Chemical Watch Service Providers Guide 2016 by Enhesa Product

Russia and CIS: SMC

Is your strategic roadmap adequate for the global markets? Are you struggling with the continuously changing regulatory environment in your target markets? Are you in need of a clear picture about the global trends in chemical policies? Here comes a conference dedicated to bring you some relief! We will provide an overview about chemical legislations and regulatory procedures in numerous important markets in the Americas and the Asia-Pacific region. Topics include: » Registration and evaluation of chemicals in Korea » Management of chemicals in China and Taiwan » Reform of the Toxic Substance Control Act (TSCA) in the USA » New substance notification in Canada » Chemical regulations in ASEAN countries » Regulations in Central and South America » Registration of Polymers on a global scale » How to deal with endocrine disruptors and other SVHC in different countries » Chemical Regulation in Turkey

Chemical Control Regulations in Asia and the Americas Register now! Cologne – July 5, 2016

Dr. Knoell Consult GmbH Dr. Michael Cleuvers Managing Director Industrial Chemicals & Biocides Tel. +49 214 20658-170 globalregistration@knoell.com www.knoell.com

Welcome to the sixth annual Chemical Watch Service Providers Guide. Combining in depth research with our annual survey results, this unique directory brings you a comprehensive view of the complex world of chemicals management and regulatory compliance. Gathering information from both service users and providers, it gives a 360 degree perspective of the global market, ranging from consultancy and legal advice, to laboratory and IT, to strategic management. This year the updated findings on our annual survey indicate safe chemicals management within companies is coming under increased pressure from regulators and the market. And, our fourth year of reporting on salaries, career prospects and training, reflects this pressure. Twice as many people are seeing teams increase in size and demand is outstripping supply in the jobs market suggesting strong growth in the regulatory compliance and service providers’ sectors. In the complementary market analysis in this year’s guide, written once again by experienced chemicals market

researcher Cynthia Challener, we look more closely at two new areas: sector-specific chemicals legislation and how supply chains in those sectors are coping with increased regulatory and market pressure; and the latest experiences of chemical testing laboratories as they prepare for the influx of REACH 2018 testing. We also look at the factors that influence companies’ choice of service providers. This year’s survey findings are based on almost 700 respondents from across the world. We hope you find these insights useful, alongside the directory of 374 service providers. This year we have a record number of companies taking a full profile - enabling you to view the services offered and select the best partner to support your compliance activities. Emma Chynoweth Managing Editor

View the Service Providers Guide online... 24x7 access to all updated profiles The online version of the guide is updated regularly to include the latest service provider data Powerful search and filtering tools help you find exactly what you’re looking for, fast Hosted online, the Guide is accessible from anywhere, 24x7 - from any device Our online and digital versions make sharing information with colleagues quick and easy

www.chemicalwatch.com/online-guide Chemical Watch | Global Service Providers Guide 2016

Page 1

Foreword

A scientific and regulatory consulting firm providing strategic, comprehensive support for global chemical registration, regulation, and sustained compliance. • Global Chemical Notification REACH, TSCA, K-REACH, CEPA, China Order No. 7 • Biocides, Pesticides, Antimicrobials, Nanomaterials, Products of Biotechnology • Hazard Communication, GHS Classification and Labelling, SDS

• Global Agent and Representative Services • Testing Strategy and Coordination • Toxicology and Ecotoxicology • Transport and Dangerous Goods • Dossier Preparation and Expert Review • Data Compensation

CONTACT OUR EU TEAM: Jane S. Vergnes, Ph.D., DABT Vice President, Scientific Affairs jvergnes@actagroup.com

Emma Louise Jackson Regulatory Specialist ejackson@actagroupeu.com

Leslie S. MacDougall Director, Strategic Program Development lmacdougall@actagroup.com

Louise C. Boardall Regulatory Associate lboardall@actagroupeu.com

Zameer Qureshi Legal Consultant to Acta EU zqureshi@actagroupeu.com

J. Brian Xu, M.D., Ph.D., DABT Toxicologist bxu@actagroup.com

www.actagroup.com Beijing, China (86-10) 8453-4538

Manchester, U.K. +44 (0) 330 223 0610

Washington, D.C. +1 (202) 266-5020

Chemical service providers editorial.....5 Combination of factors drive growth......5 Career development in the chemicals management and control sector..........14 Testing the limits....................................22 Challenges multiplying for industry sectors..................................................28 Exciting times expected for 2016 following a busy year in 2015...............43

Profiles....................................... 58 3E Company.........................................58 ACTA.....................................................60 APC.......................................................62 Apeiron-Team NV..................................64 Arcadis..................................................66 ARCHE..................................................68 bibra toxicology advice & consulting...70 Blue Frog Scientific Limited..................72 bluesign technologies ag.....................74 CEHTRA................................................76 Chemex.................................................78 ChemSafe.............................................80 Chemservice.........................................82 CHEMTREC..........................................84 China National Chemical Information Center....................................................86 CIS Center.............................................88 CiToxLAB...............................................90 CRAD....................................................92 DEKRA Insight......................................94 DHI........................................................96 DORUK SISTEM....................................98 Dr. Knoell Consult GmbH....................100 EAG Family of Companies.................102 EBRC Consulting................................104 EcoOnline............................................106 ERM.....................................................108 Eurofins...............................................110 Exponent International Limited...........112 Fieldfisher LLP....................................114 FoBiG..................................................116

CW Research Ltd, trading as Chemical Watch, publishes news and intelligence to help companies achieve sound chemicals management that responds to the many non-regulatory drivers as well as meeting responsibilities under chemicals legislation worldwide, including regimes such as REACH, CLP, GHS and TSCA. We keep you abreast of policy and business trends across the EU, North America, Asia and the rest of the world. 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, 2 Nettles Lane, Shrewsbury SY3 8RJ, 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

GAB Consulting GmbH......................118 IHS.......................................................120 International Cosmetics & Chemical Services Ltd........................................122 Intertek................................................124 JSC International Limited....................126 KFT Chemieservice GmbH.................128 Lisam Systems....................................130 National Chemical Emergency Centre (NCEC)....................................132 Ramboll Environ..................................134 REACh ChemAdvice GmbH...............136 REACH mastery..................................138 ReachCentrum....................................140 REACHLaw..........................................142 Regulatory Services International Ltd.......................................................144 Risk & Policy Analysts Ltd (RPA)........146 Royal HaskoningDHV..........................148 SCC.....................................................150 Sustainability Support Services (Europe) AB........................................152 The REACH Centre.............................154 TNO Triskelion B.V...............................156 ToxMinds.............................................158 Trade Wind B.V....................................160 TÜV SÜD Industrie Service GmbH.....162 TÜV SÜD Process Safety....................164 UL information & insights |The Wercs.166 UMCO Umwelt Consult GmbH...........168 WIL Research......................................170

Niche Profiles..............................173 1cc GmbH...........................................173 3S-SafelyServingScience...................173 A.S.C...................................................173 Altox....................................................173 Anthesis-Caleb....................................174 BIG vzw...............................................174 Bootman Chemical Safety..................174 CFCS...................................................174 Chementors Ltd..................................175 Editorial Director Mamta Patel, mamta@chemicalwatch.com Managing Editor Emma Chynoweth, emma@chemicalwatch.com Contributing Editor Cynthia Challener, cynthia@chemicalwatch.com Production and Information Editor Nick Hazlewood, nick@chemicalwatch.com Account Managers Kerry Williamson, kerry@chemicalwatch.com Lotte Spencer, lotte@chemicalwatch.com Sonja Davidson, sonja@chemicalwatch.com Head of Marketing Richard Butterworth, richard@chemicalwatch.com Commercial Director Stuart Foxon, stuart@chemicalwatch.com Managing Director Julian Rose, julian@chemicalwatch.com

Chemical Watch | Global Service Providers Guide 2016

chemtrac®..........................................175 ChIR - Chemical Innovation and Regulation...........................................175 Chymeia ApS......................................175 CONUSBAT Regulatory Services.......176 Danger and Safety srl.........................176 Distefano Law Office...........................176 DR MACH Chemical Compliance & Competence.......................................176 eSpheres.............................................177 Eurideas Linguistic Services..............177 HDTS Chemicals Inc...........................177 I+K AG................................................177 Infotox..................................................178 Jongerius Consult BV.........................178 KREATiS..............................................178 Linmark Consulting.............................178 LKC Switzerland Ltd............................179 Oriental Chemical Information Co., Ltd.......................................................179 Peter Fisk Associates..........................179 Prefusion LLP......................................179 Randis ChemWise (Shanghai) Co., Ltd.......................................................180 REACH Global Services S.A...............180 REACHWise........................................180 ReFaC.................................................180 RegScan Inc........................................181 Rovaltain Research Company............181 SCAS Europe......................................181 SciVera................................................181 Siam S.L..............................................182 Spring Trading Company, LLC............182 Tox Focus, LLC....................................182 toXcel..................................................182 Toxicon................................................183 ToxServices.........................................183 VRS Regulatory...................................183 WRc plc...............................................183 WSP UK Ltd........................................184

A-Z Listing..................................186 Distribution policy Copying of this document including electronic circulation is not permitted without consent of the publisher. Disclaimer While Chemical Watch takes every effort to ensure the accuracy of this guide, we cannot take responsibility for any adverse consequences arising from actions taken in response to our content and we recommend that readers take appropriate professional advice. Designed and typeset by Ministry of Design, Bath, UK www.ministryofdesign.co.uk Printed by Trident Printing, London. Printed on 9 Lives 80 recycled stock. Front cover images © Shutterstock, fotolia and Nick Hazlewood First published 2016 Copyright and Database Rights © 2016 CW Research Ltd. All rights reserved

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Contents

KFT

The CHEMICAL COMPLIANCE Company

INTRODUCTION Demands for chemical controls, from basic raw materials to those in finished products for both consumer and industrial applications, nearly anywhere in the world, are expanding. The pressure is coming from legislation, consumers, consumer advocacy groups, other non-governmental organisations (NGOs), and retailers and manufacturers. Any company that manufactures, uses, handles or transports chemicals, regardless of size, must comply with a burgeoning list of regulations and trade group and end customer requirements. In many cases, there is little harmonisation; the requirements may relate to the same chemicals or products, but the data needed may differ and/ or be expected in slightly different formats. In the EU, the need to register small-volume chemicals for the 2018 REACH deadline is affecting a whole new set of small and medium-sized companies that have little or no experience with chemical control regulations. Overarching substance regulations, like REACH, continue to be developed and introduced in other countries around the world, as do regulations targeting specific types of products. Greater data and reporting requirements are anticipated in the US with the reauthorisation of TSCA finally moving forward. Even so, individual states continue to actively pursue their own regulations, creating an even more intricate and challenging patchwork of compliance requirements. The country-by-country variations in the implementation of the Globally Harmonized System (GHS) of classification and labelling of chemicals are also burdensome for companies that participate in international markets.

On top of growing legal requirements, consumer product companies face intense pressure from retailers who are responding to demands from NGOs. Many large retailers, industry trade groups and manufacturers have developed restricted substance lists (RSLs) and specific chemicals management and control policies to which suppliers must commit. Suppliers are thus inundated with requests for data from multiple customers, each with their own expectations. Tracking expanding regulatory requirements and data expectations from customers has become an enormous task. Effective supply chain communication has become increasingly important, but continues to be challenging. Concern that many chemicals will be withdrawn from regulated markets is heightened. Specific trends related to REACH, GHS, TSCA, other country-specific regulations and sector-related legislation are presented below, along with the key findings of the sixth annual Chemical Watch survey of service providers and inhouse experts involved in chemical regulatory compliance. Results of our fourth annual jobs survey are also provided. A total of 693 people provided input to the survey. Additional sections on the laboratory services market and the challenges faced by the retail, cosmetics and personal care, toy, electronics, furniture and textile industries are included as well. Finally, we discuss the perceptions and general expectations for the chemicals management and control service provision market in 2016 of respondents to the Chemical Watch survey.

OVERVIEW

Combination of factors drive growth When it comes to regulatory drivers, REACH has been the most influential factor by far each year of the Chemical Watch survey. In fact, the number of respondents indicating REACH was the most important factor rose for the second year in a row from 77% in 2013 to 79% in 2014 to 83% in 2015 [Figure 1]. This number is, however, still lower than its peak value in 2012 (89%), which coincided with the run up to the 2013 REACH deadline. The REACH 2018 registration deadline was specifically noted by 62% of respondents. REACH compliance in Europe remains a very large effort for speciality chemical manufacturer Celanese due to the high number of chemicals, the need for coordination with substance

Chemical Watch | Global Service Providers Guide 2016

information exchange fora (Siefs) and the requirements for dossier preparation. Global product steward Philip Brondsema believes that registration of smaller volume products may be more complicated than that of large volume products. â&#x20AC;&#x153;Not only are there many more chemicals; the Siefs will be smaller, and the amount of existing data is likely to be limited,â&#x20AC;? he notes. Obligations for substances of very high concern (SVHCs) under REACH; compliance with US regulations; compliance with the EU classification, labelling and packaging of substances and mixtures Regulation (CLP) requirements; REACH evaluation activities and dossier updates; and China regulations were the other top regulatory drivers for respondents to the survey in 2015.

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Chemical service providers

Chemicals Management and Control

m or e t ha n c h emi c a l sa f et y on ly! ARE YOU IN NEED OF:

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30 Wall Street, 8th Floor New York NY 10005 T : +1 (917) 503 9303 E: info@sdsauthors.com

Figure 1 LEADING REGULATORY DRIVERS FOR SURVEY PARTICIPANTS REACH (any)

83%

EU REACH 2018 registration

62%

EU REACH SVHC obligations

49%

US (any)

46%

EU CLP regulation

45%

EU REACH evaluation related activities/dossier updates

Chemical service providers

44%

China regulations

40%

South Korea regulations

30%

Biocidal product regulations

27%

National GHS classification, labelling and inventory notification regulations

24%

US HazCom 2012 (GHS) Standard

23%

Food contact material regulations

22%

Taiwan regulations

21%

US EPA Work Plan on Chemicals

20%

US: California Safer Consumer Products Regulation

19%

Nanomaterials risk assessment

18%

Turkey regulations

18%

RoHS regulations

18%

Japan regulations

16%

Brazil regulations

16%

Canada Chemicals Management Program

15%

Packaging regulations

15%

Canada pending GHS in workplace legislation

14%

International Carriage of Dangerous Goods by Road (ADR)

14%

Malaysia regulations

13%

US CDR

13%

Conflict minerals legislation

12%

International Maritime Dangerous Goods (IMDG) Code

12%

Other Asean regulations

12%

Cosmetics regulations

12%

Agrochemical regulations

10%

Mexico regulations

10%

Russia regulations

10%

Other US state legislation (Washington, Vermont etc)

Toy Safety regulations

Argentina regulations

Pharmaceutical regulations

Medical devices regulations

Israel regulations

Veterinary product regulations

1% 0%

20%

40%

60%

80%

100%

% of participants

Intertek Scientific & Regulatory Consultancy places chemicals management and control regulations into two groups: OO legislative programmes that require the assessment and management of human health and environmental risks associated with existing chemicals that have already been present in the marketplace for many years, but whose risks have not yet been determined; and

Chemical Watch | Global Service Providers Guide 2016

environmental and human health protection rules that require the upfront risk assessment of chemicals deemed to be new. Both types of regulations are presenting challenges to manufacturers and users of chemicals. For regulations addressing existing chemicals, Joyce Borkhoff, senior director of Intertek Scientific & Regulatory Consultancy, notes that burdens on industry can be lessened by addressing data needs, targeting information gathering OO

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TIME IS RUNNING THE COUNTDOWN FOR REACH 2018 IS ON

COST EFFICIENT TESTING REACH DOSSIER (IUCLID/ CSR)

SIEF AND CONSORTIA MANAGEMENT

OR AND TRUSTEE SERVICES GLOBAL REGISTRATION SERVICES

GHS/ CLASSIFICATION AND LABELLING

SCC Scientific Consulting Company Chemisch Wissenschaftliche Beratung GmbH Am Grenzgraben 11 55545 Bad Kreuznach Germany info@scc-hq.de www.scc-gmbh.de

Figure 2 LEADING NON-REGULATORY DRIVERS FOR SURVEY PARTICIPANTS Downsizing of inhouse chemical management and control teams 66% Customer demands/restricted substance lists 49% Economic growth 42% Governmental policies/spending 29% Redistribution of regulatory compliance responsibilities within organisations 29% NGO pressure 26% Non-statutory voluntary corporate initiatives/CSR 23% Standards 20% Outsourcing of business support functions (by client organisations) 14% Increased commercialisation/better management of service provider business 8% Other 2% 0%

20%

40%

60%

% of participants

Chemical Watch | Global Service Providers Guide 2016

80%

Downsizing of in-house teams probably reflects a greater need for specialised expertise and the hope of increasing efficiencies and reducing costs through outsourcing. “Our main challenge with respect to chemicals management and control is complying with so many varied customer requests and requirements and the sustainability and chemicals voluntary standards that are proliferating,” says Thaddeus Owen, a safety and sustainability engineer with furniture maker Herman Miller. Consultant Florian Soldner adds: “Politicians need to act rapidly to develop legislation that ensures protection of health and the environment, but does so in a reasonable fashion that should not hinder innovation and new business development.”

REACH Companies participating in the European market continue to invest significant internal and external resources to ensure compliance with many different aspects of REACH. On the one hand, firms that registered substances in 2010 and 2013 are working to address issues raised in substance and dossier evaluations. On the other, companies are faced with dossier preparation for the much larger number of small-tonnage chemicals that must be registered by the end of May 2018. Many companies require assistance with authorisation applications, the development of authorisation roadmaps, and support during the public consultation phase for SVHCs, according to Ingrid Sekki, marketing manager for REACHLaw. She says the process is challenging due to the limited experience of all involved, particularly for authorisations based on socio-economic arguments. REACHWise’s Dr Douben agrees that authorisation is a complex process and welcomes efforts by the EU Commission to simplify it. He is also surprised that so many companies are unaware of the implications of having substances added to the Annex XIV list. REACHLawis concerned by the fact that many companies believe that the job is finished once their registration dossiers are submitted. “These companies do not understand the importance of having a chemical compliance programme to monitor changes/updates to regulations, reporting requirements and dossier evaluations,” Ms Sekki states. Companies that lack substance management programmes are also concerned about the recent EU court decision on articles. “These companies do not know what substances are present in their products [articles], nor do they have the IT and data management systems necessary to support compliance,” says KFT Chemieservice managing director Karl-Franz Torges. His clients are also frustrated by the lack of effective enforcement of REACH. “They are watching other companies who have not invested significant resources to ensure compliance over the past five years continue to do business without any consequences. As a result, some clients with excellent compliance records halted activities in 2015,” Mr Torges notes. Echa has been active in getting the word out about the third and final registration date in May 2018, according to 3E Company’s senior regulatory research analyst Scott Stephens. Those efforts are important because this deadline affects companies that place substances on the EU market in relatively low quantities (1-100tonnes/ year), many of which are small or mid-sized enterprises (SMEs) that have not previously registered a substance under REACH. In addition, the number of registrations is

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Chemical service providers

activities, and balancing non-testing approaches with the need for more data. For new chemicals, multijurisdictional notification strategies and smart testing plans are also crucial for enabling timely and cost-efficient notification of substances in many countries/regions simultaneously while avoiding unnecessary duplication of efforts. Regardless of the type of regulation, it appears that their number is increasing without any sign of a let up, according to Peter Douben, director of REACHWise. “Smaller companies are faced with rising costs that are decreasing their margins to an unsustainable extent, all to implement increasing control measures for which they see little evidence of effectiveness,” he says. He would like to see more effort directed towards raising standards in other countries to the European level, where the return on investment would be significantly greater. “That would greatly benefit human health and the environment.” he adds. Chemical Watch survey respondents were also asked about several non-regulatory drivers of the need for chemicals management and control services. The reason given by most respondents in 2015 (65%) was downsizing of in-house teams – the first time this factor has been cited most often [figure 2]. Customer demands and the growth of restricted substance lists and economic growth were chosen as important drivers by 49% and 42%, respectively, of survey participants.

Chemical service providers

expected to be much higher than observed for the previous two deadlines. “Given these challenges and the fact that SMEs have a general lack of knowledge regarding the implications REACH registration, the impact of this last deadline has yet to be fully felt,” Mr Stephens says. It is important to distinguish between substances that have not been previously registered and those that already have, according to REACHWise’s Dr Douben. First-time registration of substances presents challenges of substance identity, working in a Sief, setting up of consortia or not, and so on. Even identification of a lead registrant can meet obstacles,” he notes. For substances that were previously registered, no lead registrant needs to be identified, but the fees for letters of access (LoAs) can be very high, and may even appear anti-competitive, particularly in small Siefs, he says. It is also important to note that, while at first glance smaller tonnage substances may seem to present little difficulties, most of the compounds CEHTRA is supporting can be classified as “difficult substances”, according to senior ecotoxicologist and director Paul Thomas. “It is crucial to get as close to the true value as possible for experimental endpoints in order to avoid the possibility of misclassification and other pitfalls,” he says. Many industry sectors are slowly becoming aware of the growing need to take action with respect to REACH. Pharmaceutical companies, which use a large variety of chemical substances, some of which are SVHCs and/ or exotic chemicals, are aware that they have to commit more budget and resources to chemicals management, according to Philip Capel, marketing director for software firm eSpheres. “One problem is that some manufacturers are not aware that non-European suppliers may elect not to proceed with registration of substances they import into the EU in small volumes. What the impact will be on pharmaceutical end products is not clear. It will most likely not be realised until the point when chemical manufacturers announce that they will not be registering their products for REACH 2018 or applying for an authorisation dossier for candidate substances that were previously registered,” he comments. Lynn L Bergeson of law firm Bergeson & Campbell, PC says companies really should already be assessing their regulatory options, deciding what each wishes to do and advising downstream customers accordingly, not to mention determining their testing needs to reserve adequate and appropriate testing capacity. Failure to secure suitable capacity could trigger disastrous consequences. The law firm’s international consulting affiliate, The Acta Group, is already seeing the impact of inadequate planning and “there is a lot of scrambling going on now,” Ms Bergeson says. “SMEs and first time REACH registrants do not fully understand that they need to start preparing their registration dossiers and that the challenges will be different from those faced in 2010 or in 2013,” states Ms Sekki of REACHLaw. For instance, there are many Siefs without lead registrants, and many Sief members who submitted pre-registrations will in fact not register at all, which means there will be fewer companies to share the costs and build registration dossiers. Many companies are not only putting off the costs of registration; they are delaying the decision regarding which products to remove from the market because registration costs make them economically unnviable at low tonnages, according to Daniele Campi Martucci, general manager of Toxicon.

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REACH testing presents its own challenges due in part to a lack of understanding of the regulations. BioReliance has observed that the requirements for genetic toxicity/ mutagenicity testing are particularly confusing for many companies. “Although the initial guidelines and subsequent guidances have spelled out the assays, it is difficult for registrants to navigate the integrated testing strategy (ITS) and understand why and when each assay should be used,” explains toxicology marketing manager Scott Hickman. For the REACH 2018 deadline, in vitro bacterial gene mutation data must be reported, and any tests that provide positive results must be followed up with additional testing. Mr Hickman adds that the REACH regulations call for registrants to seek expert advice in this area.

GHS: SIGNIFICANTLY MORE COMPLEX ENVIRONMENT The varied implementation of GHS around the world is challenging companies that sell products in multiple markets. “Whilst GHS is supposed to provide harmonised regulations, to date there are significant differences in how each country has chosen to implement its hazard communication programmes, with individual customs regulations and national laws. In addition, some companies have applied older versions of the legal text whilst others are using newer versions,” explain José V Cantavella Cabedo, project manager for ChemSafe. The environment is significantly more complex now than even three years ago due to the need for communications from suppliers, knowledge of product compositions, the many destination countries and the regulation variations, agrees Dr Philip Brondsema of Celanese. The SDS development process is also quite complicated. New information and documents must flow from chemical suppliers to speciality chemical manufacturers, formulators, distributors, warehouses and finally to store shelves. At each step, a regulatory expert must review component SDSs, make a classification decision and work through an SDS and label publishing process, according to Dr Brondsema. “Importantly, each step in the supply chain can move only as fast as the pace of its slowest supplier. Since formulator companies tend to have lower regulatory expertise and larger numbers of products to be reviewed, the pace for reaching compliance for products on the shelf is very slow,” he says. Even at this stage, many downstream users do not have complete chemicals inventory lists of mixtures and substances used within their companies, and thus need to start by building them. They are not really prepared to construct safety data sheets (SDSs), let alone receive, request and evaluate them, according to eSpheres’ Mr Capel. “The most important document for hazardous chemicals communication in the supply chain is the SDS. While the quality of SDSs has generally increased, inclusion of exposure scenarios – which is required for certain substances and mixtures in the EU – remains limited. In addition, those provided by chemical manufacturers are often very complicated, making it difficult for their customers to read and understand,” he adds. In Europe, companies still find it a challenge to maintain compliance, agrees REACHWise’s Dr Douben. He also notes that record keeping is particularly important when the classification of a product changes so that companies have a clear archive of who received which version. Ashland Inc finds keeping track of SDS updates from suppliers – including those that are not provided centrally –

Chemical Watch | Global Service Providers Guide 2016

US: POSSIBLE TSCA REFORM, EPA ACTIVITIES AND MORE STATE REGULATIONS The big question in the US these days is what will TSCA reform look like? The EPA and state legislatures are not waiting to find out, though. The TSCA Modernisation Act (HR 2576) was passed by the House of Representatives in June 2015. The Senate followed suit in December, passing the Frank R Lautenberg Chemical Safety for the 21st Century Act (S 697), a significantly different approach to TSCA reform than set out in HR 2576. The House and Senate must reconcile the two bills to achieve passage in Congress and send a final version to President Obama for signing. TSCA reform supporters hope this will occur sometime in 2016 before the November general election. Ms Bergeson, a Washington, DC-based lawyer, notes that while House and Senate insiders are expressing optimism over the enactment of TSCA Reform legislation this year, it remains to be seen if election-year politics will prevent that from happening. Another uncertainty is reconciling the vastly different House and Senate versions and trying to anticipate what will emerge. Once the law goes into effect, individual regulations will need to be outlined, drafted, reviewed and promulgated. Since TSCA is the sole domestic industrial chemical management law in the US, implementing a massively revised approach will take time and careful scrutiny. Because the timing for passage is at best unclear, most companies are waiting before taking any specific actions. Despite the high level of uncertainty, there is a general consensus that most reform will impact the existing chemicals regulatory framework, according to Michael Cleuvers, managing director for industrial chemicals and biocides with Dr Knoell Consult. As with any new regulations, however, he recommends that companies need to track regulatory updates while maintaining compliance with requirements that have yet to be changed. The biggest challenges, according to James Lee, senior regulatory analyst with 3E Company, are the uncertainty

Chemical Watch | Global Service Providers Guide 2016

around what new rules EPA will promulgate as a result of TSCA reform and when the changes will take effect. “EPA has a limited budget, and promulgating and implementing new regulations will be a daunting task. In addition, the rulemaking process in the US can take a number of years, and companies will want to know when the new law’s effects will trickle down to their day-to-day operations,” he says. In the meantime, companies are proceeding as usual with new chemical notifications and preparing for the next round of chemical data reporting (CDR). Dr Cleuvers notes that there is a major shift underway towards electronic data submission (all TSCA notifications must now be made electronically), and Dr Knoell Consult is receiving numerous requests regarding how pre-manufacturing notices (PMNs) and CDR information must be submitted electronically via the EPA’s CDX portal. The EPA’s Office of Pollution Prevention and Toxics continues to make progress on its Work Plan Chemicals programme and on issuing significant new use rules (Snurs). At the state level, California will continue to attract much attention in 2016. It recently issued a draft of the Stage 1 Alternatives Analysis Guide under its Safer Consumer Products Regulations (SCPR) and is trying to amend Proposition 65. The heightened activity in California can be attributed in part to the acceleration of TSCA reform, according to 3E Company’s Mr Lee, who suspects that the state does not want to deal with federal pre-emption battles. Ms Bergeson adds that the growing number of chemical product regulations emerging from California and other states, including Washington and Oregon, has definitely accelerated the demand for TSCA Reform. The sophistication and maturity of state product laws have made states and their federal Congressional representatives fiercely protective of states’ rights to regulate, and they are aggressively committed to narrowing TSCA’s pre-emptive effect. “Without question, federal preemption is the single most controversial aspect of TSCA Reform,” Ms Bergeson asserts.

GROWTH OF CONTROL LEGISLATION IN ASIA, EXPECTATIONS FOR LATIN/ SOUTH AMERICA Asia-Pacific is the region with the fastest development of new legislation. Asean countries including Thailand, Malaysia, Indonesia and Vietnam have recently announced changes in their local chemical legislations. China, Taiwan and South Korea are also active. In addition, movement is expected in Russia, India and African countries. Governments in Latin and South America are discussing the introduction of chemical inventories as a first step towards chemicals management legislation, but it is not yet clear what type of approach they will take. In China, the fact that there are no tonnage limits for the registration of hazardous chemicals will have a significant impact, according to David Wan, head of strategic operations for Chemical Inspection & Regulation Service (CIRS). “Even if only one kilogram of a hazardous chemical is being brought into the country, that substance must first be registered,” he says. In addition, chemical identification testing will need to be completed twice, because the National Registration Centre of Chemicals (NRCC) and China’s Inspection and Quarantine (CIQ) Services each only accept testing results

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Chemical service providers

a very demanding task. Labelling of its products is one of the most challenging aspects of GHS, according to global hazard communication programme manager Esmeralda Michilsen. “We recognise the importance of accurate labelling and are working hard to make sure we have the most efficient way to label products that are sent all over the globe,” she says. In the US, many companies are still awaiting information from their suppliers before creating their US GHS SDSs, and those that are ahead of the curve are now getting ready for GHS in Canada while managing an ongoing stream of GHS implementations and updates around the world. “The level of regulatory complexity that companies must manage in order to achieve compliance continues to increase with globalisation and heightened environmental scrutiny,” says Uday Virkud, president and CEO of 3E Company. In 2015, Osha recognised the impossibility of the entire supply chain being compliant with GHS by June 2015, deferring the deadline and giving chemical manufacturers and formulators time to work in good faith to bring their products into compliance. However, distributors and warehouses anticipate significant and very expensive relabelling issues, according to Dr Brondsema.

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Chemical Watch | Global Service Providers Guide 2016

of their fellow governments, and that risk assessment decisions will be increasingly spreading from one country to another, according to Dr Borkhoff. Consequently, a risk assessment decision made in one country may very quickly impact a global business.

PRODUCT-RELATED REGULATIONS In Europe, and increasingly in other parts of the world, end product manufacturers are faced with regulations targeting specific industry sectors, such as biocides and cosmetics, material types (nanomaterials) and specific categories of chemicals (perfluorooctanoates (PFOAs), microbeads). Many use-specific regulations in the EU have an overlap with REACH because the different sector-specific uses have to be addressed in REACH registration dossiers. In addition, as there are differences between chemical notification regulations from country to country, there are also differences with product- and sector-specific regulations. “These differences across all chemicals management and control regulations can only be addressed by building areas of very specific knowledge. There is usually no ‘one size fits all approach’ possible, but a need for a really individual, case-by-case assessment,” concludes Dr Cleuvers of Dr Knoell Consult.

SUPPLY CHAIN ISSUES As well as communicating effectively about the substances they make, use and handle, companies in supply chains face increasingly complex patterns of customer needs, requiring more and better information, according to Toxicon’s Mr Martucci . “Communication within the supply chain has become crucial when we are talking about chemical compliance, and companies are struggling,” states REACHLaw’s Ms Sekki. There is an pressing need for companies to actively manage the regulatory risks, because regulatory actions can mean considerable investment to improve operating conditions, replacement or substitution and potential supply chain disruption. Therefore, a strategy and action plan is recommended to determine the potential risk management options that the authorities may apply and how to act accordingly, says Dr Ying Zhu, Partner-COO at REACHLaw. For downstream users, such exercises should start with the inventory of chemicals used along the supply chain. Doing so is not an easy task, though, as most downstream users do not have chemical or toxicological competences to determine which substances are “EHS relevant”, according to eSpheres’ Mr Capel. In addition, it is necessary to gather and manage a large number of different data sets from safety data sheets and other documents. “Many companies are relying on inadequate IT tools – largely Excel spreadsheets – and are unaware of the negative impacts and potential enforcement consequences that not using an auditable and secure chemical data management tool can have on their businesses,” Mr Capel says. Advanced software solutions are increasingly being used to help companies manage data and respond to the growing numbers of questionnaires they receive from customers throughout the supply chain, according to Mr Riku Rinta-Jouppi, Partner-Head of Global Compliance at REACHLaw. “These data management solutions can significantly reduce the workload involved in determining the compliance status of raw materials and raw material suppliers while also increasing transparency in the supply chain,” he adds.

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Chemical service providers

from their specific qualified laboratories. Finally, Mr Wan notes that beginning in 2015, notification to provincial authorities is required for existing disinfection products, which is complicated, because the different provinces have different registration processes, approaches to supervision and timing requirements. Yong Jiang, project director of the Product Registration and Compliance Department with the China National Chemical Information Centre (CNCIC) believes, on the other hand, that decentralisation of administration licensing will have the effect of simplifying regulations and making them more practical. In South Korea, there has been a lot of confusion regarding the joining of chemical substance information communicative organisations (Cicos) under the Korea REACH regulations, since a deadline of 30 November 2015 was set for companies to come forward as lead registrants, according to Taro Ishikawa of the Japanese consultancy Jemai. Cicos are similar to Substance information exchange fora (Siefs) for EU-REACH. The Korean Ministry of Environment (MOE) announced on 21 January the list of 120 substances subject to registration for which lead registrants have been selected. Dr Knoell Consult’s Dr Cleuvers is interested to see how the Korean authorities will manage the high number of dossiers that are expected under K-REACH, as well as joint submissions and data sharing. Celanese is planning on using its European REACH technical expertise with Asian leadership to meet the requirements of K-REACH, although Dr Brondsema expects the dynamics to be different. “EU-REACH compliance is largely accomplished by European experts, typically working from significant corporate regulatory centres. Korea’s industry has a very small group of Korean conglomerate companies and many multinationals, many of whom do not have a regulatory centre in Korea,” he explains. In Japan, Jemai has many clients that are working to meet the requirements of the amended Industrial Safety and Health Law (ISHL). Under the revised regulation, risk assessments must be conducted on an additional 640 substances by 1 June. These compounds must also be labelled correctly by that date. “The enormous amount of data management and the lack of consistency between regulations globally, where mandatory classifications are not aligned and existing information cannot be efficiently utilised in multiple regions is a real challenge for us,” says Ashland Services’ Ms Michilsen. Her company relies on the assistance of trade associations such as Cefic and participation in various association working groups to stay up to date on various regulatory developments. “Advocating and compliance in countries like the Philippines, Indonesia and India are more difficult than in China, Europe and the US. The ability to effectively work with regulators and regulations in these environments must be developed,” asserts Dr Brondsema. The OECD Clearing House for New Chemicals (CHNC) is attempting to address some of the issues mentioned above. Intertek’s Dr Borkhoff says: “These opportunities focus on streamlining the new chemicals notification and assessment processes by enhancing information-exchange and work-sharing, facilitating greater mutual recognition of assessments (MRA) and progressing towards mutual acceptance of notifications (MAN).” Companies should be aware that regulators across the world are reaching out to each other to understand the chemical risk assessment and risk management initiatives

Careers and salar y survey

Ton van der Kaaij, senior SHE coordinator at Quaker, , says while all parties are learning, the process is quite time consuming. Ensuring internal consistency of interpretation and compliance is an additional concern for Celanese. “More customers are asking for product compliance information for multiple countries, and supplier companies must ensure that regulations are consistently interpreted and applied,” says Dr Brondsema. Celanese’s solution has involved establishing compliance teams that are global instead

of regional and documenting decision practices as a department or as teams. Innovative companies located in the middle of supply chains may have the greatest opportunity to influence them, according to Mr Martucci. “Such companies can elect to use suppliers that guarantee complete and proper documents, import products without restricted substances and place less hazardous, alternative substances and safe products on the market,” he says.

CAREERS AND SALARY SURVEY

Career development in the chemicals management and control sector The ongoing trend of increasing chemical management and control regulations and continued growth of the global economy created conditions in the sector’s jobs market in 2015 very similar to those observed in 2014. Demand outstripped the supply of experienced candidates and recruiting continued to be a challenge in most chemical control areas, according to John Sherratt, regulatory affairs business manager with recruitment firm VRS Regulatory. While the conditions resulted in upwards pressure on salaries for many jobs, some positions saw a decline in wages. Companies looking for experienced hires are competing fiercely to attract/retain staff, while those few that are willing to hire and train new graduates are being creative with enticements in order to attract high-quality candidates. In this sixth edition of the Chemical Watch survey of professionals involved in global chemical management and control, we present our fourth consecutive set of data regarding salaries, pay rises, bonus levels and career prospects in the sector. We were once again fortunate to have the participation of people holding numerous different positions and representing many different types of organisations, and we sincerely thank them all. Without their participation, it would not be possible to provide this information. The results are summarised below and, where appropriate, are compared to those obtained for the 2014 survey. It is first worth providing some information on the survey participants. Over 80% are 30-60 years old, and just over half (54%) are men. The largest percentage (30.6%) identified themselves as specialists/technicians. Nearly as many are project or team managers (28.4%) and senior managers (22.8%). The remainder include directors or associate partners (11.2%), juniors/graduate trainees (3.5%) and government officers (3.5%). Staffing trends indicated by survey participants in 2015 were similar to those in 2014. Slightly more than double the number of respondents reported that their regulatory teams increased in size in the last 12 months, compared with those saying they were downsized, an indication of the increasing regulatory demands and improving economies (33.4% increasing versus 15.4% decreasing, Figure 3). Looking towards the next 12 months, the trend continues, with just 9.5% saying their team is likely to be downsized, compared with 34.2% saying they are likely to be increased.

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Figure 3 STAFFING TRENDS 100% 90%

9.5%

15.4%

80% 70% 60%

56.3%

51.2%

50% 40% 30% 20%

33.4%

34.2%

Last 12 months

Next 12 months

10% 0%

% of participants Decreasing

Static

Increasing

In addition, a slightly higher number of Chemical Watch survey respondents (37.2%) believe that job prospects are good within their own country compared to a year ago (35.5%). On the other hand, more participants also believe their prospects are poorer (14.0% in 2015 versus 8.4% in 2014, Figure 4). Global opportunities are greater, with 53.7% of respondents seeing them as good and just 5% as poor. However, they do not see things as positively as they did two and three years ago, when 57.1% and 59.0% of respondents rated global job prospects as good. There may be a positive note, here, however: for the first time in three years, the percentage has increased year on year. The number of respondents in 2014 that saw their global job prospects as good was 52.2%.

Chemical Watch | Global Service Providers Guide 2016

Figure 4 JOB PROSPECTS 100%

5.0%

14.0%

90% 80%

41.3%

70%

100%

50%

7.1%

90%

40%

28.4%

80%

30%

53.7%

20%

37.2%

32.4%

70% 60%

10% 0%

Figure 5 CAREER PROGRESSION OPPORTUNITIES

48.8%

60%

year [Figure 5]. The number of survey participants in 2015 that believe their opportunities for advancement are poor if they do not move elsewhere stayed similar (28.4% versus 28.5% in 2014). These results suggest that many chemicals management and control professionals are willing and even eager to switch companies.

37.6%

50% In your country

Globally

% of participants Poor

Stable

40% 60.5%

30% Good

The numbers are also slightly improved with regard to career progression. More survey respondents continue to see greater opportunities within their own companies and across the wider jobs market, although the latter results are nearly twice the former. Specifically, 60.5% and 34.0% of Chemical Watch survey respondents see good prospects in the overall market and with their current employer, compared respectively to 59.3% and 31.2% last

20%

34.0%

10% 0%

In your company

Wider jobs market

% of participants Poor

Neither

Good

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On the other hand, while survey participants may see job prospects within their companies as limited, more of them feel similarly secure in their jobs than in the previous year (68.2% versus. 65.3%, Figure 6), as slightly fewer felt more secure (20.9% versus 23.5% in 2014). Across all roles, similar levels felt that job security improved (20.1% in 2015 compared to 20.3% in 2013 and 19.9% in 2014).

Careers and salar y survey

Figure 6 JOB SECURITY COMPARED WITH 12 MONTHS AGO 100% 90%

11.0%

15.4%

80%

Figure 8

70% 60% 50%

Salaries ranged from €45,200 to €48,700 in 2014 and €37,400 to €56,700 in 2015, indicating both significant increases and decreases for different positions (although clearly samples vary year to year which means this comparison is indicative only). Most notably, the average salary for regulatory positions show a decline from €47,700 in 2014 to €37,400 in 2015, while the environment, health and safety (EHS) management category showed an average salaries increase by a similar amount, from €49,000 to €54,800. The average salaries calculated for consultants and regulatory affairs managers also increased, but those for product safety/ stewardship managers and scientists declined from 2014 to 2015. Interestingly, however, the average salary increased slightly from year to year (€47,200 in 2015 versus €46,300 in 2014).

AVERAGE SALARY BY JOB TITLE

68.2%

64.5%

Business management/development

40%

47.2 Consultant

30%

52.2

20% 10% 0%

20.9%

20.1%

In own role

Across all roles

% of participants Less secure

Similarly secure

EHS management 54.8 Other 56.7 Product safety/stewardship

More secure

42.5 Regulator

Meanwhile, unlike in 2014, the level of job satisfaction increased slightly in 2015 to 58.0% from 55.9% in 2014 [Figure 7]. The number of respondents that were neither satisfied nor dissatisfied also increased from 31.5% to 30.7%. The number of participants that were dissatisfied with their jobs declined from 12.6% in 2014 to 11.3% in 2015.

37.4 Regulatory affairs management 48.6 Toxicologist/chemist/scientist 40.3 Average salary 47.2

Figure 7 JOB SATISFACTION

Euros 000s

Dissatisfied 11.3% Satisfied 58.0% Neither satisfied or dissatisfied 30.7%

Another difference from the 2014 Chemical Watch survey appears in the distribution of average salaries by job title [Figure 8]. While little variation was observed in 2014 and 2013, a much larger distribution was revealed in 2015.

Page 16

There is similar variation in average salaries when considering the type of organisation [Figure 9], and noticeable differences compared to the results obtained in 2014 (again, presented with the caveat of different samples). For instance, survey respondents working in “other” sectors earned the highest average salary by far (€57,300); this position was held by those in engineering, automotive, aerospace and similar fields in 2014 (average salary €57,700 in 2014 compared to €49,200 in 2015). Participants with positions service providers earned the next highest average salaries (€49,500) in 2015, significantly higher than the value in 2014 (€45.800). Positions in the chemical and life sciences and other manufacturing industries earned average salaries of €47,200 and €46,300, respectively. Those working for government agencies once again earned the least of all survey participants (€39,600).

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As expected, salaries also varied with respondent age [Figure 11]. Survey participants ranging in age from 36-40 and 46-50 earned the most on average (€53,400 and €51,500) respectively. The shift in the lowest earning age bracket from the oldest respondents to the youngest continued in 2015, and survey respondents just entering the workforce earned a higher average salary of €35,900 in 2015 compared to €26,300 in 2014, and more than the average salary they earned in 2013 (€31,300).

Figure 9 AVERAGE SALARY BY ORGANISATION TYPE Chemicals, life sciences and similar 47.2 Consumer products, cosmetics and similar 42.9 Engineering, automotive, aerospace and similar 49.2

AVERAGE SALARY BY AGE

Government & agencies 39.6

21-25 35.9

Other 57.3

26-30 40.6

Other manufacturing 31-35

46.3

48.5

Service provider, including consultants, laboratories, lawyers etc

36-40 53.4

49.5 41-45

Trade association or professional body

48.1

46.0 0

Careers and salar y survey

Figure 11

Euros 000s

46-50 51.5 51-55

There was once again very little difference in average salaries when considering company size. Participants at companies with over 250 employees earned an average of €47,400, while those at medium-sized organisations with 50-250 employees earned an average of €46,700, and those at firms with less than 50 employees earned an average of €46,900. On the other hand, company location continued to have a significant impact on earning potential, according to the results of the Chemical Watch survey [Figure 10]. Respondents in Europe still earned the highest average pay by far (€54,100), while those in North America and the rest of the world earned on average slightly over two thirds that amount and less than the average annual salary of €47,200. Interestingly, the average European salary declined slightly from the 2014 figure, while salaries elsewhere increased, particularly in North America. Figure 10 AVERAGE SALARY BY JOB REGION Europe 54.1 North America

50.1 56-60 43.3 61-65 33.7 >65 51.1 0

Euros 000s For survey respondents who did not receive a promotion in 2015, the average pay rise was 2.4% (up on the 2.0% in 2014) and ranged from 1.7% in Europe to 2.2% in North America and 5.6% in the rest of the world (up significantly from 3.8% a year ago) [Figure 12]. On a positive note, over two thirds of Chemical Watch survey respondents earned an average bonus of 11.6% in 2015, which is slightly up from 11.0% in 2014. Participants in Europe and North America earned bonuses close to the average (10.4% and 10.5%, respectively), while those located in other parts of the world reported receiving much higher average bonuses of around 18%.

39.5 Rest of world 38.0 Average 47.2 0

Euros 000s Chemical Watch | Global Service Providers Guide 2016

Page 19

AVERAGE PAY RISE Europe 1.7 2.5 8.5 North America 2.2 2.9 8.5 Rest of world 5.6 7.4 11.0 Average 2.4 3.3 9.2 0

Excluding promotions

6 %

Including promotions

Only promotions The results of the Chemical Watch survey reflect key trends in the industry identified by recruitment professionals. The demand for experienced chemicals management and control professionals continues to exceed supply. The number of job openings increased in 2015, resulting in some upward pressure on salaries, according to Mr Sherratt. “The inevitable effect has been an increase in interest to switch companies,” he says. The upcoming REACH 2018 deadline may be a factor as well; he notes that people often see the passing of a big deadline as a line in the sand and an opportunity to look for something new. “Companies are fighting hard to retain staff, and over 80% of job movers have been counter offered,” Mr Sherratt adds. Quality of life is also an increasingly important issue for most candidates, and people are less willing to move from one company to another if it requires uprooting their families or giving up other benefits, according to Terry Leyden, president of recruitment firm the Leyden Group. He also notes that most experienced chemicals management and control professionals are fully employed and engaged in their jobs, so real incentives beyond higher pay are needed to get them to switch employers. Such incentives include promotions and/or greater opportunities for advancement, more fully encompassing relocation packages, continuing education opportunities and more frequent salary reviews. Companies seen as being in more attractive locations or offering greater stability may also draw experienced candidates away from a current job. Many companies are also offering cross-training into new regulations, rather than waiting for someone with the exact regulation/directive knowledge, and increasingly putting faith in general regulatory knowledge. This approach is attractive to candidates looking to broaden their knowledge base, according to Mr Sherratt. Patrick B Ropella, president and CEO of recruiting firm Ropella,

Chemical Watch | Global Service Providers Guide 2016

agrees that in today’s competitive jobs market, companies cannot worry about finding candidates with the perfect skill sets. “Companies should hire for attitude and train for skills, otherwise they will lose quality candidates and end up with unfilled positions,” he says. Mr Ropella adds that hiring is just like dating, and the relationship-building aspects of recruiting are as important as the financial package. In addition, a quick decisionmaking process is essential in a competitive jobs market; the longer it takes to choose a candidate, the more choices he/she has and the more likely the candidate will go elsewhere. An additional concern for Mr Leyden is the aging of the workforce across all industries; a large portion of workers, including chemicals management and control professionals, is rapidly nearing retirement age. “Most companies still do not see regulatory/product stewardship positions as places for career advancement and continue to seek people with experience that can start working immediately without much need for training, whether they are people with regulatory experience from other companies or internal employees that have an understanding of the company’s products, technology and culture and are likely to quickly learn the regulatory/product stewardship requirements,” he explains. That viewpoint is confirmed by Celanese’s Dr Brondsema. “New graduates are rarely recruited into chemical compliance roles. In these positions, experience in industry functions such as R&D, technical service or toxicology are highly valued and provide needed perspective to compliance experts,” he states. Hiring is difficult, though. The market for compliance professionals is mature in North America and Europe. But in Asia there is a very limited pool of established compliance professionals, and hiring and retaining qualified staff in a young regulatory culture is a significant challenge, Mr Brondsema notes. The situation is only expected to worsen, according to Mr Leyden, given that many companies continue to assume they will be able to find experienced people to meet their needs without investing in the training and education of a new generation of professionals. Another consequence of this hiring approach is that there are limited entry-level positions available for new graduates looking to start a career in chemicals management and control. One exception, according to Mr Leyden, is jobs related to safety data sheet (SDS) creation/ authoring, which have increased in response to new GHS regulations; new graduates are often hired for these positions. Mr Sherratt agrees that there was increased demand in Europe for positions dealing with classification, labelling and packaging during the first half of 2015, with demand continuing today for SDS writers at companies with very large product portfolios. Biocide regulatory skills were in demand in the latter half of 2015 and continue through 2016 due to coming product authorisations. On the other hand, Mr Ropella notes that graduates with science, technology, engineering and maths (STEM) degrees remain in short supply, and it will be years before this situation is resolved, if ever. Universities are trying to address the need for candidates with more practical experience by aligning curricula with industry needs and developments, according to Mr Sherratt. Many of these programmes include a period of time working with a company, and this relevant experience in the industrial workplace is seen as very valuable. “I think we will see an increase in these types of

Page 21

Careers and salar y survey

Figure 12

Laborator y Services

university-related internship/placement programmes over the coming years,” he says. At chemical companies, Mr Ropella finds that internships are more common at major players and less so at smaller firms. On the other hand, many consultancies, including small and medium-sized companies, have indicated that they bring on one or two interns each year, for a few months at a time, to increase their awareness of the requirements and demands of the industry. Echa also has programmes in place designed to prepare people for work in the chemicals management and control sector. Over 100 graduates from various academic, national and cultural backgrounds have participated in Echa’s traineeship scheme, gaining knowledge about EU legislation and hands-on experience with the agency’s work. As a result, many of these trainees have found employment in the industry and regulatory consultancy world, as well as Echa. Through its graduate scheme, the agency also aims to identify training programmes focused on the chemicals management and control sector. Mr Sherratt notes that while few companies offer entrylevel positions, as the economy has improved, there have been more openings to the point where graduates from “red brick” universities have a lot of options for their first jobs. Data management/software firm eSpheres is one company that hires graduates. “We look for people with a range of educational backgrounds that are IT-minded and exhibit the capability to gain chemical and regulatory knowledge,” says Philip Capel. Chemservice is also finding that due to the limited availability of experienced staff, the company must hire graduates from scientific universities and educate them in-house. This requires significant effort, according to managing director Dr Dieter Drohmann. “Regulations today are more complex than in the past, and

new staff needs to be interested in more than one field of activity,” he says. Indeed, the challenge for many consultants is to find people that are fit to work in the complex and demanding chemicals management and control environment, agrees Dr Klaus Schneider, general manager of Forschungs und Beratungsinstitut Gefahrstoffe GmbH (FoBiG). With respect to REACH, for instance, the need to address restriction, authorisation and chemical management issues is creating the need for more people with a wider range of skills, including economists, IT specialists, environmentalists, etc. On the positive side, this shift should create more opportunities for graduates, according to Riku Rinta-Jouppi at REACHLaw. “We provide both internal and external training on specific topics for further development and encourage employees to take on different roles in projects to find their own strengths and then develop them,” he says. Such practices appear to be increasingly common among consultants today. On a separate note, there are two particular recent and ongoing general events that should be mentioned because they have the potential to impact the supply/ demand balance for chemicals management and control professionals in 2016 and beyond. First, if the DuPont/Dow Chemical merger is approved, the combination of these two very large firms will likely lead to layoffs and create a pool of available and very experienced people. It must be kept in mind, however, that many of those let go will likely be people at or near retirement age, and they may not be interested in staying in the workforce. Second, reauthorisation of TSCA in the US may affect the need for regulatory personnel. New TSCA legislation is expected to require more testing and reporting, and will thus create more work and probably the need for more chemicals management and control personnel.

LABORATORY SERVICES

Testing the limits There is no doubt that the upcoming May 2018 REACH registration deadline for substances used in volumes of over 1tonne/year will impact the testing market. There is a lack of clarity, however, on how significant the impact will be and whether or not there will be sufficient capacity for the various types of testing required. The global testing and analysis services market was valued at $17.9bn in 2014 by Transparency Market Research (TMR), which projects it will expand at a compound annual growth rate of 5.6% from 2015 to 2023 to reach $29.1 bn. This growth will be driven by increasing regulatory requirements related to product characterisation, quality and safety, particularly in the pharmaceutical, medical devices, and food and beverages industries; the expansion of testing services into certain end markets (eg food safety and oil and gas analysis); and increasing demand from growing manufacturing sectors in emerging markets, such as India, Brazil, Taiwan, Mexico, and Indonesia, according to the market research firm. The market is highly competitive and very fragmented, however, and many global players and mid-sized companies have implemented acquisition strategies in order to increase their competitive advantage. TMR points

Page 22

to lab service provider SGS, which completed 32 deals since 2010, and Bureau Veritas, which has acquired 50 businesses in the past five years. Other recent and notable transactions include the merger of Huntingdon Life Sciences and Harlan Laboratories, which began operating as Envigo in September 2015, and the acquisition of Covance by Laboratory Corporation of America Holdings (LabCorp) in February 2015.

MANY DEMANDS ON LABS It is notable that the TMR press release on its report is the lack of any specific mention of the impact of REACH on the demand for laboratory services. REACH is clearly just one of many regulatory drivers influencing the laboratory services market, and companies that will need testing completed for the 2018 registration deadline should be cognisant of the significant demands placed on laboratories that are unrelated to REACH. “Many think that the capacity in the contract research industry is available on demand and all for REACH. This view is a misperception. In addition to REACH, many industries have ongoing and increasing needs for the

Chemical Watch | Global Service Providers Guide 2016

CONCERN ABOUT TOXICITY TESTING The demand for Eogrts and other toxicity testing services has raised concerns about the capacity to conduct complex studies. There is limited capacity for Eogrts, with only a certain number of CROs claiming to be capable of conducting these tests and only about a handful that have

Chemical Watch | Global Service Providers Guide 2016

practical experience with full study design, according to Wil Research’s Mr Visser. A report produced for Echa by Risk and Policy Analysts says global lab capacity for Eogrts is “significantly greater” than it was in 2012. In total, 22 labs were identified as able to conduct such studies. The report estimates that for 2016, 2018 and 2020, the number of basic study design Eogrts these labs could deliver is 88-114, 94-122 and 101-131 respectively. For full study designs, the respective estimates are 44-57, 49-63 and 61-79. However, capacity concerns persist. KFT has already received refusals from lab service providers regarding requests for human toxicity studies, according to managing director Karl-Franz Torges. As a result, he expects very significant shortages in 2017 and 2018. “Unless suppliers start their testing now and spread out their needs across the following 30 months, there won’t be sufficient capacity,” asserts Scott Hickman, marketing manager, toxicology with BioReliance. These labs will need to meet the basic testing requirements for the 2018 deadline, as well as the requirements for follow up specialty assays, such as the Comet Assay and Transgenic Rodent Assay (TGR)/Big Blue Assay, the capacity for which is even more truncated. The limited capacity is not only in Europe, either. A similar situation exists in the US and, in fact, there is limited CRO reproductive toxicology capacity on a global basis. Not only are the number of labs few in number, only a subset of them have the necessary level of experience, expertise and skill to appropriately conduct these tests and interpret their results, according to Mr Hickman. Echa notes that regarding the 2018 deadline, the Annex VIII information requirements competing with Eogrts are the OECD TG 421/422 screening study and a 28-day study. Of the two, the screening study is more crucial because the same reprotoxicity experts are needed to conduct both tests.

SUBSTANCE IDENTITY SHOULD BE THE FOCUS For the REACH deadline, the big priority for companies should be compilation of the substance identity profile (SIP). REACH starts with a correct and complete substance identity, and any delay in this fundamental step will cause delays. First, all available data on each substance to be registered must be gathered in order to determine what testing must be performed to fully characterise them. Any limitations associated with the required test methods must then be identified and gaps in test results determined. “It is also important to make sure that all identifiers in the dossier refer to the same substance, and that the information is presented in a consistent way throughout the whole dossier,” notes Toxicon general manager Daniele Campi Martucci . Companies also need to be certain they are in the correct consortium or Sief. One of the issues, however, is that many companies have not yet decided which substances they will register due to business development questions, according to Dr Dieter Drohmann, at Chemservice. “Companies with marketing departments that leave the decision on which substances to register until very late generally don’t understand the likely registration costs and timing and will have a tremendous amount of work to do to properly characterise their substances and identify and contact the likely lead registrants,“ agrees Dr Martin Richards, a principal consultant with Linmark Consulting.

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services that contract research organisations (CROs) provide. Key among them are the pharmaceutical, agrochemical and biocides sectors. As a result, we see capacity being an issue for the coming years,” says Frank Visser, European sales director for WIL Research (which is in the process of being acquired by Charles River Laboratories International in a $585m deal announced January 2016). There is, in addition, always ongoing demand for lab testing services for new substances and products developed by fine, specialty and commodity chemical manufacturers and downstream formulators. Testing for compliance with various global notification and worker safety regulations, to determine basic physico-chemical data, and to obtain data required for safety data sheets (SDSs) and labelling and packaging legislation is needed on a continual basis. Other testing for non-regulatory purposes places further demands on CROs. For example, Karen Levins, Senior VP at Intertek Cantox points to the increasing number of government risk assessments of existing chemicals, for example in Canada, where 4,300 chemicals of prioritised interest are being assessed. “This activity is adding to demands on laboratory capacity as chemical companies and trade associations respond by generating physico-chemical and toxicology test data that may refute the overly conservative, high-throughput, computer-derived estimates of the human health hazards and environmental impacts of these priority chemicals,” she says. With respect to biocides laboratory demands, Dr Douben, director of REACHWise , notes that “we have only seen the tip of the iceberg.” Most of the effort to date has concentrated on Article 95 listings for the European biocidal products Regulation (BPR), and more authorisation dossiers, which are more extensive and require further testing and additional supporting documentation. Labs are also busy with the additional testing of substances previously registered for REACH in 2010 and 2013. Many final evaluation decisions by Echa on the original submissions have included requirements for the provision of further test data in subsequent dossiers and complex studies, such as the extended one-generation reproductive toxicity study (Eogrts) and higher tier ecotoxicity testing. These tests require labs to have specific testing rooms, equipment and skilled personnel, and there is a limited number of CROs that can complete them. It is not easy to find experienced people to hire in order to expand lab capabilities, either, and this will be a restrictive factor. Because REACH is just one of many regulations contributing to the demand for testing services, CROs may not be willing to increase resources specifically for the 2018 registration deadline, according to Dr Jean Baldwin, business development manager for Intertek Chemicals & Pharmaceuticals. “It is unlikely that high lab capacities will be needed for REACH once the deadline passes, and it doesn’t make sense for labs to invest in expansions that won’t provide a return after a short period of time,” she explains.

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Chemical Watch | Global Service Providers Guide 2016

ROLE OF ALTERNATIVE TESTING? Alternative testing methods ranging from cell-based assays to structure-activity relationship and other quantitative analyses are gaining importance with the growing need to reduce animal testing. “The acceptance by competent authorities of the use of in vitro testing to fill endpoints in registration dossiers, for example in REACH, and the ban on animal testing in the cosmetics industry – for raw materials and formulated consumer products – are key drivers of the development of alternative methods,” says Mr Visser. He notes that most laboratories already offer in vitro and other alternative testing services, and many are expanding their portfolios and capacity due to the growth in demand. However, he adds that in order to provide high quality in these services, both different equipment and personnel skill sets are required. KREATiS, a business of CEHTRA, is for example expanding its portfolio of REACH-compliant, key physicoChemical Watch | Global Service Providers Guide 2016

chemical property and accurate ecotoxicity predictions for a wide set of substance structures as low-cost alternatives to traditional experimental techniques, according to Dr Paul Thomas, senior ecotoxicologist and director of CEHTRA. The company developed a large set of High Accuracy Qsar models (HA-Qsars) in order to cover several endpoints required under the REACH regulation. KREATiS also deals with natural complex substances and provides acute aquatic toxicity for such mixtures. Most recently, the company developed HA-Qsars for skin and eye irritation as human-health endpoints and is expecting to have methods in place by 2017 for REACH Annex VII and VIII endpoints. For these analyses, in silico experts first validate that the substance falls within the applicability domain of each requested model prior to conducting the analyses in order to be certain of the adequacy of the prediction method for the case. The results are also prepared in the regulatory formats required under REACH in order to meet Echa’s expectations. Dr Thomas expects that, although in silico methods are largely used for REACH (otherwise in the EU they are accepted only for impurity profiles under the plant protection products Regulation), their acceptability in the cosmetics industry is growing, particular as the HA-Qsars for these human health endpoints improve. Whether a company is interested in cell-based assays or quantitative modelling, they must keep in mind that time must be invested early on to confirm the applicability and level of justification (if any) required for specific alternative test methods. Therefore, it is often beneficial to start the testing programme earlier than usual in order to identify the greatest number of alternative options.

THE RIGHT SKILLS AND STRATEGIES ARE KEY Even if testing capacity is ultimately sufficient, companies may still have difficulty completing a successful REACH, or any other testing programme, if they lack a good strategy. “There is an urgent need to set up intelligent testing strategies, particularly for global registrations,” says Dr Knoell Consult’s Dr Cleuvers. Such strategies need to take the specific chemistry of the substances involved into account and plan for necessary study monitoring. “CROs need an experienced study monitor, well informed about the substance properties and the type of information required, to plan and perform the studies,” asserts Dr Schneider of FoBIG. Companies must also be wary of becoming too focused on individual tests; the overall strategy must always be kept in mind, according to Chemservice’s Dr Drohmann. Choice of the right CRO is clearly very important as well. “A laboratory should be able to provide guidance in advance of testing on all of the assays that may be required and what interpretation of those assays may look like, and personnel within that lab should be fully versed in all applicable and possible designs/assays and how to perform them,” says BioReliance’s Scott Hickman. In the example of REACH, he adds that the laboratory should be able to guide the supplier through these paradigms. Intertek’s Dr Baldwin also notes that for REACH testing programmes, the lab should have previous experience and be able to make recommendations for appropriate test suites that meet the information requirements. It should also have a person who is knowledgeable in REACH requirements and is accessible to clients to answer any questions regarding the chemistry and testing methodologies. On a more basic level, CROs should have advanced analytical instrumentation and a combination Page 25

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Another notable concern relates to the expectations that many registrants have regarding the gathering of data for their substances. This is because substances not previously registered will be driving demand for lab-testing capacity, and therefore the data needs might be significant, despite the use of grouping and read-across approaches. “While it may be relatively straightforward to generate the necessary data for some substances, there will be many for which it is bound to be a complex process,” says REACHWise’s Dr Douben. Substance identification will be particularly challenging for complex samples and substances of unknown or variable composition (UVCBs), according to Intertek’s Dr Baldwin. Smaller companies may also find themselves in trouble if they assume lead dossiers will have been completed by larger European companies. Some of the larger manufacturers are waiting to determine which substances to register and thus have not elected to be lead registrants yet. In addition, many of the compounds are highly specialised, and smaller companies, including some nonEuropean producers, will need to take on the role of lead registrant because these substances are not manufactured by larger firms. There are additional unknowns regarding some newer tests. Dr Klaus Schneider, general manager of FoBIG, points to the new guidelines for local effects, for example skin and eye irritation, skin sensitisation. “It is not yet clear whether there is sufficient capacity and experience available at the CROs. It is fairly certain, however, that testing and interpretation will be substantially more demanding and costly for companies,” he says. The general impression of most consultants is that the pressure on CROs will be tremendous in 2017 and 2018. While labs may be expanding capacities, they are generally focusing on lower-tier testing services, and the capacity for complex studies, for example Eogrts and TGR, remains limited. Even the expanded capacities for standard testing may not be sufficient, largely due to the fact that numerous companies have yet to decide on the substances they will register and thus have not even begun the evaluation process for substance identification. Mr Visser adds an important cautionary note on substance identification: “For complex substances, it is important that chemical companies, CROs and Echa be careful not to embark on overly elaborate research programmes to define substances,” he says. In particular, he notes that Echa should be more aware of this issue and more proactive about addressing it.

ONLY TIME WILL TELL Whether capacity issues will prevent some companies from attaining that goal of on-time submission for the REACH deadline remains unclear. “What is known,“ says Linmark’s Dr Richards, “is that there are many more substances to be registered in 2018 than under the previous two deadlines put togetheran estimated 25,000 substances in 2018 compared to 3,400 in 2010 and 3,000 in 2013.” There will, as a result, be a large demand for the 28-day repeat dose study and many physico-chemical tests required for both lead registrants and co-registrants seeking to show equivalence with the registered substance. It is also expected that the substances for 2018 present more complexity than the substances registered for 2013 as discussed above, and thus will require longer testing schedules.

Chemical Watch | Global Service Providers Guide 2016

TESTING IN ASIA Laboratory testing in Asia is largely driven by expanding regulatory requirements. The most recent developments are occurring in Vietnam, Malaysia, Indonesia and Taiwan. These are adding to the extensive testing requirements for the numerous different regulations in China. Most of the changes in regulations have to do with industrial chemicals, agrochemicals and biocides, but in general there are increasingly complex questions being raised for both new and existing chemicals in different countries, according to Dr Gunnar Kahl, managing director of Dr Knoell Consult Thai. He expects to see lots of changes in chemical regulations in Asean countries, with authorities focusing on the development of national chemical inventories and basic risk assessment schemes. “It can be expected for the foreseeable future that scientific knowledge on risk assessment and management will be needed in order for companies to be able to prepare risk assessments to submit to the authorities,” Dr Kahl says. He is also curious to see what additional steps might be taken towards harmonisation of regulations in the region. Consulting companies with REACH experience are often, but not always, able to help their clients use study results obtained for registrations for the preparation of national dossiers. For instance, companies that are not data owners but have purchased letters of access have to clarify carefully whether they are allowed to use the REACH data for other registrations, according to Dr Kahl. In addition, data requirements can differ significantly, so additional testing is still often required. Alternative testing is also not always welcomed. For instance, authorities in Asia do not always accept nontesting approaches, such as read-across and waiving, that are used for REACH registrations. In general, alternative testing is not practical in China, according to Yong Jiang at the CNCIC, although he notes that the perception is changing. David Wan, head of the Strategic Operation Department for Chemical Inspection and Regulation Service (CIRS), finds that alternative testing methods such as OECD 437, 438, 439, 430, 431 and 435 are accepted in China. He does note, however, that corresponding in vivo testing must be conducted if the results of in vitro testing are negative. In addition, almost none of these tests are used in substance notifications due to the lack of OECD GLP certification. In fact, the GLP and OECD status of Chinese laboratories has been an issue for a number of years. China is not a member of the OECD. “Chinese laboratories, even if they have implemented the most up-to-date GLP guidelines, therefore cannot be audited by OECD,” says Mr Jiang. He adds that China’s Premier Li Keqiang visited OECD headquarters in Paris in July 2015 and signed a set of agreements, but it is not clear yet whether any resolution was reached.

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of techniques that can be used to determine composition and meet any chemical analysis challenge or regulatory requirement, according to Toxicon’s Mr Martucci . Testing must also be performed according to standard methodologies and quality guidelines, and the lab must be able to offer tailored method development for specific testing applications. Many downstream users in various industry sectors prefer to work with labs with which they have had successful previous experiences. Ton van der Kaaij at Quaker Chemical, uses previous tried-and-tested laboratories, even if they are fully occupied and the company has to wait. “In general, companies have to find a direct interlocutor to plan the type of testing and/or analysis and testing methods, to establish the correct legal references and to discuss the draft of the final report,” says Toxicon’s Mr Martucci . Global consultants often fill that role, particularly when the labs involved do not have the knowledge for multiregional registrations. Such consultants must, however, have in-depth knowledge of the different data requirements and the available options that are accepted by different authorities to avoid unnecessary animal testing. Experience with multi-regional registrations, including communication with the competent authorities, is also crucial, according to Dr Knoell Consult’s Dr Cleuvers. “The ability to talk to the authorities in their mother tongue is a huge advantage, and having a local presence is very helpful; in a lot of countries, to succeed, it is necessary to discuss each case with regulators in their local language.” CEHTRA’s Dr Thomas also observes that experienced staff has become a necessity, particularly when it comes to support REACH testing/dossier development. “There is a need for senior (eco)toxicologists, physico-chemists and industrial hygienists in today’s world who can tackle the diverse range of challenges that we are seeing every day. Our biggest clients are well aware of the consequences of outsourcing dossiers to companies who tend to rely on more junior staff… the risk is they’ll have to do it all over again a couple of years down the line and the whole thing will finally cost more than if it had been done properly, closely monitored by experienced staff, the first time,” he observes. For WIL Research’s Mr Visser, it all starts and ends with high quality and ethics. “Consultants have to know the necessities and possibilities within regulatory frameworks, to perform the necessary testing and to make sure testing is not done unnecessarily, so that ultimately a fully compliant dossier is generated and submitted on time.”

SECTOR FOCUS

Sector Focus

Challenges multiplying for industry sectors Although chemical management issues are generally associated with manufacturing and industries whose products are based on formulations, chemicals are used in the production of nearly all consumer goods. Consequently, all industry sectors are affected by chemicals management and control regulations. Most obvious, perhaps, are industrial and institutional cleaners, paints and coatings, household products, cosmetics and personal care products. Many others are affected, including the automotive, construction, marine, consumer electronics, appliance, furniture, textile and toy industries. It is not just new REACH-like regulations that are driving manufacturers to evaluate their use of hazardous chemicals and implement control strategies. Several NGOs have made elimination of toxic chemicals from consumer products a top priority. Consumers are also demanding more sustainable products, partly in response to NGO campaigns, and partly due to greater awareness from the internet and social media. Large retailers have responded with the development of chemicals management policies that include “red lists” of hazardous chemicals whose use must be avoided or minimised in the products they carry. Consumer goods manufacturers are, in turn, implementing their own systems and requiring suppliers to find alternatives to hazardous chemicals on their own red lists. Industrial product manufacturers face similar expectations from their customers. In many cases, the supply chains supporting these sectors are global and highly complex. Communicating needs with respect to chemicals management to the several layers of suppliers is a huge challenge with many barriers to be overcome. Effective solutions that enable data sharing, yet still provide protection of confidential business information, will be crucial to achieving efficient chemicals management and control across these supply chains. Service providers with in-depth knowledge of specific sectors have the opportunity to play a major role in facilitating this process. Below we look at how the retail sector is responding to demands from NGOs and consumers to offer safer and more sustainable products. We then discuss the challenges that five different industry sectors are facing in terms of regulatory requirements and expectations from NGOs, retailers and consumers. The cosmetics and personal care, toy, electronics, furniture and textile industries have similar challenges with respect to complying with overarching chemicals regulations, but some also face additional regulations specifically targeting their products and processes.

RETAIL CONSEQUENCES Evidence is mounting that sustainable practices, can benefit retailers significantly, while a lack of such programmes can be detrimental. Several reports released in 2015 highlight the costs of product recalls, fines and falling stock prices of companies identified as selling products containing toxic substances versus

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the competitive advantage gained by those with active chemicals management initiatives. In its report The business case for knowing chemicals in products and supply chains, the United Nations Environment Programme (Unep) compared companies with “active” and “passive” chemicals management strategies and found that firms with the former reduce risks and create longterm value, while those with the former have the potential to face large fines and recall expenses, experience stock devaluation and lose market share. The report Advancing safer chemicals in products: the key role of purchasing, published by the Lowell Centre for Sustainable Production (LCSP) at the University of Massachusetts Lowell, has examples of how purchasing power is being used to drive the switch to safer chemicals. The Environmental Defense Fund’s (EDF) Behind the label: how business sees opportunity in safer chemistry report similarly presents two cases (AkzoNobel and Seventh Generation) of the development of novel chemistries for cleaning products in response to consumer and NGO demands for safer ingredients. The US-based Green Chemistry and Commerce Council (GC3) also published a report on the business case for adopting green chemistry. While regulations are important incentives for many retailers, NGOs and consumer activism appear to be influential factors driving companies like Target and WalMart to implement corporate-wide strategies for curtailing the use of hazardous chemicals in the products they sell. The Chemical Footprint Project – founded by Clean Production Action, LCSP and Pure Strategies – has an assessment tool and a publicly-developed standard for benchmarking, tracking and reporting corporate chemical management performance for reducing the use of chemicals of high concern and selecting safer alternatives. Clean Production Action’s BizNGO working group for safer chemicals and sustainable materials also brings together business and environmental leaders to identify strategies for the use of safer chemicals and sustainable materials. GC3, meanwhile, is a network of companies and other organisations working to advance green chemistry. Other tools to help companies determine which chemicals are in their products, assess the risks and hazards they pose, and identify safer alternatives include: OO the US EPA’s safer chemical ingredients list (SCIL); OO GreenScreen for Safer Chemicals, from Clean Production Action; OO the Pharos Project, from the Healthy Building Network; OO the Substitute It Now (SIN) List, from the International Chemical Secretariat (ChemSec); and OO the SciVera Lens Chemical Safety Assessment Platform (CSA) and Secure Supplier Platform (SSP). The Retail Industry Leaders Association (Rila) has developed sustainability management maturity model to help managers optimise their programmes by identifying their baseline position and key areas for improvement. The model considers 27 dimensions that define an effective retail sustainability programme divided into seven sections. Chemicals and toxics management falls under the environmental impacts umbrella. According to a survey of members conducted by Rila for its 2015 Retail Sustainability Management report, a little

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ELECTRONICS INDUSTRY GOING BEYOND ROHS Some industry observers believe that the EU’s first restriction of hazardous substances (RoHS) Directive, which took effect in 2006, set the electronics and many other industries on the path to greater awareness of chemicals in their products. The regulation restricts the use of lead, mercury, hexavalent chromium, cadmium, and polybrominated biphenyl and diphenyl ether flame retardants in most electrical and electronic equipment (EEE). The legislation was recast with the passage of RoHS 2 in 2011 to include products that had been previously excluded from the scope. While no new substances were regulated under RoHS2, the EU commission was delegated to review substances for addition and four compounds (DEHP, DBP, and BBP and HBCD) were highlighted for priority review. On 17 December 2014, the EC notified the World Trade Organization that it was adding four phthalates – DEHP, BBP, DBP and DIBP – to the RoHS restricted substances list, with the restrictions to take effect beginning in July 2019. Under RoHS2, EEE products covered by RoHS must also meet CE (Conformité Européenne) marking requirements, including product testing, and documentation. The RoHS Directive does include exemptions for certain applications of each substance where alternatives are not feasible. The exemptions (listed in Annex III) are temporary, however, and expire at the end of the exemption period, which has a maximum of four years. Industry must reapply, and exemptions may or may not be renewed. Many exemptions will expire in 2016 or 2017 if not renewed by the EU Commission, creating challenges for the industry, according to Fern Abrams, director of regulatory affairs and government relations for global trade association IPC Association Connecting Electronic Industries. In addition, companies must comply with RoHS-like regulations in China, Japan, South Korea and the state of California (US). Manufacturers of electronic products also expect to be busy with REACH compliance as a result of the recent EU Court of Justice ruling on the calculation of levels of SVHCs in complex articles, according to Ms Abrams. The September 2015 Court of Justice ruling said that producers must calculate the levels of SVHCs in their products at the level of the “simple” article, rather than at the aggregate level of the “complex” article that was currently being used. In December, Echa published updated guidance stating that “the substance concentration threshold of 0.1% (w/w) applies to every article supplied. This threshold applies to each article of an object made up of of more than one article, which are joined or assembled together.” As a result, manufacturers must understand and report the presence of candidate list SVHCs (current count is 163) at a much lower level in their products. For many components, SVHC contents will be above the 0.1% weight threshold. These include wire and cable products, which can contain significant amounts of phthalates, and plastic components containing UV stabilisers. “These changes to REACH are the top chemicalmanagement related concern for the electronics industry. Manufacturers of complex articles, from electronics manufacturing services (EMS) firms to OEMs, will be particularly affected,” Ms Abrams states. Not all OEMs have collected full material disclosures from component suppliers and must now quickly obtain this information to determine their SVHC disclosure needs. Component producers,

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Sector Focus

under half of respondents only meet minimum regulatory requirements, while slightly more have established restricted substance lists (RSLs) and are actively implementing programmes to reduce the use of chemicals in general, and toxics in particular. Less than 5% understand the sources of toxins throughout the value chain and what drives their use. These companies, however, also have green chemistry programmes in place to reduce toxics and conduct comprehensive assessments of chemicals in products and processes, including evaluation of hazard and exposure potentials. At this point, no survey respondents have established alliances with industry peers to further green chemistry innovation. Tentative steps have been taken, though. In early September 2014, Target and Wal-Mart co-hosted the Beauty and Personal Care Products Sustainability Summit, which was managed by Forum for the Future. Retailers are struggling, however, to manage the vast quantities of data on chemicals in the products they sell, and their suppliers are inundated with multiple requests from customers, often asking for the same information but in many different forms. The requests are modified frequently too, as retailers respond to changing expectations from NGOs and consumers. In addition, many supply chains are several levels deep; retailers must choose to contact all manufacturers directly, or rely on their immediate suppliers to obtain the necessary information. There is great need for a system that can enable effective communication and data sharing throughout the entire supply chain, despite differing regional regulations and practices. Consideration of the impact of chemicals on end products from the earliest design phase, rather than looking to see if chemicals on restricted substance lists are contained in finished products, would help alleviate much of the stress currently placed on retailers and their supply chains. In the meantime, Rila, along with retailers Lowe’s, The Home Depot, Target, Wal-Mart, American Eagle Outfitters, Meijet, Publix and Sears Holdings, developed a safety data sheet template that aligns with the 16-section format prescribed by Osha’s hazard communication Standard. The template is designed to streamline the required safety data sheet process used by suppliers and retailers to exchange chemical and product information. Some retailers are also using third-party consultants and/or data management companies to help process supplier information. This approach has the benefit of protecting confidential business information for suppliers, since retailers do not see any ingredient lists, but are only informed if products contain chemicals on their RSLs. In Europe, retailers and brand manufacturers are also responding to the recent EU court ruling in September 2015 regarding the 0.1% threshold for substances of very high concern (SVHCs) in articles under REACH. The court determined that the limit applies to each component of a complex product. Up to this point, only seven countries interpreted the regulation in this manner. Echa has promised a fast track revision of its guidance on substances in articles. Trade associations representing retailers and many brand manufacturers, are requesting a moratorium on enforcement until revised guidance is available.

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environmental benefit or even worse, an outcome that harms the environment and human health,” Ms Abrams asserts. She provides as an example the results of a US EPA study comparing lead-free and tin-lead solders (the use of lead in electronics has been restricted under RoHS). “EPA found that the increased energy use associated with the higher operating temperatures required for manufacturing lead-free soldered electronics would cause higher air pollution, acid rain, stream eutrophication and global warming impacts than those resulting from the use of tin-lead soldered electronics. This study serves as an important reminder that there are environmental tradeoffs when substituting one substance for another,” she observes. Ms Abrams goes on to add that electronics manufacturers use specific materials because of their unique properties, including energy efficiency, safety and performance characteristics. “The elimination of specific substances requires a great deal of research and development on alternative substances, requiring the investment of time and resources by electronics manufacturers, including their entire supply chain from the mine to the maker of the latest mobile devices. Similarly, implementing and enforcing regulations requires significant investment by authorities. It is essential that any substance restrictions be supported by strong scientific evidence in order to accomplish the goal of maximum human health and environmental protection,” she concludes.

REFORMULATION INCREASINGLY COMMON FOR PERSONAL CARE PRODUCT MANUFACTURERS At the global level, the regulation of personal care and cosmetic products varies by country and by region. The International Cooperation on Cosmetics Regulation (ICCR) provides a forum for discussions on the alignment of cosmetics regulations, but control measures vary significantly – for example allowable limits for certain chemicals differ, and some ingredients are restricted in one country and not in another. In Europe, the cosmetic products Regulation (CPR) addresses inter alia the composition of cosmetics in terms of general safety assessment requirements, and places specific restrictions on certain types of ingredients. In the US, the Consumer Product Safety Improvement Act of 2008 (CPSIA) restricts the use of certain chemicals, mainly in children’s products, but there is no regulation comparable to the EU’s CPR. Personal care products are generally regulated by the FDA as either cosmetics or drugs, depending on their functionality. For cosmetics products, however, while manufacturers need to demonstrate the safety of their products before placing them on the market, there is no regulatory premarket approval process. One exception is products with antimicrobial additives and a claim of biocidal activity, which may fall under the purview of the Federal Insecticide, Fungicide and Rodenticide Act (Fifra), depending on the specific intended use of the chemical and claims made for the product. US companies also face regulations passed by individual states, and in some cases local counties and cities. Chief among these legislative actions are California’s Proposition 65 and Safer Consumer Products (SCP) Regulations, Washington’s Children’s Safe Products Act and other statelevel green chemistry laws. A similar situation exists in China. Cosmetics products do not need to comply with chemicals regulations unless Page 33

Sector Focus

meanwhile, will need to provide this information to their OEM customers and can expect to be pressured to redesign their products to eliminate the use of SVHCs. In addition, companies need to monitor Echa activities with respect to the hundreds of substances currently under review that may be added to the SVHC list by 2020. The other major issue for the EEE industry is conflict minerals. In the US, publicly traded companies that manufacture products containing tin, gold, tantalum or tungsten must meet the requirements of Section 1502 of the Dodd-Frank Act, including determining whether the conflict minerals they are using originate from conflict-affected mines in the Democratic Republic of the Congo or adjacent countries. The EU is actively developing its own conflict mineral legislation. A proposal from the European Commission included voluntary self-certification for firms exercising due diligence over commodity supply chains for gold, tin, tungsten, tantalum and their mineral ores. Such selfcertification would require upstream companies that sell raw materials, for example European smelters, to demonstrate that the mineral components used in their products do not finance human rights abuses. The European Parliament adopted a number of amendments to the proposed Regulation – including one that would extend mandatory compliance to companies importing minerals in products. Further progress on the proposals is expected in the first half of 2016. The electronics industry appears to be doing well in meeting its new responsibilities in the US. Tulane University recently evaluated 1,267 public conflict mineral filings from 2014 (the second year of the programme) and determined that three electronics companies (Microsoft, Blackberry and Intel) exhibited the highest compliance with required reporting requirements. Some of that success may be attributed to industry efforts to work together to address increasing regulatory requirements and expectations by customers and consumers for more sustainable products. IPC has, for instance, created data exchange standards IPC 1752 and IPC 1755, which address data exchange on RoHS substances and conflict minerals, respectively. The Electronic Industry Citizenship Coalition (EICC), which was founded in 2004 to drive collaboration in the industry, has also established a code of conduct with standards for worker safety and environmental protection, including the management of chemicals used in manufacturing processes and incorporated into products. Individual companies have also taken major steps to implement chemicals management and control initiatives. These companies have developed RSLs based on regulated chemicals, but also include substances that are in proposed legislation, targeted by NGOs, a focus of customers, or have been shown to be potentially harmful or hazardous. Suppliers to these companies are required to report the use of chemicals on their RSLs and, in many cases, reduce or eliminate the use of substances identified to be of particular concern. Numerous OEMs have implemented voluntary phase-out programmes for certain chemicals, including polyvinyl chloride and brominated flame retardants (despite the complete lack of any science showing harm from these substances or that the substitutes are better, according to Ms Abrams). “The decision to restrict or ban a substance should not be undertaken lightly; the restriction of substances prior to evaluating alternatives can result in unintended consequences, leading to a net effect of no increased

Sector Focus

they contain a new active ingredient, and other personal care products must comply with GB15979 and specific China National standards. This is demonstrated through appropriate testing, according to David Wan at CIRS. If products claim to provide disinfection or antibacterial functionality, however, they must meet specific regulatory requirements for disinfectants. On the other hand, the ingredients used in cosmetic and personal care products are highly regulated around the world – through REACH and CLP in the EU, TSCA in the US and REACH-like regulations in many other countries (China, South Korea, Turkey, etc). Although REACH and CLP exclude finished cosmetic products, substances and mixtures used in the formulation of cosmetic products are subject to the requirements of both regulations. In fact, one of the greatest challenges currently facing the European cosmetics industry is the 2018 REACH deadline for the registration of chemicals sold annually in volumes ranging from 1-100 tonnes. Cosmetics Europe, the European Personal Care Association, is concerned about the continued availability after 31 May 2018 of cosmetic ingredients that are subject to this deadline. To this end, it is guiding its member companies, together with their suppliers, on how to prepare for this key milestone. It is also multiplying its contacts with the supplier industry associations at the European level. Changes are afoot in the US, as well. Both the Senate and the House have now passed legislation aimed at updating TSCA. The Senate’s Frank R Lautenberg Chemical Safety for the 21st Century Act (S697) was passed on 17 December 2015, while the House of Representatives passed the TSCA Modernization Act of 2015 (HR 2576) earlier in June. The two bills must now be reconciled during the conference process. Specifically with regard to personal care products, the FDA is also expected to take action on antibacterial agents in soaps, particularly triclosan and triclocarban. In 2013, the agency proposed a rule that requires manufacturers to provide additional safety data on antimicrobials in soap formulations and evidence to support their clear clinical benefit over regular soaps. If no data can be provided, the ingredients must be removed, or the products relabelled. Microbeads have also come under fire. The MicrobeadFree Waters Act of 2015, which requires companies to stop using beads in their products by July 2017, was presented to President Obama for signing on 22 December 2015. California had previously passed a bill banning personal care products containing microbeads from 2020. Cosmetics Europe has also advised its members to discontinue the use of non-biodegradable microplastics in wash-off cosmetic products by 2020. Legislation with a much wider scope is also being developed. Senators Dianne Feinstein (D–California) and Susan Collins (R–Maine) introduced the Personal Care Products Safety Act, which passed the US Senate in April 2015 (S 1014). The US Safe Cosmetics Modernisation Act (HR 4075) was then passed by the House in the fall. The former legislation was drafted in conjunction with industry and NGO participation and has the support of the Personal Care Products Council, several major companies and the Environmental Working Group (EWG). S 1014 would require the FDA to test at least five compounds a year to determine whether they are safe for use in personal care products and at what concentrations, and give the agency the power to order recalls of unsafe products. Manufacturers would also be required to register with the agency and provide information on the ingredients Page 34

in their products. The House legislation grants the FDA the authority and resources to review and approve cosmetic products for sale based on the ingredients they contain. The EWG is not waiting for government action, however. In November 2015 it launched a certification programme for personal care products. Those that meet its requirements for ingredient transparency, avoidance or limitation of certain substances of concern and best manufacturing practices can place EWG’s certification mark on their product packaging and websites. The Restricted Substance List (RSL) includes parabens, formaldehyde and formaldehyde releasers, triclosan, toluene, perfluorinated chemicals, phthalates and microbeads. Many companies are expected to seek the certification given the heightened competition for consumers preferring sustainable products and having greater awareness of potentially hazardous chemicals. The Campaign for Safe Cosmetics is pushing for disclosure of ingredients in product formulations and avoidance of the use of cancer-causing chemicals, reproductive toxicants and other unsafe chemicals, and has targeted very large consumer goods companies, including Procter & Gamble (P&G), L’Oréal and Unilever. The group has also established a red list of chemicals to avoid in shampoos, conditioners, sunscreens, hair colours, powders and skin lighteners, among other products, and a list of more than 500 cosmetic companies that it has identified as producing and selling safer cosmetics. Consumer product companies are actively reformulating products to remove petrochemical ingredients seen as potentially harmful by consumers, including the substances listed above, as well as surfactants such as sodium lauryl sulphate (SLS) and sodium laureth sulphate (SLES) and polycyclic musk fragrance ingredients. In many cases, the undesirable chemicals are replaced with “natural” compounds derived from renewable resources. The Cosmetic Ingredient Review (CIR), a scientific panel funded by the Personal Care Products Council (PCPC), has identified very few compounds that it deems unsafe and a few dozen with insufficient data to support their use. In addition, the FDA has prohibited the use of only 11 chemicals in cosmetic products.

EDUCATION OF GLOBAL SUPPLY CHAIN IS KEY FOR TOY INDUSTRY Toys are highly regulated in the US, in Europe and in other countries that have adopted international safety standards. Since 2008, toys for sale in the US have had to meet safety standards established by ASTM International. These include testing for the presence of heavy metals and other hazardous chemicals. Both the federal Consumer Product Safety Act (CPSA) and the Federal Hazardous Substances Act (FHSA) regulate the use of hazardous substances in consumer products, including toys. In recent years, several states have also passed legislation involving restrictions, bans and reporting requirements for specific chemicals in toys. Washington’s Children’s Safer Products Act (CSPA) will be fully implemented in 2018, when even the smallest manufacturers (revenues < $100,000) must be in compliance. The state will also be reassessing its chemicals of concern list in 2017 as part of a five-year review cycle. Oregon passed its Toxic-Free Kids Act, which uses the same list as Washington, in August 2015, and all manufacturers must be in compliance by January 2018. Connecticut has also passed its own State Child Protection Chemical Watch | Global Service Providers Guide 2016

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toy manufacturers to implement expanded chemicals management strategies, more extensive supplier requirements and pursue voluntary reduction/elimination programmes for chemicals that are viewed as being of potential concern. Participation in voluntary green labelling programmes is also increasing. While most of the compounds on the SVHC candidate list will not be intentionally used in toys, it is possible that some may exist as unintended contaminants, unreacted precursors/intermediates, or breakdown products at levels approaching 0.1%. As a result, it will be even more critical that toy manufacturers know what is in their products and perform rigorous chemical safety assessments as required by the revised EU toy safety Directive, according to Ms Van Reeth. Overall, TIE would also like to see greater alignment of relevant legislation at the global level to enable the toy industry as a whole to drive change in the supply change more effectively. The Chinese government has also been working with international toy manufacturers to improve the workplace and product safety in its toy industry. Notably, China National standard GB 6675 entered into force on 1 January 2016. A compliance report will be required for all toy products, which can only be obtained after completion of required testing in qualified laboratories, according to David Wan at CIRS.

FURNITURE MAKERS FOCUSED ON FLAME RETARDANTS AND FORMALDEHYDE Furniture products consist of a complex array of materials, including metals, plastics, wood and numerous additives, such as colourants, plasticisers and flame retardants. Overarching regulations such as REACH in the EU, TSCA in the US and REACH-like or other substance-based rules in many countries around the world are applicable to both furniture products and the components and raw materials used to make them. In the US, there are also federal regulations regarding the presence of chemicals in children’s furniture. Numerous state regulations also apply to children’s products – including Washington’s Children’s Safer Products Act (CSPA), Oregon’s Toxic-Free Kids Act, and Connecticut’s State Child Protection Act. California leads the way with specific chemicals regulations, including Proposition 65 and the Safer Consumer Products Regulation Both include lists of chemicals and place restrictions and/or reporting requirements on their use in various applications. California’s Technical Bulletin (TB) 117-2013 Regulation is a flammability standard for residential upholstered furniture that is having significant impact on the US furniture industry. The current standard requires a smoulder-resistance test that can be passed without the use of flame retardants. Many older flame retardants with questionable toxicity profiles are no longer used in furniture and many other products. Alternative chemistries are, however, fairly widely used in both household and office furniture, according to a December 2015 report by the Commission for Environmental Cooperation (CEC). Of 132 products tested, nearly half contained at least one of 16 replacement flame retardants, with tris(chloroisopropyl)phosphate (TCPP) as the most common. In response to growing pressure from NGOs and consumers, there is widespread support in the industry for

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Sector Focus

Act, Maine has the Toxic Chemicals in Children’s Products law and California has Proposition 65 and the Safer Consumer Products Regulation, which address all consumer products, including toys. Several counties in New York also passed legislation in 2015 banning the sale of children’s products (including toys and apparel) containing certain chemicals (for example formaldehyde, benzene, and various heavy metals), including Albany, Westchester, Suffolk and Rockland. A coalition of 11 industry trade groups including the Toy Industry Association (TIA), the American Apparel & Footwear Association (AAFA) and the American Chemistry Council (ACC) have indicated that these measures impose impossible and redundant regulations on manufacturers and retailers. “Unfortunately, many legislators at state and local levels are unaware of the robust safety net for toys that exists across the US. At the same time, concern over protecting children from ‘toxic chemicals’ has raised alarm, leading to a proliferation of restrictions, bans, and reporting requirements aimed at toys at these levels. Most of these regulations are duplicative and conflicting. In some cases they are impossible to comply with,” says Al Kaufman, senior vice president of technical affairs with TIA. The EU’s toy safety Directive went into effect in July 2011, except for Annex II part III (chemical requirements), which came into force in July 2013. Manufacturers must perform safety assessments on all toys and compile comprehensive technical information, including chemical content, in order to allow traceability – rules that were recently recognised by an EU Working Group on Traceability as an example for other sectors to follow. Importers and distributors must ensure that manufacturers have completed the necessary evaluations and complied with a number of obligations (for example affixing of warnings, addresses, identification numbers, etc). Restrictions exist for CMR (carcinogenic, mutagenic or reprotoxic) substances, heavy metals, allergens and nitrosamines/nitrosatable substances. Toy Industries of Europe (TIE) participated in the development of the TSD and worked to ensure that it was based on sound scientific evidence and evolves in line with advances in science and technology, according to director general Catherine Van Reeth. “Any new legislation should also be proportionate to risk in order to not add unnecessary burden, in particular for SMEs, which make up 99% of companies in the sector.” For instance, she points to additional testing based on restrictions for substances not used by the toy industry and environmental labelling that does not provide added value for the consumer, both of which could prove onerous while doing little, if anything, to improve the safety of toys. An additional concern for TIE is the need for good enforcement of the TSD. Reputable manufacturers put a lot of time and money into making sure their products meet strict safety standards Unfortunately, there are some companies who choose to bypass the rules. As chemical requirements increase, leading to further costs for reputable companies, it becomes more and more lucrative for rogue traders to ignore them. “We believe that good legislation goes hand in hand with good enforcement: ensuring strong, well-funded and efficient market surveillance systems are in place is key to combating non-compliance,” Ms Van Reeth says. It should also be noted that in both the US and Europe, not only increasing regulations, but also growing demands for greater environmental sustainability of products from NGOs, retailers and consumers are driving

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The trade group also recognises that problems still exist in gathering and maintaining chemical information for complex products, particularly given that simple disclosure of the presence of certain chemicals in products does not take into consideration routes of exposure, and therefore does not fully consider hazards and risks. To that end, it conducted a Material IQ (MiQ) pilot study with several suppliers and furniture manufacturers. MiQ was developed by GreenBlue, an environmental non-profit organisation, to help manufacturers identify opportunities for optimising their products and processes. The system is designed to enable communication between downstream and upstream users, providing an independent database of more consistent information, including proprietary data managed and verified by third parties who also conduct hazard assessments, including exposure and risk analyses. The data is traceable and the results are standardised for easier product comparisons.

TEXTILE INDUSTRY TAKING ON THE CHEMICALS CHALLENGE Apparel and other textile supply chains are complex, spanning multiple continents and suppliers. They begin with fibre production and include manufacturing of textile chemicals used for pretreatment, weaving, spinning, dyeing and final product finishing in processing facilities, mainly located in China, Bangladesh, India and Pakistan, but also in the Americas, Europe and Turkey. There are also many different types of textiles – fashion, outdoor, technical, automotive and other industrial types. In the context of chemical management, potentially hazardous chemicals and their precursors – for example, short-chain chlorinated paraffins, perfluorinated compounds, brominated flame retardants, phthalate plasticisers and formaldehyde – can be introduced anywhere in the supply chain. For apparel, that can include during fibre production, yarn spinning, dyeing, button or zipper production, or leather tanning. To implement a truly successful chemicals management programme, apparel companies must have transparency and traceability in their supply chains, and they therefore must develop relationships with not only their direct suppliers, but their suppliers’ suppliers. Chemicals are found mostly below tier two suppliers, and understanding the supply chain down to the chemical level is extremely challenging, according to Shelly Gottschamer, chief supply chain and sustainability officer for Outerknown. “Chemicals are most often found in dyestuffs and fabric finishes. Mapping the entire supply chain down to the dyestuff is a complex web that very few companies are able to follow, so a complete picture of all the risks is difficult to obtain,” she says. Ms Gottschamer notes that in recent years the industry has worked to keep harmful levels of chemicals out of the supply chain from the start, but she adds the standards are costly to implement and the adoption rate is low. There are numerous trade associations and collaborative groups working to improve chemicals management throughout the textile supply chain: OO The Sustainable Apparel Coalition (SAC), founded in 2011 and consisting of more than 100 brands, retailers, suppliers and NGOs, has constructed the Higg Index, a standardised supply chain measurement tool to understand the environmental, social and labour impacts of apparel and footwear products. The index includes a chemicals management module (CMM) initially

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Sector Focus

the elimination of flame retardants. This was reflected in a November 2015 petition to the US Consumer Products Safety Commission (CPSC) to adopt California’s TB 1172013 as the nation’s first flammability standard for residential upholstered furniture signed by nine industry trade groups. In fact, most companies are already taking steps to eliminate flame retardants from products, wherever possible. In addition, furniture makers have also been faced with the regulation of formaldehyde. This was designated a known human carcinogen by the International Agency for Research on Cancer (Iarc) in 2004 and the US National Toxicology Program (NTP) in 2011. In 2007, the California Air Resources Board (CARB) approved an Airborne Toxic Control Measure (ATCM) to reduce formaldehyde emissions from composite wood products. In 2010, the US Congress passed the Formaldehyde Standards for Composite Wood Products Act with limits for emissions of the substance that mirror the standards in the ATCM. The EU also has limits for formaldehyde in composite wood products used in furniture manufacturing. One consequence of these regulations is that it has become difficult for furniture manufacturers to find commercially available formaldehyde-free materials that meet high-performance specifications, according to Thaddeus Owen of furniture-maker Herman Miller. Furniture manufacturers are also being inundated with requests and requirements from customers for chemicals information and compliance with many different sustainability and chemicals voluntary standards. For instance, many retailers are requiring that furniture manufacturers comply with RSLs which may be regulatory lists, lists developed by NGOs (such as LEED for Healthcare, or the Living Futures Institute’s Red List), or their own lists. “Our biggest challenges with respect to chemicals management are obtaining the data from all of our suppliers to meet the numerous regulatory and customer requirements, and then managing that data for very complex products that can consist of as many as 300 different parts,” Mr Owen observes. There are several trade associations serving the furniture industry that are looking for ways to assist their members with this complicated task, including the Home Furnishings Association (HFA), the European Furniture Industries Confederation (Efic), the Business and Institutional Furniture Manufacturers Association (Bifma) and the European Federation for Office Furniture Associations (FEMB). Bifma has been particularly active in supporting its members with their chemicals management efforts. The ANSI/BIFMA e3 Furniture Sustainability Standard was introduced in 2008 and includes criteria for measuring a product’s sustainability, as well as materials selection and usage; energy and atmosphere; human and ecosystem health; and social responsibility impacts. The association followed up in 2009 with a sustainability certification programme for furniture. In September, 2015, Bifma announced that it was revising its sustainability standard to enhance clarity around support for green building rating systems, update the chemistry assessment process and incorporate lifecycle-based concepts. The organisation is also creating product category rules (PCRs) for the furniture industry through an open development process engaging stakeholders from around the globe. These rules are used to conduct lifecycle assessments (LCAs) for office furniture, which can then be used to create environmental product declarations (EPDs) for publication and sharing with customers.

Sector Focus

developed by the Outdoor Industry Association (OIA) that was recently streamlined. In October 2015, SAC announced that questionnaires used by the OIA and the Zero Discharge of Hazardous Chemicals (ZDHC) group will be combined and incorporated into the Higg Index, with the goal of launching an update in mid-2016. ZDHC was founded in 2011 by several apparel companies and has established a joint roadmap for achieving zero discharge of hazardous chemicals by 2020, including commitment and timelines to realise the goal and an RSL In 2015, ZDHC updated its action plan and published guidance for managing hazardous chemicals at different stages of the supply chain. The Apparel and Footwear International RSL Management working group (AFIRM) comprises US and European clothing brands and retailers and aims to reduce the use and impact of harmful substances in the apparel and footwear supply chain. Its key premises are that chemical product safety must be understood in the global supply chain as an integrated whole, from workplace to consumer; chemical product safety can only be achieved through partnership among retailers, suppliers and manufacturers; and retailers must encourage suppliers’ and manufacturers’ selfgovernance of chemical product safety. The Leather Working Group (LWG) has developed an environmental stewardship protocol. The objective is to develop and maintain a protocol that assesses the environmental compliance and performance capabilities of tanners and promotes sustainable and appropriate environmental business practices within the leather industry. The American Apparel and Footwear Association (AAFA) developed its VPEPxchange programme in conjunction with TEXbase. This subscription-based platform allows suppliers to author and publish Voluntary Product Environmental Profiles (VPEPs), supplier disclosure forms that provide vital information on the chemical makeup of products and their environmental impact. Suppliers can then securely share VPEPs with interested stakeholders. The UK Textile Finishers Association (TFA) developed the Voluntary Emissions Control Action Programme (Vecap). Initially focused on reducing emissions of brominated flame retardants (BFRs), Vecap has since become a system for more efficient management of a wider range of chemicals and processes for the European textile and plastics industries, and has also been introduced in North America and Japan. The non-profit ChemSec, introduced the textile guide, a free online chemical management tool tailored exclusively for the textile sector. The guide helps companies identify problematic chemicals in their production processes and finished garments and how to get rid of them, and includes a searchable database of more than 6,500 chemicals compiled from various regulations and company and trade association RSLs. German sustainability agency Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) and Huntsman Textile Effects have created the GIZ Chemical Environmental Management for Competitiveness Programme designed to improve chemicals management practices in textile mills in Bangladesh. The Global Apparel, Footwear and Textile Initiative (GAFTI) aims to improve efficiencies and set global standards that can reduce complexity and remove costs from common industry practices. GAFTI’s Product Safety Committee is focused on working with governments,

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brands, retailers and other industry organisations to achieve common global testing methods, common global RSLs, and common global labelling requirements that will result in safer products for consumers. All of these initiatives are designed to help apparel and other textile manufacturers gain information on the chemicals used to manufacture their products throughout the entire production process. This information is needed to meet numerous regulatory requirements In fact, the main challenge for AAFA’s members is the lack of a national (US), uniform chemicals management policy, which is further complicated by the continued proliferation of chemical management legislation and regulation at the state and local level, according to a spokesperson for the association. It is important to note, however, that while some companies rely on chemical legislation and regulation as the basis for their programmes, others have developed their own programmes to proactively eliminate certain chemicals from their supply chains. “Compliance with mandatory chemical management regulations and enforcement certainly force a change in supply chain communication, substitution of hazardous chemicals, and/or occupational hygiene/safety. However, we’re also seeing companies go beyond compliance, and coming up with innovative ways to substitute chemicals because they are responding to their customers, see it as a competitive edge or differentiator, or because it’s part of their brand,” observes the AAFA’s spokesperson. Many companies have, in fact, developed and implemented chemicals management strategies, often including RSLs for products and manufacturing processes. VF Corp (owner of 30 brands, including The North Face and Timberland) has gone even further, collaborating with the University of Leeds, the University of Massachusetts, Lowell, the Natural Resources Defense Council (NRDC) and technical service provider Modern Testing Services to develop CHEM-IQ, a programme designed to enable evaluation of chemical use at mills and identify potentially toxic substances. The company’s goal is to eliminate the “worst” 10% of chemicals (identified by hazardous composition and volume) used in its supply chain each year. Many large global chemical suppliers, including Huntsman, Archroma, CHT and DyStar, have signed up to the manufacturing standard developed by bluesign technologies. The approach considers the resource productivity, consumer safety, air emissions, discharges to water, and occupational health and safety of companies rather than focuses on finished product testing like many eco-labels. Some companies, such as Italian manufacturer Garmon Chemicals, are using tools like Clean Production Action’s GreenScreen for Safer Chemicals to assess chemicals based on their hazard rather than their risk profiles. Others are focused on finding renewable raw materials to replace those that have been identified as potentially harmful. Many also continue to seek the Öko-Tex 100 textile standard and product label, which includes limits for hundreds of substances. Greenpeace’s Detox campaign was launched in 2011 to expose the direct link between global clothing brands, their suppliers and toxic water pollution around the world. The group investigates factories in many different countries, tests branded garments for traces of hazardous chemicals and publishes the results. It also asks brand manufacturers to commit to phase out the use of toxic chemicals across the supply chain by 1 January 2020.

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use versions containing shorter-chain PFCs, because the alternatives do not provide the necessary level of water, oil and dirt repellency. They argue that it is less sustainable to use lower-performing DWRs because they wear out faster, and therefore the material is replaced or treated more frequently. Most outdoor gear manufacturers are looking for suitable alternatives. For instance, WL Gore & Associates, maker of Gore-Tex fabric, is investing $15m in the effort. Several fashion brands, including Adidas, Puma, H&M, have pledged to phase out PFCs.

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Exciting times expected for 2016 following a busy year in 2015 Existing and approaching regulations have created significant demand for chemical management and control service providers in 2015. The increasing complexity of regulatory requirements is also reflected in the results of the latest Chemical Watch survey of 693 professionals in the chemical control sector . In 2015, consulting services were most in demand by survey respondents (35.0% of total spend on service provision) [Figure 13], while laboratory testing was the most outsourced service in 2013 and 2014. Increasing pressure for improved chemical management and elimination of hazardous chemicals from the supply chain in many industries (see the discussion on sector-related issues) has also led to a growing need for effective data management and data sharing solutions designed specifically for chemicals management and control applications. Outsourcing to laboratory services (14.3%) exceeded that of IT and software service providers (12.6%). In addition, information services represented 8.7% of the total spend. Figure 13 SERVICES RETAINED BY PARTICIPANTS (BY SHARE OF TOTAL SPEND)

Information 8.7%

Ingrid Sekki, marketing manager for REACHLaw, says: “Compliance has become a market driven issue, and many companies are only buying from compliant suppliers to ensure compliance in their businesses. The heightened regulatory activities around the world have increased awareness of imported and manufactured chemicals, and there is a better focus on human health and environmental questions, according to Daniele Campi Martucci, general manager of Toxicon. Compared with 2014, the use of consultancy services in 2015 has more than doubled, as did outsourcing of representative/management and legal services [Figure 14]. These increases were offset by decreases in the use of laboratory services and training and “other” services. The different sample between the years is one factor here, of course, but the year-on-year trends are of interest. Figure 14 CHANGES IN THE PROPORTION OF SPENDING ON PROVIDER SERVICE TYPES 100% 90%

Other Training services 5.7% 1.7%

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1% 8% 3% 7%

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Greenpeace has challenged outdoor gear manufacturers to stop using per- and polyfluorinated chemicals (PFCs) in durable water repellent (DWR) treatments, even the shorterchain compounds (C4 to C6) that have replaced long-chain PFCs (C8 and longer, including PFOA and PFOS). The organisation published a study in September 2015 that found shorter-chain PFCs in remote locations, and argues that because they are persistent, used in higher quantities to achieve similar performance and volatile, they can be widely distributed. Some smaller companies have stopped using DWRs containing PFCs, but most larger manufacturers continue to

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Offices

www.gabconsulting.de

GAB Consulting GmbH Stade Germany GAB Consulting GmbH Heidelberg Germany GAB Consulting Agrociencias S.L.U. Valencia Spain

Representations France Poland Slovenia

Cooperations Italy Greece Bulgaria Russia/CIS USA Argentina Brasil Chile

Figure 15 PERCENTAGE OF CHEMICAL MANAGEMENT WORK PERFORMED BY IN-HOUSE TEAMS 100% 90% 80%

35%

36% 49%

53%

70%

53%

48%

60% 50%

27%

25%

40% 30%

13%

20%

10%

10% 0%

15%

consequently results in increasing demand for external services,” he explains. Fluctuating budgets are a real issue for service providers, though, and they have over the past several years in general been linked with REACH registration deadlines. REACHWise encourages its clients to implement long term strategies that spread the work out over time and help maintain a steady expenditure level. Director Peter Douben has found, however, that companies are increasingly reluctant to spend money on support services due to decreases in their overall budgets. “Forward planning of chemicals management helps with budgetary constraints and avoiding peaks and troughs”. On the other hand, many more companies that have not had any budget for chemical compliance in the past must establish one in order to register products for REACH if they want to continue marketing them in the EU, which will be good news for service providers, according to KarlFranz Torges, managing director of KFT. Ongoing activities, such as SDS retrieval, dangerous products data management and regulatory product checks, also require a significant budget as well for large companies that use many different chemicals, some of which are SHVCs. “Most pharmaceutical companies each have to follow up on nearly 1,000 chemicals, and these requirements are driving growth of our need for chemicals management and control services,” says Philip Capel, marketing director for software firm eSpheres. Results of the survey also suggest that fewer companies may be looking to change their approach to internal chemicals management and control. While 20% of respondents expect their companies to increasingly integrate compliance management with other activities over the next five years, and 28% expect them to switch to separate compliance divisions, the number who expect their company’s management approach to remain the same was 52%, up from 50% in 2014 [Figure 16]. Figure 16

31%

25%

28%

30%

12%

6% 8%

8% 4% 7%

7% 5% 7%

9% 5% 9%

2011

2012

2013

2014

2015

12%

15%

2010

80-100%

60-80%

20-40%

0-20%

INTEGRATION CHANGES AT SURVEY RESPONDENTS OVER THE LAST FIVE YEARS Move towards general management 20%

40-60%

This trend was particularly notable in China in 2015, according to David Wan, head of strategic operations with CIRS. “Chinese client budgets for chemicals management shrunk in 2015 due to the poor economic climate. Longerterm, however, they should increase as regulatory demands continue to grow, and more companies will be seeking outside assistance,” he says. Chemicals management and control budgets also shrunk in Asia due to the low price of crude oil, according to the CNCIC’s Yong Jiang. A similar trend was observed in Europe by Martin Richards, a principal consultant with Linmark Consulting. “When the economic climate is poor there tends to be reductions of in-house staff numbers. The need to meet regulatory compliance obligations and register chemical products in order to keep them on the market

Chemical Watch | Global Service Providers Guide 2016

Move towards separate compliance divisions 28%

Remained the same 52%

With respect to the frequency of use of chemicals management and control services, the majority of Chemical Watch survey respondents seek outside assistance on an occasional basis (36-54%), rather than on a frequent (7-36%) or a permanent (1-12%) basis, excluding IT and software services, which are retained on a permanent basis by 21% of survey participants [Figure 17]. Laboratory, consultancy, IT/software and

Page 45

Service Providers

The increased need for consulting advice reflects a growing emphasis on chemical product stewardship and the fact that regulations are not only more complicated, but that many more entities are imposing demands, according to Lynn L Bergeson, managing partner with Bergeson & Campbell PC. Downstream users are also much more impacted by chemicals management and control regulations and consumer expectations for more sustainable products today, and they do not have a lot of experience in this area. “Our end customer is definitely more focused on sustainability efforts,” says Shelly Gottschamer of clothing company Outerknown. “In the apparel industry, it is known that 70% of environmental impacts are in the supply chain, and a large percent of that in raw materials. Because material manufacturing is where most chemicals are found, that is where brands are starting to focus their efforts,” she adds. The complexity of the regulatory environment is also having an impact on the overall use of service providers compared to in-house staff. The amount of work completed on average by in-house teams decreased from 74% in 2014 to 71% in 2015, according to the Chemical Watch survey [Figure 15]. It is the first drop since 2012, but is still higher than the 62% observed in 2010.

Service Providers

information services were the most likely to be used on a frequent or permanent basis in 2015, which are also the services mostly widely used by survey participants. Strong demand for IT/software support is not surprising as companies have to monitor an increasing number of regulatory developments. “Manufactures and users of chemicals need to develop and execute proactive intelligent compliance strategies that increase efficiency, reduce risk, and support increased market penetration,” asserts Uday Virkud, CEO and president of 3E Company. To do so, he says, they need to be proactive in compliance initiatives, always anticipating the next regulatory shift or trend, and adopting new technologies and methodologies to prepare. Speciality chemical manufacturer Celanese is directing more funds towards global compliance software and service providers rather than on internal staff. “These shifts in resources support the company’s strategy to address increasing compliance challenges in more highly regulated sectors, such as automotive, medical device and food contact applications,” says Dr Brondsema, the company’s global product steward. Data management, HazComm and regulation compliance software help reduce the time needed for routine tasks and requests, but he stresses that it must mesh seamlessly with other data systems, such as SAP, and enable rapid routine compliance for new regulations.

FREQUENCY OF SERVICE RETENTION BY SURVEY PARTICIPANTS

Figure 18 CHANGE IN OVERALL SATISFACTION LEVELS FOR SURVEY RESPONDENTS 100% 90%

19%

25%

27%

26%

78%

73%

71%

72%

71%

2010

2011

2012

2013

2014

2015

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

13%

30%

48%

% of participants

Representation & management 4% 15%

Dissatisfied

36%

Legal services 17%

Laboratory 33%

36%

IT & software solutions 21%

17%

40%

Information services 22%

Neither

Satisfied

Figure 19 shows a comparison of the satisfaction levels of Chemical Watch survey participants in 2015 and 2014 for specific performance areas. Notably, satisfaction levels increased – and only slightly – in two areas: personal relationships (by 1%) and technical knowledge (2%). In all other areas, the satisfaction level was lower in 2015 than 2014 by 3-9%. The greatest declines were observed for the ability to add value on top of agreed deliverables, availability and flexibility.

51%

12%

10% 0%

Consultancy/advisory

14%

Between 2010 and 2012, the percentage of satisfied respondents to the Chemical Watch survey declined from 78% to 71%, then increased slightly to 72% in 2013. It has remained at that level through 2015 [Figure 18].

20%

Figure 17

DISSATISFACTION MAY BE ON THE RISE AGAIN

41%

Training 8%

22%

54%

Other services 7% 0%

50% % of participants

Permanent

Page 46

Frequent

100%

Occasional

Chemical Watch | Global Service Providers Guide 2016

Science at the Heart of Safety DEKRA Insight helps organisations improve organisational and process safety and implement software solutions in support of safety performance to save lives, prevent injuries, and protect assets.

www.dekra-insight.com www.chilworth.co.uk DEKRA Insight represents the collective expertise of our legacy businesses, each an institution in

Figure 19

Figure 20

SATISFACTION LEVELS IN 2015 AND 2014 Availability

SATISFACTION LEVELS OF SURVEY PARTICIPANTS WITH PRICES CHARGED FOR SERVICES

52%

Dissatisfied 14%

61%

Satisfied 25%

59% 58% Experience/knowledge in all countries in which you operate 37% 44% Offering flexibility 39% 48% Adding value on top of agreed deliverables 31% 38% Technical knowledge 68% 67% Providing value for money 37% 44% Price of service 25% 31% Delivering on schedule 52% 57% Meeting your brief 59% 64% 0%

% of participants satisfied 2015

100%

2014

With respect to pricing, the slightly higher satisfaction levels observed in the Chemical Watch survey in 2014 were reversed in 2015 with a decline of six percentage points from 31% to 25% [Figure 20]. On the positive side, the fraction of dissatisfied respondents only increased from 12% to 14%, whereas the percentage of respondents that were neither satisfied nor dissatisfied rose from 57% to 60%. Given the declines in overall satisfaction, it is not surprising that a larger percentage of respondents indicated they may change their current service providers (up from 46% in 2014 to 55% in 2015) [Figure 21]. An additional 7% said they would definitely be switching chemicals management and control providers. It is important to note, however, that dissatisfaction is not always the main driver for moving from one service provider to another.

Chemical Watch | Global Service Providers Guide 2016

Service Providers

Personal relationship

Neither 60%

Figure 21 INTEREST LEVEL OF SURVEY RESPONDENTS IN CHANGING SUPPLIERS 100% 90% 80%

46%

39%

70%

47%

44%

47%

44%

48%

46%

40%

60% 50% 40% 30%

48%

51%

53%

20% 10% 0%

10%

2010

2011

2012

2013

2014

2015

Possibly

Yes

EXPERTISE IS KEY DECISION FACTOR WHEN SELECTING SERVICE PROVIDERS Indeed, according to survey respondents, expertise of key staff and in-depth knowledge of country specific regulations are by far the two most important factors influencing the selection of service providers [Figure 22]. With just under 60% of respondents satisfied with the personal relationships they have with their outsourcing partners [Figure 19], service providers should recognise there is significant room for improvement. According to survey participants, the ability to build long-term relationships between individual staff members, strict adherence to project protocols and a willingness to put service level agreements in place are most important [Figure 23].

Page 49

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Figure 22

Figure 23

FACTORS INFLUENCING THE SELECTION OF SERVICE PROVIDERS Expertise of key staff 83%

MOST IMPORTANT RELATIONSHIP FACTORS FOR SURVEY PARTICIPANTS Building long-term relationships with individual staff 55%

In-depth knowledge of country specific regulations

Strict adherence to project protocols

74%

47%

Comprehensiveness/accuracy of proposal

Service level agreements in place

55%

44%

Ability to operate on a global scale

Suppliers keeping costs as low as possible

52%

Regularly reviewing (and at times changing) suppliers

51%

30%

Contract price

Regular face-to-face meetings 20%

40% Appropriate accreditation/certification

Paying more to get better value 18%

40% Proven experience on similar projects

Use of penalty clauses 8%

30% Recommendation from peers 29%

10%

20%

Independence of supplier organisation

30%

40%

50%

60%

% of participants

26% Inhouse equipment/software

The strong growth experienced in the last few years is therefore expected to continue in 2016. Indeed, the expectations for using in-house staff by respondents to the Chemical Watch survey were very similar to those one year ago, with 47% anticipating an increase and 45% expecting no change in 2015 [Figure 24]. The outlook for the longer term is even more positive, with 62% expecting to recruit more in-house staff.

21% ISO9001 or equivalent (quality management) 19% ISO14001 or equivalent (environmental management) 16% Proximity to your office

Figure 24

ANTICIPATED FUTURE NEED FOR IN-HOUSE STAFF

Large size of supplier organisation 7% 0%

Service Providers

33%

Availability

Next 12 months 20%

40%

60%

80%

100%

% of participants

INCREASING COMPLEXITY WILL CONTINUE TO DRIVE FURTHER GROWTH Regulatory activity continues unabated across the globe and is placing increasing pressure on chemical manufacturers, distributors and downstream users across all industry segments. Importantly, many of these regulations are impacting companies that previously had little to do with chemicals management and control issues and many will need the assistance of service providers.

Chemical Watch | Global Service Providers Guide 2016

40%

45%

7% 1%

Next 5 years 9% 0%

53%

27% 9% 1% 100%

% of participants Increase significantly Decrease

Increase

Static

Decrease significantly

Notably, outsourcing of chemicals management and control activities will expand more than internal expenditures. More respondents expect their need for external services to increase both over the next 12 months and the next five years [Figure 25]. In the short term, 54% of participants anticipate greater use of external services, which increases to 62% for the longer term.

Page 51

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ANTICIPATED FUTURE NEED FOR EXTERNAL SERVICES Next 12 months 4%

50%

40%

6% 0%

Next 5 years 9%

53%

27% 9% 1% 100%

% of participants Increase significantly Decrease

Increase

Static

Decrease significantly

Service providers are responding by hiring new employees. Many are continuing an expansion phase, while others are adding new personnel for the first time in some years in 2016. Having global providers is certainly a preference for multi-national chemical companies. “As global chemical companies adapt to worldwide regulations, there is little desire to have multiple service providers in multiple markets. Toxicity testing labs and compliance consultants must be competent in all regulating countries to minimise overhead and compliance miscues,” observes Celanese’s Dr Brondsema. Esmeralda Michilsen, global hazard communication programme manager for Ashland Inc. agrees: “We certainly have a need for expertise on a global level. However, we also need very detailed information about local legislation and prefer to work with one-stop-shop companies.”

Expectations for global support are putting pressure on service providers previously focused on REACH to evolve to meet customer needs and new market drivers by adding new skills; for those that have, chemical control management has become a business opportunity, according to REACHLaw’s Ms Sekki. Participants in the Chemical Watch survey that intend to use external services over the next 12 months are interested in many different types of support [Figure 26]. Information management services were once again most often cited (68% in 2015 versus 60% in 2014) followed by assistance with IT and software (58%), training (58%) and consultancy/advisory services (55%). These same four service categories will experience the greatest increases in demand over the next five years as well [Figure 27]. The demand for laboratory services will also increase significantly over the longer term. Figure 27 ANTICIPATED NEED FOR EXTERNAL SECTOR SERVICES BY SURVEY PARTICIPANTS IN THE NEXT FIVE YEARS Consultancy/advisory 63%

30%

Representation & management 40%

53%

Legal services 44%

50%

Laboratory 56%

37%

IT & software

Figure 26

67%

ANTICIPATED NEED FOR EXTERNAL SECTOR SERVICES BY SURVEY PARTICIPANTS IN THE NEXT 12 MONTHS

Information

Consultancy/advisory

Training

55%

40%

Representation & management 33%

60%

72%

56%

Laboratory 47%

46%

IT & software 58%

39%

Information 68%

30%

Training 58%

38%

Other(s) 16%

81%

% of participants Increase

Static

Decrease

Chemical Watch | Global Service Providers Guide 2016

100%

26%

64%

33%

Other(s) 19%

Legal services 39%

29%

79%

% of participants

0% Increase

Static

100%

Decrease

A look at the types of services in demand within each service category provides further information about the future shape of the market [Figure 28]. In the information services category, respondents expect to need the most additional support with the tracking of regulatory developments (61%). In IT and software solutions, demand will increase the most for regulatory information management (59%) and safety data sheet systems (49%), followed by substance inventory management systems (46%) and supply chain management/communication systems (45%). With respect to training assistance, respondents expect to have the greatest increase in need for courses and webinars (53%). Consultancy and advisory services that are expected to increase the most include interpretation of regulations (63%) and product compliance (54%).

Page 53

Service Providers

Figure 25

Figure 28 ANTICIPATED NEED FOR SPECIFIC EXTERNAL SECTOR SERVICES BY SURVEY PARTICIPANTS OVER THE NEXT FIVE YEARS Guidance on regulation interpretation

63%

Product compliance

Service Providers

Consultancy/ advisory

54%

44%

Registration strategies

50%

45%

Supply chain communications

48%

47%

Environmental risk assessment

40%

53%

Assessment of data quality

38%

58%

Corporate strategy/strategic planning

37%

56%

Testing strategies

37%

54%

SVHC advisory services Chemical transport and warehousing advice

32%

54%

20%

14%

63%

18%

Dossier preparation & safety assessment, including CSA/ CSR

48%

46%

Registration services

46%

47%

Representation (lead, only representative, 3rd party etc) Representation & management

29%

64%

29%

60%

12%

GHS notification

28%

60%

12%

Management (Sief, consortium etc)

27%

64%

19%

66%

Regulatory/policy tracking

15%

61%

Chemical hazard database Information

38%

50%

49%

Managed regulatory content

50%

(Material) safety data sheets

47%

Human health toxicology

46%

50%

Environmental fate & degradation

46%

50%

Laboratory

Ecotoxicology

45%

Physical & analytical chemistry

45%

Exposure testing

43%

Environmental monitoring

Supply chain management/ communications systems

46%

52%

45%

52%

29%

Emergency response Logistics Insurance

64%

23% 21% 17% 13%

0% Increase

7% 9% 43%

31%

29%

67% 53%

Lobbying/advocacy Legal representatve

62%

23%

Bespoke/inhouse training

0% 3%

CPD/CES certified training 13%

Other

49%

Training courses/webinars Training

41%

33%

Consortia/registration management solutions Laboratory information management solutions

61%

49%

EH&S solutions

63% 59%

(Material) safety data sheet systems

54%

30%

Regulatory information management Substance inventory management systems

47%

35%

SVHC testing

IT solutions

CLP notification

Business process outsourcing (BPO)

Page 54

36%

63%

77%

10%

61%

10%

70%

75%

80%

% of participants Static

100% Decrease

Chemical Watch | Global Service Providers Guide 2016

CONCERNED WITH

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RESTRICTION? Did you know that your voice matters before such regulatory decisions are made?

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Service Providers

SO WHAT WILL COMPANIES BE DOING IN 2016? Many companies have been actively expanding their specialised capabilities in anticipation of needing help. REACHLaw, for instance, has established strategic partnerships in China and South Korea and opened subsidiaries in some countries, such as Turkey, to support growing regulations. It is also helping companies create action plans towards authorisation of substances of very high concern (SVHCs) under REACH and is also supporting REACH authorisation applications as well as 2018 REACH lead registrants and co-registrants. CEHTRA is also diversifying its REACH support services (and is further developing expertise to support global compliance activities, training and in silico approaches to chemical property evaluation. KFT, meanwhile, is focused on serving small and medium enterprises (SMEs), and has expanded into areas such as cosmetics, biocides and articles under REACH in order to serve as a one-stop-shop. Service providers in Asia are also looking to expand. CNCIC is one company that intends to be more active in

the global market, with GHS and agricultural chemicals top priorities. CIRS, meanwhile, will be expanding the industries it serves, and is setting up a more purpose-built team of in-house experts and external partners that can support a wider range of specialised projects. The key for both service providers and their customers, according to Joyce Borkhoff at Intertek Scientific & Regulatory Consultancy, is to develop smart notification strategies that incorporate smart testing plans. “Doing so ensures a streamlined approach to dossier development, which maximises the acceptability of an individual study in as many jurisdictions as possible,” she says. The increasing regulatory burden and growing pressures from customers and NGOs should be seen as an opportunity, according to Outerknown’s Ms Gottschamer. “The need to better manage chemicals is encouraging all members of the value chain to work with their suppliers. The ultimate goal is to prevent harmful chemicals from entering the supply chain. If that can be achieved, there won’t be such a need for compliance testing at the end of the chain, which is wasteful, costly and slows down the time it takes to get products to market.” Service providers are playing a critical role in facilitating this process.

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www.chemicalwatch.com/biocideshub Page 56 Chemical Watch | Global Service Providers Guide 2016

GLOBAL OFFICES Carlsbad, CA, USA: 3E Company's headquarters and the worldrenowned EH&S Mission Control call centre. Copenhagen, Denmark: European headquarters and SDS authoring and related regulatory services centre-of-excellence. Montreal, QC, Canada: SDS management products and services operations. Bethesda, MD, USA: Ariel global regulatory data development and operations. Kingsport, TN, USA: SDS authoring centre-of-excellence. Canton, OH, USA: MSDgen SDS authoring platform product, operations and support centre.

CONTACTS www.3ecompany.com

E-mail

info@3ecompany.com

Head office

3207 Grey Hawk Court, Carlsbad, CA 92010, USA

Tel/ Fax

+1 760 602 8700/ +1 760 930 6662

Directors

Uday Virkud, President & CEO Leo Oves, Chief Information Officer Marie Shannon, Senior Vice President, Finance Matthew Johnston, Vice President, Global Business Development Dan Jordan, Vice President, Supplier Data Management Alex Ortiz, Vice President, Global Regulatory Content Clark VanScoder, Senior Vice President, Authoring Software & Services Tamie Webber, Assistant Vice President, Supply Chain Solutions Andrea Verspay, Vice President, EMEA Business Development

PROFILE: 3E Company

Website

Ownership

Owned by public company, Verisk Analytics

Locations

US, Canada, Europe, Asia

Founded

1988

SERVICES PROVIDED Product safety and stewardship tools and decision support Ariel® WebInsight – a subscription-based online reference tool for researching and tracking how chemicals and substances are regulated globally. ArielLogic for food and flavours – a subscription-based online reference tool for researching and tracking regulated flavours and food additives. Ariel Data Manager® (ADM) – seamlessly integrates chemical regulatory data into corporate systems and provides efficient change management and regular updates as regulations change and new ones are released. Ariel Solutions for SAP® – integrated chemical, regulatory, toxicity and eco-toxicity data, vendor SDS data, expert rules, multilingual phrases, document and label templates, and data loading tools for managing EH&S compliance activities in SAP EHS, Recipe Development and Material Master. SDS authoring and distribution

OVERVIEW 3E Company is a global provider of EH&S and supply chain compliance information services. By combining our extensive data assets with rigorous industry-leading analytics and deep domain expertise, we provide unique insights that enable our customers to improve compliance through the entire lifecycle of a chemical product. As an industry leader with more than 5,000 customers in 35 countries, we support companies in almost every industry. Leveraging our expertise in the obtainment, management and distribution of compliance information, we provide solutions that reduce risk, achieve regulatory compliance and improve disclosure management in relation to supply chain activities. VITAL STATISTICS

2014/15

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

300+

Staff, chemical service provision

80%

SDS management and workplace safety SDS management – a variety of products and services for the management of vendor supplier SDSs. Transportation – 24-7-365 global hotline access for guidance and classification of shipping hazardous materials for any mode. Emergency response – 24-7-365 emergency response to spills, ingestions or exposures, or for dispatching emergency responders to an incident. Regulatory reporting – 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 data and sustainability tools

SERVICE AREA BREAKDOWN

IT & software 10%

MSDgen® SDS Authoring Software – an enterprise software solution suite designed for companies’ in-house EH&S staff. SDS Authoring Services – provides outsourced or co-sourced assistance with authoring SDSs via 3E’s own fully-dedicated, in-house staff of highly qualified, multilingual authors. SDS Distribution – facilitates the dissemination of SDSs to all stakeholders.

3ESC®: 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.

Consultancy/ Other advisory 5% 5%

Information 80%

Page 58

Chemical Watch | Global Service Providers Guide 2016

REACH – 3E can work collaboratively with a company to produce exposure scenarios for eSDSs. GHS – classification services and consulting to companies who need assistance with understanding the implications that GHS has on their business. TSCA – services range from fully outsourcing TSCA compliance to project-based, function-specific areas. C&L Notification – assists manufacturers and importers with CLP classification and subsequent Echa notification under the European Union’s CLP Regulation. European product registration – 3E can determine which products need to be registered, perform the registration process, the maintenance of the registration and any necessary updates to SDSs and labels. DGSA (dangerous goods safety adviser) – 3E can serve as a company’s DGSA. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1998

Company founded.

2004

Acquisition: Ariel Research Corporation; international expansion.

2007

Acquisitions: HSE Systems and MSDS Solutions.

2008

REACH and GHS initiatives.

2010

Acquired by Verisk Analytics.

2013

Launched 3ESC Supply Chain platform and services.

2014

Expand global presence with new Tokyo office.

2002 -15

Long-time and frequent industry award recipient: http://3ecompany.com/about-3e/awards-recognition

ACCREDITATIONS CHMM, CSP, DGSA, CPEA, CSBA, REA, IATA, more. PARTNERS The Chemical Daily, DGM (Dangerous Goods Management Group), RGB Chemicals Co, Ltd., BIOVIA, Enablon, Airsweb, Intelex, Logical Data Solutions, SciQuest, Kelaroo, Logic1, ASD, more. CLIENTS More than 5,000 clients across 35 countries span multiple industries including chemicals; cosmetics; food contact; food; flavours and fragrances;personal care and consumer products; electronics and medical devices; healthcare; industrial, automotive and heavy equipment manufacturers; oil, gas and petrochemicals; pharmaceuticals; retail; utilities CASE STUDY 1: ArrMazz & MSDgen – working together to achieve global conformance Industry: specialty chemicals Challenge: burdened with providing accurate and comprehensive safety data sheets and labels in each of the markets it serves. Solution: MSDgen SDS and label authoring software Results: ArrMaz noticed significant improvements in efficiency and accuracy once it began developing documents in MSDgen, authoring more than 2,000 SDSs a year in a range of languages, including Arabic, Bulgarian, Croatian, Czech, Dutch, French, German, Hindi, Hungarian, Indonesian, Italian, Korean, Polish, Lithuanian, Malaysian, Norwegian, Portuguese, Romanian, Russian, Simplified Chinese, Slovakian, Spanish, Swedish, Ukrainian and Vietnamese. “3E has an expanse of regulatory knowledge that’s applied to each of its solutions, including MSDgen. Its country-specific regulatory knowledge is unparalleled and it gives us confidence that we are authoring accurate conforming documents, no matter what the language.”

Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 2: Vestas wind systems blows away global deployment challenges with 3E Online-SDS Industry: manufacturing – wind turbines Challenge: Vestas had no way to consistently and efficiently manage thousands of SDSs in multiple languages across its 14 business units. Solution: 3E Online-SDS Results: “Perhaps one of the most significant benefits is having increased confidence that SDS updates are being executed in an efficient and reliable manner. Prior to deploying 3E Online, the updating process was one of our biggest challenges. SDSs were always updated, but weren’t always proliferated to all of our different sites. STAFF SELECTION Patricia Iscaro, Senior Regulatory Research Analyst As Senior Regulatory Research Analyst for 3E Supply Chain Solutions, Patricia Iscaro is responsible for writing food-related news for 3E’s ArielLogic and Supply Chain Solutions, monitoring food regulations and analysing industry trends worldwide. She also supports ongoing consultations for 3E’s clients. Prior to joining the 3E team, she worked for AECOM (formerly URS Corporation) as an environmental policy analyst. There her research focused on existing and proposed environmental legislation and its impact on the US Department of Defence mission in Europe, Africa and Southwest Asia. As a consultant with 3E, she covered Italy and Francophone countries in Europe and Africa. Ms Iscaro is fluent in French and Italian. Nhat Nguyen, Regulatory Analyst Nhat Nguyen is a regulatory analyst for 3E’s Asia Pacific region. Mr Nguyen is responsible for providing timely and accurate regulatory content for 3E’s Ariel WebInsight and ArielLogic products, covering chemical, chemical products and food safety regulations in the Southeast Asia and Pacific region. Mr Nguyen has written articles, spoken at conferences and given webinars on Asia Pacific chemical regulations. He also provides consulting services to companies conducting business in the region. Prior to joining 3E, Mr Nguyen worked as an attorney and consultant, advising multi-national corporations on a variety of issues involving EU, US and Southeast Asian laws. Mr Nguyen holds a bachelor degree in architectural engineering from the Illinois Institute of Technology, where he specialised in structural engineering and construction management. He also holds a Juris Doctor degree from American University Washington College of Law. During law school he worked with various governmental and public agencies including the US Securities and Exchange Commission, and served as a clerk for an administrative judge at the Equal Employment Opportunity Commission. Julie Byrne, Chemical Regulatory Advisor Ms Julie Byrne is a chemical regulatory consultant whose educational background is as a chemist. Ms Byrne has experience in a laboratory environment and has 20 years of experience in providing regulatory and EHS product stewardship guidance in the chemical industry. Her focus is in supporting clients in the areas of worldwide chemical regulations (including US, Canada, China, Japan, Australia, Korea, and the EU) with a primary focus on US TSCA regulations. Ms Byrne is responsible for providing TSCA Compliance Services for clients, preparing compliance strategies including 2016 CDR reporting, preparing exemptions (such as polymer and R&D) and submissions (PMN, LVE, NOC and SNUN) as part of 3E TSCA Services. Ms Byrne also provides training and audit services via web and onsite as needed.

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PROFILE: 3E Company

Consulting and professional services

GLOBAL OFFICES The Acta Group EU, Ltd, Brook House Suite 2B, 64-72 Spring Gardens,Manchester M2 2BQ, UK. The Acta Group, LLC, 2200 Pennsylvania Avenue, NW, Suite 100W, Washington, DC 20037-1701, US Tel: +1 (202) 266-5020. The Acta Group China, LLC, 1009 Tongguang Tower, No 12 Nongzhanguan Nanli, Beijing, China 100125, TEL: +86 108 453 4538. The Acta Group China, LLC, has affiliates in Shanghai, Nanjing, and Xi’an.

PROFILE: ACTA

CONTACTS Website

www.actagroup.com

E-mail

lbergeson@actagroup.com

Head Office

The Acta Group EU, Ltd, Brook House Suite 2B, 64-72 Spring Gardens, Manchester M2 2BQ, UK

SERVICES PROVIDED

Tel

+44 (0) 330 223 0610

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, and China

Founded

2004

We represent and counsel individuals, business entities, trade associations, and industry associations. Our fundamental goals are to solve our clients’ existing problems and to minimise future difficulties. We take a multi-disciplinary approach in assisting our clients. Attention must be paid to the interplay of all branches of government and interest groups. Our capabilities, borne of site and issue-specific experience, combined with our national and international view on policy and regulatory developments, position us to handle all these tasks with judgment, creativity, and efficiency.

General consulting services

OVERVIEW

Global product registration and agent services (only representative services)

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

Regulatory chemical product notification, registration, and technical defence under the framework of global chemical programmes, including REACH, biocidal products Regulation (BPR), globally harmonised system of classification and labelling of chemicals (GHS), Toxic Substances Control Act (TSCA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Korean REACH (K-REACH), the Canadian Environmental Protection Act (Cepa), China Order No 7, and California Safer Consumer Products Regulations. Acta concentrates on obtaining, maintaining, and supporting product approvals and efficiently overcoming commercial or regulatory impediments to the successful and profitable marketing of approved products. Jurisdictions we are active in are: North and South America, EU, Switzerland, Turkey, Australia and New Zealand, Malaysia, China, Japan, South Korea, Taiwan, Philippines, Singapore, and Indonesia.

VITAL STATISTICS

Data compensation support services and trade infringement/ competition issues

2014/15

Turnover, group

Turnover, chemical service provision

No. of offices

No. of countries represented

>25

Staff, group

30+

Staff, chemical service provision

30+

Technical document preparation activities – hazard, exposure and risk assessment

SERVICE AREA BREAKDOWN Other Training 5% 5%

Consultancy/advisory 30%

Undertaking the appropriate document preparation and coordination to support registration and post-registration activities (ie chemical substance dossier preparation, exposure assessments, hazard assessments, specific effect analysis and assessments, petitions, response to comment documents, inquiries, and safety data sheet (SDS) preparation). GHS, classification, labelling and packaging (CLP) services

Legal 25%

IT & software 5% Information 10%

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Acta is engaged in numerous data compensation and competition-related issues at the global level. Activities range from supporting, evaluating, preparing, and managing data cost on behalf of the data owner as well as for those entities seeking data access. As a result of recent activities in association with the REACH legislation, many clients continue to evaluate and pursue competition-related issues. We are actively engaged in data compensation and competition-related disputes.

Representation & management 20%

Acta offers comprehensive global services, including substance classification, SDS preparation/review, label formulation, hazard communication (HazCom) services, and GHS programme development and training courses.

Chemical Watch | Global Service Providers Guide 2016

Jane S Vergnes, PhD, DABT –Vice President, Scientific Affairs

Occupational Health and Safety Assessment Series 18001; International Organisation for Standardisation (ISO) 9001; ISO 14000 B&C® Consortia Management, LLC Bergeson & Campbell, PC

An esteemed toxicologist with an impressive track record of success directing global product stewardship for Fortune 500-listed chemical companies before joining Acta, Dr Vergnes has particular expertise in toxicological testing within the regulatory framework of REACH and TSCA, including study design, laboratory practices, and data requirements for new chemical introductions.

CLIENTS

Leslie Scott MacDougall – Director, Strategic Program Development

PARTNERS

Acta EU’s clients are involved in many businesses, including basic, specialty, agricultural, and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; medical devices and diagnostic products; fibres; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution and consumer product sectors. TESTIMONIALS Our client list is maintained on a confidential basis. We do not publish client names/testimonials. CASE STUDY 1: Successful European Chemicals Agency (Echa) appeal Provided strategic technical support to our European legal counsel, Field Fisher Waterhouse, in the first successful appeal under the REACH legislation. It is important to note that at the time of the appeal, the technical completeness check (TCC) tool was not available. Echa rejected the dossier based on the premise of incompleteness. A successful appeal was performed without the need to petition Echa further. The substance was granted registration, a registration number assigned and appeal fees returned. CASE STUDY 2: Data compensation issue Prepared strategic counselling and documentation to support and submit data compensation dispute/appeal under the REACH legislation. Reviewed and issued response to Echa’s position on the data-sharing dispute. Initiated documentation to support a petition for competition law infringement in association with conduct under the framework of REACH. Our work in this area builds upon our significant and extensive data compensation work in the US under FIFRA. In other roles, we perform analysis of data valuation in association with the data rights to be granted. CASE STUDY 3: Import tolerance Provided strategic regulatory counselling on the development of import tolerances/exemption from tolerances for raw and/or processed agricultural goods exported from Europe into the US that have been treated with pesticides that are not registered in the US under FIFRA, and can be expected to have residues. Worked extensively with the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA) staff to bring cases to successful resolution. In addition, worked extensively with enforcement personnel in cases where commodities have been inadvertently imported bearing residues of unregistered pesticides and resolved matters successfully. STAFF SELECTION Lynn L Bergeson – President Ms Bergeson has for over two decades assisted individual companies and a wide range of trade groups and ad hoc consortia on chemicalspecific legislative and regulatory matters. Ms Bergeson’s practice areas include TSCA, FIFRA, REACH, and related international chemical notification, registration, and strategic product defence and product approval litigation matters.

Chemical Watch | Global Service Providers Guide 2016

Ms MacDougall has more than two decades of experience in chemical control and regulation. She spent a significant portion of her career as a programme manager for the EPA. As the managing director of Acta, Ms MacDougall’s focus is on global product registration support activities. She is a key technical advisor to legal staff in support of international litigation matters (ie, appeals, data compensation issues) and international chemical legislation developments. Karin F Baron, MSPH – Senior Regulatory Consultant Ms Baron has more than 15 years of experience leading hazard communication, industrial hygiene, and EHS programmes for multinational chemical companies. Her primary areas of practice include hazard and risk assessment and communication, industrial hygiene and EHS programmes, US FDA regulations pertaining to food contact materials, GHS and SDS, and the transport of dangerous goods. She is a certified by the Dangerous Goods Advisory Council. J Brian Xu, MD, PhD, DABT – Toxicologist Dr Xu is a board-certified toxicologist, an MD in pathology, holds a PhD in pharmacology and toxicology, and has over 15 years of industry experience as a senior toxicologist and scientist at companies such as Ashland, Inc, Schering-Plough, and Merck. Dr Xu designs safety testing, risk assessment, product safety, and regulatory compliance programmes and works with clients to place, manage, and monitor toxicological and clinical tests ensuring Good Laboratory Practices (GLP) at laboratories in the US, EU, and China. Emma Louise Jackson, CBIOL, MSB – Regulatory Specialist Ms Jackson has more than a decade of experience in testing and regulatory environments, assisting clients to achieve 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. Louise C Boardall – Regulatory Associate Ms Boardall provides support for global chemical regulatory compliance with emphasis on EU chemical regulatory programmes, including all aspects of REACH. She performs only representative support activities, including substance information exchange forum (Sief) communications, obtaining/providing letters of access, and supporting supply chain management, including downstream user communications. Zameer Qureshi – Legal Consultant to Acta EU Mr Qureshi is a chemical regulatory and international business lawyer based in the UK. Mr. Qureshi has an in-depth understanding of UK and European Union (EU) laws related to Acta EU’s practice areas, and he deploys this knowledge to assist Acta clients in achieving and maintaining compliance across multiple global regulatory frameworks. A native English/ Urdu bilingual, Mr. Qureshi is also conversant in Hindi and can read Arabic.

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PROFILE: ACTA

ACCREDITATIONS

GLOBAL OFFICES Offices in Brazil and Australia. Agents in Japan, plus a consultant network covering Europe, Middle East, Africa, Asia, Australasia SERVICES PROVIDED Regulatory dossier services

PROFILE: APC

CONTACTS

Data gap analysis, drafting of data waivers, data extrapolation, risk assessments, dossier preparation, placement and monitoring of studies, including efficacy development programmes.

Website

www.apc.eu.com

E-mail

enquiries@apc.eu.com

Head office

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

Tel

+44 (0)1937 587962

Contact

Chris O’Hara

Directors

Steve Shires, Saul Shires, Daniel Shires, Andrew Murray – Director of Development and International Business, Chris O’Hara – Director of Regulatory Affairs

Ownership

Private

Locations

UK (Wetherby and Ringwood), France (Maubec and Lyon), Poland, Czech Republic, Australia and Brazil

Founded

2001

Plant protection products

OVERVIEW Established in 2001 by Dr Steve Shires to satisfy a market need for a coordinated network of scientific consultants. APC has steadily grown to have offices in the UK, France, Poland, Czech Republic, Australia and Brazil, as well as a global network of consultants covering more than 40 countries. APC’s experienced team of chemists, agronomists, toxicologists and environmental experts can address a broad range of regulatory challenges. Working together with our network of local experts whose knowledge and contacts within various ministries around the world enables APC to design bespoke regulatory solutions for our clients’ needs. As a result of the global reach of the APC network, APC can provide sound regulatory and technical support for biocides (98/8), plant protection products (1107/2009), biocides and general chemicals (REACH). Dedicated APC project managers are assigned to each client from the beginning. They become the focal point for communications, providing the client with valuable strategic advice and timely support throughout each project to submission and during evaluation to approval. VITAL STATISTICS

2015/16

Turnover, group

€4m

Turnover, chemical service provision

€4m

No of offices No of countries represented

8 >40

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

Consultancy/advisory 100%

Staff at APC have extensive experience in the preparation and submission of dRRs in the support of zonal authorisations. APC has provided support to clients for many different regulatory projects including data matching, technical equivalence, CLP, CLH, literature reviews, support through to Annex I inclusion, Annex I renewal (AIR) and dRR Zonal dossiers. Many of these projects required an innovative and bespoke approach to the preparation of higher tier risk assessments. APC has considerable experience in obtaining international registrations outside EU including Africa, Asia and CIS countries. We have successfully managed >10 Annex II data matching programmes for protected study dossiers and gained Annex I listings for both conventional and novel active substances. We have supported numerous actives through the EU review process, including four biopesticides and managed and submitted >200 Annex III dossiers with another 50 applications for mutual recognitions. APC’s particular strength is in the use of our local consultant network to provide regulatory support for our customers, from the drafting of MSDS and labels in the local language through to in-person negotiation with the regulatory authorities. Biocides APC’s team of experts has experience in the submission and support of Annex I dossiers in support of various PT groups, including higher tier environmental and non-dietary human risk assessments. In addition, APC’s network of consultants can complete, submit and notarise national applications forms for our clients in support of applications in the transitional period before Annex I inclusion comes into force. Biopesticides APC has expertise in the submission of four Annex I dossiers in support of biopesticides. REACH and GHS APC provide a range of services from third party/only representation to dossier preparation and risk assessment for CSRs. Our experts have experience of various exposure modelling tools required for CSRs, including Ecetoc TRA, ART, Stoffenmanager, Euses, ConsExpo, BEAT etc. APC can prepare CLP/GHS proposals for MSDSs and dossiers. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2001

Company registered in England

2005

French office opened

2008

UK Wetherby office opened

2009

Polish office opened

2010

UK Ringwood office opened

2012

APC Brazil and APC Australia opened

2015

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

PARTNERS Triveritas – veterinary medicine specialist.

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Chemical Watch | Global Service Providers Guide 2016

Our current client data base has more than 100 clients from various industry sectors and disciplines. CASE STUDY 1: European plant protection product support at STEP 2 APC performed a preliminary bird and mammal risk assessment according to the Efsa Guidance (2009) for a fungicide used on a variety of crops. The critical uses of the product were discussed by ecotoxicology and efficacy experts to ensure that uses were supportable in terms of application rates, numbers of applications and timings (BBCH stages). The efficacy and residues trials programme was tailored to support the revised rates and timings with the aim of supporting the maximum number of crops at re-registration. Separate member state (MS) draft registration reports (dRR) were found to be appropriate for the Central zone as the target MS had different crop groups and environmental fate modelling requirements. On the other hand a zonal dRR was found to be appropriate for the Southern zone where there was overlap of uses and environmental fate modelling. Where necessary MS specific environmental requirements (eg UK spray drift PECsw or relevant FOCUSsw scenarios) were detailed and appropriate environmental mitigation specified. CASE STUDY 2: Annex II equivalence at Step 1 One of the Annex II data matching programmes for protected study dossiers that APC managed was for an insecticide with many complex metabolites and some very challenging environmental issues. In this project we were able to save our client >€1m of studies by drafting skilful waiver arguments and having detailed negotiations with the EU RMS. Despite the many technical challenges APC was then able to meet the tight Step 1 submission deadline and get a positive evaluation from the RMS. Finally, APC led the successful negotiations for access to protected vertebrate studies with the primary data holder. Our client was therefore able to maintain all of their existing national registrations at a cost well below what was initially expected.

In 2001 he started Agchem Project Consulting Ltd (APC), with a vision of making it a truly international consultancy offering a full range of services at national as well as central EU level. In his current role as managing director of APC Steve is responsible for providing overall company management plus guidance in both technical and business strategic issues. Andrew Murray – Director of Development and International Business Andrew’s career started in 1978 with Shell Research where he was involved in both field R&D and ecotoxicology roles. In 1985 he joined Rohm and Haas where he was the UK and Ireland R&D Manager. In 1996 Andrew moved to Inveresk Research International Limited where he helped co-ordinate a field trials department as part of the CRO’s services. Andrew joined Hockley International Limited in 2001 where he was the Registration and Technical Manager registering agricultural, public health and veterinary products with distributors and consultants worldwide together with the provision of appropriate technical support to allow the market development of the products. In 2011 he joined APC as a Project manager with responsibilities including management and development of APC’s international business, together with field study development and biocidal projects support. Andrew is now APC’s Director of Development and international business, responsible for management of APC offices in Australia and Brazil together with the running of the network of local country consultants. Chris O’Hara – Director of Regulatory Affairs

Using our large network of consultants, APC was able to organise out of season trials in South Africa, Australia and New Zealand in order to speed up the acquisition of data needed to confirm the performance of a new formulation. Our field efficacy experts were then able to justify the inclusion of this data as supporting evidence showing comparability with EU conditions where appropriate. This initiative resulted in a registration being obtained one year earlier than first anticipated.

Chris has over 20 years of regulatory experience with plant protection products, biocides and REACH gained from working at a contract research organisation and at a major consultancy. He has a comprehensive working knowledge of EU regulatory evaluation procedures and risk assessment methods, including relevant guidelines and EC regulations as they pertain to existing and new active substances. Chris has been a project manager for numerous biocide and pesticide projects. These projects included the conduct of completeness checks, preliminary risk assessments, dossier compilation and the provision of regulatory strategic support. In addition to his general regulatory project management skills, he specialises in the conduct of human health exposure and risk assessments for pesticides, biocides and chemicals and has made expert presentations at conferences on the subject. Prior to joining APC, Chris was the Head of the Human Health Group at a major consultancy co-ordinating the preparation of dossiers/risk assessments and the management of resource allocation.

CASE STUDY 4: REACH registration non-phase-in substance

Kati Pikulik – Manager, APC Poland

CASE STUDY 3: Out of season trials

APC have assisted a PPP manufacture with their REACH preparations by undertaking a full analysis of their marketed products and undertaking REACH registration procedures for the relevant substances. Within this, APC identified the requirement to register non-phase-in substances with Echa, and took the relevant action to achieve this, filing enquiry dossiers with Echa, and then using the results of this, and our in house expertise, to undertake a data gap analysis. We then oversaw the completion of any data gaps by overseeing data access agreements with previous registrants, or by constructing expert data waiving arguments for submission to Echa. This led to a full REACH registration for the substances in question. STAFF SELECTION Steve Shires – Managing Director Steve Shires started his career in the plant protection business at Shell Research in 1977, where he was a founder member of the environmental biology group. Following seven years leading ecotoxicology projects on pesticides, he spent a further four years in Shell managing development and registration in the Far East and Australia. In 1988 Steve moved to FMC as the registration manager for Europe Middle East and Africa (EMEA) and then moved to become director of development and regulatory affairs. Chemical Watch | Global Service Providers Guide 2016

Kati is the Registration Manager and Office Manager at the Poznań, Poland APC office. Her registration career began in 2000 in both sales and consultancy and she represents APC for all regulatory, development and technical activities and advice in Poland. Kati has experience in the provision of regulatory advice and registration procedures in Poland according to EU requirements as well as changes in registration procedures following Poland joining the European Union. Kati also has excellent contacts with Polish registration and evaluation authorities. François Walker – Manager, APC France François is a Registration Manager, Residue Specialist and Manager of the APC France office. François has experience in agrochemicals (including biopesticides) and biocides, gained from both industry and consultancy. François has experience in all areas of managing and making regulatory submissions. He is also one of APC’s residue experts. Working across many EU member states, François is experienced in the provision of regulatory advice and has developed cost effective regulatory strategies for a range of clients. He has placed and monitored a wide range of regulatory studies especially in the areas of residues, toxicology and ecotoxicology. François has been involved in the preparation and management of national/zonal product dossiers and also active substance dossiers in compliance with current directives.

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PROFILE: APC

CLIENTS

PROFILE: Apeiron-Team NV

CONTACTS

Web site

www.apeiron-team.eu

E-mail

info@apeiron-team.eu

Head office

Berten Pilstraat 4, 2640 Mortsel, Belgium

Tel

+32 3 808 20 67

Contact

Elke Van Asbroeck

Directors

Elke Van Asbroeck and Hiram Moerman

Ownership

Private company

Locations

Mortsel (Antwerp), Belgium

Founded

2009

Industrial services

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

2014/15

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

> 10

Staff, chemical service provision

> 10

SERVICE AREA BREAKDOWN

Training 10% Information 10%

safety assessment, analysis of alternatives, socio-economic analysis, supply chain communication; other REACH related topics: eSDS compliance training, company specific eSDS support, DU-CSR generation, mixture classification, Annex XV dossier generation, representation of clients in consortia; and biocide dossiers: biocidal product dossier generation, biocidal product family concept

Other 5%

Within the industrial services package, Apeiron-Team provides tailormade advice for a cost efficient implementation of regulations, taking into account the global business strategy and required flexibility of the client. We provide assistance in the development of chemicals management systems and product stewardship programmes. Examples of our industrial services: OO advice on import/export strategy to ensure business continuity; OO position papers and communication with authorities; OO several audit programmes (eg compliance; system; supply chain; project; due diligence and SCC audit); OO scientific advocacy in the pre-authorisation process; OO strategy for comments during evaluation and/or during preauthorisation process; OO strategy deployment for authorisation dossiers OO set up of monitoring programmes (occupational hygiene) OO engineering support for the implementation and documentation of strictly controlled conditions for intermediates. Project management and training Apeiron organises workshops on various aspects of the REACH and biocides implementation process. Examples: in-house workshop on REACH (pre)-authorisation, course on eSDS compliance, understanding REACH and its business impacts, Iuclid for REACH and for biocides, PNECs and DNELs, SVHC in articles, etc. Coming from an engineering background, we have implemented a strong systematic approach to manage our projects. This results in regular status reporting and in-time and in-budget delivery of results. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2009

Apeiron-Team NV was founded

2010

Development of a client portfolio of SMEs and multinationals in chemical and polymer industry. Successful REACH registration of >100 substances.

2011

Extension client portfolio in food and pharma industry. Expansion of services and experience in REACH-like legislations, global SDS requirements, extended safety data sheet related products e.g. eSDS compliance checks and DU-CSRs.

2012

Expansion of our services with the “E” of evaluation and “A” of authorisation within REACH. Scientific advocacy for several projects (related to restrictions, SVHC status, authorisation and evaluation). China REACH notifications (in collaboration with Chinese experts). Preparation of lead and member REACH registrations dossiers for the 2013 deadline.

2013

Successful submission of – lead and member – 2013 dossiers. Generation of 3three authorisation dossiers. Organisation of workshops on the (pre-) authorisation process. Addition of biocides- and cosmetics-related services to our portfolio.

2014

Submission of two authorisation dossiers for trichloroethylene. Preparation of several REACH Registration dossiers (new substances or 2018). Commenting on basis of scientific and regulatory arguments for a substances under substance evaluation. Defence of substance under scrutiny for PBT.

Consultancy/advisory 65%

Representation & management 10%

SERVICES PROVIDED Regulatory services We assist in the interpretation of legal texts: REACH (including requirements for nanomaterials), REACH-like legislations, CLP, biocidal product Regulation, cosmetics Regulation, food contact, and RoHS. Scientific services A selection of our services: OO REACH registration dossiers from A to Z: substance identification, hazard assessment, study monitoring, exposure and risk assessment, PBT assessments; OO REACH authorisation dossiers: strategy development, chemical

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Chemical Watch | Global Service Providers Guide 2016

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

ACCREDITATIONS OO OO OO

European Registered Toxicologists (ERT) Environmental advisor (Milieu Coordinator) Strategic advisor SME

PARTNERS Burgess Regulatory Services Ltd, eftec, Jongerius Consult CLIENTS Our references are situated in several industries and cover the entire supply chain from manufacturing to recycling: OO petrochemical industry, fine chemicals, toll manufacturing, food industry, polymer industry, refinery, tyre industry, pharma industry, retail. TESTIMONIALS “Apeiron-Team are professional and experienced, driven and engaged. With their expertise they translate the tangle of the REACH legislation into practical, concrete guidelines and actions” – BP Chembel "Apeiron-Team is a no-nonsense company delivering their services on time, in full and in budget" – Monument Chemical “For us, Apeiron-team distinguish themselves from other excellent consultants because they are able to think further in the benefit of the company together with us. We consider them as one of us” – Christeyns “During the long process of authorisation (approx. two yrs) Apeiron confirmed numerous times that our choice for them as partner was right: The work delivered exceeded our expectations. Not only have I never experienced such a pro-active consultancy so far in my business life, but they deliver excellent and high-quality work. They are approachable at any time and pick things up even before we realised it is needed. In addition, Apeiron has an almost unrivalled network of contacts to almost every import person in this line of business.” – Vlisco. CASE STUDY 1: REACH authorisation application: from strategic support to dossier generation

performed the cost evaluation of the studies based on their scientific validity. The multi-constituent was selected for further substance evaluation by the MSCA based on its potential PBT properties. During this evaluation process we assisted the lead registrant in determining the most suitable test strategy and in writing the comments to the MSCAs, and we were involved in discussion/communication with the relevant authorities. CASE STUDY 3: Development of downstream user chemical safety report model for about 500 chemicals A formulator dealing with about 500 incoming chemicals found that performing an eSDS compliance check and the associated communication was too cumbersome to allow for an efficient follow-up of the safe use of their chemicals. Apeiron-Team developed a user-friendly DU-CSR model tailored to their specific process. The model does an automatic safe use check of each incoming chemical based on limited input by the user. In case safe use cannot be demonstrated, operational conditions and risk management measures can be adapted in the model to determine which changes in use are required for a specific chemical. The model ultimately created a huge efficiency gain compared to the work required for a traditional eSDS compliance check. Moreover, new incoming chemicals are easily added to the model and the formulator is no longer dependent on his supplier for eSDS or any updates thereof. CASE STUDY 4: Union authorisation of a biocidal product family A Union authorisation dossier for a biocidal product application was prepared based on the biocidal product family (BPF) concept. This within product type 4. The composed biocidal product family, and its meta-SPCs, was evaluated in detail together with the client to ensure the different criteria of a BPF were fulfilled. Furthermore, a detailed data gap analysis was performed taking into account the data which was available and previously submitted under the BPD and the new data requirements stipulated in the BPR. All available information was integrated into Iuclid. In a final step, a draft risk assessment covering the complete BPF was generated. Both the BPF composition, data gap analysis and risk assessment were discussed with the evaluating CA before submission. STAFF SELECTION

The REACH authorisation process is complex and business critical. Vlisco (textile industry) requested our support for the authorisation of trichloroethylene, a non-threshold substance. In a first step, the dossier strategy was developed by means of in-house workshops with the company’s management. In a second step, an authorisation application was generated. A company specific exposure scenario was prepared, demonstrating minimisation of emissions. This was supported by the (bio)monitoring data generated during the course of the project. In the analysis of alternatives a long list of potential alternatives was assessed, followed by a short list, demonstrating that the potential alternatives are not technically feasible, not economically feasible and not resulting in a risk reduction. Several non-use scenarios were discussed and the most plausible one was identified. This formed the input for the socio-economic analysis. A review period of 12 years was requested. On the basis of the arguments and research plan that was provided, Rac and Seac confirmed this review period was considered justified. In a final step, the Commission also granted 12 years.

Elke Van Asbroeck – ir (Bio-)chemical engineer

CASE STUDY 2: REACH registration and evaluation for a multiconstituent

To support the registration of a high volume rubber chemical, we built the complete REACH registration dossier in the context of a consortium. The multi-constituent substance was analysed for all relevant physicochemical and toxicological aspects related to both human health and the environment. Exposure was assessed for all stages of the lifecycle including the waste stage. Scaling equations were generated allowing the downstream users to evaluate their compliance. Within the consortium we developed the cost-sharing model and

Chemical Watch | Global Service Providers Guide 2016

OO OO OO OO OO

Polymer chemistry/ waste and recycle Cost-efficient regulation implementation, import/export strategy Authorisation process, generation of authorisation dossier Auditing Supply chain communication

Hiram Moerman – ir Chemical engineer OO OO OO OO OO

Specialised in process chemistry Product stewardship/GPS Authorisation process, generation of authorisation dossier Auditing Consortium/ project management

Dr Katrien Monsieurs – PhD Organic Chemistry OO OO

OO OO

Specialised in organic synthesis Substance identification Human toxicology, classification and labelling Read-across PBT assessments

Dr Tine Vandenbrouck – PhD Ecotoxicology OO OO OO OO OO

Specialised in mixture effects Registration and authorisation dossiers Hazard, exposure andPBT assessments eSDS generation/scaling tools ERT certified toxicologist

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PROFILE: Apeiron-Team NV

2015

SERVICES PROVIDED

PROFILE: Arcadis

CONTACTS Website

www.arcadis.com

E-mail

GPSinfo@arcadis.com

Head office

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

Contact

Belgium: alain.vassart@arcadis.com +32 3360 8300 Switzerland: andreas.haener@arcadis.com +41 44732 9292 North America: tina.armstrong@arcadis.com +1 410 923 7760 APAC: grant.sprick@arcadis.com +86 136 6174 0762

Directors

Barbara Hudec (Strategic Environmental Consultancy in Europe), Fritz Krieg, CEO (Switzerland), Alex Rothchild, Operations Director (North America)

Ownership

Public company

Locations

300+

Founded

1888

OVERVIEW Arcadis is the leading global natural and built asset design and consultancy firm working in partnership with our clients to deliver exceptional and sustainable outcomes through the application of design, consultancy, engineering, project and management services. Arcadis differentiates through its talented and passionate people and its unique combination of capabilities covering the whole asset life cycle, its deep market sector insights and its ability to integrate health & safety and sustainability into the design and delivery of solutions across the globe. We are 28,000 people who generate €2.6bn in revenues. VITAL STATISTICS Turnover, group

2014/2015 €2.6bn

Turnover, chemical service provision

€8m

No of offices

300+

No of countries represented Staff, group

38 28,000+

Staff, chemical service provision

300+

IT & software Training 4% 4% Laboratory 10% Information 4% Consultancy/advisory 60%

GLOBAL OFFICES Centres of excellence for our product stewardship services are located in both Europe (Belgium and Switzerland) and the US, with staff at over 300 Arcadis global offices providing our clients a local presence in growing markets such as Asia-Pacific and South America.

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REACH full spectrum implementation Arcadis supports its clients with the development and implementation of their compliance programme, performing compliance audits and providing on-site employee training and strategy advice. The team prepares registration, authorisation, exemption, restriction dossiers, develops read-across approaches and intelligent testing strategies, acts as study monitor, performs risk assessments (CSA/CSR), evaluates extended safety data sheets and prepares risk management options analyses. Also, as consortium manager, Arcadis is responsible for the general and financial management of several consortia. In this role, we act as trustee and facilitate cost sharing between members and the Sief. Global agrochemical registration support Arcadis provides effective solutions to help our clients develop, register, manufacture, and ultimately market crop protection products within an increasingly complex global regulatory arena. We provide turnkey compliance support with individual regulations, in specific countries or entire regions. Support is initiated by carefully reviewing the individual product for compliance with the applicable regulations, followed by a thorough exploration of applicable exemptions, identification of data gaps or additional studies required. Our highly experienced staff tailors and designs field and laboratory studies, develops and manages study progress and authors final study reports. Since 1993 our team has expanded to more than 120 GLP trained staff, located across 12 countries in North America and Europe. Lasting relationships have been forged with multinational clients, local and national regulators, landowners, and farming organisations throughout the international community. We have vast experience in the design, management, and conduct of environmental fate field studies. Arcadis has successfully conducted field studies in 16 countries and has collected more than 115,000 environmental samples. Many of the laboratory studies (environmental fate, biodegradation and aquatic toxicology) are conducted at our own OECD GLP certified laboratory in Switzerland. Supply chain management and product stewardship programmes

SERVICE AREA BREAKDOWN

Representation & management 18%

We help our clients to identify and manage their business risks, enabling them to market their products in a safe, responsible, and globally compliant manner covering the whole lifecycle from production and use through the waste stage. Our practice focuses on: OO product stewardship, programmes and audit services; OO global regulatory surveillance; OO sustainability support; OO supply chain management; OO registration, permitting and licensing support; OO exposure assessments (field studies), aquatic and terrestrial modelling, risk assessment, and registration support for the agrochemical industry; and OO strategic scientific solutions, including (eco)toxicology and laboratory services.

Arcadis has helped our clients manage supply chains for products as diverse as household consumer products, automotive components, laboratory reagents and kits, polymers, metals and alloys, pesticides, and food storage containers. We work with our clients to create a structured means of identifying, informing, managing and exchanging information throughout a product’s global supply chain as well as determining regulatory applicability for product portfolios. This process can be used effectively to manage regulatory compliance, perform compliance audits, and meet extended producer responsibilities. Our global footprint allows us to help our clients to work through language and cultural barriers to gather and manage information from their suppliers and work with competent authorities to address regulatory compliance questions. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1888

Parent company Heidemij formed in the Netherlands.

1998

Global company becomes Arcadis.

2002

Establishment of a product stewardship (PS) Centre of Excellence in North America. Chemical Watch | Global Service Providers Guide 2016

Arcadis Belgium becomes a PS Centre of Excellence.

2010

Arcadis acquires LFR Levine-Fricke, USA a leader in the conduct of field studies in support of the registration of agrochemicals. Arcadis supports companies and consortia in their REACH compliance programmes. Arcadis North America established as global centre of excellence for terrestrial and aquatic modelling and spatial data analysis in support of the registration of agrochemicals

2012

Arcadis acquires BMG Engineering Ltd in Switzerland, a leader in product stewardship, ecotoxicology (including GLP compliant laboratories) and REACH.

2013

Arcadis sharpens its focus on product stewardship as a means to help clients to identify and manage business risks. Important aspects of that work include compliance audits; development of stewardship programmes; chemical notifications/ registrations in the EU and US; REACH authorisation; and GHS compliance.

ACCREDITATIONS European registered toxicologists (EuroTox); European registered chemists; Diplomat of the American Board of Toxicology (DABT). The ecotoxicology laboratory of Arcadis Switzerland is GLP-certified and also accredited according to ISO/IEC 17025. Arcadis US and UK are GLP certified to conduct field studies to assess potential environmental endpoints and exposure in support of the registration of agrochemicals. Partners Arcadis has a broad network of partners with whom we work together on an ad hoc basis (CROs, legal advisors, other consulting companies).

CASE STUDY 3: Project management and study monitoring support for a pharmaceutical company Arcadis is considered a strategic partner for a pharmaceutical company in its REACH registration project for over 100 substances/intermediates by the 2018 deadline. Arcadis supports the product stewardship team in all aspects of such a large project. We support management by tracking budget and progress status, overall and per substance. We highlight which processes need more attention and solve critical issues to guarantee business continuity. As study monitor, we support subject matter experts by managing the project through continuous status follow-up and communication with the CRO, review of study plans, evaluation of draft results and final reports. As such, the burden on the internal experts is limited. We are committed to the client and think along with them to deliver the required quality in time. STAFF SELECTION Alain Vassart, Sr. REACH / batteries/ recycling and waste expert Alain has more than 20 years’ 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 (eg, MoZo, rare earth) including the administrative and financial side. Also he has been involved in RMO (risk management option) analysis and in the preparation of authorisation or exemption dossiers. Apart from that, Alain is performing compliance assessments for multiple regulations (including EU REACH, EU RoHS, WEEE, Batteries, Extended Producer Responsibilities, etc.)

Testimonials

Timothy Negley, Agrochemical Modelling

References can be provided upon request.

Timothy has more than 12 years’ experience assessing the fate and transport of crop protection products in the environment. He currently works with agrochemical clients to promote environmental product safety through the use of GIS, modelling, and statistics. He also provides peer review, testing, and validation of models and tools developed by consultants, government, and industry. Timothy has authored more than 60 modelling reports for direct submission to regulatory authorities in the US, Canada, and Europe and also serves as a liaison at regulatory forums upon client request. He is experienced in the following software and modelling programs: ArcGIS, ArcHydro, Basins, CAKE, FIRST, FOCUSPRZM, GENEEC, IORE, KinGUI, ModelMaker, PRZM/EXAMS, PRZM GW, SCI-GROW, SWMM, Stream VOC, SYSTAT, SigmaPlot, TIM, T-REX, WARP.

CASE STUDY 1: Groundwater monitoring in support of agrochemical re-registration activities Arcadis recently completed a groundwater monitoring study at 125 real-world farming locations in the key maize-growing regions of 11 European countries. An international team used a web-based database application to conduct more than 5,000 telephone screening interviews with potential farmers. Following, completion of the phone interview phase the project team conducted more than 360 site assessments which involved the collection of detailed historical pesticide use information, characterisation of shallow soil profile, and determination the depth to groundwater at each monitoring location. A network of 375 high-quality, standardised, shallow groundwater monitoring wells were installed using Arcadis’ own environmental drilling equipment. Monitoring well sampling was conducted by local Arcadis staff on a quarterly basis. More than 700 groundwater samples were collected. This study provided unprecedented magnitude of data on the environmental fate of the agrochemical being studied. CASE STUDY 2: Product stewardship services for an international producer of consumer products For over ten years Arcadis has been helping an international company to bring consumer products to market safely and in compliance with EU regulations. Key activities include: OO product evaluation (classification, labelling, compliance with industry sector standards, regulated substances); OO compilation of safety data sheets for over 20 countries and in over 20 languages including update to the globally harmonized system (GHS); OO data management using a customised data management system; OO REACH compliance including pre-registrations via own only representative (OR) services and definition of a REACH strategy OO product notifications in several European countries; OO consultancy on new developments in the regulatory field including early warning system for critical substances; OO helpdesk for regulatory questions; overall consultancy for national requirements in several countries. Chemical Watch | Global Service Providers Guide 2016

Andreas Häner, Microbiologist / Ecotoxicologist Andreas holds an MSc in biology and a PhD in environmental microbiology. He heads the department for Chemical Safety and the Ecotoxicology Laboratory at Arcadis Switzerland. Over the last 20 years, he has specialised in the fields of chemical safety (such as global product stewardship, legal compliance, REACH, GHS) and environmental risk assessment and has supervised non-clinical GLP studies (aquatic toxicology, biodegradability and environmental fate). Andy Newcombe, Agrochemical Product Stewardship Andy has more than 25 years of international experience in the field of agrochemical research and the fate of agrochemicals in the environment. He has extensive expertise in the design, conduct, and management of complex, higher tier agrochemical fate and transport studies including studies conducted at the field, regional, national, and continentalscales. His background includes successful negotiation with European member state and United States federal and state regulators on behalf of agrochemical industry clients on environmental fate issues associated with their products and has considerable experience in providing clients with litigation support

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PROFILE: Arcadis

2006

GLOBAL OFFICES PJ Van Benedenstraat 4, box 203 3000 Leuven, Belgium Tel: +32 16 28 49 00 SERVICES PROVIDED

PROFILE: ARCHE

CONTACTS

REACH

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

The REACH Regulation is the biggest piece of chemical legislation ever. ARCHE is well placed to help you set up a REACH implementation plan and assist you with the fulfilment of your obligations as producer, importer, distributor and/or downstream user of phase 2 and 3 substances under REACH. We can assist in (a) literature search and data evaluation; (b) Iuclid; (c) exposure scenarios; (d) CSA/CSR; (e) read-across and data waiving; (f) Qsar; (g) REACH dossier submission, updating and follow-up and h) reach compliance. For the latter, ARCHE developed an unique one-to-one assistance programme called RESCUE to help downstream users to ensure REACH/CLP compliance for their substances and mixtures, as these elements will be the primary focus of enforcement authorities across the EU as embedded in the REACH-ENFORCE programmes. Join our REACH 2018 Orphan Substances Consortium (ROSC)

OVERVIEW One of the key areas of expertise is the preparation of REACH-related risk assessments and full dossiers for inorganic substances such as metals, alloys, slags, etc and, as such, the ARCHE experts have been involved in the preparation of many guidance documents (eg Echa) on these topics. Other key services include the assessment (environment and human health) and development of registration dossiers for biocidal products and plant protection products classification of substances and complex mixtures (GHS/CLP), and setting and/or evaluation of (sitespecific) 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

2014/15

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

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

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Training 5%

Consultancy/advisory 75%

Orphan substances are those substances that have no or limited data and no existing organisation working on them. ARCHE acts as a technical partner to the ROSC consortium which is an initiative together with two other renowned and experienced service providers. For more information visit our dedicated website www.rosconsortium.eu Biocides and plant protection products (PPPs) ARCHE offers a one-stop-shop for the registration of your biocides and ppp products or active substances. We furthermore generate and manage consortia for biocidal products or active substances. ARCHE has extensive expertise and a proven track record in delivering solutions to problems at all stages in the registration/review of biocides and PPPs. Offered services include: (a) consortia management for biocidal product; (b) effect and exposure assessment for active substances and products; (c) data gap identification and designing higher-tier studies; (d) exposure modelling (FOCUS suite of models, Euses, Consexpo, EASE); (e) highertier exposure scenario development; (f) CLP; (g) dossier preparation, submission and follow-up; (h) client representation in meetings with regulatory authorities; (i) product stewardship; and (i) training Iuclid for biocides. Cradle to Cradle certificationÂŽ As an authorised Cradle to Cradle material assessor, ARCHE assesses healthy and sustainable products under the Cradle to Cradle certifiedCM Products Programme. The Cradle to Cradle product standard addresses five quality categories relating to human and environmental health: (a) material health, (b) material reutilisation, (c) renewable energy and carbon management, (d) water stewardship, and (e) social fairness. The ultimate goal of the Cradle to Cradle CertifiedCM 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.

20132016

Further expansion to more than 20 people, and further development of the services on biocides and plant protection products.

Chemical Watch | Global Service Providers Guide 2016

PARTNERS

CASE STUDY 3: Consortia for biocidal products

EBRC Consulting GmbH, Hannover PietConsulting REACHLaw ECTX-Consulting

In 2015, ARCHE generated 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. Our first dossier will be submitted early 2016. ARCHE is responsible for the consortium management, testing coordination and dossier preparation including risk assessment, whereas FieldFisher acts as our legal partner for these projects.

Industrial clients and consortia related to the following chemical substances: OO metals including: Cu, Ni, Mo, Pb, Zn, Hg, V, Co, Fe, Se, Sb, Sr, Mg, Bi, Te, Ti, etc; OO organic compounds: chlorinated flame retardants, organic acids, plasticisers, amines, biocides, plant protection products; OO complex materials: Cu slags, Ti slags; and OO other inorganic substances: Ca, B, NaOH, KOH, sulphur dioxiderelated substances (SO2, sulphites, thiosulphates, dithionites), lime, nitric acid, phosphoric acid. TESTIMONIALS “IMOA has worked for the last decade with the environmental scientists working at ARCHE, and they have proved for IMOA/MoCon to be a very wise investment. We can therefore highly recommend ARCHE with regard to their technical expertise and knowledge on environmental issues (aquatic and terrestrial), organisation of research projects, and data interpretation.” – Sandra Carey, International Molybdenum Association (IMOA) “I appreciate ARCHE for the very smooth communication, the professionalism (especially regarding environmental risk assessment) and the innovativeness (use of Qsar and read-across to replace experimental testing)." – Lieve Galle, Manager product regulations, Agfa Gevaert. "ARCHE has proven to be a very valuable consultancy partner for DeLaval over the past few years. DeLaval was able to benefit from the in-depth knowledge of the ARCHE scientists on the European biocidal Regulations (BPD/BPR) and we can only recommend to others the training we received on several aspects of risk assessments (both human and environmental)." Adelheid De Ketelaere, Regulatory Affairs Manager EMEA, SEA PPMQ&AH DeLaval NV more testimonials can be found at www.arche-consulting.be CASE STUDY 1: Providing expert opinion on REACH Compliance Check Following a decision on a compliance check of a registration pursuant to article 41(3) of regulation (EC) N° 1907/2006 people at ARCHE were asked to provide expert support to the registrant in order to compare the release estimates and overall risk paradigms used in the CSA/CSR with the general guidance as provided by Echa. Attention was also given to providing a proper justification of the risk management measures (RMM) and operation conditions (OC) used in the generic exposure scenarios.

STAFF SELECTION Patrick Van Sprang − Managing Director ARCHE 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 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 his main expertise area comprises the implementation and application of statistical and modelling approaches in exposure, effects and risk/safety assessment. Currently, Dr Frederik Verdonck is the leading expert in developing and implementing new tools in the field of exposure assessment. As a certified trainer, he also deals with training programmes on various REACH and BPR risk assessment topics. An Ghekiere − Senior Science Project Manager An Ghekiere graduated as Master of Biochemistry in 2001 and obtained her PhD in Bio-engineering on endocrine disruption in invertebrates at Ghent University (Belgium) in 2006. From 2002 until 2010 she worked on projects (ENDIS-RISKS and INRAM; risk assessment of micropollutants in estuarine and marine environments. At ARCHE she is responsible for the biocides and ppp services. As a ERT certified toxicologist she also deals with human and environmental risk assessments.

CASE STUDY 2: REACH registration dossiers for low-tonnage substances (2018 deadline) ARCHE as technical partner of the ROSC (the REACH Orphans Substances Consortium) will prepare the REACH registration dossier for strontium and barium by the 2018 deadline. Although the 2018 deadline still seems very far away, starting now allows the costs to be spread over time and more substances to be kept on the market after May 2018.

Chemical Watch | Global Service Providers Guide 2016

Page 69

PROFILE: ARCHE

CLIENTS

GLOBAL OFFICES

PROFILE: bibra toxicology advice & consulting

London SERVICES PROVIDED Dossier preparation, including CSA/CSRs (DNEL/DMEL derivation) Highly skilled in working directly into Iuclid preparing technical dossiers required under REACH and the biocidal products Regulation, and in describing toxicological data in a robust but efficient way. Very experienced in interpreting/evaluating toxicity studies and working with appropriate assessment factors to derive risk-based levels of tolerable exposure (DNELs/DMELs). Accurate input of information into Iuclid facilitates the overall chemical safety assessment and production of the final chemical safety report for submission to Echa. We can also advise on relevant classification/labelling, and PBT/vPvB status. Working with partners, we cover all aspects of REACH. We also provide a Iuclid 5 web-hosting service to our clients.

CONTACTS Website

www.bibra-information.co.uk

E-mail

info@bibratoxadvice.co.uk

Head office

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

Tel

+44 (0)20 8619 0770

Contact

Peter Watts

Directors

James Hopkins, Managing Director Peter Watts, Director of Toxicology Graham Hunt, Commercial Director

Ownership

Private company

Locations

Founded

1961, acquired by current management 2005

Human health hazard and risk assessment

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

2014/15

Turnover, group

£2m

Turnover, chemical service provision

£2m

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

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

Consultancy/advisory 85%

Page 70

The bibra toxicology advice & consulting team of toxicologists has worked together over many years (<30 years in some instances), providing robust human health hazard and risk assessments for a diverse range of clients. Tailoring our output to suit the specific requirements of the client, we have worked with companies from the industrial chemicals, agrochemicals, biocides, food and food contact, consumer products, pharmaceutical and medical device sectors, as well as a number of governments (eg UK DoH and EA), international organisations (eg OECD and WHO) and respected NGOs. Our skill sets are very well matched to current requirements for toxicological hazard and risk assessment under REACH and other regulatory chemical control activities. Data searching, gap analysis and development of testing strategies We perform data searches as required under REACH (including in our Echa-approved TRACE database). Retrieved information can be quickly assessed for relevance and reliability to satisfy tonnage-relevant data requirements. Additional laboratory testing can be minimised by expertly exploring opportunities for data waiving, read-across, and use of Qsar to create weight-of-evidence approaches to fill data gaps. If further testing is necessary we can advise on testing strategies to minimise both the use of animals/overall costs to the client, while maintaining scientific integrity. We assess the impact of the results of new tests conducted and provide ongoing expert guidance on what is really needed. Extensive in-house toxicological database and databank For 55 years, bibra toxicology advice & consulting has been scrutinising emerging toxicological literature, expert reviews or pronouncements, and indexing them systematically (by endpoint and chemical). Much of this scientific literature is held in-house in our technical library and quickly accessed using its associated database, TRACE. This unrivalled resource (listed as a valuable data source in Echa guidance) allows instant access to relevant documents and is critical in helping us produce the finest hazard and risk assessment work for our clients, in the most timely and cost-effective manner. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1961

Formation of BIBRA

1961

Establishment of Toxicology Information and Advisory Department

1961

Began to build the technical library

1987

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

2000

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

2003/5

Toxicology Advice & Consulting Ltd and Bibra Information Services Ltd established as vehicles to facilitate management buyout of Information and Advisory Department, including TRACE and its associated databank Chemical Watch | Global Service Providers Guide 2016

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

2010

Relocated to new, larger offices in Wallington, Surrey

ACCREDITATIONS Our senior toxicologists are all Royal Society of Biology/British Toxicology Society and European Registered Toxicologists. We are a REACHReady approved supplier. PARTNERS Enviresearch Ltd, wca environment Ltd, REACHWise, Linmark Consulting Gmbh, ReFaC CLIENTS Many of our clients have a need for confidentiality so those listed below are just a small sample of the types of organisations that we work with: OO Actavis Group OO CSL Behring Biotherapies for Life OO Environment Agency (UK) OO Health Canada OO World Health Organization OO Groupe Danone OO Infineum UK Ltd OO Innospec Active Chemicals OO Johnson Matthey plc TESTIMONIALS “James Hopkins and his team have always delivered toxicity reviews of high quality, have always met deadlines and are very flexible in terms of adapting to changes in Environment Agency research priorities. In view of this I have no hesitation in recommending them for other work related to the derivation of human health criteria values for environmental contaminants” The Environment Agency “We involved bibra from conception to completion of a REACH dossier (with a short deadline and little data). We have been very impressed with their efficiency, professional manners, knowledge of the subject and their ongoing suggestions to help us to find solutions to meet our deadline. The dossier was ready on-time and of an impeccable quality” Product Stewardship / Reach Manager at INEOS Oligomers “We acknowledge that bibra toxicology and consulting provide services that are highly regarded among the international scientific community” Efsa “Our experience of working with Bibra is very positive. They are a highly customer focused consultancy and the work was of excellent quality and delivered on time” Reckitt Benckiser “We have worked with Bibra on a number of occasions and have always received a thorough and professional service. A number of the reports compiled by Bibra have been used to successfully support global regulatory submissions” Development Manager at Advanced Medical Solutions CASE STUDY 1: Complex REACH submission involving a large category of substances Bibra toxicology advice & consulting has been working on a number of REACH submissions that involve large categories of substances. In one case, we are supporting a consortium of companies with all the mammalian toxicology aspects of their regulatory obligations for a group of more than 70 related metal compounds. The work has involved the evaluation of a large number of proprietary studies and published literature, drafting of endpoint study records (ESRs) in Iuclid 5, assessment of Annex III compliance, complex data-gap analyses and advice on possibilities for read-across and weight-of-evidence approaches, and the development of an appropriate integrated testing strategy, to minimise the amount of animal testing required.

Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 2: Urgent request for help with chemical safety report We are very happy to take on smaller projects and have been working with a number of clients to help out with specific areas of their REACH registration dossiers. In one case we were asked at short notice to help improve an existing Iuclid 5 dossier on a petrochemical additive manufactured in the EU at greater than 1000 tpa. This urgent request involved the peer-review (and significant improvement) of previously drafted ESRs and associated endpoint summaries, and the compilation of a chemical safety report (CSR), which included calculation of DNELs and PNECs, a PBT/vPvB and exposure assessment, risk characterisation step, and documentation of the necessary risk management measures and operational conditions (RMMs/OCs). The size and capabilities of our team meant that, despite the late notice and tight deadline, we could incorporate this project into our work schedule and the client was able to successfully submit their registration dossier in time. CASE STUDY 3: Provision of alerting service to keep industry upto-date on emerging issues Bibra toxicology advice & consulting was asked by an industry sector group to provide an ongoing service to track the emerging toxicological literature on a range of chemicals of particular interest to their members. Using a range of carefully tailored search and alerting strategies (SDI – selective dissemination of information), the bibra team receives daily notification of newly published or pre-published papers, abstracts or comment, and alerts the sector group members to keep them abreast of the scientific literature and developing areas of possible concern. The service allows the industry to successfully foresee and manage arising issues in a coordinated and proactive way. STAFF SELECTION James Hopkins – Managing Director James has worked at bibra for 40 years; he is a principal toxicologist and chemical health risk assessor of high repute, and led the management buyout in 2003. The new company, bibra toxicology advice & consulting, has performed impressively under James’ guidance. James has wide experience in reviewing/evaluating toxicological data for a range of chemicals in a cross-section of industries. He has also compiled numerous critical reviews of chemicals and several strategy documents for national governments (including the UK Environment Agency and Health Canada). Peter Watts – Director of Toxicology Peter is our Director of Toxicology and is a bibra veteran of 39 years. His vast experience includes reviewing and critically evaluating toxicological data and providing health risk assessments on numerous chemicals for government departments and industrial organisations. He helped in the preparation of the REACH Guidance on Information Requirements, has authored WHO-IPCS CICADS and Environment Agency CLEA reports, acted as a temporary adviser to the WHO, and has provided peer-review services for OECD SIAMs (and CoCams). Richard Young – Principal Toxicologist Richard has 15 years’ experience at bibra, reviewing and critically evaluating toxicological data on a wide range of chemicals. He has worked with clients from a diverse range of industry sectors, international government departments and most recently has been very involved with a collaboration within the electronic cigarette industry to help meet their TPD requirements. He is intimately involved in REACH, leading the bibra toxicology advice & consulting team of toxicologists to support a number of client companies and consortia with their registration submissions (including the REACH registration of over 75 related metal compounds). The rest of the team We have another 16 highly competent and experienced toxicologists. All of the seniors are professionally qualified (RSB/BTS and European Registered Toxicologists) and, barring our graduate trainees, range in practical experience from 15 to 40 years. All are extremely skilled in chemical hazard and risk assessment and have been heavily involved in REACH-related work during the past decade. Page 71

PROFILE: bibra toxicology advice & consulting

2005

GLOBAL OFFICES Edinburgh, Scotland, UK Cardiff, Wales, UK SERVICES PROVIDED Scientific consultancy

PROFILE: Blue Frog Scientific Limited

CONTACTS

Website

www.bluefrogscientific.com

E-mail

info@bluefrogscientific.com

Head office

Scott House, 10 South St Andrew Street, Edinburgh, EH2 2AZ, UK

Tel

+44 (0) 131 523 1412

Contact

Damien Carson

Directors

Damien Carson

Tom Hargreaves

Ownership

Private limited company

Locations

UK (Edinburgh and Cardiff)

Founded

2006

OO OO OO OO OO OO

Regulatory affairs OO

OO OO OO OO

regulatory affairs for chemicals, human medicinal products, veterinary medicinal products, agrochemicals and feed additives project management product defence consortium and task force management only representation of non-EU chemical companies under REACH

Chemicals (REACH and CLP)

OVERVIEW Blue Frog Scientific is an independent regulatory consultancy, providing scientific and regulatory affairs solutions to companies in all sectors of the chemical industry. Blue Frogâ&#x20AC;&#x2122;s philosophy is achieving regulatory compliance through the application of good science, innovative thinking and clarity; ensuring that all submissions are prepared efficiently and to a high standard. We offer scientific and regulatory affairs services with particular experience in chemicals, human pharmaceuticals, veterinary medicines, agrochemicals and feed additives. Based in the UK, our core team of consultants coordinate operations and our comprehensive network of associates (including contract laboratories, 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 (eg reproductive toxicology) to address issues requiring an expert opinion, statement or report. VITAL STATISTICS

2014/15

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN IT & software 10%

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; OO pharmaceutical intermediates; OO substances of unknown or variable composition, complex reaction products or biological origin (UVCB); OO transported isolated intermediates (Article 18). We also provide supply only representative services in accordance with Article 8 of REACH for non-EU companies that manufacture or formulate chemical substances and mixtures. Consortium/Sief management Blue Frog Scientific has developed a model for managing the financial and administrative challenges of consortia and task forces. We are currently managing consortia and Siefs under REACH as well as other groups of companies collectively working on research and development projects. Our services include: OO provision of a consortium bank account; OO accounts payable and accounts receivable; OO VAT and tax accounting; OO purchase contract management; OO teleconferencing facilities; OO data storage and management via the secure Blue Frog Scientific extranet. Environmental risk assessment of human medicinal products (HMPs) and veterinary medicinal products (VMPs)

Representation & management 20%

Consultancy/advisory 70%

Page 72

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

Blue Frog Scientific has extensive experience in assessing the potential environmental risk posed by human pharmaceuticals and veterinary medicines. Environmental risk assessment: OO authoring expert reports for inclusion in European marketing authorisation applications and FDA filings; OO planning and coordinating the necessary activities required in the preparation of risk assessments for regulatory submission; OO expert evaluation of laboratory studies; Chemical Watch | Global Service Providers Guide 2016

Agrochemicals Blue Frog Scientific and associates offer a full dossier service for registering plant protection products throughout Europe. Our range of services provides cost effective solutions to support placing your products on the European market. Data gap analysis: OO overview of quality of existing studies and identification of any data gaps for re-submission of dossiers according to EC 1107/2009; OO preparation of updating statements. Study management: OO regulatory testing design; OO testing strategies and study design (GLP/GEP); OO study monitoring; OO preparation of study summaries. Dossier preparation and regulatory affairs: OO OECD and dRR sections 1 to 7 prepared to a high standard; OO communication with regulatory authorities within EU 27 to support submissions. Key sectors of experience include: OO insecticides: pyrethroid, neonicotinoid, organophosphate and carbamate; OO herbicides: organophosphorus, phenylpyrazole; OO benzoylcyclohexanedione, chloroacetanilide; OO fungicides: triazole, anilinopyrimidine, amide, pyrazole; OO other: semiochemicals and biopesticides. 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.

20122016

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

Chemical Watch | Global Service Providers Guide 2016

ACCREDITATIONS European Partner: Society of Environmental Toxicology and Chemistry (SETAC). REACH Ready Approved Service Provider. 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 feed additive companies, ranging from SMEs to large multinational corporations. We take our clients’ confidentiality very seriously and will not disclose their identity. CASE STUDY 1: REACH advisor to a European Defence Agency Provided long-term support to a European Defence Agency in defining the parameters of the defence exemption, training staff on the fundamental aspects of REACH, and developing internal procedures for assessing exempt/non-exempt chemical substances and complying with REACH. CASE STUDY 2: Assessment of the environmental fate and effects of the PPARgamma receptor agonist, pioglitazone The environmental fate and effects of pioglitazone prescribed for the treatment of type 2 diabetes were evaluated in an environmental risk assessment. A predicted environmental concentration (PEC) for surface water was estimated at 0.023μg L-1, triggering a comprehensive battery of laboratory evaluations. Pioglitazone and its major metabolites were determined not to significantly adsorb to sewage solids, were not persistent in the aquatic environment, did not bioaccumulate and were non-toxic to aquatic organisms. Pioglitazone does not pose an unacceptable risk to groundwater supplies, with concentrations not anticipated to be a risk to aquatic organisms or human drinking water supplies. Pioglitazone does not pose a risk of secondary poisoning. STAFF SELECTION Damien Carson BSc PhD – Director An expert in chemical hazard and risk assessment with more than 15 years’ experience across a wide range of sectors in the industrial and fine chemical industry. Expert in good laboratory practice (GLP) and testing strategies. 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. Expert in good laboratory practice (GLP) and testing strategies. Nigel Halsall BSc PhD – Associate Director An expert in environmental hazard and risk assessment with more than 25 years experience in the agrochemical industry. Expert in good laboratory practice (GLP) and testing strategies.

Page 73

PROFILE: Blue Frog Scientific Limited

protocol development and environmental testing requirements to GLP, and following international guidelines; OO preparing literature based weight-of-evidence risk assessments for specialist products; OO multimedia mathematical modelling of the fate of pharmaceuticals in soil, freshwater, sediment and marine compartments; OO deterministic and higher tier probabilistic assessment of effects on biota and exposure concentrations; OO preparation of conclusions of risk, with relevance to the “real world” and mitigation solutions; OO use of mammalian ADME data to refine models and aid conclusions regarding bioaccumulation and secondary poisoning. 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; OO product defence, particularly for two “priority list” substances. OO

GLOBAL OFFICES bluesign technologies ag Moevenstrasse 18 9015 St.Gallen Schweiz Telefon: +41 71 272 29 90 Fax: +41 71 272 29 99 info@bluesign.com

PROFILE: bluesign technologies ag

CONTACTS Website

www.bluesign.com

E-mail

info@bluesign.com

Head office

bluesign technologies ag, Moevenstrasse 18, Switzerland

Tel

+41 71 272 29 90

Fax

+41 71 272 29 99

Contact

Mr Christian Dreszig, Head Marketing

Directors

Mr Peter Waeber, CEO

Ownership

Ag, main shareholder SGS

Locations

Switzerland / global

Founded

2000

bluesign technologies germany gmbh Am Mittleren Moos 48 86167 Augsburg Deutschland Telefon: +49 (0)821 74 77 544 Fax: +49 (0)821 74 77 545 bluesign technologies china limited Room 1105, 11/F, Manhattan Centre 8 Kwai Cheong Road Kwai Chung, N.T.,Hong Kong Telefon: +852 22 04 83 28 Fax: +852 26 37 00 20

OVERVIEW bluesign technologies ag was founded in Switzerland in 2000. The unique combination of expertise in key segments of the textile production as chemistry, textile technology, environment technology and supply chain management characterizes our company. We not only further develop the independent bluesign® system but also ensure its implementation and maintenance. Cultivating our interdisciplinary network, our essential aim is to act as a solution provider for the entire textile industry.

SERVICES PROVIDED Product stewardship services

Turnover, group

Any chemical company should have a fully functioning product stewardship programme in place. In some instances this is not fully implemented and bluesign technologies can provide a tailored service for the textile chemistry industry to improve this. Gap analysis, implementation and training of holistic product stewardship systems for chemical companies. The main focus is on in-put stream management, process management & quality control and hazard assessment and communication.

Turnover, chemical service provision

Risk assessment of chemical product

No of offices

Full hazard and exposure assessment for chemical products regarding environment, occupational health & safety and consumer safety

VITAL STATISTICS

2014/15

No of countries represented

Global

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

Representation & management 5%

Certification of chemical products according the criteria of the bluesign® system. bluesign® audits for chemical companies Audits of chemical companies according the criteria of the bluesign® system with the target of a bluesign® system partnership

Training 20% Information 5%

bluesign® certification of chemical products

CORPORATE DEVELOPMENTS & ACHIEVEMENTS Consultancy/advisory 70%

bluesign® system

Holistic chemicals management system to monitor hazardous chemicals within the entire supply chain

bluesign®approved

Certification based on unique risk assessment including harzard and exposure scenario assessments

STAFF SELECTION Senior product stewards Long term experience in implementation and management of product stewardship Senior chemical assessors Special experience on risk assessments of chemical products for textile and relevant industries Senior chemical auditors Experienced company auditors for textile chemistry industry

Page 74

Chemical Watch | Global Service Providers Guide 2016

Do you know how your product is made? The bluesign速 system based on Input Stream Management helps a responsible industry establishing more sustainable and safe products respecting functionality, quality and design.

bluesign technologies ag Moevenstrasse 18, 9015 St.Gallen, Switzerland Phone +41 71 272 29 90, Fax +41 71 272 29 99 info@bluesign.com, www.bluesign.com

BLU-4432_008_INS_bs system_210x297_RZ.indd 1

Chemical Watch | Global Service Providers Guide 2016

Find out more about the bluesign速 system: www.bluesign.com

21.05.15 10:45

Page 75

PROFILE: bluesign technologies ag

dachcom

Managing inputs. Responsible actions.

GLOBAL OFFICES CEHTRA Lyon – 23 rue du Creuzat, 38080 L’Isle d’Abeau, France CEHTRA Paris – 4 avenue Laurent Cély, 92600 Asnières sur Seine, France CEHTRA Europe – 134, rue Saint Germain, 1410 Waterloo, Belgium CEHTRA UK – First Floor, Wellington House, 190 Derby Road, Wellington Square, Nottingham, NG7 1NF, UK CEHTRA India – TC15/1764, Forest Office Line (B51), Vazhuthacaud, Trivandrum, Kerala, Pin-695014, India CEHTRA North America – 24 Ivy Lea Crescent, Toronto, ON M8Y 2B6, Canada

PROFILE: CEHTRA

CONTACTS Website

www.cehtra.com

E-mail

cehtra@cehtra.fr

Head office

43, rue Laroque, 33560 Sainte-Eulalie, France

Tel

+33 557775610

Fax

+33 557775620

Contact

Paul Thomas

Directors

Philippe Adrian, President CEHTRA SAS and KREATiS, Manager CEHTRA Europe Peter Jenkinson, CEO CEHTRA SAS, Manager CEHTRA UK Nathalie Ledirac, R&D Director Laurence Gasnot, Manager CEHTRA Paris Paul Thomas, Manager CEHTRA Lyon, CEO KREATiS Jason Nugent, Manager CEHTRA North America

Ownership

Private company

Locations

France: Bordeaux, Lyon, Paris; Belgium: Brussels; UK: Nottingham; India: Trivandrum: Canada: Toronto

Founded

2001

SERVICES PROVIDED Regulatory dossier services

Industrial hygiene and worker exposure studies With more than 14 years of culture and experience in different industrial sectors, from pesticides to general chemicals, and a complete understanding of the tools used in risk-data interpretation, including generation of exposure limits, CEHTRA is able to bring you answers and support in industrial hygiene adapted to your specific needs.

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

Consortium and Sief management

2014/15 €5.5m

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN IT & software 2% Legal Training 6% 2% Information 5%

CEHTRA provides clients with bespoke services for the production of regulatory dossiers worldwide or together with our partners, be that in the field of general chemicals, cosmetics, biocides, pesticides or pharmaceuticals. We have all the competencies in-house to do all or any part of a project. We have contributed to, or realised over 1,800 projects since CEHTRA was founded and we have produced over 200 REACH dossiers, all of which were successfully submitted on time. We use, verify and validate the algorithms of software such as Ecetoc TRA, FOCUS (for pesticides and ART) and improve on existing tools (eg by adding a module to allow speedy formatting of final dossiers or work on Consexpo).

We offer a complete service that can either be used as a stand-alone or may be combined with the technical services provided by CEHTRA. We make sure that the milestones and deadlines of your project are met while ensuring the spirit of fairness and transparency, at the same time maintaining strict confidentiality for those areas that matter for your business. We can help you with the preparation of consortium agreements, maintaining contact lists, archiving, billing and all the aspects required for effectively running consortia and Siefs. Expert services

Our experts have been successful in proposing and supporting complex issues for CMR classifications, modifying acceptable exposure limits and other critical substance-related end-points at member state or EU level. We have also successfully used our knowledge in clinical toxicology and epidemiology to support several of our clients in court cases. REACH OR Services CEHTRA provides a REACH only representative (OR) service. Authorisation services

Representation & management 10% Consultancy/advisory 75%

CEHTRA is one of three companies in a joint venture, ChemAdvocacy, providing a full service in the field of authorisation including socioeconomic analysis and the company has already provided SEAs for specific biocidal substances. Modelling services In January 2014 CEHTRA opened a subsidiary company, KREATiS SAS, which specialises in in silico predictions (High-Accuracy Qsars), which can be used to replace laboratory studies in many regulatory dossiers such as REACH (more info on www.kreatis.eu). CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Page 76

2001

Company established.

2004

Opening of UK office. Chemical Watch | Global Service Providers Guide 2016

2008

Opening of Brussels office.

STAFF SELECTION

2008

Opening of Lyon office.

2009

Start of the Indian Joint venture.

Peter Jenkinson − PhD, GT – CEO CEHTRA SAS & Manager of UK Office

2011

Opening of North America offices.

2012

Opening of ChemAdvocacy.

2014

Opening of KREATiS.

Number of European registered toxicologists (ERT) and other certificates: OO ten ERTs; OO one IOB/UKEMS GT; OO two chartered chemists (MRSC); OO two dangerous goods safety advisors (DGSA); and OO one CIH (Certified Industrial Hygienist). PARTNERS KREATiS, LTS REACH OR, ChemService GmbH, ECOonline, Global Regulatory Communications, Microeconomix CLIENTS Chemical companies, flavours and fragrances, petrochemicals, cosmetic companies, plant protection industry, biocides, veterinary products, pharmaceuticals. TESTIMONIALS “CEHTRA helped us to submit ten 2010 REACH dossiers as lead registrant. We greatly appreciated their expertise in toxicology and ecotoxicology in particular in cases where the protocols of standard studies needed to be adapted to the test substances. In fact many of our substances turned out to be ‘difficult to test’ due to their physico-chemical properties. We have decided to use them again and are once more confident of success for our 2013 dossiers.” – signed DRT, loyal client for 2010, 2013 and 2018 dossiers. CASE STUDY 1: In silico predictions a priority

In silico methodologies to replace experimental studies are becoming a hot topic, especially with the 2018 REACH deadline approaching. CEHTRA has heavily invested in an in silico toolbox we call i-SAFERAT on the basis of high quality predictions based on best quality experimental data where necessary coupled with a read-across and weight-of-evidence approach. Our aim is to cut the cost of REACH substance submissions for lower tonnage substances without compromising data quality. CASE STUDY 2: Biocidal dossier Facing the review programme of active substances, the formulator of a biocidal product asked CEHTRA to consolidate a vulnerable dossier submitted five years before. After designing a strategy based on a strength/ weakness analysis, CEHTRA completed the missing data and provided the formulator with the key resources that were absent in the initial dossier: an in-depth risk assessment and a scientific expertise focused on environment and ecotoxicology with a positive RCR. As a result, the client met his objectives and received from CEHTRA a biocidal active substance dossier passing the completeness check and all required use scenarios. CASE STUDY 3: Authorisation dossier The biocides products Regulation requires a socio-economic analysis of substances which may be subject to substitution (CMR, PBT endocrine disruptors, etc). ChemAdvocacy has been awarded a study on a national authorisation dossier for a wood protection product (PT8), classified CMR, PBT. We are developing a methodology, the first of its kind for biocide products, inspired by the available guidance (REACH, etc), and we have presented our proposal to the French competent authorities, with expected finalisation of preparation for submission in early Summer 2013.

Chemical Watch | Global Service Providers Guide 2016

Paul Thomas PhD, ERT − Marketing Director CEHTRA, Manager of Lyon Office and CEO KREATiS Paul Thomas has a PhD in aquatic ecotoxicology and over 20 years' experience with industrial chemicals, agrochemicals and biocides gained at CIT, ATOFINA and AkzoNobel. He joined CEHTRA in 2008 as director of CEHTRA Lyon specialising in REACH-related services and is manager of the CEHTRA ecotoxicology team. Paul has contributed strongly to numerous successful registrations. He is also leading the KREATiS venture and has contributed to the development of several innovative new Qsar models Philippe Adrian PhD – President CEHTRA SAS and KREATiS and Manager of Brussels Office Philippe Adrian has a PhD in soil science and over 20 years' experience with agrochemicals and biocides. Prior to his current position he worked as research scientist in Germany. Later he worked at CNRS in France and then Rhone-Poulenc Agrochimie and FMC. In 2001 he created CEHTRA with Pierre-Gerard Pontal and manages the environmental fate team. He has developed modelling expertise for pesticides according to current models, as well as biocides using relevant TGDs. Nathalie Ledirac PhD, ERT – R&D Director Nathalie has a PhD in cellular and molecular aspect of biology and 15 years’ experience with agrochemicals. She worked as a research scientist at INRA in France on pesticide toxicity and has also participated in private research on drugs for pharmaceutical industries (HMR, Galderma). She joined CEHTRA in 2006 as a regulatory toxicologist and provides expert toxicology advice in study monitoring and data interpretation. She develops close partnerships with private and academic research by increasing the scientific participation of CEHTRA experts in research projects (research programmes, publications, model development for pesticides, accreditation, etc). Laurence Gasnot PhD – Manager of Paris Office Laurence has a PhD in material sciences. She has worked for 20 years in the industry where she has gained profound experience in polymer science as well as in food contact regulations and health products. She joined CEHTRA in 2008 developing the food and food contact market and proposing a pragmatic approach for cosmetic packaging assessment to our customers. For the last few years she has worked on several successful European authorisation dossiers on food contact, drinking water and food additives. Charles Alarcon PhD, CIH – Industrial Hygienist Charles has a PhD in geochemistry and over 14 years' experience as an industrial hygienist, and was one of the first in France to obtain the prestigious CIH certification (still one of only ten in France). He joined CEHTRA in 2009 developing exposure scenario in REACH dossiers and e-SDS. Through audits and other site studies, and using currents models in risk assessment, he has gained a large experience in many industrial sector activities and acquired a unique understanding of health and safety industrial culture. Jason Nugent MSc – Manager of CEHTRA NA Jason is a highly experienced chemical registration specialist who has worked within the North American chemical industry for more than 17 years. Over the course of his career, Jason has managed and participated in the preparation of more than 400 chemical registrations in Canada, USA, the EU, China, Australia, and Japan. In recent years he has been heavily involved in assisting North American companies to prepare for and comply with REACH. Page 77

PROFILE: CEHTRA

ACCREDITATIONS

Peter Jenkinson has a PhD in reproductive toxicology and over 30 years' experience in the CRO industry specialising in genetic toxicology. Latterly he was the director of the Chemical Business Unit at Harlan Laboratories with a primary role of developing the REACH services of the company. In March 2010 he joined CEHTRA to open the UK office and has provided expert toxicology advice, particularly for study monitoring and data interpretation.

GLOBAL OFFICES UK only SERVICES PROVIDED Marine ecotoxicology Marine testing is primarily conducted for product registration under the offshore chemical notification scheme (OCNS). Species data required for this scheme include algae (Phaeodactylum tricornutum), invertebrate (Acartia tonsa), fish (Cyprinodon variegatus or Scophthalmus maximus) and sediment reworker (Corophium volutator), all of which are provided by Chemex. Other marine species also available include Tisbe battagliai, Brown shrimp (Crangon crangon) and Oyster (Crassostrea gigas). In addition, we routinely perform toxicity testing of produced formation water and process effluents.

CONTACTS Website

www.chemex.co.uk

E-mail

enquiries@chemex.co.uk

PROFILE: Chemex

Head office Unit J, Broad Lane Industrial Estate, Cottenham, Cambridge CB24 8SW, UK Tel

+44 (0) 1954 252519

Fax

+44 (0) 1954 251764

Directors

Nathan Read Dennis Whitfield

Contact

Paul Keeble â&#x20AC;&#x201C; Client Liaison Officer

Ownership

Private Limited Company

Locations

Cambridge, UK

Founded

1987

Freshwater ecotoxicology An extensive range of acute and chronic freshwater toxicity studies can be conducted at Chemex. Species available for testing include algae (Pseudokirchneriella subcapitata, Scenedesmus subspicatus and Anabaena flos-aquae), invertebrate (Daphnia magna and Chironomus riparius), fish (rainbow trout and carp) and the aquatic plant Lemna minor. Terrestrial ecotoxicology

OVERVIEW Chemex, originally established in 1987, has now been offering Ecotoxicology testing services to a range of industries for 20 years. Our experience provides our clients with high quality, reliable test data with a focus on excellent customer service. Operating from our fully GLP Compliant laboratory facility near Cambridge, UK, Chemex has a range of controlled temperature environments allowing us to provide testing against a number of organisms, including those from marine, freshwater and terrestrial environments. These facilities are complemented by our of team of experienced study directors and our highly qualified technical team. We have a comprehensive in-house analytical facility allowing us to perform analytical support to studies, as required. Use of internationally recognised guidelines ensures that we satisfy our clientsâ&#x20AC;&#x2122; requirements. Our comprehensive management and quality systems ensure accuracy and rigorous compliance with applicable regulations. In addition to the laboratory testing services, Chemex has a multilingual consultancy team who are on hand to assist with laboratory audit and improvement programmes, analytical or quality assurance training, onsite and offshore sampling and quality assurance programme development for projects around the globe. VITAL STATISTICS

2014/15

Turnover, group

Turnover, chemical service provision

No. of offices

No. of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 5%

Consultancy/advisory 15%

Chemex offers a range of studies including soil microbial biomass, effects of soil non-target micro-organisms and toxicity to earthworms (acute, chronic and bioaccumulation). Also available is the activated sludge respiration inhibition test, which is used to assess the toxicity of substances to micro-organisms. Environmental fate testing Assessing the degradation and accumulation potential of products plays an important role in measuring their ability to persist in and damage the environment. The degradation of a test material by micro-organisms or by physico-chemical means can be measured. Bioaccumulation can be assessed by analytical techniques or by measuring the body burden following exposure of an organism to a chemical. Physico-chemical testing With the introduction of REACH it has become essential to know the physical and chemical properties of a substance. Chemex has excellent equipment and facilities that enable us to perform an extensive range of studies to help in the assessment of substances physical and chemical properties. Our dedicated study directors have many years experience of these types of studies. A wide range of physical and chemical properties of a substance can be analysed in-house. Methods include OECD, EEC, ISO and CIPAC guidelines. Examples of parameters available are below: OO appearance and physical state point EC A1 / OECD 102; OO boiling point EC A2 / OECD 103; OO relative density EC A3 / OECD 109; OO surface tension EC A5 / OECD 115; OO water solubility EC A6 / OECD 105; OO partition coefficient EC A8 / OECD 107, 117 or 123; OO flash point EC A9; OO flammability EC A10 (solids) EC A11 (gases); OO explosive properties EC A14; OO auto ignition temperature EC A15 (liquids or gases); OO oxidising properties EC A17 (solids) EC A21 (liquids); OO granulometry OECD 110; OO dissociation constant OECD 112; and OO viscosity OECD 114.

Laboratory 80%

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The ecotoxicology laboratory at Chemex is able to take full advantage of it’s comprehensive on-site analytical facility with a range of techniques and highly trained expert analysts at our disposal. This enables us to offer a GLP compliant in-house analytical support service to studies as required. In-house analytical techniques available include: LC/MS, GC/MS, HPLC, GC/ECD and ICP/MS. Consultancy services Chemex provide international consultancy services for laboratories and related activities including: OO laboratory audit and improvement programmes Chemex regularly perform audits of laboratories in the UK and overseas. Our expert team can assess facilities to national or international quality standards including GLP and ISO17025 or client specific objectives can be used. Having identified non-conformities and corrective actions we work with laboratories to implement improvement programmes. OO quality assurance programmes Chemex designs and implements quality assurance programmes for organisations working with laboratories and environmental consultancies in a range of industries. For example, writing a quality assurance project plan (QAPP) outlining the procedures a project will use to ensure that samples and data reporting are of suitable quality to meet project objectives. OO training A wide range of training programmes can be designed to meet specific client needs for laboratory and field personnel. Training can be conducted at our own facility or at the clients’ facility. Examples of the courses offered include: OO quality assurance and quality control in environmental laboratories; OO analytical techniques (including GC, LC and mass spectrometry); OO quality assurance and quality control during onsite activities. In addition, Chemex also offers experimental design and analytical method development, data review and onsite/offshore sampling services. Our multilingual team of scientists and technical experts can operate in all parts of the world. ACCREDITATIONS Good Laboratory Practice (GLP) Certification Associate Member – European Oilfield Speciality Chemicals Association (EOSCA) CLIENTS Our international client base includes chemical manufacturers and major oil companies. Testing is performed for clients from a range of industry sectors, such as oilfield chemicals, speciality chemicals, agrochemicals, biocides, surfactants, lubricants and many others. We also work with many regulatory consultants performing testing for their clients. CASE STUDY 1: Expedited HOCNF testing and reporting

eliminating the need for multiple controls and fulfilling the requirement to limit the number of test animals used. During this time the 28-day OECD306/BODIS seawater biodegradation tests were also run in separate controlled temperature cabinets. Due to our ability to provide expedited testing and data reporting, our clients have been extremely pleased to be able to process their registration documents on time to achieve their business goals. CASE STUDY 2: Laboratory improvement programme A major oil company employed Chemex to audit their contract environmental laboratories in central Asia. Based on the findings of this exercise, Chemex where employed to develop and implement an improvement programme over a number of years. The result was vastly improved data quality and significant cost savings for the customer. CASE STUDY 3: Produced formation water testing from FPSO A project was undertaken to examine ecotoxicology of produced formation water (PFW) from an FPSO off Mauritania. The project was initiated as part of an environmental monitoring plan by the oil company. Samples of PFW were collected by Chemex from the FPSO and transported to the UK in controlled conditions. Ecotoxicology was assessed over a range of organisms from bacteria through to fish representing four trophic levels. Toxicology studies undertaken were as follows: microtox microbial (Vibrio fisheri) screening test; marine algae (Phaeodactylum tricornutum) growth inhibition test; copepod (Acartia tonsa) acute toxicity test; oyster (Crassostrea gigas) larval development toxicity test and fish (Scophthalmus maximus) acute toxicity. In addition to the toxicology tests two further screening tests were performed; DR CALUX (Chemical Activated Luciferase Gene Expression) assay for dioxin-like toxicity and YES (Yeast Estrogen Screen) assay for estrogen activity. From the data, risk assessments were undertaken to determine the possible extent of toxicity in surrounding water based on typical conditions. The oil company was able to fulfil their environmental control obligations and continue operating. STAFF SELECTION Nathan Read – Managing Director Nathan has over 25 years’ experience in environmental analysis and ecotoxicology. Owner of Chemex since 2005. Extensive international consultancy experience. Matthew Rodgers – Manager of Ecotoxicology Matthew has accrued more than 25 years’ experience working for CROs as a senior study director. Mike Mallett – Chief Ecotoxicologist and Study Director Mike has 30 years’ experience in the ecotoxicology testing field, working for a range of CROs. Ramon Drake – Senior Study Director Ray has over 20 years’ experience of running biodegradation studies.

Due to the highly confidential nature of our work, we are unable to provide specific details for case studies. However, Chemex have long been a specialist laboratory servicing the regulatory requirements for the offshore chemicals industry. To this end the laboratory has invested in providing a rapid turnaround service for multiple sets of chemicals required for the HOCNF data package. Recent cases have involved sets more than ten chemicals to be tested in parallel and reported to the regulators in a very short time frame. Laboratory capacity and test organism supply is sufficient to allow multiple processing of the two key species Phaeodactylum (Algae) and Acartia (Copepod) to provide the dose concentrations for the fish limit studies. The Corophium shrimp (Amphipod) tests were also undertaken simultaneously on freshly supplied animals. This left the sheepshead minnow (marine fish) limit tests to complete the set. These were run as a single batch, thus

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PROFILE: Chemex

Analytical support

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

PROFILE: ChemSafe

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 José V Cantavella Cabedo, Attorney at Law

Directors

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

Ownership

Private company

Locations

Italy, Qatar

Founded

2001

REACH and CLP/GHS ChemSafe provides its clients with strategic, legal and technical support in order to comply with REACH and CLP/ GHS. Our technical support includes full dossier preparation (as lead registrant or joint submissions), data gap analysis, review and analysis of physico-chemical, environmental fate. It also includes ecotoxicology and toxicological data, CSA/CSR preparation, human and environmental exposure scenarios (ES) and risk assessment, and application of alternative strategies to testing such as using a read-across approach and Qsar. Iuclid 5 preparation and submission to Echa and pre and post dossier submission contact with the authorities.

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

2014/15

Turnover, group

€2.0m

Turnover, chemical service provision

€2.0m

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Legal IT & software 5% 5% Laboratory 5% Information 10%

Training 5%

Consultancy/advisory 50%

Representation & management 20%

GLOBAL OFFICES ChemSafe Srl, Colleretto Giacosa (TO), Italy ChemSafe International WLL, Doha, State of Qatar

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Sief and consortia management We can help our clients with a full/partial Sief and/or consortia management system, including preparation of all kind of legal agreements, letters of access, data sharing, maintaining contact list, archiving, billing and all the necessary daily aspects for running a successful Sief and consortia. Only representative (OR) and third party representative (TPR) In 2008 ChemSafe started to act as an only representative (OR) for non-European manufacturers and fulfilling the pre-registration and registration obligations as prescribed in Article 8 of REACH Regulation. Non-EU companies must either rely on their importers, or retain a person in the EU to represent their interests, these are the only representatives. Appointing your own OR gives your company business freedom and security as you will have regulatory independence from other members of your supply chain; you will also have a high level of confidentiality by separating the company name from proprietary product constituents; you will maintain supply chain privacy between buyers and sellers; provides expertise and third-party review for submissions to Echa and provides representation to both substance information and exchange forums (Siefs) and consortia. ChemSafe is acting as OR for different types of companies coming from USA, Switzerland, South America, Middle East and Far East countries. Furthermore we can act as a third party representative (TPR) for companies not wanting to disclose their identity to others. Legal advice We advise our clients on legal aspects of chemical trade around the world and related chemical control regulations, such as US TSCA inter alia. Biocides and agrochemicals Our team can prepare and submit dossiers for authorisation of active substances and for registration of formulated products. We can also prepare the technical equivalence data for active substances. We coordinate the regulatory strategy with the national and/or international authorities in order to deliver a successful dossier for biocidal products and agrochemicals.

Chemical Watch | Global Service Providers Guide 2016

Pharmaceutical services

CASE STUDY 1: REACH testing programme

1) Safety: OO OEL/OEB/ ASL evaluation + PDE; OO ERA (environmental risk assessment); OO in silico evaluation, including Qsar; 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 OQS (overall quality summary 2.3P and 2.3.S). OO preliminary evaluation of all documentation for the dossier and DMF preparation. 3) GLP activity: OO from candidate profiling to preclinical development.

Working together with a global supplier of hydrocarbons ChemSafe created a comprehensive testing/study programme for REACH registration of a wide range of products for that client.

OO OO OO

OO OO

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

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

More than 160 REACH dossiers done, including lead registrant and joint submission dossiers are our background; including some for UVCB substances. An important number of CSR, and hundreds of safety and extended safety data sheets (SDS and e-SDS) had also been done by our team. CASE STUDY 3: legal case In 2012 ChemSafe successfully settled a legal case with the European authorities on behalf of one of our European clients. STAFF SELECTION Dr Antonio Conto – Managing Director Biology degree, European Registered Toxicologist (ERT). Founder of Chemsafe. >26 years of experience in the chemical and toxicological field. Lara De Luca – Head of Technical Department Industrial chemist, with more than 12 years of experience. Risk assessment, exposure scenarios, CSR/CSA. Dr José V Cantavella Cabedo – Head of Legal Department Lawyer, JD in environmental law, with more than 20 years of experience. Environmental, chemical and international law.

2001

Start-up in Italy as “a one man” company.

Francesca Fasano – Head of Biocides Department

20072008

REACH and OR services offered.

Industrial chemist, with more than ten years of experience. Biocides, agrochemicals and ecotoxicology.

2009

Biocides and agrochemicals group creation.

Elena Meriano – Head of REACH Registration group

2010

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

Biologist, with more than 11 years of experience. Technical dossier preparation, study monitoring, Iuclid.

2011

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

Loredana Savin – Head of CLP/GHS group

2012

Qatar office opening.

2015

Operational quarters moved to Parella (TO)-Italy.

Biologist, with more than 11 years of experience. Classification, labelling, GHS.

ACCREDITATIONS ChemSafe is a full member of ORO, the Only Representatives Organisation. ChemSafe is a member of the Industrial Union of Turin, Italy. PARTNERS OO

ChemSafe is 100% privately owned.

CLIENTS Our clients are manufacturers and importers involved in the market sectors of: chemicals, pharmaceuticals, agrochemicals, biocides, cosmetics, food, medical devices, nanomaterials and petrochemicals worldwide. Their size goes from multinational companies to SMEs and national authorities. TESTIMONIALS Any persons or companies requesting testimonials or references will be provided with them upon individual written request.

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PROFILE: ChemSafe

Cosmetics

CASE STUDY 2: REACH dossier work

GLOBAL OFFICES Chemservice GmbH, Worms, Germany Chemservice S.A., Grevenmacher, Luxembourg Chemservice Asia Co Ltd, Seoul, Korea Chemservice EHNS GmbH, Worms, Germany Consortia Management GmbH, Worms, Germany ChemCehtra SAS, Bordeaux, France ChemAdvocacy S.A., Grevenmacher, Luxembourg

PROFILE: Chemservice

CONTACTS Website

www.chemservice-group.com

E-mail

info@chemservice-group.com

Head offices

Chemservice GmbH, Herrnsheimer Hauptstrasse 1b, D-67550 Worms, Germany / Chemservice S.A., 5, an de Laengten, L-6776 Grevenmacher, Luxembourg

SERVICES PROVIDED Global regulatory affairs consulting

Tel

+49 (0)6241 95480-0 / +352 270776-1

Fax

+49 (0)6241 95480-25 / +352 270776-75

Contacts

Karl-Heinz Reis /Dr Günter Spang

Directors

Dr Dieter Drohmann, Managing Director Karl-Heinz Reis, Director Global Regulatory Affairs Dr Günter Spang, Director Toxicology and Risk Assessment Thomas Schaefer, Director Data and System Services

Ownership

Privately owned group of companies

Locations

Germany, Luxembourg, Korea, France

Founded

2007

OVERVIEW Chemservice is one of the world’s leading global regulatory affairs consulting companies. We support our clients in gaining competitive advantage through the regulatory process. The Chemservice Group has in-depth experience in regulatory affairs and international chemical control legislation, toxicology, risk assessments and environmental sciences. Our substantial network in and knowledge of industry, academia, regulatory bodies and governments are beneficial in solving regulatory issues. Different in-house disciplines (chemists, chemical engineers, toxicologists, environmental scientists, agronomists, biologists, veterinarian, regulatory specialists etc) enables broad issue addressing. VITAL STATISTICS

2014/15

Turnover, group

~ €3m

Turnover, chemical service provision

~ €3m

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 5%

Other 5%

IT & software 10%

Information 15%

Chemservice provides a broad range of services designed to assist clients in preparing for and in complying with international and national chemical control legislation. The application range for chemistry is extensive. Therefore, chemical control legislation is comprehensive in order to assure product safety, producer liability and consumer and environmental protection to regulate the marketing of chemical substances. Beside inventory notifications we conduct registrations of biocides, cosmetics, and compile dossiers for food contact clearances and food and feed additive petitions. With our regional partners and offices we support our clients to comply with the EU-REACH-like chemicals regulations in China and Korea. REACH and GHS/CLP We provide our clients with strategic and technical support for REACH and GHS/CLP. The technical support includes, for example, data gap analysis, registration cost evaluation, testing strategy proposals, placing/ monitoring/reviewing of studies, pre-registrations and registrations, dossier preparation, compilation of chemical safety reports, exposure, hazard and risk assessments, PBT/vPvB evaluation and support on authorisation, REACH-IT and Iuclid assistance, C&L notification, safety data sheet and label creation. Through our legal entity “ChemAdvocacy” we provide REACH authorisation services (including SEA), advocacy and product stewardship consulting. Consortia, Sief and letter of access management Consortia Management GmbH provides independent secretariat, trustee and accounting services to REACH consortia and Siefs in order to enable the chemical industry and its value chain to fulfil their registration obligations according to the REACH Regulation. The automated online letter of access (LoA) tool provides an efficient LoA management for Sief members to acquire access rights for a specific substance for the submission of the joint REACH dossier. Moreover, it will help to reduce resources at lead registrant and consortia level and offers professional accounting support – including trustee account management. Only representative and third party representative Chemservice acts for manufacturers outside of the EU as only representative and covers fully the registration and pre-registration obligations. Furthermore we provide trustee services for indirect non-EU supply chains with final import into the EU. The importers of these nonEU manufacturers no longer have registration obligations and are being regarded as downstream users. Only one registration is needed by the only representative. Moreover, Chemservice acts as only representative for non-EU manufacturers of articles, which intentionally release substances and we act as third party representative according to REACH Article 4.

Consultancy/advisory 45%

Representation & management 20%

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2007

Start-up in Luxembourg

2008

Opening of Chemservice office in Germany

2009

Launch of Consortia Management GmbH as full service provider for consortia and Sief management

2010

Opening of Chemservice offices in Korea and Turkey

2011

Launch of Chemservice EHNS

2011

Launch of JV ChemCehtra with office in France

2012

Launch of ChemAdvocacy SA with office in Luxembourg

ACCREDITATIONS We are a member of ORO, the Only Representative Organisation in Brussels and comply with the quality standards of ORO. Dr Drohmann is chairing ORO as president. PARTNERS Our partner companies are listed on our website. CLIENTS Consultant for the chemical industry and its value chain, including OEMs. Our clients range from multinational chemical companies to SMEs, formulators, traders, retailers and OEMs. We do not disclose our customers publicly, but provide reference names and testimonials upon request. TESTIMONIALS Persons who request testimonials or references will be provided with them upon individual request. CASE STUDY 1: Global inventory strategy and registration We have significant experience in global inventory registrations and conducted around 120 notifications to the Turkish inventory and 300 nominations to the inventory in Taiwan. For multiple clients we have supplied global inventory strategies for new substances and conducted notifications to chemical inventories like Australia (AICS), Canada (DSL), China (IECSC), Korea (ECL), New Zealand (NZIOC), Philippines (PICCS) and USA (TSCA).

CASE STUDY 3: REACH dossier work Chemservice has experience in the creation of more than 320 Tier 1, 2 and 3 REACH dossiers, including member and lead dossiers. Moreover, a significant number of new substance registrations (non-phase-ins), inquiry dossiers, PPORDS, chemical safety reports and extended safety data sheets were successfully completed. Furthermore, we have acted on behalf of our clients with more than 1.500 C&L notifications. CASE STUDY 4: Korean REACH Chemservice Asia has conducted many new substance notifications to the Korean Inventory under the TCCA legislation. Experience under K-REACH (in act since January 1st, 2015) is as follows: around 300 substances contracted as OR, ca. 40 small volume substance registrations, ten substance registrations and ca. 50 exemption confirmations, experience as K-REACH consortium manager. STAFF SELECTION Dr Dieter Drohmann – Managing Director OO OO OO

Karl-Heinz Reis – Director Global Regulatory Affairs OO OO

Chemical Watch | Global Service Providers Guide 2016

master in biology >20 years of experience in the field of risk assessments, PBT assessments and CRO study director

Dr Günter Spang – Director Toxicology and Risk Assessment OO OO

PhD in agronomy >20 years of experience in regulatory affairs consulting, including risk assessments and dossier preparation

Thomas Schaefer – Director Data and System Services OO OO

Data management, indirect non-EU supply chains, SDS and labels >20 years of experience in IT and data systems

Natalia Jansen-Bouriatchenko – Regulatory Affairs Advisor (Ukrainian) OO OO

CASE STUDY 2: REACH-code-model REACH does not distinguish between direct and indirect imports into the EU. Therefore, non-EU business followed by export to EU is more complicated – in particular if several non-EU steps along the supply chain are involved and substances have been formulated into preparations with confidential composition. In a multi-level non-EU supply chain the manufacturer of a substance usually does not know through which channels, in which products and finally how much volume of his substances is being imported into the EU. It is an essential business secret (CBI) of traders or formulators what the components of their products and who their suppliers and customers are. Neither the non-EU manufacturer (represented by the OR), nor the importer can fulfil their obligations without disclosing CBI and potentially leading to loss of business. Chemservice has developed a software based solution to track indirect EU export. Many companies with multi-step non-EU supply chains have signed up to this system already.

PhD in environmental sciences founder of the Chemservice Group >20 years of experience in the chemical industry as regulatory affairs manager

master in biochemistry ~20 years of experience in analytical and ecological chemistry, ecotoxicology and toxicology

Ah-Reum Seo – Technical Director Chemservice Asia (Korean) OO OO

chemist 10 years of experience in R&D and regulatory affairs

Adding up the professional records, the Chemservice Group staff has >200 years of regulatory affairs experience.

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PROFILE: Chemservice

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

SERVICE AREA BREAKDOWN Other 10%

Consultancy/advisory 10%

IT & software 10%

PROFILE: CHEMTREC

CONTACTS Information 70%

Website

www.chemtrec.com

E-mail

chemtrec@chemtrec.com

Head office

2900 Fairview Park Drive

Falls Church, VA 22042-4513, Falls Church, VA 220424513, USA

Tel

+1 703-741-5500

Contact

Brian L Banks

SERVICES PROVIDED

Directors

Joe Milazzo, Director of Operations Centre John Simon, Director of Sales & Marketing Brian Banks, Product Manager Kevin Bryan, Sales Manager

Emergency response

Ownership

American Chemistry Council

Locations

USA

Founded

1971

GLOBAL OFFICES Falls Church, VA, USA

CHEMTREC’s trained and experienced staff, provides Level 1 emergency information to help mitigate HAZMAT/Dangerous Goods incidents 24-hours per day/seven days per week. CHEMTREC relays vital data to manufacturers and shippers that an incident has occurred. CHEMTREC also acts as a hub to connect first responders with manufacturers, shippers and carriers. Clients are immediately notified that CHEMTREC has received an emergency call regarding their product or shipment.

OVERVIEW CHEMTREC was established in 1971 by the American Chemistry Council (ACC) to serve the chemical industry as a public service hotline for emergency responders, such as fire fighters and law enforcement, to obtain information and assistance for emergency incidents involving chemicals, hazardous materials and dangerous goods. In addition to the public service component, registration with CHEMTREC authorises shippers of hazardous materials and dangerous goods the right to portray the CHEMTREC phone number(s) on their shipping documents, safety data sheets (SDS) and hazard communications labels. The portrayal of the CHEMTREC phone numbers(s) helps registrants to comply with government regulations, which require shippers of hazardous materials to provide a 24-hour emergency telephone number on shipping documents and/or SDS for use in the event of an emergency involving hazardous materials or dangerous goods. CHEMTREC registrants receive detailed notification following each incident that CHEMTREC handles. CHEMTREC is linked to the largest network of chemical and hazardous material experts in the world, including chemical and response specialists, public emergency services, and private contractors.. VITAL STATISTICS

CHEMTREC has a library of over six million safety data sheets (SDS). Clients provide CHEMTREC with product-specific SDSs that are stored electronically and accessed in the event of an emergency involving that specific product. CHEMTREC tracks the dates of the submissions so that we help clients maintain an updated SDS library. CHEMTREC can also provide SDS indexing of large volumes of SDS documents to add to your SDS library. Medical exposure advice CHEMTREC’s medical exposure advice service is provided by trained medical professionals through our partnership with Rocky Mountain Poison and Drug Center (RMPDC). CHEMTREC’s medical exposure advice service provides 24-hour coverage for both human and animal exposures. RMPDC is one of the best certified poison control centres in the world. RMPDC’s poison centre is certified by the American Association of Poison Control Centers (AAPCC). CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2001

CHEMTREC provided critical information to the New York City Police Hazardous Materials Team as they evaluated the potential effect of chemicals contained in the collapse of the World Trade Towers.

2003

Worldwide Service – CHEMTREC began to offer emergency information services for worldwide.

2006

CHEMTREC hosted the first International Emergency Response Summit.

2010

CHEMTREC signed a memorandum of understanding (MOU) with emergency information organisations within South America.

2011

CHEMTREC celebrates 40 years of service.

2012

CHEMTREC signed an MOU for mutual assistance with the National Registration Center for Chemicals (NRCC) of China.

2015

CHEMTREC’s SDS digital library reaches the six million SDS milestone.

2016

CHEMTREC expanded access to professional medical exposure advice services

2015/16

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

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SDS management

Chemical Watch | Global Service Providers Guide 2016

CHEMTREC has a memorandum of understanding (MOU) for mutual assistance with several emergency response organisations around the world. CHEMTREC has MOUs in place with organisations located in: OO Canada; OO Mexico; OO South America; OO China; and OO New Zealand. CLIENTS Due to our client confidentiality policy, CHEMTREC does not publish the names of our clients. CHEMTREC’s client list does include some of the largest chemical manufacturers and distributors in the world. CHEMTREC provides Level 1 emergency information, notification and support for emergency responders, manufacturers, shippers, carriers, and the overall chemical and HAZMAT/dangerous goods industry. CASE STUDY 1: Fire on a ship at sea, July 2012 Incident: A container ship caught fire after an explosion below deck and the crew was forced to abandon ship. Salvage ships extinguished the fire and towed the vessel toward port. All SDSs were inaccessible and the fire brigade would not board this ship until they could review all dangerous goods SDSs. The fire brigade reached out to CHEMTREC to assist in identifying the product names of all the dangerous goods products on the ship from limited generic shipper name information that was available. CHEMTREC’s role: From our database of over six million SDSs, CHEMTREC worked to match proper shipper names with product-specific SDS in our library. We also used our extensive database of emergency contacts to contact shippers/manufacturers and request a copy of the SDS. CHEMTREC was able to provide a complete set of SDSs to the fire brigade so that they could properly assist with this emergency. CASE STUDY 2: Dangerous goods spill at a production plant, October 2012 Incident: A plant worker in Japan called CHEMTREC through our interpreter to report a dangerous goods spill on their assembly line. The assembly line has been shut down temporarily until the spill can be cleaned up. The worker needed product-specific information to properly clean the spill so that the assembly plant could be brought online. CHEMTREC’s role: CHEMTREC was able to locate the SDS and relay the emergency information to the caller through an interpreter. The caller realised that he needed additional information that was not located on the SDS. CHEMTREC contacted the manufacturer and was able to conference in the caller and interpreter to speak directly with the manufacturer to get additional information needed to help clean up the spill and restart the assembly line.

Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 3: Chemical reaction on a military base, November 2013 Incident: CHEMTREC received a call from a military base within the Middle East region. The caller stated that a CONEX ISO shipping container filled with special-use batteries had been submerged in water for five hours and he was unsure if the seal had been broken. The caller wanted to know what precautions should be taken by the military to open the container and evaluate the condition of the special-use batteries. The caller had the SDS on hand and requested to speak with the manufacturer of the battery for additional information. CHEMTREC’s Role: CHEMTREC contacted the manufacturer’s emergency contacts and informed them of the situation. CHEMTREC was able to conference in the caller and the manufacturer together to discuss the incident. The manufacturer was able to determine that the battery casings had likely been breached. The caller was instructed to wear a self-contained breathing apparatus (SCBA) due to the gas release that had likely occurred within the ISO container. The caller said he would call back if additional assistance was needed. CASE STUDY 4: Propane tank explosion on the highway, March 2015 Incident: CHEMTREC received a call from a fire brigade chief reporting a crash involving two transport trucks on the highway. After the trucks collided, one truck hauling a propane tank trailer overturned and ripped a 40cm by 10cm hole in the tank of the truck. The hole in the propane tank created a bleve explosion and burned an area approximately 0.40km in diameter. The fire brigade chief wanted advice on how to mitigate the remaining propane on scene. CHEMTREC’s Role: CHEMTREC conferenced in the manufacturer of the material with the fire brigade chief to agree on the best method to handle the remaining material. CHEMTREC was also able to immediately notify the emergency contacts on the manufacturer’s emergency distribution list. STAFF SELECTION Joe Milazzo – Director, Operations Centre John Simon – Director, Sales and Marketing Brian Banks – Product Manager Kevin Bryan – Sales Manager

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PROFILE: CHEMTREC

PARTNERS

PROFILE: China National Chemical Information Center

SERVICE AREA BREAKDOWN Other 2% IT & software 20%

CONTACTS

Laboratory 8%

Website

www.chemhse.com

E-mail

regulation@hse.cnicic.cn

Head office

No. 53 Xiaoguan Str Anding menwai, Beijing, China

Tel

+86 10 64453413

Fax

+86 10 64428331

Contact

Jiang Yong

Directors

Chen Jiandong Jie Yubin Lu Xianfeng Minyan Liang

Ownership

China state owned company

Locations

Beijing, China

Founded

1959

Information 20%

GLOBAL OFFICES Beijing office (Headquarters): Anwai Xiaoguan Street 53, Beijing 100029, China Tel: +86 10 64453413 E-mail: regulation@hse.cncic.cn Shanghai Office: Eton Business Plaza A 2006, Dongfang Road 69, Pudong, Shanghai 200120, China Tel: +86 21 68785696 E-mail: regulation@hse.cncic.cn US office: 106W Little LN, White Hall, AR, 71602, USA Tel:+1-501-626-3347 E-mail: regulation_us@hse.cncic.cn SERVICES PROVIDED

OVERVIEW China National Chemical Information Center(CNCIC), based in Beijing and formerly named the scientific and Technological Information Research Institute of the Ministry of Chemical Industry, has a history of almost 50 years With chemical and technical professors we have overall approximately 370 people, providing a range of services such as chemical industry consulting, professional exhibitions, standard drafting, chemical regulations consulting etc. These have all have been provided to MEP, SAWS, ChemChina and some research institutes among others. Our product registration and compliance department is dedicated to acting as a professional technical group on compliance with the regulations in China and abroad. Our extensive database resources on HSE (health, safety and environment), have been of great technical assistance to hundreds of chemical manufacturers and suppliers in: OO new chemical substance notification; OO globally harmonized system of classification and labelling (GHS); OO hazardous chemical substance registration; OO pesticide registration; OO cosmetic new substance registration; OO food related products registration; and OO test arrangements etc. We provide the perfect whole solutions to improve clients’ business value, providing them with plenty of achievements, We now enjoy a high reputation both in China and the global chemical industry. VITAL STATISTICS

2014/15

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Staff, group Staff, chemical service provision

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Consultancy/advisory 50%

370 23

China new chemical substance notification service “Measures for Environmental Management of New Chemical Substance” was revised by the Third Ministerial Meeting of the Environment Ministry of PR China on 30 December, and became effective on 15 October 2010. According to the Measures, new chemical substances must be notified before producing or importing them in China. Only after the Notification Certificates of Environmental Management of New Chemical Substances are approved, can they legally produced or imported. CNCIC is the most professional consulting firm handling China New Chemical Substance Notifications. More than a third of the notification dossiers approved by the authority are developed by CNCIC. Pesticide registration China’s pesticide registration system was set up according to the “provisions of Pesticide Management Regulations” and “Measures for pesticide regulations implementation”. A pesticide registration certificate is one of the three certificates needed for entry into the pesticide market. Pesticide notifiers must submit relevant documentation to the Ministry of Agriculture in accordance with “Pesticide Registration Data Requirement” including: OO tests of toxicity; OO residue; OO environment; and OO efficacy. Pesticide registration certificates can only be issued if the requirements are met. CNCIC is the only consulting firm that can handle both China New Chemical Substance Notification and China Pesticides Registration. Globally harmonized system of classification and labelling of chemicals (GHS) related services in China The Globally Harmonized System of Classification and Labelling of Chemicals (GHS, or “Purple Book”) is a regulatory document published by United Nations to guide countries to control chemical hazards and protect human health and the environment. With a global harmonized standard in chemical hazard classification and labelling, it can enhance the protection of human health and environment, reduce the duplication of chemical test and assessment, and facilitate international chemical trade.

Chemical Watch | Global Service Providers Guide 2016

TESTIMONIALS

Food related product compliance and notification service

Ella Liang

In order to regulate safety assessment and licensing of new foodrelated product varieties, the Center of Inspection and Supervision, PR China Ministry of Health (which has been reformed into National Health and Family Planning Commission) formulated the “Regulations on Administrative Licensing of New Food-related Product Varieties”. CNCIC provides notification services according to the regulations.

Ella Liang is Senior Engineer, GHS Manager of Product Registration and Compliance Department of CNCIC, focusing on Chinese GHS law and regulations, with an emphasis on dangerous chemical. She advises companies on regulatory compliance issues, especially about GHS SDS and labelling. She participates in the formulation of GB 30000.x (the Chinese national standard about GHS). Moreover, she also specialises in the risk assessment of the new chemicals.

Cosmetic new materials notification China Cosmetics Administrative Licensing is the administrative approval for the use of new cosmetic ingredient, the production of domestic special functional cosmetics product, and the first import of cosmetics product. All imported cosmetics, including special and non-special, must not be sold until approved by the State Food and Drug Administration prior to sale. CNCIC provides notification services to the authority, including: OO new cosmetic ingredient administrative licensing notification; OO domestic special functional cosmetics product administrative licensing notification; OO domestic non-special functional cosmetics product record certificate application; OO import of non-special functional cosmetics record certificate application; and OO import of special functional cosmetics administrative licensing notification.

“CNCIC provides instant and professional service to help us successfully notified our new chemical substance product so that we can export our product to China smoothly,” says a chemical producer. Another client says: “It takes less time and gets more professional services for us to commission CNCIC for China chemical regulation issue. They are worth trusting!” STAFF SELECTION

Amy Yu Amy Yu is Pesticides Registration Manager of Product Registration and Compliance Department of CNCIC. Amy graduated from Beijing University of Chemical Technology in 2005. With ten years of experience in China and overseas pesticides registration, she leads a specialised and professional team for agricultural chemicals compliance. Richard Tong

Fertiliser registration

Richard Tong is the New Chemical Notification Manager of China National Chemical Information Center, Product Registration and Compliance Department. Richard's practice focuses on Chinese chemical regulations with an emphasis on new chemicals, helping clients solve problems in China New Chemical Substance Notification. Richard is also a Senior Engineer with over ten years’ experience in chemical consultant. Richard has plentiful experience in new chemical notification, he has successfully achieved more than 700 registration certificates for simplified notification and more than 100 copies registration certificates of general notification. He earned his MS degree from Beijing University of Chemical Technology in 2005.

Global inventory of chemicals query

Minyan Liang

Healthy food/medical devices relevant chemicals regulation consulting

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1959

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

1984

Reformed to Economical Information Center of the Ministry of Chemical Industry.

1992

Reformed to China National Chemical Information Center, a China state owned company.

1995

Product Registration and Compliance Department, founded as a branch of China National Chemical Information Center.

ACCREDITATIONS CNCIC is the biggest and most famous chemical research institute, consulting firm, and information/regulation service provider in China with more than 50 years of history. It has played an active role in building China chemical HSE, and national environmental standards/regulations. For years, CNCIC has provided instant, efficient, and professional services in Chinese standards/regulations for more than 100 domestic and overseas manufacturers and traders involved in chemicals, pesticides, food packaging material, etc.

Chemical Watch | Global Service Providers Guide 2016

Minyan Liang is Senior Engineer with more than ten years of experience in Chinese chemical regulation. She is Director of Product Registration and Compliance Department of CNCIC, focusing on Chinese chemical regulations, Standards, with an emphasis on new chemical substance notification, toxicology and ecotoxicology. She was in charge of many new substance notification cases and has had rich experiences on regulations, tests, toxicology and ecotoxicology. Yong Jiang Yong Jiang is Marketing Manager of Product Registration and Compliance Department of CNCIC, Developing market with a specialised and professional team of China chemical regulatory compliance, helping clients solve problems in China New Chemical Substance Notification, China GHS, China Hazardous Chemical Registration, China Pesticides Registration, China Food Contact Materials Notification, China Cosmetics Material Notification, and etc. Yong is also a Senior Chemical Regulatory Consultant with over 10 years of experience in inventory registration and human/environment risk assessment. Yong is a trained chemist and earned his M.S. degree in Analytical Chemistry from Tsinghua University in 2003.

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PROFILE: China National Chemical Information Center

CNCIC provides GHS related services in China, including: OO identification and classification of chemical hazards, and risk assessment; OO preparation of GHS-SDS and precautionary labels (in line with Chinese regulations); OO search and query services for data necessary for classification; OO test arrangements for identification of chemical hazards; OO 24h emergency hotline service; OO hazardous chemical substance registration.

GLOBAL OFFICES Russia SERVICES PROVIDED Identification

PROFILE: CIS Center

CONTACTS Website

www.ciscenter.ru

E-mail

info@ciscenter.ru

Head office

Nakhimovsky prospekt, 31/2, Moscow, 117418, Russia

Tel

+7 495 745 38 00

Fax

+7 495 745 38 00

CIS Center provides services for substance identification in compliance with REACH, namely: OO substance's identifiers search and selection; OO search for information on the substance composition and formula; OO Russian laboratories physical and analytical test operations in accordance with REACH Regulation; and OO mini dossier creation.

Contact

Natalia Druzhinina

Russian SDS (Russian Safety Passport)

Directors

Dmitry Skobelev Elena Vyboychenko

Ownership

Non-profit organisation

Locations

Russia

Founded

2006

All companies intending to import chemicals into the Russian Federation have to be in compliance with national requirements concerning safe handling, transportation and storage. This includes the creation of an Russian SDS according to GOST 30333 in the Russian language with its obligatory expertise and registration with the relevant authorities shown by the assigning of a registration number. CIS Center has great experience in SDS creation, and extensive communication capabilities with the relevant Russian authorities. We thereby provide our customers with the best level of service on the creation and registration of Russian SDS.

OVERVIEW CIS Center as a non-profit organisation consolidates government and commercial structures with the best experts in the field of regulation and safe handling of chemicals. The mission of CIS Center is to provide professional consultancy assistance for regulators and enterprises regarding chemicals safety across the supply chain and throughout the whole product lifecycle in order to reduce trade barriers. We can help your company find individual solutions in different areas, including the identification of chemicals, creation and registration of Russian SDS, classification and labelling according to Russian national standards, risk assessment and risk management, best available techniques (BAT) implementation, Russian national regulatory compliance training and other. VITAL STATISTICS

Classification and labelling according to Russian national standards

2014/15

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No of offices

No of countries represented

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 to classify your product according to the following national standards: OO classification of chemicals and mixture (the series of standards); OO labelling of chemicals. General requirements; OO dangerous goods. Classification and marking; and OO marking of cargoes. CIS Center will help you choose the right classification code and handling marks and prepare the proper label. SDS creation CIS Center provides services on classification, labelling and safety data sheet creation of substance and mixture, according to legislation in the European Union, US, South Korea, China, Brazil, Australia, Singapore and elsewhere.

Staff, group

Risk assessment and risk management

Staff, chemical service provision

CIS Center activities lie in the field of exposure assessment, risk estimation and evaluation of chemicals in order to minimise negative impact of chemicals on human health and the environment in accordance with the best available risk management practices. Additionally CIS Center provides training courses on chemical risk assessment and management for the chemical sector of Russian industry, Customs Union officials and regulatory experts.

SERVICE AREA BREAKDOWN Training 20% Consultancy/advisory 45%

Consulting in the field of Russian regulation on chemicals

IT & software 10% Laboratory 5% Information 15%

Representation & management 5%

The CIS Center team has extensive background knowledge and experience of national legislation and can provide you with up-to-date information on chemical regulations within the Russian Federation covering the hazard communication, reporting and testing of new chemicals, chemical inventories and the evaluation of existing chemicals. Best available techniques (BAT) implementation One of the dynamically developing activities of CIS Center is implementation of BAT Reference Documents for the different type of production in Russian Federation and development of the series of the national standards in this field. We have already published a few books on this topic and currently we are preparing the new course of experts training on BAT implementation.

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2015

CIS Center coordinates activities of several Technical Committees (TC) including TC 339 "Safety of raw materials and substances" and TC 60 “Chemistry” in the Russian Federation. Our experts are directly involved in the development of the national and interstate (in the territory of CIS countries) standards regarding chemical regulation and safe handling, including the GHS implementation.

REACH, GLP, GPS and Russian national regulatory compliance training CIS Center organises training and conferences in the field of chemical control and safety regulations. We run regular training sessions and seminars on classification, SDS and labelling creation under Russian national standards; preparation of test facilities to comply with GLP principles; chemical risk assessment and management and other training. Other OO

CIS Center was authorised by ASTM International to offer the ASTM proficiency test programme (PTP) 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). In the near future CIS Center is planning to provide training on the proficiency test programme. CIS Center is a partner of ChemADVISOR, Inc. and an official distributor of LOLI database and global chemical regulatory reports in Russian-speaking territory. Our team have done localisation of LOLI Database and some other IT products for the Russian market.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006

CIS Center founded in Moscow, Russia.

2006

Development of international standards on GHS for CIS countries.

2008

CIS Center registered as a non-profit organisation.

2009

2010

2011 2012

Organisation of the third annual conference of CIS countries “Safety regulation of chemicals. UN Recommendations and European regulations REACH and CLP” (Baku, Azerbaijan Republic). Organisation of the fourth annual conference of CIS countries on chemicals regulation (Astana, Kazakhstan). OO

2013

OO OO

2014

Organisation of the second annual conference of CIS countries “Safety regulation of chemicals. UN Recommendations and European regulations REACH and CLP” (Minsk, Belarus Republic). Development of national standard for GLP.

Organisation of the fifth annual conference of CIS countries on chemicals regulation (Kazan, the Republic of Tatarstan, Russia). Development of international standards on GHS and GLP-OECD for CIS countries. CIS Center authorised by ASTM International. Organisation of the sixth annual conference of CIS countries on chemicals regulation (Minsk, Belarus Republic). CIS Center became an official partner and distributor of ChemADVISOR products in Russian-speaking territory.

CIS Center and CRAD Cevre Risk Analiz Den. Ve Egitim Hiz. A.S. became a partners. Organisation of the seventh annual conference on chemicals regulation in the countries of CIS (Istanbul, Turkey). Renaming Coordinating Informational Service Center for enterprises. Assistance in the field of chemical safety into Coordinating Informational Service Center of CIS Member States on approximation of regulatory practices (the short name remains the same – CIS Center).

PARTNERS ASTM International, ChemAdvisor, CRAD Cevre Risk Analiz Den. Ve Egitim Hiz. A.S. CLIENTS CIS Center assists a broad range of companies of the chemical and petrochemical industry. We work with both large international companies and SMEs. CASE STUDY: Russian safety passports Until the technical regulation "On Safety of Chemical Products" enters into force (expected to be in 2017), Russian SDS are not obligatory. However, the reality is that Customs can have their specific requirements and usually demand to show this document at the border. In our practice we are often faced with a situation where companies urgently ask us to help with Russian SDS creation. They want them as soon as possible, because otherwise they will lose a lot of money due to the delay at customs. Such companies usually know about Russian SDS, but think that if they translate an existing SDS (for example EU-SDS) into Russian it will be enough. Unfortunately, they are often unaware that although Russian safety chemical legislation harmonised with GHS, it has a number of distinct features (specific format with title page, period of validity, dual classification and etc.). This means that direct and even proper translation of an SDS into Russian is not a solution. More than that, each Russian SDS has to be registered with the relevant authorities and have its own unique registration number. CIS Center knows the subtleties of Russian legislation and offers a service on the creation and registration of RSPs according to national standards, resulting in the assignment of a registration number. This enables our clients to save time and money by avoiding delays at Customs. STAFF SELECTION CIS Center team CIS Center team members are highly competent and have great experience in the field of chemicals regulation throughout the whole product lifecycle, including but not limited to chemicals identification, hazard classification, risk assessment, Russian SDS and labelling creation. Our experts within the delegation of the Russian Federation participate in the meetings of the UN Sub-Committee of Experts on the GHS, Chemical Dialogue APEC and OECD chemical safety and biosafety Committee. Our specialists are directly involved in the development of Russian Federation standards and always have up-todate information on national and international chemical control legislation.

Organisation of the seventh annual conference of CIS countries on chemicals regulation (Moscow, Russia).

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PROFILE: CIS Center

Standardisation

GLOBAL OFFICES CiToxLAB has facilities located in France, Denmark, Hungary and North America. SERVICES PROVIDED Chemical, biocide and agrochemical testing for registration

PROFILE: CiToxLAB

CONTACTS Website

www.citoxlab.com

E-mail

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

Head office

CiToxLAB, B.P. 563, Evreux, France

Tel

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

Fax

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

Contact

Erhard Vandaele, Business Development erhard.vandaele@hu.citoxlab.com

Directors

Olivier Foulon, CiToxLAB in France Alyson Leyshon, CiToxLAB in Hungary Andrew Makin, CiToxLAB in Denmark Andrew Graham, CiToxLAB in North America

Ownership

Private company

Locations

France, Denmark, Hungary and North America

Founded

1969

To meet the wide range of regulations in force around the world for chemical, biocide and agrochemical product registrations, many of the largest international companies entrust CiToxLAB with their physicochemistry, ecotoxicology and mammalian regulatory testing. Experts with in-depth knowledge of authority requirements can advise you about the most appropriate testing for your active ingredients and products, to meet your international registration or classification and labelling needs. For REACH and other chemical notifications, we provide complete regulatory packages and data-gap studies. We also propose a one-stop service for studies from Qsar and characterisation to ecotoxicology and long term rodent toxicology studies. We are experienced in dealing with a wide range of chemistry, including metals and UVCBs, and perform studies by all administration routes. Cosmetics CiToxLAB has been working with industry in the development of cosmetics, skin care products and perfumes (ingredients and finished products) for more than 40 years. Since the ban on animal testing for cosmetics came into effect, we have been at the forefront in implementing in vitro alternatives. Today, we offer one of the most extensive ranges of in vitro tests in Europe for safety assessment of raw ingredients and finished products: regulatory toxicology tests in vitro for topical (skin/eye) corrosion and irritation (Episkin, BCOP, SKINTOL, EpiOcular Eye Irritation test), skin sensitisation (DPRA, KeratinoSens, MUSST) and transcutaneous absorption/penetration, as well as all genotoxicity and cytotoxicity tests. Studies are conducted in a GLP environment. Additional services include state-of-the-art genomics techniques (NGS, Affymetrics genechips), flow cytometry (ten colours, three lasers), cellular and image analysis, and bioanalysis techniques such as ICP/MS and HPLC.

OVERVIEW CiToxLAB offers a comprehensive range of pre-clinical services for pharmaceutical, biotechnology, chemicals, cosmetics, medical devices and food companies worldwide. Our scientists and regulatory experts provide customised advice to help your development projects progress in the most effective way. Created through the merger of CIT and LABResearch, CiToxLAB has more than 850 employees working in France, Canada, Denmark and Hungary. Proximity, the latest technologies and easy access to scientists, make CiToxLAB your one-stop CRO for pre-clinical research. We offer maximum flexibility and expertise, major factors that guarantee the quality of your non-clinical programmes. VITAL STATISTICS

General toxicology and expert services

2013/14

Turnover, group

> €80m

Turnover, chemical service provision

n/a

No of offices

No of countries represented

All

Staff, group

850

Staff, chemical service provision

850

SERVICE AREA BREAKDOWN Other 5%

Laboratory 80%

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Consultancy/advisory 15%

CiToxLAB is your one-stop CRO for general toxicology studies, whether you are in the pharmaceutical, biotechnology, chemical, food additive, veterinary or crop protection industry. From method development and the first investigational new drug screening tests, through pharmacokinetics, genomics and safety assessments, to full toxicology packages including reproduction, embryo-fetal / juvenile development and carcinogenicity, our experts can accompany you with customised advice and offer you a whole range of GLP-compliant studies. Inhalation toxicology CiToxLAB, Hungary has performed more than 260 studies via the inhalation route over the past five years ranging in duration from acute to six months. OO OECD TG 403 – acute LC50 inhalation; OO OECD TG 436 – acute toxic class inhalation; OO OECD TG 412 – sub-acute inhalation; OO OECD TG 413 – sub-chronic inhalation; and OO EUR 20268 EN – quantifying inhalable fraction. Partner with our team of senior inhalation toxicologists and aerosol specialists. We provide support and guidance at all stages of programme development. Technical facilities and expertise include: OO exposure/administration suites; OO Inhalation delivery in rodents and non-rodents; OO TSE directed flow (flow-past) systems : –– nose-only or Oro-nasal exposure; –– prevents re-breathing;

Chemical Watch | Global Service Providers Guide 2016

restraint designed to minimise thermal stress; maintains homogeneous breathable atmosphere at all levels of the inhalation tower; –– state-of-the-art technologies to generate powder, liquid or vapour atmospheres; –– early stage toxicology evaluation with intra-tracheal aerosol delivery; experienced with fibres.

Ecotoxicology and biodegradation CiToxLAB offers a wide range of laboratory based ecotoxicology and biodegradation studies to meet current ecological and nature preservation concerns and the needs of industries, including chemical, plant protection and biocide sectors. We have specialised expertise in complex substances such as metals, UVCBs and polymers. The design of each study, including media preparation and analytical services, is tailored to ensure your compound registration program meets regulatory requirements for aquatic and terrestrial environmental risk assessment. OO ready biodegradability test (OECD 310) OO activated sludge, respiration inhibition test (OECD 209) OO aerobic and anaerobic transformation in soil (OECD 307) OO soil micro organisms: nitrogen transformation test (OECD 216) OO aerobic and anaerobic transformation in aquatic sediment systems (OECD 308) OO terrestrial plant growth test (OECD 208) Ecotoxicology Aquatic (acute, long term, reprotoxicity) OO daphnia OO algae OO lemna OO trout, carp, zebra fish OO early life stage fish OO fish bioaccumulation Terrestrial (short and extended/reprotoxicity studies) OO earthworm OO collembola OO honey bee OO predatory mite OO parasitic wasp Avian (acute and reprotoxicity studies) OO Japanese quail

CLIENTS OO

CiToxLAB work with the major players in each industrial sector.

STAFF SELECTION

David Esdaile – Director of Science and Regulatory Affairs David Esdaile is the Director of Science and Regulatory Affairs at CiToxLAB in Hungary and has 32 years experience in pre-clinical research. David has experience in all areas of toxicology testing including project development, acute, sub acute and chronic studies in mammalian species, carcinogenicity, inhalation, reproduction toxicity, genotoxicity, dermal toxicity, skin sensitisation, skin penetration, structure-activity assessments, ecotoxicity and physical chemistry. François Spezia – Head of the Developmental and Reproductive Toxicology François Spezia is the Head of the Developmental and Reproductive Toxicology Department at CiToxLAB in France. François has more than 25 years of experience in this specialty area. François Spézia, who is a European registered toxicologist, has developed and validated several in vitro and in vivo models for evaluating adverse effects on reproductive functions (eg embryotoxicity, fertility). He also participated in the production of an international glossary on the terminology of development anomalies in laboratory animals. Dr. Spezia offers expert consulting in all topics related to chemical-induced reproductive and developmental toxicity testing. Erhard Vandaele Erhard Vandaele is responsible for sales and liaison activity at CiToxLAB in Hungary. A graduate biologist and former practising toxicologist, he has performed a variety of toxicology studies on pharmaceuticals, agrochemicals and chemicals, including some of the first toxicology studies on industrial chemicals after the implementation of the 6th Amendment to Council Directive 67/548/EEC in 1979 (NONS) prior to REACH.

Under the EU REACH regulations and for CLP, an integrated assessment of persistence, bioaccumulation and toxicity (PBT) is required, based on the evaluation of expected chemical behaviour and toxicity in the environment. CiToxLAB offers testing services which address the required PBT assessment of chemicals, agrochemicals and biocides. Developmental and reproductive toxicology CiToxLAB offers you developmental and reproductive toxicology studies accepted by worldwide regulatory authorities for the safety testing of pharmaceuticals, biologics, gene-therapy products, food additives, chemicals, agrochemicals, veterinary medicines and consumer products. Studies cover the whole scope of developmental and reproductive toxicology, testing for potential effects on fertility, through embryo‑fetal, post-natal and juvenile stages, up to second generation reproduction. Specialised evaluations can be combined in your DART studies, such as neurobehavioral testing, sperm analysis, developmental immunotoxicology, neuro-histomorphometry, skeletal development and genomics. Routine testing includes OECD 421, 422, 414 (rat and rabbit) and OECD 443 Extended one generation studies with neurotoxicity and immunotoxicity. ACCREDITATIONS GLP certified, AAALAC accredited, ISO 9001, ISO 14001

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PROFILE: CiToxLAB

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SERVICE AREA BREAKDOWN Training 10%

IT & software 20%

PROFILE: CRAD

CONTACTS

Consultancy/advisory 40%

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/ Fax

+90 216 335 4600/ +90 216 335 4606

Contact

Melih Babayigit

SERVICES PROVIDED

Directors

Melih Babayigit, Managing Director

General consulting services

Ownership

Private company

Locations

Turkey

Founded

2008

We do provide OR Services including registration and notification service for the Turkish REACH named KKDIK. Our team’s expertise on Turkish, EU and global chemical regulations lets our clients have a focused insight into Turkish chemical regulations and helps them solve their problems with work and cost efficient compliance solutions for placing their products on the Turkish market. Also our regulatory follow up service lets companies be aware of future regulations and enables them to plan their strategy at the earliest moment possible. We also provide REACH compliance services for non-EU companies especially in Turkey and close regions such as MENA, with our capacity enriched by our strategic partners’ expertise.

Information 5% Representation & management 25%

OVERVIEW CRAD is the leading consultant company in Turkey, providing chemical regulatory compliance consultancy for the global chemical industry. With a well equipped team of consultants and with their knowledge of local regulations as well as of global and EU chemical products regulations, CRAD is capable of providing services within a wide context. Our multidisciplinary service portfolio allows our clients to have a better understanding of the compliance process, with similarities and differences between regulations in Turkey and EU. Serving more than 300 global chemical manufacturers worldwide for their compliance to Turkish Chemical Control Regulations such as CICR, Turkish CLP, Turkish compliant SDS authoring, we are ready to serve for their compliance with the KKDIK which will be the Turkish implementation of the EU REACH regulation. CRAD, acting as OR and registrant for product and substance registration schemes supports your compliance for the products placed on the Turkish market without any concerns on CBI for the exporters that they may need to share with their local distributor. Thanks to our strategic partners around the globe CRAD is also capable of providing its clients global information with a local twist. With our awareness about our responsibility to both the human and environment aspects, we not only serve our clients, but also keep an eye on our responsibilities towards the welfare of humankind and environment, particularly within the scope of our services. Aiming to be a one-stop compliance solution centre, we always aim to enlarge our portfolio of services. As of 2016 CRAD serves with a team of 14 consultant who are experienced in their field of service. A team of hazard communication experts serves our clients in SDS and label compliance for products placed on the market in Turkey and the EU.

Notification, registration and only representative services We represent companies fully on notifications and product registrations in Turkey. Our service lets global chemical industry to comply with Turkish chemical regulations in a concern free environment about their CBI concerns. They do have the comfort and confidence of keeping their CBI and strategic data undisclosed to their commercial agents. Another advantage of our representation service is that it allows the freedom of changing the commercial supply chain, without being restricted by registration ownership of the former commercial agent. Chemical safety assessor services to comply with Turkish KKDIK (T-REACH) Regulation Registration under the scope of KKDIK will require certified chemical safety assessors (cCSA). The cCSA will be preparing the registration dossiers for the KKDIK. CRAD is ready to serve with its team of cCSA for the preparation of registration dossiers and preparing e-SDS to comply with the Turkish REACH KKDIK. We are as well ready with our trainings for the certified CSAs. Biocidal/ detergent / veterinary product registration services

No of countries represented

With extensive communication capabilities with relevant Turkish authorities, we serve our clients with the best level of information and most efficient approach related to several product registration schemes such as biocidal products, plant protection products, cosmetic, household products etc. With our capacity and experience on dossier compilation and registration we provide a result-oriented service for our clients. Also representing companies in means of registration keeps manufacturers away from the CBI concerns.

Staff, group

Staff, chemical service provision

Label compliance and (M)SDS authoring services

VITAL STATISTICS

2014/15

Turnover, group

>€1m

Turnover, chemical service provision

>€1m

No of offices

Page 92

Turkish SDS provisions require SDSs to be authored by a locally certified personnel to author the SDS in compliance with the regulation and represent his certification when required by the authority. A compliant SDS and label are also one of the main components of a product registration dossier. CRAD’s team of experts in the field of classification and hazard communication provides you the SDS and label compliance and defends your cause to the authority when a case of dispute arises With our follow up service we also provide updated SDSs when the related regulations requires an obligatory revision. Chemical Watch | Global Service Providers Guide 2016

Thanks to our strategic partner Safeware Quasar’s expertise on regulatory compliance IT solutions and our in-house IT capabilities we provide “plug and play’’ and bespoke IT solutions for the chemical industry. Regulatory compliance training and bespoke training Whenever your team needs a focused insight into the Turkish regulations on chemicals, we are ready to provide a webinar for your regulatory team or an in-house training course for your team members located in Turkey with our key staff who are recognised as key speakers at international regulatory events. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007

CRAD established

2008

CRAD staff certified as SDS author by TSE

2008

Market leader in REACH compliance services in Turkey

2009

In-house training class for 20 became available

2009

CRAD has been accredited to official REACH group of MoEF

2009

CRAD launched services for Turkish regulatory compliance

2010

CRAD joined the GCC Network

2012

CRAD enlarged its offices to 420 sqm at its HQ.

2013

CRAD launched services to comply with Turkish SEA (CLP)

2014

CRAD started providing certified SDS author trainings

2015

Team of consultants at CRAD increased to 14 to serve our clients better & faster.

2015

Turkish SDS authored by CRAD exceeded 15,000 More than 3,000 substances notified to the Turkish C&L Inventory representing over 200 global chemical companies.

ACCREDITATIONS Certified for SDS training Certified SDS author (all team) Turquality and TSE certified consultant Member of REACH discussion group at Turkish CA PARTNERS Cambridge Environmental Assessments / ADAS UK Safeware Quasar Ltd UK Repre Ltd Japan Member of the GCC-Network/ Member of CHCS Full list of our strategic partners can be found on our website. CLIENTS Due to our confidentiality agreements and the nature our business, we do not release the identity of our customers. We do serve from SMEs to globally well know, NYSE listed, chemical enterprises.

CASE STUDY 1: Registering products with an appointed representative A biocidal product producer based in the EU was having problems registering and marketing their biocidal products in Turkey, due to their former sales agent’s using their formula and trade name for registering the product. As the regulation doesn’t allow a second product to be registered with the same trade name, that former registration was preventing our client registering and marketing their product in Turkey. We applied to the competent authority about the case and proposed that they ask for an appointment letter to be confirmed by Turkish consulates at the registered locations of the manufacturer, to prevent such dispute cases. The competent authority accepted our proposal for general implementation principle. and we successfully registered our client’s products as a representative independent from the supply chain. Unauthorised registrations of the former registrant was rejected. STAFF SELECTION Melih Babayigit – General Director – SDS Lecturer and Author and Classification Expert Babayigit has 20 years of experience in the chemical industry and for the last ten years he has been particularly focused on global and emerging regulations on chemicals. He has been one of the leading key experts in Turkey in the field of hazard communication and product compliance. He is an appointed consultant to the competent authorities for PPP and biocidal product registrations schemes. He is regularly published in industry magazines including Chemical Watch and is a highly sought after speaker at regulatory events. He is a member of CHCS and a certified SDS trainer and author. Bulent Özdemir – BSc-Biolog-MSc OHS SDS Author and Classification Expert Bulent Özdemir holds the academic degree of MSc in biology. He has 20 years’ experience in the chemical industry. After joining the CRAD in 2007 he has focused on risk assessment and hazard communication about chemicals. Mr Özdemir serves as an expert in the classification of chemicals, and the generation of safety data sheets with multidisciplinary approach. He is a certified SDS trainer and author and Certified H&S expert. Other members of the CRAD team In order to provide multidisciplinary services to our clients we formed a team of competent experts with academic and industrial experience and experience in several fields such as; Mrs Esra Alkan (MSc environmental engineering), Mrs Esra Demirhan (BSc chemical engineering), Mr Gökhan Ardıç (BSc chemistry, certified H&S expert), Mr Mehmet Yolcu (BSc chemistry, certified H&S expert), Ms Sevgi Tan (BSc chemistry), Mrs Sibel Şanlıtürk (BSc chemical engineering, certified H&S expert), Ms Havva Bilgili (BSc chemistry), Ms Büşra Tarakçı (BSc chemistry), Ms Betül Gürleyici (BSc chemistry), Ms Elif Koç (BSc chemistry) and all are certified SDS authors with a range of experience from three to eleven years.

TESTIMONIALS References can be provided upon request as far as our agreements with our clients’ permits.

Chemical Watch | Global Service Providers Guide 2016

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PROFILE: CRAD

Classification, SDS and chemical inventory software tools

maturity level of your PSM programmes, we can help you: OO design and create relevant PSM programmes; OO support your company in implementation monitoring and sustainability; OO correct and improve deficient programmes; and OO audit PSM programmes, comparing with best practices worldwide. Process safety engineering – specialist consulting

PROFILE: DEKRA Insight

CONTACTS Website

www.chilworth.co.uk www.dekra-insight.com

E-mail

info-uk@chilworthglobal.com

Head office

Southampton Science Park, Southampton, SO16 7NS, UK

Tel/ Fax

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

Contact

Dr David Firth, Mr Daniel Baker, Dr Andrew Starkie, Mr Jochen Dettke

Directors

DEKRA SE

Ownership

Wholly owned subsidiary of DEKRA SE

Locations

Worldwide

Founded

1925 (DEKRA)

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

Turnover, group

€2.5bn

Good process safety practice demands a thorough understanding of the hazardous physical and chemical properties of materials you process. However, we recognise that data alone is rarely useful – it is the interpretation of the data and its implication for your plant that really makes a difference. DEKRA Insight can manage your entire materials testing requirements, offering a turnkey service that not only collects data through rigorous experimentation and testing but also interprets and reports the results. Our global network of testing facilities gives your business full access to cutting-edge techniques and dedicated laboratory testing teams. We offer more than 300 standard testing procedures, as well as the research capability to conduct unusual or complex customised testing. The result is an expert and trusted service that not only delivers quality controlled results, but removes the pressure on resources, continuity and compliance associated with in-house testing.

Turnover, chemical service provision

€700m

Material testing

OVERVIEW DEKRA Insight represents the collective expertise of our legacy businesses, each an institution in safety: BST, Chilworth, Russell Consulting, RCI Safety, Optimus Seventh Generation, and RoundTheClock Resources. We have over 500 employees, and growing, in 22 offices and 16 countries. Together, we help organisations improve organisational and process safety and implement software solutions in support of safety performance to save lives, prevent injuries, and protect assets. VITAL STATISTICS

2014/15

No of offices

30+

No of countries represented

80+

Staff, group

35,000+

Staff, chemical service provision

500+

SERVICE AREA BREAKDOWN

Training 5%

Laboratory testing

Other 10% Consultancy/advisory 30%

Laboratory 50%

Representation & management 5%

GLOBAL OFFICES DEKRA SE, Handwerkstr 15, D-70565 Stuttgart, Germany SERVICES PROVIDED Process safety management – consulting Process safety management is the bedrock of excellence in process safety performance. Our global teams of PSM specialists provide the experience, knowledge and insight to support you with all the elements of your PSM programmes, whether they are concerned with process hazard assessment, risk analysis, mechanical integrity, commitment to process safety, learning from experience or management of change. Whatever the Page 94

DEKRA Insight’s laboratories in the UK can handle powdered materials, gases or vapours, even if they are toxic or highly active and can offer a fast turnaround service if required. We strive to ensure only essential testing is undertaken, that our reports are comprehensive and meaningful, and that specialists are on hand to provide expert advice on the interpretation of results. We pride ourselves on providing a broad range of fire and safety services; including fire risk assessments. Our CPE teams provide laboratory testing data with expert consultancy, for the identification and assessment of exothermic reaction hazards, thermal stability screening, reaction and adiabatic calorimetry, runaway simulation, engineering solutions and emergency vent design (DIERS). Laboratory testing services also available from DEKRA Insight include: OO explosivity, CRH and exothermic chemical reactions, fire and thermal instability and consulting and testing for energetic material assessment, propellants, pyrotechnics and explosives. Regulatory testing DEKRA Insight’s services include the complete range of physico-chemical tests required for European regulatory purposes. Through our colleagues at DEKRA, we can also provide expert testing for: OO physico-chemical analysis; OO RoHS testing; OO REACH SVHC candidate list substance testing; OO materials testing; OO product testing, eg toys, food contact materials, etc. Both REACH and CLP require information to be put into an MSDS data sheet. Our range of laboratory services from our GLP compliant testing

Chemical Watch | Global Service Providers Guide 2016

Process safety training Sharing knowledge is what we do; it is our guiding principle. By sharing our expertise, DEKRA Insight develops long-term customer relationships that give the in-depth understanding required to achieve excellence in process safety engineering and its management. We offer a range of structured courses, taught by our team of leading experts, which train, educate and develop skills for a range of audiences, including: OO individual and team training; OO company-wide training to a consistent standard; and OO global group training to a consistent corporate standard. The Process Safety Academy offers the most specific and relevant training of its type in the world, delivered globally in multiple languages across a comprehensive range of platforms and media. Ways to learn include: OO in-company courses tailored for your industry or company – and to different levels; OO open public courses – delivered to a global standard; OO internet-based learning programmes; and OO broadcast and interactive webinars.

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

1986

Foundation of Chilworth Technology Ltd.

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

1991

Chilworth Technology Inc established in US.

STAFF SELECTION

1995

Received Good Laboratory Practice accreditation.

Dr Stephen Rowe – Regional Director – Process Safety EMEA

2001

IChemE safety and environmental awards winner.

2003

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

2008

Chilworth acquires Spanish facility.

With more than 20 years’ experience in process safety, Steve has particular expertise in chemical reaction hazards testing, exothermic reaction hazards consulting and dust, gas and vapour flammability testing and consulting programmes.

2009

Acquired JCI, the UK’s electrostatic measurement experts.

2011

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

2013

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

Covering all areas of process safety, David has many years of experience working with customers in a variety of industries including chemicals, pharmaceuticals, agrochemicals, paint, polymers, adhesives, electronics, fuel additives, synthetic fibres and many others.

2015

Merged with sister companies to create DEKRA Insight

Mr Daniel Baker – Laboratories Manager - Process Safety EMEA

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

ACCREDITATIONS Good Laboratory Practice (UK); ISO9001 (UK); OHSAS18001 (UK); ISO 17025 (US) CLIENTS We work with a number of multi-site, blue-chip clients in a variety of processing industries including the petrochemical, chemical, pharmaceutical, food, drink, paper and packaging, plastics and rubber, agrochemical, automotive, aerospace and power generation sectors. TESTIMONIALS Testimonials can be provided on request. CASE STUDY 1: DEKRA Insight’s Chemical Process Evaluation laboratory worked intensively with development chemists at a global producer of pharmaceuticals to characterise a range of materials’ stability limits and examine the thermodynamics and kinetics of the formation reaction and subsequent steps of the process. Using a range of techniques, we were able to identify onset conditions for the decomposition and ensure that safe process temperatures

Chemical Watch | Global Service Providers Guide 2016

Dr David Firth – Global Account Director – Process Safety

Responsible for the management of our laboratories, Daniel has more than a decade of experience in testing and project management and brings a wealth of knowledge on regulatory test requirements. As a qualified DGSA, he provides guidance on the implication of results on classification of products. Dr Andrew Starkie – Principal Process Safety Specialist Managing our GLP programme and with over a quarter of a century of experience in the sphere of process safety testing and consultancy, Andy has particular expertise in the handling and testing of hazardous and sensitive materials and chemical reaction hazards. Mr Jochen Dettke – Head of REACH Registration Team in Germany A product manager at DEKRA Assurance Services GmbH – based in Stuttgart, Jochen heads up the REACH registration team in Germany, providing consultancy and testing advice from portfolio optimisation, through data acquisition and into dossier preparation. He also supports with occupational safety and hazardous substance management.

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PROFILE: DEKRA Insight

laboratory enable compliance and regulation for: OO aerosols, explosives and oxidisers; OO pharmaceuticals and agrochemicals; OO biocides and plant protection products; OO explosives and oxidisers; and OO transportation of dangerous goods following the UN Manual of Tests and Criteria (CLP, ADR, IMDG, Iata etc).

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

PROFILE: DHI

CONTACTS Website

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

SERVICES PROVIDED

E-mail

jet@dhigroup.com

Head office

Agern Allé 5, DK-2970 Hørsholm, Denmark

Tel

+ 45 4516 9200

Fax

+ 45 4516 9292

Contact

Jens Tørsløv, Head of Projects

Directors

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

Ownership

Not-for-profit organisation

Locations

31 worldwide offices and operations

Founded

1964

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

REACH and regulatory compliance services globally

Product stewardship, regulatory services and software tools

OVERVIEW DHI is a global and independent consulting and research organisation within the fields of water, environment, health and toxicology. To ensure product safety and mitigate environmental risk, we assess the impact of products and processes on humans and the environment. Our extensive knowledge in this field provides support to authorities and industries around the world. Our expertise in risk assessment, chemicals regulation, toxicology and ecotoxicology help the industry make critical decisions about chemical substances and assist it in complying with regulations on health, safety and prepare applicable documentation. Our integrated approach combines chemical consulting and profound insight in regulatory requirements with leading edge IT solutions and a top professional laboratory. VITAL STATISTICS

2015/16

Turnover, group

€111 m

Turnover, chemical service provision

€9 m

No of offices

No of countries represented

Staff, group

1,114

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 1%

Laboratory 47%

Representation & management 1%

Page 96

Consultancy/advisory 51%

DHI facilitates company specific GHS strategies for global companies as well as classification and labelling of chemical substances and mixtures. Preparation of safety data sheets, exposure scenarios and software tools for chemical management, SDSs and exposure scenarios. Training courses and webinars offered in CLP, SDS, exposure scenarios and related areas. Provider of chemicals management systems and content for SDS software including national lists on classification, substance names, exposure limits, CAS numbers, phrase modules with 4,500+ phrases in more than 40 languages. Environmental laboratory The DHI laboratory conducts ecotoxicological studies with organisms in water, sediment and soil. We are specialised in carrying out standardised and specialised tests concerning biodegradability, ecotoxicity, endocrine disrupting effects and bioaccumulation of chemicals. DHI has furthermore experience in using sensitive marine organisms for whole effluent testing for offshore activities. DHI also holds expertise in testing under the scheme for pharmaceuticals according to the European Medicine Agency (EMA). Biocides and pesticides DHI offers regulatory and documentation assistance for both industry and authorities: OO preparation of dossiers on biocidal active substances and biocidal products; OO preparation of dossiers on active substances and plant protection products; OO Iuclid; OO Art. 95 dossiers; OO data search, information retrieval, data gap analyses; OO toxicological evaluations; OO ecotoxicological tests; and OO phrasing of claims, notifications and expert reports. Medical devices, pharmaceuticals and cosmetics Within medical devices, cosmetics, medicinal products, veterinary and herbal medicine, DHI supports industry and authorities with human and environmental risk and safety assessments and documentation. Services include data screening, literature searches, evaluation of biocompatibility, comparative evaluation of materials/toxicity, Qsar for prediction of toxicological effects of chemical substances, preparation of cosmetic dossiers, safety assessments and selection of tests in accordance with ISO 10993 and regulatory services (EMEA, FDA, ISO 10993, ICH).

Chemical Watch | Global Service Providers Guide 2016

Food and feed safety, drinking water

CASE STUDY 2: Registration in Korea (K-REACH)

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

DHI has joined a partnership with the Korean Institute of Science and Technology (KIST) and offers access to Korean speaking specialists in K-REACH. EU companies have the option to join the K-REACH Siefs that have been formed for the first wave of substances to be registered. Our services include OR representation by a Korean partner based in Seoul. DHI offers preparation of lead registrant dossier through the same organisational set-up with KIST.

1964

Danish Hydraulic Institute (DHI) founded

1973

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

1982

VKI laboratory accredited by DANAK, the Danish Accreditation Fund

1989

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

2000

Designated as a resource centre for the Global Water Partnership

2001

Merge with VKI Institute for the Water Environment

2004

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

2005

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

2013

Offices in 31 countries around the world

ACCREDITATIONS DHI works in accordance with the quality management system standard: OO ISO 9001 as certified by Bureau Veritas. Ecotoxicology tests: OO in accordance with ISO 17025; accredited by DANAK – the Danish Accreditation Fund; OO in compliance with the OECD and principles of good laboratory practice (GLP). PARTNERS Consultancy: KIST-Europe (Korea). Software supplies: ECOonline; Knauf; Radiometer; InterSolia AB. CLIENTS AAK AB, Chevron Products Company, Coloplast A/S, Danish EPA, ECA Europe Group, European Chemicals Agency, European Commission, Ferring Pharmaceuticals A/S, JFE Mineral Company (Ltd), KIST Europe Forschungsgesellschaft mbH, Leo Pharma A/S, Maersk Oil and Gas, Magna Industrial Company Ltd, Nickel Institute, Novo Nordisk A/S, Novo Nordisk Pharmatech A/S, Novozymes A/S, Radiometer Medical Aps, Rhodia, Riemann and Co. A/S, Rockwool A/S, Statoil AB, Virbac. TESTIMONIALS Specific references can be provided to potential clients upon request. CASE STUDY 1: Assessment of alternatives DHI has conducted analysis of alternatives (AoA/SEA) for a number of substances including various nickel compounds. AoA is used as technical documentation in the context of an application of authorisation but also as documentation in industry advocacy activities targeted member state authorities. A successful AoA is quite detailed and reflects up-to-date knowledge from the sector, eg, by including academia and/or specialists from the sector. REACH aims to replace substances of very high concern with suitable alternatives over time. For most substances on Annex XIV of REACH it is, however, mandatory to document that no other suitable alternatives are available before an authorisation will be granted. An analysis of alternatives therefore plays a key role in the authorisation title of REACH.

Chemical Watch | Global Service Providers Guide 2016

STAFF SELECTION Jens Tørsløv, PhD – Head of Projects Extensive experience as project manager with references within REACH registration and CSR, analysis of alternatives, industry strategy on SVHC and application for authorisation. Jens Tørsløv joined the management team of Department of Environment and Toxicology DHI in 2007 and Jens Tørsløv plays a key role in coordination of the REACH services. He has more than 25 years’ experience providing services to industry and authorities on environmental and human risk assessment of chemicals, industrial pollution control, capacity building. A position by the Commission (ECB, Ispra) during the years of preparation of REACH gave a solid background within the REACH legislation and its practical implementation. Helle Westphal, MSc, Pharmacy – Head of Department Expert knowledge of European chemicals REACH legislation and broad knowledge on other parts of the European regulation related to chemical products. Helle Westphal has 25 years of experience in strategic and practical consultancy in health and environmental issues, including development and implementation of chemicals management systems and cleaner technologies in a number of companies. Toxicological risk assessments and a good general knowledge of the European environmental regulation. 20 years of management experience. Hülya Genc-Fuhrman, PhD, Chemicals – Senior Consultant Is an environmental engineer with over 15 years of project management experience within the areas of regulatory management of chemicals and water quality management. She has extensive experience on preparing and submitting REACH registration dossiers both at the lead registrant and company specific levels. Additionally, she has developed new substance registration strategies for the USA (ie, TSCA), Canada, Switzerland and Russia. She is an expert user of OECD Qsar Toolbox and Iuclid, and very skilled in using read across for data-gap filling in Iuclid as well as forming and facilitating Siefs and consortia. Poul Bo Larsen, MSc – Chief Toxicologist Has more than 25 years’ experience in regulatory toxicology and human health risk assessment of chemicals/chemical pollutants. Has been employed at the Danish Technological Institute, the Institute of Toxicology at the National Food Agency and for more than 14 years at the Danish EPA. Participated as a national expert on human health risk assessment of chemicals in various working groups at national level in OECD and the EU including the Risk Assessment Committee at Echa. Has worked with regulation and assessment of hydrocarbons and with the EU risk assessment document, and regulation and assessment of manufactured nanomaterials within EU and OECD. Anja Kamper, MSc, Biology – Lead Biologist, Ecotoxicology and testing Has extensive experience within ecotoxicological and biodegradability testing of chemicals in aquatic and terrestrial systems, managing and performance of laboratory studies according to OECD principles of good laboratory practice (GLP), quality assurance and quality control of laboratory activities. Furthermore, she has experience in environmental risk assessment and classification of chemicals and products.

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PROFILE: DHI

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

GLOBAL OFFICES DORUK SİSTEM A.S., KIZILTOPRAK KADIKOY ISTANBUL, TURKEY DORUK SİSTEM A.S., MARTEK/TUBITAK GEBZE, KOCAELI, TURKEY We support our clients in all countries globally. SERVICES PROVIDED

PROFILE: DORUK SISTEM

CONTACTS

REACH (TREACH / KKDIK) services

Website

www.doruksistem.com.tr and www.treach.com.tr and www.msds.com.tr

E-mail

info@doruksistem.com.tr

Head office

Itri Dede Sokak No:17 DorukSistem Building Kızıltoprak Kadikoy, 34725 Istanbul, Turkey

Tel/ Fax

+90 (0) 216 337 8383/ +90 (0) 216 337 9027

Contact

Selcuk BILGIN (selcuk.bilgin@doruksistem.com.tr)

Directors

Selcuk BILGIN – CEO / Founder Isil ERTUNCAY- General Coordinator Baris NAIM – Regulatory Compliance (RC) Department Manager Feriye Senol KAPTI – (TR & EU) REACH Department Manager Mehtap VURAL– Proses Safety (PS) Department Manager

Ownership

Incorporated company

Locations

Turkey

Founded

2005

DORUKSISTEM's consultants have significant experience in the provision of a wide range of REACH and TREACH support to our clients. These services include initial work such as regulatory strategy and advice, data evaluation and the use of intelligent testing strategies, followed by study placement and monitoring. We prepare and submit registration dossiers and chemical safety reports including exposure assessments and if necessary risk characterisation. We also provide post-submission support during evaluation and authorisation phases, including completion of authorisations applications. DORUKSISTEM has significant experience in Turkish Chemical Regulations and project management and Sief and consortia management and we can also act as your only representative (OR) registrant or third party representative in Turkey. Visit our web page www.TREACH.com.tr CLP (SEA) and SDS (GBF) services in Europe and Turkey OO OO OO

OVERVIEW

DORUKSISTEM Engineering Technology and Consultancy Co Inc was established in 2005 to guide and lead the chemical industry, industrial chemicals, cosmetics manufacturers, pesticide agrochemicals and biocidal products registrants, grower/commodity groups, trade associations, exporters, importers and chemical process industry to compliance with Turkish, EU and global regulations and in dealing with issues that affect their ability to do business effectively. DORUKSISTEM consultants have been involved in the preparation of vulnerability analyses, including the evaluation of regulatory, quality control, and business systems, and the development of standard operating procedures, global regulatory models, and compliance manuals and programmes. With a strong presence in Turkey, DORUKSISTEM has provided cost-effective regulatory support and testing services to many valued companies while doing businesses in both the EU and Turkey. DORUKSISTEM is the most experienced leader consultant company in Turkey and your partner on the way of TREACH (KKDIK).

VITAL STATISTICS

2015/16

Turnover, group

> €3m

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 12% IT & software 5% Laboratory 5%

Consultancy/advisory 26%

Information 12% Representation & management 40%

Page 98

Identification of obligations under the CLP Regulation Implementation of strategy for CLP compliance Classification and reclassification of substances and mixtures in accordance with the CLP Regulation Safety data sheets-SDS (GBF) authoring and review CLP notifications dossiers / CLP-group notifications dossiers

Biocides and agrochemicals services in Turkey OO OO

OO OO OO OO OO OO OO OO

Identification of obligations under the Turkish BPR Implementation of strategy for Turkish BPR and agrochemicals product regulations compliance Preparation of dossiers (approval of active substances and authorisation of biocidal products) and submission Turkey representative Data gap analysis Studies / tests / reports (physico-chemical properties, efficacy, Environmental fate, ecotoxicology and toxicology) Risk assessments Liaison with authorities and post-submission support Classification and labelling of biocides according to the SEA/ CLP Creation and review of TREACH compliant safety data sheets

Process safety Risk analysis and management Industrial risks: OO preliminary hazard analysis; OO hazard assessment; OO safety reports and EPD (Seveso, explosives regulation); OO quantitative risk assessment; OO risk based land-use planning; OO accident investigation. Process Hazard Analysis (PHA): OO HAZOP (hazard and operability analysis) OO LOPA (layer of protection analysis) OO “What if” OO FMEA (failure mode and effects analysis) OO HAZID (hazard identification analysis) OO process safety in accordance with applicable standards SIL analysis (safety integrity level) Reliability, availability and maintainability studies OO reliability centered maintenance (RCM) OO risk based inspections (RBI)

Chemical Watch | Global Service Providers Guide 2016

Process safety management Comprehensive safety audits Safety management systems (sms) Regulatory safety inspections Seveso and Atex regulations implementation DORUKSISTEM can assist you with assessing, designing and permitting of storage facilities for hazardous chemicals, modelling of external safety (Seveso) and assessing aspects such as explosion safety (Atex). CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2005

DORUKSISTEM founded in Istanbul, Turkey.

2006

DORUKSISTEM launched leading edge solutions for authoring and managing production quality and R&D management systems for the chemical process industry.

2007

DORUKSISTEM completed more than 50 TSE/TSEK certification for the Turkish chemical industry.

2008

MSDSMARKET is established and published on www. msdsarket.com.tr

2010

DORUKSISTEM Head Office opened. More than 4,500 CICL (Chemical Inventory Control Legislation) notifications completed for several global companies.

2011

DORUKSISTEM awarded ISO 9001 by Bureau Veritas.

2012

Process safety department established.

2013

Process safety business collaboration with INERCO started.

2014

More than 35,000 SDSs completed according to Turkish SDS legislation (DSD/DPD/CLP) in total.

2015

DORUKSISTEM R&D Technology branch opened at Tubitak Research Complex ın free zone Martek Kocaeli Area.

2016

DORUKSISTEM approved as an associated member of ORO, the Only Representatives Organisation

ACCREDITATIONS DORUKSISTEM is an associated member of ORO, the Only Representatives Organisation DORUKSISTEM is a member of ICI, Istanbul Chamber of Industry DORUKSISTEM is member of ICC, Istanbul Chamber of Commerce DORUKSISTEM is a member of SRA, the Society for Risk Analysis DORUKSISTEM works in accordance with the quality management system standard: ISO 9001 as certified by Bureau Veritas PARTNERS INERCO, Spain, TWI – The Welding Institute, Cambridge, UK, IHS, USA, REACH ITEGRA, Spain, REACH ChemAdvice GmbH, Germany, EXPONENT, UK, CHEMADVISOR, USA, NEXREG, Canada, CIRS, China, SCAS, Japan, NAM & NAM, Korea, CIS, Russia, SIAM Chemeter, Spain, CGE RISK, Holland, MAXGRIP Holland CLIENTS DORUKSISTEM clients are involved in many businesses, including industrial, basic, specialty, agricultural, and biocidal chemicals, biotechnology, nanotechnology, cosmetics, fibres; iron and steel, tyres, paints and coatings; plastic products; and chemical manufacturing, warehouse and logistics companies, as well as from manufacturing industry, formulation, distribution and consumer product sectors. Our clients include: Honeywell, Cargill, Ashland, Air Products, Ihs, Lyondellbasell, Cancarb, Cerfrit, Buckman, Albesiano, Vonnroll, Cortec, Cray Valley, Croda, Cytec, Sealed Air, Dow Agro Sciences, Dunlop Adhesives, Flint Group, Gazprom, Hemel, Ineos, Kafrit Group, Kg Chemicals, Kodak, Laviosa, Metro Groups, Novartis, Phiilsa, Aygaz, Kardemir, Toros Fertiliser, Tata, Rütgers, Struktol, Sensient, Showa Chemical Watch | Global Service Providers Guide 2016

Denko, Siemens, Tetra Chemicals, Thermphos, Tournaire, Ube Industries, Uralchem, Mane, Yamalube, Morgan Plc, Knauff, Shell, Zeon and more. TESTIMONIALS Specific references can be provided to potential clients upon request. CASE STUDY 1: Ashland Inc notification of the substances under Turkish CLP (SEA) Ashland Inc had an issue with notification of their substances (>450) under Turkish CLP (SEA). The deadline for the notification of the substances was 1 June 2015. As their OR, the regulatory compliance process of Ashland had to be accomplished perfectly by us. For that purpose, all exported products to Turkey by the company were studied, and cross-checked against the classification of the substances with the data of Turkey’s Ministry of Environment and Urbanism. And finally, all dangerous substances were successfully notified to the ministry’s system. This allows Ashland to continue to sell its products on the Turkish market via its Turkish distributors. CASE STUDY 2: Honeywell SDS compliance project Honeywell International, Inc is one of the biggest chemical suppliers in Turkey as well as in the whole world. The 13 December 2014 regulation was published in the Official Gazette. This methodises Turkish SDSs. All Honeywell products exported to Turkey must have Turkish SDSs in compliance with the regulations. Compliance is needed because, literal translations of the SDSs are not sufficient to legitimise them. Unlike other countries, Turkey’s system demands that the declaration of the SDSs competent author’s name and his/her certificate number be included. Unless having taken training ending with an examination and succeeding it, it is not possible to prepare SDSs according to Turkey’s SDS Regulation. So, to the present day 221 SDSs have been generated for Honeywell. They are revised when necessary, regenerated after the regulation changes and kept up to date. All previously prepared labels of those products are revised too according to SEA (Turkish CLP). CASE STUDY 3: CICL overview in Turkey The regulation of CICL (Chemical Inventory Control Legislation) was published on 26 December 2008. Since then more than 4,500 notifications have been completed for several global companies. Notifications are done to the online system of MoEU as CICL notifications. Companies assign us to be their OR to complete their CICL notifications, together with the other regulatory compliance processes. CICL (KEK) demands substances are declared by calculating the average tonnage for the last three years of their exports to Turkey. This process is repeated every three years. STAFF SELECTION Doruksistem RC – Regulatory Compliance team DORUKSISTEM RC team members are highly competent and have great experience in the field of chemicals regulation throughout the whole product lifecycle, including but not limited to chemicals identification, hazard classification, risk assessment, RSP, SDS and labelling creation. Our specialists always have up-to-date information on national and international chemical control and related legislations. Doruksistem PS – Process Safety team DORUKSISTEM PS have experienced team of professionals and specialists in all areas of Industrial safety and risk prevention to meet the challenges of the industrial safety and risk management, as well as providing technical assistance to ensure safety levels are consistent with its business, the environment and compliance to regulatory requirements. Doruksistem Rdt- R&D Technology team DORUKSISTEM RDT team is a highly competent and concentrated team in the field of Quantitative structure–activity relationship models (Qsar models) , regression or classification models used in the chemical and biological sciences and engineering. Page 99

PROFILE: DORUK SISTEM

Safety and emergency planning and management

Dr Knoell Consult GmbH, Leverkusen, Germany Knoell NL B.V., Wageningen, the Netherlands Dr Knoell Consult Ltd, Cardiff, UK Knoell Iberia SL, Madrid, Spain / Knoell Iberia SL, Lisbon, Portugal Dr Knoell Consult Shanghai Ltd, Pudong, Shanghai, China Dr Knoell Consult Schweiz GmbH, Basel, Switzerland Dr Knoell Consult Thai Co Ltd., Chiang Mai, Thailand Cyton Biosciences Ltd, Bristol, UK Critical Path Services, LLC, Garnet Valley, PA, US Critical Path Services, LLC, Research Triangle Park, NC, US Critical Path Services, LLC, Carrolton, TX, US Knoell France SAS, Lyon , France Knoell K.K., Tokyo, Japan Knoell Korea Ltd., Seoul, Republic of Korea

PROFILE: Dr. Knoell Consult GmbH

CONTACTS Website

www.knoell.com

E-mail

info@knoell.com

Head office

Dynamostraße 19, 68165 Mannheim, Germany

Tel

+49 (0)621-718858-0

Fax

+49 (0)621-718858-100

Contact

Dr Michael Cleuvers

SERVICES PROVIDED

Directors

Dr Hans-Emil Knoell Dr Runar Eberhardt Torsten Hauck Dr Michael Cleuvers

Global registration of industrial and specialty chemicals

Ownership

Private company, majority-owned

Locations

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

Founded

1996

OVERVIEW We are a full service provider in global regulatory affairs for industrial/ specialty chemicals, agrochemicals, biocides, pharmaceuticals, veterinary medicine and medical devices. Additionally we offer a wide range of services in the field of product safety (eg preparation of (extended) safety data sheets, classification and labelling of substances and mixtures). We will work with you to ensure that your products are in compliance with the latest developments, not only in Europe (EU and non-EU), but also in the US, Canada, South America and the entire AsiaPacific region (China, Taiwan, Japan, Korea, Australia, and the entire Asean region). With a global network of subsidiaries and co-operation partners, we match our services to support your business needs. VITAL STATISTICS

2014/2015

Turnover, group

> €40m

Turnover, chemical service provision

> €15m

Number of offices

Number of countries represented

Staff, group

approx. 480

Staff, chemical service provision

>400

SERVICE AREA BREAKDOWN Training Laboratory 5% 5% Information 7%

Consultancy/advisory 63%

Representation & management 20%

GLOBAL OFFICES Dr Knoell Consult GmbH, Mannheim, Germany Dr Knoell Consult GmbH, Berlin, Germany Page 100

Dossier preparation and submission: Iuclid 5 /6 files for REACH, TSCA registration including PMN support, registration dossiers for Korea, China, Taiwan, Japan and the ASEAN countries. Toxicological and ecotoxicological hazard and risk assessment, exposure modelling, post-submission support, communication with authorities, OR- and TPRservices, and full consortia management. Data review and analysis: strategic advice regarding testing and registration strategies, in silico methods (Qsar), read-across and waiving strategies), literature searches, data evaluation, data gap analysis, and study monitoring. Product stewardship: classification and labelling under GHS, CLP, and Osha HazCom; development and management of safety data sheets (SDSs) and extended safety data sheets (eSDSs); supply chain management and communication; management and support of formulators and article manufacturers concerning regulatory compliance in their global markets. Global registration of agrochemicals and biocides Strategic advice and consulting, literature research, data evaluation, data gap analysis, completeness checks, study management and monitoring. Dossier preparation, biological efficacy, residues and metabolism, import tolerance dossiers, dietary safety, toxicology, human exposure, exposure modelling, PEC-reports, environmental risk assessment, ecotoxicology, study-monitoring and management of bee studies, endocrine disruptors and CADDY-dossiers. Regulatory affairs, communication with authorities, post-submission report, full service provider. Medical devices, pharmaceuticals, cosmetics Classification of medical devices, CE-marking (class I, IIa, IIb, III including consultation), FDA clearance/authorisation (510(k), PMA), CMDR registration (CMDCAS), Taiwanese registration (TCP II, ISO 13485), Australian registration (TGA) biological safety assessment, review technical file, biocompatibility testing strategy and supervision of test (including justified waiving), material characterisation including toxicological evaluation, clinical evaluation, Preand Post Market vigilance/safety, implementation and review of QM system (ISO 13485/MDD/IVDD/IAMD and/or QSR), review and preparation risk management file, auditing (internal, pre-regulatory, supplier), training. Non-clinical/ pre-clinical services for human pharmaceuticals (study management, toxicology, pharmacology, metabolism, pharmacokinetics, bioanalysis, biosafety testing), medical writing (eg expert opinions, study reports, registration of cosmetics (INCI-listing, labelling etc), food and food additives, food contact materials, registration of substances in contact with drinking water. Animal health products (pharmaceuticals, immunologicals, feed additives) Strategic regulatory advice and regulatory submissions, preparation and audit of dossiers, expert reports, study management, life cycle management, pharmacovigilance, quality assurance. Authorisation of all animal health products, including veterinary medicinal products (pharmaceuticals, vaccines and biologicals), feed additives, neutraceuticals and borderline products. All routes, all therapies, all species. Chemical Watch | Global Service Providers Guide 2016

Analytical laboratory services

CLIENTS

Crop protection and agrochemicals: magnitude of residue, terrestrial field soil dissipation, and environmental fate studies including hydrolysis, adsorption/desorption, photolysis, structure elucidation, and soil and aquatic metabolism/transformation. Method validations and method development. Biotechnology: multiplexed analysis of proteins via LC–MS/MS, ELISA, and other methods. Industrial chemicals: trace level analysis in ground, drinking, and waste waters; polymers and product contaminants; animal tissues and plasma; human tissue, serum, and plasma. Method development and validation. Pharmaceuticals and medical devices: single and multi-dose GLP studies; GLP bioanalytical PK/TK in plasma, serum, and tissues with experience in humans and animals. Extractables and leachables. Method validation and method development in addition to discovery support.

We deliver flexible services to globally acting chemical companies as well as to small- and medium-sized enterprises. We work on- and off-site to support our customers’ specific local needs. 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. CASE STUDY 1: REACH consortium management and dossier preparation knoell managed a huge consortium with 58 companies covering substances in 11 sub-categories. knoell prepared and submitted successfully 157 lead registrations in 2013. To achieve this, we established a project team of more than 30 scientists including chemists, toxicologists, ecotoxicologists, and Qsar-specialists. Our team prepared the entire testing and registration strategy, including developing the category and analogue approach, Qsar and exposure based waiving. We were able to minimise additional testing by writing thorough scientific justifications.

1996

Foundation, Mannheim, Germany.

2002

Office in Leverkusen, Germany.

2007

Foundation of Dr Knoell Consult Switzerland GmbH, Basel.

2009

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

2009

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

2009

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

2010

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

2010

Opening of a new office in Wageningen (NL).

2010

Acquisition of Cyton Biosciences Ltd, Bristol, UK.

2010

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

2010

Foundation of Dr Knoell Consult Shanghai Ltd, in China.

2010

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

2010

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

2012

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

2012

Opening of a new Office in Berlin, Germany

2013

Foundation of Knoell Iberia SL, in Madrid, Spain.

2013

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

2013

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

2014

Opening of a new office in Lisbon, Portugal

2014

Foundation of Knoell France, SAS, Lyon, France

STAFF SELECTION

2014

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

Regulatory affairs agrochemicals/biocides 20 specialists

2015

Acquisition of Sitmae Reach Services

2016

Foundation of Knoell K.K., in Tokyo, Japan

2016

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

CASE STUDY 2: Agrochemicals knoell successfully managed the submission of an AIR 2 dossier (Annex-I renewal procedure) on behalf of a task force of almost 30 member companies spread worldwide. knoell wrote and compiled all study summaries, risk assessments, and dossier chapters. knoell also developed and maintained a strong relationship with the authorities to whom the dossier was submitted. The project was well-recognised by the client and the authorities. The team consisted of over 50 individuals who dedicated themselves to this project for two years. Follow-on work is on-going and entails the development of national product dossiers for the respective active ingredient. CASE STUDY 3: Biocides knoell supported the introduction and authorisation of numerous biocidal products in multiple markets within the EU according to the regulatory requirements. Currently we are working on several biocidal family dossiers based on our up-to-date knowledge. For products that fall into the scope of both BPR and other legislation such as that covering veterinary pharmaceuticals and cosmetic products, synergies were realised, because knoell is capable of advising on such borderline cases. In Asia and Latin America, we had to face the lack of a uniform legislation regulating biocidal products. Therefore we first had to define the applicable specific legislation to which the biocidal product was subject, and then we prepared the local product registration. Based on our experience in non-EU countries, label claims are key to the registration process and can make a huge difference in how a product is considered by an authority. Toxicology > 45 toxicologists Ecotoxicology > 40 ecotoxicologists Dietary safety >20 specialists Product safety specialists (C&L, MSDS preparation) > 60 specialists Global regulatory affairs for chemicals > 30 specialists

ACCREDITATIONS

Consortium management, OR, TPR > 25 consortium managers

Qualified Cefic – partner.

Residues and metabolism > 20 specialists

PARTNERS SCAS Japan, SCAS Europe, Ibacon, Currenta, Tier3 solutions.

Environmental fate and risk assessment > 60 specialists Efficacy, biological dossiers > 30 specialists Human pharmaceutical experts >20 Medical Device evaluation, testing and certification >10 Animal health experts >20

Chemical Watch | Global Service Providers Guide 2016

Page 101

PROFILE: Dr. Knoell Consult GmbH

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

TESTIMONIALS

SERVICES PROVIDED Environmental fate and biodegradability testing Unparalleled experience in the identification and quantification the fate of test substances in soil, water and other complex environmental matrices, complemented by in-house radiolabeling and structural elucidation expertise Biodegradation screening and testing (OECD 301, 310, 314, 303 etc). Environmental fate testing (OECD 307, 308, 309, 106). All these studies can be performed including metabolite identification. Specific expertise in the context of REACH is in the field of biodegradability screening and simulation testing.

PROFILE: EAG Family of Companies

CONTACTS Website

www.eag.com

E-mail

info@eag.com

Head office

4747 Executive Drive, San Diego, CA, US

Tel/ Fax

+1-800-366-3867

Contact

Kristein King

Directors

Siddhartha Kadia, PhD, Chief Executive Officer

Ownership

Private company

Locations

Australia, China, France, Germany, Japan, Singapore, South Korea, Taiwan, UK, US

Founded

1978

Endocrine disruptor screening and testing Further specific expertise lies in the field of endocrine disruption screening and testing, We have in-house histopathology services to evaluate the potential of chemicals to affect endocrine-sensitive tissues in fish, amphibians and frogs. Sediment toxicity and terrestrial plant testing

OVERVIEW EAG, Inc. provides high-value analytical, engineering and scientific testing services to a wide range of industries. We have brought together the most respected brands in laboratory services to offer the agrochemical, industrial/specialty chemical and consumer products industries a better choice for environmental assessments. The EAG family companies, which include Wildlife International, PTRL West, PTRL Europe and ABC Laboratories deliver GLP-compliant aquatic, avian, and terrestrial toxicology services, as well as residue analysis, field management, and the full range of environmental fate and metabolism testing required for global regulatory compliance. VITAL STATISTICS Turnover, group

2014/15 US$200m

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

1,200

Staff, chemical service provision SERVICE AREA BREAKDOWN

Laboratory 100%

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. Ecotoxicology testing We offer the full suite of acute and chronic aquatic and terrestrial toxicology services required to assess the acute and chronic effects of chemicals on amphibians, earthworms, honeybee and select non-target insects, as well as freshwater and saltwater invertebrates and fish in an AAALAC-accredited, GLP-compliant environment, and are capable of supporting a large number of concurrent studies. Avian toxicology One of the largest and most respected avian toxicology laboratories in the world, we offer unparalleled skill in performing avian acute and reproduction studies, as well as the ability to develop and conduct specialty studies designed to meet client-specific needs. Residue analysis Unparalleled method development know-how in the challenging discipline of residue chemistry, along the full complement of ground and surface water monitoring, dislodgeable foliar residues, magnitude of residue analyses, as well as worker and domestic exposure studies. Radiolabelling and custom synthesis Expert 14C and 3H radiolabelling of active ingredients for metabolism, environmental fate and effects testing; custom synthesis of active ingredients and metabolites and impurities â&#x20AC;&#x201C; with dedicated in-house analytical for GLP-certification of materials. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1978

Established as Charles Evans & Associates

1987-2010

Expanded operations in US, Europe and Asia

April 2012

Acquired PTRL West and PTRL Europe

Dec. 2012

Acquired Wildlife International, Ltd.

GLOBAL OFFICES

July 2015

Acquired ABC Laboratories

Australia, China, France, Germany, Japan, Singapore, South Korea, Taiwan, UK, US

ACCREDITATIONS

Page 102

Good laboratory practice (GLP) â&#x2C6;&#x2019; multiple inspections by EPA with no findings

Chemical Watch | Global Service Providers Guide 2016

OO OO OO OO OO OO OO

Agricultural chemicals Industrial and specialty chemicals Pharmaceutical and biopharmaceuticals Biocides Consumer products Animal health Food and feed

CASE STUDY: Glyphosate: fish short term reproduction assay (FSTRA) with the fathead minnow (Pimephales promelas) – a paper presented at SETAC US 2012, S. Schneider et al, Wildlife International

Jon Rhodes – Senior Scientific Advisor Mr Rhodes brings more than 25 years of perspective on successful scientific and regulatory approaches to new product development and existing product support activities, with particular expertise in the regulatory requirements for assessing the impact on non-target organisms. James Schmidt – Senior Scientific Advisor Mr Schmidt offers three decades of experience in xenobiotic metabolism and bio-analytical chemistry, and has special interests in agrochemical environmental fate and metabolism, metabolic stability, metabolite profiling and identification, chiral separations, and pharmacologically active metabolites.

The objective of this assay was to determine if glyphosate might impact the hypothalamus-pituitary-gonadal (HPG) endocrine axis resulting in the disruption of reproduction in fish. Breeding groups of fathead minnows (Pimephales promelas) were exposed to glyphosate under flow-through conditions at mean measured concentrations of 0.046, 0.23, 1.2, 6.2 and 33mg ae/L for 21 days. Endpoints that were evaluated for endocrine disruption of the reproductive system included fecundity, fertility, secondary sex characteristics (including tubercle and fatpad scores), gonadosomatic index (GSI), histopathology of gonads, as well as plasma vitellogenin. Other endpoints included survival, general observations of health, weight, and length. There were no apparent effects on survival, growth, reproduction, secondary sex characteristics, GSI, VTG or gonad histopathology in male or female fish exposed to glyphosate for 21 days. Based on the endpoints evaluated, glyphosate does not appear to impact the function of the hypothalamuspituitary-gonadal (HPG) endocrine axis in fathead minnows. STAFF SELECTION Henry Krueger, PhD – Director of Aquatic and Non-Target Plant Testing Director of aquatic toxicology with our Easton, Maryland site (formerly Wildlife International) since 1995, Dr Krueger is esponsible for all aspects of the aquatic toxicology programme including fish and amphibian endocrine disruptor studies. Expert aquatic toxicologist, with specific expertise in bioaccumulation testing sediment toxicology testing and endocrine test design, conduct and interpretation. Timothy Springer, PhD – Director of Special Projects Dr Tim Springer manages special projects and technical support. He was responsible for the development of the abbreviated in vivo fish bioconcentration test. Dr Springer has played a critical role in the revision of the OECD guideline 305, and in development methods to estimate BCF values using data from BMF studies. Edward Schaefer – Director of Fate and Biodegradation Mr. Schaefer has more than 20 years of experience in the area of degradation and environmental fate testing. Responsible for study design and oversight of testing programmes. Key contributor to development of EPA/OECD test guidelines – specifically OECD guideline 314. David Dohn, PhD – General Manager (PTRL West location) With more than 35 years’ experience in the environmental testing arena, Dr Dohn is an expert in plant, animal, and soil metabolism studies for pesticide registration, biochemical toxicology, designing regulatory packages for pesticide registration in North America and Europe.

Chemical Watch | Global Service Providers Guide 2016

Page 103

PROFILE: EAG Family of Companies

CLIENTS

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 PBT and vPvB assessment; OO technical dossier (Iuclid 5 and 6); OO identification of known uses; OO development of exposure scenarios for HH and ENV; OO risk characterisation; OO classification and labelling; OO safety data sheets; OO consortium and Sief management; and OO preparation of CLH dossiers

PROFILE: EBRC Consulting

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

Agrochemicals

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

2014/15

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

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

GLOBAL OFFICES EBRC Consulting GmbH Raffaelstraße 4 30177 Hannover Germany

Page 104

Active substance approval and national product registration. EU notification of active substances governed under regulation (EC) No 1107/2009: OO support of existing substances in the context of the renewal programme of the EU (AIR); OO support of new active substances; OO completeness checks, validation of existing studies, literature surveys; and OO full dossier preparation including risk assessments, literature search report, submission and defence of dossiers in the review and evaluation process. Product registration dossiers for national authorisations in EU member states including zonal dossiers: OO aII dossiers (dRRs) for registration and re-registration of plant protection products, label extensions and formulation changes; OO services include compilation of all required documents, conduct of exposure and risk assessments, biological dossiers, advice in closing data gaps, the supervision of experimental studies, as well as submission of the application to competent authorities and attendant contacts / services during the registration process; OO previous experience (among others) includes herbicides, fungicides, insecticides, rodenticides, nematicides and growth regulators. Biocides

Training 5%

Consultancy/advisory 75%

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; 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,

Chemical Watch | Global Service Providers Guide 2016

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1993

Foundation of EBRC (initial staffing: six people)

2015

Continual growth, leading to a current staff count of 55

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

Chemical Watch | Global Service Providers Guide 2016

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

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PROFILE: EBRC Consulting

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.

SERVICE AREA BREAKDOWN Training 10%

Consultancy/advisory 10% Information 10%

PROFILE: EcoOnline

CONTACTS Website

www.ecoonline.com

E-mail

lgp@ecoonline.com

Head office

Trudvangveien 77, N-3117 Toensberg, Norway

Tel/ Fax

+47 33 01 68 00/ +47 33 01 68 01

Contact

Mr Luis G Paulsen

GLOBAL OFFICES

Directors

Mr Øyvind Thorsen, CEO Mr Kjell Hamnes, Founder and Product Evangelist Mr Geir Falkø, VP Sales and Marketing Mr Luis G Paulsen, VP Development

Ownership

Privately held, employees

Norway Sweden Finland Denmark Switzerland

Locations

Norway, Sweden, Finland, Denmark, Switzerland 2000

SERVICES PROVIDED

Founded

IT & software 70%

OVERVIEW Leave paper and complexity behind. Connect directly online with customers and suppliers in order to exchange, communicate and manage chemical information and SDS. Try one of the most widely used services for SDS authoring, distribution, communication and chemical inventory management in Northern Europe. EcoOnline has pioneered the industry since 2000, with more than 4,000 enterprises working in services online. With solutions for handheld devices, QR codes, XML exchange and more, we are about to introduce even more features to ensure that our clients benefit from simplified work processes, flexibility and mobility, and a great user experience. In use in most industries, of all sizes, EcoOnline is the solution for businesses, institutions and members of supply chains and industry bodies seeking efficient means of exchanging, communicating and managing SDS and chemical data. All parts of the platform are offered via the cloud. Connecting suppliers and downstream users online reduces time and costs involved in nearly all aspects of handling SDSs and managing chemical inventories. A device with a web browser and internet connection are the only requirements. EcoOnline’s services are available in 25 languages, and they are designed to meet your requirements for the REACH area. Working closely with our customers, leading consultants and members of industry, our aim is to become the most preferred platform for SDS communication and management in Europe. Try us before you make your decision! A team of 67 employees, and a network of highly qualified consulting partners are ready to give a demonstration and offer a test of the applications and benefits. Welcome! VITAL STATISTICS Turnover, group

2014/15 €8.3m

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group Staff, chemical service provision

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70 -

Cloud/online: OO SDS/eSDS authoring; OO SDS/eSDS distribution; OO SDS/eSDS database; OO Chemical inventory management; OO Workplace risk assessment; OO Employee exposure tracking and storing; OO Up and downstream reporting; OO Supply chain communication; OO Metadata and XML data exchange; and OO Mobile applications. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2000

Founded by Mr Kjell Hamnes, long time industry professional with a vision to create the first and most widely used online platform for SDS communication and chemical inventory management. HQ in Tønsberg, Norway.

2001

Launched the first integrated online service.

2007

Opened office in Gothenburg, Sweden.

2011

Opened office in Helsinki, Finland.

2011

Launched leading edge solutions for authoring and managing exposure scenarios. Technical documentation and articles covered. Established representation in Germany.

2012

Ready with first mobile applications and XML comm modules. Established representation in Denmark, Iceland and Poland.

2013

Service for SMEs in the building and construction sector. QR code application for mobile.

2014

More mobile applications, and new features.

2015

New and improved features and functionality!

PARTNERS EcoOnline works closely with leading local, regional and international consulting partners in many different areas, including SDS authoring, substance inventory management, CLP, risk assessment, dossier preparations, authority notification and occupational health. Work with us!

Chemical Watch | Global Service Providers Guide 2016

CLIENTS

STAFF SELECTION

Small and large, public and private, multinationals and locals, our clients represent most segments and industries. More than 4,000 enterprises connect to the services.

Mr Kjell Hamnes – Founder and Product Evangelist

We’ll be happy to provide you with referrals that are relevant to you! Please contact us. CASE STUDY 1: Automotive industry OO OO

auto dealers and their suppliers connect directly. auto dealers and repair workshops get their SDS directly in their inventories, and reduce time spent on managing inventory and performing relevant tasks. suppliers reduce time and costs in distributing SDS.

CASE STUDY 2: Diagnostics manufacturer and their suppliers of laboratory products OO

the diagnostics manufacturer is part of a large international corporation, with production sites and laboratories in many locations its suppliers upload the relevant SDSs directly to the diagnostics company’s inventory. the diagnostics company can then use all the data from the SDS without having to re-enter them. all designated staff can work and share information in the same system, from any location. this improves communication, simplifies work processes, increases speed, and reduces time spent on relevant tasks. no installations are required, no local IT maintenance costs involved.

Ms Martina Jonsson – Product Management Martina is CEO Sweden, and international product manager. She is a key figure in Sweden on the issue of REACH and SDS management. Ms Pirjo Kuoppala – Product Management Pirjo is product manager. She has extensive background in the electronics industry, and has degrees in mechanical engineering and biochemistry. Mr Pål Mørken – Product Management Pål serves as VP of Services and Training. He has a long and extensive career within chemical health and safety, and is trained OHS professional at Harvard. Mr Luis G Paulsen – VP Development Luis is responsible for product and business development. Mr Øyvind Thorsen – CEO

CASE STUDY 3: Universities, hospitals, municipalities, public institutions OO

OO OO

a majority of universities, municipalities, schools and hospitals in Norway are connected to the service. SDSs are uploaded directly to their inventories. all data in the SDS are immediately available for use, and automatically updated. the suppliers benefit from easy authoring and distribution of SDSs, and the service to customers is greatly improved. communication upstream to the supplier is simplified in the platform no local installations are involved, the entire service is available to all users over the internet. this saves time and money in the process of authoring, distributing and managing the SDSs and documentation.

CASE STUDY 4: Building and construction sector OO

OO OO OO

automated service enabling direct communication between materials supplier, construction company and building project. SDSs are automatically transferred to the inventory for the project saves time and workload for all parties. ensures all correct documentation is in place, including technical information and workplace safety. BIM to become integral part of overall delivery.

Chemical Watch | Global Service Providers Guide 2016

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PROFILE: EcoOnline

TESTIMONIALS

Mr Hamnes founded EcoOnline. He has pioneered the development of electronic tools for SDS authoring and management in northern Europe, and is a widely used resource by industry and authorities on the issues of legislation and compliance.

Registration, evaluation and authorisation of chemicals (REACH) OO OO OO OO OO

PROFILE: ERM

CONTACTS

Website

www.erm.com

E-mail

rudolf.wilden@erm.com

Head office

Frankfurt: Siemensstraße 9, 63263 Neu-Isenburg, Germany

Tel

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

Contact

Dr Rudolf Wilden

Directors

430 Partners globally, including Karl Enters (US), John Phillips (US), Sarah Medearis (US), Jo Lloyd (UK), Simon Aumonier (UK), Sam Temara (France + BeNe), Rudolf Wilden (Germany), Robert Janssen (Germany), Thomas Wienke (Global IT), James Leu (Taiwan)

socio-economic analyses preparation of applications for authorisation REACH training/ REACH impact assessments preparation of lead and member registration dossiers chemical safety assessments CLP notifications Sief management

Toxicology, ecotoxicology and risk assessment Study placement/ protocol review and development, development of (robust) study summaries, review of data for classification purposes EHS risk assessments. Classification, labelling and packaging (CLP/GHS) Classification support, safety data sheet (SDS) and label authoring SDS and label review and improvement. Emerging chemical control laws around the world New chemical notification (eg K-REACH, China MEP Order 7), tracking of emerging legislation bans/restrictions.

Ownership

Private limited company

Downstream product legislation, eg food/food contact, biocides

Locations

140

OO OO

1971

Founded

OO OO

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 sustainability services. Global product sustainability is positioned within ERM as a strategic growth initiative. ERM offers integrated product service across all divisions within the company. VITAL STATISTICS

2014/15

Turnover, group

$699m

Turnover, chemical service provision

$25m

No of offices

150

No of countries represented

OO OO

food contact notifications compliance with country-specific legislation Fifra / BPD/BPR support national registrations local/ regional registrations labelling and claims support

Lifecycle assessment and sustainability OO OO OO OO OO

carbon footprinting and emission inventories lifecycle management (LCM) also to ISO14040 design for environment (DfE) environmental product declarations (EPDs) lifecycle analysis (LCA)

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2015

Staff, group

> 5,000

Staff, chemical service provision

>150

SERVICE AREA BREAKDOWN

ACCREDITATIONS

Training 10%

IT & software 20%

Acquisition of ReachCentrum leveraged expertise crossregionally into Korea Reach programme support. Successful development and implementation of targeted Lifecycle Sustainability Programme at Sky TV. ERM led compilation of five REACH authorisation applications and achieved exemption from restriction for one client to date.

ISO 9001 and ISO 14001 Consultancy/advisory 60%

PARTNERS Partner of Cefic, SAP, Enablon, IHS CLIENTS

Representation & management 10%

GLOBAL OFFICES We support our clients in all countries globally. SERVICES PROVIDED Product sustainability programmes OO OO OO OO

programme development information management / IT enterprise sustainability systems auditing diligence and post-merger integration

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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 “We have been working with the ERM team on REACH for a number of years now, and there are very good reasons to continue and expand this collaboration. Both on practical, communicative and technicalscientific levels ERM has provided us with active, solid and high-quality support for MSD’s REACH programme. We are pleased to observe that our collaboration has turned into a true partnership.” – Frits Wielaard, REACH programme manager, Merck Sharp & Dohme. “ERM have provided support and advice for us throughout the preregistration and registration phase of REACH and have always been totally professional, flexible and quick to respond to our needs. They Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 1: Development and implementation of global product sustainability programme for Fortune 100 chemical distributor ERM worked with the client to develop and roll out a comprehensive global chemical compliance programme which: OO addressed critical, immediate, non-compliance issues based on business risks and priorities; OO supported, as needed, the registration, notification and declaration of chemicals, polymers and biocides; OO benchmarked the clients programs against its peers; and OO trained employees in applicable requirements and systems A collective effort which has resulted in the development and implementation of chemical compliance programmes and systems which provide a framework for sustainable, consistent and dependable ongoing global operations. CASE STUDY 2: Supporting a multinational pharmaceutical company’s new chemical registration in China An ERM client needed to register a new chemical product with high toxicity (eg fish LC50(96h) < 10μg/L) in China. Due to its high toxicity the registration application was rejected in other countries. The Chinese Ministry of Environmental Protection (MEP) was highly concerned about the toxicological properties of this type of product, making registration a challenge. Benefits and value: OO successfully registered the new chemical product with one submission; OO to facilitate the approval, full and comprehensive analysis, which was not formally requested, was provided in addition to MEP; OO utilise the laboratory data, analysis results and ERM’s expertise and experience to forego several expensive and time-consuming laboratory tests, saving time and cost for the client. STAFF SELECTION ERM’s Global Product Sustainability TEAM (GPS) ERM has more than 70 professionals with extensive specific GPS experience located at various offices worldwide. These consultants are able to utilise the full resources of ERM globally to provide full back-up for all GPS-related services. Dr E Karl Enters – Global Product Sustainability Lead With a blended background in toxicology (PhD), regulatory affairs, remediation, EHS and R&D areas, Dr Enters has over 25 years of experience in providing strategic leadership across a broad-base of global regulatory targets and specialty chemical markets. Dr Rudolf Wilden – EMEA Product Sustainability Lead PhD in environmental sciences with more than 15 years’ consulting experience in the fields of EHS/product compliance, global substance registration/notification schemes and risk assessment. John Phillips – Product Sustainability Lead NA Extensive experience in the development of global stewardship programs, practices and systems that meet regulatory requirements and industry standards, facilitate global business growth and improve corporate reputation. Dr Jo Lloyd – Product Sustainability Lead UK + Ireland PhD in physical chemistry with more than 15 years’ experience in REACH and global chemical law as well as the provision of product sustainability support and benchmarking within the chemical and chemical using sectors. Dr Steven Peterson – Senior Ecotoxicologist PhD in biological sciences with 20 years of experience in risk

Chemical Watch | Global Service Providers Guide 2016

assessment, ecological research, environmental science with consulting firms, academic institutions, and government. Dr Alfred Wiedow – Senior Toxicologist, DABT More than 35 years of regulatory toxicology experience from working in the chemical industry, a governmental agency and academic research institutions. He is a recognised scientist in the fields of human and ecological toxicology and risk assessments and has initiated over hundreds of toxicity studies covering many cradle to grave scenarios. Sam Temara – Product Sustainability Lead France & BeNe 20 years of experience in EHS Information Management. Key implementation projects with Echa and founder of a Solvay branch company in the domain of SAP EHSM on demand service. Dr Robert Janssen – Product Sustainability Germany MSc Chemical Engineering, PhD Chemistry, with more than 20 years’ experience in the industrial sector, product development, process design, hazard and risk assessment, chemical management systems and regulation of chemicals. Dr Mark Lafranconi – Senior Toxicologist, DABT DABT certified toxicologist with nearly 30 years in the industrial sector designing, implementing, interpreting, and reporting hazard and risk assessment studies for evaluating human health effects and risk management of chemicals used in consumer products. Dr Eunjae Shin – Product Sustainability Lead South Korea PhD in chemical engineering with over 12 years of experience in chemical registration (TCCA, K-REACH, OSHA), chemical regulatory review, and chemical management advisory services. James Leu – Product Sustainability Lead Taiwan James is the Managing Director of ERM Taiwan with over 20 years of experience in chemical and environmental engineering as well as environmental management systems. He has directed, managed and conducted more than 400 EHS and chemical registration related consulting projects in Taiwan, China, Thailand and the Philippines. Yajuan Pi – Product Sustainability Lead China Ms Pi leads the China Product Sustainability team. She supported numerous clients with new substance notification, regulatory reviews and chemical compliance assessments since implementation of Decree 591. Kathleen Sellers, PE – Technical Director Assists clients in building and auditing global product sustainability programmes and fulfilling specific regulatory requirements for chemical registration and reporting, hazard communication, and other product compliance requirements. Recently published her fourth book, Product Stewardship, Life Cycle Analysis, and the Environment (CRC Press 2015). Dr Sarah Bull – Principal Toxicologist PhD in in vitro toxicology, with 15 years of experience of mammalian toxicology and human health risk assessments following acute and chronic chemical exposures, working both in governmental agencies and academic research institutions. Thomas Wienke – IT Implementation Specialist Mr Wienke has 22 years of experience in the field of environmental, health and safety supporting compliance risk strategies and systems. His previous work experience includes TechniData and SAP. Mr Wienke’s expertise lies in project management and software development methodologies and tools covering the complete product innovation lifecycle. Christina Clements – Principal Consultant More than 20 years of experience in regulatory compliance and toxicology, hazard communication, and environmental health and safety (EH&S). She offers proven experience in consulting on global regulatory compliance in the areas of Osha, GHS, CLP, TSCA, Fifra pesticide registration, and import/ export of industrial chemicals and consumer products. A Six Sigma Black Belt familiar with numerous operating systems, such as SAP and Oracle. Page 109

PROFILE: ERM

provide an excellent service and we look forward to continuing our partnership with them in the years to come.” – Steve Williams, Regulatory Manager Europe, Knauf Insulation. “ERM has been Momentive’s partner in the implementation of REACH since the beginning and has always provided the expert support we needed through the different stages of the project.” – Ralf Maecker, Momentive Performance Materials.

GLOBAL OFFICES Eurofins is located globally in 39 countries. Our main testing facilities for chemical / REACH services are located in Germany. SERVICES PROVIDED For the chemical, agrochemical and biocides industry Eurofins offers a broad scope of biological safety studies, which meets the international regulatory requirements and includes the following services.

PROFILE: Eurofins

CONTACTS Website

www.eurofins.com

E-mail

info-munich@eurofins.com

Head office

Brussels, Belgium

Tel

+49-89-899 650-0

Fax

+49-89-899 650-11

Contact

Dr Iris Pfisterer

Directors

Gilles Martin, Chief Executive Officer

Locations

225 locations worldwide, main offices for REACH services in Germany

Founded

1987

Toxicology for chemicals, PPPs and biocides

OVERVIEW With more than €1.5bn annual revenues and 22,000 employees in around 225 sites across 39 countries, Eurofins is the global leader in the pharmaceutical, food and environmental testing market and offers also an unparalleled range of testing and support services for the chemical, agrochemical and biocide 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. As a global service provider to the chemical industry, Eurofins offers a comprehensive range of REACH testing and REACH consultancy. Our state-of-the-art and progressive laboratories are operated by highly skilled scientists and regulatory specialists that have many years of relevant experience and qualifications, and which can be flexible in relation to client needs. This enables us to support you with all steps of the regulatory process for both phase-in and the non-phase-in substances. In vivo toxicology services are offered in cooperation with BSL Bioservice Scientific Laboratories Munich GmbH. VITAL STATISTICS

2014/15

Turnover, group

>€1.5 bn

Turnover, chemical service provision

No of offices

>225

No of countries represented

Staff, group

>22 000

Staff, chemical service provision

SERVICE AREA BREAKDOWN Consultancy/advisory 20%

We cover all common toxicology services relevant for chemicals, plant protection products (PPP’s) and biocides. This includes the classical in vivo studies from acute to repeated dose and teratogenicity studies. In addition, Eurofins puts a high emphasis on alternative in vitro testing strategies with regard to the 3R strategy for refinement, replacement and reduction of animal studies. We have established a big range of in vitro assays for all endpoints where this is possible yet. Our services include: OO irritation/corrosion (in vitro/in vivo); OO sensitisation (in vitro/in vivo); OO dermal absorption (in vitro/in vivo); OO genetic toxicity (in vitro/in vivo); OO acute toxicity; OO repeated dose toxicity; OO reproductive and developmental toxicity (DART); OO toxikokinetics; OO carcinogenicity; OO neurotoxicity; OO endocrine disruptor testing; and OO mode of action studies. Ecotoxicology and physico-chemical properties Physico-chemical and ecotoxicology services including aquatic and terrestric studies as well as studies on biodegradation and environmental fate and behaviour are also part of our portfolio. REACH services With regard to REACH we can offer the full portfolio of studies, required for the different tonnage levels according to Annex VII-X of the REACH directive. Due to the large variety of chemicals tested for the REACH deadlines in 2010 and 2013 we are well prepared to effectively support you also for the 2018 deadline or NONS registrations. Furthermore, as Echa will continue with the evaluation of the registered substances and testing proposals, we are happy to perform those higher tier studies for you and support you in updating your dossier. Studies like 90-day toxicity (OECD 408) and reproductive and developmental toxicity (OECD 414) are performed at our facilities on a routine basis. We have also established the EOGRTS (OECD 443) as an alternative to the twogeneration study (OECD 416). Endocrine disruptor testing In response to the EPA announcement of the Endocrine Disruptor Screening Programme for pesticides, chemicals and environmental contaminants, we have established endocrine disruptor testing services and can offer the full Tier 1 testing battery. In vitro safety testing OO OO OO OO

Laboratory 80%

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OO OO

mutagenicity, clastogenicity, carcinogenicity skin and eye irritation/ corrosion – several models dermal absorption photo-induced toxicity reproductive toxicity (embryonic stem cell test) sensitisation – DPRA, hCLAT, Keratinosens (participation in a ring trial for another skin model)

Chemical Watch | Global Service Providers Guide 2016

Regulatory services, testing strategies and individual study designs

STAFF SELECTION

With more than 30 years of experience with regulatory studies, our team of scientists will provide you with expert advice not only for standard studies, but also for individual study designs and testing strategies, taking into account substance properties as well as interdependency of many studies required for example for REACH. In addition we are backed up by an experienced regulatory division within Eurofins that can support you regarding regulatory issues of chemicals, agrochemicals and biocides starting from data gap analysis until dossier and CSR preparation as well as post submission support.

Dr Angela Lutterbach has more than 25 years of experience working in the contract research industry. She started working at Eurofins Munich in 1995 as study director for safety toxicology and safety pharmacology and holds the position Head of Testing Facility at Eurofins Munich since 2001. Dr Lutterbach has a PhD in veterinary medicine and is a member in various expert groups.

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,…), 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 assessment: we can help to manage and monitor your supply chain by helping to collect BOM (bill of materials) 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. Some of the tests included in our offer, within others: phthalates, PAHs, cadmium, lead, benzene, flame retardants, azo colourants etc. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1987

Foundation of Eurofins Scientific Continuous growth and aquisitions

1997

IPO on the French Stock Exchange

2008/09

Establishment of Eurofins REACH Services

2012

Change from Sciété Anonyme to Societas Europaea

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 Pharmaceutical/ biotech industry Food industry Cosmetic industry

Chemical Watch | Global Service Providers Guide 2016

Dr Marc Kunze, Scientific Director in vivo toxicology Dr Kunze studied pharmacy and toxicology and holds a PhD in medicinal chemistry and a master in toxicology. After several years at the university giving lectures on pharmacology and toxicology, he moved to the pharmaceutical industry. He specialises in non-clinical and clinical toxicology within drug development and risk assessment of chemicals. As Scientific Director in vivo, Dr Kunze acts as an internal and external consultant for all areas of toxicology. In addition he is responsible for preparation of study designs and project management of regulatory toxicological studies. Dr Albrecht Poth, Scientific Director in vitro toxicology With more than 25 years of experience in contract research, Dr Albrecht Poth is working today as Scientific Director in vitro at Eurofins Munich. His experience includes the areas of genetic toxicology, carcinogenicity and alternative toxicology including also mechanistic investigations and mode of action assessments for risk assessment of pharmaceuticals and chemicals. He has published more than 25 peer-reviewed papers and more than 80 poster presentations in these areas. He is nominated as an expert for several OECD guidelines, acting as a board member at the Industrial Platform for In Vitro Technologies (IVTIP) since 2010 and is a member of the regulatory genotoxicity working group at the German Mutagenicity Socienty (GUM). Dr. Albrecht Poth has a PhD in biology. Dr Andreas Wais, Managing Director Eurofins Regulatory After his Diploma in Chemistry and a PhD in agronomy, Dr Wais became scientific secretary of the senate commission on chemicals in agriculture of the German Research Council (DFG) in Bonn as a postdoc. From there he joined RCC in the mid 90’s, heading the residue and field trials department. Having a huge number of client contacts, he was promoted to Project Leader of the in 2002 newly formed Business Unit Agro. Key responsibilities: Studies and regulatory affairs. Dr. Wais was then promoted to Global Director Business Unit AgroChemicals and Biocides. From June 2011 he changed his responsibility to the position of General Manager of Global Registration and Strategic Consulting. In March 2012 Dr. Wais left Harlan with most of the Agro regulatory team and became Managing Director of Eurofins Regulatory AG in Switzerland, offering agro/chemical and biocidal regulatory services. He has more than 25 scientific publications, more than 40 scientific lectures worldwide and presented more than ten scientific posters. He had scientific sojourn in Brazil at University of Sao Paulo (ESALQ and CENA in Piracicaba). Dr Iris Pfisterer, REACH Manager As REACH Manager at Eurofins, Dr Iris Pfisterer is dedicated to support our clients with all enquiries and questions about REACH and project manages large projects. This may include projects from data gap analysis via laboratory testing to the final dossier preparation. Dr Pfisterer holds a master’s degree and PhD in biology and has supported our clients at Eurofins since 2009. Other staff Our highly educated and experienced staff comprises a large proportion of scientists as well as regulatory experts with a wide variety of expertise. They will provide you with excellent services and are dedicated to meeting your individual needs with a high level of flexibility.

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PROFILE: Eurofins

SVHC and restricted substances under REACH

Dr Angela Lutterbach, Head of Testing Facility Eurofins Munich

SERVICES PROVIDED REACH services

Tel

+44 (0)1332 868000

Fax

+44 (0)1332 868099

Contact

Julian Reddy

Exponent's consultants have significant experience in the provision of a wide range of REACH support to our clients and have prepared approx. 150 lead registrations. These services include initial work such as regulatory strategy and advice, data evaluation, Qsar and the use of intelligent testing strategies, followed by study placement and monitoring. We prepare and submit registration dossiers in Iuclid and chemical safety reports including exposure assessments, using Chesar, higher tier modelling and if necessary risk characterisation. We also provide post-submission support during evaluation and authorisation, including completion of authorisation applications. Exponent has significant experience in programme and project management and Sief and consortia management and we can also act as your only representative registrant or third party representative.

Ownership

Wholly owned subsidiary of Exponent Inc.

Global chemical notifications

Locations

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

Founded

2002

Our consultants have considerable experience in compiling and submitting chemical notifications worldwide; our team of specialists prepare and submit chemical notifications to all countries that operate a relevant scheme. We can prepare and submit dossiers for Australian, Canadian, New Zealand and Swiss registrations and can act as sole representative notifier utilising our Swiss office. We have a network of well-established local agents to help with the preparation and submission of regulatory documentation in China, Japan, Korea, the Philippines, Taiwan and Turkey and can call upon the experience of our US colleagues for TSCA notifications.

PROFILE: Exponent International Limited

CONTACTS Website

www.exponent.com

E-mail

jreddy@uk.exponent.com

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

OVERVIEW Exponent is one of the world's largest regulatory, engineering and scientific consultancies providing innovative solutions to complex technical problems. Exponent International Limited is a wholly owned subsidiary of Exponent Inc and is the European arm of the Chemical Regulation and Food Safety practice, with offices in Harrogate and Derby in the UK and Basel in Switzerland. Exponent combines unparalleled technical expertise with the ability to focus this knowledge to meet our clientsâ&#x20AC;&#x2122; needs within short timeframes. Our ability to create multidisciplinary teams of scientists, regulatory consultants and project managers means that we can either perform in-depth scientific research and analysis or very rapid-response evaluations to provide our clients with the critical information that they need to make day-to-day strategic decisions. VITAL STATISTICS

2014/15

Turnover, group

Est US$15m

Turnover, chemical service provision

Est US$5m

No. of offices

No. of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training Information 5% 5% Representation & management 20%

Consultancy/advisory 70%

GLOBAL OFFICES Global head office (Exponent Inc): 149 Commonwealth Drive, Menlo Park, CA 94025, US Other UK offices: 1 Pride Point Drive, Pride Park, Derby, DE24 8BX, UK; Bush House, First Floor, Office F8, Milton Bridge, Midlothian, EH26 0BB, UK Switzerland office: Nauenstrasse 67, Basel, 4052, Switzerland Plus numerous other offices in the US, Germany and China

Page 112

Biocide services Exponentâ&#x20AC;&#x2122;s biocide group has a wealth of regulatory expertise gained from working as government regulators, in industry, contract research organisations and as independent regulatory consultants. We have a proven track record of assisting clients achieve active substance approvals and product authorisations under the biocidal products Regulation (EU) No 528/2012 (BPR) and biocidal products Directive (98/8/EC). We are experienced in the interpretation of data, scientifically defensible data waiving and complex exposure modelling / risk assessments. We assess and construct product/family dossiers under the BPR, routinely using Iuclid and R4BP. We also assist clients to achieve authorisations under global national regulations in many non-EU countries. We provide bespoke training packages and consultation on regulatory strategy, product stewardship, portfolio management and task force/consortia management/representation. Cosmetic and consumer product services Our Cosmetic Regulatory team has over 20 years of experience working across all areas of the personal care industry including product development, distribution, and manufacturing of cosmetic and toiletry products. Based in the UK, the Exponent Regulatory Team can act as your responsible person for all your cosmetic and toiletry needs or provide contract and adhoc regulatory services. If you are based in the European Union, or looking to import from outside the European Union, our team will help you address compliance with all relevant regulations and so you are able to confidently offer high quality, safe and sustainable products. Other regulatory regimes Exponent's consultants have significant experience in assisting clients with EU agrochemical and food regulatory requirements including food contact notifications. For agrochemicals we can assist with regulatory strategy, data gap analysis, study monitoring, risk assessments and completion of active substance and product registration dossiers. This includes in-depth support such as managing compounds to Annex I inclusion. For clients in the food industry we can develop strategies for technical and regulatory challenges, develop food safety systems and help meet regulatory requirements, including submission of application dossier for authorisation of for food additives, food contact materials, novel foods and health claims. Chemical Watch | Global Service Providers Guide 2016

1967

Parent company Exponent Inc formed.

2001

Novigen Sciences formed.

2002

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

2006

Exponent REACH team formed.

2008

Derby, UK office opened.

2010

Basel, Switzerland office opened.

ACCREDITATIONS ISO 9001 certified PARTNERS We have no formal partners, but use an informal network of legal firms, CROs and in-country agents to provide the best service to our clients for REACH and global chemical notifications. CLIENTS Exponent Inc has worked with more than 5,000 clients and Exponent International has undertaken work for over 500 clients globally. Exponent has provided regulatory support to a range of companies across many industries; companies ranging from SMEs working in one industry to global companies conducting business in all areas of the chemical industry. TESTIMONIALS "Exponent International has consistently provided high-quality REACH and biocides services and support to our company for over five years. They produce work of the highest quality at competitive prices and are always prepared to go that bit further to ensure that they can deliver what we need within challenging deadlines. Their excellent technical knowledge and abilities mean that they are always the company we go to when we need help in these areas." − Regulatory Affairs Manager, global cleaning and maintenance products manufacturer “I am so impressed with how this went - how incredibly dedicated and persistent you all are. Your work is invaluable -you exceeded my expectations and I feel confident that this work will make a big impact on the product that will ensure its success. I look forward to working with you in the future!!!” – Producer Design Team. “Another great webinar and I thought you struck great balance between the US and the EU in the time alotted.”- Director Scientific Affairs. “Congratulations to you and your crew at Exponent working on this project and many thanks for all the efforts and support over the past few years.” - Global Regulatory, New Technologies Lead. CASE STUDY 1: Provision of technical support to an organometallic consortium Since 2009, Exponent has provided technical support to a consortium of organometallic substance manufacturers. Exponent performed the technical work required for all their substance registered in 2010, 2013 and we continue to provide support as we now head to 2018. The tasks that have been undertaken in support of this project are identification of data gaps, use of intelligent testing strategies to address gaps and, where necessary, placing and monitoring of studies. In addition Exponent is responsible for the preparation and update of the registration dossiers in Iuclid 5 and for the production of CSRs, proposing use descriptor codes for exposure assessments and in generating exposure scenarios. Due to the properties of the substances, creative yet pragmatic solutions have been necessary to demonstrate safe use and to deal with questions from Echa. In addition we have provided a considerable amount of support for post registration activities and have been involved with compliance checks as part of a dossier evaluation and also substance evaluations.

Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 2: Global regulatory support Exponent provides ongoing regulatory support for a major inorganic consortium ensuring they meet all their regulatory obligations globally. In particular we provide strategic advice for all jurisdictions that have a notification scheme in place and also those where regulations are emerging so the consortium are aware of any actions they will need to undertake to stay in compliance. Where possible we work to ensure that legislative requirements from a number of countries can be effectively overlapped and that data requirements are minimised. Exponent prepares and submits all technical dossiers and risk assessments that are required and this includes higher tier notifications in countries such as China and Korea. We handle all post submission obligations including annual reporting and first importing documentation. CASE STUDY 3: Exponent has provided assistance from data package development right through to active substance approval and product authorisation. This involved providing initial strategic advice, data gap analysis, data interpretation, study placement and monitoring, devising robust waiving strategies and bridging argumentation, exposure modelling, human health and environmental risk assessments, preparation and submission of the dossier and attending working group and competent authority meetings during the evaluation process. Discussions were held with the evaluating competent authority to confirm acceptance of the proposed product families, prior to Exponent’s specialists compiling the dossiers in Iuclid. Our team also performed technical equivalence assessments. This is just one example where Exponent’s expertise has contributed towards a positive outcome for our clients. Overall, our highly trained scientists have written over 30 active substance dossiers and numerous representative product dossiers across 17 product types, within the ongoing EU biocides review and for new biocidal active substances. STAFF SELECTION Dr Caroline Harris – Centre Director (UK) Dr Harris is the head of Exponent International and director of Exponent's Chemical Regulation and Food Safety Centre. She has a strong international reputation and acts as a technical consultant to a number of international bodies, including the FAO and the WHO, and has been a member of the UK’s Advisory Committee on Pesticides since 2009. Mr Julian Reddy – Head of Industrial Chemical Notification Services Mr Reddy is a very experienced regulatory project manager and has supervised complex regulatory programmes undertaken on industrial chemicals for 20 years. In addition, he has particular experience of Asian chemical notification schemes. Mr Reddy manages Exponent’s Derby office, which specialises in industrial chemical notifications. Dr Karen Howard – Head of Biocides (Exponent International) Dr Karen Howard is a Senior Environmental Chemist with over 20 years’ experience working in chemical regulation. She has cutting edge knowledge of EU biocide regulation and is extensively involved in provision of strategic advice, biocide dossier preparation and post-submission support for individual clients and task forces. Dr Howard leads the Exponent EU Biocides Business. Mr Stephen Johnson – Head Of Cosmetic Safety and Regulatory Affairs (Europe) Mr Johnson has experience working within manufacturing, brand development, and the retail environment and has led the development of business initiatives including cosmetic safety, regulatory compliance, sustainability, and stewardship affecting consumer products for over 20 years. Mr Johnson leads the Exponent EU Cosmetic Business. Dr Rhodri Evans – Head of Food Safety & Regulatory Affairs (Europe) Dr Evans joined Exponent International after fifteen years working with the National food regulatory authorities in the UK and Ireland. Dr Evans has a detailed understanding of European and International regulation and authorisation of chemicals in the food chain, including food additives, flavourings, enzymes and contaminants, as well as food contact materials. Page 113

PROFILE: Exponent International Limited

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

GLOBAL OFFICES OO OO

PROFILE: Fieldfisher LLP

OO OO

Website

www.fieldfisher.com

E-mail

claudio.mereu@fieldfisher.com

Head office

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

Tel

+44 (0)20 78614000

Fax

+44 (0)20 7488 0084

Contact

claudio.mereu@fieldfisher.com

Directors

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

Ownership

Limited Liability Partnership

Locations

Brussels, Düsseldorf, Hamburg, London, Manchester, Munich, Palo Alto, Paris, Shanghai

Founded

1835

OO OO

SERVICES PROVIDED Chemicals

Fieldfisher is a full service European law firm comprising over 400 lawyers, 163 of whom are Partners. Fieldfisher advises international clients on domestic and EU law and has extensive experience advising on large and complex multi-jurisdictional matters. With four partners assisted by eleven professionals in Brussels, Fieldfisher's EU Regulatory Group is the largest fully dedicated EU Regulatory team and a recognised market leader. It is the only EU Regulatory team which combines advisory, consortia management and litigation work on REACH, pesticides and biocides (at the EU and national levels) thereby constituting the “go-to” firm for product defence. The Brussels office advises and represents clients on matters arising under several areas of EU products legislation, including general product safety and eco-design requirements, and more broadly EU market access legislation. We also address related data protection and data privacy, competition and other business law issues that arise when drafting and negotiating commercial agreements or setting up and running consortia under REACH, BPR and pesticides laws. VITAL STATISTICS

2014/15

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

791

Staff, chemical service provision

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

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OO OO

OVERVIEW

Training 5%

Brussels Hamburg Munich Dusseldorf Paris London Manchester Palo Alto Shanghai (partner firm)

With more than 20 years' experience in EU chemical law – compliance, consortia management and litigation, we provide a broad spectrum of chemicals-related advice, and have substantial experience in dealing with the most significant REACH implementation and compliance issues relevant for individual companies or groups of companies. We have particular expertise in assisting companies in challenging Echa and Commission's decisions before the Board of Appeal and the European Court. For example the team has been acting against Echa in relation to a Sonc decision which it successfully annulled before the Board of Appeal. Furthermore, the team has defended consortia on the inclusion of respiratory sensitisers in the candidate list as well as the inclusion of chromium trioxide in the authorisation list. Moreover, we assist clients with regulatory compliance and data sharing, including breaches of contractual and legal requirements, dispute resolution concerning REACH. Agrochemicals/pesticides We have a reputation of excellence advising major pesticide manufacturers on the European re-registration programme laid down by Directive 91/414 and its replacement Regulation 1107/2009, including the renewal programmes under the so-called AIR regulations. We have provided legal assistance on a variety of issues ranging from initial notifications of pesticide active substances, joint and individual company dossier preparation and submission, including zonal applications and mutual recognition across jurisdictions, the creation of Task Forces and related data protection issues, including compliance with European competition laws. We have addressed these issues at both an EU-wide and Member State level. Our practice has been 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 resubmission of dossiers. Our lawyers have negotiated many data sharing/ compensation agreements and successfully handled arbitration and litigation cases in various EU countries relating to data access. Biocides The Biocides team is the longest established and leading team of its kind in the EU. Benefiting from a wealth of knowledge amassed over decades, the Biocides team is unsurpassed in legal expertise and experience. The team was awarded three tender contracts in 2015 by the European Commission to prepare guidance documents for SME's on data sharing, letters of access and consortia formation for product authorisation purposes. Product compliance and litigation The team has long been recognised as the leader in product defence, servicing clients across the globe on all aspects of EU Regulatory compliance and litigation.

Chemical Watch | Global Service Providers Guide 2016

2007

Fieldfisher's office and EU Regulatory practice established in Brussels

2010

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

2011

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

ONGOING

The Pesticides team continues to build on its litigation success and currently has approximately ten cases pending before the EU and national courts.

2012-15

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

2016

Fieldfisher is launching new consortia under BPR, pesticides renewals and REACH.

ACCREDITATIONS The Legal 500 Fieldfisher's selling point is the combination of both the advisory and litigation practice, allowing it to defend industry associations and major chemical companies. REACH specialist Claudio Mereu focuses on chemicals, pesticides and life sciences. Chambers & Partners “Fieldfisher has specific specialisations in food, chemicals and environmental law, and for that the team is excellent”. Koen Van Maldegem is especially recommended for his in-depth knowledge of chemical and biocide regulations, with a client noting that “he has extremely good insight into how the European Commission works and how we can align our expectations accordingly.” Department head Claudio Mereu’s practice covers chemicals, pesticides and biocides, with one client describing him as “the best in the field” for agrochemicals. CLIENTS We advise and represent both private clients, including major chemical/ pesticides/biocides, medical devices and pharma companies, small innovative companies, as well as groups of companies (industry associations, task forces or consortia) and have more than15 years' experience in consortia and task force management. We also represent clients in the field of product regulation, advising them on issues pertaining to the classification, packaging, and labelling of chemical substances and preparations, including 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.

Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 1: EU Reach Lime Consortium The team set up the REACH consortia for lime substances (approximately 300 members) and acted as trustee and legal secretary to several consortia of chemical companies in relation to the REACH regulation, involving antitrust compliance work, handling of confidential information, and data sharing. CASE STUDY 2: Solutia The team represented Solutia on its successful appeal against a statement of non-compliance (Sonc) from Echa. On 27 July 2015, the Echa Board of Appeal adopted an important and a first of its kind decision (Case A-019-2013) with regards to the legal nature of the so-called statement of non-compliance (Sonc) issued by Echa. The agency had issued a Sonc to the Belgian authorities indicating that the registration was non-compliant. Solutia challenged the Sonc arguing that is was both procedurally and substantively flawed. In its decision, the Board of Appeal ruled in favour of Solutia and annulled the Sonc. CASE STUDY 3: EU Silver Task Force The team has been setting-up, managing and advising the EU Silver Task Force on regulatory compliance issues concerning the approval of eight notified silver forms under the biocidal products Regulation. The silver review is known to be the most difficult review under the biocides review programme, including difficult questions regarding competition law (including data sharing) and nanosilver. Furthermore, the team has assisted a group of 13 companies in the cooperation on regulatory compliance issues concerning the regulatory compliance of certain regulated products (biocides). STAFF SELECTION Claudio Mereu – Joint Managing Partner, EU Regulatory partner, Belgium Claudio Mereu focuses on European Community law and business law, with an emphasis on the chemicals, pesticides and life sciences sectors. He advises companies on antitrust and regulatory compliance issues, consortia formation (under REACH, pesticides and biocides), product defence strategies and product circulation across the European Union. He handles related litigations before European and national courts and counsels companies on a wide range of business law matters relating to their international agreements and commercial presence in Europe. His expertise covers all aspects of chemicals, agrochemicals and biocides regulations and restrictions (including notification, data protection, mutual recognition, classification, labelling, marketing and use restrictions). He regularly represents chemical companies before the European institutions, member state authorities, scientific committees, and the European courts Koen Van Maldegem – EU Regulatory Partner, Belgium Koen’s practice focuses on EU regulatory, business and competition law, with an emphasis on chemicals, pesticides, biocides and cosmetics. He advises international and Belgian companies on regulatory compliance and free movement of products throughout the EU. His expertise covers regulatory counselling at the EU and member state level regarding data protection, data sharing and data compensation, task force formation and management, distribution and supply agreements for pesticides, biocides and chemicals, and he is specialised in solving the antitrust issues that may arise in these areas. He also handles product defence litigation before European and national courts.

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PROFILE: Fieldfisher LLP

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

SERVICES PROVIDED REACH registration FoBiG provides full-scale scientific support to meet industry’s REACH obligations: OO Iuclid 5 files (including literature searches, data gap analysis, evaluation of reliability, application of read-across and category approaches and inquiry dossiers for new substances) / all endpoints (physicochemical 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).

PROFILE: FoBiG

CONTACTS Website

www.fobig.de

E-mail

info@fobig.de

Head office

Klarastraße 63, 79106 Freiburg i Br, Germany

Tel

+49 761 386080

Fax

+49 761 3860820

Contact

Klaus Schneider

Directors

Klaus Schneider, General Manager

Ownership

Private company

Locations

Germany

Founded

1992

REACH authorisation

OVERVIEW FoBiG is a privately owned consultancy specialising in toxicological and ecotoxicological risk assessment, with more than two decades of experience in exposure assessment and risk characterisation. FoBiG’s REACH experience dates back to 2001 with participation in RIP projects, the Cefic-sponsored SPORT project, the REACH baseline study and VCI projects on exposure-based waiving and the practical guide on exposure assessment and communication in the supply chain. Together with partners, FoBiG is preparing REACH baseline studies and related reports, which are relevant parts of the European Commission’s REACH reviews. FoBiG successfully prepared numerous registration dossiers for the first and second REACH registration deadline. Furthermore, we provide ample experience in authorisation under REACH: FoBiG successfully prepared several authorisation dossiers for threshold and non-threshold Annex XIV substances and is involved in further authorisation projects at various stages of the application. Further projects deal with providing support for Corap-listed substances (“substance evaluation”) and for substances targeted by Echa dossier evaluations. VITAL STATISTICS

2014/15

Turnover, group Turnover, chemical service provision

€1m

No of offices No of countries represented

1 Europe-wide

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

REACH dossier and substance evaluation and restrictions FoBiG provides scientific support to companies whose substances are targeted in dossier and substance evaluations and are affected by restriction proposals. Services include problem analysis, dossier refinement and communication with competent authorities/committees. Biocidal product authorisation Together with RegisGate partners (see www.regisgate.eu) FoBiG offers full-scale services for authorising biocidal products according to the new BPR scheme, including data gap analysis, preparation of the Iuclid-based dossier and communication with competent authorities/Echa. Cosmetics ingredients and products FoBiG prepares cosmetic ingredients assessment reports for ingredient suppliers and performs cosmetic products safety evaluations. Pharmaceuticals Scientific services for pharmaceutical companies and for manufactures of medical devices include: OO derivation of PDE (permitted daily exposure) according to EMA guidelines for residual substances (eg for use in cleaning validation); and OO assessment of impurities, including application of TTC (threshold of toxicological concern) approaches. Consumer products Potentially harmful substances in consumer products such as textiles and toys rank high in public awareness. FoBiG prepares hazard assessments and develops exposure scenarios to derive scientifically sound product evaluations. Occupational toxicology

Training Other 4% 2% Information 2% Representation & management 2%

(Company-specific) occupational exposure limits for threshold and nonthreshold substances (the latter based on an analysis of exposure-riskrelationships according to a German methodology) support companies in their internal evaluations with regard to occupational safety and health. Other services

Consultancy/advisory 90%

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Together with partner RPA Ltd, FoBiG prepares complete application dossiers for authorisation with: OO updated CSRs, including a refined exposure assessment to demonstrate acceptable remaining risks; OO analysis of alternatives; OO socio-economic analysis; OO complete application package (Iuclid 5 dossier); and OO and provides post-submission 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.

Chemical Watch | Global Service Providers Guide 2016

1989

Founded as personal company by Fritz Kalberlah.

1992

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

2009 PARTNERS

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

OO OO

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

CASE STUDY 1: Specific REACH requirements in 2018 for substances in the 1-10 tons/year band According to REACH Art. 12 phase-in substances up to ten tons/year can benefit from reduced information requirements, if they do not fulfil the criteria of REACH Annex III. This could help to avoid costly toxicity and ecotoxicity tests when registering these substances in 2018. In order to do so, FoBiG applies adequate prediction tools such as the Qsar Toolbox to demonstrate that substances: OO are not likely to possess hazardous properties: and OO are not likely to be CMR or PBT/VPvB substances. To respond to the second Annex III condition (which requires demonstrating that the substance does not have a wide dispersive use), FoBiG provides support for gathering supply chain information and exposure information on downstream uses. CASE STUDY 2: 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 asks for detailed justifications for applying readacross 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 Echaâ&#x20AC;&#x2122;s focuses in dossier evaluation. CASE STUDY 3: Application for authorisation: CSR refinement For non-threshold substances key to a successful application for authorisation is: OO use of exposure-risk relationships, which are scientifically sound and acceptable to RAC; and OO refinement of the exposure assessment to derive realistic exposure estimates. in order to be able to conclude on low remaining risks associated with the use for which application is sought. Deviations from linear dose-response extrapolation may be justified even for genotoxic carcinogens, if sufficient information is available to conclude on a sublinear dose-response behaviour. A methodology developed under participation of FoBiG and accepted in Germany in a regulatory context Chemical Watch | Global Service Providers Guide 2016

allows developing quantitative estimates also for sublinear doseresponse data. Experience from authorisation projects clearly shows that CSRs from registration dossiers need to be improved with regard to exposure assessment: detailed descriptions of the technical processes and the conditions of use and availability of measured data (eg air and/or biomonitoring measurements), which may be supported case-by-case byTier II exposure modelling (eg by ART, RISKOFDERM, ConsExpo etc.), are key to a successful application. CASE STUDY 4: Dossier and substance evaluation: refinement of CSR and supply chain information With more and more substances being added to the Corap list, substance evaluation becomes an additional important activity within REACH. Companies, whose substances are concerned, should adopt a proactive position, communicate with the competent authority, and try to reduce existing concerns. Often, reasons for selecting a substance for evaluation include: OO aggregated tonnages; OO insufficient supply chain information; and OO wide-dispersive use situations. At the same time companies may receive Echa decision letters as a result of dossier evaluation and are requested to update registration dossiers. Improved and more detailed use descriptions, elaborated exposure scenarios and detailed justification of parameters used in the assessment (eg environmental release rates, RMM efficiencies) are often required in both REACH areas. STAFF SELECTION Klaus Schneider, PhD, DABT Klaus Schneider is the general manager of FoBiG and responsible project coordinator for all REACH-related services. With more than 20 years of experience in toxicological risk assessment he provides expertise in many areas, among them risk assessment methodologies, dose-response modelling and exposure assessment. He is member of the BfR expert group on exposure assessment and standardisation. Ulrike Schuhmacher-Wolz, PhD, ERT, Fachtoxikologin DGPT Ulrike Schuhmacher-Wolz is a senior scientist at FoBiG and acted as project leader in various projects related to REACH, food safety and other work areas. She provides special expertise in reproductive toxicology and the assessment of endocrine disruptors. Jan Oltmanns, MSc, PgDip Jan Oltmanns, senior scientist and company partner, is especially experienced in the assessment of physical hazards and in supply chain mapping and exposure sciences (worker, consumer and environmental exposure). Karin Heine, PhD, ERT, Fachtoxikologin DGPT Karin Heine, a biologist and toxicologist, provides ample experience in hazard assessment and DNEL derivation as well as in gathering supply chain information and in exposure assessment, drawn from many REACH registration projects in recent years. Markus Schwarz, PhD Markus Schwarz is an ecotoxicologist with in-depth experience in assessing environmental fate and ecotoxicological properties of chemicals and in performing PBT/vPvB evaluations as well as environmental exposure assessments. Eva Kaiser, PhD Eva Kaiser is a biologist and toxicologist, whose key areas are hazard assessment, dose-response modelling, DNEL derivation and preparation of Chesar-based exposure assessments with special expertise in consumer exposure modelling.

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PROFILE: FoBiG

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

SERVICES PROVIDED GAB Consulting is a team of experts offering qualified and reliable regulatory services for agrochemicals, biopesticides, biocides, nanomaterials, feed additives, animal pharmaceuticals and chemicals (REACH) in compliance with the latest OECD and EU requirements. We support you in developing and implementing sustainable registration strategies in Europe and overseas, and have achieved a substantial track record over the last 18 years. Our one-stop service provides cost-effective customised solutions to meet your needs. Preparation of high quality dossiers and clear documentation, combined with a prompt and competent follow-up are key elements to achieve timely approval of active substances and related products.

PROFILE: GAB Consulting GmbH

CONTACTS Website

www.gabconsulting.de

E-mail

info@gabconsulting.de

Head office

Ottenbecker Damm 10, 21684 Stade, Germany

Tel

+49 4141 80010 0

Fax

+49 4141 80010 20

Contact

Dr. Wolfgang Häußler (direct line -110)

Directors

Dr Wolfgang Häußler Dr Götz Neurath Dr Rüdiger Hauschild Dr Manuel Barrada Jose Luis Juanes

Ownership

GAB Holding GmbH, Private shareholders, Partnership

Locations

Germany, Spain, Poland, Slovenia

Founded

1998

Agrochemicals With almost 18 years of experience in registration of pesticides, our expertise spans from providing you with up-to-date information on your regulatory obligations and evaluation of data gaps to the preparation and submission of complete dossiers for active substance and product approval according to Regulation (EC) No 1107/2009 and in compliance with national regulations. Biopesticides

OVERVIEW GAB Consulting is a leading consulting company offering comprehensive registration services for the chemical industry in Europe and overseas. We meet your needs by providing competent and flexible regulatory and scientific expertise to ensure that your product gets registered. Our full range of services includes initial data gap analyses and dossier preparation, as well as risk assessments, expert statements and dossier defence. VITAL STATISTICS

2014/15

Turnover, group

€6m

Turnover, chemical service provision

€5.1

No of offices

No of countries represented Staff, group

35 50 - 100

Staff, chemical service provision

SERVICE AREA BREAKDOWN Information Training 3% 2% Representation & management 5%

We are the leading consulting company in Europe in the field of Biopesticides and have submitted dossiers for 37 strains or isolates from 32 microbial species for approval as active substances in the EU. We are also engaged in the revision of guidance documents for dossier preparation for biocides containing microorganisms as active substances and frequently participate in the OECD Bio Pesticide Steering Group, EU Commission working groups, IOBC and IBMA - ensuring that we are always at the forefront of knowledge in regulations for biopesticide registration. Biocides With over a decade of experience in registration of biocidal substances and a dedicated biocides expert group, we can assist you with scientific and regulatory support for biocidal active substances and products (disinfectants, preservatives, pest control and other biocidal products). In addition, we can provide you with strategies – tailored to your product portfolio – to meet the new regulatory challenges. Environmental risk assessment – pharmaceuticals With more than 17 years of experience in the fields of environmental fate and ecotoxicology of crop protection and biocidal products and a dedicated environmental expert group, we can assist you with scientific and regulatory support for the environmental risk assessment of your pharmaceuticals (human or veterinary drugs) and to generate data or – if applicable – waiver which will successfully meet the regulatory requirements of Europe. Feed additives

Consultancy/advisory 90%

We offer support for the authorisation of chemicals or microbials as feed additives according to European regulations. We provide you with effective and timely solutions related to the characterisation, efficacy and safety aspects of feed additives. All the regulatory aspects related to your feed additive are in safe hands with us, making sure that your products can be placed on the market. REACH

GLOBAL OFFICES Office in Stade (Germany), Heidelberg (Germany) and Valencia (Spain).

Page 118

GAB Consulting will help to identify and fulfill your obligations as importer or producer of chemicals in the EU. Classification and labelling according to the new CLP system is a requirement for all products from 2015 onwards. We offer our assistance in preparation of updated safety data sheets and CLH reports as well as communication with national authorities and the European Chemicals Agency (Echa) as well as defence of the submitted dossiers.

Chemical Watch | Global Service Providers Guide 2016

Nanomaterials

STAFF SELECTION

We are pleased to offer you scientific and regulatory support in the developing market of nanotechnologies. Our contribution spans from providing you with up-to-date information on your obligations, to the preparation and submission of complete registration dossiers.

José Luis Juanes González Physical Chemistry and Analytical Methods Department

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Dr Martina Dunker Residues & Efficacy Department

Company founded by Dr Wolfgang Häussler

1999

First A-I inclusion submission (91/414/EEC)

2000

Office relocation to Lamstedt, Germany

2002

Opening of Valencia Office, Spain

2003

Principles of Good Consulting Practice

2004

Expansion of Lamstedt Office, Germany

2006

Opening of Heidelberg Office, Germany

2007

Introduction of GAB Expert Groups

2009

New business area: veterinary medicines

2010

REACH submissions / representation in France

2011

Representations in Poland and Slovenia

2012

Introduction of GAB Roadmap Consulting Excellence

2013

New business area: nanomaterials

2014

Move of Valencia Office, Spain

2015

Implementation of new positions: SRAM and SSE

2016

Expansion of Valencia Office, Spain

Dr Andreas Häusler Environmental Fate and Modelling Department

PROFILE: GAB Consulting GmbH

1998

Prof Dr Wolfgang Pfau Head of Toxicology & Leader REACH and Feed Additives

Sascha Otto Ecotoxicology Department Dr Rüdiger Hauschild Biopesticides Department Dana Wallschläger Quality Assurance

PARTNERS We work with representation and cooperation in several European countries (France, Poland, Czech Republic, Hungary, Slovakia, Slovenia, Romania, Bulgaria, Greece and Italy) and other countries around the world (Russia / CIS, US, Argentina, Brazil, Chile, China). We always try to find solutions for our customers and we are always open to starting collaborations with new partners in order to get a closer follow up of the management of our clients´ needs. CLIENTS Companies searching for professional assessment for their substances and products in the following areas: agrochemicals, nanomaterials, biocides, biopesticides, environmental risk assessment-pharmaceuticals, REACH, feed additives. TESTIMONIALS During the past 18 years GAB has developed and maintained a reputation for professionalism, adaptability, resourcefulness and, above all, for getting the job done. This has helped our clients trust us from the very beginning to the present day. CASE STUDY: General remarks OO

OO OO OO OO OO

81 chemical and 32 microbial active substances for EU Annex-I inclusion / re-inclusion Directive 91/414/EEC Over 20 dossiers for biocidal product authorization More than 700 product registrations supported all over EU. Secure electronic client access database In-house quality assurance unit We guarantee satisfied customers by always keeping you informed about the status of your registration process. We provide you with a dedicated project manager contact to ensure permanent communication and service.

Chemical Watch | Global Service Providers Guide 2016

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GLOBAL OFFICES Willoughby Road, Bracknell, West Berkshire RG12 8FB, UK 78 Shenton Way, Singapore 4777 Levy Street, St. Laurent, Quebec, Canada H4R 2P9 Oranjesingel 34, 6511 NV Nijmegen, The Netherlands 9 Monroe Parkway, Suite 150, Lake Oswego, Oregon 97035, USA

PROFILE: IHS

CONTACTS Website

www.ihs.com/productstewardship

SERVICES PROVIDED

E-mail

operationalexcellence@ihs.com

IHS Product Stewardship Solution™

Head office

15 Inverness Way East, Englewood, Colorado 80112, US

Tel

EU: +31 (0) 24 329 7424 North America: +1-888-828-7466

Contact

Matt Bixler

Directors

Jerre Stead, CEO Anurag Gupta, Executive Vice President Strategy, Products and Operations Scott Lockhart, Sr Vice President, Operational Excellence and Risk Management

Ownership

Publicly traded company (NYSE: IHS)

Locations

Worldwide

Founded

1959

The IHS Product Stewardship Solution™ helps your business maintain access to existing markets while accelerating opportunities to introduce products in new markets. Powered by IHS Intelligent Authoring™, IHS Comply Plus® and IHS DolphinRTK™, this comprehensive solution combines software, content and industry expertise, enabling organisations to efficiently monitor and manage product compliance with rigorous regulatory mandates at every stage of the product lifecycle, from product design through manufacturing, shipping and delivery. IHS supports your company’s compliance programme with these powerful information management capabilities: OO SDS authoring – automate 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; OO documentation and labels – simplify the process of producing GHS labels and REACH compliant regulatory documents and labels; OO product compliance analysis – proactively plan for and manage impacts of evolving requirements and gain insight into calculated classifications, quickly identify substances of concern in products and make better decisions; OO chemical management – effectively manage inbound and produced chemicals by using a consolidated platform for SDS management, chemical approvals, chemical inventory tracking and environmental reporting; OO managed regulatory content – efficiently maintain compliance in the ever-evolving regulatory environment by leveraging consolidated and validated regulatory data delivered by IHS. IHS monitors global regulations, interprets changes, and delivers application ready updates to data, rules, templates and logic.

OVERVIEW Information management solutions for EHS and sustainability IHS is a global information company with leading experts in chemicals, energy, economics, geopolitical risk, sustainability and supply chain management. IHS is also the leading provider of information management solutions – combining software, content and expertise – for environmental, health and safety. In today’s business climate, corporate executives are under pressure to reduce operational costs, avoid potential disruptions, and meet escalating demands for compliance with government regulations, voluntary sustainability protocols and corporate policies. IHS enables businesses to meet these challenges and their operational excellence goals by providing the key systems that underpin their integrated management systems. VITAL STATISTICS

2014/15

Turnover, group

US $2.2bn

Turnover, chemical service provision

No of offices

140+

No of countries represented

Staff, group

More than 8,500

Staff, chemical service provision

150

SERVICE AREA BREAKDOWN Training 5%

IT & software 40%

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Consultancy/advisory 20%

Industry and domain expertise IHS domain and technology experts possess a wealth of domain knowledge and have proven experience at global implementations and integrating with key business systems such as ERP and PLM. Additionally, IHS maintains a team of regulatory experts who monitor and interpret hazard communication legislations, lead focus groups, deliver regulatory and software training as well as provide extensive safety data sheet authoring services for global companies. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1959

IHS founded

2005

IHS becomes a publicly-traded company

2007

IHS launches EHS & Sustainability Business IHS acquires Environmax

2008

IHS acquires Environmental Software Providers IHS acquires Dolphin Software

2009

IHS acquires Environmental Support Solutions

2010

IHS named Leader in Carbon and Energy Management Software by independent analyst firm IHS acquires Syntex Systems IHS acquires Atrion International

2011

IHS named Enterprise Sustainability Management Solution Leader by leading research firm IHS acquires Dyadem

Information 35%

Chemical Watch | Global Service Providers Guide 2016

Analyst study names IHS a leader in environmental management software IHS acquires CyberRegs

2013

IHS acquires RL Polk & Co.

2015

IHS named to the Dow Jones Sustainability North American Index for the 3rd Consecutive Year. 90th Percentile in Environmental Reporting and 95th Percentile in Occupational Safety.

CLIENTS For more than two decades, IHS has been trusted by hundreds of enterprise-level clients worldwide across a vast array of industries, including chemicals, pharmaceuticals, energy, mining, manufacturing, transportation, consumer goods, defence and government. 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 IHS solution enabled them transparency and accountability for audits by offering the ability to track back to chemical composition and business decision justifications. Yara was also able to streamline work processes by automating distribution of SDSs.

Results: Reassessed 3,500 reagents according to new GHS classifications and updated 70,000 safety data sheets prior to 2015 GHS deadline. Created GHS-compliant SDSs in 20 unique language formats. Avoided product interruption to customers in key GHS-affected markets. Effectively analysed product portfolio to identify substances of concern and respond effectively to customer requests. STAFF SELECTION Jeff Ladner, Senior Director, EHS and Sustainability Solutions Jeff Ladner oversees the development of unified information management solutions that enable global organisations to proactively address EHS and sustainability business challenges, as well as boost operational and financial performance. Under Ladner’s leadership, IHS has established a strong reputation for enabling corporations to develop and execute sustainability strategies through a holistic, integrated view of operational performance. He has nearly two decades of experience meeting market demand for enterprise information management systems. Francis Trudeau, Solutions Manager Francis Trudeau 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 IHS integrated information management solutions, and address legal compliance challenges and the implementation of regulations in databases and software applications. Trudeau is a recognised industry expert, serving both as a featured speaker at international conferences and leading multi-organisation task forces in establishing industry best practices for regulatory compliance. Mary Rudolph, Senior Manager – Global Content Mary Rudolph has more than 25 years of international environmental, health and safety experience, including technical and business implementations of authoring services. She offers IHS customers an in-depth and often sought after understanding of the needs of global EHS departments. She has also managed the development of EHS-related databases, including RTECS®, a recognised toxicology database. Scott Harter, Director Regulatory Content Scott Harter has more than 25 years of experience in EH&S. He has worked for 15 years in implementation, SDS authoring service, and content development. Previously he managed an EH&S department in a consulting business and worked for industry. In industry Harter managed extensive environmental investigations, the Industrial Hygiene Department, and the Radiation Protection Program for Eastman Kodak Company. He is a board certified industrial hygienist or “CIH”.

CASE STUDY 3: Lanxess

Rosemary Feiter, Senior Manager – Authoring Services

Challenge: Meet the changing regulatory compliance needs on a global scale including GHS, Osha Hazcom, EPA Fifra and CLP. Author SDSs in dozens of languages for as many destination countries. Respond rapidly to customer requests for safety information Results: Moved ahead of schedule for full compliance with GHS. Maintained and managed 4,000 products in the US, as well as a few thousand more products produced in Canada and distributed in Mexico in 39 languages for destination countries. Sent out 120,000+ SDSs companywide in 2013 and increased customer satisfaction by addressing new compliance challenges proactively.

Rosemary Feiter has over 25 years of experience in a variety of fields that are correlated to product stewardship activities such as R&D, production, quality control, distribution and EH&S assessments. Feiter leads the Business Process Outsourcing (BPO) team which provides IHS clients with safety document authoring and consulting services. The IHS authors and project managers are regulatory experts that have substantial experience and knowledge of global regulations and industrial best practices having worked on multiple authoring projects for clients with diverse product portfolio.

CASE STUDY 4: Siemens Healthcare

Carrie Decatur is responsible for monitoring and analysing GHS regulations around the world. She has nearly 15 years’ experience in health and safety management programmes, managing compliance with state and federal Osha, and US EPA regulations, ensuring product safety, and supporting SDS authoring programmes.

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.

Chemical Watch | Global Service Providers Guide 2016

Carrie Decatur, Senior Regulatory Analyst

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PROFILE: IHS

2012

PROFILE: International Cosmetics & Chemical Services Ltd

We provide full regulatory services in Europe, including labelling requirements, to meet 1223/2009 EC cosmetic Regulations for 28 EU member states. Responsible person (RP) services. RP is responsible for: OO cosmetic safety reports; OO safety assessment by qualified safety assessor; OO product information file (PIF) for each product; OO EU physical location to hold PIF; OO EU address as required for all product labelling; OO label direction to meet EU requirements; OO access for the competent authorities (28 countries) for PIFs; OO holding and maintenance of PIFs for legally required access by competent authorities. If a company does not own their formulas, we provide an agreement between the brand owner, the contract manufacturer and our company to provide confidentiality. With the agreement in place we only share information with an EU authority through access at our UK office.

CONTACTS Website

www.intlcosmetics.com

E-mail

info@intlcosmetics.com

Head office

947 Manhattan Beach Boulevard, Suite A, Manhattan Beach, CA 90266, US

Tel

+1 310 545 3223

Fax

+1 310 546 6204

Contact

Georgia@intlcosmetics.com

Directors

Janet Winter Blaschke

Georgia Boehm

Ownership

Private company

Locations

USA, UK

Founded

1997

Only representative (REACH), CLP notifications (sole representative) Only representative services for companies needing chemical registrations for the EU scheme under REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). Late pre-registration and full registrations have already been successfully provided for many clients. CLP notification services are also available, in addition to safety data sheets to meet the requirements of REACH and CLP.

OVERVIEW International Cosmetics and Regulatory Specialists LLC, a US organisation and International Cosmetics and Chemical Services Ltd, a UK entity are sister companies comprised of experienced professionals in regulatory affairs, international product registration, and international labelling compliance, with an emphasis on technical services for the EU, US, Canada, Asia, South America, and the Middle East. Please enquire about your specific needs.

US agent, cGMP audits and training, electronic US FDA registrations

Turnover, group

Turnover, chemical service provision

Products such as Acne and any product containing SPF ingredients must be registered with the FDA. We can act as the US agent for foreign manufacturers (which is mandated by FDA) and provide the mandatory facility, distributor and product FDA electronic registrations. FDA registrations must now be done electronically, which is a service we provide. We provide cosmetic and over-the-counter drug label reviews to the FDA monograph, training and 21 CFR 211 or ISO 22716 cGMP facility and standard operating procedure audits.

No of offices

Training for GMPs and ISO manufacturing standards

VITAL STATISTICS

2014/15

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 15%

A wide variety of experience facilitates custom services for international needs with the intricacies of each individual organisation in mind. Focus is given to tailoring these skills to fit the client needs for entire projects, multiple countries, or for an individual project for one country. We provide GMP training and audits to the newly-required ISO 22716 as well as FDA cGMP gap analysis to 21CFR211 for USA compliance. Foreign and US location audits performed. CORPORATE DEVELOPMENTS & ACHIEVEMENTS REACH

Representation & management 25%

Consultancy/advisory 60%

2007

Formed REACH Chemical Consulting, Ltd now known as International Cosmetics and Chemical Services, Ltd.-UK.

2008

Filed pre-registrations for US and international companies to meet the EU Regulation.

2009

Among the first only representatives to successfully complete a cosmetic ingredient full registration in 2009 prior to the first 2010 deadline. This resulted due to a company who missed the pre-registration phase while importing finished product using the ingredient at 1 ton or more the previous three years.

2010

Preparation of safety data sheets (SDS) to meet the REACH and CLP requirements.

2011

Continuing with SDS creations, REACH late-preregistrations, Sief coordination for clients and their chemicals, continue with CLP notifications.

2013

Provided assistance to companies with mid-range registrations.

GLOBAL OFFICES US: International Cosmetics and Regulatory Specialists LLC UK: International Cosmetics and Chemical Services Ltd SERVICES PROVIDED Responsible person (RP) for cosmetics CPNP notifications, product information files (PIF) 2009 December 1223/2009 EC cosmetic Regulation published. 2013 July 1223/2009 EC cosmetic Regulation enforcement begins. Page 122

Chemical Watch | Global Service Providers Guide 2016

Assisting clients with meeting CLP deadlines and with preparations for the 2018 deadline.

Georgia Boehm, AA Business Management, Glendale College

2008

Designated expert Cosmetic GMP and Microbiology workgroup in Paris.

VP of Regulatory Affairs – International Cosmetics & Regulatory Specialists LLC, expert in yield and accountability documents for compliance with REACH regulations. 30 years of experience in cGMP compliance, regulatory and quality systems, international registrations, FDA registrations, FDA drug compliance for claims and labelling and facility. Corporate experience: ten years at Neutrogena Corporation, six years at Herbalife International, and contract manufacturing management.

2009

Designated expert Cosmetic GMP and Microbiology workgroup in Baltimore, MD, US.

Deborah Rediet, BA French and Minor in International studies, California State University Long Beach

2010

Designated expert Cosmetic GMP, Microbiology and Sunscreens workgroup in London

2011

Designated expert Natural and Organic Terminology workgroup in Kyoto, Japan

2014

Staff members participated as Designated Experts in Microbiology and Terminology Working Groups.

ISO 2006

Designated expert in the Cosmetic ISO workgroup for TC217, Cosmetic GMP, Sunscreens and Microbiology in Paris.

2006

Designated expert in cosmetic GMP and Sunscreen workgroup in Den Haag, the Netherlands.

cGMP audit ICRS continues to excel in meeting cGMP compliance training and audits in the US as well as internationally. These activities are designed to meet the individual companies and their unique cultures. Staff use ISO GMPs, FDA cGMPs as well as country specific regulations depending on the market and or country needs. ACCREDITATIONS OO OO OO OO OO

Personal Care Products Council (Formerly CTFA) Society of Cosmetic Chemists (SCC) Regulatory Affairs Professionals (RAPS) American Society for Quality (ASQ). Vrije University of Brussels (VUB), qualified safety assessor training and certificate from the department of Pharmacology and Toxicology Chartered biologist, Society of Biology, UK

OO OO

Senior manager, Regulatory Affairs – ten years’ experience in regulatory affairs in Canada, the US, Europe and Asia. Expert in labelling compliance and PIF requirements. Certificated from California State University, San Diego (CSUSD) in regulatory affairs, College of Science. Fluent in French, working proficiency in Spanish.

Robert Blaschke, BA, French & Philosophy, Loyola Marymount University OO

OO OO

Regulatory affairs specialist – six years’ experience in FDA compliance in the USA . Expert with FDA electronic registrations and IT portal. IT specialist.

Silvia Yoc, BA, International Business Administration and Marketing, California State University Long Beach OO OO

Regulatory affairs specialist – three years’ experience in the US. European document compilation – Product Information File.

Adam Minc, BA, Business Marketing, Spanish, Endicott College OO OO OO

Regulatory affairs specialist – two years’ experience in the US. Data base coordinator. Government submissions.

PARTNERS Manhattan Repro (graphic design for labelling) CLIENTS Our client base consists of a wide variety of chemical companies, cosmetics & personal care companies and companies in related industries, of all sizes. STAFF SELECTION Janet Winter Blaschke, BA, Biology, University Redlands OO OO

OO OO

CEO of International Cosmetics & Regulatory Specialists LLC. CEO and founder US, and managing director of International Cosmetics and Chemical Services Ltd in the UK, serving the consumer products and chemical industries. 30 years of experience as a product formulator and regulatory expert has given her unique expertise in both the European and US regulatory schemes. Founder, instructor and lecturer for cosmetic science programme at UCLA (University of California at Los Angeles). Topics include: regulatory acceptance of cosmetic ingredients in individual countries; R&D and manufacturing for the global market; microbiology and quality control of cosmetic products. Past chairman, Society of Cosmetic Chemists; member, board of directors, Society of Cosmetic Chemists; regulatory affairs chairman, contributing author to SCC publications. Chartered biologist, Society of Biology, UK. Post graduate certificate in REACH management, University of Hull, UK.

Chemical Watch | Global Service Providers Guide 2016

Page 123

PROFILE: International Cosmetics & Chemical Services Ltd

2014

SERVICES PROVIDED Advisory – services to help you advance your business Auditing – services to help you control operations Certification – services to help you reach new markets Outsourcing – services to help you focus on core activities Quality assurance – services to help you meet expectations

PROFILE: Intertek

CONTACTS

Training – services to help you improve your performance

Website

www.intertek.com/green/chemicals/

E-mail

regulatoryaffairs@intertek.com

Testing – services to help you ensure you meet your quality standards

Head office

25 Savile Row, London W1S 2ES, UK

Tel

+44 161 245 8071

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Contact

Jeremy Ramsden

Directors

Sir David Reid, Chairman; André Lacroix, Chief Executive Officer; Edward Leigh, Chief Financial Officer

Ownership

Public

Locations

Intertek is the industry leader with more than 38,000 people in 1,000 locations in over 100 countries.

Founded

The Intertek story starts at the inception of the modern testing industry. The history of Intertek spans more than 130 years, and evolved from the combined growth of a number of innovative companies.

2010

Intertek acquired CIBA Expert Services and Cantox Health Sciences International specialising in developing scientific and strategic global regulatory plans, resolving complex toxicological and scientific issues, and facilitating timely regulatory approvals.

2013

Intertek partnered with Decernis in order to provide research, content and information systems that supply a comprehensive service to help companies manage global regulatory compliance across the entire supply chain in a wide range of industries and products.

2013

Intertek expands testing capabilities through the addition of: granulometry to complement their comprehensive suite of REACH physico-chemical property tests and chemical characterisation; and, commercial materials and surface analysis laboratory capabilities in Australia with a scanning electron microscope with energy dispersive x-ray analyser (SEM-EDXA).

2013

Intertek announced that all obligations and agreements with clients pertaining to the 31 May 2013 REACH deadline were successfully fulfilled.

2015

Intertek Scientific & Regulatory Consultancy (formerly known as Cantox Health Sciences International) celebrates 30-year Anniversary of delivering valued service.

OVERVIEW Intertek helps organisations across a wide range of industries to sharpen their competitive edge by providing advanced measurement, expert consulting related technical support services, and sustainability solutions. Our experts and laboratories provide critical support to our clients in their global trade, not just with data, but with essential knowledge to accelerate development of their next generation products, to improve their manufacturing, products or production processes or to enhance their efficiencies. VITAL STATISTICS

2014/15

Turnover, group

£2,093m

Turnover, chemical service provision

£154.8m

No of offices

1,000+

No of countries represented

100+

Staff, group

38,000+

Staff, chemical service provision

2,000+

SERVICE AREA BREAKDOWN

Other 29%

Training 3%

Consultancy/advisory 10% Information 3%

Laboratory 55%

GLOBAL OFFICES US: 25025 I-45 North, Suite 111, Spring, TX 77380, US, +1-281-364-2923 Canada: 2233 Argentia Road, Suite 201, Mississauga, Ontario, Canada, L5N 2X7, + 1-905-542-2900 Germany: Stangenstr 1, 70771 Leinfelden-Echterdingen, Germany, +49 711 27311 152 China: Room 106 Comalong Building, Shanghai Comalong Technology Service Park, No. 889 Yi Shan Road, Shanghai, China 200233, +86 021 6073 7735 Page 124

ACCREDITATIONS As a company, Intertek believes that acquiring the appropriate quality accreditations and maintaining membership (and in many cases) chairing industry regulatory groups and standards organisations is key to not only our development but to providing quality assurance and insight to our customers; and while the company holds membership to these organisations; individually Intertek has employees that represent the company on different boards. Examples of these would be: Dr Ruud Overbeek – board member of Decernis and Scientific Advisory member on Health & Beauty America; Mr Naeem Mady – industry segment council board member and a national board council member at the Plastics Industry Trade Association (SPI), and a member of the America Chemical Society and Society of Plastics Engineering; Ms Karen Levins – active member of the Industry Coordinating Group (ICG) for the Canadian Environmental Protection Act (Cepa) and the New Substances Notification Regulations (NSNR); Ms Joyce Borkhoff – active member of the Industry Coordinating Group (ICG) for the Canadian Environmental Protection Act (Cepa), The Canadian Association of Chemical Distributors (CACD), the Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers (ETAD); and Dr Michael Leise - Board member of Only Representative Organisation (ORO) AISBL, representing credible REACH only representatives active within the European Economic Area. CLIENTS Our clients include: Behr, Bosch, BP, ChevronTexaco, Citgo, ConocoPhillips, Haier, Lubrizol, Petrobas, Siemens. Chemical Watch | Global Service Providers Guide 2016

TESTIMONIALS

Naeem Mady, Vice President, Regulatory Services

Director of Quality Engineering with Instrumentation Laboratory, Jim Richard, said “Intertek assisted us in the successful execution of a complex RoHS exclusion request. Throughout the process, Intertek experts were quick to respond, highly professional and knowledgeable in the legal and political processing of our request. In addition, Intertek acted as the liaison between authorities and Instrumentation Laboratory to ensure smooth and continuous progress of the application, as well as, the successful facilitation of in-depth communication with external stakeholders.” “I would like to let you know that I appreciate the high quality work and speed your team has worked to generate e-SDS for Braskem. You made us feel important by responding with a sense of urgency to our requests. I also wanted to inform you that Braskem Netherlands BV were inspected by Dutch government in regards to OR scope for all Braskem companies and all e-SDS checked were in compliance with REACH / GHS rules. Thank you so much!” – Braskem S.A

Naeem Mady’s responsibilities include worldwide notification of U.S. products, and regulatory compliance for food contact substances. Prior to working for Intertek, Naeem was with Ciba Specialty Chemicals since 1980. His responsibilities included the design and implementation of Good Laboratory Practices (GLP) and Quality Management Systems programmes; the design and development of migration studies for FDA submissions; and ensuring FDA and EPA regulatory compliance for Ciba. Naeem expertise is evident through his contributions as an author and participation as an invited speaker for industry.

One of the first major hurdles in the preparation of the technical dossier for REACH is to ensure the registrant is certain that the substance is well defined. The better the knowledge of the substance definition, the easier it is to decide on a registration strategy. In one case our client was uncertain about the handling and interpretation of the product-by-process definition, so our expert spent several hours discussing the problem. As the descriptions became quite complicated our expert was invited to the plant to better define the case. After a few hours of explanations onsite it became quite evident that the substance in question was not eligible for registration and hence was exempted. Looking back this process was a minor investment compared to a full registration dossier. The client easily saved millions in consulting charges and multiples thereof in testing costs. 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. Add a need for reliable safety assessments while protecting confidential information, and challenges seem insurmountable. Recently, Intertek was asked by a chemical company located in the UK for help with accessing new markets in South Korea. Sending chemicals into this region would require compliance with the new ‘K-REACH’ programme, typically requiring submission of sensitive product information by the local importer to the government agency for safety assessment and pre-market clearance. Although the UK company agreed to provide the necessary information, they were reluctant to submit confidential information through the local customer. Intertek’s global team worked seamlessly with the chemical company and its customer, to prepare and submit a robust dossier, and obtained approval directly for the UK company, using Intertek’s Koreabased ‘only representative’ (OR) service, mimicking Intertek’s highly successful OR service for EU-REACH compliance. Intertek solutions go beyond addressing scientific and regulatory challenges; we protect our customers’ competitive advantage in global markets. STAFF SELECTION Torben Nörlem, Esq – Chief Legal Counsel Regulatory Services Torben Nörlem has an LLM in law from the legal faculty at Copenhagen University and 15 years’ experience working with product related legislation and regulatory framework. Torben has been working as chief counsel for health and environment with Intertek since 2008. Torben was responsible for legal affairs related to the REACH legislative process and was a participant of the Danish government negotiation team during the negotiations in the European Union. He was also responsible for implementation and administration of EU rules regarding chemicals in electronics in Denmark. Chemical Watch | Global Service Providers Guide 2016

Dr Michael Leise’s responsibilities include consulting on notification strategies for chemicals worldwide, test-programme development, chemical risk assessment, negotiations with authorities and scientific bodies. He studied at Heidelberg, researched in Boston at MIT and acquired environmental expertise at TÜV Rheinland before he joined Ciba Specialty Chemicals in Lampertheim as head of product safety in 1995. Karen Levins – SVP, Global BD and Marketing, Intertek Scientific and Regulatory Consultancy Services As a regulatory toxicologist with more than 19 years’ experience, Karen Levins helps the chemical industry understand and comply with global regulations controlling the manufacture, importation, distribution, and use of new and existing products. Helen Xue – General Manager, Chemicals & Pharmaceuticals, China Helen Xue has 20 years of experience in pharmaceutical, public health and environment area. She worked as the medical research scientist of FDA China Office, Health and Environment specialist of the US Consulate Shanghai Economic and Political Department. Helen worked at Intertek from 1998 to 2006 and re-joined in 2013. She is in charge of C&P China which provides services for GMP compliance and EHS compliance programme for pharmaceutical, medical device and cosmetic industry, chemical regulatory support (registration, consulting etc), cosmetic chemical testing and safety assessment, cosmetic efficacy study. Dr Robert Fellous – Global Business Stream Leader, Healthcare and Beauty Products Dr Robert Fellous holds more than 20 years of industry experience and is able to meet the demands of clients’ regulatory affairs and related testing challenges. Robert has also held a number of eminent industry positions such as the Chair of the EFFA REACH Task Force and Fragrance Expert Committee; and is currently a member of the COLIPA-AISE-EFFA Joint Perfumery Steering and Safety Group. He studied pharmaceuticals at the Université Paris V, gaining a Pharmaceutical PhD and attended the University of California, Berkeley where he gained a post-doctoral fellowship in biochemistry and molecular biology. Robert also holds an INSEAD MBA. Dr Ruud Overbeek – Vice President, Global Health, Environmental and Regulatory Services Dr Ruud Overbeek leads Intertek’s Global Health, Environmental and Regulatory Services (HERS) business, which offers a complete solution for global, regional, or local compliance, providing sound traceability systems and implementation of company specific policies. Services include strategy consulting, regulatory and product safety consulting, testing and analysis, legal representation, certification, scientific research, and corporate education appropriate for all types and levels of business delivering solutions to meet our customers’ needs in managing their products in today’s complex global marketplace. Ruud is a regular author in respected industry and environmental publications, a contributing editor on Harry’s Cosmeticology 9th Edition, holds advisory roles on environmental business impact within the US health and beauty industry’s governing association, and has a doctorate in chemistry.

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PROFILE: Intertek

CASE STUDY 1: Incorrect definition of substance can lead to unnecessary registration

Dr Michael Leise – Senior Expert Consultant, Regulatory Affairs

SERVICES PROVIDED Biocidal active substances and biocidal products

Website

www.jsci.co.uk

E-mail

enquiries@jsci.co.uk

Head office

The Exchange, Station Parade, Harrogate, North Yorkshire, HG1 1TS

Tel

+44 (0)1423 520245

JSC offers regulatory support for both active substances and biocidal products. We have experience of submitting active substance dossiers for a wide range of product types under the BPD/BPR. For biocidal products we routinely submit national registrations and have good contacts with regulatory authorities in all member states within the EU. We are also active in submitting BPR product dossiers following inclusion on the Union list of approved active substances. We are able to offer support on a diverse range of biocidal products. JSC can also offer more general regulatory support to biocide manufacturers and formulators in areas such as scope issues, efficacy testing, claim support and risk assessment.

Fax

+44 (0)1423 520297

REACH services

Contact

Dr Samantha Wright or Dr Richard Elsmore

Directors

Lucy Croucher, Managing Director

Ownership

Wholly owned subsidiary of ERM Limited

Locations

Founded

1992

JSC consultants have significant experience in all aspects of REACH. We have prepared a large number of registration dossiers (lead and member dossiers) and chemical safety reports (CSRâ&#x20AC;&#x2122;s) and have provided expert advice on specific areas of REACH such as data evaluation and study monitoring. JSC have Sief/consortium management experience and ensure that the deadlines of your project are met. We are able to help with the preparation of consortium agreements, communication within the consortium and ensure an effectively run consortium. JSC are able to help downstream users identify their obligations and provide training to ensure continued compliance.

PROFILE: JSC International Limited

CONTACTS

OVERVIEW JSC International Limited is a wholly owned subsidiary of ERM Limited providing European regulatory consultancy to the chemical, agrochemical and biocides industries. At JSC we have a dedicated team of highly motivated people with backgrounds from government, industry and contract research. Our integrated, cross-discipline working practices enable us to provide novel and innovative approaches to problem solving, supported by our excellent contacts with regulatory officials and scientific experts throughout the world. VITAL STATISTICS

2014/15

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

30+

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Other Training 5% 5% Representation & management 20%

Consultancy/advisory 70%

GLOBAL OFFICES JSC International Limited, The Exchange, Station Parade, Harrogate, North Yorkshire, HG1 1TS, UK

Page 126

CLP/GHS JSC experts are able to assist with classification, labelling and safety data sheet creation including the extended safety data sheet containing exposure scenarios. DGSA JSC can offer dangerous goods safety adviser services for the transport of hazardous goods. Our experts can act as your company DGSA, provide support, auditing and training. Agrochemical products JSC has extensive experience in the preparation, submission and regulatory support of EU dossiers and national draft registration reports. We have an excellent track record of successful EU approvals and national authorisations, and are well placed to assist you in the development of strategies to support your compounds in Europe. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1992

EU offices of JSC formed â&#x20AC;&#x201C; US owners

1996

Offices relocated to Harrogate

2004

Management buy-out

2005

Biocides expertise consolidated

2006

Development of expertise in REACH

2008

Consolidation of REACH capability

2010

Preparation and submission of a large number of REACH dossiers/CSRs

2014

Office relocation within Harrogate

2016

Acquired by ERM Limited

ACCREDITATIONS All technical staff are qualified to degree level or higher (MSc and or PhD). Our senior toxicologists are Society of Biology / British Toxicology Society and Eurotox registered and our DGSA has current certification. We employ a number of chartered biologists (CBiol) including two fellows of the Royal Society of Biology (RFSB).

Chemical Watch | Global Service Providers Guide 2016

Dr Richard Elsmore – Regulatory Affairs: Biocides and REACH

Network of locally recognised contacts across the globe.

Richard Elsmore has held a number of senior roles with speciality chemical manufacturers and formulators and has experience of working with a wide range of product chemistries; he has a practical background of operating within the global chemical market and with FMCG’s. Richard has worked in technical, regulatory and business management positions and has been involved with a number of industry bodies at EU level. He is also a director of the British Association for Chemical Specialities (BACS). Richard has experience of submitting a number of dossiers under REACH (1907/2006), BPD (98/8/EC) and BPR (528/2012) as well as submissions to national regulatory authorities. He has been actively 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 additionally sits on the BSi Technical Committee on disinfectant standards (CH/216) and has represented BSi within CEN. He has also worked on both method development and the assessment of individual chemicals in the human and environmental risk assessments programme (HERA).

CLIENTS Our clients range from large international companies to SMEs located worldwide. TESTIMONIALS We are unable to identify our clients due to client confidentiality constraints. CASE STUDY 1: Biocidal active substance approval JSC has successfully developed and submitted a wide range of active substance dossiers under both the BPD and now the BPR. These active substance dossiers have included uses in the majority of product types (PTs). CASE STUDY 2: Biocidal product authorisation JSC has successfully submitted a large number of biocidal product dossiers. This has involved national submissions (where relevant) in most member states within the EU as well as BPD and BPR biocidal product dossiers. Product dossier submission has included most of the BPR product types. CASE STUDY 3: REACH dossier preparation JSC has provided REACH dossier preparation for a number of complex and hazardous chemical substances. These substances have required the identification of data gaps and where necessary, placing and monitoring of studies. JSC has also been responsible for the production of the registration dossiers for the lead registrants and members of the consortia in Iuclid 5 and for developing the chemical safety report and working with the consortia members to identify downstream user descriptor codes. The project was a success culminating in the successful submission of substance dossiers for the 2010 and 2013 deadlines. During the development of these dossier and safety assessments JSC has had to work with consortia members and downstream users to identify relevant use patterns and in the development of appropriate RRM and in the production of meaningful extended SDS.

Peter Chapman – Director of Regulatory Affairs Peter has many years’ experience in pesticides registration matters having previously held senior roles in the UK regulatory authority both in a national and international capacity. He has worked extensively with the European Commission, the European Food Safety Authority and most EU member states. His main focus is on providing up to date advice on regulatory matters relating to pesticide active substances and plant protection products.

STAFF SELECTION Lucy Croucher – Managing Director Lucy Croucher has been working in the area of European agrochemical regulatory affairs since 1994. She has managed large scale projects for the preparation, submission and support of EU dossiers for existing active substances, resubmissions and new active substances under Directive 91/414/EEC. To date, JSC has been involved in the successful Approval of 17 active substances. Lucy is currently advising clients on strategies for renewal of Approval and the implications of Regulation (EC) No 1107/2009. Dr Samantha Wright – Regulatory Affairs: Biocides and REACH Samantha Wright is an experienced REACH manager with previous responsibilities for tracking and implementing worldwide legislation to ensure global regulatory compliance. Samantha has experience in the preparation and submission of REACH dossiers and consortium management, as well as a number of years authoring safety data sheets and determining classification and labelling. Samantha has been involved with strategy planning for business compliance and delivering training for REACH and CLP. Samantha has experience of submitting a number of biocide active substance and product dossiers, and provides support and guidance for companies under the BPR. Samantha’s background in regulatory affairs was gained through working with clients in the cosmetic, pharmaceutical and industrial sectors.

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PROFILE: JSC International Limited

PARTNERS

packages has been successfully introduced allowing customer’s permanent updating of safety data sheets (SDS) pursuant to statutory requirements. The total care service is completed by the latest innovation KFT SDS Control & Care, covering the management of supplier SDS. Raw materials management

Website

www.kft.de; www.kft-academy.com; www.kft-ebook24. com; www.kft-chemdoc24.com

E-mail

mail@kft.de

Head office

Im Leuschnerpark 3, 64347 Griesheim, Germany

Tel

+49 6155 86829 0

Many of our customers have entrusted KFT with the management of their raw material data. This involves the requisition and review of suppliers‘ safety data sheets, and communication with the supplier to eliminate possible deficiencies. We remotely enter the data of the suppliers' SDS into the customer’s IT systems. In addition, we update the regulatory content data in the customer systems. Our many years ‘experience with SAP EH&S allows us to guarantee proper and professional data maintenance also in these systems.

Fax

+49 6155 86829 25

Generation and maintenance of exposure scenarios

Contact

Karl-Franz Torges (PhD), Karin Schmidt

Directors

Karl-Franz Torges (PhD), Managing Partner

Ownership

Private company

Locations

Griesheim (near Darmstadt), Germany

Founded

1995

Unfortunately there is as yet no standard format for the electronic exchange of exposure scenarios (keyword ESCOM XML). Moreover, for existing registrations the data for the exposure scenarios have to be copied from our own or third party chemical safety reports (CSR) or from suppliers‘ safety data sheet appendices to our own IT system. Based on our experience with major customer projects, we can now remotely enter appendices or exposure scenarios into your IT system, enabling you, after implementation of the appropriate interface, to electronically export your compliant exposure scenarios and make them available to your customers.

PROFILE: KFT Chemieservice GmbH

CONTACTS

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

Specific services Customised substance data research, marketability check, limitations for chemicals prohibition ordinance and substances of very high concern (SVHC), special packaging and labelling requirements. Product notification

2014/15

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training Legal 12% 1% IT & software 1%

Other 8% Consultancy/advisory 50%

Laboratory 2% Information 14% Representation & management 12%

Notification of products and articles pursuant to Art. 45 of CLP, the German detergents and cleaning agents Act (WMRG) and product notification in all European countries, Turkey, the US and many other countries. REACH KFT Chemieservice has been working with REACH since 2001. Since that time we have prepared a number of companies for REACH, devised practical solutions by deploying task forces, and have carried out approximately 4,300 pre-registrations for our customers. We offer you: OO only representative services pursuant to article 8 (REACH); OO registrations according to article 10/11 and 18/19; and OO preparations of I dossiers and CSR (chemical safety reports). Our REACH and management services cover: OO impact analysis, strategic and operative REACH consulting, portfolio as well as supply chain communication consultation. Our Sief management provides: OO project management, financial processing and settlement, trustee services, conducting studies and organisation of data sharing, communication with customers, authorities and competitors. Biocide substances With an experienced team we handle registrations of biocide substances, coordinate study generation, prepare the dossiers and do the authority management. Seminars,training and coaching

SERVICES PROVIDED Safety data sheets Generation of safety data sheets (SDS) worldwide in accordance with GHS. SDS are generated according to national implementation of GHS and supplemented by country-specific requirements. Examples for countries and regions are EU, Switzerland, Canada, US, all of Asia, South America and South Africa. We generate SDS in all EU languages, also in Russian, Thai, Malay, and Mandarin Chinese. We also support specific national certifications as required in Turkey. A comprehensive concept of SDS maintenance Page 128

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 and biocides. The available selection can be found at www.kft-academy.com In-house training and customised coaching are available on demand at sales@kft.de. Monthly webinars can be accessed free of charge. The launch of eBooks on legal aspects around compliance has started 2013.

Chemical Watch | Global Service Providers Guide 2016

ordinance on detergents; cosmetics regulations; biocide regulations; environmental regulations; commodities regulations; transport law (hazardous materials) etc; and ultimately issues approval for marketing.

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 (GIZ).

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

According to Article 45 of the CLP Regulation, importers and/or downstream users must register with the responsible agencies in each country all products that are classified as dangerous mixtures according to the rules of the CLP Regulation. The requirements and registration process differ from country to country. We collate all the related documents for our clients and handle correspondence with the responsible agencies.

1995

Foundation of KFT Chemieservice in Rellingen, near Hamburg, Germany.

1996

First training for the generation of MSDS for Europe and US.

1998

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

2000

Relocation of the company to Griesheim, Germany.

2008

First only representative contract with Brazilian company.

2010

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

2010

Launch of KFT-ChemDoc24.de.

2011

First substances in articles notified.

2012

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

2013

Launch of KFT-EBook24.com with laws, regulations and guidance documents worldwide.

2014

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

2016

Co-operation with Lisam systems to market and implement ExESS software systems.

ACCREDITATIONS VCH (association of chemical suppliers) subsidiary of FECC (European Association of Chemical Distributors) Member of ENES (European network on exposure scenarios) Member of SCHC (Society for Chemical hazard Communication) PARTNERS Tradas Translations and Consulting Services Laus GmbH (GLP certified testing laboratory) Chemtrec/GIZ Nord (Security number services) KTR Europe GmbH (China and Korea New Chemical Substance Notification Service) LISAM Deutschland GmbH (ExESS chemical compliance software solution) 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: Marketability study 1 Consumer goods providers must take many legal stipulations into consideration. Particular attention is paid to hazardous materials and hazardous cargo. Usually, these providers are distributors and not manufacturers of the products. Therefore, a few traders have established a partnership with KFT Chemieservice GmbH, in order to verify product compliance. Together with the tender, suppliers of the consumer goods providers are asked to submit a confirmation from KFT Chemieservice GmbH that all documents and labels conform to legal regulations. KFT Chemieservice checks the requirements and legal conformity with regard to: OO chemical legislation;

Chemical Watch | Global Service Providers Guide 2016

OO OO OO OO OO

CASE STUDY 2: Marketability study 2

CASE STUDY 3: REACH lead registrant support Our strength is the support of the medium-sized industry, whose core competence does not lie within the production or handling of chemical products. The REACH requirements are particularly problematic here. KFT Chemieservice verifies the requirements. If there is no lead registrant or Sief facilitator appointed for strategic products, we evaluate the registration capacity of the material by our customers, check the competition situation and identify possible co-registrants. After a positive economic evaluation by our customer, we facilitate the registration of the material. Thus, we cover all steps of the process. We perform the Sief survey with the available data in consideration of the interests of other Sief participants, find the existing data and data gaps, undertake negotiations with data keepers and contract testing labs to close the data gaps. We create the Iuclid file and the CSR and take care of registration with the Echa. As a result of this, the client receives the registration number. KFT markets the letter of access to other registrants. As an additional service, we create the safety data sheets with appendix (exposure scenarios) in all EU languages. We provide one-stop service for the client. STAFF SELECTION Dr Karl-Franz Torges (PhD) – Managing Partner Dr Karl-Franz Torges is founder and managing partner of KFT Chemieservice GmbH, heading the business unit REACH and registrations. Familiar with hazardous materials, hazardous goods, MSDS and registrations since 1989. Several years experience in working with software companies focusing on compliance software (SAP EH&S). Since 2001 instrumental participation for the development of software tools for REACH processes. Member of Cefic and VCI working groups. Consulting for the development of Iuclid 5.0. Consulting and training projects and workshops for hazardous materials management, registrations, and chemical compliance. Angelika Torges – Member of the board Board member and heading the division hazardous materials, marketability study and MSDS. Experience and responsibilities in these segments since 1989. Certified dangerous goods officer for several companies. Expertise in toxicology, ecotoxicology, chemical compliance ie. for washing and cleaning agents and has expert certificate for §5 of Restriction Ordinance on Chemicals. Other staff Majority of staff are PhD chemists, biologists and experts in food technology with years of experience for material registrations and MSDS. In-house training is a strong focus and sustainable external training is obligatory.

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PROFILE: KFT Chemieservice GmbH

Emergency numbers

GLOBAL OFFICES Belgium, Brazil, Canada, France, Germany, India, Romania, Singapore, Turkey, UK, US SERVICES PROVIDED Regulatory advisory services

PROFILE: Lisam Systems

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, Brazil, Canada, China, France, Germany, India, Japan, Korea, Romania, Singapore, Turkey, UK, US

Founded

1999

OVERVIEW Founded in 1999, Lisam Systems is a global provider of Environmental, Health and Safety (EH&S) compliance management software solutions and services, operating from offices worldwide. By combining an easyto-use, flexible technology built on the Microsoft .NET platform, with the latest regulatory content, Lisam brings innovative, affordable and timely solutions to solve EH&S challenges faced by manufacturers, distributors and users of chemical products. Working with industry associations and partners, Lisam has developed, proprietary, vertical EH&S solutions for the chemical, specialty chemical, cosmetics, aromas and flavourings, detergents, paints, coverings, coatings, plastics and energy industries. Today, more than 800 clients 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 50 languages. VITAL STATISTICS

2014/15

Turnover, group

€11m

Turnover, chemical service provision

€11m

No of offices

No of countries represented

Staff, group

113

Staff, chemical service provision

107

SERVICE AREA BREAKDOWN Training 5%

IT & software 65%

Page 130

Consultancy/advisory 18% Representation & management 2% Information 10%

Lisam Services (Telegis) is the regulatory expertise department of Lisam Systems, partner of the chemical industry in regulations on health, safety and environment for 20 years. With pragmatic knowledge and experience they will guide you in making strategic decisions and bring support in the following areas: OO safety data sheets: issue of quality SDSs in compliance with REACH and other regulations specific to your activities; OO exposure scenarios authoring: preparation and translation of exposure scenarios in the latest standard format; OO consultancy and regulatory studies: compliance projects on REACH, GHS, CLP, (e)SDS, dangerous goods transport, notifications of hazardous substances, biocides … including preparation of chemicals’ dossiers; OO regulatory monitoring and watch, general and on-demand; OO biocides: declaration of biocidal products and quantities, composition validation, monitoring of studies and environmental fate assessment, request for market authorisation, inclusion on list of authorised active substances, labels; OO hazard assessment by in silico methods: predictive evaluation of substance properties and hazards with computer models to guarantee cost and time savings compared to in vitro and in vivo studies; OO REACH only representative: REACH obligations for non-EU manufacturers; and OO REACH third party representative: Lisam acts in your name for data submission, data sharing and cost sharing discussions, while your identity remains confidential. Our regulatory department also includes IT experts to advise you on the most adequate IT environment, install Lisam Systems’ EH&S modules, train your teams and support you with change requests and incidents. ExESS® EH&S Packages ExESS EH&S applications are easy to use and flexible to configure. The system provides a powerful, open strategy for integrating with customer and third-party content. It allows for real-time API integration with a broad range of enterprise systems, and batch integration with built-in integration tools: OO SDS and labels authoring and distribution: user-friendly, comprehensive and globally compliant solution for authoring and distribution of safety data sheets and labels, installed on single workstations, over worldwide corporate networks or accessed and used via the cloud; OO chemical management: efficient and effective management of all materials information relating to regulatory compliance, hazard communication, environmental reporting and inventory management. OO 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; OO substance volume tracking: simplification and automation of regulatory volume tracking and reporting, for EU REACH (including SVHC), US inventory update reporting and chemical data reporting, and Japan Chemical Substance Control Law; OO regulatory content: cost effective, integrated regulatory content such as OEL lists, EU GHS and REACH libraries, US state/federal lists, and choice of fully integrated third-party regional libraries, including BIG for EU, JCDB for Japan, SRICI for China, or ChemADVISOR’s LOLI® for global content; and OO more solutions for waste management, risk assessment, detergents, fragrances, cosmetics, gas…

Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 1: Gas industry centralised SDS/label software

Our services are proposed in several languages: OO regulatory trainings: REACH, GHS, CLP, Iuclid, (e)SDS…; 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.

Context: OO multiple tools used for SDS and labels authoring; OO some subsidiaries using the same tool, but with different approach; OO some subsidiaries sharing a centralised database whilst others use independent ones; OO no synergy, SDS and labels layouts all different, no efficient working way. Achievements: OO unification of the software’s patchwork under Lisam ExESS®; OO central unique database for all subsidiaries; OO limited migration of data: interface ExESS® with ERP/lab software; OO work done by one is benefiting to all; OO one corporate standard for all compliance documents.

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

Lisam Services has been supporting successfully global actors in cosmetics, commodities, fine chemicals, stationary etc with their: OO ingredients, raw materials and products compliancy under REACH OO under other regional regulations; OO early regulatory qualification processes; OO preparation and submission of inquiries as well as individual and joint REACH registration dossiers; OO creation of thousands of (e)SDSs, meeting different regional GHS implementations.

2012

Lisam UK opens in Hartlepool

2013

Lisam Canada opens in Montréal, Québec

STAFF SELECTION

2014

Lisam Deutschland opens in Berlin

2014

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

2015

Lisam opens offices in Turkey, Romania and Brazil

2016

Singapore branch for APAC region is open

ACCREDITATIONS REACH Ready certification Full member of ORO (REACH Only Representative Organisation) EIGA preferred solution Microsoft Gold Partner CLIENTS With premises and partners around the globe, Lisam applications and regulatory advisory services are adopted by more than 800 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.

Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 2: Global regulatory success stories

Michel Hemberg, CEO Michel is a founder and majority owner of Lisam Systems. Since June 2012, Michel took over the CEO position, managing the global expansion of the company. Michel got a civil engineer degree in 1986 and worked for 25 years as IBM mainframe consultant in the financial market. Dirk Stevens, R&D Director Dirk is head of the ExESS R&D development at Lisam systems. He got a civil engineer degree in 1985 and has more than 20 years’ experience in software engineering, consultancy and product management in EH&S. Maxime Juste, Ch.E., Head of Delivery and Support Maxime got a civil engineer degree in chemistry and is head of delivery and Support. He has experience in the management and distribution of SDS/Label as well as data and product management in the EH&S domain. Since 2010, he is account manager for the gas sector, represented in the association EIGA, and is active in other industrial associations. Françoise Saint-Romain, Managing Partner Lisam Service Telegis After working in industry then in continued training, Françoise has created and developed a wide regulatory affairs competence centre over 20 years. She is acting as auditor of ORO (REACH Only Representative Organisation) and is cultivating the synergy between the ExESS EHS software and her regulatory consultancy activities. Magaly Courtois, Senior Consultant (e)SDS authoring & CLP With 16+ years’ experience in chemicals’ compliance, Magaly is expert in the development of safety data sheets and GHS/CLP classification and labelling questions. She has prepared and submitted registration dossiers at an early stage of REACH, and is an experienced Iuclid trainer. Aude Carton, Senior Consultant Regulatory dossiers Together with strategic advice, Aude is providing her pharmacy and toxicology skills for five years. From test monitoring and label or technical document drafting, to final product compliancy, Aude’s unique blend of scientific, regulatory and business knowledge is supporting our customers in meeting the necessary regulatory requirements in Europe (REACH, biocides) and abroad (Australia, Canada,…). Page 131

PROFILE: Lisam Systems

Training, services and support

PROFILE: National Chemical Emergency Centre (NCEC)

SERVICES PROVIDED Emergency response

Website

www.the-ncec.com

E-mail

ncec@ricardo.com

Head office

Ricardo plc

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

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; OO dedicated telephone numbers with over 40 local lines globally; OO worldwide multilingual support in over 37 languages; OO liability protection five times contract value; OO global compliance, including China through our partnership with the National Registration Centre for Chemicals (NRCC); and OO crisis notification to help companies fulfil their duty of care and ensure timely response throughout their crisis system.

Tel

+44 (0) 1235 753654

Software

Fax

+44 (0) 1235 753656

Contact

ncec@ricardo.com

Directors

Jonathan Gibbard

Locations

Founded

1973

Chemdata® – provides instant access to clear and concise chemical hazard information on more than 50,000 substances and is used by all UK and most Australian fire services. Pocket Chemdata® – for handheld devices, running Windows Mobile, Android and iOS operating systems. ChemeDox® – document management system, with functionality for COSHH compliance and distribution.

CONTACTS

OVERVIEW For over 40 years the UK’s 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 risk and crisis management training; OO chemical handling and regulatory compliance support; and OO REACH consultancy, crisis notification and SDS authoring. VITAL STATISTICS

2014/15

Turnover, group

£257.5m

Turnover, chemical service provision

£5m

No. of offices

> 30

No. of countries represented

Staff, group

>2,700

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 10% IT & software 10%

Consultancy/advisory 20%

Information 10% Representation & management 50%

GLOBAL OFFICES UK, China, Czech Republic, Denmark, Germany, Hong Kong, India, Italy, Japan, Korea, Malaysia, Russia, Spain, The Netherlands, US

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SDS services SDS authoring services and management software – keeping your safety data sheets legal and compliant with REACH and GHS. ChemeDox® – document management system, with functionality for COSHH compliance and distribution. Training NCEC provides online and on-location 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; OO first aid for chemical exposure; OO implementing a high end crisis management system; and OO exercises to develop, implement and embed capacity for crisis readiness. Consultancy Classification, labelling and advice on chemical safety legislation and risk management REACH and GHS services REACH Glossary of terms and abbreviations. Dangerous Goods Safety Advisor (DGSA) services – including site audits, preparation of annual report and post-incident reporting CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1973 NCEC established by UK government 1974 Launch of Chemsafe provides essential chemical emergency response to UK fire, police and ambulance services 1980 NCEC begins supporting private sector clients with emergency response services 1983 Chemdata emergency response software launched for emergency responders around the globe 1997 Launch of safety data sheet (SDS) consultancy 2000 Carechem 24 hour service offered to international clients 2008 NCEC holds first annual Hazmat Conference 2012 NCEC receives over 4,500 calls per year 2013 Emergency telephone system upgraded to increase capacity for global clients 2014 Crisis management services launched, NCEC receives 7,000 calls a year Chemical Watch | Global Service Providers Guide 2016

NCEC hosts Global Chemical Congress (GCC) conference NCEC expands emergency response and support teams NCEC signs MOU with American Response Centres to help share emergency response best practice NCEC invited to help author new National Operational Guidance on Hazmat response for the UK Fire and Rescue Services

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 OO ISO 14001: 2004 Training OO Training courses are accredited by the Royal Society of Chemistry PARTNERS NCEC is part of Ricardo plc, as well as: OO REACH Consultant Network; OO Global Chemical Consultants Network; and OO supported by the Department for Transport (DfT) and the Chemical Industries Association (CIA). 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. CLIENTS NCEC’s clients include governments, trade associations and over 800 industrial customers. We take client confidentiality seriously and only discuss individual relationships with expressed permission. TESTIMONIALS “We reviewed a number of options for the provision of emergency numbers and customer call handling. 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 “Carechem 24, like all the services provided by the National Chemical Emergency Centre, is a robust solution for people working with dangerous goods, be they consignors, consignees, transport and warehousing operations, whether they use road, rail, air or sea traffic. 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 Carechem 24 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. 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 delivers agrochemical solutions to customers across industry, while maintaining a commitment to environmental protection and social responsibility. BASF originally managed its emergency telephone and chemical response requirements internally, but decided to appoint a partner after

Chemical Watch | Global Service Providers Guide 2016

an internal audit revealed that they were unable to meet the Cefic best practice guidelines of a ten-minute response. Solution: BASF selected NCEC’s emergency response service to help meet its commitment to customer safety and comply with industry regulations for the transport of dangerous goods. The NCEC solution includes dedicated emergency telephone 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 centre 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. The hospital had copies of the necessary safety data sheets (SDS), but required more detailed chemical insight in devising a treatment plan. On contacting the poison centre, however, staff found that the necessary information was not available. They then contacted the NCEC. 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 had been exposed to and prepare a suitable medical response which 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. STAFF SELECTION Jon Gibbard - Practice Director Dan Haggarty – Head of Emergency Response Lynn Aitken – Customer Service Manager Bethan Davies – Chemsafe Maria Stearn – Chemdata Chris Sowden – SDS Authoring Manager Mike Kent – SDS Management – ChemeDox Caroline Raine – Business Area Manager – Regulatory Consultancy Simon Jones – Training Manager Stephen Walker – DGSA Manager (supported by three other DGSA qualified staff) Chris Lewis – Crisis Management

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PROFILE: National Chemical Emergency Centre (NCEC)

2015

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

PROFILE: Ramboll Environ

CONTACTS

SERVICES PROVIDED

Website

www.ramboll-environ.com

E-mail

sbullock@ramboll.com

Head office

Artillery House, 11-19 Artillery Row, London, SW1P 1RT, UK

Tel/ Fax

+44 20 7808 1420

Contact

Sue Bullock

Directors

137 partners worldwide including: Sue Bullock (UK) Dr Martina Vosteen (DE) Dr Bob De Mott (US) Dr Salvatore Giolando (US)

Ownership

Private limited company

Locations

124 offices worldwide

Founded

1982

Risk management, strategic support and regulatory compliance (REACH, CLP, biocides, PPP, cosmetics, food contact materials) Ramboll Environ works in partnership with clients to develop and support product regulatory compliance strategies and prepare robust technical dossiers and risk assessments for substances in industrial, agricultural, biocidal and consumer applications. We balance clients’ technical, regulatory and commercial interests through sound science and strategy; clients trust us with their most critical problems. We provide strategic, scientific and regulatory support for substances targeted for substitution including impact assessment, applications for authorisation under REACH and supply chain management and audit of product regulatory compliance systems. We support communication with the EC, Echa and MSCA, and development of policy, regulation and guidance. Ramboll Environ also acts as consortium manager and only representative, and is independent from testing facilities. Global chemical notifications and regulatory compliance support

OVERVIEW Ramboll Environ is the environment and health business of leading global engineering, design and consultancy company Ramboll, formed by the integration of Ramboll’s environment and health specialists with independent environment, health, safety and sustainability consultancy ENVIRON at the end of 2014. Together we address some of the most important issues facing our global community, including the environmental and health implications of urbanisation, climate change and resource scarcity. Our global team helps companies gain regulatory approval for products to comply with chemical regulations around the world. We help industry leaders and innovators engage with policy makers and regulators, and provide effective product stewardship programmes to manage risk, reduce liability and enhance support from stakeholders. At the leading edge of science, we deliver thoughtful and innovative solutions in product safety. Clients around the world benefit from our unique ability to bring clarity to issues at the intersection of science, business and policy. We provide a single point of support for chemical regulation and risk management. VITAL STATISTICS

2014/15

Turnover, group (2015)

$376m

Turnover, chemical service provision No of offices

124

No of countries represented

Staff, group

2,100

Staff, chemical service provision (dedicated)

SERVICE AREA BREAKDOWN

Representation & management 10%

Ramboll Environ evaluates obligations and provides support for regulatory approvals required to market products across Asia Pacific, America, Europe and Africa. We assess new market opportunities, substance notification and regulatory obligations, classification and labelling (GHS) and packaging. Our established global network covers Argentina, Australia, Brazil, California, Canada, China, Europe, India, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Philippines, Russia, Singapore, South Africa, Switzerland, Taiwan, Turkey and the US. 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 toxicokinetic modelling) OO Epidemiology OO Exposure modelling, measurement and reconstruction OO Risk assessment and mitigation OO Ecotoxicology OO Environmental fate OO Chemistry OO Occupational health OO Regulatory affairs OO Supply chain and stakeholder management OO Product vigilance OO Advocacy We are ideally placed to advise clients on problems across the spectrum of product safety and stewardship including product substitution and sustainable chemistry. We couple internationally recognised expertise and a reputation as a leader in risk management with client-focused solutions. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Laboratory 5%

Consultancy/advisory 85%

1982

Environ founded in Washington, DC, USA

2010

Chemical Industry Association (CIA) REACH service provider of the year

2014

Ramboll Environ formed by the integration of Ramboll’s environment and health specialists with ENVIRON.

CLIENTS Clients span all industrial sectors including industrial and specialty chemicals, petrochemicals, agrochemicals, food and food packaging, cosmetics, medical devices, electronics, manufacturing, aerospace and defence, apparel and consumer products. Page 134

Chemical Watch | Global Service Providers Guide 2016

TESTIMONIALS

CASE STUDY 7: Proposal to re-classify as CMR

“We are working with ENVIRON 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, manager, global product safety, SASOL. “Environ has been, and is, an essential element in the success of our ongoing REACH programme. Their seamless integration into our team and systems creates an unprecedented collaboration that enables high quality, cost effective and timely solutions. Our dossiers have been consistently ahead of schedule and have been fully satisfactory when reviewed by the competent authorities. Environ'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 ENVIRON in the first place this whole process would have been so much cleaner and easier. Thank you for all of your hard work on this and in the short time frame requested” – Michelle T Quinn, associate general counsel, regulatory affairs and general litigation, Catalent Pharma Solutions.

An industry association asked Ramboll Environ to review all available and relevant evidence in order to comment on the basis and technical merits of EC proposals to re-classify the substance as a carcinogen.

Prepared comprehensive REACH dossiers and CSRs for a group of high profile hazardous organic substances with potential endocrine disrupting properties. Used, measured and modelled data and innovative methods to characterise chemical fate, exposure and effects on humans and the aquatic environment and elaborate well-defined, practical and safe exposure scenarios. CASE STUDY 2: Application for authorisation under REACH Prepared and submitted one of the first applications for authorisation under REACH on behalf of an aerospace/defence sector client. The dossier provided necessary evidence to support the continued use, beyond the sunset date, of two substances in specialist applications. The application received a positive recommendation from the RAC and SEAC. Concomitantly, Ramboll Environ is preparing highly complex applications for authorisation of several chromates, covering the interests of various industry sector groups. CASE STUDY 3: Advocacy for SVHC under REACH Provided strategic and scientific support to help industry develop and justify to policy makers a more credible, yet effective, risk management option for a chemical than phasing out its use under REACH. Supported a programme of direct engagement with key stakeholders to communicate concerns regarding proposals and inform the policy development. CASE STUDY 4: Assured global compliance of new product Advised on regulatory obligations in more than 50 countries, considering chemical notification, packaging and labelling requirements, for a company wishing to market a new consumer product globally. The process allowed prioritisation of key market opportunities, substitution of one constituent and modification of marketing claims. CASE STUDY 5: Comprehensive exposure assessment Detectable levels of perfluorooctanoate (PFO) have been measured in the blood of the general population. Our expert team evaluated exposure to PFO from certain articles (eg treated carpets, clothing, upholstery and cookware) in the consumer environment for a multinational client, as a critical component of its product stewardship programme. The findings provided a strong basis for communication with external parties including regulators. CASE STUDY 6: Regulatory action related to product contamination A food packaging producer faced numerous challenges when residual levels of a potential carcinogen were unexpectedly found in a key product. We showed that consumer exposure to the contaminant from handling the packaging and ingesting the packaged foods was within safe levels, avoiding regulatory action. The work also informed decisions regarding product viability, consumer perception and communications. Chemical Watch | Global Service Providers Guide 2016

Sue Bullock – Principal, product safety and stewardship Leading Ramboll Environ’s Product Safety and Stewardship services, for over 20 years Sue has provided strategic, regulatory and technical assistance to industry relating to chemical policy and presence of chemicals in the environment, the workplace and consumer products. Dr Martina Vosteen – Principal, chemist and product safety Martina has over 15 years’ experience as a consulting chemist. She is experienced in product related regulatory support including registration of and authorisation applications for chemicals, biocides and cosmetics. Dr Joe Rodricks – Principal, toxicologist Joe is an internationally recognised expert in the field of toxicology and risk analysis in chemical regulation, management and stewardship. Juliana Ding – Managing Director, Asia Juliana has over 20 years’ experience in environmental and health consultancy, particularly regulatory advice, health, safety and environmental assessments, product stewardship and supply chain management. Dr Salvatore Giolando – Principal, product safety and stewardship Salvadore has more than 28 years’ experience directing product stewardship programmes for global supply chains and chemical products and is a leading expert on EU REACH and REACH implementation. Dr Camilla Pease – Senior Manager, toxicologist Camilla has 20 years’ experience in chemical toxicology and advises on safety and risk assessment of consumer products including cosmetics. Her expertise includes skin toxicology, human metabolism and bioavailability, mechanistic toxicology and alternatives to animal testing. Mike Padgham – Senior Manager, regulatory affairs Mike is a chemist and toxicologist with 30 years’ experience working in regulatory affairs and toxicology, providing strategic, regulatory and technical support to industry in the area of chemical registration, including REACH. Thomas Birk – Senior Manager, exposure assessor Thomas Birk is an epidemiologist, with more than 20 years’ experience and expertise in the areas of occupational and environmental health, exposure assessment and exposure reconstruction. Dr Thomas Rücker – Senior Manager, toxicologist Thomas Rücker has more than 15 years’ experience in biochemistry and toxicology consulting including the hazard and risk assessment of chemicals, and strategic and regulatory support for products under REACH and related legislation. Dr Thomas Sendor – Manager, ecotoxicologist Thomas Sendor is a biologist with ten years’ experience in regulatory support for chemicals regulated under the biocidal products regulation, REACH and the plant protection products pegulation, specialising in risk assessment of chemical substances. Samantha Deacon – Manager, ecotoxicologist Samantha Deacon is an ecotoxicologist with 20 years’ experience in environmental regulation, consultancy and research in the assessment of chemicals in the environment, particularly agricultural products. Dr Gavin Thompson – Principal Dr Gavin Thompson has more than 20 years of experience advising manufacturers, marketers and industry associations on characterising chemical exposures to humans from consumer products, food, food processing and packaging, household items and environmental media. Page 135

PROFILE: Ramboll Environ

CASE STUDY 1: REACH registration and evaluation

STAFF SELECTION

SERVICES PROVIDED REACH services OO OO OO

PROFILE: REACh ChemAdvice GmbH

CONTACTS

Website

www.reach-chemadvice.com

E-mail

info@reach-chemadvice.com

Head office

Am Marktplatz 5, D-65779 Kelkheim / Taunus, Germany

Tel/ Fax

+49 6195 96 199 0/ +49 6195 96 199 33

Contact

Dr Rudolf Staab

Directors

Dr Rudolf Staab, Managing Partner

Ownership

Privately owned company

Locations

Germany, USA, India, Portugal, Sweden, China

Founded

2007

OO OO OO OO

OO OO OO OO OO

OVERVIEW

REACh ChemAdvice GmbH is a sister company of ChemAdvice GmbH. It was formed by a group of senior executives with many decades of experience in the chemical industry, in collaboration with a team of REACH specialists. Originally founded to help Non-EU manufacturers to comply with the REACH legislation as only representative, the company meanwhile supports EU manufacturers and importers as consultant and/ or as third party representative and downstream users as consultant in all REACH matters. Unlike most advisers, we offer the complete scope of REACH related services in-house and through our network. We also support manufacturers, importers, distributors and users of chemicals on the implementation of CLP and BPR (biocidal products Regulation). Our services for non-EU manufacturers include also EU Representative for Article 95 of the biocidal products Regulation. VITAL STATISTICS

2014/15

Turnover, group

c â&#x201A;Ź1.5m

Turnover, chemical service provision

c â&#x201A;Ź1.5m

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

OO OO OO OO OO OO

CLP services OO OO OO OO OO OO

OO OO

Other 5% OO OO OO

Information 20%

Consultancy/advisory 60% Representation & management 5%

identification of obligations under the CLP Regulation implementation of strategy for CLP compliance CLP workshops and customised training CLP due diligence project management classification and reclassification of substances and mixtures in accordance with the CLP Regulation safety data sheets (SDS) authoring and review CLP notifications dossiers / CLP-group notifications dossiers

Biocides services OO

SERVICE AREA BREAKDOWN

Training 10%

identification of obligations under the REACH Regulation implementation of strategy for REACH compliance only representative (Art.8 of the REACH Regulation) third party representative (Art.4 of the REACH Regulation) late pre-registration Sief communication management import certificates for REACH compliance creation and submission of Iuclid dossiers (registration, inquiry, PPORD notification, authorisation, substance in articles notification, downstream user report) to Echa in REACH-IT consortia management / consortia representation toxicological evaluation / studies / tests / reports SVHC inventory and monitoring SVHC testing and screening creation of chemical safety reports (CSR) strategy development for the registration REACH and Iuclid workshops customised training REACH due diligence data gap analysis project management support on the purchase of letters of access audits to suppliers concerning REACH compliance audits / REACH compliance verification (preparation for inspections) creation and review of REACH-compliant SDS/ e-SDS (safety data sheets) in all EU-member states languages analysis of exposure scenarios and implementation of risk management measures

OO OO

identification of obligations under the BPR implementation of strategy for BPR compliance preparation of Iuclid dossiers (approval of active substances and authorisation of biocidal products) and submission in the R4BP EU representative for Article 95 support on the purchase of letters of access data gap analysis studies / tests / reports (physicochemical properties, efficacy, environmental fate, ecotoxicology and toxicology) risk assessments liaison with authorities and post-submission support classification and labelling of biocides according to the DSD/DPD and CLP creation and review of compliant safety data sheets BPR and Iuclid workshops

GLOBAL OFFICES

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

REACh ChemAdvice GmbH, Germany Regional offices: Portugal, Sweden, USA, India, China

2007

Start up in Frankfurt am Main, Germany

2007

Opening regional office in USA

2008

Opening regional office in India

2009

Relocation to new offices in Kelkheim/Taunus

2011

Opening regional office Sweden

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Chemical Watch | Global Service Providers Guide 2016

Expansion into the Iberian peninsula (Portugal and Spain)

2013

Start China REACH consultancy with the establishment of strategic partnership

2014

Start Korea REACH consultancy with the establishment of strategic partnership

2015

Start acting as Sales Representative of Telematic Safety Data Sheets Software Epy in Portugal and UK

ACCREDITATIONS REACH ChemAdvice GmbH is a member of ORO, the Only Representatives Organisation in Brussels and complies with the quality standards of this trade association. PARTNERS Our partners can be viewed on our website. CLIENTS Our clients are located in Europe, United States of America, Latin America, Africa, Middle East and Asia. TESTIMONIALS Testimonials or references will be provided upon individual request. CASE STUDY 1: REACH Only Representative The company started offering only representative services for NON-EU clients in 2007. We represent more than 100 companies with sizes ranging from SME to multinational firms. We also represent European clients as third party representatives and offer consultancy work under REACH. CASE STUDY 2: Consortia management We successfully managed consortia or represented our clients in consortia. We support our clients throughout the whole REACH registration process from registration strategy development, data generation, and dossier preparation to dossier submission. CASE STUDY 3: Biocides industry REACh ChemAdvice supports clients all over the EU with defining the best strategy for compliance with the BPR as well as preparing dossiers for article 95, technical equivalence and chemical similarity, active substance approval and biocidal products authorisation. STAFF SELECTION Dr Rudolf Staab – Managing Partner Dr Staab has held many senior jobs in the industry including: senior vice president Masterbatches Clariant International, responsible for the reorganisation and re-engineering of business processes and the introduction of new marketing approaches for key accounts. He was vice president additives within Hoechst AG and Clariant International and vice president specialty chemicals within Hoechst AG in charge of strategy development and implementation, business re-engineering, efficiency improvement activities and relocation efforts. He looked after the development of new markets and applications M&A transactions, and has been a member and chairman of the board of several companies within the chemical, food ingredients and plastic processing industry. He has an MSc in inorganic chemistry (Diplom-Chemiker – Saarbrücken, Germany, and a PhD in inorganic chemistry (Dr rer nat – Saarbrücken, Germany).

Chemical Watch | Global Service Providers Guide 2016

Carlos Fazendeiro – Director Regulatory Affairs, Regional Head Portugal Mr Fazendeiro has worked in regulatory compliance (CTR Lda, Portugal), and has considerable experience in classification, labelling and packaging of chemicals, safety data sheets and giving regulatory support to clients and business units (REACH, CLP and biocides). He has worked as a consultant (SGS Portugal SA) and on REACH implementation (mainly in the petrochemical industry), with extensive experience of pre-registrations and REACH registration dossiers. He worked as a regulatory officer at INFOTOX in Portugal where he dealt with administrative issues related to REACH, assessment of test data reliability under the biocidal products Directive and gave support to business development activities. With a master’s degree in industrial chemistry (University of Beira Interior, Portugal) he also has practical education and training on REACH, CLP/ GHS, the biocidal products Regulation, Iuclid, REACH-IT, R4BP and SDSs. Silvia Teige – Finance and Administration Ms Teige’s experience includes working as a management assistant at both ChemAdvice GmbH and to the head of regional business unit Europe, NME, Africa, Clariant Masterbatches. She has been executive assistant to head of division pigments and additives, Clariant, and executive assistant to head of business unit additives, Hoechst AG and Clariant, fulfilling the same role to the head of division chemicals, Hoechst AG. Dr Sebastian Hoffmann – Scientific Consultant Dr Hoffman has extensive experience as a REACH consultant (TÜV Rheinland BioTech GmbH), as well as project management and scientific consulting and hazard and risk assessment. He is an expert on human health hazards and in vitro toxicological methods, having worked as a scientific officer at the European Commission’s Joint Research Centre in Italy). His speciality is assessment (validation) of in vitro test methods and management of scientific projects. He is qualified to assess data reliability and relevance, and has 25 peer reviewed publications to his name. Jim DeLisi – Regional Head, North America Jim DeLisi is a president of Fanwood Chemical, Inc, where he looks after the sale of organic intermediates in North America, South America and Europe, as well as tariff and trade affairs, monitoring of imports and exports and REACH. He has been chairman of Socma’s International Trade Committee, and chairman of the Industry Trade Advisory Committee on Chemicals, Pharmaceuticals, Health/Science Products and Services. He has a BA in business administration (Rutgers College, USA), and an MBA in chemical marketing (Fairleigh Dickinson, USA). Barbara Fertl – Regional Head, Sweden Barbara Fertl has extensive experience having worked at: the Institute for Physical Biochemistry, Munich; Munich Municipal Hospital Group; Linde AG, Munich; DQS Deutsche Gesellschaft zur Zertifizierung von Managementsystemen, Frankfurt; Sasol, Hamburg. She has been a chemical consultant for Kemikalierådgivare in Sweden and has experience of safety data sheets, registrations, national and international regulations on chemicals Ms Fertl has an MSc in biology (Diplom-Biologin, Ludwig-MaximiliansUniversity, Munich, Germany), and is a certified auditor for quality management systems.

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PROFILE: REACh ChemAdvice GmbH

2012

markets. Our business development experts will support companies with the most effective advice, in compliance with the provisions of the regulation. OO Implementation of IT systems for chemical management Companies will internally develop new management systems to integrate existing tools to monitor the presence of chemical substances, including deadlines, total amounts, risk management measures etc. REACH services

PROFILE: REACH master y

CONTACTS Website

www.reachmastery.com

E-mail

info@reachmastery.com

Head office

Via Giovio 16, 22100 Como, Italy

Tel

+39 031 269513

Contact

monicalocatelli@reachmastery.com

Directors

Monica Locatelli

Ownership

Private company

Locations

Italy

Founded

2008

OVERVIEW REACH mastery is a provider of a wide range of services in the area of chemical regulatory affairs. The staff are a highly motivated team, skilled in different scientific areas: chemistry, biology, human health and environmental toxicology. Our commitment is to assist clients along the supply chain with our industrial experience and to help them in the cost efficient implementation of the European regulations. Our mission is to look for innovative solutions and to develop strategies using, when applicable, alternatives to animal testing like in vitro and in silico methods, through the high quality of our services and the expert support. VITAL STATISTICS

2015/16

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training Legal 5% Other 1% 2% Information 2% Representation & management 15%

Consultancy/advisory 75%

SERVICES PROVIDED General consulting services Supply chain communication Importers and manufacturers, downstream users and manufacturers/ importers of article, are all responsible for the effective communication flow of information. We provide all the necessary support by distributing standard templates or customised forms to properly manage the communication flow between customers and suppliers. OO Chemical management and product stewardship The market will constantly evolve over time. Companies will face new challenges to strategically select secure suppliers and to identify growing sector OO

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Consortia management A lot of experience has been gained on consortia rules and management. We provide also legal advice, agreement documents, meeting location, cost calculation, managing of LoAs. OO Data gap analysis and data collection Gathering existing information is the first step in the preparation of any registration dossier, but is not enough. All these data have to be really collected, in respect to the right to use. The latter requires the negotiation of the conditions for use according also to the quality of the data. Each single study is evaluated and rated to check relevance and adequacy to fill the requirements. OO Testing strategy development, in vitro strategies development, Qsar modelling, read across evaluation. An integrated testing strategy is the first step for cost reduction and building rationale for waiving. International well known partners are helping us in focusing on the right choice. The expertise in Qsar modelling (OECD Toolbox, VEGA, customised models) has been often successful in discussion with the national authorities and scientific working groups OO Managing of analytical identification and inquiry dossiers Our great expertise in analytics and experience in enquiries let us face without problems one of the most critical aspect of REACH regulation. OO PPORD dossier REACH mastery can assist in the preparation of PPORD dossiers OO Test monitoring In case new tests are required, REACH mastery will take care of selecting the most appropriate lab, will review the protocol and check the results. OO Dossier preparation (Iuclid compilation) Dedicated experts are managing Iuclid compilation and informatics tools for submission (REACH-IT). OO Human health and environmental risk assessment The focused experience and the support of high experienced toxicologists let us make of the risk assessment the core part of the developing registration dossier. OO Exposure modelling Exposure modelling can be performed with most of the recognised official tools like EUSES, Ecetoc TRA, EASY TRA, ART, CONS EXPO, RISKofDERM OO CSA-CSR REACH mastery is part of the consultation group of Chesar in Echa. We followed the development of the tool since the beginning and we are among the first experts in Europe to use it. The tool is also used to develop translated exposure scenarios and extended safety data sheets OO Authorisation dossiers REACH mastery acquired the expertise to develop authorisation dossiers complete with analysis of alternatives and socio-economic analysis OO CLH dossiers REACH mastery can prepare CLH dossiers for re-classification on behalf of industry to be discussed and presented to the member states authorities and within the Member State Commettee OO

CLP/GHS services OO OO OO OO OO

Data collection and assessment of classification and labelling CLP notification MSDS compilation Extended safety data sheets Exposure scenarios scaling and translation

Chemical Watch | Global Service Providers Guide 2016

OO OO OO OO OO

Full dossier preparation for active substances and placing a biocidal product in the market Testing strategy development Study monitoring Risk assessment Finalisation and discussion with national and EU authorities. Post-submission support

PHARMA services OO

OO OO OO OO OO OO OO OO

REACH mastery offer assistance in drug development from discovery to registration. We have competence in the toxicology review for new chemical entities Review of toxicological in new drug discovery (new chemical entities) Contracting and monitoring of new tests Human health risk assessment Environmental risk assessment Dossier strategy evaluation Authorisation process and dossier Determination of the PDE (permitted daily exposure) Assessment of mutagenic impurities

FEED and FOOD registration OO OO OO OO

Dossier preparation Risk assessment Test monitoring Assistance to customer for Efsa calls for data

EU cosmetic directive OO OO OO OO OO OO OO OO

Regulatory compliance support Product notifications Assistance in GMP certification Cosmetics ingredient profiles Product information files Clinical studies: design and monitoring Cosmetic product safety reports Product labelling review and support

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2008

Foundation of REACH mastery within HBJ consultancy group

2010

About 120 successful registrations for the 2010 deadline

2012

Implementation of the group to broaden the regulatory area to biocides and plant protection products

2013

Implementation of the group to finalise 2013 deadline registrations.

2014

Preparation and submission of the first application for authorisation

2015

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

PARTNERS RTC, Qsar group of Bicocca University, Vitroscreen, REACH & Colours, CAAT Europe as preferred cooperations. CLIENTS We are working for about 100 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.

Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 1: TIER 3 REACH registration The group has proved itself as one of the most professionally prepared in the European scenario to manage all different aspects of a REACH dossier. REACH mastery prepared about 20 lead dossiers for the 2013 second Tier registration, many of them with a full study plan ordered and monitored, 40 intermediate dossiers and actually about 40 joint registrations. UVCBs and difficult substances are the main specialisation area. The group has gained a great expertise in substance identification and difficult inquiries and is timely preparing his customers to the 2018 Tier 3 Registration with over 100 lead dossiers. CASE STUDY 2: Family dossiers for biocidal products During 2015 REACH mastery discussed and prepared and submitted a number of family dossiers for biocidal products, as the first experience in Italy under the new Regulation. CASE STUDY 3: Substance evaluation With the implementation of the Corap and the number of Echa compliance check, a number of dossiers need to be re-evaluated, discussed and improved from the first submission of 2010. REACH mastery has been chosen to improve the exposure scenarios, read across justifications, and the overall quality of the existing dossiers. STAFF SELECTION Dr ssa Monica Locatelli – Founder and Director After a degree in chemistry, ten years in R&D and a specialisation in toxicology applied to risk assessment, she has been working in regulatory and implementation of REACH regulation since 2001, when it was still a proposal. The co-operation with many specialists within international companies and universities let her specialise in consortia management and dossier preparation. Dr ssa Costanza Rovida – REACH Regulatory Specialist Graduated in chemistry, after 15 years’ experience in the field of analytical chemistry, she worked for three years at the European Commission, participating in two groups of RIP 3.3 (REACH Implementation Project, Technical Guidelines to Industries) and as a leader of a work package in a European project focused on integrated development of alternative toxicological methods to animal testing. She is responsible for the management of individual projects and global customer assistance. Francois Busquet– Eco toxicologist François Busquet studied biotechnologies at the ENSTBB in France. He graduated from the TU Dresden, completing his PhD at the MerckSerono group in Germany on the development of a new screening assay to detect proteratogenic compounds using zebrafish embryos. After his studies, he worked in Ecvam at the Joint research Centre (European Commission) in Italy on the coordination of the OECD validation study of the zebrafish embryo toxicity test. Since 2012, he has been responsible for the CAAT-EU policy programme in Brussels. Dr Daniele Ferrario – Toxicologist Graduated in biological science, he earned a PhD in toxicology in 2009. He gained knowledge in cellular and molecular biology techniques, as well as having a strong background in metal toxicity on mammalian immune and haematopoietic systems. While working for five years at the laboratory of European Centre for The Validation of Alternative Method of the European Commission he was actively involved in the validation of CFU-GM as alternative to animal testing to evaluate immunotoxicity. He is now responsible for the evaluation of toxicological outcomes of testing in compliance with REACH Regulation.

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PROFILE: REACH master y

BPD services

SERVICES PROVIDED Business solutions

Website

www.reachcentrum.eu

E-mail

info@reachcentrum.eu

Head office

Avenue E van Nieuwenhuyse 6, B-1160 Brussels, Belgium

Tel/ Fax

+32 26767400/ +32 2 6767499

Contact

Francesca Furlan

Directors

Emma Farthing, Managing Director

Ownership

Private company

Locations

Brussels, Belgium

ReachCentrum offers expert consultancy to support REACH implementation within companies and stakeholder groups, to help customers adopt the most effective strategy to fulfil REACH requirements. ReachCentrum services focus on four main groups of activities: lead registrant, consortia and co-registrant support and post registration activities. Main services are project management, Sief communication, finance and data management, legal support, letter of access and training and learning. As for post registration activities, services include dossier update, evaluation and authorisation. ReachCentrum has set up a series of transversal services beyond REACH regulation: OO CLP Regulation; OO non-European chemicals regulations, in particular K-REACH; and OO biocidal products Regulation (BPR), where it works to promote joint submission for product families with same active ingredients.

Founded

2006

Project management

PROFILE: ReachCentrum

CONTACTS

ReachCentrum has extensive experience in managing consortia and supporting lead registrant to prepare companies meet their regulatory obligations, gained during 2010 and 2013 REACH registrations. Dedicated staff is available to cover all aspects required by regulations.

OVERVIEW ReachCentrum is the professional services body established originally in 2006 by Cefic, to help companies fulfil the REACH requirements through their value chain. It was acquired by ERM, the worldâ&#x20AC;&#x2122;s leading sustainability consultancy, in May 2015. ReachCentrum addresses all aspects of Registration, Evaluation, Authorisation of Chemicals Regulation (REACH), Regulation on classification, labelling and packaging of substances and mixtures (CLP) and biocidal products Regulation (BPR). Services include: consortia and project management, lead registrant support, consultancy and learning and development. ReachCentrum also supports European and non-European clients with respect to K-REACH and other global REACH-like legislation. VITAL STATISTICS

Authorisation support ReachCentrum is involved in authorisation since the first applications (DEHP). ReachCentrum has deep knowledge of the processes, steps and potential pitfalls, and it keeps companies up to date of any new aspect and development. Companies can benefit as from the very first inclusion to the substances of potential concern list from of ReachCentrum extensive network and contact to industry association, REACH authorities in member states, European Commission, and Echa.

2015/16

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 20%

Consultancy/advisory 30%

Training, workshops and e-learning solutions ReachCentrum organises training courses covering all aspects of REACH legislation, CLP and BPR. It applies blended learning to its courses to offer flexibility and convenience to participants â&#x20AC;&#x201C; classroom, web-based, virtual and e-learning. To increase awareness and show business opportunities of chemical regulations, ReachCentrum can organise tailored workshops for companies and trade associations. Project management for biocides ReachCentrum is supporting companies to prepare their authorisation application dossier for product(s) containing certain active substances within certain product types (PTs). The service offers support to companies requiring biocidal product Regulation compliance and it includes customised training for BPR compliance, dossier preparation and risk assessment. Project Management for K-REACH

Legal 13% IT & software 5% Information 2%

GLOBAL OFFICES Global coverage as part of ERM group

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Representation & management 30%

ReachCentrum is supporting companies to prepare their dossier for substances registration under K-REACH. Local dedicated and highly experienced K-REACH team is available to cover all aspects required for project, technical and legal management. Secured IT-systems and processes are in place to support joint registration, access and purchasing data from Europe, data sharing and cost sharing for a successful dossier registration. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006

Founded by Cefic (European Chemical Industry Council).

2010

LoA e-shop successfully launched.

2010

Through the LoA e-shop 342 lead registrants allowed their Sief members to access the registration dossier.

2010

About 900 people attended ReachCentrum events (about 90 events). Chemical Watch | Global Service Providers Guide 2016

Set up of three authorisation consortia.

2014

Submission of the first joint application for authorisation (HBCDD).

2014

Creation of the first biocidal product family (BPF) preconsortium, sodium hypochlorite.

facilitation (supply chain, data access), application for authorisation and review of documents, analysis of alternatives and socio-economic analysis, and also setting up interest groups, taskforces and consortia to serve a common goal for registration and evaluation and authorisation. STAFF SELECTION

2015

Acquired by ERM.

Emma Farthing – Managing Director

2015

Launch of K-REACH activities.

2016

Launch of Data Brokerage Platform for K-REACH.

2016

Full technical and administrative support for biocidal products authorisation according to BPR and to nonEuropean Regulations.

Emma was appointed Managing Director of ReachCentrum in July 2015 and is a Partner at ERM. At ReachCentrum, Emma is responsible for the day to day operations and strategic development of the company. She has 25 years of environmental and sustainability consulting experience in a number of technical fields and has been responsible for managing teams of consultants delivering on REACH and REACH-like regulations within Europe and other regional jurisdictions.

PARTNERS OO OO

An ERM Group Company Cefic list of preferred partners

CLIENTS ReachCentrum offers its services to a wide range of companies, from major multinationals to SMEs and only representatives (OR) from all over Europe and beyond, including downstream users and distributors. TESTIMONIALS "ReachCentrum was selected first as consortium secretariat based on its experience with consortia management, more particular relating to in financial and communication aspects but also due to their knowledge of REACH authorisation process as such. During preparation for application, ReachCentrum has proven to be very supportive in translating between the language of pure technical service providers and the understanding of our group. Also in reviewing documents for application, ReachCentrum’s input is very helpful." – Ingrid Brassart, chairperson of the Sodium Dichromate authorisation consortium, Akzo Nobel. “Super training, super trainers, topics well described and goals met 110%.” - Magali Dolon, attending a training course on biocides, Virbac. CASE STUDY 1: Biocidal product authorisation support ReachCentrum is working with a multinational company to support it in launching biocidal products on European and non –European markets. ReachCentrum is providing strategic advices, including a global action plan with timelines and costs, to better placing products in the markets. Services also include legal and regulatory advice, technical dossier preparation, cooperation with local authorities before and after submission of specific documents. CASE STUDY 2: Support consortia on Data Sharing for K-REACH ReachCentrum is currently supporting consortia members with a comprehensive strategy to share existing EU data for K-REACH purposes. Consortia can benefit of legal support, including advises and verification of current EU agreements. An assessment of the financial value of data and studies is managed by ReachCentrum, together with communication with potential registrants in South Korea and analysis of data to be shared. The process will be supported by a highly developed dedicated IT platform, the Data Brokerage for K-REACH. CASE STUDY 3: Analysis of alternatives listed as good example by Echa A downstream user analysis of alternatives (AoA), figures among a list of good examples published by Echa. ReachCentrum and ERM worked together and the analysis, submitted by DOMO Caproleuna GmbH for trichloroethylene, was used by Echa as an example of a downstream user analysis of alternatives. Since ReachCentrum’s acquisition in May 2015, ReachCentrum and ERM have combined their technical and management expertise to support industry under REACH authorisation. services include regulatory advice, strategic planning, communication Chemical Watch | Global Service Providers Guide 2016

Inneke Claes – Project Manager Inneke joined ReachCentrum as project manager in October 2014. Prior to that, she worked for almost 15 years in European industry associations representing the interests of paper, cement and non-ferrous metals industry sectors. She handled topics related to REACH and CLP, as well as environmental issues and helped cement companies with REACH implementation. Inneke holds a PhD in physics and a degree in environmental sciences. Cornelia Tietz – Project Manager and Authorisation expert Cornelia joined ReachCentrum team in April 2009 as project manager, in charge of consortia and Lead registrants support projects. Since 2010 she has been looking into all aspects of substance evaluation and authorisation under REACH and she is now the ReachCentrum responsible person for those aspects of the legislation. Having previously worked four years in Cefic, her working experience included managing sector groups and developing and strengthening relations with downstream users and retailers. Magdalena Kornacka – Project Manager Magdalena is project manager with several years’ experience in consortia management. During her career, she has been involved in REACH at different levels – administrative, regulatory and also technical. As Director of an Industry Association, she has been also responsible for the regulatory affairs and participated in the legislation process for wastes and environmental regulations. At ReachCentrum Magdalena is responsible for REACH consortia and for authorisation of biocidal products. Sam Temara – Commercial Director Sam is bioengineer with almost 20 years of industrial experience. Sam has expertise on supporting various industries on implementing global product sustainability strategies and HSE information systems. He joined ReachCentrum in May 2015 as commercial director, with the responsibility of leading the organisation through the commercial landscape. At ReachCentrum he oversees service development, identifying new market opportunities, and directs marketing operations. Willi Muenninghoff – Project Manager Willi is responsible for consortia management in ReachCentrum. With over 30 years’ experience in the chemicals industry and having a chemistry background, he started his career in R&D then moved to Technical Customer’s Services, Business Development and finally Compliance. Since 2006 he has been involved in all sorts of regulatory issues on an international scale, such as REACH, GHS, biocides, transport classification, import and export regulations to name just a few.

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PROFILE: ReachCentrum

2012

SERVICES PROVIDED 2018 REACH registration services

Website

www.reachlaw.fi

E-mail

sales@reachlaw.fi

Head office

Vänrikinkuja 3 JK 21. FI-02600 Espoo. Finland

Tel/ Fax

+358 (0)9 412 3055/ +358 (0) 9 412 3049

We help co-registrants and lead registrants as their service provider or as only representative (OR) in fulfilling all REACH requirements. We have vast experience in taking companies through the different phases of the registration process including Sief and consortium. We provide resources and expertise for the hazard assessment, exposure assessment and risk characterisation, when needed. We provide the customer with a complete chemical safety report and necessary collection of information in the supply chain, handling of third party access rights and financial transactions, completing the technical dossier and submitting it to Echa.

Contact

Mr Frederik Johanson, Partner

REACH authorisation and advocacy support services

Directors

Mr Jouni Honkavaara, CEO, Partner Mr Frederik Johanson, Partner Mr Lasse Musakka, Partner Dr Ying Zhu, COO, Partner Mr Riku Rinta-Jouppi, Head of Global Compliance, Partner

Ownership

Private company

Locations

Finland, Belgium, India, Turkey

Founded

2006

REACHLaw combines the best expertise and a deep understanding of your business and regulatory requirements to provide you with a full set of services for authorisation. Our support covers the overall strategy and scope of the authorisation to performing the work needed in the different stages of the authorisation process (eg analysis of alternatives, socio-economic analysis, chemical safety report and full authorisation application). Furthermore, through our advocacy support services we also assist you before authorisation and restriction decisions are made. We help you to achieve the best possible outcome for your business by supporting you in the public consultations phase, as well as with the RMOAs, exemption studies and legal consulting.

PROFILE: REACHLaw

CONTACTS

OVERVIEW REACHLaw provides chemical regulatory compliance and product safety solutions to fit each customer and their needs. We help companies and organisations to gain market access for their chemical products and we support them with different chemical regulations such as: ”EU REACH & CLP”, “Turkey KKDIK, SEA, & GBF”, “K-REACH and GHS”, “China REACH & GHS” and many more. Furthermore, our out-tasking EHS services as well as our digital solutions will help you manage and control your chemicals and your supply chain globally. Having a multicultural team, REACHLaw is able to serve its clients in the following languages: English, Finnish, French, German, Spanish, Swedish, Chinese, Hindi, Russian, Ukranian and Turkish. VITAL STATISTICS

2014/15

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

40+

Staff, group

30+

Staff, chemical service provision

25+

SERVICE AREA BREAKDOWN Training 5% Legal 20%

Consultancy/advisory 30%

IT & software 10% Laboratory 5% Information 5%

Representation & management 25%

Out-tasking services For companies to keep the long term maintenance of REACH and CLP regulatory compliances is a big challenge as the regulatory contents change and evolve. Using our out-tasking solutions ensures you continued REACH and CLP regulatory compliance that saves your time, resources and money. We help you to stay focused on your core business while we take care of all your regulatory compliance tasks. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006

Established in Helsinki.

2008

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

2009

REACHLaw received internationalisation award from the president of Finland. Customers in 40+ countries. Brussels and New Delhi offices opened. REACHLaw delivered more than 50 events globally, having 1,500+ attendees in total.

2010

300+ REACH registrations submitted. REACHLaw launched global compliance services outside the EU. The attendees to our events increased considerably reaching more than 2,500+.

2011

Istanbul office opened. REACHLaw supported large companies to ensure compliance with global chemical regulations.

2012

20+ REACH lead registrant cases. First authorisation cases. Several global notifications were completed. REACHLaw became shareholder in eSpheres Ltd: www.espheres.com

2013

REACHLaw launched www.compliantsuppliers.com. REACHLaw supported several hundred REACH registrations, numerous authorisation projects, 20+ lead registrant and BPR cases.

2014

Delivering several REACH lead registrations and a large number of authorisation projects. Providing SDSs for mixtures. Providing IT management solutions especially related to supply chain compliance and risk management.

2015

Supporting companies in creating strategies for biocides product authorisation. Acting as EU representative related to Article 95. REACHLaw launched THEBLOG: www.reachlaw. fi/theblog

GLOBAL OFFICES Helsinki, Brussels, New Delhi and Istanbul.

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Chemical Watch | Global Service Providers Guide 2016

Supporting several companies with public consultations. At present working on different authorisation cases and supporting 2018 lead registrations and co-registrations.

ACCREDITATIONS Internationalisation award from the president of Finland in 2009. Innovative – Growth sustainable company by Europe Innova in 2011. Among 200 fastest growing companies in Finland by Kauppalehti in 2011. Young Innovative Growth Company Programme by TEKES completed in 2012. PARTNERS REACHLaw collaborates with several industry associations and has partners in different continents. CLIENTS Major industry sectors served: oil, chemicals, specialty chemicals, pulp and paper and metals. Downstream users in the electronics and space sectors. Our customers are manufacturers, importers, traders, downstream users, retailers and governmental organisations. TESTIMONIALS “Over the years REACHLaw has advised Freeport on several strategic REACH and CLP issues and in the planning of our 2010 registrations. For one substance REACHLaw managed the whole lead registrant registration process in 2010. We are very pleased with REACHLaw service” – Dr Thomas Slotte, Freeport Cobalt Oy. CASE STUDY 1: Authorisation application – chromate space task force Chromium trioxide, a substance commonly used in formulations for surface treatment of aluminum alloy parts used in launchers and space vehicles, has been included in the REACH authorisation list with a sunset date in September 2017. A space-specific analysis of alternatives and socio-economic analysis for authorisation has been prepared to ensure continued use after the sunset date. REACHLaw – in collaboration with ASD-Eurospace – has conducted a survey of task force members to collect relevant information on the use, alternatives and socio-economic impacts of non-use. A high-level summary was submitted as a comment to Echa to support a supplier-driven authorisation application for aerospace uses including the use in question. CASE STUDY 2: Out-tasking – metals manufacturer and recycler, Germany Maintaining REACH and CLP Regulatory compliances is becoming increasingly time-consuming and demanding due to regulatory changes, new interpretations and constantly updating reporting software and IT solutions. Keeping up with and maintaining an organisation to manage these is resource demanding and costly, without the possibility of optimisation as most regulatory tasks are unique. This is the case with the chemical supplier, too many REACH and CLP compliance issues to follow and compliance tasks to maintain. REACHLaw offered the chemical supplier with a REACH and CLP out-tasking and support service that, amongst others, maintains dossier compliance and follows and alerts of regulatory changes affecting the products of the chemical supplier. The supplier is still in control of overall compliance but REACHLaw provides a service that takes care of the technical and special compliance tasks that need special competence which otherwise would be costly and resource demanding to maintain within the company.

Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 3: Advocacy support services – electronic component manufacturer The European Commission launched a public consultation on restriction proposal for perfluorooctanoic acid (PFOA), PFOA salts and PFOArelated substances. A substance included in this category is used in the manufacturing process of electronic components by a DU company. REACHLaw prepared a DU company specific comment comprising of a realistic non-use scenario, socio-economic analysis and analysis of alternatives. The arguments used were in line with the comment from the industry sector representative. Based on the comment, Echa committees proposed to exempt the use of the PFOA-related substance in electronic component manufacture without a review period. STAFF SELECTION Mr Tim Becker, MA (Law) – Chief EU Compliance Officer Mr Becker has been acting as legal adviser and key account manager at REACHLaw since 2008. He has also worked previously with Echa in its guidance team. His track record includes internal capacity building and assistance to REACHLaw’s global customer base in obtaining REACH registration, legal status confirmations (exemptions, importer, transfer of registrations, SME, etc) and most recently authorisation. Since 2011 he has been the person responsible for advising actors in the European space sector on REACH-related issues. Other areas of expertise include BPR, CLP and RoHS. Dr Ying Zhu, PhD (Biochemistry), MSc in Economics, COOPartner Dr Zhu has both a scientific and economic educational background. She has also worked in various management positions in industry for more than ten years. Her unique educational background and work experience enable her to act as a leading expert in the area of REACH authorisation and Advocacy services. Dr Zhu has advised companies from four different continents on REACH compliance issues since 2008. In addition, she also has in-depth knowledge on global chemical regulations and compliance issues. Mr Riku Rinta-Jouppi, MA (Law), MSc – Head of Global Compliance-Partner Graduate of Cambridge University. He is widely recognised as one of the leading European legal experts in chemicals regulations. In addition to his legal qualifications he holds a masters degree in bio-information technology. Mr Rinta-Jouppi is responsible for REACHLaw global compliance services. Mr Sami Vesikansa, MSc (Biochemistry) – Specialist in human health hazard assessment Mr Vesikansa is working as a toxicologist for REACHLaw. His responsibilities include management of lead registrant projects,chemical safety assessment, Sief management and the responsibilities of the REACH only representative (OR). He specialises in the field of human health hazard assessment and risk characterisation of chemicals and products. He has over ten years of experience in toxicity tests of pharmaceutical and industrial chemicals. Sini Suomela (MSc in Organic Chemistry) – Technical Project Manager Ms Suomela has been responsible for REACH member registrations since 2010 and has successfully completed hundreds of registrations during this time. She has extensive knowledge of all kinds of REACH registrations and inquiries. She has also worked with the physicochemical part of the REACH lead registration projects and has been involved in REACH authorisation work.

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PROFILE: REACHLaw

2016

SERVICES PROVIDED

PROFILE: Regulator y Services International Ltd

Chinese new chemical notifications

CONTACTS Website

www.rsireg.com

E-mail

andy@rsireg.com

Head office

Suite 1009 Tongguang Tower, 12 NongzhanguanNali, Chaoyang District , Beijing, 100125, China

Tel

+44 1223 969 972

Contact

Andy Burgess

Directors

Andy Burgess

Ownership

Private company

Locations

China, UK and US

Founded

2010

OVERVIEW With Regulatory Services International (RSI) our focus is on gaining and maintaining your compliance with chemicals legislation with a particular specialism in China. We dedicate ourselves to understanding and navigating the intricacies of the legislative requirements for new chemicals in China and work tirelessly to gain approvals in a timely and effective manner. We devise and implement tailor made compliance strategies that are robust and resilient. We handle the complexity of gaining approvals for you. We are one of the leading service providers specialising in Chinese chemicals legislation and have long-term and extensive experiences and expertise with a huge range of new substances for different industries. VITAL STATISTICS

2014/15

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

Study contracting, arrangement and monitoring The notification of substances under chemicals legislation requires a wide range of studies and inevitably leads to data gaps being found. Arranging and monitoring these studies takes time and expertise. We provide a service that saves your time, expertise and money. We do this by taking care of contracting, arranging and supervising the performance of these data gap studies. We work with a range of laboratories in different countries involved in all study types as required under new chemicals legislation, including specialist in-country testing. We focus on understanding your requirements and needs, compare these with a range of labs to identify compatible matches and then take care of contracting, all the operational arrangements and study monitoring activities to deliver the completed study package. Chinese hazardous chemical services

SERVICE AREA BREAKDOWN Information 5%

Our focus is your compliance. The Chinese legislation for new chemicals (MEP Order No 7) is a challenge for all: data requirements are high, approvals are time consuming, requirements are not explicit, and a number of ecotoxicology studies need to be performed in-country. We dedicate ourselves to handling these challenges and through many years of continual efforts by our team we have successfully gained approval for hundreds of new substances under new chemicals legislation in China. We understand the challenges in China and start by guiding you through the business options available, so you can determine if pursuing a registration is viable or even necessary. Where a registration is required, we then identify your options, define their requirements and required data gap studies. We work with all parties in the supply chain to deliver your submission on-time. This includes: OO data gap analysis; OO inventory searches; OO registration dossier preparation; OO risk assessments; OO study arrangement and monitoring; and OO submission package translation into Chinese. We handle the submission and post-submission support activities through SCC-MEP and its multi stage reviews: OO submission and post-submission support with regulatory authorities; OO registration agent (using our local partner in China) We take care of all aspects of this process for you.

Consultancy/advisory 15%

Representation & management 80%

We have an evolving range of services for companies meeting the challenges of State Order Decree 591 and its supporting legislation including Registrations under SAWS Order No 53, MEP Order No 22 and SAWS Order 60. These services include: OO strategic review and analysis of obligations; OO regulatory guidance and investigations; OO chemical inventory searches; OO registration of hazardous chemicals; OO SDS and label preparation; and OO arrangement of emergency 24 hour hotline service (using a local partner in China).

GLOBAL OFFICES

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

China: Suite 1009 Tongguang Tower, 12 NongzhanguanNali, Chaoyang District, Beijing, 100125. UK: P.O. Box 1280, Peterborough, PE2 2NG, UK USA: Suite 100-1212, 1024 Iron Point Road, Folsom, CA 95630, USA

2010

Company founded with team of three, opening of Beijing office and UK office

2011

US office established

2011

Opening of Shanghai office

2012

Opening of Nanjing and Xian offices

Page 144

Chemical Watch | Global Service Providers Guide 2016

Renke Dai, PhD â&#x20AC;&#x201C; Chief Scientist

We work closely with a growing range of service providers with backgrounds in laboratory testing, regulatory services and legal services. We are actively looking to deepen and widen our partnerships.

Extensive and wide ranging experience in chemistry, biosciences and environmental toxicology. Dr Dai earned his PhD degree from the University of Nebraska-Lincoln and has been previously employed at the US National Cancer Institute, Chinese Academy of Sciences Guangzhou Institute of Biomedicine and Health as well as industry experience. Dr Dai acts as technical adviser for the scientific related issues of regulatory projects.

CLIENTS We work with innovative companies. Our clients include manufacturers, formulators and users involved in a wide range of market sectors including chemicals, agrochemicals, pharmaceuticals, cosmetics, paints and coatings, electronics, medical devices, petrochemicals, plastics and many others. Our clients come in all shapes and sizes, from multinational companies to SMEs. TESTIMONIALS Specific references can be provided to potential clients upon request.

Manna Tang â&#x20AC;&#x201C; Regulatory Specialist Six years of chemical registration and compliance experience in complying with the Chinese chemicals legislation. Graduate of Northwest University with a master degree in chemical technology and Qingdao University with bachelor degree. She has had a leadership role in Chinese new chemical notification projects and has developed detailed knowledge of chemicals legislation as well as a strong network of contacts with authorities and approved laboratories in China.

CASE STUDY 1: Company strategic evaluation Chemicals legislation in China is complex and involves juggling multiple pieces of legislation. In this project we partnered with a multinational chemicals company that was struggling in handling all the regulatory requirements in China. Together we mapped and strategically analysed their compliance obligations under Chinese legislation covering both new and hazardous chemicals. Through using this compliance framework the company has a much stronger understanding of the situation and by acting on this their compliance status became far more robust. CASE STUDY 2: Registration planning The new chemicals registration requirements in China are complex and involve significant time to gain compliance. Advanced planning can bring quantifiable benefits in avoiding supply interruptions. In this project we worked with an innovative company that created large numbers of new chemicals but was struggling as product launches were being delayed while awaiting regulatory compliance. We tackled this by developing a compliance framework that is now integrated within their product development process. This has resulted in significant reductions in sales delays from lack of regulatory compliance. CASE STUDY 3: Registration of complex substances In this situation we were entrusted to handle the registration of a difficult new substance. The substance itself was a multi constituent substance that was unstable in water. As part of the registration in China this required specific ecotoxicology studies to be performed in China. To achieve this it required extensive investigations to determine a suitable testing protocol and close cooperation between our client and the testing lab in China. A suitable protocol was developed, studies were run and the registration gained regulatory approval. STAFF SELECTION Andy Burgess â&#x20AC;&#x201C; Managing Partner Extensive experience in global chemical registration and testing services. Expert knowledge of Chinese chemicals legislation. Specialism in practical understanding and translating Chinese requirements into a form that can be understood and acted on by a non-Chinese audience. Previously managed groups responsible for global regulatory submissions and study management in the CRO environment. Wealth of experience with practical strategic support in anticipating and complying with regulatory requirements.

Chemical Watch | Global Service Providers Guide 2016

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PROFILE: Regulator y Services International Ltd

PARTNERS

SERVICE AREA BREAKDOWN

PROFILE: Risk & Policy Analysts Ltd (RPA)

Training 5%

CONTACTS Website

rpaltd.co.uk

E-mail

post@rpaltd.co.uk

Head office

1 Beccles Road, Loddon, Norfolk, NR14 6LT, UK

Tel

+44 1508 528465

Fax

+44 1508 520758

GLOBAL OFFICES

Contact

Panos Zarogiannis

UK, Belgium

Directors

Pete Floyd Meg Postle

SERVICES PROVIDED

Ownership

Private

Locations

UK, Belgium

Founded

1990

Consultancy/advisory 95%

REACH authorisation RPA assists industry clients with the development of applications for authorisation of SVHCs under REACH. These studies involve detailed analyses of supply chains, of alternatives and the preparation of SEAs. REACH restriction

OVERVIEW Risk & Policy Analysts Ltd (RPA) was established in 1990 as an independent specialist consultancy. RPA has gained extensive experience in undertaking impact assessments and evaluations, including the development of quantitative and qualitative methodologies to assess policy impacts, chemicals policy, chemical risk assessment and management. RPA is the market leader in the development and application of socio-economic analysis (SEA) to chemical risk management and is particularly proud of its reputation for preparing applications for authorisation of SVHCs under REACH for industry clients. RPA has been working with industry clients since 2001 on the implications of the new EU regime for chemical risk management. We have also been working closely with the European Commission (EC) and the European Chemicals Agency (Echa) on the development and implementation of REACH and many other directives relating to chemical risk management. Our experience covers a wide range of industry sectors including bulk chemicals, ferrous and non-ferrous metals, paints and coatings, oil and gas, speciality and novel chemicals (including nanomaterials), etc, and this has resulted in detailed studies on over 50 high profile chemicals. RPAâ&#x20AC;&#x2122;s multi-national staff routinely undertakes detailed analysis and consultation with industry and regulators in most European languages. VITAL STATISTICS Turnover, group

2014/15 -

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. 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, CLP, CMRs at work, toy safety, cosmetics, biocides, drinking water and WFD. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1992

RPA develops a risk-benefit analysis methodology for chemical risk management for the UK authorities.

1998

RPA wins major framework contract for the UK authorities on chemical risk management leading to numerous risk reduction strategies.

2000

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

2004

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

2009

RPA contracted by industry clients to support applications for authorisation under REACH with a focus on SEA work.

2011

RPA leads consortium for the second Echa REACH framework contract.

Turnover, chemical service provision

No of offices

2012

Focus on EU-28, EEA and candidate countries

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

2013

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

2014

RPA clients obtain the first granted REACH authorisations.

2015

RPA supports the submission of another nine applications for authorisation.

2016

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

No of countries represented Staff, group

Staff, chemical service provision

PARTNERS RPA works with FoBiG, Ă&#x2013;kopol, Triskelion B.V., Denehurst, Milieu, DHI, RIVM, ARCHE, Cranfield University, BiPRO, ReachCentrum, Anthesis and Acta among others.

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OO OO

European Commission (including DG GROW (previously Enterprise) DG Environment, DG Employment and DG Justice and Consumers). National authorities (including those in the UK, Germany, Sweden, Denmark, France and the Netherlands). European Chemicals Agency. Numerous European/international industry/trade associations (including AISE, APEAL, Cefic, Cosmetics Europe, DEHP ATF, Etinsa, Eurocommerce, Eurometaux, European Plastics Recyclers, ICMM, IMnI, International Zinc Association, Lead Development Association, Nickel Institute and UKWIR). A range of companies (from multinationals to SMEs) and consortia.

TESTIMONIALS “I am grateful for RPA’s assistance … I would definitely recommend your firm ” – REACH authorisation client. “My thanks to you for successful accomplishing of the very ambitious survey programme, as well as the equally challenging work on developing the model for the 2018 registration costs.” – European Commission client. “They are committed to the job, responsible, punctual, reliable and always ready to assist and help” – industry client. Please note that our industrial clients have indicated that they would be happy to provide a formal positive testimony should such a reference be requested. CASE STUDY 1: Provision of analysis of alternative and socioeconomic analysis support services RPA is currently providing REACH authorisation support to several consortia of manufacturers of SVHC substances. The work includes preparation of an analysis of alternatives (involving an assessment of the technical and economic feasibility of alternative chemicals and techniques), supply chain communication to develop information on uses and users’ responses to the loss of the SVHC in question and preparation of socioeconomic analyses of the impacts of the loss of the SVHC. As part of this work, we are managing the services of specialist toxicology and risk assessment consultants. CASE STUDY 2: Undertaking a regulatory fitness check of the legislative framework of chemicals RPA is currently assisting the European Commission in undertaking a study of the regulatory fitness check of the legislative framework governing the risk management of chemicals (excluding REACH), in particular the CLP Regulation and related legislation. The purpose of this study is to identify and evaluate the impact and consequences of implementing the CLP Regulation and to evaluate the interface with other related chemicals legislation. This is based on the criteria of effectiveness, efficiency, coherence, relevance and EU added value in accordance with the Commission’s evaluation and fitness check guidelines. CASE STUDY 3: QALYs and DALYs RPA was contracted by Echa to provide an analysis of the quantification and valuation of the human health impacts of chemicals based on quality and disability-adjusted life-years (QALYs and DALYs). The project involved an extensive review and analysis of studies and academic literature drawn from Europe, Asia, Australasia and the Americas. This project was awarded under the Framework Contract led by RPA to provide scientific services for Echa and was completed in 2015.

Chemical Watch | Global Service Providers Guide 2016

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 (EC), the UK government and a range of industry bodies on business, health and environmental impact assessments of REACH and of proposed restrictions and other controls on the use of hazardous chemicals within the EU. As a leading expert on socioeconomic analysis (SEA), she guides the preparation of SEAs to support authorisation and restriction activities. Panos Zarogiannis – Technical Director, Chemicals Policy Panos is a chemist with extensive experience of developing risk reduction strategies for chemical substances under the Existing Substances Regulation as well as SEA-related studies and in the development of TGDs for REACH. He has managed studies in support of the development of Annex XV dossiers by Echa and is leading our work for major industrial clients on the development of authorisation dossiers. Linda-Jean Cockcroft – Technical Director, Business, Industry and Growth Linda-Jean has almost 20 years’ consulting experience, with most of the last six years focussed on sustainability, REACH and chemicals regulation. She has a unique combination of both inside-industry and consulting experience and has worked in a number of EU countries. Dave Fleet – Principal Consultant, EU Policy Dave is an economist with wide project management experience and socio-economic analysis expertise. He has extensive experience of managing RPA’s impact assessments and evaluations for the European Commission. He is currently co-ordinating consortium-wide and company- specific SEA outputs for applications for authorisation. Anthony Footitt – Principal Consultant, Chemicals Anthony has 19 years of experience and undertook a great deal of the risk and economics work underpinning the EU REACH chemicals strategy on behalf of the European Commission where this included work on all of the business impact assessments (BIAs) and many subsequent analyses/impact assessments. He was also responsible for much of the modelling work that RPA carried out for the EC on the impacts of introducing the GHS. Most recently, he has been working on REACH impact assessments and on nanomaterials. Marco Camboni – Senior Consultant, Chemicals Marco specialises in the evaluation of the European chemicals legislation and its synergies with the occupational health and safety, product safety and environmental legislation. He has been involved in numerous studies looking at how to better regulate nanomaterials and he is currently managing RPA work for the European Commission on the strategy for a non-toxic environment of the 7th Environment Action Programme and for the Danish EPA on the development of the Danish society towards a circular economy. Tom Persich – Senior Consultant, Chemicals Much of RPA’s work on REACH authorisation for industry clients benefits from Tom’s detailed research and analysis into their uses of the SVHCs for which authorisation is being sought. Tom has also prepared core AoA and SEA arguments at sector level for a key set of downstream users. He has also undertaken extensive supply chain mapping activities to assess potential vulnerability of downstream user groups to the loss of a key substance. Byron Georgalas – Consultant, Chemicals Byron, a chemical engineer by training, is currently developing a database to support hazard and risk communication and RMM efficiency analysis for Cefic and managed a study for Sweden’s KemI in preparing a restriction dossier under the RoHS 2 directive. He has expertise in compliance with EU chemicals, environmental and waste legislation and in preparation of AoA, SEA and REACH registration dossiers.

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PROFILE: Risk & Policy Analysts Ltd (RPA)

CLIENTS

GLOBAL OFFICES HaskoningDHV Nederland BV: Jonkersbosplein 52, 6534AB Nijmegen, The Netherlands Haskoning UK Ltd: Rightwell House, Bretton, Peterborough, PE3 8DW, UK Haskoning Belgium SA: SchaliĂŤnhoevedreef 20D, B-2800 Mechelen, Belgium

PROFILE: Royal HaskoningDHV

CONTACTS Website

www.royalhaskoningdhv.com

E-mail

IB-NL.Secretariat.Health.Safety

Head office

HaskoningDHV Nederland BV, Laan 1914 nr. 35, 3818 EX Amersfoort

Tel

+31 88 348 69 18

Fax

+31 24 323 93 46

Contact

Mr Christiaan van Daalen / Mr Tjeerd Bokhout

Directors

Mr Ronald de Vries, Director Advisory Group - Health, Safety & Environment

Ownership

Private company

Locations

100 Locations worldwide. Key locations: Nijmegen, Amersfoort (NL), Peterborough (UK), Mechelen (Be)

Founded

1881

SERVICES PROVIDED REACH Royal HaskoningDHV provides a full range of REACH services, varying from consortium management to preparation of the technical dossier and the chemical safety report. Royal HaskoningDHV experts prepare and submit both lead and individual registration dossiers and support clients with both their regulatory strategy and day-to-day practical questions, both in the EU and Turkey. Although Royal HaskoningDHV does not provide laboratory services, it provides support in laboratory selection and study monitoring. Royal HaskoningDHV has good working relations with many laboratories. GHS/CLP

OVERVIEW The firm was founded in 1881 in the Netherlands. In 2012 Royal Haskoning and DHV merged to the current organisation. Our employees combine a wide range of knowledge and experience. Rooted in a technical background, our consulting services focus on the broad field of interaction between people and their environment. We are committed to working enthusiastically with our clients to achieve sustainable solutions in an increasingly complex society. The expertise and experience of our professionals in a variety of disciplines allows us to consider all technical, logistical, legal, organisational, social, environmental and economic aspects of the projects of our clients, in order to subsequently develop sustainable and practical solutions. We have been working with the industry on chemicals management for several decades and contributed to the implementation of numerous legislative programmes. VITAL STATISTICS

2014

Turnover, group (2013)

â&#x201A;Ź655 m

Turnover, chemical service provision No of offices

100

No of countries represented

Staff, group

6,836

Staff, chemical service provision

50 - 100

IT & software 5% Laboratory 2% Information 15%

Representation & management 15%

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Safety data sheets Royal HaskoningDHV provides a full safety data sheet service including the preparation of the annex of the extended SDS (eSDS). In addition to these services advice is provided on the organisational and technical implementation of information from the eSDS. Chemicals management Royal HaskoningDHV provides a unique combination of knowledge on (eco)toxicology, chemical control legislation, safety and engineering to deliver lean and mean organisational and technical solutions for both these challenges. The key challenges for chemicals management: Effective communication of (REACH) information on hazards of substances and their safe use up and down the supply chain, is the key issue for the next years. Based on this information companies will need to reassess their working practices and habits. Improvement of the risk management of SVHCs and the demonstration that the control is at the appropriate level. Storage of chemicals and (external) safety Royal HaskoningDHV can assist you with assessing, designing and permitting of storage facilities for hazardous chemicals, modelling of external safety (SEVESO) and assessing aspects such as explosion safety (ATEX). Other services Royal HaskoningDHV provides a wide range of services that provide solutions for multidisciplinary challenges to industry, such as engineering/ design of installations and buildings, responsible care and environmental impact assessments.

SERVICE AREA BREAKDOWN Legal 5%

Royal HaskoningDHV can assist you with services varying from technical support to total solutions for implementation of GHS. The services include, but are not limited to: regulatory consultancy and compliance checks, GHS/CLP implementation, CLP notification, (re-)classification of substances and mixtures, training on GHS/CLP.

Training 8%

Consultancy/advisory 50%

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1881

Founding fathers Johan van Hasselt and Jacobus de Koning start their business in Nijmegen.

1917

Founding fathers Dwars, Hederik en Verheij start their business in 's Gravenhage.

1981

Haskoning is granted the designation 'koninklijk' (Royal) at its 100th birthday.

1991

EaSI is developed by Royal Haskoning: a database with hazard information from legislation all over the world

Chemical Watch | Global Service Providers Guide 2016

1994

Royal Haskoning developed Rosetta, one of the first programs able to produce multilingual safety data sheets.

STAFF SELECTION

2005

RIP 3.10 on characterisation and checking of substance identity is prepared by Royal Haskoning.

2007

Royal Haskoning joins the organisation of ChemCon Conferences.

2012

Merge between Royal Haskoning and DHV.

2013

Royal HaskoningDHV completes a three-year EU-project impact assessment and training for the implementation of REACH in Turkey.

2014

Royal HaskoningDHV submits first full supply chain REACH application for authorisation of two pigments

Berend Mensink studied environmental sciences and is a registered toxicologist (EuroTox). Although interested in the hazards and impacts of chemicals on humans and the environment, he is specialised in ecotoxicology and environmental fate and behaviour of chemicals. He holds over 15 years of experience in the chemical industry, including overall management of a laboratory studying properties, fate and effects of chemicals in the aquatic environment. He was responsible for a wide range of product and substance registrations for applications and markets within Europe in the chemical industry, including assessing hazards and risks.

ISO 9001/ ISO 14001/ OHSAS 18001 PARTNERS ChemCon Conferences, EPPA SA, The Wercs CLIENTS The clients of Royal HaskoningDHV are located in many different industries. Because Royal HaskoningDHV provides more services than chemicals management alone, it has service relations with clients covering a wide variety of solutions. Clients are, for example, in pharma, flavours and fragrances, plastics, petrochemicals, paints and coatings, minerals and metals. CASE STUDY 1: Application for authorisation of two pigments For a producer of inorganic pigments Royal HaskoningDHV prepared an application for authorisation in collaboration with EPPA SA. The application covered the entire supply chain complicating the risk assessment and socio-economic analysis. To determine actual exposure conditions site visits were performed at downstream user sites throughout Europe. The information gathered was used to extensively describe the uses applied for and to refine the risk assessment and demonstrate safe use using higher-tier modelling (ART). The application for authorisation was supported by an analysis of alternatives showing no suitable substitution candidates. Other project activities included updating the existing lead registration dossier and official meetings with Echa (PSIS and Trialogue). These efforts combined are expected to lead to an authorisation by the European Commission as of 2015. CASE STUDY 2: Preparation for substance evaluation (REACH) For a consortium of producers of cosmetic product ingredients we have reviewed the dossier to see whether indubitably it can be said that the substances are not PBT and are not to be assessed as endocrine disrupting. Based on the results of the review we have provided several options to strengthen the statement of the dossier which will help the involved companies to defend their substances vital to the human health, protecting European consumers from thousands of serious illnesses per year. CASE STUDY 3: Supply chain communication For a client who formulates over 1,000 different products from over 350 substances we created a tool that allows the formulator to make informed decisions on the lead substances used for the assessment of the risk. After a pilot we were able to prepare sets of only eight different risk management measures for over 30 mixtures prepared from more than 80 hazardous substances. Based on this pilot we estimated that for the entire product portfolio a maximum of 30 sets of safe operational conditions and risk management measures were needed to inform the downstream user on safe use. Our method also allows downstream formulators to determine the contribution of these mixtures to the secondary mixtures produced without having to reveal the exact composition. This will help protect the client’s confidential business information. Chemical Watch | Global Service Providers Guide 2016

Joanne Salverda, PhD – Senior Expert Toxicology As a senior toxicologist, Joanne Salverda has been involved in the assessment of chemical hazards for more than 12 years. She has a background in nutrition, human health and toxicology, followed by a PhD in cancer development. In the past, she worked for the National Institute for Public Health and the Environment (RIVM) and in this role she has advised Dutch ministries on safety issues related to chemicals used in specific consumer product applications, including cosmetics, medicines and biocides. At Royal HaskoningDHV she is closely involved in the preparation of REACH registration dossiers with a focus on human risk assessment, but also other topics including nanotechnology and endocrine disruption have her attention. Conny Hoekzema, Msc – GHS/CLP and SDS Expert Conny Hoekzema has nine years’ experience in the field of chemicals management. She has extensive knowledge and experience in safety data sheets and classification and labelling. Furthermore, she is closely involved in the preparation of REACH registration dossiers and chemical safety reports, both with a focus on the environment. She is an experienced trainer who provides training courses on Iuclid, SDS and classification and labelling for a variety of audiences. Tjeerd Bokhout, MSc MBA – Consortium Manager Tjeerd Bokhout is an experienced consultant and project manager on environmental and chemicals management projects in Europe and abroad (mainly Asia). Tjeerd holds both an MSc and MBA and has a strong focus on the business case of his clients. Tjeerd has a vast network in the global community on chemicals legislations. He has experience in the support of chemical industry and governmental bodies with requirements of REACH. Tjeerd manages several REACH consortia and provides strategic advice on REACH implementation. Tjeerd is also active as director of ChemCon Conferences, the world’s leading conference on chemical control legislation and trade aspects. Leo van der Biessen, Msc – Senior Expert Occupational Exposure Leo van der Biessen has more than 25 years’ practical experience in controlling and managing chemical exposure risk in the chemical process industry and its downstream users. In 1990 he joined a leading health and safety service provider in the Netherlands where he devised chemical risk assessment and control strategies as well as worker protection regimes. He joined Royal HaskoningDHV in September 2002. Since 2008 he has focussed on creating realistic risk assessments under REACH, assisting companies with authorisation and the communication of REACH results in the supply chain. Leo was a board member for chemical safety of the Dutch Industrial Hygiene Association. Christiaan van Daalen, Msc – Project Manager Christiaan van Daalen is trained as an environmental scientist, specialising in both regulatory toxicology and business communication with a focus on REACH. He has been involved in the production of several large dossiers under REACH and advises on various REACH implementation processes. Besides the preparation of technical dossiers Christiaan acts as project manager in many REACH registration projects for individual companies and consortia.

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PROFILE: Royal HaskoningDHV

ACCREDITATIONS

Berend Mensink, PhD – Senior Expert Ecotoxicology

GLOBAL OFFICES Headquarters Bad Kreuznach (Germany), Office Berlin and Liaison Office Japan SERVICES PROVIDED Registration of chemicals – REACH and international programmes

PROFILE: SCC

CONTACTS Website

www.scc-gmbh.de

E-mail

scc@scc-gmbh.de

Head office

Am Grenzgraben 11, 55545 Bad Kreuznach, Germany

Tel

+49 671 298 46-0

Fax

+49 671 298 46-100

Contact

Dr Werner Koehl (Chemicals / REACH, Consumer Products, Cosmetics, Feed & Food Additives)

Directors

Dr Friedbert Pistel, owner and President Dr Albrecht Heidemann (Agrochemicals and Biopesticides) Dr Monika Hofer (Regulatory Science, Pharma Preclinical) Dr Werner Koehl (Chemicals / REACH, Consumer Products, Cosmetics, Feed & Food Additives) Dr Hans-Josef Leusch (Biocides)

Ownership

Private company

Locations

Germany and Japan

Founded

1989/ regulatory experts for more than 25 years

OVERVIEW SCC – Scientific Consulting Company – was founded in 1989 by Dr Friedbert Pistel, and is today one of Europe's largest privately-owned and independent consulting companies for the registration of chemicals, cosmetics, consumer products, agrochemicals and biopesticides, biocides, feed and food additives, food contact materials and pharma pre-clinical. VITAL STATISTICS

2014/15

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

120

Staff, chemical service provision

SERVICE AREA BREAKDOWN IT & software 2%

Training 1% Other 1%

Regulatory science The scientific specialists in the SCC regulatory science department are the backbone of the company and the key to its success. SCC unites experts from all regulatory relevant disciplines, such as chemists, physicists, food chemists, biologists, geo-ecologists, toxicologists, ecotoxicologists, environmental fate specialists, agronomists etc. This access to a wide spectrum of expertise ensures that clients of SCC can take advantage of a highly efficient service. Registration of agrochemicals and biopesticides

Information 10%

Representation & management 18%

SCC has prepared hundreds of chemical notifications for new chemical substances (ELINCS) including high volume products of more than 1,000t/a) and successfully filed over 100 dossiers each for the 2010 and 2013 deadline under REACH. In addition, more than 50 PPORD and more than 50 inquiry dossiers were submitted. SCC has notified new chemical substances in China, Japan, Korea, Australia and Canada. Also, SCC has established a network with the competent authorities within the entire EU and abroad and is recognised as a reliable and competent partner by the authorities (eg Echa) and EU industry organisations (eg Cefic or HERA). SCC can provide you with: OO only representative support; OO trustee service for supply chains (non-EU, EU); OO support in the (late) pre-registration process; OO support in prioritisation/advice on required action in your company for the 2018 REACH deadline and regarding international requirements for chemicals; OO literature (re)search and evaluation; OO data review and identification of data gaps; OO analysis of potential analogous/family approaches; OO development of registration/ testing strategies (including global programmes) as well as organising and monitoring of these studies; OO support with uses, use categories, PROCs, and (sp)ERCs; OO exposure modelling (eg EUSES, Risk of Derm, CONSEXPO, EASYTRA, ART); OO human and environmental risk assessments; OO preparation of the chemical safety report; OO submission/defence of the dossier at authority level; OO support in the Corap and SVHC/authorisation procedure; OO Sief and consortia support/management including trust account; OO C&L support (CLH dossier according to Annex XV, Rac evaluation); OO eSDS including Annex; OO scientific/regulatory support at EU expert meetings; OO Qsar tools.

Consultancy/advisory 68%

The SCC agrochemicals and biopesticides department considers current and future regulatory and legislative needs and developments in the common agricultural policy of the EU, and stays up-to-date on the latest scientific research data. For this reason, the agrochemicals and biopesticides department is at the forefront in strategic planning and defence, negotiations with authorities, or task force support. Registration of biocides The SCC biocides department has successfully submitted dossiers for more than 20 existing biocidal active substances according to the biocidal products Directive 98/8/EC, covering nearly all product types. We have established good working relationships with many competent authorities in the EU and have become an acknowledged partner of authorities and industry. Currently, we are involved twofold: defending active substance dossiers already submitted and preparing dossiers for biocidal products under Regulation (EU) No 528/2012.

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Registration of feed and food additives

TESTIMONIALS

The SCC Feed and Food Additives department successfully managed 36 application dossiers for re-authorisation as a feed additive for the 2010 deadline, which is about 10% of all dossiers filed. Our expertise and connections with authorities and industries enable us to put together the optimal portfolio of scientific data and expert statements for your products. These portfolios will be as concentrated as possible and as extensive as necessary. In addition, we have been and currently are active in the area of food contact materials.

Many of our clients have been customers for a long time, some going back to the start of our company. New clients are often recommended to us via existing clients.

SCC has successfully supported the cosmetics and consumer product industry for more than two decades. Detailed knowledge of all relevant national and international regulatory directives and regulations are the basis to meet all challenges originating for example from the new cosmetics Regulation (EC) No. 1223/2009 or detergents Regulation (EC) No. 648/2004. SCC has proven experience for exposure and risk assessments on different scenarios. Data gap analysis, dossier preparation as well as placement and monitoring of studies are other fields of expertise. SCC has successfully prepared numerous safety dossiers for challenging cosmetic ingredients like hair dyes, UVfilter, preservatives, nanomaterials, botanicals and CMR categorised substances.

All the names of our clients and projects are restricted under the highest level of confidentiality. Therefore we are unable to focus on individual case studies. Our consultancy has an excellent proven track record in all regulatory areas where we are active. Only one proof of our success is the fact that in the two decades of our existence, we have grown from a small national business to become a global player. STAFF SELECTION Dr Werner Koehl – Head of Chemicals/REACH, Consumer Products, Cosmetics, Feed & Food Additives Dr Koehl has a PhD in food chemistry and is a certified expert for toxicology. He has been with SCC since 2001 and is head of Chemicals/ REACH, Consumer Products, Cosmetics, Feed and Food Additives. He previously worked for the scientific committee on food safety and a large chemical multinational, and has gained many years of experience in the registration processes of consumer products and chemicals worldwide.

GLP and regulatory/scientific archiving

Isabel Kirbach

SCC has more than 25 years of archiving experience. SCC offers a complete archiving concept for all regulatory needs (regulatory/scientific and GLP-compliant storage). Our EDDMS (Electronic Document and Dossier Management System) with versatile tools can be used as regulatory dossier management system with worldwide access to all regulatory and scientific information. SCC can also be of assistance in securely archiving GLP raw data: in 2004, SCC was successfully certified as first GLP contract archive in Germany. SCC can act as your European or worldwide central archive.

Mrs Kirbach has a master’s degree in chemical engineering. She has been with SCC since 2004 and her focus is on Sief, Iuclid and consortia management since 2006.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1989

SCC GmbH founded

1989

Establishment of Agrochemicals and Biopesticides department

1989

Establishment of Regulatory Science department

1996

Establishment of Chemical and Consumer Products department

2000

Establishment of Biocides department

2004

GLP archive certification

2007

Establishment Liaison Office Japan

2007

Establishment of Feed and Food Additives

2014

25 years of SCC

2014

Establishment Office Berlin

ACCREDITATIONS GLP archive (since 2004)

Dr Karsten Schilling Dr Schilling, head of the BU consumer products and cosmetics, has a PhD in veterinary medicine and more than two decades experience in this field. Dr Ingo Walter Dr Walter has a PhD in food chemistry. He has been with SCC since 2008, focusing on risk assessments, C&L and eMSDSs. Dr Monika Hofer – Head of Regulatory Science, Pharma PreClinical Dr Hofer has a PhD in chemistry. She has been with SCC since 1998 as head of Regulatory Science, Pharma Pre-Clinical. Dr Albrecht Heidemann – Head of Agrochemicals and Biopesticides Dr Heidemann has a PhD in biology. He has been with SCC since 1994 as head of Agrochemicals and Biopesticides. Dr Hans-Josef Leusch – Head of Biocides Dr Leusch has a PhD in agronomy. He has been with SCC since 2000 as head of Biocides. Dr Bernd Brielbeck – GLP Archive Dr Brielbeck has a PhD in chemistry. He has been with SCC since 2001 and is responsible for our GLP-certified archive.

PARTNERS Through our Headquarters in Bad Kreuznach (Germany), our Office Berlin and our Liaison Office Japan, we have a global network with CROs, governmental institutions, local regulatory experts and scientists. We can support our clients all over the world. CLIENTS Small to large (global) companies in the areas of chemicals and consumer products, agrochemicals and biopesticides, biocides, feed and food additives and food contact materials.

Chemical Watch | Global Service Providers Guide 2016

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PROFILE: SCC

Registration of consumer products

CASE STUDY: General remark

PROFILE: Sustainability Support Services (Europe) AB

SERVICE AREA BREAKDOWN Training 10% Legal 10%

CONTACTS

IT & software 10%

Website

www.ssseurope.org

E-mail

sk@reach-onlyrep.eu

Head office

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

Tel

+46 46 2850418 & +46 46 2114615

Contact

Shisher Kumra

Directors

Shisher Kumra and Mukta Kumra

Ownership

Private Limited Company

Locations

Sweden and India

Founded

2008

Sweden, India and affiliate in South Korea SERVICES PROVIDED Late pre-registration (LPR)

SSS is one of the most sought after chemical regulatory compliance service provider based in Sweden. Today, SSS has diversified its service portfolio to also include conformity assessment and compliance management services. SSS services have the distinction of being accredited as a third party inspection services for chemical regulatory compliance, with special focus on REACH; as per the ISO 17020 standard. All regulatory compliance activities of SSS are processed through this system. SSS also provides neutral third party inspection services to textile exporters for confirming adherence to the code of conduct of the European apparel brands. SSS has an extensive network of European, Indian and other Asian business intermediaries and has been working to facilitate businesses to comply with the requirements of REACH and various other European regulations as well as the chemical regulations in place in other countries like USA, China, Japan, South Korea, Malaysia, Canada, etc. SSS has a memorandum of understanding (MoU) with the following organisations, namely OO TISAMAX Technical Co., Ltd, OO China Chamber of Commerce of Metals Minerals and Chemicals (CCCMC); and OO China International Electronic Commerce Center (CIECC). OO Randis ChemWise (Shanghai) Co.,Ltd, China SSS is also actively contributing towards the finalisation of India’s National Chemical Policy (NCP), Hazardous Substances (Classification, Packaging and Labelling) rules sometimes referred to as India GHS and the National Chemical Inventory, a demonstration of which has been recently presented to the Indian Chemical Ministry. SSS and its group company in India are all geared up to help companies comply with the Indian regulations when they become a law. 2015/16

Turnover, group

€2.8m

Turnover, chemical service provision

€2.5m

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

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Laboratory 10% Representation & management 10%

GLOBAL OFFICES

OVERVIEW

VITAL STATISTICS

Consultancy/advisory 50%

SSS offers LPR services to help non-European companies, either new manufacturers or first time exporters of substances, to late pre-register their substances that were not pre-registered during the June-December 2008 period. Since the pre-registration deadline, SSS has successfully completed the LPR for 1783 substances, with more in the pipeline. CLP notification SSS provides the CLP notification services to non-European companies for which the company has to furnish the identity of the substance like the CAS No, EC No. SSS has successfully completed over 1862 CLP notifications. Registration Since 2011-12, SSS is working very hard to help its client companies successfully meet the last registration deadline of 31 May, 2018. SSS successfully registered around 225 substance; including 125 substances as the lead registrant by the end of 2014 and is expected to help its clients register around 500 chemicals by the last REACH registration deadline of 31 May’ 2018. REACH and CLP compliant SDS SSS is also engaged in compiling the 16 point REACH and CLP compliant SDS for the chemical substances and preparations meeting the criteria of classification as dangerous. Extended SDS (e-SDS): SSS also provides e-SDS for the classified registered substances with the relevant exposure scenarios that have to be annexed to the SDS. SDS translation: SSS also provides the service of translating the SDS into other languages of European member states (for example, German, French, Spanish, Dutch, or Italian). SSS has till date prepared over 2955 REACH & CLP compliant SDS. Compliance with K-REACH The Act on the Registration and Evaluation of Chemical Substances (ARECS) regulation also known as K-REACH has come into effect in South Korea from 1 January 2015. Non-Korean suppliers (through their OR) have the obligation of annual reporting of the use and tonnage to Ministry of Environment (MoE), Korea, which will be starting from 1 January 2016 for all phase-in chemicals. This shall be for the exports done from January - December 2015. For the companies approaching SSS with a request for this service, SSS has started offering the services of OR representation and annual tonnage reporting within the K-REACH regulation.

Chemical Watch | Global Service Providers Guide 2016

Companies exporting articles to European countries need to confirm the presence or absence of substances of very high concern (SVHC) and the REACH compliance obligations. SSS offers a very economical and technically sound solution to these companies for fulfilling their REACH obligations and certification requirement of their European buyers. This solution is in line with the guidance provided by Echa. So far, SSS has provided this service to many Indian and Asian companies exporting articles/substances to Europe. SSS also provides compliance assistance on the following: OO OO OO OO OO

GHS; Proposed – Indian National Chemical Policy and India GHS; China REACH; and Compliance with chemical management in Malaysia (EHSNR); and Responsible person service within European cosmetic regulation.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2008

Established and registered as a private limited company.

2008

Successfully pre-registered over 7,000 substances within REACH.

2009

Professionals trained in Iuclid from REACH Centrum.

2009

Trained over 100 industry professionals in use of Iuclid.

2010

35 REACH registrations successfully completed.

2010

Delivered 1,500 REACH and CLP compliant SDS.

2011

Acquired capacity in Chesar and Qsar.

2011

Mandated as lead registrant for 50 substances.

2012

Mandated as lead registrant over 60 additional substances.

2013

Successfully registered over 225 chemicals by the 2013 deadline.

2014

Over a dozen companies (20 companies) changed over to SSS as the OR from their earlier OR.

2015

SSS group company is accredited as a certified inspection body.

2016

SSS has an affiliate in S.Korea to offer services pertaining to K-REACH compliance.

PARTNERS OO OO OO OO OO

Confederation of Indian industry (CII), India China International Electronic Commerce Center (CIECC), China Tisamax Technical Co. Ltd (Tisamax), Taiwan Randis ChemWise (Shanghai) Co.,Ltd, China Associated with Ricardo’s CareChem24 chemical emergency helpline services through its Indian group company NS Support Services Pvt Ltd

CLIENTS

global achievement for any OR service providing organisation wherein all its compliances shall be inspected and validated prior to completing the compliance process request of its clients. This shall ensure accurate regulatory compliance and conformance with the technical product standards. CASE STUDY 2: SSS and its sister concern have jointly initiated a Forum for review of Global Chemical Regulatory Updates Problem: Chemical exporters of India were finding it difficult to keep themselves updated of the changing chemical regulations requirement and therefore expressed the need to SSS to provide a suitable solution for the same. Solution: In October 2015, the inaugural meeting of the Forum was held in Mumbai, India, to discuss the upcoming REACH like regulation in South Korea. It was well attended by all the invited chemical companies. The SSS team briefed the company representatives on their roles and responsibilities to comply with this upcoming regulation. The Forum provides the companies the much required platform for discussing global chemical regulatory updates to be prepared in time rather than facing difficult situations of noncompliance. It is envisaged that the Forum shall meet twice or thrice a year depending upon the need in order to help the company’s understand the regulatory requirements and facilitate compliance. CASE STUDY 3: Guidance to many Sief members for successfully completing their REACH registration in the 2013 deadline Problem: SSS received requests from considerable Sief members to provide know-how on how to complete the REACH registration process as they were unaware of the same. Solution: The technical team at SSS, provided the know-how to the Sief members relating to the finalisation of their registration dossiers, TCC clearance and submission of the member dossier on the REACH-IT by joining the joint submission (JS). Some of these requests were received very close to the deadline and the timely inputs from SSS helped companies meet their registration deadline. STAFF SELECTION Mr Shisher Kumra – Executive Director Area of expertise includes specialisation in regulatory affairs, legal expertise, chemical assessment, toxicology. Dr Rashmi Naidu Area of expertise includes REACH data inventory, REACH registration process, environmental toxicology, bio-assay and other regulatory affairs. Mr Shrirang Bhoot Area of expertise includes specialisation in the software’s like Iuclid, Qsar, Ecosar, dossier preparation, eco-toxicology. Dr Chitralekha Datta Area of expertise includes chemical safety assessment (CSA), chemical safety report (CSR), toxicology, software like Iuclid, Chesar and CLP.

SSS has 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.

Dr Shruti Ralegaonkar

TESTIMONIALS

Responsible for evaluation of toxicological reports and for dossier quality assurance for toxicological endpoints and CSR.

On the service quality criteria, 97% of our client companies have rated the REACH compliance assistance services being offered by SSS as very good. CASE STUDY 1: SSS group company in India is accredited for an internationally recognised standard for inspection bodies With a view to provide quality regulatory compliance services to its client companies, SSS has helped prepare its Indian group company in getting accredited to an internationally recognised standard for the competence of inspection and certifying bodies. This is probably a first of its kind Chemical Watch | Global Service Providers Guide 2016

Area of expertise includes REACH and Articles, SVHC assessment and REACH compliance verification. Dr Martina Holst

Dr Cecilia Hultin Responsible for evaluation of Eco-toxicological reports and for dossier quality assurance for the Eco-toxicological endpoints and CSR. Ms Hyunju Jeong Manages the activities related to K-REACH compliance and coordination with the Korean regulatory authorities in the capacity of Korean representative at SSS. Page 153

PROFILE: Sustainability Support Services (Europe) AB

SVHC applicability analysis

GLOBAL OFFICES The company has offices and representation in the UK, Italy, the US, Japan and China. SERVICES PROVIDED

PROFILE: The REACH Centre

CONTACTS

EU REACH

Website

www.thereachcentre.com

E-mail

enquiries@thereachcentre.com

Head office

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

Tel

+44 (0) 1524 510278

Fax

+44 (0) 1524 510588

Contact

Sandra Meijer

Directors

Jonathan Lutwyche Dr Kath Carr Dr Sandra Meijer Adam Rowntree

Ownership

Privately owned

Locations

UK, Italy, US, Japan, China

Founded

2007

OO OO OO OO OO OO OO OO OO OO OO

Regulatory services OO

OVERVIEW The REACH Centre is one of the leading international providers of regulatory guidance, scientific and analytical services, and training to industry in the field of chemicals management and risk assessment. Our integrated services ensure our customers are able to effectively manage and comply with current and future chemicals legislation. The REACH Centre employs a team of experts in chemistry, (eco) toxicology, environmental and occupational exposure, offering services for EU REACH, equivalent global notification systems, GHS and the EU CLP implementation, cosmetics, detergents and biocidal products Regulations, RoHS and conflict minerals, and the developing nanomaterials regulatory framework. Providing a global capability, the company has offices and representation in the UK, Europe, USA and Asia. VITAL STATISTICS

2015

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Global

Staff, group

Staff, chemical service provision

OO OO OO

OO OO OO OO OO

OO OO OO OO

Safety data sheets Classification to GHS and CLP Exposure scenarios for eSDS Product labelling and packaging

Scientific and analytical services OO OO OO OO OO

Substance characterisation Testing strategies for chemicals, including nanomaterials REACH exemption statements Data acquisition and management Chemical safety assessment and reporting

Chemicals management

Information 5%

Business impact assessment Member state notification Biocidal product authorisation Active substance approval Treated articles

Hazard communications

Training 10% IT & software 5%

Global regulations incling US TSCA, China MEP Order No. 7, Korea ARECS (K-REACH), Taiwan TCSCA and Osha, Japan CSCL and ISHL etc. OSPAR Conflict minerals and RoHS Toys, cosmetics, detergents and aerosols

EU biocides

SERVICE AREA BREAKDOWN

Laboratory 20%

Lead registration Joint registration Late pre-registration Only representative Third party representative Non-phase-in substance inquiry PPORD notifications Sief and consortia management Iuclid Authorisation Support ongoing responsibilities such as; monitoring on tonnages and regulatory status, supply chain communication, management of Echa fees.

Impact assessment Policies, procedures and management systems Regulatory and supply chain audits chemtrac® chemicals management solution

Technical expert services and legal support OO

Consultancy/advisory 40%

OO OO

Expert witness services Litigation support Substitution and product optimisation strategies

Training Representation & management 20%

Classroom courses, virtual classroom, e-learning and bespoke in-house training on REACH, hazard communications, Iuclid, biocidal products Regulation, OSPAR and Asian-Pacific regulations. ACCREDITATIONS Our training courses are approved by the Royal Society of Chemistry and by IOM3.

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Chemical Watch | Global Service Providers Guide 2016

Kath Carr – Director of Science

Our global customer base across 35 countries incorporates manufacturers, distributors and retailers across several industry sectors along with multiple trade associations and government bodies.

Kath established The REACH Centre's scientific service seven years ago and has built an extremely strong team of experienced chemists whose work is highly regarded across the chemical industry. One of Kath's particular strength's is her ability to resolve complex technical issues and she specialises in the characterisation of UVCB substances. She provides scientific support for The REACH Centre's lead and joint registration activities, for inquiries and for PPORD notifications. Her work is underpinned by her 18 years' industrial research experience in the speciality chemicals sector.

CASE STUDY 1: REACH A client has a portfolio of several hundred substances that potentially need to be registered in 2018. Working closely with the client, we have developed a robust strategy allowing them to ensure REACH compliance in the most cost-efficient manner. We first of all identified those substances that can be exempt from REACH as per Annex V. For the remaining substances, communication with the supply chain has been undertaken to explore the options for taking advantage of only representatives and re-imports. An action plan has subsequently been put into place to ensure all relevant substances are going to be registered, with the client acting either as joint or as lead registrant. Undertaking this work early on has been essential in order to ensure compliance throughout. CASE STUDY 2: Sameness and substance identity A client had developed a new hydrocarbon-based UVCB and needed to submit both an Inquiry dossier and a lead registration dossier. The REACH Centre was able to demonstrate substance identity to Echa in the Inquiry through rigorous analytical characterisation. Using this information, it was possible to identify similar substances for read-across purposes. This involved a considerable amount of background literature research, which identified a shortlist of options from which the most similar substance was identified. As a result, the client was able to purchase data for read across, thus avoiding unnecessary animal testing and reducing the overall cost of registration. CASE STUDY 3: Biocides A number of clients have developed devices which use in situ generated active substances to produce a biocidal effect. These devices are newly under the scope of the biocidal products Regulation (BPR). The REACH Centre’s expertise was used to determine the regulatory requirements associated with marketing the devices in the EU under the BPR. Collaboration between the scientific and analytical team and the regulatory management team allowed The REACH Centre to conduct thorough literature searches and data gap assessments to identify data which may be used in an active substance approval submission while keeping up to date with the latest information on the management of in situ generated active substances from the EU Commission. This has included representing clients at meetings with EU member state competent authorities, in particular with a view to understanding where data adapted in accordance with the provisions of the BPR. For example, exposure based waiving may be accepted by the evaluating competent authority, with a view to allowing those clients to build compliant dossiers with a significant cost saving against the cost of commissioning studies which may be scientifically unjustified. STAFF SELECTION Sandra Meijer – Director of Business Development Sandra manages our Regulatory Management Services team. As a recognised expert on REACH and chemicals management, Sandra has taken the lead on numerous lead registration projects, SVHC and REACH audits and in developing our chemtrac chemicals management solution. Sandra is a well-known speaker and principal trainer for the oil trading and automotive industries. She delivers classroom and bespoke REACH training. Sandra is an honorary fellow of Lancaster University's LEC.

Chemical Watch | Global Service Providers Guide 2016

Alex Paul – Managing Regulatory Consultant Alex oversees The REACH Centre's Asian business activities including the management of lead and joint registrations for non-EU clients and the provision of only representative services. In addition to maintaining and further developing The REACH Centre's strong position in Japan through collaboration with our strategic alliance partner JEMAI, Alex is responsible for developing new partnerships and business in Asia as Asian countries implement REACH-like notification systems. Since 2014, The REACH Centre has established new partnerships in China, South Korea, Thailand and Taiwan. Alex formerly managed The REACH Centre's Hazard Communication Division which allowed him to become one of the world's leading experts in chemical classification regulations and is regularly invited to speak at workshops and seminars on the subject. Rosalinda Gioia – Managing Regulatory Scientist Rosalinda is an internationally recognized expert on ecotoxicology and is highly experienced in understanding chemical regulations. She has provided expert scientific advice and policy support to government regulators on chemical risk assessments relating to the oil and gas industry, for which she has authored technical bulletins and papers to the annual meeting of OSPAR's Offshore Industry Committee (OIC). Rosalinda project manages REACH lead registrations and biocides active substance approval and product authorisation dossiers. She also provides technical leadership and advice relating to the environmental fate of chemicals, persistence, bioaccumulation and toxicity (PBT) and risk assessments in the aquatic environments. Siobhan Murphy – Senior Regulatory Scientist Siobhan leads The REACH Centre's biocidal product consultancy services, including biocidal product authorisation and biocidal active substance approval applications, member state marketing approvals, and ensuring compliance of treated articles. In addition, Siobhan is responsible for the management of data for REACH lead registrations and the coordination of Iuclid 5 dossiers. Siobhan leads The REACH Centre's biocides training, along with Iuclid training for both REACH and biocidal regulatory applications. Tarn Brown – Managing Regulatory Consultant Tarn heads The REACH Centre’s Hazard Communication department and manages our SDS scheduling and delivery services. Her focus is the development of services including SDS and eSDS compilation, and the full range of classification, labelling and packaging (CLP) services. Tarn also has extensive knowledge and expertise in REACH, DSD/DPD, the EU detergents Regulation, EU aerosols Directive and in UN Transport of Dangerous Goods.

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PROFILE: The REACH Centre

CLIENTS

SERVICES PROVIDED

PROFILE: Triskelion B.V. I a TNO company

Risk assessment and chemicals management Our focus is on REACH and its implementation. Besides registration, authorisation and building exposure scenarios, we support the evaluation of risk management options. We can audit your own implementation and communication under REACH and its eSDS’s. Additionally, we support biocides and the safe use of nanoparticles. TNO and Triskelion B.V. have together developed a range of assessment tools to help evaluate human exposure and to avoid and reduce health risks. Our expertise is available to address your regulatory issues as well as to solve your day-to-day chemicals management problems.

CONTACTS Website

www.triskelion.nl

E-mail

chemistry@triskelion.nl

Head office

Utrechtseweg 48, PO Box 844, 3700 AV Zeist, The Netherlands

Tel

+31 88 866 16 28

Fax

+31 88 866 69 70

Contact

chemistry@triskelion.nl

Ownership

Private company, wholly-owned by TNO

Locations

Zeist, The Netherlands

Founded

TNO, 1933; Triskelion B.V., 1/1/2011

Experimental toxicology

OVERVIEW It is important for you to unequivocally demonstrate the quality and safety of your products. This is at the heart of our business. Triskelion B.V. safeguards the use of chemical products through individual attention, personal advice and excellent research. Our chemical risk assessment services combine research-driven excellence in the classical disciplines of toxicology and advanced analytical chemistry, with new developments in risk assessment, in order to produce intelligent testing strategies and thereby, cleaner, safer, chemical products. VITAL STATISTICS

2014/15

Turnover, group

€30m

Turnover, chemical service provision

€15m

No of offices

No of countries represented

Staff, group

200

Staff, chemical service provision

150

SERVICE AREA BREAKDOWN Training IT & software 5% 5% Consultancy/advisory 30%

Analytical chemistry Triskelion B.V.’s analytical research centre, with its history of TNO R&D excellence, has expertise in developing challenging analytical chemical methods for a very broad range of substances including: organotins, fluorocarbons, formaldehyde, biocides, pesticides, fragrance materials, to name but a few. At the interface of the fields of toxicology and risk assessment, our tailor-made services can make a difference, for example: OO test substance identification and characterisation; mechanistic studies of toxic compounds in vivo using sophisticated analytical techniques; OO human and environmental exposure studies in various settings (industrial, agricultural). Food packaging petitions, migration testing and plastics recycling Triskelion B.V. offers regulatory affairs services, migration and toxicity testing of food contact materials (FCM) for petitions to the European Food Safety Authority (Efsa) and for food contact notifications (FCN) to the US Food and Drug Administration (FDA). Examples are monomers and additives used in plastics described in Directive 2002/72/EC. We sharpened our knowledge by participating in the technical committees of the Efsa. How we work

Laboratory 45% Representation & management 10% Information 5%

GLOBAL OFFICES Headquarters group TNO: The Hague, The Netherlands Headquarters group Triskelion B.V.: Zeist, The Netherlands Sales Offices: Japan, USA, Canada and Turkey

Page 156

We offer high quality toxicology studies, specifically tailored to the needs of REACH, biocides, pesticides and nanomaterials customers. Our toxicological research centre provides new and improved methods in toxicology, especially inhalation, reproduction, immuno-toxicology and (in vitro) skin adsorption. We have been developing novel methods to reduce, refine and replace animal testing for nearly two decades and are proud of our performance record in this field, especially resource saving combined in vivo studies such as repeat-dose (28/90d), repro screening and in vivo genotoxicity (also Comet assay) in the same study. We can offer the OECD 443 guideline for an extended one-generation reproduction toxicity (EOGRTS) study, with already several studies performed in our laboratories.

Project management – your assignment with Triskelion B.V. is always led by one of our experienced project managers, your primary contact person, who manages your project, interacts with the scientific team, and ensures you that deadlines are met and that the assignment meets your needs. Your project manager maintains contact with you during phone and/or conference calls (scheduled as and when you require), and also provides regular update reports. 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) is reviewed by a senior staff member before being sent out to you. Relationship management – in addition to strong project management, our sales and account managers are also there to assist you. Our customer services department is there to guide you to the correct technical contacts within Triskelion B.V., who will help you find the right solution.

Chemical Watch | Global Service Providers Guide 2016

1932

TNO The Netherlands Organisation for Applied Scientific Research is founded.

1946

Founding of the Central Organic Chemistry Institute in Zeist.

2004

Completion of five-year HPV programmes on various chemical groups including organotins.

2006

Participated in REACH implementation projects (data requirements, exposure assessment).

2007

Commenced REACH partnership with Sabic Europe.

2010

Successful completion of 325 full and partial REACH dossiers.

2011

Incorporation of Triskelion B.V. as a private company.

2011

ReachCentrum and Triskelion B.V. join forces to offer REACH workshops and training courses.

2012

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

2013

AAALAC accreditation obtained; REACH 2013 dossiers submitted on time!

2014

First EOGRTS study accommodated in our laboratory.

2015

Substantially expanded our animal facilities and made some mayor steps in becoming a larger global player.

ACCREDITATIONS In compliance with GLP (toxicology and analytical chemistry); ISO 9001 and AAALAC certified; Some analytical services under ISO 17025. PARTNERS TNO Quality and Safety (R&D): we work together with TNO on development of alternative toxicological methods and (bio)analytical methods. Where needed we supply additional services like ecotoxicology, physicochemical testing and special evaluations (as SEA) through our network of co-operators. CLIENTS Three top-10 and 15 top-50 global chemicals manufacturers are our clients. We have provided long-term chemical safety services to the following chemical sectors: fluorochemicals, hydrocarbon distillates, organotins, biocides, chlorinated solvents, fuel oxygenates, organic peroxides, formaldehyde, amines, polyols and isocyanates, silicates and mineral oxides (micro and nano grades), coal chemicals, fragrances. TESTIMONIALS “Triskelion B.V. recently performed a comprehensive risk assessment on behalf of our industry. As well as their knowledge and experience, and their scientific integrity, we have been impressed by their skill in communicating across the interfaces within the industry.” – Phil Hope, Secretary General, Formacare. "Since 2007 Triskelion B.V. has supported Sabic in all aspects of REACH and other Product Stewardship assignments. It is a thorough and scientifically reliable CRO for addressing compliance and product safety aspects of chemicals." – Harm Jan Krips, Sabic. “Triskelion B.V. has been supporting BASF SE in a variety of registration activities since the beginning of REACH. WE were and we are impressed by the broadness and depth of the expertise, the professionalism in conducting complex projects and their flexibility to adhere to our time requirements.” – Edgar Leibold, BASF SE.

Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 1: Successful registration within REACH, post-2010 2013 follow-up and 2018 preparations With Phase II REACH registration completed by mid-2013, within 2014 and 2015 a number of our customers already started with REACH 2018. We can combine the necessary data searches, propose testing where needed, perform a chemical safety assessment, and prepare chemical safety reports and eSDS, all under the same roof. Results from several 2010 substance evaluations are coming in and it’s clear that authorities may have in-depth questions on specific parts of your dossiers, for example the DNEL derivations, exposure assessment and read across justifications. We will support you in the communication with Echa and take care of your dossier update. Based on our extensive experience, Triskelion B.V. will help you plan the registration, guide you through the process, and work with you to ensure timely and successful registration for 2018 as well. Grouping and read across will be needed to keep costs down. Feedback of Echa and member states on 2010 and 2013 dossiers has shown that more data development is needed to support this. CASE STUDY 2: Echa test proposal evaluations including EOGRTS REACH requires that for substance volumes of 100-1,000t and >1,000t, missing higher tier safety studies be included in the registration dossier in the form of a test proposal. Echa is in the process of evaluating these proposals and (draft) decisions are being sent to lead registrants. Many have already been published on the Echa website and were open for public comment for several weeks. OO Our advice to clients faced with an Echa test-proposal that diverges from their own, is to enter, as far as possible, into a dialogue with Echa. We can help develop and support the scientific arguments to support your case to Echa. OO Should testing be needed, Triskelion B.V. is specialised in higher tier testing with difficult test materials. Our inhalation toxicology skills cover gases, volatile liquids, solids and nano-grade materials, while our reproduction toxicology skills are second to none and include the EOGRTS (OECD 443). We were involved in the guideline development of OECD443. Therefore several EOGRTS studies were already performed. Triskelion B.V. is well equipped to perform several OECD443 studies with the most challenging substances; e.g. by inhalation. CASE STUDY 3: Authorisation Is your substance included in the candidate list or even already prioritised for authorisation? Based on our substantial experience in dealing with consortia and sector groups, including downstream user communication, and our strong expertise in exposure and risk assessment, we will support you with: OO advocacy and strategic support, including communication; OO appropriate responses to candidature or Annex XIV prioritisation; OO formal replies to Echa notices; OO revision and optimisation of the chemical safety report and exposure scenarios; OO socio-economic analyses and report writing; OO analysis of alternatives; OO preparation of substitution plans; OO application for authorisation. STAFF SELECTION Our key staff members have long experience in the analysis, testing and risk assessment of a wide diversity of substances for the chemical, pharmaceutical and food industry. This solid background is applied to your substances as well. A steady inflow of young academics ensures that we remain vigorous and up to date.

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PROFILE: Triskelion B.V. I a TNO company

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Based in Brussels, we are up-to-date on the latest EU developments and regulatory changes. This, coupled with our access to experts in the European institutions and member states, allows us to best represent the interests of our clients. Thanks to the international nature of our team, we interact with our clients in various languages including English, German, French, Italian, Portuguese and Hindi.

PROFILE: ToxMinds

CONTACTS

Chemical and product safety

Website

www.ToxMinds.com

E-mail

info@toxminds.com

Head office

116, Avenue de Broqueville, 1200 Brussels, Belgium

Tel

+32 (2) 762 91 45

Fax

+32 (2) 762 91 46

Contact

Ms Silvia Balletta

Directors

Dr Thomas Petry Dr Francesca Tencalla

Ownership

Private company

Locations

Belgium, Germany

Founded

2006

OVERVIEW ToxMinds BVBA is a product safety and regulatory affairs firm located in Brussels, Belgium. Our passion and motivation is the use of good science, but we also understand the reality of our tightly regulated chemical world. With our broad industry experience, we support our customers in bringing safe, regulatory compliant and publicly acceptable products to the market. VITAL STATISTICS

2014/15

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

10 - 25

Staff, chemical service provision

10 - 25

SERVICE AREA BREAKDOWN

Consultancy/advisory 75%

GLOBAL OFFICES Brussels, Belgium SERVICES PROVIDED Our core team of industry-experienced toxicology, environmental and regulatory affairs consultants and analysts provides chemical safety, regulatory and product stewardship support to the following industries: OO industrial chemicals; OO biocides; OO agrochemicals; OO cosmetic and consumer products; and OO green biotechnology.

Page 158

Regulatory strategy and compliance Our team of regulatory experts supports and guides our clients through all the necessary steps to achieve regulatory compliance with European regulations for industrial chemicals, consumer and cosmetic products, biocides and agrochemicals. Our regulatory services include: OO portfolio review and regulatory strategy consulting OO registration dossier preparation under: OO REACH Regulation (EC) No 1907/2006; OO biocidal product Regulation (EU) No 528/2012 (‘BPR’); OO plant protection product pegulation (EC) No 1107/2009 (‘PPPR’); OO preparation of SCCS-compliant cosmetic ingredient dossiers; OO post-submission support, including the preparation of responses to authority requests or advocating and defending scientific approaches with public authorities; and OO cosmetic product information files (PIF). Product stewardship

Training Information 5% 5% Representation & management 15%

Our chemical and product safety services include: OO literature and desktop searches; OO quality analysis, study summaries and presentation of information related to the effects of chemicals on human health and the environment; OO structure activity analysis (Qsar); OO analogue identification and chemical similarity assessments; OO data gap analysis under consideration of non-testing approaches; OO identification of intelligent hazard assessment and testing approaches ('Iata') to fill information gaps, including: OO non-testing hazard and safety assessment strategies OO hypothesis and mechanism-based in chemico and in vitro testing OO in vivo testing strategies; OO (eco)toxicology study monitoring and management; OO exposure modelling using REACH, BPR or PPPR recommended modelling tools; OO tiered human and environmental risk assessments; and OO green chemistry and R&D candidate evaluations.

We support our clients in their product stewardship activities with the following services: OO development of REACH-compliant extended safety data sheets; OO generation of ICCA-compliant product safety summaries; OO tailored trainings to PS and RA or product stewardship staff on, for example: OO principles of human and environmental hazard, exposure and risk assessment of chemicals; OO Qsar modelling and hazard-specific endpoint training; OO regulatory frameworks and related IT tools (eg, Iuclid); OO REACH exposure modelling and CSR/CSA creation software; OO creation of REACH-compliant extended safety data sheets (eSDS); OO establishment and moderation of scientific review panels; OO science-based advocacy and client representation with regulatory authorities; and OO hazard and risk communication to various audiences. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006

Creation of ToxMinds BVBA

2009

Opening of ToxMinds headquarters in Brussels

2014

Collaboration with Deskin Associates LLC to provide direct support to US-based clients

Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 4: Biocides

ToxMinds provides (eco)toxicology, product safety and regulatory compliance services to a wide range of multinational fortune 100 companies, SMEs, and industry associations from the chemical, biocidal, plant protection, metal/mining, consumer product, biotechnology and pharmaceutical sectors.

We work with manufacturers of biocidal actives and products to ensure chemical/product safety and regulatory compliance under the BPR. In this context, our activities include: OO portfolio review and strategic consulting; OO identification of data gaps and management of testing programmes; OO development of Iuclid datasets and documents required to register biocides under the BPR; OO human and environmental exposure modelling and risk assessment OO determination of classification of substances and mixtures under the CLP/GHS; OO BPR registration management, including data sharing discussions; OO post-submission support and client representation with EU regulatory bodies; and OO consortium management and client representation in technical advisory groups.

TESTIMONIALS “We have been working with ToxMinds BVBA for many years on various complex toxicology, ecotoxicology and regulatory issues. The professionals at ToxMinds are thorough, knowledgeable and always meet the demands and difficult timelines […]. We continue to rely on ToxMinds as experts in the fields of toxicology, ecotoxicology and EU regulatory compliance.” – Senior regulatory manager, international specialty chemical company. CASE STUDY 1: REACH support ToxMinds provides REACH support for a number of consortia as well as individual chemical companies. Our technical work includes: OO desktop research and data gap analysis; OO Qsar modelling and analysis; OO design of intelligent testing strategies; OO placement and monitoring of testing programmes; OO development of Iuclid 5 registration dossiers, chemical safety assessments and reports (CSR); OO strategy advice and support during registration and evaluation phases; OO client representation in discussions with authorities; and OO strategic and technical support during application for authorisation. CASE STUDY 2: Human and environmental risk assessment Our (eco)toxicology consultants have extensive experience in conducting human and environmental risk assessments of commodity and specialty chemicals. The human health risk assessments considered human exposures to chemicals at the workplace, in indoor/outdoor air or due to their release from consumer products such as cosmetics, cleaning or pest control products. The environmental assessments typically included environmental fate and ecotoxicity evaluations of chemical releases into the environment at manufacturing or usage sites, field uses in the case of agrochemicals or from “down the drain” consumer products. CASE STUDY 3: Non-animal testing based chemical safety assessments ToxMinds is supporting chemical and consumer product companies in identifying non-animal testing based safety assessment approaches. We use a transparent rule-based SAR- and analogue identification process to support business strategies and regulatory submissions. The process can also be applied in a general product safety or product stewardship context. Our integrated process takes into account predicted chemical similarity and reactivity, structure activity, physico-chemical properties, metabolic pathways and toxicokinetic behaviour. In case toxicological data gaps are identified, a strategic testing approach to meet a regulatory purpose is proposed by taking into account the existing understanding of a chemical’s mode of action along the adverse outcome pathway (AOP). This process allows for the prioritisation of candidate chemicals (eg, biocidal actives, food contact materials, cosmetic ingredients) for further R&D qualification at early stages of the R&D cycle by considering hazard profile, predicted testing costs and expected time to completion of the required testing programme. In a more regulatory context, available tools are used to support guideline-compliant read-across and/or grouping approaches or for REACH phase III chemical portfolio prioritisation.

Chemical Watch | Global Service Providers Guide 2016

STAFF SELECTION Thomas Petry, PhD, ERT, DABT Dr Petry, Managing Director of ToxMinds BVBA, is a product safety and regulatory affairs consultant with more than 20 years’ industry, consulting and research experience in the human safety assessment of chemical exposures occurring at the workplace through their use or presence in consumer products or via the environment. He is a European registered toxicologist (ERT) as well as a Diplomate of the American Board of Toxicology (DABT). Francesca Tencalla, PhD, ERT Dr Tencalla, Director at ToxMinds BVBA, is an (eco)toxicology and regulatory affairs consultant with more than 20 years of industry and research experience in the human and environmental safety assessment of chemicals, metals, agrochemicals and pharmaceuticals. She is a European registered toxicologist (ERT). Louise Assem, PhD Dr Assem is a senior toxicology and regulatory affairs consultant with more than ten years of consulting experience in the human hazard and risk assessment of chemical substances. Louise is a trained chemist and (eco)toxicologist and earned her PhD in molecular environmental toxicology from the University of Birmingham. Sanghamitra Mishra, MPharma Mrs Mishra is a consultant at ToxMinds BVBA. She supports the team in (eco)toxicological hazard assessments, desktop searches, review of study protocols, data gap analysis, Qsar modelling, compiling of Iuclid files as well as classification and labelling of substances and mixtures as per CLP and GHS. She also has substantial experience with study valuations and REACH dossier (‘LoA’) cost calculations. Sanghamitra obtained a Master’s degree in Pharmacology from the Indian Institute of Technology (IIT). Daniela Jeronimo Roque, MSc Ms Jeronimo Roque is a consultant at ToxMinds BVBA. She specialises in the area of human and environmental exposure modelling as for example required under the REACH, BPR and agrochemicals regulation. She further supports our team in developing and compiling registration files, conducting (eco)toxicological hazard and risk assessments as well as providing ad-hoc regulatory analyses. Daniela has a biomedical license in life science and health/biology with a specialisation in Nutrition. Monica Autiero, PhD Dr Autiero is a consultant at ToxMinds BVBA. Monica specialises in nonanimal based safety assessments with particular focus on Qsar modelling and identifying analogue and grouping-based hazard assessments approaches. Monica is a trained biologist with a PhD in biochemistry and molecular biology from the University Paris XI.

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CLIENTS

GLOBAL OFFICES The Hague,The Netherlands New York, 30 Wall Street, 8th Floor,USA SERVICES PROVIDED Chemicals management software

PROFILE: Trade Wind B.V.

CONTACTS Website

www.twnl.com

E-mail

info@twnl.com

Head office

Haagsche Hof, Parkstraat 83, 2514 JG The Hague, Netherlands

Tel

+31 70 214 3040

Fax

+31 84 747 24 99

Contact

Mrs Daniëlle Nuijten-Dijns

Directors

Mr Harro Elsborg

Ownership

Elsborg Holding B.V.

Locations

The Hague, Holland

Founded

1998

Implementation, optimising, supporting and training on ExESS of Lisam Systems, one of the leading software solutions for SDS-drafting, translating and distribution of safety data sheets, exposure scenarios, volume tracking, health and safety, incident management and waste management. SDS-distribution management through DeDoks Our internet (SAAS) solution will take care of SDS distribution to your downstream users. It can be documents in a pdf-format, or links to SDSs already on your website. According to REACH art.31 you have to provide your recipient with an SDS when it concerns a classified substance or a classified preparation. DeDoks will take care of this and will also send new versions of the SDS to recipients that have received a previous version less than 12 months before. DeDoks will also allow you to publish your SDSs on your website from where they can be downloaded. This will be registered in order to be able to resend new versions. SDS authoring

OVERVIEW Trade Wind helps companies to fulfil their obligations with regard to drafting, translating and distributing safety data sheets. We can provide you with a state-of-the-art software system (ExESS) that will create and translate your SDSs into more than 45 languages and according to all local GHS-varieties. ExESS can also help you to manage your volume tracking, inventories, your complete H&S, maintenance etc. Any documents such as labels, work instruction cards and overviews can be created with just a few clicks of the mouse. Our internet solution DeDoks helps companies distribute their SDSs in pdf-format or be linked to URLs without any software needing to be installed. With the use of FTP or a webservice the process can be completely automated. If required all SDSs can be published on the internet within any website. Companies can outsource their SDS-authoring to SDS Authors (a Trade Wind brand). We will assess your raw materials and, on the basis of your formulations, draft your SDSs, translate them and even distribute them to your customers. VITAL STATISTICS

2014/15

Our SDS-outsourcing service will take care of all your worries as it comes to creating, translating and distributing your SDSs. Our team is able to draw up your documents according CLP and most of the other GHS dialects in the world. We have 45 languages available. SDSs can be designed according to your wishes; fonts, colours and layout can be adjusted to your needs. Documents are available in pdf of Word-format. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1998

Establishment of Trade Wind B.V.

2002

Distributor agreement with Lisam Systems Belgium

2011

ExESS becomes part of the portfolio

2011

Reach Annex II and CLP seminar (120+ attendants)

2012

DeDoks for SDS-distribution is operational

2013

Dutch paint industry implements DeDoks for all members (VeiligmetVerf)

2015

Establishment of SDS Authors, New York

PARTNERS

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

CLIENTS

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

Training 10% Legal 10%

Lisam Systems Belgium Lisam Telegis, Paris Dutch Paint Association (VVVF), AKZO, PPG, 3M, L’Oreal, Nestlé,Total, P & G, Ducros, Holland Colours Apeldoorn, Vlisco and many small to medium sized companies (250+ in the Netherlands, Lisam ExESS 700+ worldwide) ExESS users in the Netherlands and Switzerland: IMCD, Dunlop, Hunter Douglas, Vlisco, Helichem, Alpheios, Van Dam Bodegraven, Mardenkro, Mibelle (Migros).

Consultancy/advisory 40%

IT & software 20%

Information 20%

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“Trade Wind has provided us with a state of the art solution ‘VeiligmetVerf’ which enables the Dutch paint industry and its distributors to fulfil their REACH obligations to send SDSs and SDS updates to their downstream users electronically. The underlying solution DeDoks saves our industry at least € 700,000 each year.” – Martin Terpstra, managing director VVVF, Netherlands “Our SDS Software ExESS has enabled us to speed up the process of creating SDSs tremendously. Not only has the process been simplified, but also our possibilities have increased enormously: CLP, GHS (all area’s), 45 languages, all European OELs, labels, work instructions, detergent reporting, interfaces etc. All available within one system and easy to manage.” Herbert Meier, manager Dangerous Goods and Regulatory Affairs, Switzerland CASE STUDY 1 The Dutch Association of the Paint and Printing ink industry (VVVF), the Dutch Association of Adhesive and Sealants Manufacturers (VLK) and the Dutch Association of Paint Distributors (VVVH) have more than 200 company members. The Ministry of Economic Affairs was aware of the big administrative burden of distributing SDSs and launched a project to reduce this and its costs. The ministry, together with Trade Wind and the VVVF developed a solution by implementing additional functions to DeDoks to make it compliant with REACH and to tackle the problem of the wholesalers at the same time. The solution which was created has two main benefits. First of all, the new DeDoks (implemented as VeiligmetVerf or VmV) enables VVVF and the VLK members (paint and adhesive manufacturers) to distribute SDSs through the so-called ERP link. This can be done manually, by uploading an MS-Excel sheet with order information, or an FTPservice, or through a completely automated web service. At the same time, it allows downstream users (distributors and wholesalers) to use VmV for distributing SDSs to their customers in the same way as the manufacturers distribute their SDS to them. All they need to do is refer to the products that have already been uploaded by the manufacturers. When customers buy a product for the first time, they automatically receive an email with a deep link to the SDS (or the SDS in pdf-format). This means that they don’t need to look for their SDS on a website. By just clicking the deep link they immediately open the SDS. When a revised version of an SDS is published by the paint supplier, they receive a new deep link or a pdf-document (12 months period). The use of deep links has been approved by the inspectorates. By introducing VeiligmetVerf, the Dutch paint industry complies with REACH, reduces its costs and contributes to a saver workplace by getting the SDSs to the workplace faster and easier.

CASE STUDY 3: Van Meeuwen Lubrication BV outsources SDSauthoring to Trade Wind Since 2011 Van Meeuwen Lubricants and Van Meeuwen Chemicals have outsourced the drafting of SDSs. On the basis of formulations , supplier SDSs and physical properties we create the SDSs, with the Van Meeuwen corporate identity, in the languages that are required. SDSs are supplied within ten days, or within 24 hours depending on urgency. STAFF SELECTION Harro Elsborg – Managing Director Harro has a law degree from the University of Leiden and has been working in the industry since 2002. Previously he was a consultant and sales director at Cap Gemini. Chiho Tang (Bio-Pharmaceutical Sciences, Leiden) – Consultant Chris Meijboom (AMBI, IT and Organisation) – Consultant Meibo Cheng (Life Science and Technology, Leiden and Delft) – Consultant Mehenash Alidjan (BASc Life Science Research, Rotterdam) – Consultant Daniëlle Nuijten-Dijns – Office Manager

CASE STUDY 2: Alpheios Alpheios is one of the largest companies in the field of professional cleaning products, systems and strategies in the Benelux. When Alpheios was looking for a software system to help them to create high quality SDS’s, complying with the detergent Regulation (REGULATION (EC) No 648/2004), it chose ExESS. Not only are more than 1,000 substances, classified by Aise, in the database, but also all relevant functionalities (labelling of contents in Chapter 15 of SDS, ingredient data sheet on website, full listing of all ingredients for medical personnel) are available in the system. Exposure scenarios can be included and 45 languages are available.

Chemical Watch | Global Service Providers Guide 2016

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PROFILE: Trade Wind B.V.

TESTIMONIALS

SERVICES PROVIDED

PROFILE: TÜV SÜD Industrie Service GmbH

Only representative TÜV SÜD Industrie Service acts as reliable and impartial OR to numerous manufacturers of substances established outside the community. The obligations of an OR outlined in Article 8 of the REACH regulation comprise not only registration but also all obligations for importers under REACH. Calling in an OR has the following advantages: importers need not become active themselves, and manufacturers established outside the EU can bundle notifications and do not have to address each importer individually. We experience that often manufacturers address to us when their previous OR failed to act to their satisfaction or did not fulfil its obligations.

CONTACTS Website

www.tuev-sued.de/plants_buildings_technical_facilities

E-mail

REACH@tuev-sued.de

Head office

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

Tel

+49 / 89 / 5791-1004

Fax

+49 / 89 / 5791-1174

Contact

Dr Dieter Reiml

Ownership

TÜV SÜD Holding AG

Locations

TÜV SÜD Group employs more than 22,000 people in 80 countries in ca. 800 locations

Founded

1866

REACH initiative for mid-sized and small companies All companies must register their chemicals by mid-2018 at the very latest – which is especially challenging for small and mid-sized businesses! TÜV SÜD aims to help these companies ensure that REACH is not a threat, but a path to safeguarding business. With the special needs of small and mid-sized companies in mind, TÜV SÜD has created a service package that provides these companies with assistance in all questions related to chemicals. The spirit of initiative: focus on your core competences, not on REACH. Authorisation

OVERVIEW The principle of REACH, "No data, no market", may seem alarming. Additionally, comprehensive obligations governing the provision of information along the supply chain and to Echa have came into effect. 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. In view of the 2018 registration deadline TÜV SÜD developed a service package custom tailored for small and medium-sized enterprises (SME) as well as for global players. Since 2013 we have expanded our range of services to biocides. Our maxim is “REACH – Made easy with TÜV SÜD expertise.” VITAL STATISTICS

2015/16

Turnover, group

€2,060m

Turnover, chemical service provision

No of offices

800

No of countries represented

Staff, group

20,200

Staff, chemical service provision

SERVICE AREA BREAKDOWN IT & software 10% Laboratory 5%

Training 5% Consultancy/advisory 35%

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 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; 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

Information 10%

1926

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

1960

Establishing chemical services

Representation & management 35%

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

GLOBAL OFFICES Japan, Singapore, China, India, Croatia, Indonesia, Thailand, Vietnam, Serbia, Russia, Ukraine, South Korea, USA Page 162

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Expansion of services in Asean by acquiring Singaporebased PSB Group

2007

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

ACCREDITATIONS GLP CLIENTS Due to client confidentiality individuals cannot be named. Our clients from more than 30 countries are active in all fields of industry and professional sectors. We support a network of chemical plants. Company size varies from worldwide operating entities to SMEs. We support clients in all their roles under the REACH regulation and for all types of substances. In 2013 we expanded our range of services to biocides as to the biocides products Regulation. CASE STUDY 1: Consortium management A consortium with representatives from five countries took over to register a series of substances with registration deadlines from 2010 to 2018. The duty to act as lead registrant was shared among the individual consortium members. The main bodies of the consortium are the steering committee, the technical committee and the secretariat. TÜV SÜD rendered consortium management to all bodies. Technical REACH consultancy and financial consultancy was part of the services to be delivered. CASE STUDY 2: Support in REACH implementation An EU manufacturer of articles and substances required support in implementing a REACH system for the entire company. The tasks focused on communication in the supply chain, registration, SVHC, training and organisational building. A team was formed for continuous assistance; the core team was fully integrated in the client’s activities on-site. CASE STUDY 3: Complete service package for lead registrants Several clients from the chemical industry lacked capacity to prepare lead dossiers. TÜV SÜD prepared and submitted the lead dossiers on behalf of the clients. Additionally, all accompanying steps were performed as well: Sief communication, data-gap analyses, testing, expert statements, Qsar modelling, communication within consortium, preparation of safety data sheets, cost calculation of letter of access, handling of letter of access. CASE STUDY 4: Testing strategies and testing The lead registrant of four substances had to conduct studies in order to fulfil the information requirements under REACH. Two of the substances were classified as hazardous according to CLP, the classification of the others was not yet clarified. TÜV SÜD performed all steps to comply with the information requirements. All available information that had been gathered was assessed for its adequacy for classification and labelling. Cost for data sharing is one of the crucial issues of negotiations in Siefs. High quality data outsell a higher price than data of low quality. Some data gaps were closed by Qsar and read-across. Other data gaps had to be closed by testing following to a meaningful test strategy. TÜV SÜD operates its own GLP testing laboratory capable of performing all testing required by REACH. CASE STUDY 5: SVHC A EU-based group with legal entities in several member states was seeking support in making an inventory of SVHC of the articles put into market, as well as in implementing a system to comply with the duties to communicate information on SVHC in articles. TÜV SÜD offered an integrated approach over all affected legal entities in order to avoid duplication of work. Representative articles were selected for chemical testing in case of uncertainty on the presence or concentration of SVHC. Testing was performed in TÜV SÜD’s own chemical laboratory. As a result of the investigation and consulting, a unified system was Chemical Watch | Global Service Providers Guide 2016

implemented in the entire group. The system ensured full compliance with REACH Art. 33 to 36. Furthermore, supply contracts were amended to increase legal certainty, to avoid the risk of lawsuits and to avoid image problems. CASE STUDY 6: Only representative TÜV SÜD acts as OR for many non-EU manufacturers. In several countries this is performed by involving local TÜV SÜD offices. This approach guarantees direct contact to the end-client and avoids language barriers where applicable. Thus, also smaller non-EU manufacturers can benefit from OR services which are not sufficiently conversant with English and technical terms. STAFF SELECTION Dr Fritz Prechtl Fritz Prechtl is a chemist and certified REACH multiplicator with more than 30 years' professional experience. His core activities are OO only representative; OO preparing registration dossiers; OO communication up and down the supply chain; OO communication in Siefs and with authorities; OO complex role analyses; and OO regulatory affairs. Dr Dieter Reiml Dieter Reiml is a molecular biologist and certified REACH multiplicator with more than 30 years' professional experience. His core activities are OO consortium management; OO authorisation; OO only representative; OO preparing lead dossiers; OO CSA / CSR; and OO consultancy on REACH and CLP. Dr Daniel Mauder Daniel Mauder is a chemist and certified REACH multiplicator with ten years' professional experience. His core activities are OO preparing lead dossiers; OO CSA / CSR; OO supply chain communication; OO biocides; OO dangerous goods and OO consultancy on REACH and CLP. Ing. Rupert Scherer Rupert Scherer is an engineer and certified REACH multiplicator with 15 years' professional experience. His core activities are OO implementing REACH systems; OO supply chain communication; OO RoHS; OO management systems and IT; OO biocides and OO downstream users. Dr Yvonne Fery Yvonne Fery is a food chemist, toxicologist and certified REACH multiplicator with ten years' professional experience. Her core activities are OO toxicology; OO authorisation; OO supply chain communication; OO dossier preparation; OO finance management and OO consultancy on REACH and CLP. 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. Page 163

PROFILE: TÜV SÜD Industrie Service GmbH

2006

GLOBAL OFFICES TÜV SÜD Iberia S.A.U. (TÜV SÜD Process Safety): C/ Lope de Vega, 22-24. 08005 Barcelona, Spain. Taiwan Sales Office: 13F, No 83, Jian Sing Rd, SanMin Dist, Kaohsiung 807, Taiwan, ROC. SERVICES PROVIDED

PROFILE: TÜV SÜD Process Safety

CONTACTS

REACH and product safety

Website

www.tuv-sud.es/process-safety

E-mail

info.es@tuev-sued.es

Head office

C Lope de Vega, 22-24, 08005 Barcelona, Spain

Tel

+34 933 036 612

Fax

+34 933 036 612

Contact

Montserrat Fernández (REACH Group Leader) Alex Arévalo (Operational Manager)

Directors

Jordi Campos (Business Director of TÜV SÜD Process Safety)

Ownership

TÜV SÜD

Locations

Spain, Taiwan

Founded

1945

TÜV SÜD Process Safety assists a high number of companies outside the European Union to comply with REACH Regulation. We prepare registration dossiers of their substances, submit them to Echa and provide the necessary documentation to their downstream users. We also act as third party representative, offering consultancy services to European companies, preparing their registration dossiers and SDS adapted to the REACH and CLP Regulations. We are members of ORO (Only Representative Organisation). Laboratory testing

OVERVIEW TÜV SÜD Process Safety is the TÜV SÜD brand for the COG business unit that offers consulting and training services on process safety (chemical, petrochemical, pharmaceutical and food industries). TÜV SÜD Process Safety works to promote safety in the industry and particularly in the industry dedicated to chemicals and chemical processes. Our commitment to industrial, process and labour safety is our top priority. We work hand with hand with clients, but we also participate in research institutes, international safety organisations and standardisation committees. Our activities focus on three main areas: consulting, laboratory testing and training. VITAL STATISTICS

2014/15

Turnover, group

€5.2m

Turnover, chemical service provision

€1.5m

No of offices

No of countries represented

Global

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN

Legal 8%

TÜV SÜD Process Safety offers more than 150 different tests in the fields of thermal process safety, fire and explosion protection, electrostatics, physico-chemical REACH and GHS tests and also those related to substances of very high concern. We offer these services thanks to the TÜV SÜD Process Safety laboratories located in Switzerland which are certified in accordance with ISO/IEC 9001, and tests accredited under ISO/IEC 17025. TÜV SÜD Process Safety can offer all kind of REACH test thanks to good relationship with international laboratories (GLP). Process safety and loss prevention We conduct audits and risk analysis in our fields of expertise: process safety, Atex, electrostatics, environment, thermal process safety, occupational risk prevention and machine directive. We apply recognised methodologies such as HAZOP, ZHA, FTA, LOPA and FMA and propose cost-effective solutions. We belong to the EPSC – European Process Safety Centre. Environment consultancy We perform environmental risk analysis, quantify the consequences of possible damage, help companies to integrate their activities in the environment, and perform administrative procedures associated to each regulation and to environmental licenses. We also implement safety management systems. Crisis management We are accredited to prepare emergency plans and also help companies to implement them with training and emergency exercises aimed at both the companies’ management and staff. As part of the global services we give to our clients, we develop crisis management and communication manuals to minimise negative publicity. Behavioural safety Companies and TÜV SÜD Process Safety create a challenge together to influence the culture and behavioural safety of a company. Reaching challenging goals is the only way for a commitment and to solve critical situations. In our methodology all the org chart is included in the behavioural safety, from upper-top management to operator.

Training 8%

Laboratory 12%

CORPORATE DEVELOPMENTS & ACHIEVEMENTS Consultancy/advisory 72%

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1945

Company founded in Switzerland.

2004

Company established in Barcelona, Spain.

2008

REACH department is set up.

2008

Sales company in Taiwan.

2012

Delegation in Murcia, Spain.

2013

TÜV SÜD acquires the company.

2015

TÜV SÜD Process Safety (legal entity name Instituto Suizo para el fomento de la Seguridad, Swissi-España SLU) merges into TÜV SÜD Iberia S.A.U. Chemical Watch | Global Service Providers Guide 2016

ACCREDITATIONS

Joan Marc Juncosa – REACH and Machine Directive consultant

Our Swiss laboratories are certified in accordance with ISO/IEC 9001 and our test laboratories are accredited under ISO/IEC 17025.

Joan Marc Juncosa is chemical engineer. He is a consultant specialising in REACH, classification, labelling and packaging (CLP), explosive atmospheres (Atex) and machinery safety.

Our clients are companies that produce or handle chemicals and chemical products. They belong to the chemical, pharmaceutical, petrochemical and agrifood sectors, among others. We work for all kinds of companies, from multinationals to small and medium-sized local companies.

Dolors Vinyoles – REACH, ORP and environment consultant Dolors Vinyoles holds a degree in chemistry. She is a consultant specialising in REACH Regulation, environmental safety, safety management systems, and occupational risk prevention. Before joining the company, she worked at Clariant Spain, where she used to be ESHA (environment, safety, and health affairs) country head.

CASE STUDY 1: REACH management platform and customer care

Ester Pellicer – REACH and Crisis Management consultant

TÜV SÜD Process Safety developed in 2009 an IT tool for our REACH clients so that they are able to manage all the information derived from the registration process. The information is made available both to our clients and to their respective supply chains. That way their European clients can access the IT tool to download relevant documentation related to the substances they import (only representative certificates, tonnage certificates, SDS, etc). We also have a close relationship with our REACH clients. We visit them on a yearly basis to provide them with updates on the latest issues related with the registration process. We organise REACH and product safety seminars and train them depending on their specific needs.

Ester Pellicer holds a degree in communication science. She is a consultant specialising in crisis communication and management, and emergency exercises. As part of the REACH team, she keeps up to date clients in topics related to REACH through newsletters and updating the REACH IT tool.

CASE STUDY 2: Tailor-made proceedings Companies are increasingly concerned by safety, health and environment. To meet its clients’ needs, TÜV SÜD Process Safety provides consultancy services to develop tailor-made proceedings to help companies to manage its procedures and thus increase effectiveness and reduce costs. This service is the fruits of years of experience in consulting. STAFF SELECTION Jordi Campos – Business Director Jordi Campos is the business Director of TÜV SÜD Process Safety since 2014. Before his new appointment, Campos worked as consultant specialised in emergency plans, major accidents (Seveso) and safety management systems. Jaume Sagarra – Operational Manager – Process Safety Jaume Sagarra has a chemical engineering degree and is specialised in electrostatics, process safety, accident investigation and risk analysis. Alex Arévalo – Operational Manager – Product Safety Alex Arévalo has a degree in chemistry (Organic) and is specialised in REACH, product safety, occupational risk prevention behavioural safety and safety management systems. He has a long experience in chemical and pharmaceutical sectors. Montserrat Fernández – REACH Business Group Leader Montserrat Fernández holds a degree in chemistry. She is a consultant specialising in REACH Regulation, safety data sheets (SDS), classification, labelling and packaging (CLP) and transport safety (ADR). She also worked at the R&D department of Clariant, where she held various positions. Gema Fernández – REACH consultant and testing leader Gema Fernández holds a PhD in chemistry and Masters in environment and occupational risk prevention. She is a consultant specialising in REACH. Her tasks are related to registration dossiers, supply chain communication, web service and testing solutions provider.

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PROFILE: TÜV SÜD Process Safety

CLIENTS

PROFILE: UL information & insights (The Wercs)

SERVICES PROVIDED The Wercs offers a unique mix of leading software automation tools and professional services to help clients achieve global hazard communication requirements, chemical data management and distribution, as well as supply chain risk mitigating solutions. EHS and SDS chemical data management solutions

CONTACTS

Tel

+1 800 572 6501

Fax

+1 518 640 9299

Contact

Jon Pipas

Utilised by regulatory departments worldwide, our flagship software, WERCS, is a robust hazcom solution to author, manage and distribute safety data sheets, labels and other chemical documents according to all local, national and international regulations, including GHS, EU-CLP and other global formats. As a true global, scalable and automated solution, WERCS compares regulatory rules against 5,300 monitored regulatory lists and results can be distributed in over 45 languages comprised of 21,000 credentialed phrases.

Directors

Lou DeSorbo Tom Carter Eric Vangarderen Adam Sawyer Karen Lintz Jim O’Keefe

Self service SDS – ULGHS.com Designed to meet the needs of customers with small inventories, ULGHS.com is a self-service tool that allows users to quickly and accurately create an SDS through a secure web interface. Our proprietary logic tree of questions encodes everything you’ll need to be GHS-compliant, updating alongside evolving regulatory guidelines.

Ownership

UL, LLC

Supply chain compliance

Locations

44 Countries

Founded

1894

The Wercs Supply Chain Compliance solutions uniquely combine regulatory content, localised expertise, and technology that provides customers with the ability to identify and manage risk within their supply chain.

Website

www.thewercs.com

E-mail

info@thewercs.com 23 British American Blvd, Latham, NY 12110, US

OVERVIEW UL Information & Insights, The Wercs provides leading and comprehensive software tools and services for: OO GHS SDS authoring, managing and distribution; OO retail and Industrial manufacturing supply chain compliance and data management solutions; and OO green chemistry and sustainability solutions. After nearly 30 years in operation, in November 2013, The Wercs became part of the UL family, a trusted company, with a 120 year tradition and over 150 offices around the globe. UL’s principles are deeply rooted in science and dedicated to innovation for complex global supply chain challenges, holistically and efficiently. Today, WERCS software products and services are considered the gold standard in global regulatory and sustainability compliance solutions. VITAL STATISTICS

2014/15

Turnover, group

US $2bn

No of offices

159

No of countries represented

113

Staff, group

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1984

WERCS global hazcom software launched

2003

Wercs Professional Services founded

2006

WERCSmart Retail Platform created

2013

The Wercs acquired by UL

PARTNERS OO

ChemAdvisor, DHI, JCDB Japan, Brandywine Drumlabels, Royal Haskoning, SAP, Oracle

CLIENTS More than 11,000 customers worldwide using various WERCS products and services. Major industry sectors served: adhesives, consumer products, flavour and fragrance, life sciences, paints and coatings, petrochemical, pharma, retail, and specialty chemicals.

11,000

Staff, chemical service provision

160

SERVICE AREA BREAKDOWN Other 15%

Consultancy/advisory 25%

Training 10%

IT & software 50%

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Chemical Watch | Global Service Providers Guide 2016

Due to recent GHS regional requirements, a company had 1,500 out-ofdate or missing SDSs. With limited in-house regulatory resources, SDS authoring demands were historically outsourced to regulatory experts within respective regions around the globe. Time and accuracy were critical for the company to achieve compliance and it was realised that traditional outsourcing was not an option. The Wercs solution began with porting component level data from the company’s SAP system into UL Secure Connect (ULSC), a lightweight WERCS application that is designed to leverage the powerful hazcom automation capabilities of the WERCSmart Platform. Once the company’s new product library was mapped within ULSC, new SDSs were created and reviewed via WERCSmart automation. Data and documents were delivered back into the company’s ULSC library for global distribution. Benefits: OO increased accuracy. No manual data entry. Increased control of product data and documents; OO speedy turnaround for SDS creation; OO Documents created for multiple regions simultaneously via WERCSmart automation; OO ULSC became a centralised repository for all product data and documents; and OO added comfort of a UL-approved GHS SDS template. CASE STUDY 2: Supply chain compliance with WERCSmart Due to increasing regulatory demands, a leading retailer was looking for a solution to bridge the gap between the chemical data provided by suppliers and the data required to assure the correct handling, transportation, storage and disposal of the chemical containing products on their store shelves. The WERCSmart Retail Platform created a portal where suppliers can enter required data as part of the on-boading process with the retailer. Through logic automation, WERCSmart then determined the data points necessary for the retailer to correctly handle, transport, store and dispose of the chemical-containing products on their shelves. With advanced access to data beginning at procurement, the retailer now manages their entire supply chain before products arrive at the dock – switching from reactive to proactive and establishing real control over compliance issues. Today, WERCSmart has over 40 leading retailers participating in the programme. Benefits: OO create a trusted third party portal for suppliers to input product composition data without disclosing critical confidential business information; and OO WERCSmart Platform allows retailers to convert legacy MSDS’s to the Osha GHS standard seamlessly.

Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 3: Global substance volume tracking For one WERCS customer, the process of generating a final substance volume report for just one EU REACH regulation was taking approximately two man months. With growing regional substance volume tracking requirements, the customer needed a more efficient method of creating reports that would allow them to calculate quantities of substances across geographies over various time spans. The Wercs Substance Volume Tracking solution allowed the company to use the material data already available in their WERCS software, then married the data with the associated sales volumes within their ERP systems. The solution now calculates quantities of substances by geography and time at unprecedented speeds. What once took them two man months to complete can now be accomplished within minutes. Benefits: OO no more manual calculations; OO real time global trade compliance; and OO one person with five years of data can now create a full EU REACH SVT calculation in ten minutes STAFF SELECTION Lou DeSorbo – VP and Managing Director Lou DeSorbo is the Managing Director of UL i&i, The Wercs, a company he spearheaded in 1993 with the creation of a MSDS (material safety data sheet) system. Today, Lou and The Wercs provide software solutions to thousands of chemical companies across Europe, Asia, North America, the Middle East and Africa. Prior to The Wercs, Lou consulted for North American Technical Consultants and was assigned to General Electric. It was during this assignment as a computer programmer that he developed the commercial software that would become the basis for The Wercs. Lou is a global leader with a flair for business development, visionary leadership and dynamic technology foresight. Lou holds a BS and a MS from the University of Albany – State University of New York. Karen Lintz – Director of Regulatory Services Karen Lintz is the Director of Regulatory Affairs for UL i&i, The Wercs, and has been since 2005. Ms Lintz came with experience in toxicology and regulatory affairs, previously from GE Silicones, and The Carborundum Company, a division of BP Chemicals. In these previous positions she directed toxicology testing for new materials, FDA compliance efforts, and MSDS and labelling programmes. She holds a master’s degree in pharmacology, toxicology, and therapeutics from the State University of New York at Buffalo. She has been working on regulatory data solutions for supply chain management for nine years. Christine Lepisto – Senior Regulatory Specialist Christine Lepisto offers over 25 years of industry experience. Mrs Lepisto holds honours degrees in chemistry and mathematics and built her career managing global compliance and best practice systems for HES (health, environmental, safety), product stewardship, and sustainability.

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PROFILE: UL information & insights (The Wercs)

CASE STUDY 1: Replacing traditional SDS outsourcing with automation.

GLOBAL OFFICES Germany: Hamburg, Cologne, Rottweil SERVICES PROVIDED Chemicals management

PROFILE: UMCO Umwelt Consult GmbH

CONTACTS

Website

www.umco.de

E-mail

umco@umco.de

Head office

UMCO Umwelt Consult GmbH, Georg-Wilhelm-Straße 183, 21107 Hamburg, Germany

Tel

+49 (0)40 / 79 02 36 300

Fax

+49 (0)40 / 79 02 36 357

Contact

Jan Mönster

Directors

Hubert Oldenburg Peter Duschek Ulf Ch. Inzelmann

Ownership

See directors

Locations

Germany

Founded

1982

OVERVIEW

Everything from one source Compliance for substances, plants and processes along the chemicals value added chain – worldwide. UMCO has been offering compliance solutions for the worldwide distribution and handling of chemicals over the last 30 years. We provide complete and high quality advisory services to our customers on substances, plants, organisations and transport. Our 60 employees in Hamburg, Cologne and Rottweil provide consultancy services for more than 1,000 enterprises in the chemicals, pharmaceuticals, logistics and processing industries worldwide. Our service portfolio includes: OO chemicals management; OO REACH; OO SHE management; OO dangerous goods; and OO emergency services. VITAL STATISTICS

2014/15

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%

Information 10% Representation & management 5% Consultancy/advisory 75%

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OO OO OO

determination of the status of all the substances used or traded by your company with regard to their worldwide marketability; auditing and advising regarding chemicals management at company or corporate level and the integration of responsibilities and documentation into management systems; general advice concerning questions and applicability of the biocidal products Regulation, including support in the EU authorisation of biocidal products; determination of classification and labelling in accordance with chemical and dangerous goods legislation, water hazard Classification or VOC; compilation and monitoring of SDS and exposure scenarios (for all European regions/languages using UMCO SDS software UHCS); international SDS compilation and monitoring performed in conjuntion with our network partners support with regard to worldwide chemicals management:, including analysis of national requirements for marketing of chemicals and notification/registration in cooperation with our network partners; permanent monitoring of substance and product data with regard to legislative amendments or changes in the formulation, including the updating of all necessary documents; customised interfaces to generate the automatic import and export of data in standard XML format into/from UMCO SDS software UHCS; web services for customer specific evaluations, for example current stock or dangerous goods lists and functions; online calculation tool in accordance with the CLP Regulation; automated export of data for compiling CLP/GHS labels; company-internal hazardous material management; compliance service for restricted / banned substances in mixtures / articles; and formulation of options for action with regard to substances becoming subject to authorisation

REACH management Registration management for co-registrants: OO support in joint registration: communication regarding substance sameness and letter of access (LoA); OO compilation of dossiers and submission to the European Chemicals Agency (Echa); and OO only representative (OR) for non-EU manufacturers according to article 8 of the REACH Regulation. Comprehensive support for lead registrants: OO Sief management: communication with co-registrants and preparation of contractual arrangements for data and cost sharing; OO dossier management: collection and evaluation of information for technical dossier and chemical safety report; and OO secretariat and trustee function for groups of registrants or consortia. Communication in the supply chain: OO strategies for the communication with suppliers and customers; OO integration of registration information in the eSDS; OO support regarding the identification of uses (use mapping); OO implementation of exposure scenarios in daily practice; and OO consultation regarding substances of very high concern (SVHC). Strategic consulting OO consultation and evaluation of organisations and structures in order to ensure REACH conformity.

Chemical Watch | Global Service Providers Guide 2016

OO OO

OO OO OO OO OO

OO OO OO

provision of a SHE manager; provision of external company advisors for the fields of occupational safety, emission protection, water pollution control, waste, hazardous incidents, fire protection; carrying out of approval procedures; advice on storage of dangerous materials; explosion protection consultation; preparing operating instructions and risk assessments; compiling safety reports and further hazardous incident documentations such as safety management systems and corporate alarm and hazard control plans; training and instruction; management systems: ISO 14001, 18001 (OHSAS), 50001; and conducting internal audits.

Dangerous goods OO OO

OO OO OO OO OO OO OO OO

provision of an external Dangerous Goods Safety Advisor (DGSA); establishment of a company individualised dangerous goods organisation and analyses for optimising procedures; inventory and dangerous goods audit; dangerous goods consulting; checklists, working and operating instructions; verification of correct classification and labelling; instruction and training courses; preparing and checking of documents; information about legislative changes; and project organisation.

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

compilation of SDS for different chemical traders and producers of chemical mixtures; and more than 60,000 SDS compiled and regularly updated.

CASE STUDY 2: Business process outsourcing OO

assumption of product stewardship and legal chemical product service for paint companies, including determination of classification and labelling for products in all EU regions and languages; and compilation of SDS and CLP / GHS labels.

CASE STUDY 3: REACH consortium management OO OO OO OO

secretariat of the REACH Selenium and Tellurium consortium; financial management, management of subcontractors, trustee; registration management, Sief and LoA-management; and representation of the consortium in the Eurometaux REACH Forum.

STAFF SELECTION We support our customers with 60 engineers, scientists and legal experts, working on an interdisciplinary basis, to ensure the economic viability, quality, adherence to deadlines and success of projects.

Emergency services OO

emergency telephone number for safety data sheets according to REACH Regulation (together with “GIZ Göttingen”); and GlobalChem24 – 24 hour emergency number for chemicals transport worldwide (together with the NCEC).

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006

Co-founder of the Global Chemical Consulting Network (GCCN), an entity which provides further services regarding foreign legal regulations.

2012

New development of an independent, proprietary software solution – UMCO Hazard Communication System (UHCS) – for monitoring products and compiling documents for hazard communication.

2013

Customised interfaces for the automatic import and export of data per XML transfer from our UMCO SDS software (UHCS) to ERP systems of our customers.

2015

Development of a proprietary software, in conjunction with the Haufe Group in Freiburg, designed to internally update legal and liability compliance regulation information in the areas of environmental protection and occupational safety. This software allows for a more up-to-date, precise and complete understanding of specific operator obligations.

2016

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

PARTNERS OO OO OO OO OO

NCEC GIZ GCCN Haufe group AS-Trainer

Chemical Watch | Global Service Providers Guide 2016

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PROFILE: UMCO Umwelt Consult GmbH

Safety health environment management

PROFILE: WIL Research, a Charles River Company

GLOBAL OFFICES Headquartered in the US, our main facility is in Ashland OH, with support offices in Hillsborough NC, Skokie IL and Boothwyn PA. In Europe, our main agrochemical, biocide and REACH safety testing facilitiy is in ‘s-Hertogenbosch NL. Our other location is in Lyon, France, with support offices in Switzerland and the UK. Additional support offices in Tokyo, Japan.

CONTACTS Website

www.wilresearch.com

E-mail

info@wilresearch.com

Head office

1407 George Road, Ashland Ohio, 44805

Tel

+1 (419) 289-8700

Fax

+1 (419) 289-3650

Contact

info@wilresearch.com

Ownership

Owned by Charles River Laboratories as of 4 April 2016

Locations

Main offices: US, the Netherlands and France. Support offices in the UK, Japan and Switzerland.

SERVICES PROVIDED Our objective is to contribute to better human health, environmental safety and industrial progress by accelerating the development process of our client’s products. We support our clients by providing quality driven contract research services. Our added value results from dedicated staff working together with our client’s project team and enhancing the processes through clear communication and scientific interpretation of results. Our staff create the company’s value and this is enhanced by continuous education, exciting career opportunities and personal development. By these means our team remains dedicated and its objectives clear.

OVERVIEW

REACH compliance

In April 2016, WIL Research was acquired by Charles River. In addition to the information included below, Charles River offers a full range of services to support chemical development and registration. For more information, please visit www.criver.com. Our company consists of over 1,400 dedicated scientific, technical and support personnel with locations in the United States, Europe and Japan. The United States locations include Ashland OH, Skokie IL, Hillsborough NC and Boothwyn PA. WIL Research provides regulatory affairs support and programme management for the chemical industry, helping you to focus on the core activity of your company and advancing your compounds and products to the market. Our experts give advice on the full range of regulatory and exploratory studies you will need. Importantly, they are skilled experts and able to deliver relevant information to you with full transparency. Our site in the Netherlands specialises in personalised contract research and expert consultancy for the registration of pharmaceutical products, biocides and (agro)chemicals worldwide. More than 600 well-trained and dedicated specialists and modern purpose built laboratories and offices are available to perform your regulatory (eco)toxicology studies. Our operations have been endorsed by the GLP monitoring authorities (OECD/EPA/FDA/JMAFF certification).

REACH consultancy and Sief management and full testing portfolio

VITAL STATISTICS

2014/15

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

40-50

Staff, group

1400

Staff, chemical service provision

Full service portfolio for REACH Annexes 7-8-9-10 Registration chemicals worldwide We provide regulatory affairs support and programme management, helping you to focus on the core activity of your company and advancing your compounds and products to the market. Registration of agrochemicals and biocides EDSP – endocrine disruptor screening programme (complete set of assays) in conformity with EPA requirements. Safety testing including (eco) toxicology and risk assessment Toxicology and ADME, general toxicology, genetic toxicology, in vitro toxicology, developmental and reproduction toxicology, carcinogenicity, ADME and kinetics, safety pharmacology, special toxicity studies, environmental toxicology, formulation development, juvenile toxicity studies, lead optimisation, single rat PK ACCREDITATIONS OO

Consultancy/advisory 17% Representation & management 3%

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To help you comply with the regulations, we have set up a ten-step action plan, which will cover all aspects of the registration needs for both phase-in (EINECS materials) and the non-phase-in substances (new chemicals). The different steps are given below. For each of these steps we can provide more details on the activities within that step and the cost estimation for completing that part of the work.

SERVICE AREA BREAKDOWN

Laboratory 80%

REACH safety testing

Achieved good laboratory practice (GLP) compliance status for more than 30 years, with the most recent GLP endorsement statement signed in May 2015. A company publication was referenced in the guidance document 117 for OECD 443 guideline. Published company article is referenced in the guidance document 126 for the OECD 203 guideline. We’re proud of our longstanding accreditation through the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC). We never get complacent about quality. Constantly striving to improve it, we regularly analyse our processes and have established quality improvement teams as part of our total quality management (TQM) policy.

Chemical Watch | Global Service Providers Guide 2016

CASE STUDY 3: complete hazard and exposure assessments

Non-disclosure agreements prohibit this level of information.

The regulatory affairs department provides a complete service for the registration of agrochemicals under the regulations 91/414/EC, 1107/2009. We provide complete hazard and exposure assessments for operators, workers, bystanders and consumers, as well as for the environment (groundwater, surface water, soil, air, non-target organisms). These assessments are carried out using various modelling tools and are based on the most up to date guidelines. Our experienced team consists of regulatory experts in chemistry, environmental fate and behaviour, residues, ecotoxicology and human toxicology. In addition to outstanding technical knowledge, WIL Research has well-established contact with EU and national authorities and has a thorough understanding of the procedures involved in obtaining registrations for agrochemicals. We assist you with dossier preparation at EU (Annex II) and member state level (Annex III) – taking into account the national dossier requirements. Our services are custom-made to suit your needs. They include dossier compilation (electronic submissions, CADDY), technical dossier writing, data gap analysis and project management, outsourcing and study monitoring, risk and exposure assessments and post-submission support. We further assist you with classification and labelling issues, import tolerance dossiers, and setting of MRLs or help you with complete dossiers or single sections and smaller regulatory questions.

CASE STUDY 1: Our ten steps to REACH compliance We understand clearly that each situation is different and we therefore advocate discussing this in a personal meeting going through the following distinct steps: OO Step 1 - Inventory; OO Step 2 – (late) Pre-registration or inquiry Step 3 - Refinement of inventory; OO Step 4 - Data evaluation; OO Step 5 - Determination of data gaps; OO Step 6 - Completion data requirements (Annex VII/VIII); OO Step 7 - Chemical safety assessment/report (CSA/CSR); OO Step 8 - Prepare a test proposal (> 100 t/y); OO Step 9 - Dossier preparation, finalisation and submission; and OO Step 10 - Safety data sheet. CASE STUDY 2: biocidal registration Our regulatory affairs department provides a complete service for the registration of biocides under The EU Biocides Regulation 528/2012 EC. Our aim is to provide you with a high quality service, which will help you in achieving product registrations in a fast and efficient way. We provide complete hazard characterisation and exposure assessments for operators, workers, bystanders and consumers as well as for the environment (groundwater, surface water, soil, air, non-target organisms). These assessments are carried out using various modelling tools (eg USES, EUSES, etc.) and are based on the most up to date guidelines and emission scenario documents. WIL Research’s experienced team consists of regulatory experts in chemistry, environmental fate and behaviour, residues, ecotoxicology and human toxicology. In addition to outstanding technical knowledge, we have well-established contact with EU and national authorities and a thorough understanding of the procedures involved in obtaining registrations for biocides. We assist you with dossier preparation at EU and Member state level. We compile complete dossiers (Documents I, II, III and study reports) in electronic format. Prior to dossier compilation, we assist you in identifying data gaps and project management, outsourcing and study monitoring, writing data waivers to save costs and time, and discussions with authorities. Our services are custom made to fit your needs and range from assistance with single sections and smaller regulatory questions to the preparation of complete dossiers.

Chemical Watch | Global Service Providers Guide 2016

STAFF SELECTION Wilbert Frieling, DVM – Senior Vice-President, European Operations Wilbert Frieling graduated in veterinary science from the University of Utrecht, the Netherlands, in 1991. From 1991 until 1996 he directed a veterinary practice. He joined WIL Research as a supporting veterinarian in December 1994. In April 1996 he was appointed as section head General and Industrial Toxicology, in 1997 he was appointed as head of Toxicology and in 2004 he was appointed director of Toxicology. When WIL Research joined WIL Holding in 2005, he was appointed as managing director of WIL Research BV. Since 2000 he has been registered as a Eurotox board certified toxicologist. He is also a board member of NVDEC (Dutch society of animal ethical committees). He has presented various papers on international meetings on toxicology (mini-pig in toxicology, continuous infusion technology and preclinical safety testing strategies). Steven D Barkyoumb, DVM, PhD – Senior Vice-President, US Operations – Nonclinical Safety Assessment Steve has more than 25 years of non-clinical safety assessment experience in the pharmaceutical and contract research industries. He brings extensive experience in regulatory-driven toxicology, pathology and laboratory sciences. Most recently, he served as Vice President, Nonclinical Safety Assessment for Covance Laboratories and held the role of Global Chief Scientific Officer, Pathology and Immunology Services. He directed the growth of Covance’s toxicology business in North America and managed the pathology and immunology services across six sites in the United States, Europe and Asia. Clients describe Steve as a leader with high integrity, strong principles and outstanding operational skills with a sharp focus on scientific excellence and quality. Prior to joining Covance, Steve served as the Executive Director for Nonclinical Drug Safety at Quintiles and the Director of Regulatory Toxicology and Safety Pharmacology for the Drug Safety Evaluation unit at Abbott Laboratories. He began his career with a series of roles with increasing responsibility with Hoechst Marion Roussel and its predecessor companies. Steve holds a Doctor of veterinary medicine degree and a PhD in veterinary pathology from Kansas State University. He is a Diplomate, American College of Veterinary Pathologists (1984 – present) and previously a Diplomate, American Board of Toxicology (1989-2004).

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PROFILE: WIL Research, a Charles River Company

CLIENTS

Ownership Locations Founded

www.1cc-consulting.com compliance@1cc-consulting.com GEO PARK I, Max-Eyth-Straße 35, 71088 Holzgerlingen, Germany +49 7031 4 39 38 - 0/ +49 7031 439 38-222 Ms Eva Hink, Consultant, Ms Nadiia Kaiun, Consultant Ms Katrin Schneikert, Legal Counsel Private Germany, US, Italy, China 1996

OVERVIEW 1cc GmbH offers consulting and compliance services for chemical legislation in EMEA, North and South America and Asia-Pacific region. Our REACH related services focus on identification of legal requirements and administrative handling of obligations such as coregistration or LoA administration, workshops and training. Our customers benefit from our: consulting expertise, specialist knowledge concerning specific compliance issues, multilingual members of staff and long standing experience in the fulfilment of producer obligations. SERVICES PROVIDED Our consulting and compliance service portfolio in the area of chemical legislation encompasses following areas and service elements. REACH/CLP (GHS) services: (co-)registration: dossier creation and handling; only representative for non –EU suppliers; communication services (Sief, Echa, supply-chain); LoA (letter of access) administration services: handling, cost-sharing models and reimbursement system; testing (in collaboration with partner laboratories); and consulting on individual questions on REACH and CLP. Supporting services: monitoring of regulatory developments; impact assessment on legal obligations; workshops and trainings; audits, compliance-checks; and communication, SDS, supply-chain. CLIENTS We provide our consulting services to more than 130 customers, across various industries many of which are globally active companies, and assist industry associations’ members in fulfillment of legislative requirements.

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

www.3s-chem.gr info@3s-chem.gr 133, El Venizelou Str, 16343 Athens, Greece +30 2109901150/ +30 2109901151 Panos Drougas Private 2007

OVERVIEW 3S–SafelyServingScience is a distinctive company providing specialised advice and guidance at each stage of a chemical’s lifecycle. Our mission is to contribute with knowledgeable care and best practices to our customers efforts to identify and harmonise with compliance requirements governing the production, supply and transport of chemicals; and conscientiously discharge their environmental, health and safety duties. Our +23y experience in the global supply of chemicals, matched with a certified knowledge on Transport-HSEQ management systems, enables us to better understand the challenges our customers face in an increasingly regulated business environment. Aiming to provide efficient, reliable, high value-added services, we have recently adopted the modern project management principles supported by the latest technology software. We are passionate about creating and sharing value and look forward to offering you the best possible customer experience! SERVICES PROVIDED Here’s a detailed listing of the out-of-shelf deliverables and services we offer: OO CHEMICAL MANAGEMENT AND REGULATORY COMPLIANCE (SDSs/C&L/ studies-reports-notifications/SEVESO III inventory-classification); OO ENVIRONMENTAL PERMITS (EIAs/ISO14001*/HazWastes classification [WFD-EWC/ADR-IMDG]); OO HEALTH AND SAFETY AT WORK (safety officer outsourcing services/ISO18001*/ risk assessments of chemical hazards/ business conduct policies [EH&S]); and OO DANGEROUS GOODS SAFETY ADVISER (DG transport classification/transport documentation (ADR/IMDG/IATA-DGR)/ independent supplier audits [EH&S, SQAS]). *implementation guidance and internal auditing

Chemical Watch | Global Service Providers Guide 2016

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

www.ambrosiconsulting.com contact@asc-consult.eu A.S.C., 23, rue de Moeuvres, 62860 Inchy-en-Artois (France) +33 (0)6 26 14 64 99 / +33 (0)6 84 85 21 42 +33 (0)3 20 88 85 92 Aurély Béghin / Sophie Aviron-Violet Private company France and Poland 1999

OVERVIEW Whatever your activity in the chemistry area, you are necessarily subject to numerous and complex regulations, whose non-compliance can be fatal to your business. Since 1999, A.S.C. is consulting company, expert in regulatory chemistry. Our mission is to inform you about the regulation that applies to your activity, and to help you providing the authorities with the necessary dossiers in order to be authorised to produce, import or sell your substance or product, either new or existing. Our teams currently pool 35 scientists, whose backgrounds cover all areas related to chemical risk assessment: physico-chemistry, analysis, toxicology, ecotoxicology, biological efficacy, etc SERVICES PROVIDED OO Iuclid dossiers (REACH, biocides) OO Risk assessments for human and environment OO Classification, labelling and SDS OO R4BP demands for biocidal a.s. and products OO Transitional registrations of biocides in all Europe OO Building or update of PIF, online notification through CPNP for cosmetics OO Study monitoring OO Expert statements, literature search on chemical substances OO Regulatory support in all European countries, including answer to authorities OO Regulatory watch on chemicals/REACH, biocides, cosmetics, PPP and fertilisers CLIENTS From SMEs to large companies, our clients have businesses in chemicals (CLP, REACH), biocides, cosmetics, PPP… A.S.C. can assist chemical manufacturers, formulator, importers, distributors...

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

www.altox.dk altox@altox.dk Tonsbakken 16-18, DK-2740 Skovlunde, Denmark +45 3834 7798 Pernille Hjaltalin Private limited company Denmark 1992

OVERVIEW Altox is a consultative company that provides counselling and training within: OO REACH and CLP requirements of chemicals and articles (C&L, SDS, Echa registrations and communication); OO biocides; OO cosmetics and toys; OO other registration services (eco labelling, national product registers, Colipa etc); OO general safety counselling for professional and private use (on-site handling, storage etc in relation to regulations for occupational health and environment); OO Scandinavian regulations (eg MAL codes and order on carcinogenic substances). SERVICES PROVIDED At Altox we assist private companies (SMEs as well as large companies), authorities and trade organisations and work in collaboration with the client to find the most appropriate result. We aim at finding practical solutions based on science and regulatory requirements. Altox is widely recognised for the development of helpful desk tools to ease implementation of C&L and preparation of SDS. Being independent from software solutions (C&L, SDS) and test laboratories (CRO) allows for a more flexible approach towards regulatory changes. CLIENTS Importers, downstream users and manufactures of chemicals primarily in Europe. Altox also provides counselling to trade organisations, universities and other professionals within the chemical area.

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NICHE FIRM PROFILES

CONTACTS Website E-mail Head office Tel/ Fax Contact

Incorporating

Bootman

CONTACTS Website E-mail Head office

NICHE FIRM PROFILES

Tel/ Fax Contact Ownership Locations Founded

Chemical Safety Ltd. www.anthesisgroup.com info@calebgroup.net The Stables, Somerset House, Church Road, Tormarton, Badminton, Gloucestershire, UK +44 (0)1454 269330/ +44 (0)1454 216030 Stuart Burrow Private company UK, Germany, US, Asia-Pacific 1994

OVERVIEW Anthesis-Caleb is a policy and regulatory consultancy that has been active in the field of chemical regulation since 1994, and part of the sustainability specialist Anthesis group since 2014. Anthesis-Caleb’s clients range from governments, multi-national companies and worldwide consortia to small companies with a single substance. Anthesis-Caleb tailors its support to take account of a client’s internal resources in order to maximise the value of our contribution. The company has a considerable track record in sustainable management recently adding a sustainable procurement support service for our clients. SERVICES PROVIDED OO Consortium management OO REACH dossier development and registration OO Sief management OO CLP compliance management OO SDS authoring and management OO OR and TPR services OO Sustainable procurement support OO Supply chain mapping OO REACH authorisation / restrictions CLIENTS Anthesis-Caleb supports SMEs and large corporations, European and global industry associations and task forces globally. Currently the company is OR or TPR for about 20 companies and provides consultancy support for many more. Anthesis-Caleb also supports more than ten REACH consortia as managers and advisors.

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

www.big.be info@big.be Technische Schoolstraat 43A, 2440 Geel, Belgium + 32 14 58 45 47 / +32 14 58 35 16 Zita Snellinx Non-profit organisation Belgium 1979

OVERVIEW BIG is an independent information and emergency call centre for dangerous chemical substances. Information is gathered on physico-chemical and (eco)toxic properties, as well as regulations on safety, health, environmental protection and transport related to hazardous materials. Based on these data BIG delivers a large number of products and services to clients from diverse sectors, including: industry, emergency services, governmental and inspection services, healthcare and academia. SERVICES PROVIDED BIG offers expertise concerning information on hazardous substances. For REACH and CLP this means assisting our clients in determining what their role and obligations are, the complete registration process from A to Z (including CSA/CSR), notifications, communication up- and downstream (compilation of ext-SDSs, CLP compliant labels), onsite training in REACH and/or CLP, onsite REACH audits, only representative and third party representative services. BIG also specialises in downstream user reports and DU CSA/CSR/ES for non-identified uses. CLIENTS BIG is only representative for many global players, providing customised services to large international companies and SMEs. Our clients are in many sectors, such as: raw chemicals, fine chemicals, polymers, adhesives, plastics, healthcare, pharmaceuticals, coatings and paints, article manufacturers.

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www.bootmanchem.com info@bootmanchem.com Diss Business Centre, Diss, Norfolk, IP21 4HD, UK +44 (0)1379 640534 Chris Lewis Limited company UK 1994

OVERVIEW Bootman Chemical Safety Ltd is an established UK-based consultancy, offering a wide range of scientific and regulatory services to support our clients through the process of chemical safety assessment. We have in-depth knowledge of REACH, CLP and other chemical regulations, in combination with expertise in industrial toxicology and risk assessment to serve a worldwide client base. SERVICES PROVIDED We are focused on providing the best service to our clients whatever the size of project. REACH forms a major part of our work and highlights a number (but not all) of the areas where we provide expertise: Registration strategy, dossier preparation, prior-registration inquiries, PPORD application, chemical safety assessment including exposure assessments and risk characterisation, only representative/third party representative services, SVHC product statements, study monitoring, support on classification and labelling, safety data sheet authoring or review, preparation of CLP notifications and the list continues! We also offer technical support to major Siefs/consortia on behalf of clients or as an independent contractor, discussing strategies for registration or evaluation; literature searches and other critical data reviews are also undertaken. CLIENTS Client confidentiality precludes our naming them, but we serve a wide range from SMEs to global corporations. All our clients expect high-quality service and this can be provided to you.

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

www.cfcs-consult.com info@cfcs-consult.com CFCS-Consult GmbH, Essen - Stuttgart, Moorenstraße 8, 45131 Essen, Germany +49 201 79870 191/ +49 201 79870 386 Dr Barbara Lohmann Dr Barbara Lohmann (CEO), Dr Felix Endres (CEO) Private company Germany, Italy 2007

OVERVIEW CFCS is a team of experienced: toxicologists, chemists, ecotoxicologists, biologists and environmental chemists. Our experts specialise in the areas of: regulatory affairs, chemical assessments, chemical safety, risk assessment, environmental protection and occupational safety. Our main focuses are: REACH services, project and finance management, risk analysis, classification and labelling according to GHS/CLP, authorisation of biocides and biocidal products, authorisation of pharmaceuticals and veterinary drugs, assistance with the certification process for the ecolabel, workshops for REACH, Ecetoc TRA, Iuclid 5, Chesar, cosmetic safety assessment, CPNP notification, PIF generation, assistance with the establishment of cosmetic GMP. SERVICES PROVIDED CFCS is a qualified partner offering services in various life science disciplines dedicated to the assessment of the biological or chemical impact of substances on humans and on the environment. We provide ample support on regulatory issues and project management to our clients. Among our services, our clients can benefit from our network of well renowned and certified scientific partners and institutions. Consequently, and even for very complex projects, we are always available as your key reference partner. CLIENTS Manufacturers, importers or downstream users of industrial chemicals, veterinary drugs, plant protection products or cosmetic ingredients.

Chemical Watch | Global Service Providers Guide 2016

www.chementors.eu jan.nylund@chementors.eu Raisionkaari 55, FI-21200 Raisio, Finland +358 407473393 Dr Jan Nylund Private Helsinki, Tampere, Raisio, Kokkola, Hong Kong 2012

OVERVIEW Chementors provides services to companies affected by REACH, the biocidal products Regulation and the cosmetic products Regulation. We offer top notch research and expert services to support our customers’ registration tasks. We help you with the whole process starting from data acquisition, testing strategies and data evaluation to preparation of the final registration documentation. We provide GLP-certified laboratory services, data and exposure assessments, dossier and document preparation, Iuclid, Chesar, R4BP and REACH-IT expertise. We assist customers to comply with the CLP Regulation on classification, labelling and packaging and to prepare appropriate and correct safety data sheets (SDS) and other documents required by law. Our SDS service include SDS translations to all EU and other languages. We provide only representative (OR) services and we help companies exporting chemicals to China. Formulation and substance substitution is one of our core services as well. SERVICES PROVIDED OO Substance substitution - R&D-services, formulation OO Only representative services OO REACH and biocide expertise OO China REACH and exporters to China OO Cosmetics safety assessment OO SDS preparation and translation OO Human health and environment assessment OO EHSQ: ISO 9001, ISO 14001, OHSAS 18001 OO Qualified Dangerous Goods Safety Adviser OO Laboratory and testing CLIENTS Metso Minerals Ltd, Oriola Ltd, Radico India, Mayer Industries. REACH, biocides, cosmetics, CLP: manufacturers/importers

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

www.chemtracglobal.com info@chemtracglobal.com Lancaster Environment Centre, Lancaster University, Lancaster LA1 4YQ, UK +44 (0) 1524 510278/ +44 (0) 1524 510588 Anna Holden Privately owned UK, Italy, US, Japan, China 2007

OVERVIEW chemtrac® is a complete online solution for chemicals management, regulatory intelligence, specialist training, custom IT development and hands-on support services. SERVICES PROVIDED Comprehensive database with essential and key information on more than 230,000 chemical substances. Global regulatory obligations – comprehensive and concise overview of more than 150 global regulations comprising of over 500 lists, including listings on governmental, NGO and sector lists. Manage business risk and compliance – view and cross-reference information relating to chemical’s regulatory status, hazard classification, common uses and chemical grouping. Current and informed – actively reviewed and managed by our in-house regulatory experts. Alerts – control and monitor the substances and regulations of specific interest to you and to stay on top of the latest amendments by receiving systematic updates in a clear and concise form into your mailbox. Minimise product risk – identify at-risk product and optimise testing strategies. Share your knowledge – share and store your information, lists and files to enhance internal communication. Regulatory advice service – access the expertise of our team of regulatory consultants, chemists, environmental scientists and toxicologists. On-demand software development – complex applications and systems integration requirements across various chemical management and regulatory topics. CLIENTS Global manufacturers, distributors and retailers along with multiple trade associations and government bodies from across several industry sectors.

Chemical Watch | Global Service Providers Guide 2016

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

www.emmcchir.org emmcchir@ualg.pt University of Algarve, Gambelas Campus, 8005-139 Faro, Portugal +35 1 289 800 003 +35 1 289 800 025 Professor Isabel Cavaco (Programme Coordinator) Public institution Portugal, Spain, Italy, UK 2012

OVERVIEW The Erasmus Mundus Master Course in Chemical Innovation and Regulation, EMMCChIR, is a joint MSc degree offered by the Consortium of the University of Algarve, University of Barcelona, University of Bologna and Heriot-Watt University. Students study in at least two different countries, and gain from the enlarged academic offer, experience and services of four universities. The degree has duration of two years: one year of 30 optional stand-alone, one-week modules, and one year of research. Modules are offered in the fields of design of new safe chemical substances, industrial processes, marketing and public perception of the chemical risk, assessment of chemical, toxicological and environmental risks and international chemical regulations. SERVICES PROVIDED The ChIR curriculum prepares professionals with all the knowledge and tools needed to manage the risks of chemicals from a scientific, regulatory, and economic perspective, and meet the requirements of chemical legislation worldwide. The final degree is a joint diploma, recognised internationally. Clients Candidates must hold a degree equivalent to a first cycle (180 ECTS), in a field where chemistry plays an important role: chemistry, biology, pharmaceutical sciences, biochemistry, environmental engineering, chemical engineering, food engineering, clinical analysis, etc.

CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded

www.chymeia.com info@chymeia.com Universitetsparken 2, DK - 4000 Roskilde, Denmark +45 72 40 16 22 Lars Bugge Private, limited company Denmark 2006

OVERVIEW CHYMEIA ApS’ core business is software solutions for complying with the chemical legislation in an efficient and user-friendly way. CHYMEIA ApS is specialised in SDSauthoring with a very high degree of automation and a built-in CLP calculator. Our main product is the chemical management software AlphaOmega, which is an advanced solution for generating and updating SDS, chemical safety documents and inventory labels. SERVICES PROVIDED The SDS-authoring software AlphaOmega has an integrated CLP calculator that combined with an intelligent phrase library – offers the user a unique automated SDS authoring process. In 2010, CHYMEIA ApS was among the world’s first companies to introduce a completely automated CLP calculator. The calculation engine was developed by CHYMEIA ApS and was initially tested in cooperation with the Danish Environmental Protection Agency, for which CHYMEIA ApS also developed a version of the CLP calculator. AlphaOmega includes comprehensive chemical management functions, control functions and smart update functions. SDS output is available in more than 25 languages. AlphaOmega can also be used for authoring of chemical safety documents like APB (DK), COSHH (EN), Skyddsblad (SE) Betriebsanweisungen (DE) etc. CHYMEIA also provides consultancy including lectures and seminars on chemical legislations. CLIENTS CHYMEIA ApS serves a wide range of companies, industries and sectors. AlphaOmega is used by the chemical industry, the pharmaceutical industry, schools, research facilities and manufacturing including paint and coating, flavours and fragrance, detergents, adhesive and sealants, ink and colours etc.

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Head offices Tel

Contact Ownership Locations Founded

www.conusbat.com Business development: steven.hanft@conusbat.com Technical regulatory: annelie.struessmann@conusbat.com Germany: Kruppstr 18, D-52072 Aachen, Germany Dr Annelie Struessmann: +49 241 518 5 7790 Skype: annelie.struessmann Steven L Hanft: +49 241 93917084 Skype: steven.hanft Dr Annelie Struessmann, Technical Regulatory Director Private ownership Aachen, Germany 1995

OVERVIEW CONUSBAT is an internationalisation regulatory service provider with expertise dealing with EU legislation for cosmetics, personal and consumer health products, household cleaning agents and fine chemicals. Working with global strategic partners, we also provide full services for worldwide product stewardship. SERVICES PROVIDED In-depth expertise for the EU market: OO Regulation (EC) No 1223/2009 on cosmetic products; OO Regulation (EC) No 1907/2006 (REACH); OO Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP); OO international representation: - responsible person (RP) for cosmetic products - only representative (OR) for cosmetic ingredients, specialty chemicals. Global knowledge for cosmetic ingredient compliance: regulatory frameworks for cosmetics, borderline products and chemicals, GHS. Strategic regulatory partnerships: USA/Canada, Brazil/Latin America, Japan, S Korea, Taiwan, Asean, India, Israel, Turkey, S Africa, Russia. Training (online/onsite): EU / global cosmetics regulatory affairs workshops. CLIENTS OO Manufacturers, importers and distributors of cosmetics, personal and consumer health care, household cleaning products, fine chemicals. OO Training firms and academic institutes/ international or governmental agencies.

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

www.dangerandsafety.it info@dangerandsafety.it Via Bugatti, 53, 56022 Castelfranco di Sotto (Pisa), Italy +39 0571367427 +39 0571382829 Paola Ulivi Private company Italy 2000

OVERVIEW With more than ten years of experience, Danger and Safety provides prompt and professional services within the fields of risk assessment, environment, health and in general for chemicals’ regulatory affairs (Reach-CLP-dangerous goods transport). All the staff are highly qualified (chemists and biologists). SERVICES PROVIDED OO full regulatory support for REACH regulation (Sief and consortium management; dossier development and submission; CSA and CSR) OO CLP compliance management OO SDS and e-SDS authoring for substances and mixtures OO risk and hazard assessment for health in working place OO specific training and workshops (generic and in-house) OO biocides: AS approval and product authorisation. OO assistance for outside EU Regulations through local partners CLIENTS We serve a wide variety of clients, from very small to large enterprises, operating in many fields as industrial chemicals, fragrance sector, pigments and dyes. Deep experience in chemicals for leather industry.

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www.distefanolawoffice.com flavia.distefano@distefanolawoffice.com Bastion Tower, Place du Champ de Mars 5, 1050 Brussels, Belgium +32 2 733 08 00 +32 2 733 12 72 Ms Flavia Distefano Private company Brussels, Belgium

OVERVIEW Distefano Law Office (DLO) is an independent law firm specialising in EU regulatory and antitrust law, and related EU litigation. Our team has significant experience in a wide range of regulatory and competition matters for international clients. We counsel and litigate on all aspects of EU chemicals regulations, including REACH, CLP, biocides, plant protection products (agrochemicals), food contact materials, cosmetics, as well as medical devices. By drawing on our sector-specific regulatory experience, we are specially positioned to provide tailor-made antitrust advice on chemicals related matters. We have advised REACH registration and authorisation consortia, as well as biocides and pesticides task forces, on antitrust-sensitive issues such as membership conditions, data sharing and licensing, confidential information exchanges and joint REACH authorisation applications. We work closely with a “friendly firm” local counsel network to offer clients seamless regulatory, competition, and litigation representation and counselling across various jurisdictions worldwide. SERVICES PROVIDED Legal regulatory and competition advice; representation before EU agencies and courts; representation in data sharing disputes before Echa; drafting of agreements (eg on data licensing or setting up consortia/task forces); structuring commercial contracts (including vertical agreements with customers and distributors) to ensure regulatory and antitrust compliance; assist on regulatory aspects of M&A due diligence process. CLIENTS Clients include European and non-European companies and trade associations in the chemicals, metal, energy and downstream industries.

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

www.mach-chemguide.com info@mach-chemguide.com Boernsener Str 16f, 21039 Hamburg-Boernsen, Germany +49 40 729 10 933/ +49 40 729 10 934 Dr Bettina Mach Private Germany 2011

OVERVIEW We guide you through REACH and CLP and the cosmetic Regulation 1223/2009. We rely on more than 20 years of experience in product safety in the chemical and cosmetic industry. SERVICES PROVIDED OO identify your obligations OO prepare late preregistrations OO prepare Echa inquiries OO prepare dossiers in Iuclid 5 OO prepare all kinds of notifications OO represent your interests in Siefs and consortia OO monitor toxicological studies OO advise on classification and labelling and prepare C&L notifications OO prepare product notifications according to Art 45 CLP in several EU countries OO conduct safety assessments and prepare chemical safety reports for cosmetics according to EC 1223/2009 CLIENTS DR MACH Chemical Compliance and Competence focuses on the European chemical and cosmetic industry: manufacturers, importers, distributors and downstream users of chemicals as well as manufacturers and importers of cosmetic products.

Chemical Watch | Global Service Providers Guide 2016

www.espheres.com charlotte.crauwels@espheres.com Pères Blancs Street 4, 1040 Etterbeek, Brussels, Belgium + 32 (0)2 740 43 36/ + 32 (0)2 740 43 87 Charlotte Crauwels Private Belgium, France, Finland, Germany, The Netherlands November 2011

OVERVIEW eSpheres, HSE Information management consultants, founded in 2011 as a Solvay spin-out. eSpheres is a global leader in delivering cloud health, safety, environment (HSE) software solutions to organisations worldwide. Our in-depth IT solutions and HSE support services help industrial companies in improving their management of safety, industrial hygiene and occupational health processes. SERVICES PROVIDED SAP EHS Consulting: eSpheres experts are readily available to help companies with complex SAP EHS issues. eSpheres supports SAP EHS projects and strengthens corporate EHS and IT departments by efficiently providing them with adequate resources to lead and implement SAP EHS into any organisation. SAP Netweaver and SAP Fiori architecture and implementation. Consultancy services expertise: project management, implementation and maintenance for product safety and safety datasheet management; incident and accident, occupational health management; safety datasheet distribution; global label management; dangerous goods, conflict minerals and chemical management. eSpheres Compliant Chemicals software for chemicals management and (vendor) SDS management; substances and product inventory management, regulatory compliance checks for SVHC’s and other regulations; incident/accident management; multilingual safety working instruction cards, risk management for workplaces. CLIENTS Team members have been working for a large number of industries and segments, like (petro)chemicals, pharmaceuticals, mining and minerals, steel and alloys, pulp and paper, but also at downstream users like polymers and polymer transformation, electronic, semiconductor, cosmetic, automotive industry.

CONTACTS Website E-mail Head office Tel Contact Locations Founded

OVERVIEW HDTS Chemicals Inc was established in 2001 to assist foreign chemical manufacturers manage sales and marketing in Canada within the context of the Canadian Environmental Protection Act (Cepa) and specifically the New Substances Notification Regulations (NSNR). HDTS Chemicals Inc provides NSN notification services for new substances being introduced to Canada as well as Canadian agent and importer of record services. SERVICES PROVIDED HDTS Chemicals will assist foreign chemical manufacturers develop strategies to supply non-DSL chemicals and polymers into Canada by acting as Canadian agent and/or importer of record. All foreign notifiers must use the service of a Canadian agent or establish an account with Canada’s revenue agency. Develop and implement Environmental Emergency and Pollution Prevention Plans including Transportation of Dangerous Goods Emergency Response Assistance Plans (ERAP). HDTS Chemicals Inc. also provides label design and safety data sheet authoring services using TECIS® software developed by Trivalent Data Services to meet Canada’s workplace hazardous materials information system (WHMIS) worker right to know regulations. We are assisting many Canadian and US companies transition the Globally Harmonized System. CLIENTS Nexeo Solutions Inc, ADLI Logistics Inc, Chemroy Canada Inc, Ethox Chemicals LLC, Madison Chemical Industries Inc, Pro Form Products Ltd, Tri Art Canada, Vivier Pharma

CONTACTS Website CONTACTS Website E-mail Head office Tel

www.eurideastranslation.com translation@eurideastranslation.com 523 Avenue Louise, 1050 Brussels, Belgium +32 (0)2 669 7701 / +32 (0)2 669 77 87

Fax Contact Ownership Locations Founded

+32 (0)2 627 5655 Kristina Bitvai Private company Belgium 2007

OVERVIEW Eurideas Linguistic Services provides professional translation and interpretation services. We specialise in chemical, technical, medical translations, as well as in other fields such as EU legislation, law, environment, health and many more. Our native speaker chemical translators are experts of the REACH regulation and other related EU, international and local legislations. We have great experience in translating SDSs and other regulatory documents. We have developed our own unique methodology through years of translating REACH documents, and are therefore able to offer 60% discount for the repetitions. SERVICES PROVIDED We provide translation, certified translation, proofreading, editing services in all EU languages, in many Asian, African and Latin American languages. The translations are always done by a native speaker translator and proofread by a second native speaker translator. We also carry out a thorough quality check on the ready translation. CLIENTS We have worked on REACH, BPR and other chemical related projects for Cefic, REACHCentrum, ISOPA, EuPC, Glencore International Imports, Rio Tinto, FEFCO, Molymet, the International Molybdenum Association, the International Lead Association, the Nickel Institute, Aurubis AG, Arche, DonauChem, Euromines, EcoMundo, Chemtopia, Tokyo Chemical Industry, and many more.

Chemical Watch | Global Service Providers Guide 2016

www.hdtschemicals.com service@hdtschemicals.com 33 Bisset Avenue, Brantford, Ontario N3T 0H2, Canada +1-905-220-4016 Dave Saucier Canada 2001

E-mail Head office Tel Contact Ownership Locations Founded

www.i-k.ch, www.compliance-footprint.com (Partner), www. mplogistics.ltd.uk weggimann@i-k.ch, info@i-k.ch I+K AG, Hadlaubstrasse 154, CH-8006 Zurich, Switzerland +41 79 4041733, +41 44 3642233 Walter Eggimann, PhD Chem Ing Private, Swiss AG company Zurich, Switzerland 1993

OVERVIEW What makes the difference? OO taking the complexity out of chemical compliance OO making «safe use of chemicals» a «communication network» OO where everything intelligently connects OO where everyone has instant access to essential information along the supply chain of the chemical OO where XML based digital exchange of safety data to your downstream users is becoming a reality OO where modern IT, intensive know-how and collaboration between you and us makes it work, within the entire scope of safety data sheet/ language-specific, GHS label, printing capabilities for IBCs/drums/small size packages, working instructions, import/export restrictions, customs tariffs and beyond. SERVICES PROVIDED We combine know-how, IT, stable operation, vision and global experience. OO REACH, CLP and GHS compliance at your fingertips OO Capability to eliminate risk of penalties OO Simple, quick and easy solution, modular, fit to business purpose, cost effective Net benefit: If you connect people with safe use information, they make chemistry safe, creating more innovation, more creativity, more opportunity. CLIENTS Wide range from small size companies to global corporations. Manufacturers, importers, downstream users. Representation in Switzerland, EU, other global areas.

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NICHE FIRM PROFILES

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www.infotox.pt info@infotox.pt INFOTOX, Lda, Rua de Moscavide 4.28.02B-7B, Parque das Nações, 1990-160, Lisbon, Portugal + 351 933 289 564 Elsa Casimiro Private company Portugal and UK 2004

OVERVIEW Originally, founded in 2004, INFOTOX is a specialist consulting company providing toxicology, human health and environmental risk assessment and advisory services to the private and public sector. Commitment to service excellence and innovation. We follow a holistic approach to ensure that projects are grounded in both leading edge technical expertise and in the context of current regulation and practical business realities. SERVICES PROVIDED Our regulatory services include expert support for biocidal products Regulation (BPR) and cosmetic products Regulation, REACH, CLP/GHS, in terms of: OO dossier/product information files (PIFs) data gap analysis; OO Iuclid dossier preparation; 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 exposure and risk assessments; OO production of chemical safety reports (CSR)/cosmetic product safety reports (CPSRs); OO safety data sheets production; OO reviewing and updating marketing/efficacy claims and product label; and OO guidance on setting up a post-market surveillance programme. We also provide a wide range of environmental health services including health impact studies for EIA, soil clean-up and climate change projects. CLIENTS Our clients include regulators, professional organisations, multinational companies and SMEs.

CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded

www.jongeriusconsult.com info@jongeriusconsult.com Begijnenhof 26, 6584 CW Molenhoek, the Netherlands +31 615962071 Onno Jongerius Private company Netherlands 2009

OVERVIEW Jongerius Consult BV want to contribute to an efficient and effective implementation of (EU) chemical regulatory compliance (CRC) by industry towards the main purpose of safe use of chemical products in the supply chain and at the workplace. We want to work with (European) companies and industry sectors that take their CRC responsibilities seriously by supporting them in the best practical implementation of the CRC requirements (like REACH and CLP), aligned to the business case, and up to safe use of the products in the supply chain and on the workplace. OO Check our mission/vision at www.jongeriusconsult.com/vision-mission/ SERVICES PROVIDED Are you a chemical manufacturer, importer, formulator, distributor and/or user of chemical products in the EU and are you looking for strategic/practical support to efficiently comply with the EU chemicals legislation (REACH and CLP)? OO Check our website for practical support and project references OO Contact me to discuss your specific business case in a 30 minutes free call: info@ jongeriusconsult.com. CLIENTS Our clients are those companies that want to deal efficiently with REACH and related legislation in alignment with their business needs. We are proud of our partners, satisfied customers and the many satisfied participants who attended our REACH compliance training programme. We’ll continue to focus on providing added value and making REACH and CLP work for industry.

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www.kreatis.eu contact@kreatis.eu 23 rue du Creuzat, 38080 L’Isle d’Abeau, France +33 428190106 Paul Thomas, CEO Private company France January 2014

OVERVIEW KREATiS aims to offer its clients an alternative to experimentation to fulfil REACH obligations. Each value provided is guaranteed to be as accurate as its equivalent laboratory study at just a fraction of the price. The endpoint values are supported by the appropriate documents for REACH regulatory acceptance. SERVICES PROVIDED KREATiS is building on its existing portfolio of high accuracy Qsars (HA-Qsars) based on Annex VII and VIII studies for use in REACH. Critical ecotoxicity and physicochemical endpoints are currently available and many more are in the pipeline. For each study ordered from KREATiS, you get a complete service: each requested endpoint is scrutinised individually by our staff to verify applicability domain and then to use the appropriate algorithm to provide you with a high accuracy result. Qsar model reporting format (QMRF) and Qsar prediction reporting format (QPRF), necessary for successful submission of endpoints to Echa, are provided in the KREATiS study report. If required a complete Robust summary can be prepared by KREATiS in i5z format. KREATiS is also offering tailor-made in-silico services to meet its clients’ requirements. KREATiS offers a money back guarantee on all of its products. For terms and conditions, visit our website or contact us directly. CLIENTS Client profiles include several renowned companies from the chemicals and fragrance industries and several dossiers containing KREATiS predictions have already been successfully submitted in REACH dossiers.

CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded

www.linmarkconsulting.com martin.richards@linmarkconsulting.com Bernoullistrasse 20, CH-4056 Basel, Switzerland +41 79 500 9719 Dr Martin G Richards Private company Switzerland, UK 2007

OVERVIEW Linmark Consulting is a consulting and service company engaged in regulatory affairs, toxicology, advocacy and communications for the chemical and life sciences industries. Linmark Consulting is headquartered in Basel, Switzerland, a major European industrial centre with good communications globally. Its UK subsidiary, Linmark Consulting Europe Ltd, offers only representative (OR) services under REACH, for importers into Europe. SERVICES PROVIDED Particular skills in generating new business and protecting client businesses through regulatory knowledge and practice, stakeholder analysis, problem-solving, global network and communications with diverse stakeholders including value chain, government authorities and NGOs. Offerings based on over 30 years’ senior operational experience in regulatory affairs management, consultancy and product development functions in multinational chemical, agricultural biotechnology and biopharma companies in UK, USA and Switzerland. Commissioning mammalian and ecotoxicology studies. REACH OR and third party representation. Key strengths in consortium management, REACH, global chemical regulation, reputation management and advocacy. CLIENTS Client confidentiality is guaranteed. Recent contracts include management of six REACH consortia, where 2010 and 2013 registration deadlines were successfully met. Consortia support continues for Reach registration, authorisation and other objectives. Linmark Consulting has successfully managed global and EU chemical advocacy programmes for industrial chemical and biocide clients. Global and smaller companies in chemicals, agriculture and life sciences represented in EU and Switzerland.

Chemical Watch | Global Service Providers Guide 2016

www.LKC-ltd.com LKC@lkc-ltd.com Postfach 167, Hauptstrasse, Fuellinsdorf, Switzerland +41 61 906 8500 / +41 61 906 8509 Dr David Kane Private company Switzerland, UK 2001

OVERVIEW LKC provides European registration and development services to the international chemical and biochemical industry. The LKC team is multi-disciplined, offering both technical and regulatory experience, project management proficiency and strategy planning expertise. Specialty chemical manufacturing clients benefit from our range of regulatory services to achieve the successful registration of products for crop protection, biocides, veterinary medicines and industrial chemicals. SERVICES PROVIDED Regulatory: data gap analysis, data evaluation, design, contract and management of data requirements including higher tier studies, chemistry, analytical methodology, mammalian toxicology, ecotoxicology, environmental fate and efficacy studies, PECreports and GLP multi-site residue studies. Conducting risk assessments and modelling for dietary, human and environmental exposures. Dossiers: for active substance submissions for Annex I inclusion, product dossiers for national registrations, provisional and union authorisations and mutual recognition. CADDY.XML dossiers, Iuclid dossiers, re-registrations, renewals, label extensions, setting EU import tolerances/MRL’s, REACH, CLP and JMAFF (METI) dossiers. Technical support: pre and post submission discussion with authorities, negotiation communications, data package compensation for data-sharing and product registration maintenance and defence. CLIENTS LKC’s clients are specialty chemical and biochemical manufacturers who benefit from technical support in market sectors that include crop protection, biocides, animal health and general chemicals.

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

www.oci.net.cn david.chang@oci.net.cn Room 2006, Moma Towers, Chaoyang North Street No.199, Chaoyang District, Beijing (100026), China +86-10-68091928 extn 8008 +86-10-68091928 extn 8018 David Chang Limited company China 2006

OVERVIEW OCI (北京正智远东) was established in June 2006 and is one of earliest and leading legal regulatory services providers in China and the Far East. We deal with more than 3,000 registration approvals, in relation to chemicals, food, cosmetics and agrochemicals. Our succesful operation now also owns partnerships in Korea, Taiwan, Japan and the Philippines. SERVICES PROVIDED OO China and Far East chemical regulations consultation and registration services. OO Food, cosmetics, fertilisers products registration. OO MSDS and GHS compiling and data base upgrading services. CLIENTS KAO, BASF, Akzo Nobel, Ashland, Degussa, etc.

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

www.ecotoxchem.co.uk peter.fisk@ecotoxchem.co.uk Saxon House, John Roberts Business Park, Pean Hill, Whitstable, Kent, CT5 3BJ, UK +44 (0)1227 470901/ +44 (0)1227 765117 Dr Peter Fisk Limited company UK Originally founded in 1995. Founded as a limited company in 2006

OVERVIEW Peter Fisk Associates offers specialist services to industry and regulatory organisations in the fields of environmental chemistry, toxicology and risk assessment. We bring expertise and high-level experience to chemical consultancy, tailored to our clients’ needs. We collaborate closely with our clients to harness their insights into their own products. SERVICES PROVIDED PFA provides a wide range of commercial and technical services associated with chemical safety and regulation, based on over 20 years experience. Our services include: chemistry, toxicology, ecotoxicology, quantitative structure-activity relationships, exposure assessment and modelling, risk management options, consortium management, supply chain analysis and authorisation support. We apply this range of expertise to support industrial and regulatory clients, within and beyond REACH: in all aspects of REACH and CLP requirements (dossier development and chemical safety assessment for more than 150 substances in Phases 1 and 2); socio-economic analysis, biocidal products Regulation, cosmetics, plant protection products, food safety and other areas of chemical regulation and voluntary assessment. We can collaborate with reliable expert partners to provide complementary services. We have successfully provided secretariat services, including REACH consortium management and Sief communications. We also offer training in our areas of expertise, including custom-built courses tailored to our clients’ individual needs. CLIENTS A wide variety of industrial clients including chemical manufacturers’ consortia from several sectors, downstream users of chemicals and regulatory authorities.

CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded

www.prefusion.co.uk info@prefusion.co.uk 1 Orchard Grove, Brixham, TQ5 9RH, UK +44 (0)1803 850843 Professor Geoff Le Grys / Dr Qintao Liu Limited Liability Partnership UK, China 2010

OVERVIEW Prefusion provides chemical regulation and strategy consulting services. We are skilled at helping prepare compliance documents, their submission and advocacy for companies to the EU market, and supporting international companies to comply with Chinese regulations. We have extensive experience with a number of industry sectors and government policymakers in EU and China. Our outstanding capability lies in sustainability strategy, supply chain communication and product stewardship. SERVICES PROVIDED We help prepare regulatory documents and submission for market entry into the EU and China. These include, in the EU: REACH, CLP, BPR, PPP, medicinal products regulation, endocrine disrupting chemicals, cosmetic products Regulation, novel foods, health / nutritional claims, RoHS and eco-labels; in China, new chemical registration (China REACH); hazardous chemical registration; disinfectants regulation, food safety and health related regulations. We also provide technical documents translation and policy interpretation. Our featured services include: 1) intelligent testing strategies – helping design environmental and health testing strategies that save money and meet regulatory requirements; 2) hazard and risk assessments in the environment and workplace – PBT, CMR, exposure assessments and chemical safety reports; 3) representation and advocacy – representing clients to REACH and other consortia; and 4) substances of very high concern (SVHCs) and supply chain management. CLIENTS Industry, NGO and government clients in a wide range of sectors, such as industrial chemicals; energy; agrochemicals; pharmaceuticals; medical devices; veterinary medicines; personal care products; pesticides; biocides / disinfectants; water and sewage treatment; food and ingredients; electronic chemicals; construction materials and consumer products.

Chemical Watch | Global Service Providers Guide 2016

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www.randis.cn / www.randischem.com frankwang@randis.cn, randis@randischem.com Unit 505, KeChuang Building, #350 Xianxia Road, Changning District, Shanghai, 200336, PR China +86 (21) 6275 7818 / Skype: randischemwise Frank Wang Private company China, Taiwan 2004

OVERVIEW Although not big but very professional, Randis is managed by a team of experts with dozens of years of experience working for famous multinational chemical companies in China. We provide timely and cost-effective services on regulatory compliances for China and Taiwan. SERVICES PROVIDED OO full regulatory support for China IECSC registration (China REACH), including being the notification agent, data gap analysis, GLP lab service, full notification dossier preparation, etc. OO GHS classification, (Chinese) GHS SDS/label conversion and compilation. OO cosmetics registration to China FDA. OO hazardous chemical notification to NRCC-SAWS. OO China 24hr chemical emergency hotline service. OO food contact additive registration (GB9685). OO import and export application for toxic chemicals. OO Taiwan new and existing chemical substance registration. OO other China chemical regulation services. CLIENTS Randis provides services to chemical-related industries all over the world that have and want to have business with China, including manufacturers, exporters, importers, distributors, downstream users of chemicals and cosmetic products. Our language ability: English, Japanese, Chinese, Taiwanese and French.

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

www.reach-gs.eu info@reach-gs.eu Rond Point Schuman, 6 Box 5, B-1040 Brussels, Belgium +32 (2) 234 77 78/ +32 (2) 234 79 11 Mr A Ecmel Yorganci Chemicals and Chemical Products Exporters’ Association (IKMIB) 95% and Steel Exporters’ Association (CIB) 5%. Two divisions of Istanbul Minerals and Metal Exporter’s Association. Headquarters: Brussels, Belgium; Offices: Istanbul, Turkey. Locations ideal for European and Turkish chemical industry and proximity to the EU Commission and Cefic in Brussels and Echa. 2008

OVERVIEW REACH Global Services SA (RGS) specialises in regulatory consulting services advising and assisting private sector clients in the chemicals and allied industries to comply with European Union and Turkish chemicals legislations. RGS’ experienced scientific staff, based in Brussels and Istanbul, consults on behalf of a diverse array of international and Turkish chemical companies operating across a range of industrial sectors. SERVICES PROVIDED REACH and related services include only representative services to non-EU manufacturers. EU cosmetics Regulation compliance services for non-EU exporters to the EU. Turkish chemicals legislation compliance including Turkish REACH (KKDIK), by-law on chemicals inventory and control, Seveso II compliance to worldwide manufacturers exporting to Turkey. Regulatory compliance training. CLIENTS RGS’ client portfolio ranges from multinational blue chip and leading Turkish chemical and allied industry companies to small and medium enterprises.

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www.reachwise.eu info@reachwise.eu 22, St Albans Avenue, London W4 5JP, UK +44 (0)20 87470873 Peter Douben Private company UK, Netherlands, Germany 2007

OVERVIEW With extensive knowledge of REACH and CLP, REACHWise provides tailor-made services overseen by Peter Douben, formerly Director REACH, Cefic, and head of environmental protection, Unilever. Our focus on REACH, CLP and BPR means our efforts are targeted. We change complex situations into manageable elements, and provide cost-effective solutions, using IT tools where possible. SERVICES PROVIDED Impact of REACH, CLP and BPR: finding comprehensive solutions for companies on the best way to approach the REACH, CLP and BPR “problem” and to remain compliant. Sief support: we provide the whole spectrum of Sief and consortium management. REACH registration: for individual and groups of companies, our REACH support covers data evaluation and sharing, preparation of the technical dossier, use and exposure requirements, chemical safety assessment and exposure scenarios. Safety data sheets: we prepare and update SDSs (body and annexed ESs) including translations. Exposure scenarios: for individual substances as well as mixtures we ensure they are comprehensive and communicable: you discharge your obligations; your customers find them easy to understand. Downstream uses: using specialist models we ensure that your conditions are compliant even when they deviate from the registrant’s information. Biocides: actives or products, we take care of them. CLIENTS We provide added value and have satisfied customers from the ceramics industry, fertilisers and related industries, fragrance sector, health care sector, home and personal care, lubricants manufacturers and suppliers, metals sector, minerals sector, pigments and colorants sector, speciality chemicals industry.

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

www.refac.eu Rachel.Green@refac.eu Group House, Southmere Court, Electra Way, Crewe, Cheshire, CW1 6GU +44 (0)1270 258530/ +44 (0)1270 258444 Ms Rachel Green Chemical Business Association UK 2007

OVERVIEW ReFaC provides regulatory assistance to companies, within Europe and from across the world, who seek to comply with regulatory schemes such as REACH, CLP, BPR etc. Our team of regulatory professionals provide efficient and expert services to SME companies, multinational organisations, industry associations and consortia. Wherever possible ReFaC aims to reduce the burden imposed by regulation and provides tailored support to clients in order to maximise the value of our contribution. ReFaC delivers REACH compliance solutions using its own staff and a select group of industry partners, including Bibra, Envigo, Intertek and AMG Analytical Services. ReFaC is owned by the Chemical Business Association. SERVICES PROVIDED ReFaC provide a complete range of services for those seeking compliance with chemicals regulations. Our services include: REACH dossier development and submission; data gap analysis, hazard and exposure scenario development and CSR authorship; consortium and Sief management; consultancy and study monitoring; PPORD notification; OR and TPR services; SDS and eSDS authorship; CLP compliance management; toxicology consulting and study monitoring; worldwide notifications; dangerous goods consultancy and DGSA service, and compliance with the biocidal products Regulation. CLIENTS ReFaC supports SMEs and large organisations from across the chemical industry, both within Europe and Worldwide. In addition, ReFaC assists a number of industry associations and consortia that require management, consultancy and study monitoring services.

Chemical Watch | Global Service Providers Guide 2016

www.regscan.com info@regscan.com 800 West Fourth Street, Suite 202, Williamsport, PA 17701, US +1 570-323-1010 +1 570-323-8082 Robert Lang, Vice President of Engineering and Marketing Privately held Global 1987

OVERVIEW One World, One Platform – Founded in 1987, RegScan provides regulatory compliance services to companies worldwide. Unique online tools enable easy access to regulatory information. Access all your global data on the same platform, and create custom legal registers and audit protocols for more than 140 jurisdictions. Do your research and get your alerts through the RegScan One system, or have your content exported via web services to any online environmental management system. SERVICES PROVIDED Business services, information services, regulatory alerts and compliance assistance, legal registers and audit protocols, research, online databases, integration with EMIS systems. CLIENTS A wide variety of clients ranging from single industrial chemical manufacturers to Fortune 1000 companies.

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

www.scas-eu.be/ scaseurope07@scas-eu.be SCAS Europe (Sumika Chemical Analysis Service), Leonardo da Vincilaan 19 (MC Square Offices) B-1831 Diegem, Belgium +32 (0) 2 719 0475 +32 (0) 2 719 0480 Dr Rick Stanton Sumika Chemical Analysis Service, Tokyo, Japan For parent company: Japan, China, Singapore, Taiwan, South Korea 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. Our parent company SCAS is a major analytical service provider with laboratories in Japan, China, Korea and Singapore. Founded in 1972, SCAS has consistently been satisfying requirements of its customers by providing the best analytical solutions in many industrial sectors. SERVICES PROVIDED EU REACH registration and OR for Asia clients; Asia chemical regulation support for Asia and Western clients. CLIENTS From many sectors, including both manufacturers and downstream users, for example in the following industries: chemical, petrochemical, electronics, pharmaceutical, automotive, paint, ink, rubber, fibre and others.

CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded

www.rovaltainresearch.com Contact@rovaltainresearch.com 1 avenue de la gare, BP 10313 - 26958 VALENCE Cedex 9, France +33 4 82 48 00 31 Martin Lawniczak Private company France 2014

OVERVIEW Rovaltain Research Company is a global expert service and contract research organisation for ecotoxicology and environmental toxicology. We are a company that specialises in providing a distinctive blend of innovative and classical approaches to evaluating the potential risks of chemical and biological contaminants for researchers and industrial clients. We offer a range of services from fundamental research, applied research, and experiments to more classical studies concerning environmental toxicology and ecotoxicology. SERVICES PROVIDED Ecotoxicology tests (including testing of BSL-2 ‘substances’) on micro-organisms, aquatic macrophytes, and microalgae, aquatic invertebrates, aquatic vertebrates, plants, terrestrial invertebrates to international guidelines (OECD, ISO etc). Fate of substances and contaminants (distribution, accumulation, biodegradation and metabolism). Behavior analysis using videotracking. Indoor soil, aquatic and sediment mesocosms with simulation of urban, agricultural and natural climatic conditions. Validation and implementation of analytical methods with biomarker identification Metabolomics, enzymatic assays and MALDI imaging, substance and metabolite profiling, monitoring of contaminants (environmental biota, biofluids). CLIENTS General chemical industry, human and animal pharmaceutical industry, biocides industry, plant protection products industry, ‘biocontrol’ industry, plastics industry, personal care products industry, flavours and fragrances industry. Research institutes and universities, government bodies, NGOs.

Chemical Watch | Global Service Providers Guide 2016

CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded

www.scivera.com knowmore@scivera.com SciVera LLC, 300 Preston Avenue, Charlottesville, VA 22902, US +1 434 974 1301 Erika Palmer Private US 2008

OVERVIEW SciVera® is a global provider of product chemical data collection and chemical safety assessment products and services that enable corporations of all sizes to better assess their toxicological risk and compliance to fast-changing European and North American regulations and standards. SERVICES PROVIDED SciVera is the only web-based software solution giving efficient and cost-effective collection and processing of product and material data for toxicological risk assessment. Protected by secure internet protocols and firewalled customer datastores, clients process bill of materials (BOM) and bill of substance (BOS) data using SciVera Lens® through an encrypted internet connection. SciVera Lens automatically processes thousands of chemical, component, and product-level chemical safety reviews including exposure and risk assessment. SciVera’s added level of chemical risk assessment supports compliance efforts on North American and EU regulations as well as market requirements such as California Prop 65, REACH CSA/CSR, EU toy safety Directive conformity assessment. SciVera is also a licensed GreenScreen® for Safer Chemicals profiler. SciVera Lens enables manufacturers to efficiently and securely gather BOM/BOS data from suppliers while protecting supplier proprietary information. SciVera’s strategy and toxicology services support customers’ efforts to engage suppliers and reduce business risk by improving product chemical knowledge. CLIENTS SciVera Lens has applicability to virtually all product categories where articles and formulations need chemical safety assessment for toxicological hazard and risk. Active engagements include small and large manufacturers and suppliers in: automotive, electronics, footwear/apparel, household goods, office furniture, toys, textiles, personalcare and specialty chemicals.

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Website: www.siam-it.net Product website: www.chemeter.eu info@chemeter.eu Ortega y Gasset 17 bajo, 26007 Logroño, Spain +34 941286749 Private company Europe 2008

OVERVIEW Siam is a company that developed the software Chemeter for the generation of SDS, labels and transport documents according to European legislation. Our vision and commitment is to making sure that all chemical companies have legislative compliance with regards to REACH, CLP, GHS, etc. SERVICES PROVIDED Siam offers complete customer support with data accuracy, quality and integral services. Our main services include reference and integrated regulatory data, SDS authoring systems, SDS distribution and management, transport documentation and support. CLIENTS From the beginning Siam has been oriented towards having an international network. Today we have a well-established international presence trhrough our sales network in many countries like: France, Italy, Portugal, Finland, Poland, Greece, Romania, Sweden etc. Our clients are European and non-European companies manufacturing and distributing all kinds of chemical products in many sectors, such as: cleaning, paints and coatings, paints, rubber, detergents, adhesives and sealants, flavours and fragrances etc.

Spring Trading Company CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded

www.springtradingcompany.com james@springtradingcompany.com 10805 W Timberwagon Circle, Spring Texas 77380-4030, US +1 281-367-9356/ 877-227-2597 James Yowell, Bradley Hayes Private company US 2009

OVERVIEW Spring Trading Company has the experience and expertise you need to meet the everchanging agricultural registration and regulatory requirements federally, in the 50 states, and in over 80 countries. Your products will be expertly moved through the regulatory process. Our extensive knowledge within the EPA and industry helps you to plan and fulfil all the requirements for difficult registrations, timely and effectively. Get the best regulatory care available and avoid the additional burden and cost of hiring an employee to manage your pesticide and fertiliser registrations, including conventional and biological products. SERVICES PROVIDED We offer a full range of regulatory compliance services for active and inert ingredients, enduse, and technical products, for new chemistry, and generic products under FIFRA, TSCA and many others. We have experience negotiating data compensation, acquiring new data, and planning corporate strategies. We also provide complete state registration services for pesticides and fertilisers as well as tonnage reporting to keep your products up-to-date. We offer toxicology services, and access to the top laboratories in the industry to produce OECD, US, GLP compliant data, and field testing data to support your applications. CLIENTS Spring Trading Company helps some of the largest to some of the smallest companies in the pesticide and fertiliser industry and provides service supporting conventional and biological products. From unique applicators (precisely targeted pesticide applications and tree injection technologies) to PGR reclassifications to fee and data waivers – our clients are diverse and satisfied.

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

www.toxfocus.com barbara.vogt@toxfocus.com 2 Glenridge Road, Little Rock, AR 72227, US +1 501 351 4389 Barbara Vogt, PhD, DABT Private company USA 2008

OVERVIEW Tox Focus LLC provides the toxicologic and scientific content for REACH, cosmetics Regulation, and other regulatory programmes, drawing upon 20 years experience in corporate and clinical toxicology. The consultancy authors Iuclid 5 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, including data gap filling, adaptations to data requirements, identification of analogues and categories, computer modelling and support (QMRF, QPRF), laboratory test monitoring, robust study authoring, construction of Iuclid 5 files with completeness 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 Cytec Industries Inc, The Redstone Group, Unilever, Mayer Brown International LLP, Lucite International, Ineos Europe Ltd, The Cyanide Council, Evonik-DeGussa GmbH, Abercrombie and Fitch, Air Products and Chemicals Inc, Vertellus Specialties Inc, Arch Chemicals Inc, Gerber Scientific International, AW Chesterton Company, Calumet Specialty Products Partners LP, Gulf Bayport Chemicals LP, The Nail Consultants, Ltd., United States Department of Commerce.

CONTACTS Website E-mail Head office Tel Contacts Ownership Locations Founded

www.toxcel.com Christine.McAlinden@toxcel.co.uk / info@toxcel.com PO Box 93, Ledbury, HR8 9JE, UK +44(0)1531 638999 (UK) / +1 703 754 0248 (US) Christine McAlinden (UK) / Alan Katz (US) Limited company UK, US 1999

OVERVIEW toXcel’s European and North American offices work closely together to provide a coordinated regulatory resource for seamless development and execution of strategies, designed for cost-effective regulatory approvals, leading to domestic, regional, and global export market expansion. SERVICES PROVIDED toXcel provides a full range of services to support obtaining marketing approvals by governmental agencies, with emphasis on regulatory strategy development and all aspects of preparing applications and dossiers. toXcel advises companies about compliance with REACH, CLP, the biocidal products Regulation, the cosmetics Regulation, the plant protection products Regulation, and other EU registration requirements. We can provide you with a full REACH registration service (including only representative function), or we can support your in-house activities as required. Our experts provide FIFRA, TSCA, and FDA services to our global clientele in our US office. toXcel has global experience in the performance of exposure and risk assessments, environmental assessment, safety and toxicological evaluations, nanoparticles, and the design and management of GLP analytical chemistry, residue, efficacy, environmental fate, mammalian toxicity, metabolism/pharmacokinetics (ADME), and ecotoxicity studies. CLIENTS Our leading consultants focus their collective professional talents on assisting chemical manufacturers, formulators, pharmaceutical companies, personal care/consumer product manufacturers and suppliers, trade associations, law firms, and the food industry.

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Chemical Watch | Global Service Providers Guide 2016

www.toxicon.it info@toxicon.it Via Robolini 1, 27100 Pavia, Italy +39 0382 1938015 / +39 0382 1938026 Raffaella Butera, MD Private company Italy 2010

OVERVIEW Toxicon provides a wide range of expert advice services in regulatory fields and in the areas of toxicology, pharmacology and occupational medicine for companies and institutions. Our know-how is based on a solid academic background in risk assessment. Our team consists of specialists in different areas: physicians, pharmacologists, biologists, chemists, biotechnologists, food technologists, economists and lawyers. We believe that complex problems can be solved with success and quality only through teamwork. SERVICES PROVIDED Overall services: guidance on regulatory interpretation, compliance support, auditing. REACH: data sharing, Sief and consortium management. Data gap analysis and testing strategy development, including the use of Qsar models. Dossier preparation (inquiry, lead and member registrants) including CSA/CSR. PPORD notification. SDS and e-SDS. Compliance check with exposure scenario (ES), scaling, CSR-DU development. ES development for mixtures. Applications for authorisation including SEA. CLP/GHS: hazard assessment, classification and labelling, notification to Echa C&L inventory and to member states bodies for emergency health response on mixtures. BPR Regulation: data sharing agreements, dossier development for active substances approval and biocidal products authorisation at national and UE level. Cosmetic products: safety assessment, product information file, notification. Medicines: CTD, genotoxic impurities assessment, PDE assessment, environmental risk assessment, provisional OELs for APIs and other chemicals. Occupational medicine: risk assessment and management (Directive 98/24/EC). Other: training for companies, universities and institutions.

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

www.vrs-regulatory.net jobs@vrs-regulatory.net Vantage House, 26a Northenden Road, Sale, M33 3BR, UK +44 (0)161 976 2825 +44 (0)161 976 2561 John Sherratt Limited company UK 2006

OVERVIEW VRS Regulatory is the specialist regulatory affairs and risk assessment recruitment division of scientific recruiter VRS. We focus on recruitment in regulatory affairs, registrations, REACH, CLP, SDS authoring, product safety, compliance, risk assessment, regulatory toxicology, regulatory ecotoxicology and environmental fate in the chemicals, agrochemicals and biocides sectors. We recruit for jobs at all levels from experienced regulatory professional to someone just starting their career in the regulatory / risk assessment field. We focus on the UK and often have opportunities based in continental Europe or even further afield. SERVICES PROVIDED OO Recruitment consultancy for regulatory affairs and risk assessment positions. OO Contingency and search and selection OO Advice on salaries, skills availability, recruitment methods OO Careers advice to regulatory affairs job hunters CLIENTS We work with many UK based companies – SMEs and multinationals – manufacturers, distributors, retailers, consultancies, CROs and government bodies. We focus on organisation involved in chemicals, agrochemicals and biocides.

CLIENTS Toxicon assists large companies and SMEs. Moreover, Toxicon works in partnership with institutions, industries and associations for R&D and compliance projects.

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

www.toxservices.com info@toxservices.com 1367 Connecticut Avenue NW, Suite 300, Washington, DC 20036, US +1 202-429-8791/ 202-429-8788 Margaret H Whittaker, PhD, MPH, CBiol, FSB, ERT, DABT Limited Liability Company USA 2003

OVERVIEW ToxServices is a leading 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. SERVICES PROVIDED ToxServices is a world leader in assessing human health and environmental hazards posed by chemicals throughout the supply chain. ToxServices is an authorised third-party profiler/assessor for the U.S. EPA Safer Choice programme (SCP), GreenScreen® for Safer Chemicals, CleanGredients®, Health Product DeclarationsTM (HPDs), and the Cradle to Cradle CertifiedTM programme. Additionally, ToxServices offers GreenScreen® assessments in accordance with the TCO Certified Displays 7.0 Program. ToxServices’s Full Materials DisclosureTM (FMDTM) Program provides a streamlined platform for chemical hazard assessments and supports claims related to safer chemicals. Core competencies include: quantitative exposure and risk assessments; MOS/MOE; RSL and MRSL creation; Qsar; alternatives assessments; personal care product and cosmetic safety assessments; Proposition 65 compliance including NSRLs/MADLs; impurity assessments; dossier and SDS preparation; and expert witness/legal support. We help clients comply with international, federal, state, and local environmental health and safety regulations, and provide third-party auditing services to ensure compliance with GMPs and GLPs. CLIENTS ToxServices assists a diverse range of clients located across the world. Our clients include multinational corporations with extensive portfolios, including manufacturers, suppliers, and distributors of personal care products, medical devices, electronics, textiles, and household and consumer products.

Chemical Watch | Global Service Providers Guide 2016

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

www.wrcplc.co.uk ncet@wrcplc.co.uk Frankland Road, Swindon, UK 01793 86 5000/ 01793 86 5001 Jo Rowland Private company UK 1927

OVERVIEW WRc’s REACH team consists of experienced mammalian and environmental toxicologists, risk assessment analysts, chemists, Qsar and exposure scenario modellers and REACH legislation experts. WRc has extensive experience of dealing with national and European regulators (including the Echa) and industrial clients and consortia. SERVICES PROVIDED OO Identification of registration requirements OO Arrangement of toxicological and ecotoxicological testing OO Compilation and evaluation of physico-chemical, environmental, fate, toxicological and ecotoxicological data packages OO Substance grouping, Qsar and read across for data gap filling and test replacement for some endpoints OO Exposure modelling and derivation of exposure scenarios OO Reviews of epidemiological data and health monitoring studies OO Hazard classification and labelling (CLP) OO Preparation of technical dossiers in Iuclid 5, chemicals safety reports (CSRs) and safety data sheets (SDSs) OO Validation of registration dossiers prior to agency submission. OO Emergency response OO Training CLIENTS A wide variety of clients ranging from single industrial chemical manufacturers to multinational consortia.

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Global Service Providers Guide 2016

www.wspgroup.com alan.ritchie@wspgroup.com 70 Chancery Lane, London, UK +44 20 3116 6072 Alan Ritchie/ Dr Stephen Bounds Private company UK, Europe, worldwide 8 April 1987

OVERVIEW WSP provides a wide range of environmental, health and safety, product stewardship and regulatory consultancy services. Our global REACH Group includes chemical industry professionals experienced in all aspects of chemical regulation and includes registration specialists, toxicologists and ecotoxicologists experienced in dealing with REACH and other chemical regulatory projects for a wide range and size of clients. We are a leading global design and engineering firm with over 30,000 staff around the world. SERVICES PROVIDED We offer a complete range of services to deal with all our client’s REACH, biocidal products Regulation requirements including: identifying a client’s REACH and biocidal registration obligations and developing the registration strategy; Sief and consortium management; all aspects of substance registration dossier preparation and submission; joint registration submission; socio-economic analysis; authorisation of a substance (WSP was the technical advisor on the first ever application for authorisation to clear Echa); classification, labelling and packaging (CLP) management and compliance; only representative (OR) and third party representative services; safety data sheet (SDS) preparation and management; REACH compliance checks. We also now provide a full service for supporting the new EU cosmetics Regulation including cosmetic product safety assessments, notifications to the cosmetics products notification portal and artwork reviews. CLIENTS WSP assists a large group of companies to fulfil their REACH obligations ranging from SMEs through to large multinational corporations. Our clients include manufacturers, importers and downstream users. We act as only representative for approximately 15 companies and provide support over and above the basic service as required. We specialise in helping companies respond to their business challenges and effectively manage compliance.

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3S-SafelyServingScience A.S.C. Accenture ACTA Actio Software Corporation Advinus Therapeutics Limited Aegis Regulatory Inc AG-HERA AGREXIS AG Alan Best Alberi EcoTech Alchemy Compliance Ltd Alemare Solutions ALSTER Consulting > Chemical Compliance Altox AMEC Environment and Infrastructure

173 Greece 173 France Belgium 60 UK USA India Canada UK Switzerland UK USA UK UK Germany 173 Denmark UK

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ARCHE Argentum Environment ASCHEM Chemical Consulting Assent Compliance

Belgium Sweden Poland Canada

ATOUT REACH Austen Business Solutions Ltd AW-ChemAdvice Ayansan Chemical Consultancy Plastic Trd. Ltd. Co.

France UK The Netherlands Turkey

Baytouch Ltd Beijing BoardingCard Chemical Consulting Co., Ltd.

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25-50 Europe, Colombia, 5,000 plus Africa Germany, USA 100-500 France, Poland, 25-50 Czech Rep, Australia, Brazil 10-25 Belgium, Switzerland, 5,000 plus North America 10-25 UK 100-500 1 USA, Germany, UK, 100-500 Taiwan, India, Kenya 2-5 2-5 1 5-10

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5-10 10-25

50-100 10-25 25-50 Japan, Thailand, USA 25-50 25-50 500-1000 5-10  Germany, HK, 50-100  representatives globally Boeije Consulting Belgium 1 Bootman Chemical Safety 174 UK 2-5 Borenius & Kemppinen, Attorneys at law Ltd Finland 100-500 Bristol Environmental USA 100-500 Buckman USA 2,000-5,000 Bureau Veritas France 5,000 plus Bureau Veritas HSE Denmark A/S Denmark 5,000 plus Burges Salmon UK 500-1000 Cambridge Environmental Assessments UK 5-10 Cardno ENTRIX USA South America, 1,000-2,000 Canada CEHTRA 76 France Belgium, Canada, 50-100  India, UK Centro Reach Italy 5-10 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% 

Beveridge & Diamond, PC bibra toxicology advice & consulting BIG vzw BioQuanta BIOVIA, Dassault Systemes Bird & Bird LLP Blue Frog Scientific Limited bluesign technologies ag

Other locations United States

Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)

Organisation 1cc GmbH 24-7 Response 3E Company

www.annraytest.com/eindex.asp e e e e e www.anteagroup.com e www.anthesisgroup.com www.apc.eu.com

e e e www.apeiron-team.eu e a a a www.arcadis.com e e gge ge gg

m i

www.arche-consulting.be www.argentumenvironment.se www.aschem.waw.pl www.assentcompliance.com

www.baytouch.com www.bjboardingcard.com

www.bdlaw.com www.bibra-information.co.uk www.big.be www.bioquanta.net m www.accelrys.com ii www.twobirds.com m mg e a www.bluefrogscientific.com me e g www.bluesign.com

100-500 50-100 5-10 5-10 25-50

egegeee eg geee i g g m ii e m

50-100

mea

aee

2-5

iee

www.boeijeconsulting.com www.bootmanchem.com www.borenius.com m www.bristolenvironmental.com www.buckman.com www.bureauveritas.com www.bvhse.dk www.burges-salmon.com www.cea-res.co.uk www.cardnoentrix.com www.cehtra.com www.centroreach.it

Chemical Watch | Global Service Providers Guide 2016

Information

IT solutions

Laboratories

Training Other

                                                                                   

   

Annray Test Co., Ltd. Antea Group

       

Anthesis-Caleb APC

                    

Apeiron-Team NV Arcadis

                                      

ARCHE Argentum Environment ASCHEM Chemical Consulting Assent Compliance

   

                                                   

ATOUT REACH Austen Business Solutions Ltd AW-ChemAdvice Ayansan Chemical Consultancy Plastic Trd. Ltd. Co. Baytouch Ltd Beijing BoardingCard Chemical Consulting Co., Ltd. Beveridge & Diamond, PC bibra toxicology advice & consulting BIG vzw BioQuanta BIOVIA, Dassault Systemes Bird & Bird LLP Blue Frog Scientific Limited bluesign technologies ag

   

             

Boeije Consulting Bootman Chemical Safety Borenius & Kemppinen, Attorneys at law Ltd Bristol Environmental Buckman Bureau Veritas Bureau Veritas HSE Denmark A/S Burges Salmon Cambridge Environmental Assessments Cardno ENTRIX

         

CEHTRA

                        

          

              

                                              

    

                 

                          

   

   

   

    

                  

          

                   

                                                                                        

               

                  

       

  



   

  

       

             

       

 

  

         

      

          

   

                                   

Centro Reach             Key: Icons above represents the extent to which the company provides the service as follows:

                                              

          



   



    



     

  



                 

 



                    

     

                 

                 

                              

      

                                                                                                   

     

                                           

                                             



 

               

      



A-Z LISTING

Organisation 1cc GmbH 24-7 Response 3E Company

Repre./management

Guidance on regulatory interpretation Product compliance Corporate strategy/strategic planning Testing strategies Supply chain communications Registration strategies Assessment of data quality Chemical transport/warehousing SVHC advisory services Environmental risk assessment Representation Management (Sief, Consortium etc) Business process outsourcing (BPO) Registration services Dossier preparation GHS notification CLP notification Regulatory/policy tracking Managed regulatory content Chemical hazard database (Material) safety data sheets Legal representation Substance inventory management (Material) safety data sheet systems EH&S solutions Regulatory information management Supply chain management Consortia/registration solutions Laboratory management solutions Ecotoxicology Environmental fate & degradation Physical & analytical chemistry Environmental monitoring Exposure testing Human health toxicology SVHC testing Training courses/webinars Bespoke/in-house training CPD/CES certified training Lobbying/advocacy Insurance Emergency response Logistics

Consultancy/advisory

  



                     



     



 



       

                

                        

    

                                            

                  



      

 Core service  Service that is occasionally provided  Service provided by partners and third parties

Chemical Watch | Global Service Providers Guide 2016

Page 187

A-Z LISTING



 

ChemService Srl Controlli e Ricerche chemtrac® 



 

CHEMTREC CHEMWATCH

Page Headquarters 174 Germany USA USA Switzerland USA Luxembourg 175 Finland Finland 78 UK Ireland USA Israel UK Finland UK USA 80 Italy 82 Germany, Luxembourg Italy 175 UK 84

CHESSOL, chemical safety sheets online China National Chemical Information Center 86

USA Australia The Netherlands China

ChIR - Chemical Innovation and Regulation Chris Braun Consultancy Chymeia ApS CIS Center CiToxLAB CJV Consulting Ltd

175 Portugal The Netherlands 175 Denmark 88 Russia 90 France UK

Clariant Complianca LLC Compliance & Risks Compliance Footprint AG Compliance Services International compliance2business Consortia Management GmbH CONUSBAT Regulatory Services Cosmetic Design Laboratories CRAD

Italy USA Ireland Switzerland USA Italy Germany 176 Germany UK 92 Turkey

Other locations Italy France UK Germany Belgium

Global staff 5-10 5,000 plus 5,000 plus 25-50 50-100 5-10 China 5-10 2-5 10-25 1 1 1 2-5 1 2-5 50-100 Qatar 10-25 South Korea, France 25-50

Chemical staff 5-10 50-100 50-100 5-10 50-100 5-10 5-10 2-5 10-25 1 1 1 2-5 1 2-5 50-100 10-25 25-50

Agent in China Italy, USA, Japan, China

25-50 25-50

g e

25-50 Offices in 22 other 100-500 countries worldwide 5-10 100-500

25-50 100-500

e ge

2-5 25-50

ge i

Spain, Italy, UK

5,000 plus 1 10-25 50-100 1,000-2,000 1

50-100 1 10-25 25-50 100-500 1

5,000 plus 5-10 25-50 5-10 10-25 1 2-5 5-10 2-5 10-25

100-500 2-5 10-25 5-10 10-25 1 2-5 10-25 1 10-25

m www.emmcchir.org m e www.cbconsult.nl e m e www.chymeia.com ie e e e g www.ciscenter.ru e m e www.citoxlab.com mee e e cjvconsultingltd.wix.com/ cjvconsultingltd i gg e www.clariant.com i ge e e www.complianca.com www.complianceandrisks.com e ii i i e www.compliance-footprint.com www.complianceservices.com meeeee gge e g www.compliance2business.eu m www.consortia-management.com www.conusbat.com mg www.cometicdesignlaboratories.co.uk e m ig g e e www.crad.com.tr

25-50 5-10 100-500 25-50 25-50 5-10 1 10-25 1 2-5 10-25 5-10 50-100

www.crowell.com m mg e e www.csregulatory.com g m e e www.cttlab.com geei a a www.analytik.currenta.de www.cyprotex.com me me e g www.dangerandsafety.it g i g www.dangoods.co.uk www.teknologisk.dk ge m m www.datalabsj.com g g i g gg g www.dla.mil mg e www.dekra.de/reach me e e www.dekra.de/en/reach

100-500 2-5 10-25 50-100 2-5

ge i ig ia e

Hungary

India, Kenya USA, UK, Belgium global offices UK

25-50 25-50

Representatives in EU, UK, USA, Japan, Korea Crowell & Moring USA UK, Belgium 1,000-2,000 CS Regulatory Ltd UK 5-10 CTT China 100-500 Currenta GmbH & Co. OHG Germany 100-500 Cyprotex PLC UK USA 100-500 Danger and Safety srl 176 Italy 5-10 DanGoods Training & Consultancy UK 1 Danish Technological Institute Denmark 500-1000 Datalab USA 2-5 David Ryberg Norway 10-25 Defense Logistics Agency USA 1,000-2,000 DEKRA Assurance Services GmbH Germany 25-50 DEKRA Consulting GmbH Germany France, Hungary, 100-500 Turkey, UK DEKRA Insight 94 UK 80+ globally 5,000 plus  Dell Tech Laboratories Ltd. Canada 5-10 Delphic HSE Solutions Limited UK Hong Kong 10-25 DHI 96 Denmark 31 worldwide offices 1,000-2,000  DIPHEX Ltd UK 5-10 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% 

Page 188

Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)

Organisation CFCS CGI Charles River Chem-Academy - part of Vereon AG ChemADVISOR ChemAdvocacy S.A. Chementors Ltd Chemest Ltd. Chemex Environmental International Ltd ChemHaz Solutions Chemical Consultant, Joseph E. Sabol, PhD Chemical Regulatory Affairs - Israel ChemPharmaServe Ltd Chemphex ChemRegs (UK) Ltd ChemRisk ChemSafe Chemservice

me e

ee mg m

g m i i e m m i i m m m i i

em e iee ge e geee e eee ee m e e e e i

Further information e www.cfcs-consult.com www.cgi.com www.criver.com www.chem-academy.com www.chemadvisor.com www.chemadvocacy.com www.chementors.fi www.chemest.fi www.chemex.co.uk www.chemhazsolutions.com chem-consult.com

i www.chempharmaserve.com www.chemphex.com g www.chemregs.co.uk www.chemrisk.com g e e e e e www.chemsafe-consulting.com g e e e e www.chemservice-group.com e

e iie

www.chemservice.it www.chemtracglobal.com

em e www.chemtrec.com i e e www.chemwatch.net g g e www.chessol.nl egg a www.chemhse.com/english

i g e i

e e www.chilworth.co.uk www.delltech.com i e e www.delphichse.com a www.tox.dhigroup.com e m www.diphex.com

Chemical Watch | Global Service Providers Guide 2016

Information

IT solutions

Laboratories

Training Other

       

                               

                              

     



   

    

     

   

    

                

      

   

 



                      

                                     

         

                                      

            

   

   

   

              

                                          

ChemService Srl Controlli e Ricerche chemtrac®

                 

CHEMTREC CHEMWATCH

            

         

        

CHESSOL, chemical safety sheets online China National Chemical Information Center ChIR - Chemical Innovation and Regulation Chris Braun Consultancy Chymeia ApS CIS Center CiToxLAB CJV Consulting Ltd

                

 

        

    

                 

         

Crowell & Moring CS Regulatory Ltd CTT Currenta GmbH & Co. OHG Cyprotex PLC Danger and Safety srl DanGoods Training & Consultancy Danish Technological Institute Datalab David Ryberg Defense Logistics Agency DEKRA Assurance Services GmbH DEKRA Consulting GmbH

      

                   

 



    

        

         

     

                                                     

    



    

            

       

                                                                  

             



                                                  



 



   

  

 

        



 

   

      

                                           

                                                        

 

           

     

                                                  

                  

A-Z LISTING

Repre./management

Consultancy/advisory

        



                                                                          

        

                                

  

  

 



                 





DEKRA Insight                   Dell Tech Laboratories Ltd.                        Delphic HSE Solutions Limited              DHI                           DIPHEX Ltd 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

Chemical Watch | Global Service Providers Guide 2016

Page 189

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A-Z LISTING

 



Page 176 98 176

Headquarters Belgium Turkey Germany

Eagle Environmental EBRC Consulting ECD Compliance ECETOC Ecolab Ecomatters EcoMundo EcoOnline

South Africa 104 Germany Canada Belgium USA The Netherlands France 106 Norway

India Italy 100 Germany Germany 102 USA

Ecotox Services International Edupalli Ramakrishna eftec EggCentris EHS Strategies, Inc EHSCareers.com, Inc elc group

Australia India UK Belgium USA USA UK

Elemica Emveo Enthone BV Envigo

USA Belgium The Netherlands USA

Other locations

China, Germany, Japan, Singapore, Taiwan

Canada Sweden, Finland, Denmark, Switzerland

Belgium

Czech Republic, India, Romania Europe, Asia

Global staff 2-5 25-50 1

Chemical staff 2-5 10-25 1

1 1 100-500 1 1,000-2,000

1 1 100-500 1 100-500

m g m ee mg e mg m

2-5 50-100 2-5 5-10 5,000 plus 5-10 25-50 50-100

1 25-50 2-5 5-10 50-100 2-5 25-50 5-10

i me ig

5-10 500-1000 10-25 5-10 1 5-10 50-100

5-10 100-500 10-25 5-10 1 2-5 10-25

m e m

100-500 1 10-25 500-1,000

ige

2-5 2-5 2-5 2-5 5-10 100-500 1 25-50

g i m m m m i g

5-10 1 5-10 2-5 100-500

me gie m m g m

2,000-5,000

100-500 1 2,000-5,000 Offices in 14 countries2,000-5,000 worldwide Environmental Assessments Germany Sweden 2-5 Environmental Science Limited UK 2-5 EnviroPlanning AB Sweden 5-10 EquiTox France 2-5 ERA Technology Ltd UK 50-100 ERM 108 UK Worldwide offices 5,000 plus  ES4chem The Netherlands 1 eSpheres 177 Belgium Finland, Germany, 25-50 France, Netherlands ETC Slovakia 10-25 Eupoc Germany 1 Eurideas Linguistic Services 177 Belgium Hungary 5-10 Euro Safety and Health UK 2-5 Eurofins 110 Belgium Germany, UK, 5,000 plus  Switzerland, Denmark, Asia, US Eurofins Air Toxics USA Denmark, Germany, 5,000 plus France, China Euromines Belgium 5-10 Eversheds LLP UK Europe, Middle East, 2,000-5,000 Asia Exitss Belgium 10-25 Exponent International Limited 112 UK USA, Switzerland, 500-1,000  China f_OXYDE GmbH Austria 5-10 Fanwood Chemical, Inc USA Germany 2-5 Fieldfisher LLP 114 UK Belgium, France, 100-500  Germany FinnREACH Finland 2-5 Flashpoint srl Italy 10-25 FoBiG 116 Germany 10-25  Food and Environment Research Agency (Fera) UK 5-10 Foresite Systems USA 25-50 Fraunhofer ITEM Germany 100-500 Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%

Page 190

Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)

Organisation Distefano Law Office DORUK SISTEM DR MACH Chemical Compliance & Competence Dr Prerna Shinde Dr. Andrea Volpato Dr. Knoell Consult GmbH Dr. Philipp Langenbach GmbH EAG Family of Companies

Further information gai a a e www.distefanolawoffice.com gi e e e e www.doruksistem.com.tr me e www.mach-chemguide.com ee www.andreavolpato.it e e e www.knoell.com www.dr-langenbach.de www.eag.com

m www.eagleenv.co.za e www.ebrc.de e e e e www.ecdcompliance.com m www.ecetoc.org m www.ecolab.com e e www.ecomatters.nl e a www.ecomundo.eu m e e www.ecoonline.com e

a m ii e

www.ecotox.com.au www.bhu.ac.in www.eftec.co.uk www.EggCentris.com m e www.ehsstrategies.com m www.ehscareers.com e a e a www.elc-group.com m i

m e

e m

i i e

ae eaee g e g ig

e g

2-5 25-50

ee e

ee ee ge

2-5 2-5 10-25

me m eem

2-5 5-10 10-25 5-10 5-10 25-50

ge m ma m e ge

www.equitox.eu www.era.co.uk www.erm.com www.ES4chem.eu www.espheres.com www.ekotox.sk www.eupoc.de www.eurideastranslation.com www.eurosh.com www.eurofins.com

www.euromines.org www.eversheds.com

m gge mg

www.enas-online.com www.esldatasheets.com

www.airtoxics.com

2-5 50-100

www.elemica.com www.emveo.be www.cooksonelectronics.com www.envigo.com

e e e e www.exitss.eu e e www.exponent.com g www.foxyde.com www.fanwoodchemical.com e www.fieldfisher.com

e www.finnreach.com g www.flashpointsrl.com a a a www.fobig.de e www.fera.defra.gov.uk www.foresitesystems.com m i e e www.item.fraunhofer.de g

Chemical Watch | Global Service Providers Guide 2016

Eagle Environmental EBRC Consulting ECD Compliance ECETOC Ecolab Ecomatters EcoMundo EcoOnline

Information

IT solutions

Laboratories

Training Other

                                                           

                                       

                  

             

   

    

   

                       

                               

 

                                                

 



   

   

   

    

    

Ecotox Services International Edupalli Ramakrishna eftec EggCentris EHS Strategies, Inc EHSCareers.com, Inc elc group

                         

Elemica Emveo Enthone BV Envigo

   

                                                     

Environmental Assessments Environmental Science Limited EnviroPlanning AB EquiTox ERA Technology Ltd ERM ES4chem eSpheres

       

       

       

ETC Eupoc Eurideas Linguistic Services Euro Safety and Health Eurofins

               



   

   

 

                                                    

     

                     



A-Z LISTING

Organisation Distefano Law Office DORUK SISTEM DR MACH Chemical Compliance & Competence Dr Prerna Shinde Dr. Andrea Volpato Dr. Knoell Consult GmbH Dr. Philipp Langenbach GmbH EAG Family of Companies

Repre./management

Consultancy/advisory



  

     

      

   

                                                                           

                            

 

   

   

   

                       

                                       

   

                  

                                

          

    

 



 

                                                                                      

 

 

 

  

 

      

Eurofins Air Toxics Euromines Eversheds LLP

                                                        

Exitss Exponent International Limited

                             

f_OXYDE GmbH Fanwood Chemical, Inc Fieldfisher LLP

                                 

FinnREACH              Flashpoint srl              FoBiG              Food and Environment Research Agency (Fera)    Foresite Systems             Fraunhofer ITEM              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

Chemical Watch | Global Service Providers Guide 2016

Page 191

A-Z LISTING



  

Page Headquarters 118 Germany

Gain Claude Gentrochema BV GHS Training & Consulting GHS-expert Ltd Gillies Associates Limited GlobalMSDS GLTaC, Inc. Golder Associates

France The Netherlands Canada Hungary UK UK USA Italy

GreenSoft Technology, Inc

USA

Greenwich Chemical Consulting H2 Compliance Haley & Aldrich Hangzhou RUIO Technology Co. Ltd HAZMAT Ltd HDTS Chemicals Inc. herbert smith llp HFL Consulting Ltd Hohenstein Textile Testing Institute

USA Ireland USA China Israel 177 Canada UK UK Germany

I+K AG IBACON GmbH ICF International

177 Switzerland Germany USA

IDRG (International Development of Regulatory Globalization) IFF China IGCON IHS Infotox International Cosmetics & Chemical Services Ltd Intertek IOM IPO O/Pszczyna iPoint-systems Jaehak Jung Japag Regulatory Consultancy Japan Chemical Safety Institute Jean Warshaw, Esq. Jones Day

Germany China The Netherlands 120 USA 178 Portugal 122 USA 124 UK UK Poland Germany South Korea India Japan USA Belgium

Global staff 50-100

Chemical staff 50-100

1 2-5 1 1 2-5 5-10 10-25 5,000 plus

1 1 1 1 2-5 5-10

Offices in over 20 countries Taiwan, Japan, China, 50-100 Spain 1 USA 10-25 500-1000 50-100 UK 25-50 2-5 2,000-5,000 25-50 Bangladesh, 500-1000 Cambodia, China, Hong Kong, India, Parkistan, Turkey, USA, Vietnam 5-10 100-500 Belgium, Brazil, 2,000-5,000 China, Russia, India 2-5

Worldwide India, UK UK 110+ Countries Singapore AT, CN, FR, JP, SV, USA, UK China, Vietnam

North America, Europe, Japan

Page 192

USA, UK

50-100

m iiee g m m e e m e i gg e e gie mg

50-100

Further information www.gabconsulting.de www.gentrochema.nl www.ghstc.com www.REACHexpert.eu www.gilliesassociates.co.uk www.globalmsds.co.uk www.gltac.com www.golder.com www.greensofttech.com

1 10-25 5-10 50-100 10-25 2-5 2-5 2-5 100-500

m m m e m i

2-5 100-500 50-100

gee

2-5

5,000 plus 1 5,000 plus 2-5 5-10

50-100 1 100-500 2-5 5-10

g mg g me mg

5,000 plus 100-500 50-100 50-100

1,000-2,000 10-25 50-100 10-25

e i a a g www.intertek.com www.iom-world.org meeee www.ipo-pszczyna.pl m g m e e www.ipoint-systems.com

50-100 2-5 1 2-5 5,000 plus

2-5 2-5 1 2-5 50-100

g e e g e e e e www.kotiti.re.kr m eee eme m www.jonesday.com m

1 100-500 25-50 1 25-50 10-25 25-50 2-5 10-25 10-25 2-5 25-50 50-100

iee e m mg ii m e m me ieaa ggm i m eeaa

50-100 2-5 5-10

mg igg

1 100-500 25-50  1 1,000-2,000 10-25 Belgium China 100-500 2-5 10-25  2,000-5,000 2-5 25-50 Asia, South America, 5,000 plus Europe, USA, Middle East LGC UK 1,000-2,000 Linmark Consulting 178 Switzerland UK 2-5 Linnunmaa Oy Finland 10-25 Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5% Jongerius Consult BV JRF Global JSC International Limited K J Bray & Associates K&L Gates LLP Kathrin Lanz Keller and Heckman Kerona Consulting Ltd KFT Chemieservice GmbH Konica Minolta Business Expert, Inc KREATiS LAUS GmbH LG CNS

178 The Netherlands India 126 UK UK Belgium Germany USA Ireland 128 Germany Japan 178 France Germany South Korea

Other locations Spain, Poland, Slovenia

Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)

Organisation GAB Consulting GmbH

e e m g e

e e e ee g e

m m ee

g ee

gge m

m i

www.grcci.com www.h2compliance.com e www.haleyaldrich.com e www.reach24h.com www.hazmat.co.il www.hdtschemicals.com www.herbertsmith.com hflconsulting.uk www.hohenstein.com

www.i-k.ch www.ibacon.com www.icfi.com www.idrgplantprotection.eu

ggge e e www.igcon.nl i g e www.ihs.com/productstewardship e www.infotox.pt e www.Intlcosmetics.com

www.jongeriusconsult.com www.jrfonline.com e e www.jsci.co.uk www.kjba.talktalk.net www.klgates.com gm e www.qualisys.eu www.khlaw.com www.kerona.ie a e e e www.kft.de www.konicaminolta.com www.kreatis.eu i e

g i a a www.lgcns.com

m e

e www.lgc.co.uk www.linmarkconsulting.com www.linnunmaa.fi

Chemical Watch | Global Service Providers Guide 2016

Information

IT solutions

Laboratories

Training Other

                     

Gain Claude Gentrochema BV GHS Training & Consulting GHS-expert Ltd Gillies Associates Limited GlobalMSDS GLTaC, Inc. Golder Associates

 

GreenSoft Technology, Inc

         

       

Greenwich Chemical Consulting H2 Compliance Haley & Aldrich Hangzhou RUIO Technology Co. Ltd HAZMAT Ltd HDTS Chemicals Inc. herbert smith llp HFL Consulting Ltd Hohenstein Textile Testing Institute

        

      

I+K AG IBACON GmbH ICF International

           

    

IDRG (International Development of Regulatory Globalization) IFF China IGCON IHS Infotox International Cosmetics & Chemical Services Ltd Intertek IOM IPO O/Pszczyna iPoint-systems



     

                      

      

       



      

      

      

         

                    

             

      

             

          

   

             

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 Kathrin Lanz Keller and Heckman Kerona Consulting Ltd KFT Chemieservice GmbH Konica Minolta Business Expert, Inc KREATiS LAUS GmbH LG CNS

                          

  

   

 

    



     

          

      

      

    

   

      

       

   

              

 

  

 



       

                                              

    

     

     

     

     

             

     

              

   

                     

                     

 



  

     

 





 

                                         

                                   

                           

        

            

                                                            

 

   



 

                                                   

      



           

                                             

      

   



   

   



 

                     

 



 

       

                               

                                           

LGC    Linmark Consulting                          Linnunmaa Oy                            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

Chemical Watch | Global Service Providers Guide 2016

Page 193

A-Z LISTING

Organisation GAB Consulting GmbH

Repre./management

Consultancy/advisory

A-Z LISTING



Page Headquarters 130 Belgium

LKC Switzerland Ltd Loufakis Chemicals SA

179 Switzerland Greece

LSR Associates MB Research Laboratories McKenna Long & Aldridge LLP Mercer

UK USA USA USA

Mérieux Nutrisciences

USA

Miami Chemical Micromeritics Analytical Services Modern Testing Services (Global)

USA USA Hong Kong

MSDS Europe

Hungary

National Chemical Emergency Centre (NCEC) 132 UK Neuralog, LP NimkarTek Technical Services Pvt. Ltd Noerr LLP NovaTox Oriental Chemical Information Co., Ltd

USA India

Global staff 100-500

Chemical staff 100-500

5-10 25-50

5-10 2-5

me ee

1,000-2,000 25-50 Belgium 100-500 Asia-Pacific, EMEA, 100-500 Americas Italy, Brazil, France, 2,000-5,000 China 10-25 10-25 US, UK, Germany, 1,000-2,000 China France, Germany, 10-25 Poland, Italy, Spain 100-500

25-50 25-50 10-25 2-5

1,000-2,000

5-10 1 100-500

10-25

eieaege

Canada Sri Lanka, Bangladesh

10-25 10-25

10-25 2-5 5-10

m ie

25-50 10-25

1,000-2,000 Ireland, UK 2-5 Japan, Taiwan, 10-25 France, Philippines, Korea, Germany Pace Analytical Regulatory Services USA 50-100 Paul Illing Consultancy Services Ltd UK 1 PeerAspect USA Canada, UK, India 10-25 Penman Consulting Belgium UK, The Netherlands 5-10 Pera Technology UK 100-500 Peter Fisk Associates 179 UK Belgium 10-25 pIEt Consulting BVBA Belgium 1 Pinnacle Associates UK 2-5 Pirjo Heikkilä Finland 1 Polgar ACRO Hungary Belarus, Kazakhstan, 10-25 Moldova, Russia, Ukraine Pöyry Finland Oy Finland 2,000-5,000 Prefusion LLP 179 UK China 5-10 Proactima AS Norway 100-500 ProductIP The Netherlands China, Hong Kong, 25-50 Germany, UK Prosacon GmbH Germany 5-10 PwC The Netherlands Global presence 2,000-5,000 Ramboll Environ 134 UK 124 in 26 countries 1,000-2,000  Randis ChemWise (Shanghai) Co., Ltd. 180 China Taiwan 10-25 REACH Advice GmbH Germany 1 REACh ChemAdvice GmbH 136 Germany Portugal, Sweden, 5-10  USA, India, China, South Korea REACh ChemConsult GmbH Germany UK 5-10 Reach Chemical BV The Netherlands 1 REACH Delivery UK USA, Japan 25-50 REACH Global Services S.A. 180 Belgium Turkey 10-25 REACH mastery 138 Italy 10-25  REACH Monitor Spain 10-25 Reach Only Representative Ltd UK Agents: Asia, Middle 5-10 East Reach Registration Services UK 10-25 REACH24H Consulting Group China Ireland, USA 100-500 ReachCentrum 140 Belgium EU, Asia-Pacific, USA 10-25  REACHLaw 142 Finland Belgium, India, Turkey25-50  REACHReady Ltd UK 5-10 ReachSpektrum, s.r.o. Czech Republic 2-5 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%

Page 194

Germany Canada 179 China

Other locations USA, Canada, UK, France, Germany, Romania, India, Singapore, Turkey, Brazil UK Bulgaria, Servia, Macedonia USA, Japan

Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)

Organisation Lisam Systems

mee

e e

Further information www.lisam.com

www.LKC-ltd.com

m www.loufakis.gr

www.lsr-associates.com www.mbresearch.com a e www.mckennalong.com www.mercer.com m ee

m geg m

www.merieuxnutrisciences.com

www.miamichemical.com www.particletesting.com www.mts-global.com

m m

www.msds-europe.com

e e e a the-ncec.com

www.neuralog.com

m m

50-100 1 5-10 5-10 10-25 10-25 1 2-5 1 5-10

ie me

10-25 5-10 10-25 25-50

m ie m e e

5-10 25-50 50-100 5-10 1 5-10

g i m m i m

5-10 1 25-50 10-25 5-10 2-5 2-5

m m e g m m g

2-5 50-100 10-25 25-50 2-5 2-5

g m g g i m

m g www.nimkartek.com

www.noerr.com www.novatox.ca e e e e e www.oci.net.cn e www.pacelabs.com/regulatory

aai m eee

ig m me m i m m

eee e i

www.peeraspect.com www.penmanconsulting.com www.peratechnology.com www.ecotoxchem.co.uk www.pietconsulting.eu www.pinnacleassoc.com

www.polgar-acro.eu

ee eee g me

www.poyry.com www.prefusion.co.uk www.proactima.no/en www.productip.com

i e e e e e e prosacon.eu i g www.pwc.nl/nl/reach www.ramboll-environ.com e e eee e e www.randis.cn, www.randischem.com gg e www.reach-advice.com e g e e www.reach-chemadvice.com a g m e m a aa ea ae e e geeeee g e g g e

ee e e ge aa

e e e e a

e e a e e e

www.reach-chemconsult.com www.reacheu.nl www.reachdelivery.com www.reach-gs.eu a www.reachmastery.com www.reachmonitor.org www.rorltd.com

e a www.reach-rs.com e www.reach24h.com/en-us g www.reachcentrum.eu e www.reachlaw.fi g www.reachready.co.uk g www.reachspektru.eu

Chemical Watch | Global Service Providers Guide 2016

Information

IT solutions

Laboratories

Training Other

      

  

       

    

LKC Switzerland Ltd Loufakis Chemicals SA

                       

LSR Associates MB Research Laboratories McKenna Long & Aldridge LLP Mercer

                                         

Mérieux Nutrisciences

                

MSDS Europe

                  

National Chemical Emergency Centre (NCEC) Neuralog, LP NimkarTek Technical Services Pvt. Ltd



Noerr LLP NovaTox Oriental Chemical Information Co., Ltd

                                                              

Pace Analytical Regulatory Services Paul Illing Consultancy Services Ltd PeerAspect Penman Consulting Pera Technology Peter Fisk Associates pIEt Consulting BVBA Pinnacle Associates Pirjo Heikkilä Polgar ACRO

                                            

Pöyry Finland Oy Prefusion LLP Proactima AS ProductIP

   

                                                

Prosacon GmbH PwC Ramboll Environ Randis ChemWise (Shanghai) Co., Ltd. REACH Advice GmbH REACh ChemAdvice GmbH

     

REACh ChemConsult GmbH Reach Chemical BV REACH Delivery REACH Global Services S.A. REACH mastery REACH Monitor Reach Only Representative Ltd

                              

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            

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     

                             

   

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          

      

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      

     

     

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         

     

           

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      

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 

               

   

      

                                                         

                                                     

    

  

  

   

                                                       

Reach Registration Services             REACH24H Consulting Group            ReachCentrum            REACHLaw             REACHReady Ltd             ReachSpektrum, s.r.o.             Key: Icons above represents the extent to which the company provides the service as follows:

  

       

                                                    

                                





 

     



                   

 

          

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                                               

Miami Chemical Micromeritics Analytical Services Modern Testing Services (Global)

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

A-Z LISTING

Organisation Lisam Systems

Repre./management

Consultancy/advisory

                

                        

 

                         



                                                  

     

    

     

  

       

          

 Core service  Service that is occasionally provided  Service provided by partners and third parties

Chemical Watch | Global Service Providers Guide 2016

Page 195

A-Z LISTING



Page Headquarters 180 UK

Redeker Sellner Dahs Rechtsanwälte ReFaC RegScan Inc. Regulatory Services International Ltd Regulatus Ricerca Biosciences, LLC RimaOne Risk & Policy Analysts Ltd (RPA)

Germany 180 UK 181 USA 144 China UK USA Germany 146 UK

Risk Control Services Ltd Riskchem Rivendell International



UK South Africa Ireland

RoHS Ready LLC Roisin McEneany Rovaltain Research Company Royal HaskoningDHV RTC - Research Toxicology Center SAFENANO Safety Data Services Safeware Quasar Ltd

USA Ireland 181 France 148 The Netherlands Italy UK UK UK

SAP AG SAP Japan Co, Ltd SATRA Technology SCAS Europe

Germany Japan UK 181 Japan

SCC Science & Environnement SciVera Selcia ServiREACH, S.A. SGS

150 Germany Switzerland 181 USA UK Spain Switzerland

ShawCor SHES Chemical Consulting Co., Ltd Shridhar Rajappanavar Siam S.L.

Canada South Korea India 182 Spain

SIEF-IT SiteHawk Sitmae Reach Services BV Smithers Viscient Spetsinterproject Oy Spinnaker Coating, LLC Spring Trading Company, LLC Stefanie Merenyi Steptoe & Johnson LLP Stewardship Solutions Ltd Subvise Surface Science Western Sustainability Consult Sustainability Support Services (Europe) AB

Poland USA The Netherlands USA Finland USA 182 USA Germany USA UK Germany Canada Belgium 152 Sweden

Other locations The Netherlands, Germany Belgium

UK, USA

Belgium UK

USA, Spain and Japan

Page 196

Global staff 2-5

Chemical staff 2-5

100-500 2-5

5-10 2-5

g m mg

10-25 1 500-1,000 25-50 25-50

10-25 1 500-1,000 25-50 10-25

em m ee m

www.ricerca.com www.rimaone.com www.rpaltd.co.uk

1 2-5 10-25

1 1 10-25

m ge iee

m g

www.linkedin.com/in/rossfielding www.riskchem.co.za www.rivendell.ie

1 1 1 50-100 100-500 25-50 1 10-25

m i gg e m e ieeaeee m m g e m e g m e

www.rohsready.org

www.sap.com www.sap.com www.satra.co.uk www.scas-eu.be

2-5 1 25-50 100 offices worldwide 5,000 plus 100-500 Singapore 100-500 1 USA, Ireland, Greece, 50-100 Japan, Turkey, The Netherlands 5,000 plus 1,000-2,000 China 100-500 China, Singapore, 1,000-2,000 South Korea, Taiwan Japan 100-500 France 5-10 10-25 USA 50-100 10-25 China, France, 5,000 plus Germany, Hong Kong, UK, USA 2,000-5,000 10-25 2,000-5,000 France, Italy, Greece, 5-10 Portugal, Poland, Romania, Finland, Ireland, UK, EL 5-10 25-50 2-5 UK 100-500 Russia 5-10 2-5 5-10 1 Belgium, China, UK 1,000-2,000 2-5 2-5 10-25 5-10 India 25-50

SustChem Engineering Ltd Greece Syska Voskian Consulting USA Denmark TB-Klade Austria Ted Simon LLC USA TEI Analytical, Inc USA Telematic srl Italy Tenviro Sweden The Netherlands 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%

Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)

Organisation REACHWise

5-10 2-5 1 1 5-10 10-25 1

5-10 5-10 25-50

Further information www.reachwise.eu www.redeker.de

e e www.refac.eu www.regscan.com ii www.rsireg.com e m m

i m

www.safeware.co.uk

e m

25-50 5-10 10-25 50-100 10-25

me me g

a e a a www.scc-gmbh.de e e e www.sci-env.ch m e e www.scivera.com www.selcia.com m eg e servireach.com m a www.sgs.com/reach

2-5 10-25 50-100 10-25

m me

5-10 25-50 2-5 5-10 5-10 2-5 2-5 1 25-50 2-5 2-5 10-25 1 10-25

5-10 2-5 1 1 5-10 5-10 1

me e m m m e m e m ggg g

i e

rovaltainresearch.com www.royalhaskoningdhv.com www.rtc.it www.safenano.org

www.shawcor.com e e i i e www.cae.com e m e e www.chemeter.eu

i ii

ii g a m m e i

m e meaeaa e e e g g em ee g e e m g m e m ieeee e e g

e g

e www.sief-it.com www.sitehawk.com g www.sitmaereachservices.com m www.smithersviscient.com spetsinterproject.com/en www.spinps.com Springtradingcompany.com www.merenyi.net www.steptoe.com e www.stewardshipsolutions.co.uk www.subvise.com www.surfacesciencewestern.com sustainabilityconsult.com a www.ssseurope.org www.sustchem.gr www.sysvoskconsulting.com www.tb-klade.at www.tedsimon-toxicology.com www.teianalytical.com www.epyplus.com www.tenviro.eu

Chemical Watch | Global Service Providers Guide 2016

Information

IT solutions

Laboratories

Training Other

           

       

Redeker Sellner Dahs Rechtsanwälte ReFaC RegScan Inc. Regulatory Services International Ltd Regulatus Ricerca Biosciences, LLC RimaOne Risk & Policy Analysts Ltd (RPA)

     

    

Risk Control Services Ltd Riskchem Rivendell International

                                                                    

RoHS Ready LLC Roisin McEneany Rovaltain Research Company Royal HaskoningDHV RTC - Research Toxicology Center SAFENANO Safety Data Services Safeware Quasar Ltd

                                                            

SAP AG SAP Japan Co, Ltd SATRA Technology SCAS Europe

   

SCC Science & Environnement SciVera Selcia ServiREACH, S.A. SGS

                                                                                                                                             

ShawCor SHES Chemical Consulting Co., Ltd Shridhar Rajappanavar Siam S.L.

                                                                 



                         

 

     

                                

  

  

   

      

                               

   

 

         

                                   

 

    

                                                      

   

   

   

  



 



                  

   

SIEF-IT      SiteHawk  Sitmae Reach Services BV             Smithers Viscient           Spetsinterproject Oy            Spinnaker Coating, LLC       Spring Trading Company, LLC          Stefanie Merenyi      Steptoe & Johnson LLP             Stewardship Solutions Ltd             Subvise Surface Science Western    Sustainability Consult  Sustainability Support Services (Europe)             AB SustChem Engineering Ltd            Syska Voskian Consulting         TB-Klade   Ted Simon LLC     TEI Analytical, Inc     Telematic srl           Tenviro            Key: Icons above represents the extent to which the company provides the service as follows:

  

                      

                                                 

 

  

    

                                                                                         



A-Z LISTING

Organisation REACHWise

Repre./management

Consultancy/advisory



                                  

 

                                

 



                                                                       

                                               

                          

 Core service  Service that is occasionally provided  Service provided by partners and third parties

Chemical Watch | Global Service Providers Guide 2016

Page 197



Page Headquarters USA

The REACH Centre

154 UK

A-Z LISTING

The Redstone Group The Sapphire Group The Windsor Consulting Group, Inc. TJS Technical Services Inc. Tox Focus, LLC toXcel Toxicon Toxikon ToxMinds ToxServices TraceGains Trade Wind B.V. Tradebe UK TRASYS Triskelion B.V.

USA USA USA

Global staff 5,000 plus

Chemical staff 25-50

25-50 10-25 5-10 5-10

2-5 2-5 USA 10-25 5-10 Belgium 100-500 10-25  25-50 25-50 5-10  Spain, USA, France 1,000-2,000 Europe 500-1000 Japan, USA, Canada 100-500  (sales offices) TSG USA 100-500 TSGE Consulting UK Ireland, Spain, 50-100 Germany, France, Slovenia, Poland TUV Rheinland USA Germany, China, 5,000 plus Japan, India, Taiwan, South Korea TUV Rheinland Hong Kong Ltd Hong Kong 5,000 plus TÜV Rheinland LGA Products GmbH Germany Europe, China, 5,000 plus Japan, Thailand, Vietnam, India, North America, Brazil, Russia, Australia, South Africa, TUV Rheinland of North America, Inc. USA Germany, Hong Kong,1,000-2,000 Shenzhen, Shanghai TÜV SÜD Industrie Service GmbH 162 Germany Japan, Singapore, 2,000-5,000  China, India TUV SUD Japan Japan 100-500 TÜV SÜD Process Safety 164 Spain Taiwan 50-100  UL UK USA, Switzerland, 5,000 plus Bangladesh UL information & insights |The Wercs 166 USA France, Belgium, 5,000 plus  UK, China, Germany, Japan UMCO Umwelt Consult GmbH 168 Germany 50-100  Universit Bordeaux Segalen France 500-1,000 Vanta Bioscience India 25-50 Verdant Law, PLLC USA 2-5 Vidaris, Inc. USA 100-500 Von Roll REACH GmbH Germany 2-5 VRS Regulatory 183 UK 5-10 W.E. Train Consulting USA 2-5 wca environment UK Scotland, Italy 10-25 Weeset Advisors USA 1 WIL Research 170 USA The Netherlands 1,000-2,000  Wildlife International, a Division of EAG, Inc USA The Netherlands 100-500 Wilmer Tox Consulting Switzerland 1 WRc plc 183 UK 100-500 WSP UK Ltd 184 UK Wordwide 5,000 plus WTConsulting Switzerland 5-10 Xiaodan Pei China USA 100-500 YASH Technologies USA Europe, Asia, 2,000-5,000 Australia Zanos Limited UK 2-5 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%

Page 198

Canada 182 USA 182 UK 183 Italy USA 158 Belgium 183 USA USA 160 The Netherlands UK Belgium 156 The Netherlands

Other locations Germany, Canada, UK Italy, USA, Japan, China The Netherlands

Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)

Organisation Tetra Tech

Further information www.tetratech.com

eeg

25-50

geee

10-25 5-10 2-5

me m e eee

1 2-5 10-25 5-10 5-10 10-25 10-25 25-50 2-5 500-1000 50-100 100-500

m m i g e m m

50-100 50-100

me me

10-25

100-500 500-1000

e e e e www.chn.tuv.com g e g g g www.tuv.com

50-100

eeee

2-5 10-25 500-1000

em e m ee e m

100-500

25-50 100-500 10-25 2-5 2-5 2-5 2-5 1 10-25 1 100-500 50-100 1 10-25 50-100 5-10 100-500 50-100

mee e e www.umco.de e e e g e e e e www.u-bordeaux2.fr www.vantabio.com m www.verdantlaw.com m m e www.vidaris.com me e www.vonroll.com m www.vrs-regulatory.net g m e www.WEtrainConsulting.com www.wca-consulting.com mg

e e i e gee m e

i e em e ge ge i

m e e m i m m e g

g e e www.redstonegrp.com www.thesapphiregroup.com ee e g g windsgroup.wix.com/ windsconsultingroup tjstechnical.com a a toxfocus.com e a a www.toxcel.com a e e a www.toxicon.it www.toxikon.be e e www.toxminds.com e e e www.toxservices.com www.tracegains.com m g g e www.twnl.com www.tradebe.co.uk i e www.trasys.be e e e www.tnotriskelion.com e e e www.tsgusa.com www.tsgeurope.com g

www.tuv.com/us/green-solutions

www.tuv.com/us

www.tuev-sued.de/technical_ installations/reach a a www.tuv-sud.jp e a www.tuv-sud.es/process-safety e e e ul.com/consumer-products e e www.thewercs.com

www.thereachcentre.com

m m

i e e eeie m

e e e e e

www.wilresearch.com a a www.wildlifeinternational.com e www.reachwilmer.com e www.wrcplc.co.uk e www.wspgroup.com e www.wtconsulting.ch e a www. hach.com a a www.yash.com m www.zanos.co.uk

Chemical Watch | Global Service Providers Guide 2016

Information

IT solutions

Laboratories

Training Other

      

            

               

The REACH Centre

                           

The Redstone Group The Sapphire Group The Windsor Consulting Group, Inc.

                                                                                                     

TJS Technical Services Inc. Tox Focus, LLC toXcel Toxicon Toxikon ToxMinds ToxServices TraceGains Trade Wind B.V. Tradebe UK TRASYS Triskelion B.V.

      

TSG TSGE Consulting

                      

           

TUV Rheinland

      

                    

TUV Rheinland Hong Kong Ltd TÜV Rheinland LGA Products GmbH

   

            

          

TUV Rheinland of North America, Inc.

 

   

 

TÜV SÜD Industrie Service GmbH

                  

TUV SUD Japan TÜV SÜD Process Safety UL

      

      

      

                                 

                               



              

          

   

   

   

   

                    

                                                                          





  

   

  



 

 

  

   

          

 



   

  

  

     

                

UL information & insights |The Wercs

  

     

    

UMCO Umwelt Consult GmbH Universit Bordeaux Segalen Vanta Bioscience Verdant Law, PLLC Vidaris, Inc. Von Roll REACH GmbH VRS Regulatory W.E. Train Consulting wca environment Weeset Advisors WIL Research Wildlife International, a Division of EAG, Inc Wilmer Tox Consulting WRc plc WSP UK Ltd WTConsulting Xiaodan Pei YASH Technologies

     

                                                

                        

                                             

         

        

                

 

                 

Zanos Limited     Key: Icons above represents the extent to which the company provides the service as follows:



 









   

                                                                                 



 

                                               

           



  

                                        

                 



              

        

        



  

  

   

              



   

A-Z LISTING

Organisation Tetra Tech

Repre./management

Consultancy/advisory

 

       

     



 Core service  Service that is occasionally provided  Service provided by partners and third parties

Chemical Watch | Global Service Providers Guide 2016

Page 199

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