OO Iuclid dossier preparation and submission. Yordas continues to provide ongoing management of these REACH registrations to address evaluations (dossier, substance and testing proposals) and ensure the dossiers are kept up to date. yordasgroup.com/case-studies/japan-reach-registrations

CASE STUDY 3: Materials obsolescence management Plan for BAE Systems Maritime The Client BAE Systems, a leading maritime manufacturer, produces various product ranges for the naval industry, and develops new technologies across a number of sectors to meet the demand and requirements of the defence industry. Many businesses of this type rely on a number of highly specialised chemical formulations in order to manufacture their finished products. With extremely long and onerous approval cycles for products and components, their supply chains have a high potential of being severely impacted by obsolescence. Yordas Hive’s functionality gives our clients the advantage of managing their materials obsolescence company-wide to address both current and upcoming chemicals legislation. Yordas Hive helps maintain visibility of high-risk products Using Yordas Hive, BAE Systems has been able to take advantage of our information-rich database to determine the obsolescence risk of their substances. The Hive Notifier tool further allows the client to maintain risk status by monitoring changes in relevant regulations. The Yordas Hive software allows BAE to customise their compliance database and upload their Bill of Materials and chemical constituent information in order to maintain visibility of high-risk products. In turn, this enables the client to prioritise any required action to mitigate against obsolescence and keep track of the impact of regulatory changes on their products. As a result, BAE Systems saves considerable time and effort, while being reassured that they are getting the most current information about regulatory changes that affect their products, both now and in the future. yordasgroup.com/case-studies/bae-systems CASE STUDY 4: Substance evaluation support for BPA-PO CoRAP The regulatory challenge: In 2015, the European Chemicals Agency (ECHA) took the decision to carry out a Substance Evaluation for the UVCB 4,4’-propane-2,2diyldiphenol, polymer with 2-methyloxirane (Propoxylated Bisphenol A). The initial grounds for concern were the UCVB classification as a suspected Carcinogenic, Mutagenic, Reprotoxic (CMR), the high aggregated tonnage (1,000–10,000 tonnes p.a.) and wide dispersive use. Our solution: As only representative for the lead registrant, Yordas took the lead for this substance evaluation, commissioning and managing required tests and managing communication between registrants and other stakeholders, including governmental authorities The project was challenging due to the substance being a UVCB commercially available as various grades. Available experimental data generated on different grades of the substance indicated they could be expected to display different properties. Identifying the most relevant grade for each endpoint – ie, the grade expected to represent the worstcase scenario – proved to be a critical part of the project. Benefits for the client Yordas managed all the requirements of the Community Rolling Action Plan (CoRAP), including engagement with the Authorities, review and comments of the draft decision. The evaluation was completed in May 2020 concluding that the information available is sufficient to address the concern(s) raised in the CoRAP for the time being.. yordasgroup.com/case-studies/substance-evaluation-support-for-bpapo-corap

www.chemicalwatch.com/SPG

Profile: Yordas Group

185

Niche firm profiles

186

CONTACTS

CONTACTS Website

www.3s-chem.gr

E-mail

info@3s-chem.gr

Head office

133, El. Venizelou Str, 16343 Athens, Greece

Tel/Fax

+30 2109901150 / +30 2109901151

Fax

+30 2109901150 / +30 2109901151

Contact

Panos Drougas

Ownership

Private

Founded

2007

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 +28 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*: OO authoring multilingual SDSs and labels; OO classification & labelling studies; OO Iuclid Cloud services (REACH, PCN, C&L notifications, biocides); OO creation and maintenance of cloud-based chemical inventory; OO Chemical storage system according to chemical compatibilities; OO Seveso III (notification/safety report); OO UN transport classification (ADR/RID/IMDG/IATA-DGR); OO HazWastes classification (WFD Annex III); OO emergency Response (Plans and Level-1 service)/risk assessments of chemical hazards/Business conduct policies (EH&S); and OO SQAS.org (preparation for assessment). *For customers based in Greece and Cyprus, please visit our website

Website

www.anthesisgroup.com

E-mail

contact@anthesisgroup.com

Head office

Unit J, Taper Studios, 175 Long Lane, London, SE1 4GT

Tel/Fax

+44 (0)1865 250 818

Contact

Helen Kean

Ownership

Private company

Locations

UK, Europe, the US, China, Philippines

Founded

1994

OVERVIEW Anthesis provides policy and regulatory consultancy in the field of chemical regulation and management, and has done so since 1994 as 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 OO

OO OO OO OO OO OO OO OO

www.cea.adas.co.uk

E-mail

enquiries@cea-res.co.uk

Head office

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

Tel/Fax

+44 (0)1954 268298

Contact

Adrian Terry

Ownership

Private

Locations

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

Founded

2001

OVERVIEW Cambridge Environmental Assessments (CEA), part of RSK ADAS, provides technical and strategic expertise and dossier support for chemical registrations. This encompasses agrochemicals, biocides, veterinary and human pharmaceuticals, food additives, fertilisers and general chemicals. Our team of 25 people is based in the UK and Ireland. It comprises specialists in environmental fate and behaviour; field fate and stewardship; exposure and spatial modelling; aquatic ecotoxicity testing; ecotoxicology and risk assessment; toxicology and human health risk assessment; and regulatory affairs. SERVICES PROVIDED Our services include: specialist regulatory support and consultancy across many chemical types; higher tier, non-standard support for challenging products, including design and conduct of higher tier studies; full dossier preparation and support service under the BPR; REACH and 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 risk assessment. CLIENTS We work with clients that encompass agrochemical, biocide, veterinary and human pharmaceutical, food, fertiliser and general chemical companies from around the globe. We also provide specialist policy advice and research to government clients and consultancy services to water companies and their associations.

CONTACTS

Website

Consortium and Sief management REACH – dossier development for registration, evaluation and authorisation / restrictions OR and TPR services for EEA and for UK Brexit (if required) CLP compliance management SDS authoring and management Product compliance under REACH, RoHS and Extended Producer Responsibility Sustainability strategy development and implementation Sustainable procurement Chemical management including supply chain mapping, design & implementation Environmental due diligence

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.

Global Service Providers Guide 2021

Website

www.chemforward.org

E-mail

info@chemforward.org

Head office

Washington, DC

Tel/Fax

+1 919 452 7157

Contact

Stacy Glass

Ownership

Private non-profit nongovernmental organisation

Founded

2018

OVERVIEW ChemFORWARD is an independent, non-profit, science-based value-chain collaboration established to scale a centralised, globally trusted source of cost-effective chemical hazard data and safer alternatives. ChemFORWARD’s database is populated and continually updated by licensed toxicologists using an enhanced GHS-based methodology. Each assessment is peer reviewed by independent toxicologists. A challenge process serves to resolve inconsistencies and arrive at a definitive profile for each chemical. We believe that reliable chemical data underpins the pathway to a safe, circular, and equitable economy. SERVICES PROVIDED We offer a subscription-based access to a globally harmonised collection of comprehensive, verified chemical hazard assessments and safer alternatives curated for industries including beauty and personal care, electronics and food packaging. ChemFORWARD features curated data organised by sector. Each collection includes relevant regulatory and industry lists, a selection of fully assessed alternatives organised by function, the ability to request new assessments as needed, and B2B reporting options that promote transparency while allowing suppliers to control their confidential business information. For chemical suppliers, ChemFORWARD offers a platform to verify and amplify safer alternatives to reach an audience of companies that are actively seeking safer alternatives. CLIENTS We support retailers, brands and their supply chains to eliminate chemicals of concern, avoid regrettable substitutions and identify safer alternatives. For chemical suppliers, we verify and amplify their safer alternatives. And we assist regulators and policy makers in substantiating the availability of safer alternatives to advance science-based regulations. ChemFORWARD co-design partners include Google, Target, Nike, Sephora, HP, Credo and H&M.

CONTACTS Website

www.chem-academy.com

CONTACTS

E-mail

info@chem-academy.com

Website

https://com4chem.de/en/about/

Head office

Bahnhofsplatz 2, D-16321 Bernau bei Berlin, Germany

E-mail

info@com4chem.de

Tel

+49 3338 75157 0

Head Office

Contact

Dr Bjoern Nehls

Chilehaus A, Fischertwiete 2 20095 Hamburg, Germany

Ownership

Private company

Tel

+49 1736176387

Locations

Germany

Fax

+49 40 320 052 00

Founded

2007

Contact

Kerstin Heitmann

Ownership

Kerstin Heitmann

Locations

Hamburg

Founded

2020

OVERVIEW Chem-Academy organises high-class conferences, congresses and training courses covering a range of topics from the chemical, food contact and pharmaceutical industries. The events are distinguished by practical orientation, networking opportunities, and premium speakers from relevant authorities, science and industry. You will meet executives from leading chemical industry firms, including 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. Online streaming is also offered for all of our events. SERVICES PROVIDED Conferences and courses on chemical regulation and implementation. CLIENTS A wide variety of clients and delegates from industry, authorities, and service providers.

OVERVIEW We deal with issues relating to chemicals legislation on a daily basis. We have been involved with REACH, CLP and other regulations since 2001, when the first drafts for a new European Chemicals legislation were developed. During the course of our consultancy work, we can draw on many ‘best practice’ examples. We are also aware that companywide solutions and cooperation agreements are becoming increasingly important. We can help, acting as a moderator and a coordinator. Chemical compliance also means thinking outside the box. New legal challenges must be detected early on in order to incorporate them, and to enable sustainable product development on the market. European chemicals legislation is not rigid structure. Other developments relate to legal provisions for individual substances, for example classification, restriction and authorisation. New or more stringent general requirements are added. Com for Chem follow up these developments and discuss them with our extensive interdisciplinary network. SERVICES PROVIDED OO

CONTACTS Website

https://en.chemmanage.com/

E-mail

info@chemmanage.com

Head office

Konaklar, Beyaz Karanfil Sk, No:9, 34330, Levent, Beşiktaş, İstanbul,Turkey

Tel

+90 216 567 59 11

WeChat

+90 505 351 67 32

Contact

Demet Gonca AKALIN

Ownership

Private Company

Locations

Turkey

Founded

2018

OO OO OO OO

Technical and regulatory support for registrants, including lead registrants, consortia, co-registrants. Application for Authorisation Strategic REACH consultation, compliance monitoring for substances. Substances in articles, SVHC and SCIP notifications. Inhouse seminars, webinars and workshops.

CLIENTS OO OO OO

REACH Selenium & Tellurium Consortium. Metals producers and distributors. Paint manufacturers. Producers of medical devices. Chemicals distributors.

OVERVIEW ChemManage was established to consult our clients on compliance with chemical regulations such as the KKDIK (TR-REACH), SEA (TR-CLP), the BPR and agricultural products legislation and on compliance with some international chemical regulations (for Turkish exporters) through our in-depth knowledge and understanding of the legislation and governments’ regulatory processes. We help clients place their products on the Turkish market and other international markets by preparing all the necessary documentation in accordance with relevant national rules and legislation. We represent companies from outside Turkey as their OR (only representative) and our certified KDU (chemicals assessment expert) staff document their registration dossiers as stipulated by Turkish national authorities. If requested, we can also give companies training or presentations on Turkey’s chemicals regulations. SERVICES PROVIDED OO

OO OO

Consultancy service, for compliance with the KKDIK, SEA, BPR and agricultural products legislation OR service, preparation/registration of dossiers and notifications to fulfil the obligations under the KKDIK, SEA and BPR SDS authoring and management service in Turkish Classification and Turkish label support in accordance with SEA for biocidal and agricultural product. Alternative name application under the KKDIK Translation of scientific documentation and other documentation into Turkish language Consultancy service for Turkish exporter companies in chemicals sector

CLIENTS Client confidentiality is guaranteed. We give consultancy support and OR service to different sized companies that have manufacturer, importer, downstream user and distributor roles. We are also willing to work with consultancy companies outside of Turkey to serve their clients on compliance with Turkish legislation.

CONTACTS Website

www.coracle.global

E-mail

info@coracle.global

Tel/Fax

+44(0)1484 866777

Contact

Claire Clarke

Ownership

Private Limited Company

Locations

Founded

2015

OVERVIEW Experts in complex 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 industrial chemistry, research and development, and bioinorganic chemistry. SERVICES PROVIDED OO OO OO OO OO OO OO OO OO OO

Complex Analytical Interpretation Substance Identification IUCLID Dossier Preparation REACH / BPR Process Development Product Stewardship Batch Testing Purity Analysis / Screening SDS Reviews and Authoring Supplier Audits

www.chemicalwatch.com/SPG

Niche firm profiles

187

Niche firm profiles

188 ®

CONTACTS Website

www.csregulatory.com

E-mail

helpline@csregulatory.com

Head office

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

Tel/Fax

+44 1332 380 692 / +44 1332 380 692

Contact

Steven Green, Craig Deegan

Ownership

Privately owned

Locations

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

Founded

2007

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 the Republic of Ireland, CS Regulatory is ideally placed to assist with all aspects of EU REACH and CLP and the onset of UK REACH, including providing an only representative function in both the EU and UK, working with both EU and UK manufacturers, importers and current DUs for each jurisdiction. With a network of strategic partnerships throughout the globe, we can assist with worldwide notification of chemicals, the production of associated chemical safety documents, liaison with authorities, advice on testing strategies and project management of data packages and the acquisition of existing data. SERVICES PROVIDED OO OO OO OO OO OO

OO OO

Website

www.espheres.com

E-mail

Philip.capel@espheres.com

Head office

rue des Pères Blancs 4, 1040 Etterbeek, Brussels, Belgium

Tel/Fax

+ 32 (0)2 740 43 36/ + 32 (0) 473 58 14 73

Contact

Philip Capel

Ownership

Private

Locations

Belgium, Finland, Germany

Founded

2011

OVERVIEW

CONTACTS

REACH and CLP (EU and UK) Worldwide notification of chemicals Only Representative in EU and UK Grandfathering and DUIN in UK Production of SDS, classification and labelling, hazard assessments (CSA/ES) Liaison with authorities and product defence Advice on testing strategies, including administrating and project management of data packages Acquisition of existing data Compliance audit services

CLIENTS A broad range of clients, from niche suppliers to global multinationals with customers throughout the world.

eSpheres, a Solvay spin-out in SAP®EHS consultancy delivering health, safety, environment (HSE) software and service solutions to organisations internationally. As a REACHLaw Partner, we also focus on product safety and product compliance. Our in-depth IT solutions, SAP®EHS consultancy, data maintenance and out-tasking services help companies and institutions improve their management safety processes. SERVICES PROVIDED SAP®EHS Consulting: eSpheres supports projects and strengthens corporate EHS and IT departments with adequate resources to lead and implement SAP®EHS into any organization. Wide experience in implementations, project management and maintenance services. Experts in SAP®EHS and HSE data management, we have developed IT-tools to facilitate the use of EHS systems. eSpheres implements, deploys and integrates the SAP®EHS(M) modules; implements SAP Poison Centre Notification software and SAP Product Compliance for S4HANA and helps to meet the requirements of Regulations (PCN, SCIP). Expertise in product safety, product stewardship, SVT, Vendor SDS management, IDMP and recipe management, global label management, dangerous goods. Outsourced EHS regulatory content update (Verisk 3E, Sphera CE) for SAP Product Safety, SAP Product Compliance and SDS authoring. SAP®EHS Training: expert Rules creation, SDS release generation, tailored SAP®EHS programs. Software tools to file, extract and manage EHS data from SDS.pdf into XML, CSV files, to facilitate HSE data management for SAP®EHS. CLIENTS (petro)chemicals, pharmaceuticals, paintings, steel and alloys, pulp and paper, polymers, electronic, semiconductor, cosmetic, automotive industry.

CONTACTS

CONTACTS Website

www.delphichse.com

E-mail

ray.boughton@delphichse.com

Head office

Building B, Watchmoor Park, Camberley, Surrey GU15 3YL. UK

Tel/Fax

+44 (0)1252 856 700

Contact

Ray Boughton

Ownership

Private (Ltd)

Locations

UK, Hong Kong, Netherlands, China and Australia

Founded

2005

OVERVIEW Globally-established safety and compliance services We are a multinational consultancy providing specialist product safety and regulatory compliance services to the global consumer and industrial chemicals markets. Our experts help organisations of all sizes meet the complex regulatory needs of their products and consumers. Delphic HSE represent and support all parts of the supply chain, allowing businesses to focus on performance. Primarily serving the global cosmetic, toy and household industries. SERVICES PROVIDED Toxicological Risk/Safety Assessments on consumer products Global regulatory checks OO Label/Artwork Reviews on Consumer products OO Product claims Identification and Substantiation on Consumer Products OO Legal Representation where industry regulation requires such an entity OO Product Registration where industry regulation requires such an entity OO Training and Consultation OO Bespoke Risk Assessments OO Expert Witness And much more OO OO

CLIENTS Not Available Due to Confidentiality

Global Service Providers Guide 2021

Website

www.eurideastranslation.com

E-mail

translation@eurideastranslation.com

Head office

Square de Meeûs 35, 1000 Brussels, Belgium

Tel

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

Fax

+32 (0)2 627 5655

Contact

Kristina Bitvai

Ownership

Private company

Locations

Belgium, Germany, Hungary

Founded

2007

OVERVIEW Eurideas Language Experts provides professional translation and interpreting services. We specialise in chemical, technical, medical translations, but cover other fields such as EU legislation, law, environment, health and many more. Our native speaker chemical translators are experts in the REACH Regulation and other related EU, international and local legislation. We have huge 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 any repeated work. SERVICES PROVIDED We provide translations, certified translations, proofreading, editing services in all EU and in many Asian, African and Latin American languages. The translations are always by a native speaker translator and proofread by a second native speaker translator. We also carry out thorough quality checks on the prepared 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.

SAFETY & HEALTH www.eurosh.com

CONTACTS

Website

www.eurosh.com

Website

www.kerona.ie

E-mail

sean@eurosh.com

E-mail

info@kerona.ie

Head office

2 The Dana, Shrewsbury SY1 2HP

Head office

Tel

01743 362076

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

Contact

Dr Sean Mahar

Tel/Fax

+353 (0)1 8495284

Ownership

Private Company

Contact

Dr Irene McGrath

Locations

Shrewsbury

Ownership

Private Company

Founded

2000

Locations

Ireland and Spain

Founded

2014

SERVICES PROVIDED OO OO OO OO OO OO OO OO OO OO OO

Industrial hygiene services Occupational health and safety consulting Workplace air sampling Noise measurements Vibration assessments Ergonomic assessments Indoor air quality studies Regulatory reviews Covid-19 mitigation Training REACH only representative services

CLIENTS We serve a variety of industries and are proud to list companies such as Amazon, Tiffany and Co, United Technologies, Moog, Safran, Triumph and General Electric as customers.

CONTACTS Website

www.infotox.pt

E-mail

info@infotox.pt

Head office

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

Tel/Fax

+ 351 218 063 659

Contact

Elsa Casimiro

Ownership

Private company

Locations

Portugal and UK

Founded

2004

OVERVIEW

OVERVIEW With offices in Ireland and Spain, Kerona Scientific is an award-winning regulatory consultancy providing a wide range of services for the registration of biocides, plant protection products, plant biostimulants, fertlisers, chemicals and cosmetics throughout the EU and Middle East. SERVICES PROVIDED Kerona provides a full range of expert services to support client registration in Europe and the Middle Eastern regions, including 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, such as data gap analysis, data review, study commissioning, dossier preparation, technical equivalence, and risk assessments for human health and the environment. We also provide a wide range of support services, for data access negotiations, representation with EU authorities and consortia, only representative, preparation of SDS/label/SPC, CLP/GHS, SDS authoring and literature searches. Drawing on our experience of more than 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.

CONTACTS Website

www.LKC-ltd.com

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.

E-mail

LKC@lkc-ltd.com

Head office

Postfach 167, Hauptstrasse, Fuellinsdorf, Switzerland

Tel/Fax

+41 61 906 8503 / +41 61 906 8509

SERVICES PROVIDED

Contact

Mr Matthew Kane & Dr David Kane

Our regulatory services include expert support for the biocidal products Regulation (BPR) cosmetic products Regulation, detergent Regulation, medical devices Regulation, REACH, CLP/GHS, ADR and PIC in terms of: OO dossier data gap analysis; OO Iuclid dossier preparation for BPR and REACH; OO electronic submissions and updates (CPNP, R4BP and REACH-IT); OO toxicological reviews and expert support (including Qsar); OO design of testing programmes (efficacy tests and (eco)toxicity); OO safety data sheets production, review and translation; OO reviewing and updating marketing/efficacy claims and product label; OO guidance on setting up a post-market surveillance programme; OO BPR specific services, including transitional period biocidal product registrations in the EU/UK, product assessment report (PAR), consortia for biocidal products and Article 95 listing of active substances; OO poison centre notifications in the EU/UK; OO REACH specific services, for example only representative services and production of chemical safety reports (CSR); and OO cosmetic products specific services, including responsible person services, product information file (PIF) review and compilation and cosmetic product safety reports (CPSR). We also provide a wide range of environmental health services, including health impact studies for environmental impact assessment (EIA), soil clean-up and climate change projects.

Ownership

Private company

Locations

Switzerland, UK and EU

Founded

2001

CLIENTS Our clients include regulators, professional organisations, multinational companies and SMEs.

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. Speciality 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 Technical & Scientific: pre- and post-submission discussion with authorities, data assessment and compensation, registration success forecasting, maintenance and defence. 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/MRLs, REACH and CLP dossiers. CLIENTS LKC’s clients are international speciality 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 medicines and chemicals.

www.chemicalwatch.com/SPG

Niche firm profiles

189

Niche firm profiles

190

CONTACTS Website

www.mediator.as

E-mail

info@mediator.as

Head office

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

Tel/Fax

CONTACTS Website

www.chinaoci.com

E-mail

david.chang@chinaoci.com

+45 75 54 08 24

Head office

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

Contact

Jens Haugaard

Tel

+86-10-68091928 EXTN 8008

Ownership

Jens Haugaard

WeChat

+86 13910863852

Locations

Denmark

Contact

David Chang, Cissy Zhou

Founded

2011

Ownership

Licensed company

Locations

China Beijing, Shanghai, Guangzhou

Founded

2006

OVERVIEW Mediator A/S is a consultancy where all of our consultants are specialised in working with chemicals and their impact on human beings and the environment. We take pride in knowing the our customers’ business and the challenges they face. We work alongside authorities to deliver practice-oriented solutions for our customers. SERVICES PROVIDED We give expert counselling about formation of rules and the 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 of work.

OVERVIEW OCI (北京正智远东化工) is the earliest and leading legal regulatory services provider and the main vendor of World top 500 in China and Far East, with more than tremendous successful cases in the aspects of Chemicals & Pesticide Registration, food relevant declaration, Cosmetics & New ingredient Notification, Supply chain Compliance of Fertilizers & Feed, etc. Compliance over decade, heritage beyond century SERVICES PROVIDED OO OO OO OO OO

CLIENTS We assist more than 500 active customers from both within Denmark, and also from all over Europe and abroad. We advise entrepreneurs starting a business and also serve as specialists for large scale companies.

Compliance assessments in various products/supply chains/regions Pre-staged RA proposal/data gap analysis China and ASEAN chemical registration focus Global policy and regulation news production and presentation Site RA support and emergence team backup Strong petition capability of Food-Cosmetics-Feed new additives

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

Locations

Founded

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

OVERVIEW Peter Fisk Associates is a scientific consultancy that provides high quality and objective scientific/technical and policy support on the regulation of chemicals. We are expert in assessing the regulatory and political landscape within which scientific information on chemical risks is interpreted. SERVICES PROVIDED Peter Fisk Associates Limited, works in collaboration with PFA-Brussels SRL on REACH and other regulatory work including: OO expert advice and technical consultancy in chemistry, toxicology (including toxicokinetic modelling), ecotoxicology, quantitative structure-activity relationships, exposure assessment and modelling (human and environmental), risk management options, supply chain analysis and authorisation support; OO secretariat services, including consortium management and joint submission OO communications; OO strategy for regulatory compliance. We can provide you with a full service to meet the requirements of chemical regulations, including UK and EU REACH and CLP requirements, EU cosmetics and biocides regulations, food safety and other areas of chemical regulation and voluntary assessment; OO provision of only representative (OR) services for non-UK exporters; OO strategic needs within REACH risk management; OO authorisation, restriction, RMO and evaluation. As chemical hazard, risk and control measures experts, we provide a comprehensive service to identify potential substances of high concern and deliver successful authorisation applications (including working with partners on socio-economic analysis); OO development of chemicals policy and strategy on substances; OO product stewardship, advantages and drawbacks of proposals. Our in-depth knowledge of the industry means we can offer clients a solid analysis and understanding of the regulatory framework within which chemicals and products are made and marketed; and OO appeals/awareness. If you are facing legislation challenges, we have the experience and scientific expertise to work with you and your legal representatives for a successful outcome.

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 experts at assessing the regulatory and political landscape within which scientific information on chemical risks is interpreted. SERVICES PROVIDED As a wholly owned subsidiary of Peter Fisk Associates Limited, PFA-Brussels SPRL works in collaboration with PFA Ltd on REACH and other regulatory work including: OO expert advice and technical consultancy in chemistry, toxicology (including toxicokinetic modelling), ecotoxicology, quantitative structure-activity relationships, exposure assessment and modelling (human and environmental), risk management options, supply chain analysis and authorisation support; OO secretariat services, including consortium management and joint submission communications; OO strategy for regulatory compliance. We can provide you with a full service to meet the requirements of chemical regulations, including EU and UK REACH and CLP requirements, EU cosmetics and biocides regulations, food safety and other areas of chemical regulation and voluntary assessment; OO provision of only representative (OR) services for non-EU exporters; OO strategic needs within REACH risk management; authorisation, restriction, RMO and evaluation. As experts on chemical hazard, risk and control measures, we can provide a comprehensive service to identify potential substances of high concern and deliver successful authorisation applications (including working with partners on socio- economic analysis); OO development of chemicals policy and strategy on substances; product stewardship, advantages and drawbacks of proposals. Our in-depth knowledge of the industry means we can offer clients a solid analysis and understanding of the regulatory framework within which chemicals and products are made and marketed; and OO appeals/awareness. If you are facing legislation challenges, we have the experience and scientific expertise to work with you and your legal representatives to optimise a successful outcome.

CLIENTS

A wide variety of clients, including chemical manufacturers and importers, downstream users and related manufacturing industries, and regulatory authorities and government organisations.

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 2021

CONTACTS Website E-mail Head office Tel/Fax Contact Ownership Founded

www.reachready.co.uk enquiries@reachready.co.uk Kings Buildings, Smith Square, London SW1P 3JJ +44 (0) 20 7901 1444 Rachel Nabudde REACHReady is a wholly owned subsidiary of the Chemical Industries Association 2006

OVERVIEW REACHReady offers a confidential and comprehensive service to help businesses fulfil their specific chemical regulatory compliance needs for both the UK and EU REACH, CLP and BPR regulations. Through REACHReady’s robust training and consultancy services, businesses have access to expert ongoing technical helpdesk support and are kept up to date with chemical regulation developments through regular technical alerts and regulatory guidance documents on the member’s area of our website. Our webinars and face to face meetings, as well as services provided via our Approved Service Provider programme, gives global manufacturers, importers, retailers, and formulators access to a broad network of technical expertise within the chemical industries. Our strong reputation and extensive experience of the chemical and downstream industries makes us the best choice for REACH, CLP and BPR services. Our 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. Contact us today. www.reachready.co.uk SERVICES PROVIDED OO OO OO OO

Helpdesk Consultancy Training Matchmaker

CLIENTS OO OO OO OO OO OO

Chemical manufacturers Formulators Downstream users of chemicals Article manufacturers Retailers Service providers

Niche firm profiles

191

CONTACTS Website

www.regartis.com

E-mail

box@regartis.com

Head office

Rubeška 393/7 190 00 Prague Czech Republic

Tel/Fax

+420 739 463 410

Contact

Jan Holomek, CEO

Ownership

Private Company

Founded

2020

OVERVIEW REGARTIS was founded in 2020 by merging companies ReachSpektrum and EcoMole Compliance, supported by the Association of Chemical Industry of the Czech Republic. Both companies have provided expert knowledge and high quality services to companies dealing with chemicals management since 2007. 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 lead registrant and co-registrants. REACH lead registrant secretariat services. Data gap analysis, literature search, testing services in partner GLP labs. SIEF management. Only representative activities. Complete REACH Authorisation application development from initial analysis to submission. CLP – EU GHS: Classification, labelling and packaging, preparation of labels and notification to the ECHA inventory. SDS management for all EU and several non-EU regions. BPR: Complete consultancy and services in the biocidal products area. REGARTIS specialises in authorisation of the biocidal products Regulation, mutual recognition applications and risk assessment. Training, workshops: REGARTIS organises workshops on REACH and the CLP Regulation, Iuclid6 and Iuclid Cloud training sessions. The sessions may be tailored to your needs, and conducted in your company or virtually. Scientific projects: REGARTIS has worked on numerous scientific projects for Echa, Efsa, EC, JRC, etc, providing research on various topics – from toxic natural substances to nanomaterials. Complete consultancy services for UK REACH. CLIENTS EC, ECHA, EFSA, Privredna Komora Srbije, KAYAKU Safety Systems, Prague Airport, Cleveland Scott York, TEVA, Hranipex, BASF, Unipetrol, DEKRA, OSRAM, ORC International, EVONIK, SAP, Skoda Auto, TUV SUD, etc.

CONTACTS Website

www.reachwise.com

CONTACTS

E-mail

info@reachwise.com

Website

rovaltainresearch.com

Head office

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

E-mail

contact@rovaltainresearch.com

Tel/Fax

+44 (0)20 87470873

Head office

2 rue René Truhaut – 26300 Alixan

Contact

Peter Douben

Tel/Fax

+33 4 82 48 00 31

Ownership

Private company

Contact

Martin Lawniczak

Locations

UK, Netherlands

Ownership

Private

Founded

2007

Locations

Frabce

Founded

2014

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: OR services for both the EU27/EEA and UK jurisdictions providing efficient and effective services and maximum flexibility. Impact of REACH, CLP and BPR (EU/EEA&UK): 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 ensuring 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.

OVERVIEW Rovaltain Research Company (RRCo) is a global expert service and CRO for ecotoxicology and environmental fate. We specialise 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, physical chemistry and ecotoxicology, to applied research. We also offer more conventional tests following ISO, ASTM, OECD and CIPAC guidelines. SERVICES PROVIDED OO

OO OO

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.

Ecotoxicology: Acute and chronic tests from series 2xx. Tests can be realised according to OECD/ISO guidelines or adapted at client’s request. Physico-Chemical properties and environmental fate: Relevant physico-chemical properties and regulatory studies on biodegradability and bioaccumulation. Analytical and bioanalytical chemistry: LC-HRMS, LC-MS/MS, GC-MS/MS, IC, HPLC-UV, HPLC-14C detection, UV, IR… Stability and Storage studies: Stability tests can be realised according to CIPAC guidelines. Endocrine disruptors: RRCo perform in-vivo studies according to OECD guidelines 229, 230, 231, 234, 240, 241… Studies in mesocosm: We offer the possibility to work in climatic chambers with BSL2 to handle potentially dangerous substances or organisms. 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.

CLIENTS OO OO

Industries Research institutes

www.chemicalwatch.com/SPG

Niche firm profiles

192

CONTACTS

CONTACTS Website

www.scas-eu.be

Website

www.sweco.fi

E-mail

scaseurope07@scas-eu.be

E-mail

sds@sweco.fi

Head office

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

Head office

Finland

Tel/Fax

+358 20 739 3000

Contact

Eeva Punta, +358 40 029 8465

Ownership

Public company

Locations

Finland, Sweden, Belgium, Germany

Founded

1898

Tel

+32 (0) 2 719 0475

Fax

+32 (0) 2 719 0480

Contact

Dr Rick Stanton

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 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. SCAS is a major analytical service provider with laboratories in Japan, China, Korea and Singapore. Founded in 1972, SCAS has consistently satisfied its customers’ requirements 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.

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 Europe’s leading engineering and architecture consultancy with 17,000 employees and net sales €1.9bn. There are more than 30 experts in the compliance team. SERVICES PROVIDED OO OO OO OO OO OO OO OO OO OO

CLIENTS Our clients work in many sectors, with manufacturers and downstream users in industries including chemicals, petrochemicals, electronics, pharmaceuticals, automotive, paint, ink, rubber, fibre and others.

OO OO OO OO OO OO

Chemical safety REACH Safety data sheets (SDSs), CLP, exposure scenarios (ES) Biocides, BPR Toxicological and ecotoxicological risk assessments Cosmetics safety assessments Medical device compliance Food safety Contact material safety Legal advice Regulative services Process safety Machine safety Functional safety Risk analyses (HAZOP) SIL-verification

CLIENTS OO OO

CONTACTS Website

www.selerant.com

E-mail

sales-ehs@selerant.com

Head office

Tel/Fax

Selerant srl Via Leonardo da Vinci, 19 20051 Cassina de’ Pecchi, Milan, Italy Phone + (39) 02 786203 Fax + (39) 02 95341389

Contact

Stéphane Beaurepaire

Ownership

OO OO

Industry Brand owners Retail Public organisations

CONTACTS Website

www.toxfocus.com

Private Company

E-mail

barbara.vogt@toxfocus.com

Locations

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

Head office

8967 Hunters Way, Highlands Ranch, CO 80129, US

Tel/Fax

+1 501 351 4389

Founded

1990

Contact

Barbara Vogt, PhD, DABT

Ownership

Private company

Locations

Founded

2008

OVERVIEW Founded in 1990 in Italy, Selerant is a leading global provider of regulatory compliance and safety data sheet authoring solutions. Additionally, Selerant provides formula-based PLM software and consulting services within the process manufacturing segments of specialty chemicals, detergents, paints, coatings, flavours, fragrances and personal care/ cosmetics. Selerant has offices in Europe, the US and Asia-Pacific regions. 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: OO worldwide GHS regulations; OO SDS distribution; OO transport classification; OO hazard labelling; OO UFI management and EU poison centre notifications; OO exposure scenarios; and OO IFRA and more. Devex PLM is a powerful software solution for managing complete chemical product lifecycle, from new product development and formulation, to regulatory compliance, with ability to integrate with ERP. All these tools are designed to reduce time-to-market and accelerate your business. CLIENTS Selerant has a global customer base and provides EHS solutions across a wide range of industries serving local specialist producers, distributors and manufacturers to multinational giants.

Global Service Providers Guide 2021

OVERVIEW Tox Focus LLC provides 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 REACH: quality toxicology assessments and strategic planning for compliance with data requirements of regional chemical control legislation, including data gap filling, adaptations to data requirements, identification of analogues and categories, computer modelling and support (QMRF, QPRF), laboratory test commissioning and monitoring, robust study authoring, construction of Iuclid 6 files with validation reports, chemical safety reports, risk assessments, classification, labelling and packaging (CLP), and evaluation support/dossier defence. EU cosmetics Regulation: product risk assessment certificates and cosmetic product safety reports (CPSR) as part of the product information file (PIF). CLIENTS The Redstone Group/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, Calumet Specialty Products Partners LP, Gulf Bayport Chemicals LP, Gerber Scientific International, AW Chesterton Company, Medi-Ray Inc., GE Healthcare NL, 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

Founded

2010

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 areas including physicians, pharmacologists, biologists, chemists, food technologists, economists and lawyers. We believe that complex problems can be solved with success and quality only through teamwork. SERVICES PROVIDED OO OO

OO OO

OO OO OO

Niche firm profiles

193

Overall services: guidance on regulatory interpretation, compliance support, auditing. 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. 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. BPR Regulation: data sharing agreements, dossier for active substances approval and biocidal products authorisation at national and UE level. Cosmetic products: safety assessment, product information file, notification. Medicines and Medical Devices: CTD, genotoxic impurities, PDE assessment, environmental risk assessment, provisional OELs for APIs and other chemicals. Leachables and extractables assessment. Occupational medicine: risk assessment and management (CAD, CMD). Toxicological risk assessment: documents, expert advice and consultancy. Other: training for companies, universities and institutions.

CLIENTS Toxicon assists large companies and SMEs. Toxicon also works in partnership with institutions, industries and associations for research and development and compliance projects.

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

Ownership

Private Company

Locations

UK, Europe, worldwide

Founded

8 April 1987

OVERVIEW WSP is one of the world’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 and related sectors, which we combine with our multidisciplinary services to support clients throughout the life cycle of their processes and projects. We actively engage with our clients to help identify and provide solutions to the challenges they face. For example, 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: OO EU REACH, and worldwide registration and authorisation dossier preparation and submission; OO only representative services, strictly controlled conditions and REACH audits and training; OO safety data sheet and exposure scenario preparation and management; OO CLP harmonised poison centre notification management and SCIP notifications; OO support with EU cosmetic regulations and EU biocidal product regulations; and OO support with non-EU chemical regimes (Brexit, K-REACH, TSCA). 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.

TRAINING COURSES

Build your skills and confidence as a regulatory professional Get the training you need to stay informed, develop your product safety and compliance strategies. Attend our training courses around the world, led by accredited trainers who are experts in their field. Key training course topics include: • Biocides

• TSCA

• Toxicology

• REACH

• Chemistry

• Food contact regulations

Discover the right training course for you and start your professional development journey: events.chemicalwatch.com/training-courses

www.chemicalwatch.com/SPG

194

US US UK India Canada US UK Switzerland UK US UK UK Germany Belgium Denmark UK US The Netherlands China US

UK, Belgium, China

Anthesis Group APC

186

UK UK

   

Europe, US, China, Philippines UK, Austria, Poland, Czech Republic, Hungary, Australasia, Brazil

Apeiron-Team NV Arcadis Arcerion GmbH ARCHE Consulting Argentum Environment

68 70 72 74

Belgium The Netherlands Germany Belgium Sweden

 

Arrow Regulatory Ltd 76 Artemisa d.o.o. 78 AsiaInspection Assent Compliance asseso AG ATOMIUM ATOUT REACH Austen Business Solutions Ltd Auxilife Scientific Services Pvt. Ltd AW-ChemAdvice Ayansan Chemical Consultancy Ltd. Co. Battelle UK Ltd Baytouch Ltd Beijing BoardingCard Chemical Consulting Co., Ltd. Beveridge & Diamond, PC bibra toxicology advice & consulting

UK Slovenia Hong Kong Canada Germany Croatia France UK India The Netherlands Turkey UK UK China US UK



BIG vzw BioDetection Systems bv

Belgium Nederland



BioGenius GmbH BioQuanta BIOVIA, Dassault Systemes Bird & Bird LLP

Germany France US Belgium

Blue Frog Scientific Limited bluesign technologies ag Boeije Consulting Bond Dickinson 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 Switzerland Belgium UK UK Finland US US Austria Denmark Denmark UK UK Germany Italy

France Germany, HK, representatives globally

Cambridge Environmental Assessments Cardno ChemRisk

186 86

UK San Francisco, CA, US US Slovenia

Republic of Ireland

2,000-5,000 25-50 100-500 100-500

m e g

South America, Canada

1,000-2,000 2-5

25-50 2-5

m m

500-1000 50-100

25-50 25-50

g m e

2-5 5-10 5-10

2-5 2-5 5-10

i e e i g m e



Cardno ENTRIX CE.way: Cosmetics Regulatory and Testing Solutions Cefas CEHTRA Centro Reach Srl CERM CFCS

UK France Italy US Germany

Belgium

US UK UK

Germany, Netherlands, US

Europe, Colombia, Africa

Belgium, Switzerland, US, China

UK Ireland, Austria Slovakia, Poland China, US United States, Amsterdam, Kenya, Malaysia

No Hungary Switzerland, US US

Japan, Thailand, US

Republic of Ireland

China, Hong Kong, France, Germany, US

US Germany

Belgium, Germany, Spain, UK, India, Canada, Luxemberg Italy

Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%

Global Service Providers Guide 2021

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

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

100-500 100-500

5-10 50-100

10-25 5,000 plus 10-25 25-50 100-500

10-25 50-100 10-25 25-50 25-50

10-25 10-25 1,000-2,000 100-500 5-10 2-5 2-5 2-5 10-25 1 5-10 100-500 5-10 10-25 50-100 10-25

10-25 5-10 50-100 100-500 5-10 2-5 2-5 1 10-25 1 5-10 100-500 5-10 10-25 10-25 10-25

25-50 10-25

25-50 5-10

25-50 25-50 25-50 500-1000

10-25 10-25 25-50 2-5

10-25 50-100 1 1,000-2,000 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

10-25 5-10 1 50-100 2-5 5-10 100-500 1 50-100 50-100 2-5 50-100 10-25 5-10

m g m m m i m m i e g i a m e m m m m m i m g i m

g e g e

e g

e e e a i g e m

e g

Other(s)

2-5

Equipment

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

2-5 5,000 plus

Training

Greece Belgium

Information services

186

e e

IT & software solutions

3S-SafelyServingScience Accenture

m m m g i

Laboratory services

Legal services

Representation/management

Page



Other locations US

Chemical Global staff staff 25-50 2-5 50-100 10-25

Organisation 1cc GmbH 24-7 Response



Headquarters Germany UK

Consultancy/advisory

A-Z LISTING

e e e e e i e e e e m m

g e

g e g m g e e

e e a e

e e e e e

e e

e e g e e i a

e e e e e e e e e e e e e g g e a a a a m e g e g e a g g g e e i e e e e e i g g i i m g e e m i g e e e e g m e m g g i e m m e a a a i e g e e e g i e e e m m i i m m g m e e g i i m m g e e m m e g e g e e e m i e g e e e i g g m m g g i m e g

e i e

g m

e a e e e g e e e

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

Anthesis Group APC

             

      Arrow Regulatory Ltd  Artemisa d.o.o. AsiaInspection  Assent Compliance  asseso AG  ATOMIUM  ATOUT REACH  Austen Business Solutions Ltd  Auxilife Scientific Services Pvt. Ltd  AW-ChemAdvice  Ayansan Chemical Consultancy Ltd. Co.  Battelle UK Ltd  Baytouch Ltd  Beijing BoardingCard Chemical Consulting Co., Ltd.  Beveridge & Diamond, PC  bibra toxicology advice & consulting   BIG vzw BioDetection Systems bv   BioGenius GmbH BioQuanta  BIOVIA, Dassault Systemes  Bird & Bird LLP   Blue Frog Scientific Limited bluesign technologies ag Boeije Consulting  Bond Dickinson  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  Apeiron-Team NV Arcadis Arcerion GmbH ARCHE Consulting Argentum Environment

                 

                                              

   

          

  

                     

        

             

   

 

           



  



      

           

     

     

    





                                                                                                                                    

      

  

         

           

       

       

       

                                      

        

    

      

                     

  

     

    

Centro Reach Srl CERM CFCS

     

 

  

www.bluefrogscientific.com www.bluesign.com www.boeijeconsulting.com www.bonddickinson.com www.bootmanchem.com www.borenius.com www.bristolenvironmental.com www.buckman.com www.tb-klade.at www.bvhse.com www.bvhse.dk www.burges-salmon.com www.butterworth-labs.co.uk www.csb-online.de www.biologie.uni-konstanz.de/leist/ caat-europe/ www.cea-res.co.uk cardnochemrisk.com/ www.cardnoentrix.com www.ceway.eu

 



 

                    

     

www.cefas.co.uk                                www.cehtra.com      

  

                  



195

A-Z LISTING www.biogenius.de www.bioquanta.net www.accelrys.com www.twobirds.com

Cardno ENTRIX CE.way: Cosmetics Regulatory and Testing Solutions Cefas CEHTRA

 

US HCS

www.big.be www.biodetectionsystems.nl

 

                                                   



COSHH

www.ayansan.com www.battelleuk.com www.baytouch.com www.bjboardingcard.com www.bdlaw.com        www.bibra-information.co.uk   

                                    

Further information www.1cc-consulting.com www.24-7response.org

    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

Cambridge Environmental Assessments Cardno ChemRisk



CAD

CMD

Toy Safety Directive

RoHS

Medical devices Regulation 

 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  

                                                                                     

                      

     

Food contact



                                      

      

Agrochemical registrations

EU cosmetics Regulation

      

Biocidal products Regulation

      

New TSCA/LCSA

REACH Global chemical notifications

Occupational

Food (contact)

Medical devices

Cleaning products

Textiles & apparel

Construction

Aerospace, automotive & engineering

Toys/children's products

                                                                                                                                                       

       

            

Electrical and electronics

Veterinary medicine

Biocides

Biotechnology

Personal care (inc. cosmetics)



GHS-based regulations

        



Regulatory expertise

CLP

3S-SafelyServingScience Accenture



Medical & pharmaceuticals

Organisation 1cc GmbH 24-7 Response

Industrial chemicals Agrochemicals

Focus of activities

www.centroreach.it www.Cermonline.com www.cfcs-consult.com

Key: Icons above represents the extent to which the company provides the service as follows:  Core service  Service that is occasionally provided  Service provided by partners and third parties

www.chemicalwatch.com/SPG

196



 



 



US Turkey

UK, Netherlands, France, Hungary

5,000 plus 5-10

100-500 5-10

Chem-Academy ChemADVISOR, Inc. ChemAlert

187

Germany US Australia

Germany Belgium, Singapore

10-25 50-100

5-10 50-100

CHEMDOX Chementors Ltd Chemest Ltd. Chemex Environmental International Ltd

Austria Finland Finland UK

US China, Vietnam

50-100 5-10 2-5 10-25

10-25 5-10 2-5 10-25

ChemFORWARD ChemHaz Solutions

186

US Ireland

5-10 1

Chemical Check GmbH Chemical Compliance Chemical Consultant Chemical Regulatory Affairs – Israel Chemical Safety Consulting

Germany DE US Israel Germany

50-100 1 1 1 1

25-50 1 1 1 1

CHEMLEG ChemManage ChemPharmaServe Ltd Chemphex ChemRegs (UK) Ltd

94 187

Turkey Turkey UK Finland UK

10-25 2-5 2-5 1 2-5

ChemSafe Chemservice

96 98

25-50 50-100

5-10 50-100

ChemService Srl Controlli e Ricerche Chemtopia Co., Ltd.

Italy Germany, Luxembourg, Korea Italy South Korea

i i e e m m m m i m g i i m m i i

25-50 50-100

25-50 25-50

g m g e e e e

chemtrac® CHEMTREC Chemwatch CHESSOL B.V.

UK US Australia The Netherlands

Agent in China EU, US, Canada, China, Thailand, Japan, Vienam, Malaysia Italy, US, Japan, China US, Brazil, China US, Europe, Asia Belgium, France, Italy

25-50 50-100 100-500 5-10

25-50 50-100 100-500 2-5

China

100-500

50-100

Portugal The Netherlands Denmark Mauritius Netherlands

Spain, Italy, UK

5,000 plus 1 Denmark 10-25 Brazil, Romania, India, Singapore 100-500 Cloud based chemical information service provider 2-5

50-100 1 5-10 10-25 2-5

China Russia France UK

Ireland, US，South Korea，UK

100-500 50-100 1,000-2,000 1

25-50 50-100 100-500 1

Italy

5,000 plus

100-500

Germany

50-100 5-10 10-25 1

10-25 Globally

10-25 5-10

5-10 10-25

5-10 5-10

2-5

10-25

25-50

5-10

5-10 25-50 100-500 100-500 100-500 5-10 10-25 1

5-10 25-50 100-500 25-50 25-50 5-10 10-25 1

100-500 2-5 10-25 2-5 50-100 50-100 1,000-2,000 5,000 plus 25-50 100-500

25-50 1 2-5 2-5 50-100 10-25 10-25 100-500 5-10 50-100

China National Chemical Information Center Co., Ltd. ChIR – Chemical Innovation and Regulation Chris Braun Consultancy Chymeia ApS CIDP Cindax BV

100

CIRS CIS Center Citoxlab CJV Consulting Ltd

102 104

com for chem – Compliance for Chemicals Compliance & Risks Compliance Footprint AG Compliance Services International compliance2business

187

Concept Life Sciences Consortia Management GmbH CONUSBAT Regulatory Services

106

UK Germany Germany

Coracle Cosanta

187

UK The Netherlands

Ireland Switzerland US Italy

CRAD

UK 108

Turkey US

CS Regulatory Ltd CSB Compliance Group CTT Currenta GmbH & Co. OHG Cyprotex Danger and Safety srl dangerousgoods.com DanGoods Training & Consultancy

188 110

Danish Technological Institute Datalab David Ryberg de ViB fabriek Decernis Decernis LLC Defense Logistics Agency DEKRA DEKRA Assurance Services GmbH DEKRA Consulting GmbH

112

UK Germany China Germany UK Italy US UK Denmark US Norway Netherlands US US US UK Germany Germany

Germany

Switzerland, Spain, UK, US, Turkey

Hungary

US, UK global offices UK

The Netherlands, Germany, Austria, Belgium, Finland, Denmark, Sweden, UK, Poland, Spain, France, Italy, Portugal. Representatives in EU, UK, US, Japan, Korea Republic of Ireland US, UK US Europe – China

Germany, Thailand, Chile 80+ globally France, Hungary, Turkey, 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 2021

g e e i i

g e g g e e e e e m m e a a e

e e e m e g e i g e e m g e e e e e e e e g a a a e e i g e e e a a

g e g e

g g e e e e e g e e e

e g m m e e e

m e

i i e m i e g

e e

e e m i

e e e e g e e g m m g e a i e e a i g

e m i g e e

g i g e g i

m e e i m m e g e e g g g g

e e a

g m e e

g g e m g m e

m e e

i g g i g e

g m g g g

e e g e

e m i e e e e e i e e e e g e m m e e e e

i i m g g g m i g

Other(s)

Equipment

Charles River CHD Global

Training

Other locations US, France

Information services

IT & software solutions

Laboratory services

Headquarters Canada

Crowell & Moring 

Legal services

Page

Cosmetic Design Laboratories 

Representation/management

Organisation CGI

Clariant



Chemical Global staff staff 5,000 plus 100-500

Consultancy/advisory

A-Z LISTING

e g e g i g e

m m g g

g m

e e

g e e e e e

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

Charles River CHD Global Chem-Academy ChemADVISOR, Inc. ChemAlert CHEMDOX Chementors Ltd Chemest Ltd. Chemex Environmental International Ltd ChemFORWARD ChemHaz Solutions Chemical Check GmbH Chemical Compliance Chemical Consultant Chemical Regulatory Affairs – Israel Chemical Safety Consulting CHEMLEG ChemManage ChemPharmaServe Ltd Chemphex ChemRegs (UK) Ltd

                                                                                                                                                 

    

                       

    

    

   

ChemService Srl Controlli e Ricerche Chemtopia Co., Ltd.

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chemtrac® CHEMTREC Chemwatch CHESSOL B.V.

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Concept Life Sciences Consortia Management GmbH CONUSBAT Regulatory Services Coracle Cosanta Cosmetic Design Laboratories CRAD Crowell & Moring CS Regulatory Ltd CSB Compliance Group CTT Currenta GmbH & Co. OHG Cyprotex Danger and Safety srl dangerousgoods.com DanGoods Training & Consultancy Danish Technological Institute Datalab David Ryberg de ViB fabriek Decernis Decernis LLC Defense Logistics Agency DEKRA DEKRA Assurance Services GmbH DEKRA Consulting GmbH

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Clariant com for chem – Compliance for Chemicals Compliance & Risks Compliance Footprint AG Compliance Services International compliance2business

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           www.chemicalsafetyconsulting.com   www.chemleg.com     en.chemmanage.com/ www.chempharmaserve.com www.chemphex.com  www.chemregs.co.uk             www.chemsafe-consulting.com              www.chemservice-group.com www.chemservice.it www.chemtopia.net

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             www.chemtracglobal.com www.chemtrec.com              www.chemwatch.net www.chessol.nl          www.chemhse.com/english

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                                                                

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www.complianceandrisks.com www.compliance-footprint.com www.complianceservices.com www.compliance2business.eu

www.coracle.global www.cosanta.nl www.stoffenmanager. com www.cosmeticdesignlaboratories.co.uk www.crad.com.tr

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com4chem.de

www.conceptlifesciences.com www.consortia-management.com www.conusbat.com

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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

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www.chemforward.org www.chemhazsolutions.com  www.chemical-check.de www.pl-chemical-compliannce.de www.chem-consult.com

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197

A-Z LISTING US HCS

COSHH

CAD

CMD

Medical devices Regulation

Toy Safety Directive

RoHS

Food contact

Agrochemical registrations

EU cosmetics Regulation

Biocidal products Regulation

www.chem-academy.com              www.chemadvisor.com   www.rmtglobal.com         www.chemdox.com www.chementors.fi          www.chemest.fi     www.chemex.co.uk

                        

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CIRS CIS Center Citoxlab CJV Consulting Ltd

New TSCA/LCSA

Further information                               www.cgi.com/environment                            www.criver.com www.chd.com.tr               

ChemSafe Chemservice

China National Chemical Information Center Co., Ltd. ChIR – Chemical Innovation and Regulation Chris Braun Consultancy Chymeia ApS CIDP Cindax BV

GHS-based regulations

CLP

REACH Global chemical notifications

Occupational

Food (contact)

Medical devices

Cleaning products

Regulatory expertise

Textiles & apparel

Construction

Aerospace, automotive & engineering

Toys/children's products

Electrical and electronics

Veterinary medicine

Personal care (inc. cosmetics)

Biocides

Biotechnology

Medical & pharmaceuticals

Organisation CGI

Industrial chemicals Agrochemicals

Focus of activities

www.crowell.com   www.csregulatory.com  www.csb-compliance.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            decernis.com www.dla.mil            www.dekra-process-safety.co.uk www.dekra.de/reach    www.dekra.de/en/reach   

www.chemicalwatch.com/SPG

198

Dell Tech Laboratories Ltd.

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Delphic HSE 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

188

EBRC Consulting ECD Compliance ECETOC Ecolab Ecomatters BV EcoMole Ltd.

114

UK US Denmark UK Belgium Turkey US Germany India Italy Germany Canada US United States US South Africa

Hong Kong, Netherlands, China, Australia Belgium 26 offices worldwide

5-10

2-5

50-100 100-500 1,000-2,000 5-10 2-5 25-50 2-5 1 1 1 1

25-50 10-25 10-25 2-5 2-5 25-50 2-5 1 1 1 1 50-100 2-5 100-500 1

i i i g m e g g i m m m m

g e e g a

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Other(s)

Equipment

Training

Information services

IT & software solutions

Laboratory services g

e e m

m g e e e a e a g g e e e g e e g

Spain Czech Republic

50-100 2-5 5-10 5,000 plus 5-10 5-10

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

France UK

Canada, Korea, US (New-Jersey) Belgium

25-50 10-25

m e m

g e e a

Norway Australia Germany UK India Belgium US US UK Belgium US Belgium Belgium The Netherlands US UK UK Germany UK Sweden Germany UK France

Sweden, Finland, Denmark, Switzerland

50-100 5-10 25-50 100-500 500-1000 5-10 1 5-10 50-100 2-5 100-500 1 100-500 2,000-5,000 2,000-5,000 10-25 10-25 2-5 2-5 5-10 25-50 25-50 5-10

5-10 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 2-5 10-25 25-50 5-10

m e e

Germany Canada Belgium US The Netherlands UK

Czech Republic, India, Romania Europe, Asia France, Germany, UK US, China, Japan, Canada Offices in 14 countries worldwide Portugal Sweden

116 118

France UK The Netherlands

eSpheres ETC EUPHOR Eupoc

188

Belgium Slovakia US Germany

Finland, Germany

Eurideas Language Experts Euro Safety and Health Eurofins

188 189 120

Belgium UK Belgium

Hungary, Germany

US Denmark Belgium UK Belgium UK Austria US England

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Fieldfisher LLP Flashpoint srl

122

UK Italy

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FoBiG Foresite Systems Formulator Software LLC Fraunhofer ITEM GAB Consulting GmbH Gain Claude

124

Germany US US Germany Germany France

GBK GmbH Global Regulatory Compliance Gensuite

126

Worldwide offices

100-500 5,000 plus 1 5-10 10-25 50-100 1

10-25 2-5 Germany, UK, Switzerland, Denmark, Asia, US, UK, 5,000 plus China, India & Australia Denmark, Germany, France, China 5,000 plus Europe, China, US 5,000 plus 5-10 Europe, Middle East, Asia 2,000-5,000 10-25 US, Ireland, London, Switzerland, China 500-1,000 5-10 Germany 2-5 England, UK 100-500 Belgium, France, Germany, Italy, Spain

Italy, Cyprus, Slovenia, Spain, Poland

Germany US

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 2021

Chemical Global staff staff 100-500 100-500

Austria, Germany, France Germany 5,000 plus United States 2-5 China, France, Germany, Japan, Singapore, Taiwan 1,000-2,000 2-5

ERBC ERM ES4chem

Eurofins Air Toxics Eurofins Product Testing A/S Euromines Eversheds LLP Exitss Exponent International Limited f_OXYDE GmbH Fanwood Chemical, Inc Fera Science Ltd

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Other locations UK France Spain India China US

Canada

EcoMundo Economics for the Environment Consultancy Ltd. (eftec) EcoOnline Ecotox Services International ECT Oekotoxikologie GmbH Edif ERA Edupalli Ramakrishna EggCentris EHS Strategies, Inc EHSCareers.com, Inc elc group Elements Advisory Elemica Emveo Enhesa Enthone BV Envigo Enviresearch Enviresearch Ltd Environmental Assessments Environmental Science Limited EnviroPlanning AB epos Software & Service AG EPP EquiTox  

Headquarters UK

Legal services

Page

Representation/management

Organisation DEKRA Process Safety

Consultancy/advisory

A-Z LISTING

i i m e i g

10-25 5-10

10-25 25-50 5-10 100-500 50-100 1

10-25 5-10 5-10 25-50 50-100 1

25-50 100-500

10-25

e e e

m g g i

i e e

e e e e e

g e g m m m g e m m e

m e e

m g e g

e a e a e m i g m e

g m g m g i i m g

m i g 5-10 5-10 m 10-25 e 1 g m 10-25 m 2-5 1,000-2,000 e

500-1000 10-25

i m

e m

100-500 1

2,000-5,000 100-500 2-5 25-50 2-5 50-100 2-5 2-5 50-100

m m

g e m

m m m g e g e e e e

e e e e

e e m e g a e a m m e g e i g m e a a m m e e e e e i i

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Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

Dell Tech Laboratories Ltd. Delphic HSE 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

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EBRC Consulting ECD Compliance ECETOC Ecolab Ecomatters BV EcoMole Ltd.

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ERBC ERM ES4chem eSpheres ETC EUPHOR Eupoc Eurideas Language Experts Euro Safety and Health Eurofins Eurofins Air Toxics Eurofins Product Testing A/S Euromines Eversheds LLP Exitss Exponent International Limited f_OXYDE GmbH Fanwood Chemical, Inc Fera Science Ltd Fieldfisher LLP Flashpoint srl FoBiG Foresite Systems Formulator Software LLC Fraunhofer ITEM GAB Consulting GmbH Gain Claude GBK GmbH Global Regulatory Compliance Gensuite

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Further information www.dekra-uk.co.uk/en/process-safetyoverview/ www.delltech.com

         www.ecoonline.com www.ecotox.com.au www.ect.de  www.edifgroup.com    www.bhu.ac.in  www.EggCentris.com  www.ehsstrategies.com www.ehscareers.com www.elc-group.com  www.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  www.esldatasheets.com www.gefahrstoff.com www.eppltd.com www.equitox.eu

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www.erbc-group.com/                www.erm.com       

      

                                                

     

     

     

                       

                     

          

      

                 

199

A-Z LISTING US HCS

COSHH

CAD

CMD

Medical devices Regulation

Toy Safety Directive

RoHS

Food contact



              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      www.ebrc.de www.ecdcompliance.com  www.ecetoc.org www.ecolab.com    www.ecomatters.nl    www.ecomole.com/reach-clp-consulting.        html       www.ecomundo.eu www.eftec.co.uk    

                                                                                            

Agrochemical registrations

EU cosmetics Regulation

Biocidal products Regulation

New TSCA/LCSA

GHS-based regulations

CLP

REACH Global chemical notifications

Occupational

Food (contact)

Medical devices

Cleaning products

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 DEKRA Process Safety

Industrial chemicals Agrochemicals

Focus of activities

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.com www.foresitesystems.com www.formulatorus.com      www.item.fraunhofer.de/en.html www.gabconsulting.de

          

  www.gbk-ingelheim.com www.gensuite.com

www.chemicalwatch.com/SPG

200

GlobalMSDS GLTaC, Inc. Golder Associates Gradient GreenSoft Technology, Inc Greenwich Chemical Consulting 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



130

Ireland US China Japan Israel Canada UK UK UK Germany Belgium Switzerland Germany Poland US Germany

US, UK, Poland

Bangladesh, China, Hong Kong, US, India US

Belgium, Brazil, China, Russia, India

Switzerland China The Netherlands Germany

France Italy Spain Brazil UK US, Turkey UK Germany, UK, Denmark, Serbia

INERIS INFOTOX INSCX exchange International Cosmetics & Chemical Services Ltd Intersolia

132 189

France Portugal UK US Sweden

Intertek IOM IPO O/Pszczyna iPoint-systems gmbh

134

UK UK Poland Germany

Jaehak Jung Japag Regulatory Consultancy Japan Chemical Safety Institute Jean Warshaw, Esq. Jones Day Jongerius Consult BV JRF Global JSC International Limited K J Bray & Associates K&L Gates LLP KAELTIA Compliance Services

Taiwan, Japan, China, Spain

South Korea India Japan US Belgium The Netherlands India UK UK Belgium Spain

110+ Countries Singapore Austria, France, Benelux, Sweden, UK, US, Japan, China, South Korea China, Vietnam

US, Europe, Japan US, UK

5-10 10-25 5,000 plus 100-500 50-100 1 2-5

5-10

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 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 2,000-5,000 2-5

100-500 25-50 50-100 2-5

50-100 5,000 plus 1 25-50

2-5 50-100 1 5-10

50-100 2-5 1 2-5 5,000 plus 1 100-500 25-50 1 1,000-2,000 5-10

2-5 2-5 1 2-5 50-100 1 100-500 25-50 1 25-50 5-10

10-25 5-10 10-25 100-500

5-10 2-5 10-25 25-50

100-500 5-10 10-25 100-500 2,000-5,000 2-5 100-500 5-10 1 50-100 1 5,000 plus 1,000-2,000 10-25 2-5 10-25

25-50 5-10 10-25 100-500 10-25 2-5 2-5 2-5 1 25-50 1 50-100 50-100 10-25 2-5 5-10

UK Canada



Kelley Drye & Warren Kerona Scientific Ltd KFT Chemieservice GmbH Knoell Konica Minolta Business Expert, Inc KREATiS Krogerus Attorneys Ltd. Kumi Consulting Ltd KV Consulting Services BVBA LAUS LEORAT NATHALIE CONSULTING LG CNS LGC Linge Agroconsultancy Linmark Consulting GmbH Linnunmaa Oy

138 189 140 142

US Ireland Germany Germany Japan France Finland UK Belgium Germany France South Korea UK The Netherlands Switzerland Finland

Brussels Spain

Lisam Systems

144

Belgium

LKC Switzerland Ltd Logic SDS Logscale Ltd

189

Switzerland UK Finland

US, Canada, UK, France, Germany, Romania, India, 100-500 Turkey, Brazil UK, Ireland 5-10 France 2-5 2-5



UK, Malta

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 2021

g e a a a a a e g a e a 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

Italy Canada Germany US

Asia, South America, Europe, US, Middle East

i i

m i i m e m m i

e g m g 1,000-2,000 1,000-2,000 g m 5-10 5-10 5-10 2-5 g 5-10 5-10 m 100-500 10-25 g i 5,000 plus 5,000 plus 100-500 10-25 m 50-100 50-100 100-500 25-50 g

136

France, US and UK

g g g i e

m e

Kahlberg Consulting Kalium solutions inc. Kathrin Lanz Keller and Heckman LLP

 

i e m m

e e m i



Belgium, France, China

10-25 50-100 50-100 1 2-5

m e e e

Other(s)

100-500

i i e e m g m e m i e e e e

Equipment

100-500

Training

Chemical staff 1 100-500 1 1 2-5

IT & software solutions

India, South Korea, Ireland, UK, Taiwan, Turkey and Russia

UK US France US US US Romania

ibacon GmbH ICB Pharma ICF International IDRG (International Development of Regulatory Globalization) IES Ltd IFF China IGCON imds professional GmbH & Co. KG 

Sweden

Australia, Canada, Chile, New Zealand, UK

Global staff 2-5 5,000 plus 1 1 2-5

Laboratory services

128

Other locations

Legal services

Global Product Compliance

Headquarters The Netherlands US Canada Hungary UK

Representation/management

Page

Information services



Organisation Gentrochema BV GHD GHS Training & Consulting GHS-expert Ltd Gillies Associates Limited

Consultancy/advisory

A-Z LISTING

i g g g e e e g i e e i e e a e e i g g e m e g e e a e e e e e m m e

100-500

g e e g e e e e m e e e e m e m m g g e g g e m m g e e i i m m e e e e i g 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 i i e e m e m i i e e m i i g e e a a g i a a m e m m g i g g e a e m e

5-10 2-5 2-5

m e e e e m i g e

e e

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

Global Product Compliance GlobalMSDS GLTaC, Inc. Golder Associates Gradient GreenSoft Technology, Inc Greenwich Chemical Consulting 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

         



       

   

              



INERIS INFOTOX INSCX exchange International Cosmetics & Chemical Services Ltd Intersolia

        

    

     

    

    

           

    



    

    

                

                           

        

         

    

www.globalmsds.co.uk www.gltac.com www.gradientcorp.com www.greensofttech.com www.grcci.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.complinace-footprint. com www.ibacon.com www.icbpharma.com www.icfi.com www.idrgplantprotection.eu



www.ies-ltd.ch

            

 

   

     

  

 

                 

   



 



                                

            

                                                                 

                                                                                              

Lisam Systems

                                                                                                         

LKC Switzerland Ltd Logic SDS Logscale Ltd

                  

www.igcon.nl www.imds-professional.com

  

www.ineris.fr www.infotox.pt www.inscx.com www.Intlcosmetics.com www.intersolia.com

 

             

    www.intertek.com www.iom-world.org www.ipo-pszczyna.pl           www.ipoint-systems.com

   

www.kotiti.re.kr

                         

www.jonesday.com www.jongeriusconsult.com www.jrfonline.com www.jsci.co.uk

  



                        

    

www.klgates.com www.kaeltia.com

www.kahlbergconsulting.com en.kaliumsolutions.com/ www.qualisys.eu         www.khlaw.com      www.kelleydrye.com  www.kerona.ie       www.kft.de         www.knoell.com www.konicaminolta.com www.kreatis.eu www.krogerus.com       www.kumi.consulting www.kvconsultings.com    www.laus.group    

                                              

                                    



201

A-Z LISTING US HCS

COSHH

CAD

CMD

Medical devices Regulation

Toy Safety Directive

RoHS

Food contact

Agrochemical registrations

EU cosmetics Regulation

Biocidal products Regulation

New TSCA/LCSA   



                    

www.gpcgateway.com

 



    

   





       

    

                

    

                           

   



GHS-based regulations

CLP

REACH Global chemical notifications

Occupational

                                            

      

Food (contact)

    

    

                  

Further information www.gentrochema.nl   www.ghd.com www.ghstc.com www.REACHexpert.eu www.gilliesassociates.co.uk    

           

       

Kahlberg Consulting Kalium solutions inc. Kathrin Lanz Keller and Heckman LLP

Medical devices

           

      

Cleaning products

                                        

ibacon GmbH ICB Pharma ICF International IDRG (International Development of Regulatory Globalization) IES Ltd IFF China IGCON imds professional GmbH & Co. KG

Intertek IOM IPO O/Pszczyna iPoint-systems gmbh

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 Gentrochema BV GHD GHS Training & Consulting GHS-expert Ltd Gillies Associates Limited

Industrial chemicals Agrochemicals

Focus of activities

www.lgcns.com www.lgc.co.uk www.lingeagroconsultancy.nl www.linmarkconsulting.com www.linnunmaa.fi www.lisam.com



www.LKC-ltd.com  www.logicsds.com logscale.fi/en/   

www.chemicalwatch.com/SPG

202



Pace Regulatory Services Paul Illing Consultancy Services Ltd PeerAspect Pengin Oy Penman Consulting Pera Technology

US UK US Finland Belgium UK

Peter Fisk Associates PFA-Brussels pIEt Consulting BVBA Pinnacle Associates Pirjo Heikkilä Polgar ACRO Pöyry Finland Oy Prefusion LLP Primetra Global Regulatory Consultants Proactima AS ProductIP Prosacon GmbH PwC Quality Technical Services LLC

190 190

Ramboll Randis ChemWise (Shanghai) Co., Ltd. REACH Advice GmbH REACh ChemAdvice GmbH REACH ChemConsult REACh ChemConsult GmbH Reach Chemical BV REACH Delivery

148



REACH Global Services S.A. REACH Monitor REACH n Roll Oy



China Portugal Germany

UK, The Netherlands

m e e e e m

i m

25-50 100-500 10-25 5-10 10-25 50-100 10-25 10-25 2-5 1 5-10 10-25 2-5

i e e e e i e g g

2,000-5,000 1 10-25 1 5-10 100-500

100-500 1 5-10 1 5-10 10-25

m m e

25-50 5-10 1 2-5 1 10-25 2,000-5,000 5-10 1 100-500 25-50 5-10 2,000-5,000 10-25

10-25 5-10 1 2-5 1 5-10 10-25 5-10 1 10-25 25-50 5-10 25-50 10-25

5,000 plus 10-25 1 5-10 5-10 2-5 1 25-50

100-500 5-10 1 5-10 5-10 2-5 1 25-50

g e a e e e e m

e e g

e e i

e g

g e e e e e e m e e e g e e e g e e a a e e m g e e e i

Belgium UK

Denmark China Germany Germany Germany Germany The Netherlands UK

35 countries Taiwan

150

Belgium Spain Finland

Turkey

10-25 10-25 2-5

10-25 2-5 2-5

Reach Only Representative Ltd REACH Orphan Substances Consortium bvba ROSC Reach Registration Services REACH24H Consulting Group ReachCentrum SA REACHECK Solutions GmbH

152

UK Belgium

Republic of Ireland

5-10 2-5

10-25 100-500 10-25 5-10

2-5 50-100 10-25 2-5

REACHLaw REACHLINKED

154

Finland China

25-50 5-10

REACHReady REACHwise Redebel Regulatory Affairs S.C.R.L. Redeker Sellner Dahs Rechtsanwälte ReFaC

191 191

UK UK Belgium Germany UK

5-10 2-5 50-100 100-500 2-5

2-5 2-5 50-100 5-10 2-5

REGARTIS RegScan Inc. RegTox Solutions Inc. REGULATORING Consultancy Sole Venture REGULATORING Consultancy SV Regulatory Services International Ltd Regulatus

191

Serbia

10-25

g m e g g g i m m g m i

Canada, US

1 1 1 10-25 1

i m e e m e m e e i a i e a m

UK China Belgium Germany

Czech Republic US Canada Hungary Hungary China UK

China

China, Hong Kong, Germany, UK Global presence US

Portugal, Sweden, US, India, China, South Korea

US, Japan

Ireland, US EU, Taiwan, Vietnam, S.Korea, China, US Belgium, UK, Turkey, Russia, India

The Netherlands Belgium

UK, US

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 2021

e e

a a e

e g e e e i

e e e e

UK Belgium Belgium UK Finland Hungary Finland UK Canada Norway The Netherlands Germany The Netherlands China

Belarus, Kazakhstan, Moldova, Russia, Ukraine

e g

m i m m m m i m m m i i m e m i m m m i m m m m e e m g m i

e e e e

m e

m e m e i e a e m m a g e m m m g m m i e e a m m e

2,000-5,000 500-1000 Canada 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

France

i m

e e

Other(s)

190

5-10 2-5 1,000-2,000 5-10 1 100-500 10-25 2-5

Equipment

OCI ONLY CORE CHEM, UNIPESSOAL LDA PACA GmbH

UK UK US Canada India Germany Germany Italy Canada Trinidad & Tobago

US, UK, Germany, China France, Germany, Poland, Italy, Spain

10-25 100-500 2,000-5,000 10-25 10-25 1,000-2,000 10-25 2-5

e e i g

Training

146

Asia-Pacific, EMEA, Americas Italy, Brazil, France, China

Chemical staff 2-5 25-50 5-10 25-50 2-5

Information services

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

Denmark US US US US Hong Kong Hungary US

Global staff 25-50 1,000-2,000 10-25 100-500 25-50

IT & software solutions

189

Other locations Bulgaria, Servia, Macedonia US, Japan Munich, Berlin, London, Bergen

Laboratory services

Mediator A/S Mercer Mérieux Nutrisciences Miami Chemical Micromeritics Analytical Services Modern Testing Services (Global) MSDS Europe MSDSWriter LLC

Headquarters Greece UK Germany US US

Legal services

Page

Representation/management

Organisation Loufakis Chemicals SA LSR Associates Makersite GmbH Manatt, Phelps & Phillips, LLP MB Research Laboratories

Consultancy/advisory

A-Z LISTING

g e e e e e g g m e e e

e e e e e g g e a g e e g m m a a e g g g e e i a

e e e g e e e

e a e

a a

e g e

a e

a e e e e e i e g e g a g e e

e g

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

Mediator A/S Mercer Mérieux Nutrisciences Miami Chemical Micromeritics Analytical Services Modern Testing Services (Global) MSDS Europe MSDSWriter LLC National Chemical Emergency Centre (NCEC) National Physical Laboratory (NPL) Neuralog, LP Nexreg Compliance Inc. NimkarTek Technical Services Pvt. Ltd NOACK Laboratorien GmbH Noerr LLP NORMACHEM S.r.l NovaTox NRM Solutions

              

     

     

    

     

    

     

  

 

REACHLaw REACHLINKED REACHReady REACHwise Redebel Regulatory Affairs S.C.R.L. Redeker Sellner Dahs Rechtsanwälte ReFaC REGARTIS RegScan Inc. RegTox Solutions Inc. REGULATORING Consultancy Sole Venture REGULATORING Consultancy SV Regulatory Services International Ltd Regulatus



    

    

           

                                       

   

 

   

   

   

     

                 

     

                                                   



    

    

    



 

            

                      

           

           

                        

 

                           

           

       

           

US HCS

CAD

COSHH

  www.peeraspect.com www.pengin.fi www.penmanconsulting.com www.peratechnology.com

www.polgar-acro.eu www.poyry.com www.prefusion.co.uk    www.primetra.com www.proactima.no/en www.productip.com www.prosacon.eu www.pwc.nl/nl/reach www.qtsinspect.com      www.ramboll.com www.randis.cn, www.randischem.com www.reach-advice.com www.reach-chemadvice.com www.reach-chemconsult.com www.reach-chemconsult.com/  www.reacheu.nl www.reachdelivery.com  www.reach-gs.eu www.reachmonitor.org      www.reachnroll.com

                        

       

 www.chinaoci.com www.onlycorechem.com   www.paca.de/sicherheitsdatenblatterstellen www.pacelabs.com/regulatory

www.pfagroup.eu www.pfagroup.eu www.pietconsulting.eu www.pinnacleassoc.com

      



203

A-Z LISTING



                        

                   

              

CMD

Medical devices Regulation

Toy Safety Directive

RoHS

Food contact

Agrochemical registrations

EU cosmetics Regulation

Biocidal products Regulation

New TSCA/LCSA

GHS-based regulations

   

Further information www.loufakis.gr   www.lsr-associates.com             makersite.io www.Manatt.com   www.mbresearch.com           www.mediator.as www.mercer.com www.merieuxnutrisciences.com   www.miamichemical.com www.particletesting.com www.mts-global.com   www.msds-europe.com          www.msdswriter.com     www.the-ncec.com www.npl.co.uk  www.neuralog.com       www.nexreg.com www.nimkartek.com www.noack-lab.com    www.noerr.com             www.normachem.it www.novatox.ca   www.nrmsolutions.org/ 

                            

 

                  

                  

   

                                                                                                                                                                                                          

         

    

                   

CLP

REACH Global chemical notifications

Occupational

Food (contact)

Medical devices

 

                         

                           

Reach Only Representative Ltd REACH Orphan Substances Consortium bvba ROSC Reach Registration Services REACH24H Consulting Group ReachCentrum SA REACHECK Solutions GmbH

Cleaning products

                    

Pace Regulatory Services Paul Illing Consultancy Services Ltd PeerAspect Pengin Oy Penman Consulting Pera Technology

REACH Global Services S.A. REACH Monitor REACH n Roll Oy

Textiles & apparel



                

Ramboll Randis ChemWise (Shanghai) Co., Ltd. REACH Advice GmbH REACh ChemAdvice GmbH REACH ChemConsult REACh ChemConsult GmbH Reach Chemical BV REACH Delivery

Construction

Aerospace, automotive & engineering

Toys/children's products

Electrical and electronics

Veterinary medicine

Personal care (inc. cosmetics)

Biocides

                                              

OCI ONLY CORE CHEM, UNIPESSOAL LDA PACA GmbH

Regulatory expertise

               

       

Biotechnology

Medical & pharmaceuticals

Organisation Loufakis Chemicals SA LSR Associates Makersite GmbH Manatt, Phelps & Phillips, LLP MB Research Laboratories

Industrial chemicals Agrochemicals

Focus of activities

www.rorltd.com www.ROSconsortium.eu 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.reachwise.com www.redebel.com www.redeker.de www.refac.eu www.regartis.com www.regscan.com  www.regtoxsolutions.com www.regulatoring.com www.regulatoring.com www.rsireg.com

www.chemicalwatch.com/SPG

204



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.

192

500-1,000 25-50

e e

25-50 1 2-5 10-25 5-10 1 1 1

10-25 1 1 10-25 5-10 1 1 1

m m g i m m i g e i e m m g i

25-50 5,000 plus 100-500 Singapore 100-500 1 US, Ireland, Greece, Japan, Turkey, The Netherlands 50-100 5,000 plus 1,000-2,000 China 100-500

Japan Germany Switzerland UK US UK

China, Singapore, South Korea, Taiwan Japan, UK France

Italy Sweden Spain US China Switzerland Canada South Korea India Spain

US, India, China, Germany, France, Serbia Sweden, US

10-25 50-100 50-100 25-50 1 10-25

Germany Finland

Russia, Ukraine

2-5 5-10

e i e

5-10 25-50 2-5

i e

m i e a m m

Worldwide

1,000-2,000 100-500 2-5 2-5 5-10 2-5



Staphyt Regulatory

162

France

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

100-500

50-100

500-1000 1 100-500 5-10 2-5 10-25 5-10 25-50 5-10

50-100 1 25-50 5-10 2-5 10-25 1 25-50 5-10

100-500 2-5

25-50 2-5

10-25 1 5-10 10-25 1 2-5 5,000 plus 2-5 25-50 1 10-25 50-100 10-25 5-10 2-5

10-25 1 5-10 5-10 1 2-5 25-50 2-5 10-25 1 10-25 1 10-25 5-10 2-5

Sweco Industry Ltd Syska Voskian Consulting 

192

TEAM mastery 164 Ted Simon LLC TEI Analytical, Inc Telematic srl Tenviro TERRA-The Electronics Reuse & Recycling Alliance Tetra Tech The Chemical Compliance Coach The Compliance Map Ltd. The Economics Interface Limited The Isosceles Group The Martec Group The Redstone Group The Sapphire Group the SDS factory | de ViB fabriek

Finland US Italy US US Italy Sweden US US The Netherlands UK UK US US US US The Netherlands

Finland Denmark

The Netherlands US Germany, Canada, UK Spain US, Australia

Germany, China, Japan, Brazil, Chile The Netherlands UK, Germany, Belgium

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 2021

i i

2-5 2-5

US US US

i e i m

m g m g

160

India, South Korea, Ireland

m m e

5-10 5-10

Sphera Solutions Spinnaker Coating, LLC Spring Trading Company, LLC

Belgium

g g



China Germany US UK Germany Canada Belgium Sweden Greece

m g e

e e

50-100 5-10 10-25 25-50

spectra Consult GmbH SpetsInterProject Oy

e e e e

100-500 10-25 10-25 25-50

Poland US The Netherlands US France France

5,000 plus 2-5 10-25 50-100 25-50

5-10 5-10

10-25 50-100

SIEF-IT SiteHawk Sitmae Reach Services BV Smithers Viscient SOCOTEC – Health and Product Safety Agency SOCOTEC Environment

10-25 50-100

More than 140 countries

m e e e e e e e m g e e m e i m e m e m m e a a e a m e e e e g m e g m e e m e e e i e g m e i e g e g g i

1,000-2,000 25-50 100-500 25-50 5-10 5-10

5,000 plus 2,000-5,000 10-25 2,000-5,000 Spain, USA., Denmark, Switzerland, Norwey, Island, 25-50 Estonia, Latvia, Lithuania, Finland, Greece, Cyprus, Holland, Belgium, India, Israel, Italy, Czech Republic, Potugal, UK, Ireland, Romania, Serbia 5-10 25-50 2-5 UK 100-500 5-10 France 5,000 plus

Star Wang Stefanie Merenyi Steptoe & Johnson LLP Stewardship Solutions Ltd Subvise Surface Science Western Sustainability Consult Sustainability Support Services (Europe) AB SustChem Engineering Ltd

500-1,000 25-50

100 offices worldwide

Other(s)

192 158

US, Spain and Japan Italy Canada

Equipment

SCAS Europe SCC Science & Environnement Scitegrity Scivera Selcia Ltd.

France The Netherlands Italy UK UK UK Germany Japan UK

UK, Italy

Training

191

UK UK South Africa Ireland Italia US Ireland Belgium

Information services

Rovaltain Research Company Royal HaskoningDHV RTC, Research Toxicology Centre S.p.A. SAFENANO Safety Data Services Safeware Quasar Ltd SAP AG SAP Japan Co, Ltd SATRA Technology

US Germany

Chemical Global staff staff 1 1

IT & software solutions

156

Other locations

Laboratory services

Risk & Policy Analysts Ltd (RPA) Risk Control Services Ltd Riskchem Rivendell International RNI SRL RoHS Ready LLC Roisin McEneany ROSC bvba

Headquarters UK

Legal services

Page

Representation/management

Organisation Renfrey Regulatory and Compliance Consultancy Ltd Ricerca Biosciences, LLC RimaOne

Consultancy/advisory

A-Z LISTING

i i i m

e g e

g i a m e a e a a e e e e e

m g e e m m g m i m m m m m e e g

e e e e e e g

e e a e g a e

e a m

g g m i e m e g e e m i e m m m e m

e g g

e e g e e m e e e e i e

e e g e

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

Risk & Policy Analysts Ltd (RPA) Risk Control Services Ltd Riskchem Rivendell International 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 Safeware Quasar Ltd SAP AG SAP Japan Co, Ltd SATRA Technology SCAS Europe SCC Science & Environnement Scitegrity Scivera Selcia Ltd. Selerant SenzaGen ServiREACH, S.A. SFS Chemical Safety SGS SGS Agriculture, Food and Life ShawCor SHES Chemical Consulting Co., Ltd Shridhar Rajappanavar Siam S.L.

SIEF-IT SiteHawk Sitmae Reach Services BV Smithers Viscient SOCOTEC – Health and Product Safety Agency SOCOTEC Environment spectra Consult GmbH SpetsInterProject Oy Sphera Solutions Spinnaker Coating, LLC Spring Trading Company, LLC Staphyt Regulatory Star Wang Stefanie Merenyi Steptoe & Johnson LLP Stewardship Solutions Ltd Subvise Surface Science Western Sustainability Consult Sustainability Support Services (Europe) AB SustChem Engineering Ltd



                      

         

     

     

   

    

                     

     

           



  

                                       

                   

    

             

    



    

    

www.ROSconsortium.eu

                  

rovaltainresearch.com www.royalhaskoningdhv.com www.rtc.it www.safenano.org

www.safeware.co.uk      www.sap.com      www.sap.com    www.satra.co.uk         www.scas-eu.be               www.scc-gmbh.de www.sci-env.ch     www.scitegrity.com                 www.scivera.com www.selcia.com             www.selerant.com www.senzagen.com www.servireach.com                  www.chemicalsafety.com   

 

www.sgs.com/en/agriculture-food www.shawcor.com

           

  

                                       

www.cae.com www.siam-it.com

       

                             

    

    

        

    

    

       

                           

    

                                                                         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        The Compliance Map Ltd.              The Economics Interface Limited               The Isosceles Group              The Martec Group                 The Redstone Group                  The Sapphire Group        the SDS factory | de ViB fabriek        

Further information www.rrandcc.com

www.ricerca.com     www.rimaone.com               www.rpaltd.co.uk 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-sante-etrisques-produits www.spectra-consult.de/ www.spetsinterproject.com         www.sphera.com www.spinps.com www.springtradingcompany.com  www.staphyt.com/regulatory 

 www.merenyi.net www.steptoe.com www.stewardshipsolutions.co.uk www.subvise.com www.surfacesciencewestern.com www.sustainabilityconsult.com www.ssseurope.org www.sustchem.gr

                      

                                

                       



www.sweco.fi www.sysvoskconsulting.com



     

                                      

    

205

A-Z LISTING US HCS

COSHH

CAD

CMD

Medical devices Regulation

Toy Safety Directive

RoHS

Food contact

Agrochemical registrations

EU cosmetics Regulation

Biocidal products Regulation

New TSCA/LCSA

GHS-based regulations

CLP

REACH Global chemical notifications

Occupational

    

                

      

                

Food (contact)



            

    

Medical devices

Cleaning products

Textiles & apparel

Construction

Aerospace, automotive & engineering

Regulatory expertise

                                                                                   

          

       

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

Industrial chemicals Agrochemicals

Focus of activities

       

                    

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 www.martecgroup.com www.redstonegrp.com www.thesapphiregroup.com www.theSDSfactory.com | www. deViBfabriek.nl

www.chemicalwatch.com/SPG

206

TJS Technical Services Inc. TO21 Co. Ltd.

 



Canada South Korea

2-5 50-100

1 25-50 1 10-25

Tox Focus LLC toXcel

192

US UK

1 25-50

Toxicon Toxi-Coop Toxicological Research Centre Ltd. Toxikon

193

Italy Hungary US

Switzerland, US Belgium

5-10 50-100 100-500

5-10 25-50 5-10

TOXIT & S-IN Soluzioni Informatiche Srl ToxMinds

166

Italy Belgium

India, Germany

10-25 10-25

2-5 10-25

ToxServices LLC ToxSolve LLC ToxStrategies TraceGains Trade Wind B.V. Tradebe UK TRASYS

168

US US US US The Netherlands UK Belgium

25-50 1 25-50 25-50 5-10 1,000-2,000 500-1000

10-25 1 5-10 25-50 5-10 500-1000 50-100

Triskelion TSG TSGE Consulting TUV Rheinland TUV Rheinland Hong Kong Ltd TÜV Rheinland LGA Products GmbH

170

The Netherlands US UK US Hong Kong Germany

Japan, US, Canada (sales offices)

TUV Rheinland of North America TÜV SÜD Iberia S.A.U.

US Spain

US Spain, US, France Europe

100-500 100-500 Ireland, Spain, Germany, France, Slovenia, Poland 50-100 Germany, China, Japan, India, Taiwan, South Korea 5,000 plus 5,000 plus Europe, China, Japan, Thailand, Vietnam, India, US, 5,000 plus Brazil, Russia, Australia, South Africa, Germany, China, Hong Kong, India 5,000 plus Taiwan 100-500



TÜV SÜD Industrie Service GmbH TUV SUD Japan UetlibergPartners GmbH

172

Germany Japan Switerland

Japan, Singapore, China

5,000 plus 100-500 2-5

 

UL UMCO GmbH Universit Bordeaux Segalen Vanta Bioscience

174 176

US Germany France India

UK, Germany, France, Belgium, China, Japan

5,000 plus 50-100 500-1,000 25-50



Veeva Systems

178

United States



Canada, France, UK, Germany, Spain, Hungary, China, South Korea, Japan, India, Singapore, Brasil, Australia

VelocityEHS Verdant Law, PLLC

180

US US

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 Wercs Professional Services WIL Research Wiley Rein LLP WILLIAM WILSON Wyeside Consulting Ltd Wilmer Tox Consulting Womble Bond Dickinson (UK) LLP

182

US US Belgium Spain Germany UK US UK US US US US UK Switzerland UK



WRc plc



US, Canada, Europe, Asia

Scotland, Italy Belgium, Germany, China, Japan The Netherlands

United States

WSP UK Ltd WTConsulting XCellR8 YASH Technologies

193

Yordas Group Zanos Ltd

184

UK Switzerland UK US

Wordwide

UK UK

Germany, Canada, Turkey, Japan, China

Europe, Asia, Australia

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 2021

100-500 50-100 50-100 10-25 100-500 500-1000

e e e m i m i g e e g m i m m m e g g m m g i

1,000-2,000 25-50

g m g 50-100 2-5 e 2-5 m 1,000-2,000 e m 25-50 100-500 e 10-25

2,000-5,000 100-500

5-10

100-500 100-500 10-25 50-100 2-5 5-10 2-5 10-25 1 100-500 1,000-2,000 100-500 2-5 1 1,000-2,000

100-500 2-5 10-25 25-50 2-5 2-5 1 10-25 1 10-25 100-500 10-25 1 1 50-100

100-500

10-25

5,000 plus 5-10 10-25 2,000-5,000

50-100 5-10 10-25 50-100

50-100 5-10

50-100 2-5

g e a i e g e e a m m g g e e g g a m g m e e i e m e e i e e e e g e

Other(s)

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g e e g g

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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 m g e a m g e i e e i i m e g m i m m e g i e

Equipment

Training

Information services

Chemical Global staff staff 5-10 2-5

IT & software solutions

Other locations

Laboratory services

Headquarters US

Legal services

Page

Representation/management

Organisation The Windsor Consulting Group, Inc.

Consultancy/advisory

A-Z LISTING

i e e e

e e

e e e e e

m e a e e e e e

a e m

Search across 75 specific services and other criteria at www.chemicalwatch.com/spg

TJS Technical Services Inc. TO21 Co. Ltd. Tox Focus LLC toXcel Toxicon Toxi-Coop Toxicological Research Centre Ltd. Toxikon TOXIT & S-IN Soluzioni Informatiche Srl ToxMinds ToxServices LLC ToxSolve LLC ToxStrategies TraceGains Trade Wind B.V. Tradebe UK TRASYS Triskelion TSG TSGE Consulting TUV Rheinland TUV Rheinland Hong Kong Ltd TÜV Rheinland LGA Products GmbH TUV Rheinland of North America TÜV SÜD Iberia S.A.U. TÜV SÜD Industrie Service GmbH TUV SUD Japan UetlibergPartners GmbH UL UMCO GmbH Universit Bordeaux Segalen Vanta Bioscience Veeva Systems 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 Wercs Professional Services WIL Research Wiley Rein LLP WILLIAM WILSON Wyeside Consulting Ltd Wilmer Tox Consulting Womble Bond Dickinson (UK) LLP

Yordas Group Zanos Ltd

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 

                   



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                                                                  

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                     

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Further information 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.toxit.it/en/ 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.tsgUS.com www.tsgeurope.com www.tuv.com/us/green-solutions www.chn.tuv.com www.tuv.com           

www.tuv.com/en/US/home.jsp www.tuv-sud.es/process-safety

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www.tuvsud.com/de-reach www.tuv-sud.jp www.uetlibergpartners.com       ul.com         www.umco.de www.u-bordeaux2.fr  www.vantabio.com        www.industries.veeva.com/chemical

  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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207

A-Z LISTING US HCS

COSHH

CAD

CMD

Medical devices Regulation

Toy Safety Directive

RoHS

Food contact

Agrochemical registrations

EU cosmetics Regulation

Biocidal products Regulation

New TSCA/LCSA

GHS-based regulations

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                                                                                                                                                                            

CLP

REACH Global chemical notifications

Occupational

Food (contact)

Medical devices

Cleaning products

Textiles & apparel

Construction

Aerospace, automotive & engineering

Toys/children's products

Electrical and electronics

Veterinary medicine

Personal care (inc. cosmetics)

Biocides

Biotechnology

Regulatory expertise

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WRc plc WSP UK Ltd WTConsulting XCellR8 YASH Technologies

Medical & pharmaceuticals

Organisation The Windsor Consulting Group, Inc.

Industrial chemicals Agrochemicals

Focus of activities

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www.thewercs.com www.wilresearch.com www.wileyrein.com www.wyesideconsulting.com www.reachwilmer.com www.womblebonddickinson.com/uk/ sectors/manufacturing/chemicals www.wrcplc.co.uk www.wsp.com www.wtconsulting.ch www.x-cellr8.com www.yash.com

         www.yordasgroup.com www.zanos.co.uk

www.chemicalwatch.com/SPG

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