Global Service Providers Guide
2015
A guide to global chemicals management and control services sponsored by
North America
South East Asia
Korea
Japan
South America
China & Taiwan
Are you ready to entwine your strategies for regulations around the globe? There are a lot of challenges beyond REACH. Acting in a global business environment brings a lot of opportunities, but also new duties for the chemical industry. A key factor for global success – besides the high quality of your innovative products - is to stay compliant with local laws and regulations. Are you sufficiently informed and ready to cope with these challenges?
We have been an independent service provider for the chemical and pharmaceutical industries since 1996, with currently over 450 employees at sites within the EU, Asia and the USA. For further information visit www.knoell.com or call us.
knoell operates a team of experts for global regulatory affairs which is continuously monitoring the quickly changing regulatory landscape. Our service portfolio includes, but is not limited to: Strategic advice how to meet the regulatory requirements in your target markets Global inventory status check Check of catalogues of hazardous substances and restricted substances Registration in China, Japan, Korea, Japan, Taiwan, USA, Canada, Australia and other countries Global SDS service
Dr. Knoell Consult GmbH Dr. Michael Cleuvers Managing Director Industrial Chemicals & Biocides Tel. +49 214 20658-170 globalregistration@knoell.com www.knoell.com
Foreword
Chemical Watch | Global Service Providers Guide 2015
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: the drivers and trends for software services to support chemicals management and compliance; and the emergence and acceptance of alternative methods to test chemical safety. We also look at the factors that influence companies’ choice of service providers. This year’s survey findings are based on almost 1,300 respondents from across the world. We hope you find these insights useful for you as an individual and for your company’s prospects Mamta Patel Editorial Director
Foreword
Welcome to the fifth annual Chemical Watch service providers guide and directory. 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 market, ranging from consultancy and legal advice, to laboratory and IT, to strategic management; from California to Brussels, Beijing to Seoul. This year the updated findings on our annual indicators show safe chemicals management within companies is coming under increased pressure from regulators and the market. Yet, our third year of reporting on salaries, career prospects and training, highlights some concerning trends regarding the demands placed on people working in the sector, as some companies cut back on human resources deployed in regulatory compliance.
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A scientific and regulatory consulting firm providing strategic, comprehensive support for global chemical registration, regulation, and sustained compliance. • Global Chemical Notification REACH, TSCA, K-REACH, CEPA, China Order No. 7 • Biocides, Pesticides, Antimicrobials, Nanomaterials • Hazard Communication, GHS Classification and Labelling, SDS
• Global Agent and Representative Services • Testing Strategy and Coordination • Toxicology & Ecotoxicology • Transport and Dangerous Goods • Dossier Preparation and Expert Review • Data Compensation
CONTACT OUR EU TEAM: Leslie S. MacDougall Director of Regulatory Affairs lmacdougall@actagroup.com
Emma Louise Jackson Regulatory Specialist ejackson@actagroupeu.com
Ruth C. Downes-Norriss Regulatory Specialist rdownes@actagroupeu.com
Gyöngyi (Pearl) Németh, M.Sc. Regulatory Specialist pnemeth@actagroupeu.com
Jane S. Vergnes, Ph.D., DABT Director of Scientific Affairs jvergnes@actagroup.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 Chemicals management grows in complexity............................................... 5 Solid outlook for chemicals management jobs market..................... 14 IT critical to knowledge on chemicals.. 23 Regulatory acceptance key for alternatives to animal testing................ 27 Outlook for chemicals management and control service providers............... 31 Concluding remarks............................. 44
Profiles........................................42 3E Company......................................... 48 ACTA..................................................... 50 APC....................................................... 52 Apeiron-Team NV.................................. 54 ARCADIS............................................... 56 ARCHE.................................................. 58 bibra toxicology advice & consulting... 60 Blue Frog Scientific Limited.................. 62 BSL BIOSERVICE Scientific Laboratories GmbH.................................................... 64 CEHTRA................................................ 66 Centro Reach........................................ 68 Charles River......................................... 70 Chemsafe.............................................. 72 Chemservice......................................... 74 CHEMTREC.......................................... 76 Chilworth – a DEKRA Company........... 78
EquiTox.................................................. 94 ERM....................................................... 96 Exponent International Limited............. 98 Fieldfisher............................................ 100 FoBiG.................................................. 102 GLTaC.................................................. 104 International Cosmetics & Chemical Services Ltd........................................ 106 Intertek................................................ 108 iPoint-systems..................................... 110 KFT Chemieservice............................ 112 National Chemical Emergency Centre (NCEC)................................................ 114 REACh ChemAdvice GmbH............... 116 REACH mastery.................................. 118 ReachCentrum.................................... 120 REACHLaw.......................................... 122 Regulatory Services International Ltd.124 Risk & Policy Analysts Ltd (RPA)........ 126 Royal HaskoningDHV.......................... 128 SCC..................................................... 130 SSS (Europe) AB................................. 132 TNO Triskelion..................................... 134 ToxMinds............................................. 136 Trade Wind B.V.................................... 138 TSG..................................................... 140 TÜV SÜD Industrie Service GmbH..... 142 TÜV SÜD Process Safety.................... 144 UMCO Umwelt Consult GmbH........... 146 WIL Research...................................... 148
CIS Center............................................. 80 CiToxLAB............................................... 82
Niche Profiles.............................. 151
DHI........................................................ 84
3S-SafelyServingScience................... 151 Anthesis-Caleb.................................... 151 BIG vzw............................................... 151 Boeije Consulting................................ 151 Bootman Chemical Safety.................. 152
Dr. Knoell Consult GmbH...................... 86 EBRC Consulting.................................. 88 EcoOnline.............................................. 90 ENVIRON.............................................. 92
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
Editorial Director Mamta Patel, mamta@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 Glen Marechal, glen@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 2015
CFCS................................................... 152 Chementors Ltd.................................. 152 Chemical Regulatory Affairs – Israel.. 152 Chymeia ApS...................................... 153 CONUSBAT......................................... 153 Danger and Safety srl......................... 153 Distefano Law Office........................... 153 DR MACH Chemical Compliance & Competence....................................... 154 eSpheres............................................. 154 Eurideas Linguistic Services.............. 154 HDTS Chemicals Inc........................... 154 Infotox.................................................. 155 Jongerius Consult BV......................... 155 KREATiS.............................................. 155 Linmark Consulting............................. 155 LKC Switzerland Ltd............................ 156 McKenna Long & Aldridge LLP.......... 156 Peter Fisk Associates.......................... 156 Prefusion LLP...................................... 156 Randis ChemWise (Shanghai) Co., Ltd................................................ 157 REACH Global Services..................... 157 Reach Only Representative Ltd.......... 157 REACHWise........................................ 157 ReFaC................................................. 158 Rovaltain Research Company............ 158 SCAS Europe...................................... 158 SciVera................................................ 158 Siam S.L.............................................. 159 Spring Trading Company, LLC............ 159 Tox Focus, LLC.................................... 159 toXcel.................................................. 159 Toxicon................................................ 160 ToxServices......................................... 160 WRc plc............................................... 160
A-Z Listing.................................. 162
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 2015 Copyright and Database Rights © 2015 CW Research Ltd. All rights reserved
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Contents
Contents
MARKET ACCESS MANAGEMENT CONSULTING ADVOCACY LEGAL SERVICES REACH AUTHORIZATION REACH REGISTRATION LEAD REGISTRATION BIOCIDES GLOBAL REGULATIONS
Strengthening your business globally.
OUT-SOURCING PROCESS MANAGEMENT OUTTASKING REGULATORY MONITORING
Focusing on your core.
DIGITAL SOLUTIONS SUPPLY CHAIN MANAGEMENT COMPLIANT SUPPLIERS CONSULTANCY
WWW.REACHLAW.FI
Thriving through technology.
INTRODUCTION “Increasing complexity� is the key phrase in the chemicals management and control sector today. The number and types of regulations affecting the use, handling and transport of chemicals have multiplied within and across all regions of the world. European legislation continues to be a major driver of demand for both in-house and external chemical management and control services, including overarching substance regulations and legislation targeting specific product groups. In the US, a question still hangs over reform of the national chemicals management and control legislation, causing individual states to take action and pass their own regulations. As a result, a complex patchwork of compliance requirements is emerging across the US. An increasing number of national regulations around the world, including some in Europe, are further complicating the situation for international companies. The fact that the Globally Harmonized System (GHS) of classification and labelling of chemicals is not consistently applied from country to country is also causing a headache for many. The need for detailed information on chemicals in products is also placing pressure on brand owners, suppliers and testing labs. Communication of information throughout the supply chain is improving but still has a long way to go to be fully efficient and effective. Managing the data generated for compliance is another increasingly
complex and growing challenge, particularly for companies with many products that are sold into lots of different markets. Ensuring the security of all of that data is a further concern. While some companies have invested in additional staff in response to the growing level of work, others are under budget constraints and have limited resources. As in previous years, small and medium-sized enterprises (SMEs) struggle the most, but even some larger companies are finding chemical management and control to be an increasingly daunting task. There is, in fact, real concern that many substances will be withdrawn from certain regulated markets due to the inability of suppliers to meet the various data requirements for registration and authorisation of their use. A discussion of key trends in the chemical management and control market, and highlights of the results of the fifth annual Chemical Watch survey of the regulated community, including both service providers and in-house experts involved in chemical regulatory compliance, are presented below. In addition, we provide an annual summary of the current jobs market. Special sections on alternatives to animal testing and current trends in information technology are also included. We conclude with our annual discussion of user perceptions and general expectations for the chemicals management and control service provision market.
OVERVIEW
Chemicals management grows in complexity Each year, the Chemical Watch survey seeks to identify the top regulatory and non-regulatory drivers of demand for chemicals management and control expertise, whether those services are provided by internal staff or external experts. Not surprisingly, as in all four previous years of the survey, REACH has been selected as the number one regulatory driver of the market, with 79% of respondents indicating it is the top choice [Figure 1]. The figure is slightly up from the number in 2013 (77%), but still down from the 89% peak in 2012, which coincided with the run up to the 2013 REACH deadline. Specific parts of REACH also scored high with survey participants: the REACH 2018 registration deadline; obligations for substances of very
Chemical Watch | Global Service Providers Guide 2015
high concern (SVHCs); and evaluation-related activities and dossier updates are important to 54%, 48% and 43% of survey respondents, respectively. The EU classification, labelling and packaging of substances and mixtures Regulation (CLP) and chemicals legislation in the US are as important as these individual REACH-related issues, with 55% and 48% of respondents, respectively, indicating they are key drivers of the market for chemical management and controls services. Other top issues identified by Chemical
Watch survey respondents include legislation in China and South Korea, national implementation of GHS, and the EU biocidal products Regulation.
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Chemical service providers
Chemicals Management and Control
GET EXPERTS ON YOUR SIDE “You can do your business, we remove the regulatory roadblocks.”
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Figure 1 LEADING REGULATORY DRIVERS FOR SURVEY PARTICIPANTS
EU CLP regulation
55%
EU REACH 2018 registration
54%
EU REACH SVHC obligations
48%
US (any)
48% 43%
EU REACH evaluation related activities/dossier updates China regulations National GHS classification, labelling and inventory notification regulations
36% 32% 32%
US HazCom 2012 (GHS) Standard
30%
South Korea regulations
28%
Biocidal product regulations Food contact material regulations
21%
US EPA Work Plan on Chemicals
21%
US: California Safer Consumer Products Regulation
19%
Nanomaterials risk assessment
19%
Taiwan regulations
18%
Packaging regulations
18%
Japan regulations
16%
Turkey regulations
16%
Canada pending GHS in workplace legislation
14%
Canada Chemicals Management Program
14%
International Maritime Dangerous Goods (IMDG) Code
13%
Cosmetics regulations
13%
International Carriage of Dangerous Goods by Road (ADR)
13%
Brazil regulations
13%
Conflict minerals legislation
12%
Agrochemical regulations
11%
US CDR
10%
Russia regulations
9%
Malaysia regulations
9%
Mexico regulations
8%
Pharmaceutical regulations
7%
Medical devices regulations
7%
Argentina regulations
5%
Israel regulations
4%
Veterinary product regulations
3%
0%
Chemical service providers
79%
REACH (any)
20%
40%
60%
80%
100%
% of participants Regulatory requirements and the development of new regulations have a clear and direct relationship with the need for chemicals management and control expertise. However, there are several drivers that are not related to specific chemicals legislation that can have a significant influence on the development of chemical regulations, Chemical Watch | Global Service Providers Guide 2015
and as such are important indirect drivers of the service provision market. In the most recent Chemical Watch survey, respondents indicate that economic growth and customer pressure are almost equally important as the top non-regulatory drivers [Figure 2]. Next in importance are government policies and Page 7
Figure 2 LEADING NON-REGULATORY DRIVERS FOR SURVEY PARTICIPANTS Customer pressure 46% Economic growth 44% Governmental policies/spending 33% Redistribution of regulatory compliance responsibilities within organisations 30% NGO pressure 25% Non-statutory voluntary corporate initiatives/CSR 21% Downsizing of inhouse chemical management and control teams 21% Outsourcing of business support functions (by client organisations) 11% Increased commercialisation/better management of service provider business 10% Other 2% 0%
20% 40% % of participants
60%
What is clear is that companies’ chemicals management and control departments are inundated. Whether they have in-house staff, rely completely on outside experts, or use a combination of both, they are investing heavily in the area. For example, Axalta Coatings Systems tracks all of the major regulations, but particularly REACH in the EU, the Korean Act on the Registration and Evaluation of Chemicals (known as K-REACH), the Toxic Substances Control Act (TSCA) in the US, and the activities of Environment Canada, each of which can also serve as benchmarks for other national regulations. The company also monitors the CLP/GHS programme worldwide as it is adopted by countries and works with suppliers and customers to address conflict minerals reporting requirements, according to Janis L Nutini, director of global technology planning for product stewardship and regulatory affairs for Axalta. “The biggest challenge is keeping up to date on evolving regulatory requirements and business impacts while managing the internal resources and determining what external resources may be required to augment expertise,” she states. Dr Mayank Dave, head of quality
Chemical Watch | Global Service Providers Guide 2015
with the Indian chemical manufacturer Atul sums it up best: “We must comply with all regulations, whether they are REACH-like or product-specific. It can be very difficult, because they all have different guidelines and requirements, but new or revised legislation keeps on coming and non-compliance is not an option.”
REACH STILL ON TOP Europe’s REACH regulation continues to be the main driver of demand for chemicals management and control services, both for internal compliance teams and external consulting and testing firms, but for many the work is evolving. In the initial years and up to 2013, most REACHrelated projects were driven by dossier preparation and substance registration, whilst today’s efforts increasingly involve follow-up work from the 2010 and 2013 dossiers, such as testing proposals and compliance check evaluations. In addition, the number of chemicals undergoing substance evaluation is increasing, the candidate list is continuously expanding, and assessment activities (for persistent, bioaccumulative and toxic (PBT) and endocrine disruption (ED) properties) require significant effort. “It is becoming very difficult for any company that has a reasonably large number of registered substances. Although the regulators, meaning European Chemicals Agency (Echa) and member states, seem to be involving industry, and registrants in particular, earlier in the process, it is a challenge to remain on top of all potential issues around chemicals,” asserts a product stewardship and regulatory affairs manager from a speciality chemical company. REACH also continues to be a very large project for Celanese, another speciality chemicals manufacturer. “Continuing registration work, volume tracking and reporting require significant technical expertise, as does tracking for deadlines and volume thresholds,” says Philip J Brondsema, global product steward for the company. He adds that REACH implementation is the project with the largest staff, and is expected to remain so for several years to come. Many companies have turned to service providers to assist with this ongoing work. For Forschungs und Beratungsinstitut Gefahrstoffe (Fobig), in 2014 its main consultancy services included preparing authorisation applications, updating existing registration dossiers, either due to the client’s own initiatives or in response to Echa decisions, and support of companies with regard to substance evaluation for the Community Rolling Action Plan (Corap), according to Klaus Schneider, general manager of Fobig. He notes that the three areas require dedicated, sophisticated approaches to exposure assessment, including information on supply chains and exposure conditions, and in-depth hazard identification for specific endpoints, such as those addressed in Echa decisions or as part of substance evaluations. This phase of REACH can be challenging both for the producers and users of chemicals and the compliance experts helping companies meet the regulatory requirements. “Much of the current REACH work involves answering Echa’s questions from 2013 registration submissions and evaluations, which means responding to projects as they arrive, and often with limited time to do so. It is consequently difficult to plan under these circumstances,” says Martin Richards, a principal consultant with Linmark Consulting. Administrative activities related to REACH have also been in high demand. For KFT Chemieservice, managing
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Chemical service providers
the redistribution of regulatory compliance responsibility within organisations, although these two drivers are much less significant than the first two. It is interesting to note that for the second year running, the redistribution of regulatory compliance responsibilities within companies (30%) is thought by survey participants to be nearly as important as governmental activities (33%).
Chemical service providers
joint registrations and addressing numerous questions concerning purchases of letters of access (LOA) as part of its management activities relating to substance information exchange fora (Siefs) have become daily activities for its major and medium-sized clients. The regulatory proposal by the European Commission to improve management and transparency of Siefs “has polarised opinion between consultants, lead registrants and small and mediumsized enterprises,” according to Rachel Green, technical manager of the Regulatory Facilitation Company (ReFaC). “The former group fears increased workload for little return, whilst the latter group is demanding more transparent and equitable cost sharing based only on the data actually required,” she observes. Dr Richards, for example, believes that the proposed Sief Regulation has the potential to create a huge amount of extra legal work with no benefit to anyone, apart from lawyers. REACH authorisations, which have been a key issue in 2014, are expected to continue as a major source of work for service providers for the near term. “We received many requests regarding the REACH authorisation process, because it is not well understood yet. It is not clear which uses are covered by a granted authorisation, such as whether the use is valid for the entire supply chain, and whether it covers research and development quantities over one tonne,” says KFT managing partner Karl-Franz Torges. ReachCentrum believes that the European Commission’s focus on simplifying the process for the granting of authorisations is an important, positive development. Several industry experts indicate that the first successful authorisations in 2014 are some of the most important events of year. For an executive at a Europeanbased speciality chemicals manufacturer, the granting of the first authorisation to Rolls-Royce for the use of diethyl hexyl phthalate (DEHP) was notable, because it highlighted a possibly unexpected impact of REACH on downstream users. He also finds the very recent decision to consider DEHP as an endocrine disrupting chemical (EDC) is striking, because it seems to completely change the picture for those applying for an authorisation for this substance. The successful authorisations in 2014 are good news in a practical sense to Rick Stanton, director of SCAS Europe. “Authorisation allows time for innovation or continued use when necessary for the specific cases where substitution of a substance of very high concern (SVHC) would be very difficult or impossible from a process or functional viewpoint,” he explains. Exposure scenarios continue to be an issue as well. In many cases, KFT’s Dr Torges notes, suppliers are still not prepared or willing to deliver exposure scenarios for substances. In addition, those that do provide exposure scenarios as annexes to safety data sheets, often only provide them in English. The reconciliation of exposure scenarios developed under REACH with those required by individual countries is another important issue that service providers help address, according to Daniele Campi Martucci with Toxicon. “It is not sufficient to support REACH-specific issues for clients. They also need help resolving the differences between those requirements and the requirements of Italian regulations, particularly with respect to exposure scenarios, which can be both complex and extensive,” he says. On top of the work related to the 2010 and 2013 registration deadlines, service providers have begun to receive a growing number of requests for assistance with the upcoming 2018 deadline for the registration of substances that are manufactured or imported in quantities
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between 1-100tonne/year. “We are increasingly involved as representatives of clients in 2018 substance consortia, and we see this business area growing,” says Paul Thomas, senior ecotoxicologist and director of CEHTRA (Lyon Agency). Many service providers are finding that the 2018 deadline is presenting a different set of challenges compared to the previous registration deadlines. For instance, it is necessary to determine the substances for which lead registration dossiers have already been submitted. For these obtaining an LOA will be sufficient for co-registrants (apart from the company-specific parts of their registration dossier), according to Peter Douben, director of REACHWise. He says that for substances yet to be registered, it will be imperative to start early. But, he adds that there is significant reluctance to do so. “There is fear of the unknown, because a large number of the companies that must comply with this deadline have not yet been significantly involved in REACH registrations, leaving aside the pre-registration aspects, and therefore do not appreciate the processes involved,” he explains. They also often do not appreciate the benefit of starting the process early on, but he warns that leaving matters until the last minute will pose challenges with respect to providing the required elements of the registration dossier. As REACH implementation progresses, the demand for support services is also continuously increasing from nonEU companies. This work can be particularly challenging, according to Michael Cleuvers, managing director for industrial chemicals and biocides with Dr. Knoell Consult. “Sometimes the lack of detailed information and guidance documents is causing problems,” he comments.
GHS/CLP A HOT TOPIC As a growing number of countries adopt their versions of GHS, manufacturers and downstream users are faced with a need to comply with standards that deviate, sometimes in minor ways, from the harmonised approach. “Most of our clients are very dissatisfied to learn that harmonisation does not mean complete harmonisation.” says KFT’s Dr Torges. He also notes that in some cases, the task is becoming more complicated because the differences in GHS implementation are only very small, for example different threshold values or no substance specific threshold values are applied. Paying attention to the differences is crucial, he says. Some clients are electing to generate general GHS (purple book) safety data sheets (SDSs) and classifications rather than country-specific documents. “We are finding that it is necessary and difficult to make non-EU clients understand that CLP classification and EU-standard SDSs are not only independent of REACH registration but are required now,” says ReFaC’s Ms Green. REACHWise’s Dr Douben finds that he needs to keep reminding his clients that in nine months’ time matters will be streamlined as a result of GHS to a significant extent. “This regulation simplifies supply chain communication and as a consequence they will receive fewer queries from their customers,” he says. He also believes that implementation of the newest adaptations to technical progress (ATPs) and increased familiarity will help. Companies that are choosing to comply with national GHS implementation are also struggling to determine how the language differs from the original European regulations, according to John M Robinson, project manager with GLTaC. “In addition to our core translation services, we
Chemical Watch | Global Service Providers Guide 2015
PRODUCT-RELATED REGULATIONS GAINING TRACTION In addition to REACH and GHS, product-specific regulations are gaining in importance. In Europe, legislation covering the use of biocides, plant protection products, cosmetics and food contact materials and packaging are all demanding the attention of branded product manufacturers, their suppliers and regulatory experts. Similar regulations can be found in an increasing number of other countries. “The growth of these product-specific regulations, at the same time as REACH and REACH-like regulations, continue to require significant attention. It is important for chemical management and control personnel to have both a broad view and regulation-specific knowledge,” asserts REACHWise’s Dr Douben. In particular, he points to updates and changes to product-specific regulations like the biocidal products Regulation in the EU, which creates challenges for everyone involved. “It is important to be aware of the general rules but also some substance-specific ones which should not be overlooked,” he notes. Registration of biocidal formulations in former Commonwealth of Independent States (CIS) countries, such as Russia, also
Chemical Watch | Global Service Providers Guide 2015
requires specialised and individual attention according to Dieter Drohmann, managing director of Chemservice, because these regulatory frameworks are generally not yet very specific. The most important aspect of the BPR today, according to Leondina Della Pietra from ReachCentrum, is Article 95, concerning the list of suppliers of active substances. From 1 September 2015, a biocidal product cannot be placed on the EU market if the active substance or product supplier is not included in the list for the relevant product type. The companies listed have all committed to supporting their substances through EU review programme for existing biocidal products. Ms Della Pietra also notes that Echa’s launch of the public activities coordination tool (PACT) in September 2014, which lists the substances for which a risk management option analysis (RMOA) is either under development or has been completed is an important development with respect to the BPR because several biocidal active substances are included. It is also troubling to Dr Torges of KFT that many SMEs are not aware of the impacts of the BPR, or do not believe it will affect them and as a result have not taken appropriate action. “Article importers and producers are not aware of the new labelling demands according to the Regulation, and many have not yet communicated with their suppliers in Asia. As a result, a large percentage of Asian companies will most likely not be on the Article 95 list of the biocidal products Regulation in September,” he comments. KFT predicts that 80% of the smaller companies who supply biocidal products will be out of the market by 2016. Toxicon’s Mr Martucci notes that his company has received increasing requests for assistance with compliance efforts related to the BPR and the EU cosmetic products Regulation. Because the BPR is so complex, Toxicon is in the process of evaluating which aspects of the regulation it will support. For clients in need of assistance with cosmetic product compliance, Toxicon is focusing on the generation of product information files (PIFs). Numerous cosmetics and food product regulations emerging in 2014 are significantly impacting the regulatory landscape, according to Christina Widodo, director of regulatory research for 3E Company. “There has been increased demand from our customers for data and services related to cosmetics and food regulatory compliance in Asia Pacific and Latin America. From a consumer products point of view, the challenge is that we not only need to understand the raw materials and ingredients used in the formulation of these products, but also how each of the products, for example lipsticks, sunscreens and toothpastes, is regulated,” she observes. She also notes that less developed countries often present their own unique challenges as there can be a lack of clarity in their regulations. To more fully support international clients in the cosmetics industry, some service providers have made a point of developing global knowledge on this growing aspect of the regulatory sector. Conusbat Internationalization Regulatory Service, for example, has established a global network of strategic regulatory partners in addition to providing core product stewardship services for EU cosmetics regulations. According to company president Steven L Hanft, having a global network of experts in cosmetic product regulations is increasingly important, because regulations should be looked upon as a challenge and not a hindrance towards entering a new market.
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Chemical service providers
have been receiving enquiries for help with understanding section headings, hazard statements and precautionary phrases, because they are not always equivalent,” he says. With so many GHS implementation deadlines on the horizon, it is not surprising that a noticeable increase in demand for SDS authoring services occurred in 2014. “Both manufacturers and distributors of all sizes increasingly faced challenges related to globalisation in the marketplace and changing international regulatory initiatives. This situation directly affected their ability to efficiently and effectively produce and maintain the currency of SDSs, labels, and other hazard communication documents for their products,” observes Clark van Scoder, vice president of authoring solutions and services for 3E Company. For US companies in particular, there is concern over Canada’s delay in implementing GHS because there is lack of clarity regarding both the interim and long-term cross acceptance of SDSs and labels with the US, according to Celanese’s Dr Brondsema. For all companies, Dr Torges believes that implementation of GHS and CLP for mixtures will drive significant demand for outside support, in particular for exposure scenarios for mixtures, over the next 18 months. He estimates that only 30% of KFT’s clients have changed their classifications and SDSs for mixtures to meet the EU CLP requirements, and he is not sure that all companies will meet the 1 June 2015 deadline. Finally, several service providers have had requests from clients regarding emergency number information for various countries, even within the EU. Many countries have implemented country-specific requirements for emergency number information that are very different from one another. In addition, the regulations are written in the local language and the people manning the help desks only speak the language of the country. Furthermore, in some countries the information must be provided physically, with an individual form for each mixture. “A European solution is in development related to CLP, but it is not in place yet,” notes Dr Torges. “What is in fact needed is a global solution. We are working with a major US company to provide such a service,” he adds.
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In addition to REACH, EU CLP and national implementations of REACH and product-specific regulations, producers and users of chemicals continue to be challenged with growing numbers of country-specific REACH-like and product-specific regulations, as mentioned above. With respect to country-specific regulations, K-REACH came into force at the beginning of 2015. This legislation is but one of many REACH-like regulations that are being promulgated in countries around the world, including Turkey, Taiwan and China. Many other governments are in the process of developing chemical control legislation, including others in Asia, as well as in India, Russia, and Central and South America, Africa, and the Middle East. As a speciality chemical company, Johnson Matthey has found itself increasingly involved in ensuring that Asian suppliers of raw material are compliant with the prevailing legislation in their countries of operation. This task can be challenging because official translations of the regulations in these countries are not always available, according to Mark Raffray, Johnson Matthey’s group product stewardship director. He adds that the issue is compounded because both official translations of the regulations and guidance authorised by the regulatory agencies are not always available in these countries – often leading to doubts about precise interpretation of requirements. Lack of both guidance materials and the ability to directly communicate with the authorities further compounds the problem, says Chemservice’s Dr Drohmann. For instance, for K-REACH, the registration and reporting rules and guidance materials were not finalised when the Act came into effect on 1 January of this year. Differences between country-specific regulations also increase the complexity of compliance and often result in the need for more resources. Celanese is focusing on K-REACH, registration requirements and implementation tracking in Taiwan, and registration submissions in China, which are time consuming and, for some product categories, such as food contact materials, uncertain because the regulations are still being established. Compliance with country-specific regulations can also be difficult due to specific requirements for the use of domestic testing labs and specific testing species, such as is the case for China, according to José V Cantavella Cabedo, project manager with ChemSafe.
STATE REGULATIONS ARE A CHALLENGE IN THE US During 2014, significant progress on a bipartisan bill to modernise the major chemical control legislation in the US – the Toxic Substances Control Act (TSCA) – was lauded by many stakeholders. The Republican takeover of both houses of Congress boosts the chances of passage of a bill in 2015. However uncertainty over TSCA reform has resulted in many states developing their own legislation. Leading the way is California with its Safer Consumer Products Regulations, which became effective in October 2013. In 2014, the state released its initial list of three priority products and the draft priority products work plan, which outlines the product categories that will be examined and possibly subject to regulation in 2015-2017. Separately, the state’s Office of Environmental Health Hazard Assessment (OEHHA) proposed new warning requirements under Proposition 65 in March of 2014. The proposals for
Chemical Watch | Global Service Providers Guide 2015
revised labelling content, certain composition disclosures and adoption of GHS labelling elements, received strong opposition from stakeholders. Further amendments are expected in 2015. So-called “green chemistry” legislation was passed in several other states in 2014, including Maine, Vermont and Washington. Today, state regulatory activity ranges from banning specific substances in specific products to charging state agencies to develop lists of priority chemicals for which manufacturers and users must provide reports and make certain disclosures. Concern from industry centres on the attention given to substances’ hazardous properties, without any consideration for the actual risk presented by use of chemicals in consumer products. These regulations also pose a significant challenge to any company marketing products that contain chemicals into the US, because for the most part each state acts independently. As a result companies need to develop state-by-state strategies for product manufacturing, compliance assurance, regulatory tracking and supply chain management, that also take into consideration any relevant national regulations.
DATA MANAGEMENT Not surprisingly, as the complexity of the global regulatory environment has increased, the need for management of the data involved in substance identification, volume tracking and all other aspects of chemical management and control has increased dramatically. “Data management is a critical aspect of ensuring compliance with global regulations,” states Johnson Matthey’s Mr Raffray. The company has elected to manage this activity in-house and is directing increased resources to its effort. There is also, according to Kami Blake, a solutions engineer with 3E Company, a widening of the gap between the information needed to meet compliance obligations and the data that is available from suppliers to satisfy regulatory requirements and customer requests for information. “These demands seem to be imposed more frequently and have exponentially increased in size and scope in a very short period of time, and this trend will continue in 2015,” she says. The key to success, she adds, is to focus on the desired outcomes and essential deliverables of all involved stakeholders across the supply chain. She says this can be achieved by: determining required data sources; launching data acquisition efforts; transforming data and compliance content into actionable business intelligence; integrating intelligence with customer-specific materials and products; and aligning information with compliance requirements, such as client questionnaires, disclosures, certifications and agency-required reports. Getting the information is the real challenge. Ms Blake acknowledges that sourcing is a significant undertaking, dependent upon knowledgeable resources with the capacity and capability to effectively manage the effort. In addition, the work is not finished once the data and documents are obtained. Validation, enrichment, and contextualisation are the next steps in analysing and repackaging the information in order to fulfil a host of compliance obligations. To add to the workload, Ms Blake notes that compliance requirements can change rapidly, often with little warning. Most information collected to support supply chain material compliance efforts must be re-certified at least annually. As a result, the ripple effect of a data requirement revision can have significant upstream and downstream impacts.
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Chemical service providers
COUNTRY-SPECIFIC REGULATIONS ATTRACTING ATTENTION
Careers and salar y survey
Chemservice’s Dr Drohmann adds that mixtures present an additional challenge, because many substances, and hence suppliers, can be involved for each mixture, and the confidentially claims of the actors in the supply chain come into play. “Not only is the organisation of data important; secure management of data is crucial, and trustee services may be the only effective solution when formulation and other proprietary information must be shared for various reporting purposes,” he says.
HOW ARE SERVICE PROVIDERS HELPING? With such a complex regulatory landscape, it is not surprising that different service providers offer support on different types of regulations, different regions of the world, or in some cases different client sets. Toxicon, for example, focuses on clients in Italy and helps them with general regulatory interpretation and compliance support, development of testing and registration strategies, as well as providing legal support for the purchase of LOAs under REACH, toxicological evaluations for substances and mixtures, and data gap analyses. KFT Chemieservice, on the other hand, has been increasingly providing general consultancy services for all areas and regions, whilst clients turn to Dr. Knoell Consult for regulatory and scientific support, plus study management and general strategic advice. In addition to project management, ReachCentrum has experienced growing demand for its data and financial management, legal support, Sief communications and authorisation and evaluation support services. Outsourcing to testing laboratories remains high, as well, and Dr Thomas of CEHTRA believes that pressure is building in this area, with the most popular labs already fully booked for months ahead. His company’s KREATiS subsidiary, which provides high accuracy quantitative structure–activity relationship (HA-Qsar) analysis services, is benefiting as companies look for alternatives that can replace lab testing. Separately, in response to growing demand from consumer product importers, some of which have had bad experiences with enforcement decisions, KFT Chemieservice is establishing
a separate department to help companies determine the marketability of consumer products in the EU. Of course, the use of external service providers varies widely from company to company as well. Axalta Coating Systems relies on its internal regulatory staff for the most part, but uses qualified testing laboratories for toxicology testing to support registrations and outside counsel when global regulatory interpretations are needed, according to Ms Nutini. Celanese takes a similar approach, with the majority of regulatory compliance work done inhouse even though there is increasing complexity and volume of “routine” product regulatory work, according to Dr Brondsema. The company does contract out legal services for unusual registrations and occasionally for communications with regulatory agencies. Toxicity and ecotoxicity studies are also routinely contracted out, although each study done is designed to meet as many countries’ requirements as possible. In addition to testing support, data management and analysis are also the key areas for which a European speciality chemical manufacturer uses service providers. “Testing demand is high, particularly for higher tier testing, for example the extended one-generation reproductive toxicity study (Eorgts), developmental toxicity, environmental fate and bioaccumulation. At the same time, data management with respect to dossier preparation and maintenance also remains important, as does the need for expert interpretation and evaluation of the data and results. All of these activities are increasingly handled by outside expert consultants,” notes a company representative. Atul, an Indian chemical manufacturer, also looks to service providers to meet data management and analysis and testing requirements, and uses those firms that have experience with the regulations in each country in which it operates, according to Atul’s Mr Dave. For Johnson Matthey, consultants have been used to provide support for new chemical substance notifications in China, where the company has recently acquired manufacturing sites. In addition, as required by Chinese regulations, local contract research organisations are used to perform certain mandated toxicity tests.
CAREERS AND SALARY SURVEY
Solid outlook for chemicals management jobs market Further, albeit slow, economic recovery in much of the world, combined with an increasing chemical regulatory burden, continued to keep the jobs market for chemicals management and control professionals fairly healthy in 2014. With this fifth edition of the Chemical Watch survey of professionals involved in the chemical management and control sector, we are able to report our third round of results regarding salaries and career prospects. As in years past, many people from a wide variety of organisations and holding a wide range of positions elected to participate in the Chemical Watch salary survey. We thank all of them for sharing this information, without which we would not be able to provide any useful data on salaries, pay rises, and bonus levels in the global chemical management and control community. The results are summarised below and
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where appropriate compared to those obtained for the 2013 survey. Of the survey participants, 31.1% are project or team managers, 29.0% are specialists or technicians, 22.6% are senior managers, and 10.7% are directors or associate partners. Juniors, trainees and government officers each accounted for approximately 3% of the respondents. Interestingly, despite the growth of global regulations and the continued recovery of the global economy, more respondents indicated this year that the size of their regulatory team decreased in the last 12 months than did last year (14.5% compared to 12.2%). On the other hand, a similar number indicated that they saw and expect no change (52.5% and 58.6%, respectively, this year, Figure 3, compared to 53.9% and 57.4% last year).
Chemical Watch | Global Service Providers Guide 2015
Figure 3
Figure 4
STAFFING TRENDS
JOB PROSPECTS
100% 90%
9.0%
14.5%
100%
80%
80%
70%
70%
60%
58.6%
52.5%
50%
40%
40%
30%
30%
20%
20%
10%
32.9%
32.4%
Last 12 months
Next 12 months
0%
Decreasing
Static
Increasing
In addition, fewer Chemical Watch survey respondents (35.2%) believe that job prospects are good within their own country compared to a year ago (40.9%), although fewer believe they are poorer (8.4% in 2014 versus 10.1% in 2013) [Figure 4]. Whilst the numbers are more positive when survey participants consider global opportunities, they still do not see things as positively as they did a year ago; 52.2% see global job prospects as being good today compared to 57.2% a year ago.
44.2% 56.4%
60%
50%
3.6%
8.4%
90%
52.2% 35.2%
10% 0%
In your country Poor
Stable
Globally Good
With respect to career progression, survey respondents also see greater opportunities across the wider jobs market than they did within their own companies, but the numbers are again lower than a year ago. Specifically, 59.3% and 31.2% see good prospects in the overall market and with their current employer [Figure 5] compared to 63.2% and 35.2% last year, respectively. Furthermore, a higher number in 2014 (28.5% versus 24.7% last year) believe that their opportunities for advancement are poor if they do not move
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elsewhere. These results suggest that a greater number of the professionals in the chemical management and control sector that are participating in the job market today are hoping to improve their positions. Figure 5 CAREER PROGRESSION OPPORTUNITIES
Careers and salar y survey
100%
7.0%
90%
28.5%
80%
33.7%
70%
Meanwhile, the level of job satisfaction dropped slightly in 2014 to 55.9% from 59.9% in 2013 [Figure 7]. This change was accompanied by an increase in the number of respondents that took a neutral position (31.5%, up from 27.5%), with no change in the number of participants that are dissatisfied with their jobs (12.6%). The reduced level of satisfaction may be due to an increased workload as many companies in the US and EU are finding it difficult to hire people with mid-level experience that can start contributing from day one. Those few companies that are willing to invest in the training of younger candidates, however, seem to have a greater chance of attracting highquality workers. Figure 7
60%
JOB SATISFACTION
40.3%
50%
Dissatisfied 12.6%
40% 30%
59.3%
20%
31.2%
10%
Satisfied 55.9%
0% In your company Poor
Wider jobs market
Neither
Good
Despite these downward trends in expectations for job prospects and progression, 65.3% of Chemical Watch survey participants felt as secure in their jobs in 2014 as they did the previous year [Figure 6]. Interestingly, however, slightly fewer felt that jobs across all roles were more secure than their own roles (19.9% versus 23.5%, respectively). Figure 6 JOB SECURITY COMPARED WITH 12 MONTHS AGO 100% 90%
11.3%
12.6%
65.3%
67.5%
23.5%
19.9%
In own role
Across all roles
Neither satisfied nor dissatisfied 31.5%
Looking at the average salaries by job title [Figure 8, overleaf], little variation was observed in 2014, as was the case for 2013. Average salaries ranged from €45,200 to €49,000. Due to a strengthened pound and dollar against the Euro, all of the average salaries were noticeably higher when looked at in Euros than a year ago (€38,900 to €46,300). However, at constant exchange rates this year’s average is slight down (from €47,100 to €46,300).
80% 70% 60% 50% 40% 30% 20% 10% 0%
Less secure
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Similarly secure
More secure
Chemical Watch | Global Service Providers Guide 2015
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Figure 8
Figure 9
AVERAGE SALARY BY JOB TITLE
AVERAGE SALARY BY ORGANISATION TYPE
Business management/development
Chemicals, life sciences and similar 46.9
48.2 Consultant
Consumer products, cosmetics and similar 42.7
45.2 EHS management 49.0
57.7
Other
Government & agencies 47.4
40.6
Product safety/stewardship
Other 46.4
42.6
Regulator
Other manufacturing
47.7
43.4
Regulatory affairs management
Service provider, including consultants, laboratories, lawyers etc
45.6
45.8
Toxicologist/chemist/scientist
Trade association or professional body
45.6
43.5
Average salary 46.3 0
Careers and salar y survey
Engineering, automotive, aerospace and similar
10
20
30
40
50
0
10
20
30
There is, however, more variation in average salaries when considering the type of organisation [Figure 9]. Survey respondents working in the engineering, automotive and aerospace industries earned the highest average salary by far (€57,700). Participants with positions in the chemical and life science industries (€46,900) and for service providers (€45,800) earned the second highest average salaries. Consumer product companies, trade associations and other manufacturing industries paid average salaries of €42,700 to €43,500. Those respondents working for government agencies earned the least of all survey participants (€40,600). There is not much difference in average salaries when considering company size, although they did trend higher with the number of employees. Participants at companies with over 250 employees earned an average of €47,100, whilst those at medium-sized organisations with 50-250 employees earned an average of €45,300, and those at firms with less than 50 employees earned an average of €43,000. Notably, however, the average salaries for each company size are slightly lower at constant exchange rates than they were in 2013.
50
60
70
Euros 000s
60
Euros 000s
40
Once again, company location has a significant impact on earning potential according to the results of the Chemical Watch survey [Figure 10]. Respondents in Europe earned the highest average pay by far (€54,800), whilst those in North America and the rest of the world earned on average just under two thirds that amount (€35,000 and €36,300, respectively), and less than the average annual salary of €46,300. Figure 10 AVERAGE SALARY BY JOB REGION Europe 54.8 North America 35.0 Rest of world 36.3 Average 46.3 0
10
20
30
40
50
60
Euros 000s
Chemical Watch | Global Service Providers Guide 2015
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KFT
The CHEMICAL COMPLIANCE Company
Not surprisingly, salaries varied with respondent age [Figure 11]. Survey participants ranging in age from 46 to 50 earned the most on average (€54,100), which is down slightly on the €54,800 earned in this bracket last year, at constant exchange rates. Another difference from 2013 is the shift in the lowest earning age bracket from the oldest respondents to the youngest. In addition, those survey respondents just entering the workforce earned an average salary of €26,300, which is down from an average of €33,900 in 2013 (at constant exchange rates).
Figure 12 AVERAGE PAY RISE Europe 1.5 2.0 4.7 North America
Careers and salar y survey
2.4
Figure 11
3.3
AVERAGE SALARY BY AGE
8.4
21-25
Rest of world 3.8
26.3
4.9
26-30 35.7
6.8 Average
31-35
2.0
47.2
2.8
36-40 49.7
6.2
41-45
0
48.8 46-50 54.1
2 Only promotions
4
%
Including promotions
6
8
10
Excluding promotions
51-55 47.4 56-60 41.5 61-65 42.9 >65 30.9 0
10
20
30 Euros 000s
40
50
60
For survey respondents who did not receive a promotion at their last pay review, the average pay rise is 2.0% (slightly down on the 2.2% the previous year) and ranged from 1.5% in Europe to 2.4% in North America and 3.38% in the rest of the world (down significantly from 5.1% a year ago) [Figure 12]. On a positive note, approximately two thirds of Chemical Watch survey respondents earned an average bonus of 11.0% in 2014, which is slightly up from 10.8% in 2013. Participants in Europe and North America earned bonuses close to the average (~10% and 11%, respectively), while those located in other parts of the world report receiving much higher average bonuses of around 16%.
Chemical Watch | Global Service Providers Guide 2015
The relatively stable and positive metrics uncovered in the Chemical Watch survey support the notion of a healthy jobs market in the chemical management and control sector. “The role of regulatory affairs continues to grow in prominence and regulatory budgets continue to rise to meet the challenges of increasingly complex regulations,” says John Sherratt, regulatory affairs business manager for European-based recruitment firm VRS Regulatory. He adds that deadlines for regulatory change can create surges in demand for chemical management recruits that in the past were frequently filled by using interim solutions or consultancies, but in many cases companies today believe the growing demands are a step change rather than a blip, and are thus looking to increase permanent head counts within their regulatory functions. In addition to the growing number of regulations being promulgated around the globe, the improvement in the global economy has played a significant part in driving the upsurge in demand for toxicologists and people with regulatory affairs and product stewardship expertise, according to Terry Leyden, president of the Leyden Group, a Colorado-based professional recruiting and executive search firm focused on toxicology, product safety and regulatory affairs. Mr Sherratt agrees that some of the demand is created by renewed investment by companies looking to enter new markets, many of which now have their own regulatory compliance requirements. The sector is facing a significant challenge in terms of the number of qualified and skilled personnel, which may have long-term consequences. Demand continues to outstrip the supply of qualified chemical management professionals, particularly in countries with improving economies. UK personnel with integrated knowledge of REACH, CLP, transport, and biocides regulations are difficult to find, which can be an issue for small
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Careers and salar y survey
consultancies operating across the full spectrum of EU regulatory requirements, according to ReFaC’s Ms Green. European companies in general, according to Dr Torges of KFT Chemieservice, are looking for experienced specialists, but they are few and far between. In India, there is a shortage of reasonably-experienced application and analytical scientists and general health, safety and environmental (HSE) professionals, according to Atul’s Mr Dave. Skilled staff are also in short supply in Asia, according to Dr Brondsema from Celanese. “The chemical industry is relatively young, and chemical management regulations are quite new. As a result there are fewer senior people in the chemical industry, less expertise for those in chemical management, and fewer people in the general chemical industry from which to recruit.” “It is a huge challenge that is driven by market demographics,” states Mr Leyden. Whilst there are a lot of people with many years of experience, companies are looking for people with sufficient experience to go straight to work without any need for training, but not so much that they fall into a substantially higher pay scale. The lack of experienced people can be attributed to the fact that chemical management is not a typical career choice for new graduates and frequently not identified as an alternative for mid-career professionals. As a result there is a limited pool of potential candidates for the increasing number of positions, according to Dr Brondsema. The need for experienced people is driven by the fact that the requirements associated with chemicals legislation are becoming more complex, according to Chemservice’s Dr Drohmann. He notes that technical staff must be expert in not only the regulations, but also their interpretation and the planning of required testing. “The current cadence of chemical regulation compliance deadlines is an inhibitor in terms of training ‘early career’ staff – hence the tendency to seek more experienced individuals who can be immediately effective on project work, and who also do not require diversion of valuable staff time for training purposes,” observes Johnson Matthey’s Mr Raffray. He does note, however, that this approach reflects a myopic perspective given the need to develop the next generation of professionals. “Another part of the problem is that companies have never presented positions in regulatory affairs or product stewardship as positions from which careers can be built,” says Mr Leyden. As a result, at least in the US, there are few graduates fresh out of school that are intending to go into the field. Toxicology, however, is an exception to this situation, according to Dr Brondsema. “The role of toxicologists in industrial chemical management is well established and is a routine career path for both new graduates and mid-career professionals,” he says. In the UK, Mr Sherratt notes that there are a lot of graduates on the job market, but few have the solid academic qualifications and the right attitude, but those that do have a choice of positions. Karen Machol Piraino, global director of talent acquisition at Axalta Coating Systems agrees that in the US there is increased competition for the top new graduates that are looking for regulatory affairs positions because companies have started to re-engage their college recruitment programmes. “Students are receiving multiple offers, and the starting salaries have been increasing. To attract these bright, young people, it is critical to understand what drives their generation and how careers in a company or industry align with those drivers,” she observes. ReFaC, on the other hand, has not had a problem finding new graduates with suitable education and motivation for entry-level positions, but Ms Green notes Page 22
that there is a shortage of suitable external training in these areas, and therefore the majority of training is performed in-house. KFT has a similar view. “We have had excellent experiences with new graduates. They are young, motivated and looking for challenges,” says Dr Torges. His company also offers extensive in-house training and sends employees to special training courses once or twice a year. As a consulting firm that offers training, he finds that one of the best ways to help new employees learn is to involve them in the development of new training programmes. “They receive excellent training this way because they have to look very deep into the content and the processes,” he explains. Training of new graduates can be a big effort that requires significant time and resources that many smaller firms do not have, however, notes Dr Drohmann. Even for companies that do not generally hire graduates direct from university, but start people with at least a Masters degree, must do training to some extent, according to Dr Thomas, at CEHTRA (Lyon Agency). We generally hire people with a Masters 2 degree, which means they have worked for two years after receiving their degree in France. Even these people have a limited understanding of regulatory toxicology, unless they have worked on a REACH-related subject as part of an internship. “Thus, there is a significant mentoring effort required, even for these hires,” he says. Internships are viewed by some companies as a way to assess graduates and search for potential new staff. However, according to Chemservice’s Dr Drohmann, for small companies with higher workloads and fewer employees, it is difficult to take on the additional burden of managing interns. Thus, internships are more likely to be offered in bigger companies. Axalta, for example, offers internships across all functional areas, including regulatory affairs and product stewardship. “Our internship programme is multi-faceted and is intended to help the college student obtain a broad understanding of the business world and how it is applied in Axalta,” says Ms Piraino. Companies that wish to attract professionals with midlevel experience are offering higher salaries and total rates of pay. Some offer more flexible working conditions as a quality of life incentive, such as working from home, but in general, according to Mr Sherratt, working at a permanent office is still highly valued by most companies. Travel to conferences and seminars and continued training are other benefits that help to attract the right types of candidates. Many, however, do not have any luck finding people with the level of experience that they want, according to Mr Leyden. Often these companies end up transferring someone from another part of the company to the regulatory affairs department. Because such individuals are familiar with the company’s products and culture, less training is required to get them up to speed. Others, and particularly small and medium-size enterprises (SMEs), are in the biggest predicament, according to Dr Thomas, because they cannot afford to increase non-production staffing levels, but at the same time they are rather nervous about signing big contracts with consultancies. Many companies seem to be maintaining an internal core team for chemicals management with a trend towards more outsourcing, according to Dr Cleuvers from Dr. Knoell Consult. Outsourcing is particularly attractive for certain types of regulatory work, such as the writing of safety data sheets, that do not need to be done on site and do not require that the person doing the job has extensive training in the company’s business processes and manufacturing procedures. It therefore makes sense to hire the work out to Chemical Watch | Global Service Providers Guide 2015
In the meantime, companies looking to fill chemical management positions generally advertise on: their own websites; on industry specific job boards, sites like Chemical Watch with jobs information targeting the chemical management and control sector; and media websites, such as the websites of trade magazines and large job sites such as careerbuilder.com and monster.com. The use of specialist recruitment firms with proven track records is also popular when companies are looking to fill technical positions. Very little advertising takes place in print publications any more. Some companies also work closely with universities and their associated alumni organisations, trade industry associations and social media, particularly LinkedIn.
IT SOLUTIONS
IT critical to knowledge on chemicals As outlined in the overview of the chemical management and control sector, chemical regulations will continue to increase around the world at a rapid pace. This growth is driving the recognition that chemical management must be considered as a core business process, according to Brian Stafford, vice president of EHS for Biovia-Dassault Systèmes (previously Accelrys). “Savvy businesses that are seeking to streamline operations will be implementing software solutions that will enable better work flows throughout the organisation and reduce bottlenecks and risk,” he asserts. “In addition, whilst the desire will remain for specialised solutions that address specific business needs, the day of isolated data silos is over. Data of all types will need to be accessible and integrated digitally to enable businesses to become and remain competitive.” Information technology (IT) solutions are in fact fundamental to the success of any chemical management and control programme, and because there are many different tasks associated with chemical management, there are several different types of solutions available to facilitate the completion of those tasks. It is important, therefore, to understand what tasks need to be accomplished to ensure the appropriate system is selected, according to Vincent Hauville, director of product management at Enablon. The main tasks include: compliance with classification and labelling systems, such as GHS, CLP and the like; onsite hazardous materials management, for example substance registration and tracking chemicals by hazard class, to meet the reporting requirements of regulations such as TSCA; and compliance with REACH and REACH-like regulations that are tied to volumes manufactured and imported. Because of different demands, companies tend to use different software solutions for research and production facilities. For research facilities, the first requirement, relating to classification and labelling, can be met using a barcodebased inventory management system that enables centralised chemical tracking. Such systems can be located on site or used as a software-as-a-service (Saas) (on-demand or cloud-based) system. They provide real time chemical container data from receipt to disposal for all chemicals on site, detailing quantity and storage location. Biovia’s Cispro program is designed to ensure that the
Chemical Watch | Global Service Providers Guide 2015
second requirement, regulatory reporting, is also met; a feature the company claims is unique. Cispro compiles the data required for global environmental and right-toknow regulations while other chemical management tasks are being performed. This enables accurate reports to be generated when required, according to Biovia’s Mr Stafford. Some of the reporting requirements, such as average total quantity per day per chemical, would be difficult to meet without digital tracking of chemical use data. “It is also important to note that for multinational companies, the use of the same chemical inventory management system for all sites across the globe is the most efficient approach,” he says. To meet the chemical management tasks required by REACH, however, the above-described chemical inventory management systems are inappropriate, because they are designed to track laboratory use and not the shipment of materials. For compliance with REACH and similar regulations, product formulation data and chemical container data generated by operation planning, manufacturing and logistics systems are needed for efficient global supply chain management, according to Biovia. In general, effective software systems can help companies secure rapid growth in new regions and markets and accelerate the speed of innovation with integrated processes that drive rapid time to market while ensuring product safety and stewardship throughout the entire product lifecycle, according to Marko Lange, solution manager at SAP. “Many companies today wish to have business intelligence solutions relating to chemicals management. These can include software functionalities such as dashboards and customisable views of various metrics that can be used for administrative, or operational or functional purposes, such as risk assessments or chemical quantities by hazard,” says Jerome Marinkovic, chief marketing officer with Chemwatch (Australia). He also notes that chemical approvals with customisable work-flows are very important, because each approval involves several aspects, such as financial, environmental, and safety and health. More specifically, according to Enablon’s Mr Hauville, software systems can help companies address many different key business needs, including:
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IT Solutions
qualified people, many of whom are overseas, and often in India, according to Mr Leyden. The shortage of talented and experienced people will become an even bigger issue in the US in the not too distant future when many regulatory affairs and product stewardship specialists are due to retire. Companies will lose a major portion of their experience and knowhow within a short period of time. Mr Leyden believes companies should be preparing today. “There is too much short-term thinking, rather than interest in investing for the long term. Companies really should be looking for bright people with chemistry, chemical engineering, and toxicology degrees and training them,” he asserts.
IT Solutions Page 24
Chemical Watch | Global Service Providers Guide 2015
Chemical Watch | Global Service Providers Guide 2015
health and safety, and quality management,” he notes. Chemwatch’s Mr Marinkovic adds: “The ability to interface, or integrate, is becoming more and more important as large enterprise resource planning providers have stabilised their technologies. As a result, web service application programming interfaces is something that nearly everyone asks for, even if they are not immediately ready to integrate.” One of the main benefits of using integrated software solutions is the avoidance of data duplication. “An integrated, centralised solution that can provide visibility for the same data to all business units helps ensure that the same data is used by everyone,” says Stafford. Having centralised access to the same data across the entire enterprise or having “one version of the truth” is very important, agrees Enablon’s Mr Tesler. Currently there are only a few software companies that offer comprehensive platforms for sustainability, EHS, and risk management, product stewardship and compliance. “Software systems from these vendors each use a unified and common database, data format and data model across all business solutions that are part of the same platform. Customers simply decide which specific applications or modules to purchase and enable,” Mr Tesler explains. Johnson Matthey is one company that is moving towards using a single tool to manage purchasing, sales, R&D, production and compliance. This project is long-term. “Integration with enterprise resources planning systems at realistic cost will be a key enabler for the future,” says Mr Raffray. Celanese has found that close communication between regulatory, commercial, manufacturing and procurement benefits the company, but fully integrated systems are not yet available, according to Dr Brondsema. “The challenge,” he says, “is to develop an overarching software solution that can work with multiple large incumbent systems, but if achieved, such a program would facilitate fast and accurate decisions.” There is also large demand for quality tools that are not designed specifically for use with SAP systems, because most smaller companies do not use this type of business management software, according to CEHTRA’s Dr Thomas. One example is the development of fit for purpose e-SDS tools, which he believes is a massive challenge. The utility of more advanced software systems, however, largely depends on the accuracy of the data. “Industry’s demand for accurate data and comprehensive, innovative solutions has never been greater,” says Uday Virkud, CEO and president of 3E Company. “Properly applied and managed, data and technology can have a dramatic impact on the bottom line, ultimately helping companies mitigate risk, increase workplace and employee safety, achieve compliance, and avoid costly fines and penalties,” he adds. As a consequence, software providers need to evaluate the quality of the data flowing through their solutions, as do the companies that use them. From the collection, creation, validation, and distribution of compliant documents, through the use and eventual disposal of products, data addresses multiple compliance tasks in the enterprise and it can add value across and within companies and industries, according to Mr Virkud. “Software is only as good as the data that flows through it,” he asserts. Two challenges associated with data collection relate to product composition information and regulation tracking, according to Dr Brondsema. “Current systems for raw material procurement, manufacturing records and product records frequently do not include chemical compositions
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IT Solutions
ensuring compliance with product and chemicals regulations around the world, calculating volumes of chemical substances throughout an enterprise, and throughout entire product lines, in order to comply with regulatory reporting obligations; OO determining the compliance status and marketability of products in different countries; OO determining the physical and chemical characteristics and classifications of materials procured from suppliers; OO providing timely and convenient access to safety data sheets and critical health and safety information on chemicals; and OO authoring safety data sheets in a way that saves time and costs, and reduces risks of inaccuracies and noncompliance. Many organisations still manage these various tasks manually, spending considerable time and effort tracking chemical data and double-checking the data for accuracy, according to Biovia’s Mr Stafford. “There are IT platforms available today that accommodate a variety of different systems for managing chemicals throughout the product development and distribution life cycle. Digital solutions can streamline and expedite these tasks considerably whilst also ensuring real time, accurate data and reports,” he adds. Mr Hauville from Enablon observes that these various needs are addressed by: OO providing access to SDS data on materials and regulatory content on substances; OO analysing the full composition of products, calculating volumes of chemicals at various levels, for example enterprise, business unit, country, individual plant, and screening chemicals using regulatory lists; OO calculating substance volumes through the use of inventory data on materials and products, and through roll-up of quantities using composition information; OO obtaining updated SDSs from suppliers; OO storing SDSs electronically; and OO automating the SDS creation process. SaaS systems, or cloud-based solutions, represent the latest evolution of chemical management software. Whilst on-premise software still dominates, most software providers also offer an SaaS option. “The increasing use of SaaS solutions is one of four main trends occurring in chemicals management and control software development,” says Philippe Tesler, CEO of Enablon North America. The other three include: the convergence of chemical management functionalities under a single solution or platform; increased integration of chemicals management software with the software controlling other business processes; and the growing use of mobile devices. “Over the past several years, IT and business process complexity has grown significantly and has reached a critical limit,” asserts SAP’s Mr Lange. “We see many companies now standardising and harmonising on a single platform, unless a best-of-breed application delivers very compelling business benefits which can overcome the cost savings derived from simplification,” he says. Companies are in fact realising increased efficiency by investing in comprehensive and complete solutions that provide all functionalities as part of a single platform, rather than using disparate systems, according to Mr Tesler. “Similarly, chemical management solutions are being more integrated with solutions that cover other business functions in the enterprise, such as supply chain management, enterprise resource planning, environmental, OO
IT Solutions
at the level needed for regulatory compliance,” he notes. In addition, the pace at which new regulations are introduced globally is a challenge, particularly in countries with a smaller chemical industry, which results in a smaller group of professionals from which to draw. SDS programs can also be limited, according to ReFaC’s Ms Green. For example, she says they often are not updated to reflect the latest Echa guidance and requirements, which change regularly; those that do carry additional costs. Dr Drohmann of Chemservice agrees that satisfactory IT systems for extended safety data sheets remain elusive. Online systems for REACH registrants also do not typically reflect the current status of the Regulation, according to Ms Green. “For example, it may be that a preregistration number for a substance is required to log on to an information sharing site for a Sief, but if the substance is a new substance to your business and you intend to register via an Article 26 duty to inquire dossier, no preregistration number exists,” she says. Because there are issues with some of the data in many software systems, Ms Green also finds that most IT system outputs still require audit/correction by a competent person before being used. On a positive note, Dr Drohmann points to significant improvement in some REACH tools in recent years, such as the development of more databases and modelling approaches for use in Echa’s chemical safety assessment and reporting (Chesar) tool. For some, assessing the performance of chemical management software systems is premature, because the systems are so new and constantly evolving. A global speciality chemicals manufacturer, for example, uses Qsar software and software for the preparation of safety data sheets, both of which are immature. An expert at the company adds that SDS software is difficult to assess because of the complexity of safety data sheets and in part because the output from the software must be processed by users with experience and knowledge of chemicals. Data security is another challenge facing chemical management and control software system developers. On-premise solutions are typically deployed behind the organisation’s firewall to ensure data security, which addresses most concerns. On-demand systems can also be extremely secure as well, according to Biovia’s Mr Stafford. “Most Saas solutions incorporate data encryption technology, intrusion detection, malware protection, firewalls, two-factor authentication, and more, as part of the service and are delivered by highly secure ISO 27001 compliant server centres,” he explains. Identity Management (Single Sign On) is the latest trend being mass-adopted, according to Chemwatch’s Mr Marinkovic. For Dr Drohmann, the challenge with respect to security is finding a reliable partner to manage the systems, but at the same time ensuring access to the data is restricted. “Protection of confidential business information is a crucial issue,” agrees Enablon’s Mr Hauville. User access controls need to be considered so that only authorised people can gain access and their access level is geared to their role. Some may have read-only access or read/ write access, while others might need the ability to assign or approve tasks, or edit regulatory content. Further, companies need to think about how to control access for one site or business unit versus the entire organisation. Ensuring the security of mobile devices is equally important, including both access to the device and secure data transmission. Interestingly, along with the evolution of chemical management and control software to on-demand, integrated systems, there has been a general shift in Page 26
interest away from customised IT solutions to off-theshelf packages that can be configured by the user. Most of Chemwatch’s large, multinational clients have some bespoke requirements, but the vast majority can be met using configurable systems combined with some advanced training and support – an approach that was not possible in the past, according to Mr Marinkovic. “We have found that the only true sustainable solution is to purchase a system from a company that has a proven track record with a successful product that comes with some user-configurable functions,” says Biovia’s Mr Stafford. Arguments in favour of off-the-shelf systems, according to Mr Tesler from Enablon, include: automated and easy updates by the software developer in response to changing regulatory requirements; the incorporation new or changing industry best practices; one annual fee versus ongoing costs for internal IT staff; and possibly external support. Celanese has come to the same conclusion, according to Dr Brondsema. “With off-the-shelf systems, upgrades and updates are easier and cheaper to implement, while customised systems are more expensive to acquire and maintain,” he comments. It should be noted, however, that not everyone has come to prefer off-the-shelf systems. “We are aware of publiclyavailable software but principally rely on a tailored in-house system that we enhance as needed,” says Ms Nutini from Axalta Coating Systems. In most cases, Dr Drohmann finds off-the-shelf software to be less flexible and designed for specific tasks only. However, he says larger companies may prefer such an approach in order to allow standardised data exchange between different systems. On the other hand, he believes that bespoke software better integrates with company work flows, and the flexibility of such software enables smaller companies in particular to more rapidly adapt to changing needs. Quick responses to the constantly changing regulatory environment are required by all companies that use chemicals. As a result, the trends toward cloud-based and more integrated systems, particularly with supply chain data and risk management systems, and the increasing use of mobile devices will continue going forward. “As regulations continue to increase in number and complexity, it will become ever more challenging for companies to ensure product and chemical compliance with using cloud-based systems, because they need to exchange information relevant to compliance with business partners and respond to rapid regulatory changes. On-premise software will most likely be too slow and too private for an automated exchange of large quantities of data,” says SAP’s Mr Lange. Enablon also expects to see greater use of industry portals to increase the efficiency of the purchasing process for companies that source from multiple suppliers. Purchasers want the ability to automatically import data to their own systems. “We also expect to see movement towards a more holistic approach to the management of suppliers and materials, with the adoption of one management system for chemicals, manufactured parts, and so on,” says Enablon’s Mr Hauville. Substitution simulation scenarios will also be more widely used as companies look to identify materials that should be phased out or replaced to ensure the quality, sustainability and compliance of their products. “One important aspect of new REACH and REACH-like regulations is the influence of the supply chain,” Mr Lange says. “The more these types of regulations occur and the more supply chains globalise, the more endangered the Chemical Watch | Global Service Providers Guide 2015
Drohmann also hopes that more software systems will be based on scientific approaches that are recognised by the authorities, for example. cross-reading of mandatory data endpoints. Companies developing these more advanced chemical management and control software systems include Actio, Biovia-Dassault Systèmes, Chemwatch, Decernis CGI, Enablon, Enhesa, IHS, Lisam, QEHS Management; Safetec UL, Safeware Quasar, SAP, SiteHawk and 3E Company.
ALTERNATIVES TO ANIMAL TESTING
Regulatory acceptance key for alternatives to animal testing It has been recognised for many years that the use of animals for testing the toxicity of chemicals presents many problems. In Europe, the use of animals for the testing of cosmetics products was banned in 2004 through the seventh amendment to the cosmetics Directive. In 2013, the marketing of cosmetics tested on animals was also prohibited. REACH also strives to minimise animal testing, and registrants may only carry out new animal tests when they have exhausted all other relevant and available data sources In the US, the Animal Welfare Act and the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals require that alternatives be considered before using animals for research and testing. In addition, the NIH Revitalisation Act of 1993 requires the US National Institutes of Health (NIH) to reduce, refine, and replace animal use in biomedical research and develop and validate methods that will reduce and replace animals in acute and chronic safety testing. The US Environmental Protection Agency (EPA) is an active member of the US Interagency Coordinating Committee on the Validation of Alternative Methods (Iccvam), which was created to facilitate the development, validation, and regulatory acceptance of new and revised toxicology test methods that reduce, refine, or replace animal use in testing. Despite the recognition of the need for alternative test methods, however, their adoption and implementation is slow as risk assessors and regulators need to ensure the new tests are effective. There is a great market demand for in vitro and in silico alternatives to in vivo testing, according to Scott Hickman, marketing manager for toxicology with BioReliance. He notes that BioReliance has seen a greater than 60% increase in demand for in vitro testing services. The drivers for alternatives to animal testing are numerous. First are the ethical concerns associated with animal testing, and there is a general and widespread understanding that animal testing should ultimately be eliminated. Many companies, and particularly those in Europe, have adopted the “reduce, refine or replace” approach, according to Paul Brooks, head of discovery research services for BioReliance. This approach involves using test methods that require fewer animals, lessen or eliminate pain or distress, or replace animals with non-animal systems, such as computer models or cell-based systems, or use less highly-developed species. Second, according to Agathe Devaux, business development manager at Celenys, a biotechnology company offering 3D cell culture and scaffolds for testing applications, the use of animals is very costly and animal Chemical Watch | Global Service Providers Guide 2015
testing is highly regulated. Third, and perhaps most importantly, animal models often do not provide satisfactory correlations with humans and frequently are not good predictors of responses in human beings. A telling figure for Stephen Minger, chief scientist for cellular sciences with GE Healthcare Life Sciences, is the 80-85% of promising drug candidates fail at the preclinical testing stage due to toxicity. “These candidates progress through early development stages because initial animal test data suggest they are safe. In many cases, however, the animal models are inaccurate, or the drug suffers from dose-dependent toxicity, which is not identified by animal testing. Alternative human cell-based tests that more accurately identify problems much earlier in the drug development process are clearly needed,” he says. Awareness of alternative test methods appears to be greatest in the pharmaceutical and cosmetics industries, the former given the need to increase drug development efficiencies and the latter due to regulatory requirements, particularly in Europe. Many companies in industries outside of these sectors, whilst perhaps slower to adopt alternative testing methods, are increasingly familiar with them and the advantages they provide. A global speciality chemicals manufacturer is interested in alternative testing methods for all of the reasons outlined above. Legislative constraints, the increasing attention paid to animal suffering and the improved effectiveness of in vitro and in silico tests are all valid points to consider, according to a company expert. Johnson Matthey’s Mr Raffray adds that there appears to be increasing business acceptance of in vitro and in silico alternatives as useful initial assessment tools, particularly at the R&D stage of projects, for filtering out high hazard technologies with lower prospects of market success. Examples are the recently-released in vitro OECD test guidelines for skin sensitisation (DPRA and KeratinoSens) assays. Despite the high level of awareness of alternatives to animal testing, the actual replacement of animal testing has been slow to occur. Even in the pharmaceutical industry, which is a leader in the development of alternative test methods, companies tend to be fairly conservative and hesitate to adopt any new technologies, according to Dr Minger. “There are many, many years of data obtained using existing methods, and companies do not want to lose this data or risk regulatory approvals,” notes Dr Devaux. The same is true for toxicologists across most industries, according to Mr Hickman. “Many companies are still using in vivo methods because that is what they have always Page 27
Alternatives to animal testing
marketability of products becomes and the more supply disruptions can occur due to the need for a change in supplier or raw material. Only the combination of chemical / substance-related and logistics / business-related information systems can oversee all of that,” he asserts. Global compliance solutions software that allows workflows and approvals involving multiple stakeholders and the integration of chemical management software with inventory (RFID and barcode) data can all be expected as a result, according to Chemwatch’s Mr Marinkovic. Dr
Alternatives to animal testing
done. It is a box to check along the development process. The toxicology market has always been a slower adopter of change, and if a toxicologist knows he or she can trust a data set, it is easier not to try something different,” he says. The most significant barrier to real uptake of alternative testing methods for REACHWise’s Dr Douben is knowing when and how they will satisfy the regulators. Dr Richards of Linmark Consulting, agrees that the speed of adoption of alternative test methods is limited by how quickly they can be validated and accepted by regulators. In addition, according to ChemSafe’s Dr Cantavella Cabedo, the acceptability of alternative tests varies significantly from country to country, which can inhibit their use for products that are marketed globally. Mike Mitchell, marketing manager, Admet (absorption, distribution, metabolism, excretion and toxicity testing) for BioReliance agrees that there is a lack of clear guidance on how chemical manufacturers should proceed when in vivo testing is absolutely necessary to resolve the hazard identification for a chemical. Dr Douben believes alternative tests would be more widely used if regulators would provide clear examples. Dr Devaux believes that a few leading examples of companies that have adopted alternative approaches to animal testing are needed to demonstrate that regulatory requirements can be met, and only then will others follow. “Testing companies must provide evidence that their alternative methods are as good as or better than existing animal models and that the results will be acceptable to regulatory bodies. That will not take place overnight. In fact, it will take time, energy and commitment,” asserts Dr Minger. He is confident, however, that the regulations will ultimately change. There are challenges associated with the test methods themselves that cannot be ignored. Truly predictive tests may not be feasible in some cases, according to Dr Stanton of SCAS Europe. In particular, making predictions for complex and multi-system endpoints such as reproductive toxicity has yet to be demonstrated, notes Johnson Matthey’s Mr Raffray. “There is a significant challenge to developing alternatives that provide the data points customers need; the question remains whether in vitro testing could ever fully replace in vivo testing because of the predictive quality,” Dr Brooks adds. The available alternative toxicity tests for chemicals are, in addition, validated only for a few endpoints, which Fobig’s Dr Schneider believes is limiting their practical application. The OECD, which develops harmonised test methods for chemical safety and good laboratory practice, has published eight test guidelines that consider the welfare of animals, including three tests (two for toxicity and one for skin sensitisation) that involve reduced animal use, and five in vitro tests, including a mammalian cell micronucleus test, a test for the detection of oestrogen receptor agonists and antagonists, a cellbased steroidogenesis assay, skin irritation and corrosion tests using human epidermis models and an assay for genotoxicity testing. Five draft in vitro test guidelines are also available, including two cell transformation tests, a recombinant oestrogen receptor alpha binding assay and an assay for the detection of androgenic and antiandrogenic activity. There is also a sixth draft guideline on the use of cytotoxicity tests to estimate starting doses for acute oral systemic toxicity tests as a method for reducing animal testing. In the US, Iccvam has reviewed more than 185 alternative test methods, but recommended alternatives for only the four most commonly-used product safety tests,
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namely for acute lethality, sensitisation, and skin and eye corrosion. The EPA also recommends a selection of tests for its high production volume testing programme that can significantly reduce the number of animals required. According to the agency, if traditional acute, reprotoxicity, developmental and 28-day repeated dose toxicity studies and an in vivo micronucleus test were separately employed for a given chemical, a total of 440 animals might be used. Its recommended alternative approach – up-and-down toxicity test (OECD 425), combined reproductive and development toxicity protocol (OECD 421), 28-day repeated dose testing using the endpoints for oral toxicity test (OECD 407) combined with the toxicity screen in OECD 422 and using the males from OECD 422 for mammalian micronucleus testing – may reduce the number of animals used to as low as 118, savings of 322 animals. Most contract research organisations and testing laboratories do offer some types of alternative testing methods. “At BioReliance, we offer guidance to customers on what they need to use, how they need to screen, and how they can predict what to do down the line in their production stages,” says Dr Brooks. The company has collaborated with various industry groups, for example it worked with Cosmetics Europe to develop in vitro models such as the 3D skin micronucleus assay for cosmetics testing on simulated skin. Also it has found ways to drastically reduce animal use from the hundreds to the tens when in vivo tests are still required, according to Mr Mitchell. “We are trying to help customers overcome the frustration of knowing that they cannot or should not use in vivo models, but not having access to a properly-validated alternatives,” he states. Given the European legislation banning the use of animal testing for cosmetics products, it is not surprising that outside of the pharmaceutical industry, cosmetics firms are leading the way in the development of alternative testing protocols. L’Oréal has two validated skin models, Episkin and RHE by SkinEthic, for the evaluation of skin irritation and corrosion. Also, it has received pre-validation in 2010 for its reconstructed eye cornea model for the evaluation of eye irritation. In addition, in September, 2014 L’Oréal was granted a Chinese business licence for Shanghai Episkin Biotechnology, which will market its Chinese Episkin skin models reconstructed from Asian keratinocytes. The company is also currently validating alternative tests to evaluate skin allergies using skin sensitisation tests. L’Oréal is a founding member of the European Partnership for Alternative Approaches to Animal Testing (EPAA) and plays an active role in the European Union Reference Laboratory for alternatives to animal testing (EURL Ecvam), which validates methods that reduce, refine or replace the use of animals for safety testing and efficacy and potency testing of chemicals, biologicals and vaccines. The company also promotes the development and dissemination of alternative methods and approaches, their application in industry, and their acceptance by regulators. It has funded a three-year doctoral course to validate the applicability of the US EPA’s ToxCast screening tool based on over 700 in silico tests through comparison of calculated results to actual data in L’Oréal’s scientific database of 5,000 ingredients. One of the challenges the company faces is developing skin models that represent the diverse array of skin types, not only from different ethnic groups, but also different ages, disease states, and so on. The company is also
Chemical Watch | Global Service Providers Guide 2015
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Chemical Watch | Global Service Providers Guide 2015
Alternative methods (Jacvam) and the European Centre for the Validation of Alternative Methods (Ecvam). Also in the US, the Johns Hopkins University Centre for Alternatives to Animal Testing (Caat), which was founded in 1981, promotes humane science by supporting the creation, development, validation, and use of alternatives to animals in research, product safety testing, and education. Members of Caat are also involved in the Transatlantic Think Tank of Toxicology, or t4, which was established to help implement the recommendations of the June 2007 report Toxicity Testing and Assessment in the Twenty-first Century: A Vision and a Strategy, which was published in by the National Academy of Sciences (NAS) and indicated the need to shift from whole-animal based systems to testing founded primarily on in vitro methods, human cells in culture, in silico biokinetic modelling, and mechanisms of toxicity as understood through systems biology.
SERVICE PROVIDERS
Outlook for chemicals management and control service providers Service providers in 2014 report being very busy responding to Echa decisions on existing registrations. Some had clients preparing for the 2018 REACH registration deadline. REACH-like regulations around the globe and product-specific regulations in many different countries created significant demand as well. The management of numerous GHS-related compliance projects also figure high in the workload. Expenditure on outsources chemicals management and control services in 2014 was measured in the Chemical Watch survey. The 273 respondents who are purchasers of services invested on average approximately €1.24m on outsourced services within their teams, and €2.50m within their companies. This equates to a yearly expenditure of €340m within the teams and €683m within companies. Alongside this, an increasing proportion of work – some 74% – is being performed by in-house teams. Toxicity and other test data are required for most regulations underpinning this work. Not surprisingly, then, laboratory testing remained the largest type of outsourced service in 2014, accounting for 29% of the total spend on external services by respondents to the Chemical Watch survey [Figure 13]. However, this number is significantly lower than the 47% figure reported in 2013 [Figure 14], which was most likely high due to the work being completed in advance of the 2013 REACH deadline (although a difference in the sample year to year can also explain variations). Consultancy services have been used less extensively by survey participants in 2014, with the share at 12.1% versus 27% the year before.
Chemical Watch | Global Service Providers Guide 2015
Figure 13 SERVICES RETAINED BY PARTICIPANTS, BY VALUE Other services 7.1% Training 12.4%
Consultancy 12.0% Representation & management 3.9% Legal 3.4%
Information 13.5%
IT & software 20.0%
Laboratory 27.7%
The drop in laboratory use was countered by an increase in share for other services; the demand for training increasing from 8% of the total last year, to 12% in 2014, and that for IT support tripling from 7% to 20%. In addition, the share of “other services” was greater by almost a factor of ten in 2014 compared to 2013 (7.1% versus 0.8%). It should be noted that the relative high demand for laboratory services peaked in 2013, although the share in total spend by the respondents using laboratory services is still higher in 2014 than in 2010. The higher level of training in 2014, however, is the highest yet and may reflect an increased level of demand from companies preparing for
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Service providers
working to develop a model of reconstructed skin with hair to more accurately represent underarm and scalp skin. Work is also under way to develop high throughput analysis systems using much smaller models, which will speed up testing and reduce the quantity of cells required. It is also worth mentioning that the US government actively supports the search for alternative testing methods through the National Institute of Environmental Health Sciences (NIEHS), which operates under the National Toxicology Program Interagency Centre for the Evaluation of Alternative Toxicological Methods (Niceatm), and Iccvam. The Scientific Advisory Committee on Alternative Toxicological Methods (Sacatm) also advises Niceatm, Iccvam, and the Niehs. Iccvam coordinates activities within the Federal government relevant to new test method evaluation, acceptance and use and facilitates international collaboration on the development of alternative test methods through participation in the International Cooperation on Alternative Test Methods and the Test Guidelines Programme of the OECD and through interactions with the Japanese Centre for the Validation of
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Chemical Watch | Global Service Providers Guide 2015
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Special Services
Industrial Chemicals – REACH
the 2018 REACH registration deadline. The shifts in the use of chemical management and control services may also reflect the growing use of more specialised consultants to support a core staff of general experts.
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47%
8%
6% 7%
5% 3%
24%
26%
27%
8%
30%
3%
2011
2012
2013
36%
70% 7%
60%
12%
50%
14%
40%
20%
28%
27%
25%
30%
13%
15%
20%
10%
12%
10%
15%
12%
0%
2010
3% 4%
2014
Other services
Laboratory
Training
Legal
Information
Representation & management Consultancy
IT & software
35%
80%
12%
0% 2010
90%
The complexity of the regulatory environment is also having a significant impact on the use of in-house staff. At Johnson Matthey, for example, the rate of change and importance of global chemicals control regulations has led the company to recruit additional regulatory and toxicology experts to its corporate group product stewardship team. Dr Brondsema of Celanese adds that the growth of Asian regulations is increasing the need for experienced staff. “This increasing complexity on a global scale, combined with the growing number hazard communication deadlines with REACH and GHS, is creating a need for us to streamline routine work. Reducing the time needed for routine tasks allows our experts to focus on more complex projects,” he says. Indeed, the amount of work completed on average by in-house teams is slowly trending upward, according to the Chemical Watch survey; on average the percentage has increased from around 62% in 2010 and 2011 to around 74% in 2014. “We are mindful of the evolving regulatory landscape and assign our in-house resources accordingly to continue to manage regulatory monitoring and compliance,” notes Axalta’s Ms Nutini. It is also possible that the difficult economic conditions in much of Europe and the slower-than-expected recovery worldwide may be reflected in the higher rate of in-house spending. Also reflecting the increasing complexity and quantity of regulatory requirements, companies continue to move more toward the use of separate compliance divisions rather than using an integrated management approach.
Chemical Watch | Global Service Providers Guide 2015
2011
53%
49%
53%
25%
31%
28%
8% 6% 8%
8% 4% 7%
7% 5% 7%
2012
2013
2014
80-100%
60-80%
20-40%
0-20%
40-60%
Johnson Matthey is a prime example. In addition to adding corporate product stewardship staff in 2014, a number of the company’s business groups also increased product stewardship and regulatory affairs head-counts in 2014, according to Mr Raffray. In fact, 29% of Chemical Watch survey respondents reported that their companies are separating compliance responsibilities compared to 21% who are integrating compliance activities with overall management responsibilities [Figure 16]. Figure 16 INTEGRATION CHANGES AT SURVEY RESPONDENTS OVER THE LAST FIVE YEARS Move towards general management 21% Remained the same 50% Move towards separate compliance divisions 29%
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 (32-55%), rather than on a frequent (6-28%) or a permanent (0-11%) basis [Figure 17]. In 2014, consultancy, laboratory, training, information services and IT are the most likely to be used on a frequent or permanent basis by survey participants.
Page 33
Service providers
CHANGES IN THE PROPORTION OF SPENDING ON PROVIDER SERVICE TYPES
90%
PERCENTAGE OF CHEMICAL MANAGEMENT WORK PERFORMED BY IN-HOUSE TEAMS 100%
Figure 14
100%
Figure 15
Service providers
Measuring the level of satisfaction with service providers On a positive note, it appears that service providers did a better job of meeting client expectations in 2014, at least for respondents to the Chemical Watch survey; there is an uptick in the level of satisfaction for the first time in the last four years that the survey has been conducted. From 2010 to 2013, the percentage of satisfied respondents steadily declined from 88% to 71%, but increased slightly in 2014 to 72% [Figure 18]. The number of dissatisfied survey participants remain quite low at 2%, however the number of survey respondents that consider themselves neither satisfied nor dissatisfied also remained the same at 26%, which means that significant improvements are still required. More detail can be seen in Figure 19, which shows a comparison of the satisfaction levels of Chemical Watch survey participants in 2014 and 2013 for specific performance areas. Satisfaction has increased in several areas. Survey respondents are quite a bit happier with: the ability of service providers to add value beyond the agreed deliverables and pricing in 2014; and slightly happier about provider experience with country regulations and flexibility; and their value for money. However, survey respondents are significantly less satisfied with: provider availability and technical knowledge; and their ability to establish personal relationships; and meet schedules and briefs.
FREQUENCY OF SERVICE RETENTION BY SURVEY PARTICIPANTS
11%
29%
44%
9%
90%
3%
2%
2%
2%
19%
25%
27%
26%
78%
73%
71%
72%
2011
2012
2013
2014
80% 70% 60% 50% 40%
88%
30% 20% 10% 0% 2010
Dissatisfied
Neither
Satisfied
6% 11% Legal services 6% 12%
52%
Laboratory 28%
39%
IT & software solutions 19%
35%
Information services 25%
41%
Training 24%
55%
Other services 6% 0% Permanent
40% % of participants Frequent
Occasional
61% 57%
58% 61% Experience/knowledge in all countries in which you operate 44% 39% Offering flexibility 48% 45% Adding value on top of agreed deliverables 38% 31% Technical knowledge 67% 68% Providing value for money 44% 41% Price of service 31% 31% Delivering on schedule 57% 56% Meeting your brief 64% 64%
32%
8%
SATISFACTION LEVELS IN 2014 AND 2013
Personal relationship
Representation & management
4%
3%
100%
Availability
Consultancy/advisory
8%
CHANGE IN OVERALL SATISFACTION LEVELS FOR SURVEY RESPONDENTS
Figure 19
Figure 17
11%
Figure 18
100%
0% 2013
% of participants satisfied
100%
2014
Looking more closely into the question of pricing, the trend to lower satisfaction levels observed in the Chemical Watch survey in 2012 and 2013 has been halted in 2014. The percentage of survey respondents satisfied with the price they paid for external chemicals management and control services has increased by one point to 31%, while the Page 34
Chemical Watch | Global Service Providers Guide 2015
Service providers Chemical Watch | Global Service Providers Guide 2015
Page 35
Service providers Page 36
Chemical Watch | Global Service Providers Guide 2015
Figure 20 SATISFACTION LEVELS OF SURVEY PARTICIPANTS WITH PRICES CHARGED FOR SERVICES Dissatisfied 12%
Satisfied 31%
experience on similar projects are the top three factors driving the choice of external service providers [Figure 22], with expertise being the most important criterion. Interestingly, these three factors are also identified as the most important in 2013. Also the same as in 2013, proposal quality and provider availability are important to over 50% of respondents, whilst the ability to operate on a global scale and having appropriate certifications are characteristics of good service providers for over 40% of participants. “Service providers that have consistently offered a high quality of service have remained in business despite the financial pressure on them. In addition, whilst things may go wrong, such as unexpected additional requirements or an increase in the cost of a project, we have found that being transparent and honest is the key to a positive relationship with our clients,� says Peter Douben of REACHWise. Figure 22 STRONG RELATIONSHIP MOST IMPORTANT FACTOR FOR SURVEY PARTICIPANTS
Neither 57%
Expertise of key staff With overall satisfaction levels general better than 2013, in 2014 slightly fewer participants in the Chemical Watch survey are indicating that they might change their current service providers, with 47% saying they have no plans to change, compared with 44% last year [Figure 21].
84% Proven experience on similar projects 79% In-depth knowledge of country specific regulations 70%
Figure 21 INTEREST LEVEL OF SURVEY RESPONDENTS IN CHANGING SUPPLIERS
Comprehensiveness/accuracy of proposal 55% Availability
100%
49%
90%
Ability to operate on a global scale
80%
46%
39%
70%
47%
44%
43% 47%
Appropriate accreditation/certification 40%
60%
Contract price 34%
50%
Recommendation from peers
40% 30%
48%
51%
44%
48%
46%
27% ISO9001 or equivalent (quality management)
20%
22%
10% 0%
6% 2010 No
10% 2011
In-house equipment/software 9% 2012 Possibly
7% 2013
7% 2014 Yes
The areas of significant dissatisfaction are seen in Figure 19. It should also be noted, however, that dissatisfaction is not always the driver for change. As increasing numbers of countries around the world promulgate their own chemical substance registration and product-focused regulations, some clients are switching to providers with expertise in these areas. In fact, according to the respondents of the Chemical Watch survey, the expertise of the staff, the level of in-depth knowledge of country specific regulations, and proven
Chemical Watch | Global Service Providers Guide 2015
20% Independence of supplier organisation 20% ISO14001 or equivalent (environmental management) 17% Proximity to your office 6% Large size of supplier organisation 4% 0%
20%
40% 60% % of participants
80%
100%
Page 37
Service providers
percentage of dissatisfied respondents is one point lower to 12% [Figure 20].
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Figure 23 MOST IMPORTANT RELATIONSHIP FACTORS FOR SURVEY PARTICIPANTS
expect demand for in-house staff to decrease in the next year. It should be noted, however, that the longer-term outlook in 2014 is less positive than that of respondents in 2013, when 65% expected an increased need for personnel in the next five years. Figure 24 ANTICIPATED FUTURE NEED FOR IN-HOUSE STAFF Next 12 months 10%
47%
45%
12%
46%
Decrease
28%
% of participants
Increase significantly
Building long-term relationships with individual staff
6% 1%
Next 5 years
0%
Strict adherence to project protocols
39%
Increase
11% 3%
100% Static
Decrease significantly
44% Service level agreements in place 35% Suppliers keeping costs as low as possible 25% Regularly reviewing (and at times changing) suppliers 25% Regular face-to-face meetings 22% Paying more to get better value 17% Use of penalty clauses 3% 0%
10%
20%
30%
40%
50%
% of participants
WHAT DOES IT ALL MEAN FOR THE SERVICE PROVIDER MARKET? The increasing number and complexity of regulations, the increasing growth in the jobs market for people with expertise in chemical regulations, and the continued improvement in economic conditions in most areas of the world suggests that service providers can expect a growth in demand for their services, at least through to the 2018 REACH deadline, and most likely beyond. In fact, the expectations for use of in-house staff by respondents to the 2014 Chemical Watch survey were very similar to the expectations of a year ago, with 49% anticipating an increase and 45% expecting no change in the market [Figure 24]. The survey participants also have a more positive outlook for the longer term, with 58% expecting to recruit more in-house staff and just 28% expecting no change. Less than 10% of participants
Chemical Watch | Global Service Providers Guide 2015
Interestingly, more survey respondents expect the demand 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 64% for the longer term. Several service providers have, in fact, added personnel recently in anticipation of growing demand. Companies such as Fobig and ReFaC have increased staff, largely in anticipation of the increased demand associated with the 2018 REACH registration deadline. Dr. Knoell Consult is also continuously adapting its capacities and capabilities to meet changing demands, according to Dr Cleuvers. That includes expansion on a global level to meet the growing need for compliance with country-specific regulations outside of established initiatives, most notably REACH. Others have chosen to continuously develop and hone their expertise, rather than add personnel. “As REACH has moved from the dossier submission stage to the evaluation and regulation stage, we are evolving as well in order to provide a good service in all of the new areas,” says SCAS’s Dr Stanton. At CEHTRA, the approach has been to retain staff through lean and growth periods, and as a result the company says it now has a highly-efficient team of people with at least several years of experience. “The result has been a positive effect on dossier turnaround time and so, despite increasing demands over the last three years since a rather poor 2011, we have not made dramatic changes to our staffing levels,” says Dr Thomas. On the other hand, he notes that CEHTRA has also continuously improved its working practices in order to make project teams work more smoothly and efficiently. It is also worth noting that while companies see higher short term growth, longer term expectations are slowing. The percentage of respondents expecting more use of external services in the short term is slightly higher in 2014 compared with the results obtained in 2013. But the percentage of respondents to the Chemical Watch survey that expect to see an increase in demand for external services in the long term is less than that in 2013 (54% versus 62%). This reduction may reflect the fact that much of the service provision market is currently driven
Page 39
Service providers
Respondents to the Chemical Watch survey agree that the ability to establish a strong connection between the client and service provider is critical to the successful completion of projects. The dissatisfaction of Chemical Watch survey respondents with this characteristic of their service providers [Figure 19] is a telling statistic that service providers should investigate. Of course, such relationships can take many forms. For survey participants, the ability to build long-term relationships with individuals at their service providers and strict adherence to project protocols are the two most important factors by far for ensuring success (44% and 47%, respectively) [Figure 23]. Having service level agreements in place is also important for 35% of survey participants.
Service providers Page 40
Chemical Watch | Global Service Providers Guide 2015
by REACH, and the final registration deadline will be passed within that five year period. “We recently reduced two positions to address the decline in work following the 2013 REACH deadline. At this point we are waiting for new project gains before we determine if we will need to expand staff as the next REACH deadline approaches,” says Toxicon’s Mr Martucci. Figure 25
Figure 27 ANTICIPATED NEED FOR EXTERNAL SECTOR SERVICES BY SURVEY PARTICIPANTS IN THE NEXT FIVE YEARS Consultancy/advisory
ANTICIPATED FUTURE NEED FOR EXTERNAL SERVICES
33%
60%
Next 12 months
7%
Representation & management 49%
40%
57%
33%
5% 1%
10%
Legal services Next 5 years
52%
43%
11%
53%
28% 7% 1%
Laboratory 35%
57% 0%
100%
% of participants
Increase significantly Decrease
Increase
Figure 26 ANTICIPATED NEED FOR EXTERNAL SECTOR SERVICES BY SURVEY PARTICIPANTS IN THE NEXT 12 MONTHS Consultancy/advisory 4%
Representation & management 64%
7%
Legal services 35%
61%
3%
Laboratory 48%
46%
6%
IT & software 53%
43%
4%
Information 60%
38%
2%
Training 55%
41%
4%
Other(s) 12% 0% Increase
86%
3%
% of participants Static
3%
Information
For those Chemical Watch survey participants who will be using external services over the next 12 months, additional assistance will be needed across many service categories [Figure 26]. In fact, 60% of survey respondents indicate they would need greater assistance with information management, whilst over 50% of respondents expect to use more training, IT/software and consultancy services.
29%
32%
28% 3%
69%
45%
8%
IT & software 65%
Static
Decrease significantly
51%
5%
Decrease
Chemical Watch | Global Service Providers Guide 2015
100%
Training 32%
63%
5%
Other(s) 81%
17% 0% Increase
% of participants Static
2% 100%
Decrease
A more granular look at the expectations of respondents to the latest Chemical Watch survey reveals several interesting patterns [Figure 28]. With respect to consultancy and advisory services, participants indicate that they will need more assistance with the interpretation of regulations (59%) and product compliance (55%), and more than 40% of respondents expect to need increased help with registration strategies, environmental risk assessment and supply chain communication. In the information services category, survey participants indicate a similar level of increased need for the tracking of regulatory developments (55%) and access to chemical hazard databases (51%). With respect to laboratory testing, the Chemical Watch survey results suggest that there will be a similar increase in the need for nearly all types of testing services. In the IT solutions area, demand will increase the most for regulatory information management solutions (54%), safety data sheet systems (47%) and substance inventory management systems (46%). With respect to training assistance, the demand for courses and webinars will increase far more (57%) than the need for other services in this category (32% or less). Notably, the areas where survey participants expect to see the greatest increase in the use of external service providers are consultancy and advisory support with respect to the interpretation of regulations (59%) and product compliance (55%), training (57%), information services related to the tracking of regulations and policies (55%), and IT for regulatory information management systems (54%).
Page 41
Service providers
5%
These same 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 28 ANTICIPATED NEED FOR SPECIFIC EXTERNAL SECTOR SERVICES BY SURVEY PARTICIPANTS OVER THE NEXT FIVE YEARS Guidance on regulation interpretation
59%
Product compliance
Service providers
Consultancy/ advisory
55%
Registration strategies
46%
Environmental risk assessment
46%
Supply chain communications
4%
48%
6%
52%
2%
53%
5%
60%
3%
Assessment of data quality
37%
Testing strategies
35%
57%
9%
SVHC advisory services
32%
58%
9%
Chemical transport and warehousing advice
28%
65%
21%
8% 11%
68%
Dossier preparation & safety assessment, including CSA/ CSR
51%
6%
52%
7%
44%
Registration services
42%
GHS notification
31%
62%
8%
CLP notification
30%
61%
9%
Management (Sief, consortium etc)
29%
64%
7%
Representation (lead, only representative, 3rd party etc)
27%
67%
6%
Representation & management
Business process outsourcing (BPO)
15% 55%
Chemical hazard database
Information
11%
73%
Regulatory/policy tracking (Material) safety data sheets
2%
46%
48%
4%
48%
42%
Exposure testing
2%
43%
51%
Managed regulatory content
3%
55%
47%
3%
51%
Environmental fate & degradation
43%
51%
6%
Human health toxicology
43%
55%
3%
Laboratory
Ecotoxicology
42%
52%
7%
SVHC testing
41%
56%
3%
Physical & analytical chemistry
35%
Environmental monitoring
7%
58%
32%
Regulatory information management
9%
59% 54%
1%
45%
(Material) safety data sheet systems
47%
50%
2%
Substance inventory management systems
46%
50%
4%
Supply chain management/ communications systems
41%
EH&S solutions
24%
Laboratory information management solutions
21%
Training courses/webinars CPD/CES certified training Lobbying/advocacy Other
Legal representatve Insurance
16%
0% Increase
7%
72%
2%
41%
6%
64%
8%
76%
32% 22%
7%
69%
30% 16%
3%
60%
57%
Bespoke/inhouse training
3%
56%
37%
Consortia/registration management solutions
Training
Page 42
4%
41%
42%
Corporate strategy/strategic planning
IT solutions
37%
5%
63%
6%
72%
5%
78%
% of participants Static
100% Decrease
Chemical Watch | Global Service Providers Guide 2015
Scientific & Regulatory Affairs Consulting REACH 2018: A Deadline not to Underestimate info@bluefrogscientific.com www.bluefrogscientific.com
Chemicals I Human Pharmaceuticals I Veterinary Medicines I Agrochemicals I Feed Additives
Concluding remarks
Concluding remarks The regulatory landscape for chemicals is continuously in flux and becoming increasingly complex. This situation is creating pressure for everyone involved – from chemical producers to downstream users and service providers. Service providers have been changing in light of these dynamics. In anticipation of the final 2018 REACH registration deadline, many providers have diversified their offerings, for example by supporting the many emerging country-specific regulations. Product specific legislation is also becoming an increasing issue that requires specialised expertise that companies often do not have, and those firms that have developed a knowledge base in these areas are expecting further growth, even beyond 2018. KFT Chemieservice, for example, has created centres of excellence for specific areas, including cosmetics, consumer goods and biocidal products, and for particular regions and countries, according to Dr Torges. The idea is to build up more detailed knowledge of the regulations and issues that surround them. “Diversification and specialisation have occurred simultaneously in order to meet the changing needs of clients, and more of both can be expected going forward,” says Dr Drohmann of Chemservice. Collaboration between service providers at a high level will also benefit clients, according to REACHWise’s Dr Douben, because they will have access to a larger set of capabilities without the need to pay for the multiple overhead costs they would incur if working with the same providers individually. The benefits of a good service provider relationship will likely be very important to product manufacturers. “At the same time that supply chains are becoming more global, we are also seeing many more regulations in emerging market countries, so there is growing need to cover even more regulatory requirements,” says Dr Cantavella Cabedo of ChemSafe. In many of these countries, however, compliance is a significant challenge, because local language skills and knowledge are important. “We have found that in some cases, global service providers are not always as efficient as smaller, domestic consultancies,” notes ReFaC’s Ms Green. The task of complying with chemical regulations can be overwhelming for some companies. “We are aware of businesses that genuinely have budget limits and there is little doubt that their substance portfolios will suffer. Many customers are facing the choice of pay or throw away and they know they cannot cover all their needs with the available budget,” says CEHTRA’s Dr Thomas. “Despite all of the efforts made on read-across methodologies, there are still too many costs involved when it comes to the testing of substances and there still are no cheap alternatives to some of the most expensive studies,” he adds. In particular, he notes that small and medium-size enterprises (SMEs) are struggling the most to cope with REACH and other regulations, and many keep delaying their serious involvement because of the cost. “It seems like some type of compromise will be needed by 2018, otherwise many of these companies will end up being noncompliant with REACH and, theoretically at least, excluded from the EU market,” Dr Thomas concludes. Of course, REACH is not the only regulation causing concern. Participants of the Chemical Watch survey highlight many other areas that are attracting their attention. Nanomaterials and endocrine disrupting chemicals
Page 44
(EDCs) are repeatedly mentioned as key issues, as are packaging and food safety regulations. Emissions from building materials, non-intentionally added substances, the handling of monomers and polymers, and issues related to textiles and apparel are additional concerns identified in the survey. Many respondents also mention more general issues, including the withdrawal of substances from the market because of regulatory requirements and restrictions, substance management activities by retailers and brand owners, and NGO campaigns. Several respondents also note an increase in political decisions that are not based on sound science. Additional concerns include: reduced competitiveness of SMEs as they direct a greater proportion of resources to regulatory compliance and away from investment in innovation; pressure from sales and marketing groups to comply, exempt, or avoid regulatory requirements; standardisation of EHS responsibilities across the entire company, rather than using an individual site-based approach; and business integration of chemical issues. Finally, respondents to the Chemical Watch survey are also struggling with the proliferation of chemical control regulations that are similar, but not identical, which complicates the work and can lead to inconsistent approaches to communication and data management across industries. In closing it is valuable to consider the challenges that a global speciality chemicals manufacturer faces with respect to the regulatory complexity of today. The company must comply with regulations related to both chemical substances and formulated consumer products. In addition, the company has grown rapidly in recent years, both internally and through acquisitions, which has created further challenges in the area of chemical regulatory compliance. In most cases, according to a company spokesperson, this manufacturer is a downstream user of chemicals and relies on its suppliers to obtain the necessary chemical inventory registrations and to inform it of their status. Unfortunately, there are many local suppliers who struggle to understand the requirements in other countries; these suppliers are in need of expert resources to provide clear and simple guidance so that they can appropriately inform their customers. The global speciality chemicals manufactorer is also a major manufacturer of polymers for use in its products and consequently submits polymer notifications in those countries with chemical control regulations. In these instances, a company spokesperson explains, greater effectiveness and efficiency has been achieved by working with local service providers in each of these countries to complete the notifications. These service providers are used because they have both detailed knowledge of their national regulations and working relationships with the authorities to assist with obtaining clear guidance. This global speciality chemicals manufacturer is supportive of appropriate legislation and regulations for hazardous chemicals in order to control risks to human health and the environment. According to a company spokesperson, well-drafted regulations with clear supporting guidance improve the efficiency and effectiveness of industry implementation. On the other hand, ill-drafted regulations with late publication of
Chemical Watch | Global Service Providers Guide 2015
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PROFILE: 3E Company
Website
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Owned by public company, Verisk Analytics
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US, Canada, Europe, Asia
Founded
1988
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
7
No of countries represented
Global
Staff, group
350+
Staff, chemical service provision
80%
SERVICE AREA BREAKDOWN
IT & software 10%
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 management and SAP Material Master. 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, multi-lingual authors. SDS Distribution – facilitates the dissemination of SDSs to all stakeholders. 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 and online 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 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/ advisory 5%
Professional services
Information 80%
Page 48
Product safety and stewardship tools and decision support
SDS authoring and distribution
OVERVIEW
Other 5%
SERVICES PROVIDED
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. Chemical Watch | Global Service Providers Guide 2015
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, eRPortal, Intelex, Kelaroo, SciQuest, more. CLIENTS More than 5,000 clients across 35 countries span multiple industries including chemicals; cosmetics; food contact; food; flavours and fragrances; consumer products; electronics and medical devices; healthcare; industrial, automotive and heavy equipment manufacturers; oil, gas and petrochemicals; pharmaceuticals; retail; utilities CASE STUDY 1: leading global manufacturer enhances competitive agility, enables market access, and reduces risks with 3ESC Industry: Electronics Challenge: Global manufacturer and supplier of consumer electronics products struggled to comply with existing and emerging supply chain product compliance obligations, including conflict minerals. Solution: 3ESC Supply Chain Solution Results: The manufacturer leverages the 3ESC platform to support its supply chain compliance initiatives, specifically its efforts to comply with conflict minerals regulations, such as section 1502 of the Dodd-Frank Act. 3ESC helps the company obtain, document and manage the wealth of product-specific data necessary to inform a complete compliance-based product risk profile and substantiate the due diligence activities required by the Dodd-Frank Act. Working with 3E helped the company achieve compliance more quickly and efficiently than if they had attempted this major initiative alone. CASE STUDY 2: leading biotechnology company finds cure for chemical management challenges with 3E Industry: Biotechnology Challenge: Burdened by requirement to maintain and ensure the accessibility and currency of chemical information and more than 30,000 SDSs across multiple locations. Solution: 3E Online-SDS and integrated SDS data with 3rd party chemical management systems provided a central location for entire enterprise to access chemical information, eliminating inconsistencies and redundant efforts to maintain data. Results: 50-60% cost savings over previous disparate systems.
Chemical Watch | Global Service Providers Guide 2015
CASE STUDY 3: global food and flavours manufacturers relies on Ariel content to feed SAP EHS Industry: Food and flavours Challenge: The global food and flavouring manufacturer did not have a clear understanding of its SDS and labelling requirements, especially those related to Osha’s Hazard Communication Standard 2012. Solutions: Ariel Content for SAP EHS, Ariel Data Manager-VSDS and an array of services Results: The popular manufacturer leverages Ariel North American and European product safety data, physical-chemical, toxicological and ecotoxicological content (PCTEC), expert rules, templates and phrases to fuel their SAP EHS platform that they use to author SDSs. They also use ADM-VSDS to obtain and integrate vendor data for use in SDS authoring. The solution has proven to be a very useful tool for integrating data into the company’s SAP EHS platform instead of doing it manually, and has significantly streamlined their compliance processes as well as increased their level of compliance. STAFF SELECTION Miki Nishimura, SDS Author Miki Nishimura, based in 3E’s Copenhagen office, is responsible for coordinating the production of SDSs, authoring SDSs and interfacing with 3E customers. She ensures that 3E’s Japanese SDSs and label templates conform to relevant regulations. Prior to joining 3E, she worked in research and development at Figaro Engineering, Inc, a semiconductor gas sensor manufacturer. Ms Nishimura earned a Bachelor of Engineering degree in chemical science and technology from Kyushu University in Japan. She also earned a degree in economics from Tietgen Business College in Denmark. Mary Jane Emigh, SDS Author As an SDS author, Mary Jane Emigh produces and manages global hazard communication documents for 3E clients, providing hazard assessment and classification in accordance with Osha, WHMIS, CLP, GHS and international transportation regulations. She has 15 years experience in the areas of hazard communication and regulatory compliance and is an expert user of the SAP EHS module. Prior to joining 3E Company in 2005, Ms. Emigh worked in regulatory compliance and hazard communication at a global photographic chemical company. Her background includes significant analytical experience, project management, training and coaching, and process improvement. She holds a Bachelor of Science degree in biology from the State University of New York at Buffalo. Emilia Vassileva, Regulatory Analyst, Central and Eastern Europe Emilia Vassileva is responsible for researching, analysing and monitoring the chemical regulatory framework and the EH&S related regulations in Central and Eastern Europe, including Russia, the Eurasian Economic Union and the former Soviet Republics. Her duties include maintaining the existing database for the particular geographic area, addressing client questions and providing regulatory support for consulting projects. Before joining the 3E team, she had extensive judicial experience and more than four years regulatory research and analysis experience on US and EU laws on a wide variety of topics. Ms Vassileva is a licensed attorney in Bulgaria. She is a Bulgarian native speaker, fluent in English, Russian and Macedonian, and has a working level (reading and comprehension) of Serbian, Croatian and Ukrainian languages. Ms Vassileva has a law degree from the Sofia University ”St. Kliment Ohridski” and an LL M degree (Master of Law) in international law from the Washington College of Law, American University, DC.
Page 49
PROFILE: 3E Company
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.
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
lmacdougall@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
lmacdougall@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
3
No. of countries represented
>25
Staff, group
>25
Staff, chemical service provision
>25
Technical document preparation activities – hazard, exposure and risk assessment
SERVICE AREA BREAKDOWN Training 5%
Other 5% Consultancy/ advisory 30%
Legal 25%
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
Representation & management 20%
IT & software 5% Information 10%
Page 50
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.
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 2015
1998
Parent company, Bergeson & Campbell, PC, formed in Washington, DC, US.
2000
Bergeson & Campbell, PC establishes consulting affiliate, The Acta Group, LLC, in Washington, DC, US.
2004
The Acta Group, LLC establishes an international consulting affiliate, The Acta Group EU, Ltd, in the UK.
2010
Bergeson & Campbell, PC establishes a consulting affiliate, B&C® Consortia Management, LLC, in Washington DC, US.
2011
The Acta Group, LLC establishes an international consulting affiliate, The Acta Group China, LLC.
ACCREDITATIONS Occupational Health and Safety Assessment Series 18001; International Organisation for Standardisation (ISO) 9001; ISO 14000 PARTNERS B&C® Consortia Management, LLC Bergeson & Campbell, PC CLIENTS Acta EU’s clients are involved in many businesses, including basic, specialty, agricultural, and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; medical devices and diagnostic products; fibres; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution and consumer product sectors. 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. Chemical Watch | Global Service Providers Guide 2015
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 chemical-specific 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. Leslie Scott MacDougall – Director of Regulatory Affairs 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. Ruth C Downes-Norriss – Regulatory Specialist Ms Downes-Norriss specialises in REACH registrations and worldwide notifications. She provides expert counsel and project management for all REACH-related activities as well as document preparation to support international registration activities. Ms Downes-Norriss has strong links with national competent authorities and communicates with competent authorities frequently. She participates in substance information exchange fora (Sief) and consortia supporting registration activities. Karin F Baron, MSPH – 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. Jane S Vergnes, PhD, DABT – Director of Scientific Affairs 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. Gyöngyi (Pearl) Németh, MSc – Regulatory Specialist Ms Németh has extensive international experience in REACH, CLP, SDS, and product stewardship support, including document preparation for International Uniform Chemical Information Database (Iuclid 5) dossiers, chemical safety reports (CSR) ,and SDSs. She has experience in scientific matters with a background in toxicology. 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.
Page 51
PROFILE: ACTA
CORPORATE DEVELOPMENTS AND ACHIEVEMENTS
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 Website
www.apc.eu.com
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
Data gap analysis, drafting of data waivers, data extrapolation, risk assessments, dossier preparation, placement and monitoring of studies, including efficacy development programmes. 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
2013/14
Turnover, group
€4m
Turnover, chemical service provision
€4m
No of offices
8
No of countries represented
>40
Staff, group
28
Staff, chemical service provision
23
SERVICE AREA BREAKDOWN
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 a 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. Training APC runs training events in ecotox, biopesticides and new EU pesticide regulations CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Training 2%
Consultancy/ advisory 98%
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. Page 52
Chemical Watch | Global Service Providers Guide 2015
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. CASE STUDY 3: out of season trials Using our large network of consultants, APC was able to organise out of season trials in South Africa, Australia and New Zealand in order to speed up the acquisition of data needed to confirm the performance of a new formulation. Our field efficacy experts were then able to justify the inclusion of this data as supporting evidence showing comparability with EU conditions where appropriate. This initiative resulted in a registration being obtained one year earlier than first anticipated. CASE STUDY 4: REACH registration non-phase-in substance APC 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.
Chemical Watch | Global Service Providers Guide 2015
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. 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 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 Kati Pikulik – Manager, APC Poland 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.
Page 53
PROFILE: APC
CLIENTS
OO
OO
PROFILE: Apeiron-Team NV
CONTACTS
OO
Web site
www.apeiron-team.eu
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 client focused. VITAL STATISTICS
generation of REACH authorisation dossiers from A to Z: strategy development, chemical 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; biocide dossiers: biocidal product dossier generation, biocidal product family concept.
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
1
Staff, group
> 10
Staff, chemical service provision
> 10
SERVICE AREA BREAKDOWN
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); and 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. Consortium management. REACH training for Belgian federation of chemical industry.
2011
Extension client portfolio in food and pharma industry. Expansion of services and experience in REACH-like legislations, global SDS requirements and chemicals management. Product portfolio inclusion of extended safety data sheet related products: generation of user friendly eSDS Annexes, organisation of eSDS compliance workshops, development of eSDS compliance check tool and development of company specific 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: submission and post-submission follow-up with authorities (in collaboration with Chinese experts). Preparation of lead and member REACH registrations dossiers for the 2013 deadline.
2013
Successful submission 2013 dossiers (Lead and member dossiers). Generation of 3 authorisation dossiers. Organisation of workshops on the (pre-) authorisation process. Addition of biocides- and cosmetics-related services to our portfolio. Move to a new location in Mortsel (Antwerp).
Other 5% Training 15%
Information 10%
Consultancy/ advisory 60%
Representation & management 10%
SERVICES PROVIDED Regulatory services We assist in the interpretation of legal texts: REACH (including requirements for nanomaterials), REACH-like legislations, CLP, biocides Regulation, cosmetics Regulation, food contact, and RoHS. Scientific services A selection of our services: OO generation of REACH registration dossiers from A to Z: substance identification, hazard assessment, study monitoring, exposure and risk assessment, PBT assessments;
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Submission of two authorisation dossiers for trichloroethylene and follow-up of these dossiers during public consultation. 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.
ACCREDITATIONS OO OO OO
European Registered Toxicologists (ERT) Environmental advisor (Milieu Coordinator) Strategic advisor SME
PARTNERS OO
Burgess Regulatory Services Ltd, Caleb, eftec, Jongerius Consult
CLIENTS Our references are situated in several industries and cover the entire supply chain from manufacturing to recycling: 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 "We have found Apeiron to be very engaged and passionate in providing support in our application for authorisation. They cover the full scope of activities, from hands-on work on hazard and risk assessment, analysis of alternatives and socio economic analysis to full project management. Apeiron kicked off the project with a two day workshop for our stakeholders, which was much appreciated by all and in particular by top management" – Parker Hannifin CASE STUDY 1: REACH authorisation application: from strategic support to dossier generation The REACH authorisation process is complex and business critical. Vlisco (textile industry) requested our support for the authorisation of trichloroethylene. In a first step, the dossier strategy was developed by means of in-house workshops with the company’s management. For this non-threshold substance, 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 by the applicant. The draft opinion from RAC and SEAC confirms the 12 years on basis of the arguments and the research plan provided by the applicant 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. Chemical Watch | Global Service Providers Guide 2015
Within the consortium we developed the cost-sharing model and 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 ca. 500 chemicals A formulator dealing with ca. 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: strategic support aligning REACH registrations with business objectives While REACH registration is to a large extent a scientific exercise involving a lot of communication throughout the supply chain, REACH is also very much a business driven effort. Apeiron-Team has supported several multinationals in the development of their REACH registration strategy taking into account their specific markets and import/export strategies. In addition, where warranted, position papers have been written in order to defend the exemption status for specific substances under REACH. By doing so, a cost effective registration strategy was developed avoiding unnecessary registration costs while securing optimal business continuity and flexibility. STAFF SELECTION Elke Van Asbroeck – ir (Bio-)chemical engineer 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 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 and PBT assessments eSDS generation/scaling tools ERT certified toxicologist
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PROFILE: Apeiron-Team NV
2014
markets such as Asia-Pacific and South America. Contact us at: ARCADIS Belgium, Citylink, Posthofbrug 12, 2600 Antwerpen-Berchem, Belgium. Contact: Alain Vassart, +32 3 328 62 48, a.vassart@arcadisbelgium.be; and: BMG Engineering Ltd, Ifangstrasse 11, CH-8952 Schlieren, Switzerland. Contact: Andreas Häner, +41 44 732 92 52, andreas.haener@bmgeng.ch; and: ARCADIS US, 1 Executive Drive, Suite 303, Chelmsford, MA 01824. Contact: Kate Sellers, +1 978-322-4514, kate.sellers@arcadis-us.com
CONTACTS www.arcadis.com/Global_Product_Stewardship.aspx www.bmgeng.ch
PROFILE: ARCADIS
Website E-mail
a.vassart@arcadisbelgium.be / kate.sellers@arcadis-us. com / bmg@bmgeng.ch
Head office
Gustav Mahlerplein 97-103, 1082 MS Amsterdam
PO Box 7895, 1008 AB Amsterdam, the Netherlands
Tel/ Fax
+32 3 360 83 00/ +32 3 360 83 01 (ARCADIS-BE) +1 513 985 80 20 / +1 513 860 87 01 (ARCADIS-US) +41 44 732 92 92/ +41 44 730 66 22 (BMG, Switzerland)
Contact
Alain Vassart (Europe), Kate Sellers (US), Andreas Häner (BMG, Switzerland)
Directors
Wouter Gevaerts, Executive Director Environment (Belgium), Alex Rothchild, Operations Director (US), Fritz Krieg, CEO (BMG, Switzerland)
Ownership
Public company
Locations
300+
Founded
1888
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 €3bn in revenues. 2013/2014
Turnover, group
€3bn
Turnover, chemical service provision
€5m
No of offices
300+
No of countries represented
38
Staff, group
28,000+
Staff, chemical service provision
47
SERVICE AREA BREAKDOWN IT & software 4% Laboratory 10%
Training 4%
Information 4% Representation & management 18%
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 Page 56
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, use and up to the waste stage. Our GPS practice focuses on: OO product stewardship systems, 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 laboratory services. REACH full spectrum implementation
OVERVIEW
VITAL STATISTICS
SERVICES PROVIDED
ARCADIS supports multinational companies in the chemical and pharmaceutical sector with the development and implementation of their REACH compliance programme, organises compliance audits and provides on-site employee training. Our areas of expertise include: REACH, CLP/GHS, biocidal products, nano, (e)SDS, waste regulatory Framework, water framework Directive... 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 prepare RMO risk management options) analysis in order to support our clients. Finally, as consortium manager, ARCADIS is responsible for the general and financial management of several consortia. In this role, we act as trustee and guarantee fair, transparent and non-discriminatory cost sharing between members and the Sief. Global agrochemical registration support ARCADIS provides sustainable, effective solutions to help our clients develop, register, manufacture, and ultimately market crop protection products within increasingly complex regulations that require the development and submittal of robust data to support registration eligibility decisions. We provide turnkey compliance support with individual regulations, in specific countries or entire regions, depending upon our clients’ level of need. 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, and then completion of licensing or permitting documentation. Where possible we maximise the use of existing data to minimise the costs by making use of exemptions, read-across strategies, and quantitative structure activity relationships (Qsar). Our highly experienced staff tailors and designs laboratory studies, develops and manages study progress and develops final study reports. Many of these studies (environmental fate, biodegradation and aquatic toxicology) are conducted at our own OECD GLP certified laboratory located in Zurich, Switzerland, following GLP standards and/or ISO/IEC 17025 to meet client needs. Our international team has strong relationships with multinational clients, international regulators, grower associations, and landowners across the international agricultural community. Supply chain management and product stewardship programmes ARCADIS has helped our clients manage supply chains for products as diverse as household consumer products, automotive components, pulp and paper, polymer, metals and their alloys, pesticides, and food Chemical Watch | Global Service Providers Guide 2015
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1888
Parent company Heidemij formed in the Netherlands.
1998
Global company becomes ARCADIS.
2002
Establishment of a global product stewardship (GPS) Centre of Excellence in Cincinnati, OH, US.
2006
ARCADIS Belgium becomes a GPS Centre of Excellence.
2010
ARCADIS is engaged by multinational companies, consortia and competent authorities as a key service provider for developing and implementing their compliance strategy related to REACH and CLP and prepared ~100 REACH registration dossiers.
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 BMG is GLP-certified and also accredited according to ISO/IEC 17025. Partners ARCADIS has a broad network of partners with whom we work together on an ad hoc basis (CROs, legal advisors, other consulting companies). Testimonials References can be provided upon request. CASE STUDY 1: groundwater monitoring in support of plant protection product registration ARCADIS is conducting a groundwater monitoring study at 125 vulnerable locations in the key maize-growing regions of 11 European countries. Candidate sites were identified by contacting farmers regarding their product usage. An international team of ARCADIS staff used a web-based database application to manage and analyse the resulting information from several thousand phone interviews. Following identification of candidate farmers, the project team collected detailed historical pesticide use information, characterised shallow soils, and determined the depth to groundwater at each monitoring location. A network of 375 high-quality, standardised, shallow groundwater monitoring wells was installed using ARCADIS’s own environmental drilling equipment. Monitoring well sampling is being conducted by local, in-country ARCADIS staff on a quarterly basis for the duration of the study. More than 730 groundwater samples have been collected across 125 instrumented monitoring sites. This data will provide unprecedented data on the environmental fate of the compounds being studied. CASE STUDY 2: product stewardship services for an international producer of consumer products For almost ten years BMG 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 Chemical Watch | Global Service Providers Guide 2015
OO OO
OO OO
OO OO
OO
sector standards, regulated substances); compilation of safety data sheets for over 20 countries and in over 20 languages including update to the globally harmonized system of cassification and labelling of chemicals (GHS); data management using a customised data management system; REACH compliance including pre-registrations via own only representative (OR) services and definition of a REACH strategy product notifications in several European countries; consultancy on new developments in the regulatory field including early warning system for critical substances; helpdesk for regulatory questions; overall consultancy for national requirements in several countries
CASE STUDY 3: assessment of the regulatory landscape for an international consumer goods company Household chemicals are highly regulated. The regulatory process to obtain marketing authorisations in certain regions, despite regional harmonisation efforts, is still highly country-specific. The PSS team within ARCADIS has been requested by an international consumer goods company to develop a global regulatory landscape assessment, addressing the major standards and regulations related to detergents and household care products. This is to ensure regulatory compliance and product conformance. The work encompassed a review of regulations and standards outlining the measurement requirements in defined geographies and a high-level trend analysis of the obtained standards and regulations. STAFF SELECTION Alain Vassart – Sr. REACH / batteries/ recycling and waste expert Alain has more than 20 years’ experience in the chemical and recycling industry, more particularly in the production of non-ferrous and hazardous chemicals and their recycling. He was involved in various task forces related to fungicides, animal feed and waste. 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), assuming currently 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 consultancy projects, RMO (risk management option) analysis and in the preparation of authorisation or exemption dossiers. Sandy Jacobs – Regulatory toxicologist Sandy has eight years’ experience as toxicologist and scientist in pharmacology in the pharmaceutical industry. Her focus was on antibodyderived therapeutic proteins targeting acute and chronic diseases across a broad range of therapeutic areas, such as cardiovascular, pulmonary and inflammatory diseases. She contributed to design, outsourcing and reporting of toxicology studies, as well as pharmacokinetic and in vivo efficacy models, and to regulatory filing of medicinal product dossiers. She has a PhD in biology. Timothy Negley, BSC MSc 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 50 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, FOCUS-PRZM, GENEEC, IORE, KinGUI, ModelMaker, PRZM/EXAMS, PRZM GW, SCIGROW, SWMM, Stream VOC, SYSTAT, SigmaPlot, TIM, T-REX, WARP.
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PROFILE: ARCADIS
storage containers. We work with our clients to create a structured means of identifying, informing, managing and exchanging necessary information throughout a product’s global supply chain. This process can be used effectively to manage regulatory compliance, perform third-party 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.
SERVICES PROVIDED REACH 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.
PROFILE: ARCHE
CONTACTS Website
www.arche-consulting.be
info@arche-consulting.be
Head office
Stapelplein 70, box 104, 9000 Gent, Belgium
Tel
+32 9 265 87 58
Contact
Marnix Vangheluwe
Directors
Marnix Vangheluwe
Â
Patrick Van Sprang
Ownership
Private company
Locations
Gent and Leuven, Belgium
Founded
2009
REACH enforcement services: CLP-compliance and uses evaluation
OVERVIEW ARCHE has an unique track record in the field of environmental toxicology, exposure modelling and the preparation of risk assessment dossiers in general. 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, pharmaceuticals and plant protection products classification of substances and complex mixtures (GHS/CLP), and setting and/or evaluation of (site-specific) environmental quality standards. In addition, ARCHE is also a certified Material Health Assessor, assisting companies towards certifying their products in line with the Cradle Certified Products Program CM (cradle-to-cradle). VITAL STATISTICS
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
2
No of countries represented
1
Staff, group
16
Staff, chemical service provision
16
SERVICE AREA BREAKDOWN
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. Biocides and plant protection products (PPPs) ARCHE has extensive expertise and a proven track record in delivering solutions to environmental problems at all stages in the registration/ review of biocides and PPPs. Offered services include: (a) effect and exposure assessment for active substances and products; (b) data gap identification and designing higher-tier studies; (c) exposure modelling (FOCUS suite of models, Euses, Consexpo, EASE); (d) higher-tier exposure scenario development; (e) CLP; (f) dossier preparation, submission and follow-up; (g) client representation in meetings with regulatory authorities; (h) product stewardship; and (i) training Iuclid for biocides. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Training 10% IT & software 5% Representation & management 10% Consultancy/ advisory 75%
GLOBAL OFFICES
ARCHE developed a 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 REACHEN-FORCE programmes. Through benchmarking the onsite operational conditions (OC) and risk management measures (RMMs) with those that are reported in the ES, a complete compliance check for each hazardous substance is undertaken. When on-site conditions of use are not in agreement with those that have been outlined in the ES, several options are explored in consultation with the DU. The deliverable of the RESCUEprogramme is a fully documented evaluation that demonstrates REACH and CLP compliance for each evaluated substance.
2009
Foundation of ARCHE (staff: five people).
2010
Expansion of the team to 12 people, with offices in Ghent and Leuven.
20132014
Further expansion to 16 people, and further development of the services on biocides and plant protection products.
PARTNERS EBRC Consulting GmbH, Hannover PietConsulting ReachCentrum ECTX-Consulting
PJ Van Benedenstraat 4, box 203 3000 Leuven, Belgium Tel: +32 16 28 49 00
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Chemical Watch | Global Service Providers Guide 2015
CLIENTS
Marnix Vangheluwe − Managing Director ARCHE
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.
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 was co-founder of EURAS, a company specialising in environmental risk assessment. He is the main author of the metal risk assessment guidance document (Merag) and the official REACH Appendix R.7.13-2.
“IMOA has worked for the last five years 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. ARCHE worked with numerous metal consortia for REACH, and is widely recognised by the metals industry as the experts in their field.” – Sandra Carey, International Molybdenum Association 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.
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 scenario building. Hilde Dosogne − Senior Science Project Manager Hilde Dosogne graduated as bio-engineer (1992) and obtained a PhD in veterinary sciences at Ghent University (1998). From 2001 until 2004 she worked as R&D and regulatory affairs consultant for Pharmavize. From 2004 until 2011 she worked as regulatory affairs manager (Europe, Middle East, Africa) for DeLaval. Her responsibilities at ARCHE include European biocidal product dossier preparation, submission and follow-up, both on national level and according to the mutual recognition procedure.
CASE STUDY 2: compliance with the new MARPOL Annex V and IMSBC requirements Marine shipping regulations MARPOL 73/78 (Annex V) and the IMSBC Code are aimed to ensure that risks towards men and environment as a result of the transport and use of hazardous substances overseas are reduced to an absolute minimum. Recently, criteria have been included in these legislations for the classification of hazardous substances based on the GHS classifications schemes. ARCHE has been asked to draft guidance documents on this topic for both complex organic as inorganic substances. CASE STUDY 3: human health risk assessment of PT8 biocidal products (wood preservatives) Human health risks were calculated for three different PT8 biocidal products, each containing three active substances. The risks were calculated according to the new guideline for risk assessment of biocidal products (Dec. 2013), where the hazard quotient (HQ) = internal exposure/ acceptable exposure level (AEL) was calculated for each substance. In order to address toxicity of the mixture, the hazard index (HI = Σ HQ of each active substance) was also calculated. Results of the assessment were used to support strategic decisions on products to be maintained on the market. 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). Chemical Watch | Global Service Providers Guide 2015
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PROFILE: ARCHE
TESTIMONIALS
Frederik Verdonck − Senior Science Project Manager
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. We can also advise on relevant classification/labelling. 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
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
Ownership
Private company
Locations
United Kingdom
Founded
1961, acquired by current management 2005
Human health hazard and risk assessment
Peter Watts, Director of Toxicology Graham Hunt, Commercial Director
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 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 regulatory responsibilities.
The bibra toxicology advice & consulting team of toxicologists has worked together over many years, 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 international governments 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. Retrieved information can be quickly assessed for relevance and reliability to satisfy tonnage-relevant data requirements. Additional 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
Turnover, group
£2m
For 54 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.
Turnover, chemical service provision
£2m
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
VITAL STATISTICS
2013/14
No of offices No of countries represented
1
1961
Formation of BIBRA
1
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
2005
The new combined entity began to trade as bibra toxicology advice & consulting from Sutton, Surrey offices
2010
Relocated to new, larger offices in Wallington, Surrey
Staff, group
23
Staff, chemical service provision
20
SERVICE AREA BREAKDOWN Information 4% Representation & management 10%
IT & software 1%
Consultancy/ advisory 85%
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Chemical Watch | Global Service Providers Guide 2015
CASE STUDY 2: Urgent request for help with chemical safety report
Our senior toxicologists are all Society of Biology/British Toxicology Society and European Registered Toxicologists. We are a REACHReady approved supplier.
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.
PARTNERS Enviresearch Ltd Linmark Consulting Gmbh wca environment Ltd ReFaC Campden BRI group 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 2015
CASE STUDY 3: Provision of alerting service to keep industry up-to-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 toxicology advice & consulting team receives daily notification of newly published or prepublished 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 co-ordinated and proactive way. STAFF SELECTION James Hopkins – Managing Director James has worked at bibra for 39 years; he was a senior toxicologist of high repute before leading the management buyout in 2003. The new company, bibra toxicology advice & consulting, has performed impressively under James’ guidance, reporting record results in 2012/13. James has wide experience in reviewing/evaluating toxicological data for a range of chemicals in a cross-section of industries and has also compiled numerous critical reviews of chemicals and several strategy documents for national governments. Peter Watts – Director of Toxicology Peter is our Director of Toxicology and is a bibra veteran of 37 years. His vast experience includes reviewing and critically evaluating toxicological data and providing 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 provides peer-review services for OECD SIAMs (now CoCams). Philip Copestake – Senior Toxicologist Philip has more than 30 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 acted as an author and advisor to the WHO-IPCS. 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. The rest of the team We have another 16 highly-competent toxicologists, all of whom are professionally qualified (the majority are SB/BTS and European Registered Toxicologists) and, barring our graduate trainees, range in practical experience from 12 to 41 years. All are extremely skilled in chemical hazard and risk assessment and have been heavily involved in REACH-related work during the past five to six years. Page 61
PROFILE: bibra toxicology advice & consulting
ACCREDITATIONS
GLOBAL OFFICES Edinburgh, Scotland, UK Cardiff, Wales, UK SERVICES PROVIDED Scientific consultancy
PROFILE: Blue Frog Scientific Limited
CONTACTS
OO
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
Website
www.bluefrogscientific.com
info@bluefrogscientific.com
Head office
10 York Place, Edinburgh, Midlothian, EH1 3EP, UK
Tel
+44 (0) 131 523 1412
Contact
Damien Carson
OO
Directors
Damien Carson
Regulatory affairs
Â
Tom Hargreaves
OO
Ownership
Private limited company
Locations
UK (Edinburgh and Cardiff)
Founded
2006
OO OO OO OO OO
OO OO OO OO
OVERVIEW Blue Frog Scientific is an independent regulatory consultancy, providing scientific and regulatory affairs solutions to companies in all sectors of the chemical industry. Blue Frog’s philosophy is achieving regulatory compliance through the application of good science, innovative thinking and clarity; ensuring that all submissions are prepared efficiently and to a high standard. We offer scientific and regulatory affairs services with particular experience in 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
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
2
No of countries represented
2
Staff, group
10
Staff, chemical service provision
10
SERVICE AREA BREAKDOWN IT & software 10%
Representation & management 20%
Chemicals (REACH and CLP) Blue Frog Scientific provides a full technical and administrative registration service for chemical substances under Regulation (EC) No 1907/2006 (REACH). Our team is highly qualified and experienced in preparing registration dossiers, chemical safety assessments, coordinating with Siefs and consortia, and liaising with regulatory authorities during and post dossier submission. Key sectors of experience include: OO monomers, process chemicals, coatings and catalysts; OO oilfield chemicals and petroleum products; OO fragrances; 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)
Consultancy/ advisory 70%
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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
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 2015
Agrochemicals
ACCREDITATIONS European Partner: Society of Environmental Toxicology and Chemistry (Setac). REACH Ready Approved Service Provider. Member of the Only Representatives Organisation (ORO). 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 adviser 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
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.
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.
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Nigel Halsall BSc PhD – Associate Director
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.
20122015
Sustained growth leads to major expansion of company with new staff and offices to support growing client base.
Chemical Watch | Global Service Providers Guide 2015
STAFF SELECTION Damien Carson BSc PhD – Director An expert in chemical hazard and risk assessment with more than ten 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 15 years experience in veterinary medicinal products, human pharmaceuticals, agrochemicals and chemicals. Expert in good laboratory practice (GLP) and testing strategies. 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.
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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
PROFILE: BSL BIOSERVICE Scientific Laboratories GmbH
GLOBAL OFFICES Our facilities are located in Planegg/Munich, Germany. In addition, we have representatives in Switzerland, Japan, India, Poland, Scandinavia, Italy and other countries. Through the Eurofins Group BSL BIOSERVICE is represented globally. SERVICES PROVIDED
CONTACTS Website
www.bioservice.com
info@bioservice.com
For the chemical, agrochemical and biocides industry BSL BIOSERVICE offers a broad scope of biological safety studies, which meets the international regulatory requirements and includes the following services.
Head office
Behringstr 6/8, 82152 Planegg / Munich, Germany
Toxicology for chemicals, PPPs and biocides
Tel
+49-89-899 650-0
Fax
+49-89-899 650-11
Contact
Dr Iris Pfisterer
Directors
Berthold Hackl, General Manager
Locations
Germany
Founded
1984
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 DART studies. In addition, BSL 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.
OVERVIEW BSL BIOSERVICE Scientific Laboratories GmbH is an internationally active CRO with a focus on safety and efficacy trials for industrial chemicals, agrochemicals, biocides, cosmetics, medical device, food and pharmaceuticals. The interdisciplinary and internationally accepted approach of the institute with its various accreditations, certifications and numerous successful audits (GLP, DIN EN ISO 17025, GMP, FDA) guarantees high-quality biological trials. The laboratories have in the meantime been certified for the eighth time in accordance with GLP, most recently in 2012, and all tests are performed in accordance with the internationally valid guidelines (OECD, ISO, ICH, EU, EPA, MHW, FDA). With more than 30 years of experience our team of scientists offers a broad spectrum of biological test systems and is dedicated to meeting the customer´s individual needs with a high level of flexibility. BSL BIOSERVICE is renowned for its communication, scientific input and high quality standards. BSL BIOSERVICE is the preferred toxicology partner of the Eurofins Group, which is a global leader in the pharmaceutical, food and environmental testing market and also offers a comprehensive portfolio for the chemical and agrochemical product sectors. The Eurofins Group, with annual revenues of more than US$1bn, has over 16,000 employees in more than 200 laboratories across 36 countries. VITAL STATISTICS
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
6-10
Staff, group
200+
Staff, chemical service provision
-
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. These services are offered in cooperation with the Eurofins Group and other experienced partners and are project managed by BSL BIOSERVICE. 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 upcoming deadlines. 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 BSL on a routine basis. With regard to the latest discussions we have also established the EOGRTS (OECD 443) as an alternative to the two-generation study (OECD 416). Endocrine disruptor testing
SERVICE AREA BREAKDOWN Consultancy/ advisory 20%
In response to the EPA announcement of the Endocrine Disruptor Screening Programme for Biocides, we have established endocrine disruptor testing services and can offer the full Tier 1 testing battery. In vitro safety testing OO OO
Laboratory 80%
OO OO OO OO
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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 under development)
Chemical Watch | Global Service Providers Guide 2015
STAFF SELECTION
With more than 30 years of experience, BSL BIOSERVICE and 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 to our internal consulting services we are backed up by an experienced regulatory division within the Eurofins Group and other partners that support us in covering the regulatory issues of chemicals, agrochemicals and biocides.
Dr Angela Lutterbach, Head of Testing Facility
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1984
Foundation under the name Dr MĂźller Lierheim AG.
1992
GLP certification.
1995
Within a management-buyout the company was renamed to BSL BIOSERVICE Scienitific Laboratories GmbH.
1995
Accreditation according to DIN EN ISO 45001/DIN EN ISO 17025 as first laboratory in Europe.
2006
BSL BIOSERVICE becomes a partner laboratory of the Eurofins Group.
2007
Acquisition of an additional building and establishment of a brand new state-of-the-art in vivo facility with a laboratory area of 3,000m2.
2009
BSL BIOSERVICE takes a leading role within the Eurofins REACH Task Force as toxicology partner.
2013
Expansion into an additional building to increase the in vitro laboratory space for bioassay and biosafety testing.
ACCREDITATIONS Good Laboratory Practice (GLP) DIN EN ISO IEC 17025 Good Manufacturing Practice (GMP) FDA approved Radioactive handling permission CLIENTS Chemical industry Agrochemical industry Biocides industry Pharmaceutical/ biotech industry Food industry Cosmetic industry
Chemical Watch | Global Service Providers Guide 2015
Dr Angela Lutterbach has more than 25 years of experience working in the contract research industry. She started working at BSL in 1995 as study director for safety toxicology and safety pharmacology and holds the position Head of Testing Facility at BSL since 2001. Dr Lutterbach has a PhD in veterinary medicine and is a member in various expert groups. Dr Marc Kunze, CSO 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 CSO at BSL BIOSERVICE, 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 With more than 25 years of experience in contract research, Dr Albrecht Poth is working today as Scientific Director at BSL BIOSERVICE. 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 Iris Pfisterer, REACH Manager As REACH Manager at BSL BIOSERVICE, 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 BSL since 2009. Other staff In total more than 200 people work for BSL BIOSERVICE. Our highly educated and experienced staff comprises a large proportion of scientists 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: BSL BIOSERVICE Scientific Laboratories GmbH
Consulting, testing strategies and individual study designs
GLOBAL OFFICES CEHTRA Lyon – 80, rue Condorcet, 38090 Vaulx Milieu, France CEHTRA Paris – Avenue Laurent Cély, 92600 Asnières sur Seine, France CEHTRA Europe – 134, rue Saint Germain, 1410 Waterloo, Belgium CEHTRA UK – 6th Floor City Gate East, Toll House Hill, Nottingham, NG1 5FS, UK CEHTRA India –245, Level 2, Elegance Building, Mathura Road, Jasola, New Delhi, 25, India CEHTRA North America – 24 Ivy Lea Crescent, Toronto, ON M8Y 2B6, Canada
PROFILE: CEHTRA
CONTACTS Website
www.cehtra.com
cehtra@cehtra.fr
Head office
43, rue Laroque, 33560 Sainte-Eulalie, France
Tel
+33 557775610
SERVICES PROVIDED
Fax
+33 557775620
Regulatory dossier services
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: New Delhi: Canada: Toronto
Founded
2001
Industrial hygiene and worker exposure studies
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
2013/14
Turnover, group
€5m
Turnover, chemical service provision
-
No of offices
7
No of countries represented
5
Staff, group
65
Staff, chemical service provision
57
SERVICE AREA BREAKDOWN
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 1,600 projects since CEHTRA was founded and we have produced over 120 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). With more than 13 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. Consortium and Sief management 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.
IT & software Legal Training 6% 2% 2% Information 5%
Authorisation services 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.
Representation & management 10%
Consultancy/ advisory 75%
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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).
Chemical Watch | Global Service Providers Guide 2015
2001
Company established.
2004
Opening of UK office.
2008
Opening of Brussels office.
2008
Opening of Lyon office.
2009
Start of the Indian Joint venture.
2011
Opening of North America offices.
2012
Opening of ChemAdvocacy.
2014
Opening of KREATiS.
ACCREDITATIONS Number of European registered toxicologists (ERT) and other certificates: OO 11 ERTs; OO one IOB/UKEMS GT; OO two chartered chemists (MRSC); 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: SEA dossier for biocide 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 and this was finalised according to plan. CASE STUDY 2: 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.
STAFF SELECTION Peter Jenkinson − PhD, GT – CEO CEHTRA SAS and Manager of UK Office Peter Jenkinson has a PhD in reproductive toxicology and over 30 years' experience in the CRO industry specialising in genetic toxicology. Latterly he was the director of the Chemical Business Unit at Harlan Laboratories with a primary role of developing the REACH services of the company. In March 2010 he joined CEHTRA to open the UK office and has provided expert toxicology advice, particularly for study monitoring and data interpretation. Paul Thomas PhD, ERT − Marketing Director CEHTRA, Manager of Lyon Office and CEO KREATiS Paul Thomas has a PhD in aquatic ecotoxicology and 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. 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 14 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 worked more than 18 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 13 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 16 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 European Union, China, Australia, and Japan. In recent years he has been heavily involved in assisting North American companies to prepare for and comply with REACH.
Chemical Watch | Global Service Providers Guide 2015
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PROFILE: CEHTRA
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
SERVICES PROVIDED REACH consultancy Centro Reach provides in-company support on the REACH Regulation, including impact assessment and liabilities, product portfolio analysis and subsequent REACH compliance actions, supply chain communication assessment up and down, helpdesk consultancy. REACH services
PROFILE: Centro Reach
CONTACTS Website
www.centroreach.it
inforeach@centroreach.it
Head office
Centro Reach Srl, Via Giovanni da Procida, 11, 20149 Milan, Italy
Tel/ Fax
+39 02 8724 5901/ +39 02 3456 5631
Contact
Ralf Knauf
Directors
Bruno Brianzoli
Sergio Treichler
Ownership
Private company
Locations
Milan
Founded
2007
Centro Reach offers skills in management of registration dossier preparation for individual lead registrants, and/or among consortia, and for joint submission applicants. We provide assistance and information for registration requirements, Iuclid 5 compilation and registration submission, letter of access management, Sief management and late pre-registrations. Consortium management in technical, administration, legal and coordination field is one of the key activities of Centro Reach. The company's wide network of experts is able to fulfil all our customers’ support needs. CLP and SDS management Consultancy and submission of CLP notifications under the CLP Regulation, safety data sheet assistance and management for EU territory as well as extra-EU areas under GHS requirements are also basic activities of Centro Reach. Other chemical regulatory needs
OVERVIEW Centro Reach was founded on 20 February 2007 on the initiative of Federchimica and Assolombarda. Federchimica, the Italian Chemical Industry Association, controls 53.3 % of the capital stock, the remaining part is held by ten other industrial associations. The company mission is to provide professional consultancy support to chemical industry firms and downstream users, helping them meet the REACH, CLP and other regulations concerned with the management of chemicals and safety in the workplace. Centro Reach assists chemical manufacturers and importers in the dossier preparation for substance registration either on an individual basis or in consortia and has participated or is participating in almost 20 consortia working on registrations for 2010 and 2013. We have expertise in: CLP notifications, support for safety data sheets, training courses, in-company consultancy, legal assistance for chemical regulations, regulatory services for non-EU countries thanks to our international network, and R&D in the field of NTM methods (Qsar projects). VITAL STATISTICS
2014
Turnover, group
Centro Reach and its network is able to support companies in the field of biocides and food contact material requirements, also outside Europe. Our network experts have proven experience in submitting chemical notifications in key-areas like North and South America, China, Japan, Korea, India and Australia as well as countries like Turkey, Switzerland and others. TSCA notifications in the US are supported by our network, and safety data sheet management is also among the services we offer. Training courses Since the very beginning training on REACH and CLP regulation has been a core activity of Centro Reach. Between 2007-2014 more than 3,600 participants have attended our training sessions, which are also offered through Confindustria system and dedicated service activities. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007
Founded by Federchimica (Association of Italian Chemical Industry) and Assolombarda – the largest regional enterprise organisation in Italy.
2008
A further ten industrial associations belonging to the Confindustria system become stakeholders Centro Reach. Partnership with Reach Centrum in Brussels begins
2009
Publication of Inventory on certified Italian laboratories for REACH registration studies. Set-up of expert network and co-operation agreements. Involvement in more than 15 national and EU consortia Intensive training activities involving almost 500 professionals, both in-house and in-company courses
2010
Individual registrations for 95 companies successfully submitted. Management and involvement in 20 consortia for 2010 registration. Intensive training specifically on CLP regulation and notification process, safety data sheets and labelling. Service for SDS management launched. CLP notifications of more than 550 substances.
2011
Centro Reach served around 310 customers, in large part not Federchimica members, about 40% of them being downstream users. More than 50 training course sessions, and two national workshops with over 150 participants. Centro Reach supports Italian University Master Reach activities. Co-operation with Reach Global Services (RGS) for substance notifications of Italian companies in Turkey.
ca €1m
Turnover, chemical service provision
ca €0.7m
No of offices
1
No of countries represented
All of the EU
Staff, group
6
Staff, chemical service provision
3 (plus wide expert network)
SERVICE AREA BREAKDOWN Training 20%
Legal 5% Information 5% Representation & management 15%
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Consultancy/ advisory 55%
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Centro Reach supported again around 300 customers, many of them not Federchimica members. More than 40 training course sessions and one national workshop with over 120 participants were organised. Centro Reach supports Italian University Master Reach activities and published an updated version of its inventory on certified Italian laboratories for REACH registration studies.
2013
During the first half of 2013, Centro Reach focused its activities on the May 2013 Reach registration deadline. Around 450 customers and managers took advantage of our services during the year, a significant share from nonassociated companies. Around 35 training course sessions, both in-house and at company sites, were delivered. Centro Reach is actively involved in two EU financed LIFE + projects which started during 2013.
2014
In a year without any registration or notification deadline Centro Reach activities were spread in many fields. During the second half of 2014 Centro Reach started to offer support in the field of biocides and its capability to organise consortia for product authorisation. Almost 50 training courses were put in place many of them directly at company level. In December 2014 a Centro Reach national workshop for the management of chemicals in the extra-EU countries saw a participation of more than 100 managers.
ACCREDITATIONS Certified ISO 9001 PARTNERS Assogomma, Certiquality, Mario Negri Institute, Assoservizi, Intertek, DGM Italia, Field Fisher, WasteandChemicals, ARPA Em Romagna, Reach Centrum ,others CLIENTS Mainly SMEs but also companies like MAPEI, BASF Italia, Bracco, Polynt, Clariant Italia, DSM Italia, Versalis, others as well as non-Italian customers SPECIAL CASE 1: assistance to Dye-Staff Cooperation Centro Reach is coordinating and supporting a group of mainly Italian SMEs, called Dye-Staff Cooperation, in order to bring their huge dye substance portfolio in an economically sustainable way through the REACH registration process by May 2018. Many actions have been put in place versus national authorities, EU institutions and with Echa. Substantial increase of attention to the problems of SMEs, and support of all these institutions, has been achieved by this group.
Chemical Watch | Global Service Providers Guide 2015
SPECIAL CASE 2 : EU financed project LIFE+ named inReach Centro Reach is a partner in a new EU financed project LIFE+ named inReach, which started in sept 2014. The overall objective of the project is to improve the protection of health and the environment by facilitating information exchange on chemicals imported into the EU and their compliance with the REACH and CLP Regulations, by means of innovative solutions. Specific objectives are to streamline REACH and CLP compliance checks for goods imported into the European Economic Area and the EU customs space, by simplifying access to and tracking of relevant REACH and CLP information, such as substance identity, registrant identity, substance registration status, safety data sheets and the presence of SVHCs. A more efficient collection and sharing of data on origin and destination of REACH and CLP-related goods for customs and enforcement authorities will facilitate transit through EU main access points, while ensuring proper data security and correct policies of access to them, in order to preserve confidentiality, industrial and intellectual property rights. STAFF SELECTION Bruno Brianzoli – Coordinator In 1964, after graduating in chemical engineering at Politecnico di Milano, Bruno joined the multinational group Solvay, where he worked until January 2007. As managing director of the Solvay Group from 1997 to 1999 he was in charge of managing the business of the Solvay Sodi Company (the production of sodium carbonate) in Bulgaria. From 2000-07 he was general manager of Solvay. Sergio Treichler – General Director At present Sergio is the central technical – scientific director of Federchimica. He previously worked in the industrial and financial fields for the World Bank in Uganda, Ethiopia and Paraguay. Sergio has been a member of important groups in Cefic such as the Product Stewardship Programme Council and HSE, Logistics and Energy Programme Council. He is a member of the board of directors of Certiquality Srl and an advisor of ICS-UNIDO. Ralf Knauf – Business Development Manager In 1980 after finishing his professional education in economy and industry at the head office of Bayer AG, Germany, Ralf moved to Bayer Italia's AgChem division, where for more than 25 years he was responsible for international business and regulatory coordination in several different Italian AgChem companies. In 2007 he joined Federchimica's product safety within technical and scientific department, focusing on REACH and related regulations. Since 2009 he has been heavily involved in Centro Reach, coordinating training, R & D projects and consortia activities. Stefano Arpisella – Technical Manager Graduated in chemistry and pharmaceutical technologies. After his activity in R&S at Università di Ferrara, he worked in the Federchimica technical and scientific department for chemicals and product safety. He has huge practical experience in REACH thanks to more than 400 in-company activities and visits.
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PROFILE: Centro Reach
2012
SERVICE AREA BREAKDOWN
Laboratory 100%
PROFILE: Charles River
CONTACTS Website
www.criver.com
askcharlesriver@crl.com
Head office
251 Ballardvale Street, Wilmington, MA, US
Tel
+44 1875 614545/ 1- (877) CRIVER-1 (US)
Fax
+44 1875 614555
Contact
Karen McCusker
251 Ballardvale Street Wilmington, MA United States
Directors
James Foster
Ownership
Public limited company
SERVICES PROVIDED
Locations
Global locations and offices
Founded
1947
GLOBAL OFFICES
Services to meet REACH requirements Charles River has supported the chemical industry for over 40 years. Drawing on this extensive experience, we offer a full range of studies to meet the requirements of REACH.
OVERVIEW Charles River is the market-leading provider of contract testing services to the pharmaceutical, chemical and agrochemical industry and has been providing high-quality research models and laboratory animal support expertise since 1947. Our unique safety assessment portfolio spans the entire research and development process, allowing for flexible, customised approaches to support both single-study and broad-based programmes. With facilities in Europe, North America and Asia, we are well-positioned to help optimise the discovery and development of our clients’ drugs, chemicals, agrochemicals, medical devices and therapies. Our customer base includes major pharmaceutical and biotechnology companies, as well as leading companies in the chemical and agrochemical sectors, academic institutions and government research centres. Always leading with science, our exceptional team of toxicologists, pathologists, veterinary surgeons, regulatory specialists and support personnel designs and conducts safety studies ranging from acute to chronic toxicity and carcinogenicity studies. Charles River is also at the forefront of the industry in the fields of developmental and reproductive toxicology, inhalation toxicology and other specialty toxicological assessments. We offer an expanding portfolio of in vitro methods to replace traditional in vivo studies where possible. All of our studies are conducted to GLP and are supported by the highest quality analytical services, including bioanalysis, central laboratories, immunology, drug metabolism and pharmacokinetics and formulation development.
Physico-chemical testing Our service includes all the characterisation and physico-chemical studies necessary to support worldwide registrations for both active ingredients and formulated products. We offer a full range of testing services that meet REACH requirements, either as packages or stand-alone studies conducted to the appropriate guidelines. Tests available include: OO physical state; OO melting point/freezing point; OO boiling point; OO relative density; OO surface tension; OO vapor pressure; OO water solubility; OO organic solvent solubility; OO octanol/water partition coefficient; OO dissociation constant; OO flammability; OO pH; OO viscosity; OO oxidizing or reducing properties; OO hydrolysis as a function of pH; and OO spectra (UV, UV/VB, IR, NMR, MS) Acute toxicology
Turnover, group
-
Turnover, chemical service provision
-
A full spectrum of regulatory-compliant studies is offered to evaluate oral, dermal and inhalation toxicity, dermal and ocular irritation and skin sensitisation. In vitro models are available to assess dermal irritation or corrosivity and ocular irritation.
No of offices
-
Repeat, reproductive and chronic toxicology
VITAL STATISTICS
No of countries represented Staff, group Staff, chemical service provision
2013/14
17 7,500 -
We routinely perform repeat dose studies from short term to chronic, including carcinogenicity. Reproductive toxicology screening to OECD 421 and 422 is available, as well as developmental toxicology in rats and rabbits and multigenerational studies in rats. Genetic toxicology Studies typically follow a tiered approach beginning with an in vitro Ames test and progressing to short-term in vitro assays, including the mouse lymphoma and chromosomal aberrations assays, and in vivo assays such as the rodent micronucleus test. In addition to standard study designs, we are also able to offer customised protocols for the rapid screening of candidate molecules for toxicity profiles.
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Chemical Watch | Global Service Providers Guide 2015
Ecotoxicology
STAFF SELECTION
Charles River’s custom-designed ecotoxicology building provides flexible, modern facilities for the conduct of aquatic and terrestrial ecotoxicity investigations. Each laboratory has independent environmental control to accommodate a wide variety of test organisms. Additionally, standalone maintenance cabinets are used to house a range of species, while separate environmentally controlled laboratories are used for biodegradation studies. Our team of expert scientists is experienced in handling difficult test items (eg, volatile, unstable, complex and poorly soluble mixtures), and have the facilities and equipment to deal with complex test situations. We have a proven ability in the conduct of studies in accordance with the OECD guidance document on Aquatic toxicity testing of difficult substances and mixtures. Most ecotoxicology tests can be conducted with a radiolabelled test item if necessary.
Director, Laboratory Sciences
Charles River has over 25 years’ experience conducting environmental fate studies to meet European, US and Japanese regulatory requirements. Modern open-plan laboratories are provided for the in-life and analytical phases of environmental fate and related studies. There are eight large incubation rooms, each with independent environmental control, ensuring full compliance with worldwide guidelines for chemical product registration.
OO
Joined Charles River in 1988 Has responsibility for all aspects of the services provided by Charles River to chemical, agrochemical and veterinary product companies
Operational Area Manager, Chemistry OO OO
OO
Joined Charles River in 1988 Experienced in xenobiotic metabolite identification, residue analysis and analytical chemistry Responsible for managing a team of study directors handling physico-chemical, analytical and stability studies
Head, Environmental Fate and Metabolism OO OO
Joined Charles River in 1994 Oversees the design and conduct of studies intended to characterise the fate of chemicals in the environment and to study the nature of metabolites and metabolic pathways using a range of chromatographic and spectrophotomic techniques
Analytical support A validated analytical method is required to support many product chemistry and ecotoxicology tests. Experienced analysts are available to establish new analytical methods or to transfer existing methodology using a wide range of up-to-date equipment. The storage stability and shelf-life of the formulated product can be determined under a variety of specified storage conditions. Solid, liquid, semi-solid and aerosol formulations can all be evaluated using real-time and accelerated storage stability testing. We have dedicated facilities to stress the material using monitored heat, humidity or light parameters. ACCREDITATIONS AAALAC, GLP, GCPv, GEP CLIENTS A broad range of companies producing pharmaceutical, agrochemical, chemical, biocide and animal health products. Our client base includes consortia, start-ups, virtual companies and SMEs as well as global corporations. TESTIMONIALS Testimonials can be provided on request CASE STUDY Our clients and their programmes are protected by our strict confidentiality agreements; therefore, we are unable to discuss specific case studies. All our study directors have extensive experience ranging from five to over 25 years, giving them the depth of expertise required to deliver to the highest standard on studies and provide a flexible, solutions-driven approach to the design of both individual studies and entire registration programmes. With emphasis on quality and technical excellence, enforced through continuous training, internal audit programmes and proactive communication, our scientific staff will work together with your own teams to produce work of the highest standard to meet your registration requirements.
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PROFILE: Charles River
Environmental fate studies
OO
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
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, Lawyer
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
2
No of countries represented
2
Staff, group
12
Staff, chemical service provision
10
SERVICE AREA BREAKDOWN Legal IT & software 5% 5%
Training 5%
Laboratory 5% Information 10% 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 for agrochemicals.
Chemical Watch | Global Service Providers Guide 2015
Endocrine disruptor chemicals (EDCs) services
TESTIMONIALS
Based on US EPA EDSP and the OECD conceptual framework for testing and assessment of EDCs we can offer the following services: a) pre-screening activity based on OO substance characteristics; OO uses and exposure scenarios for: b) data search on the substance and on similar substances OO epidemiological data; OO ADME (absorption, distribution, metabolism and excretion) c) regulatory lists check-out (EPA, OECD). d) in silico pre-screening with a particular emphasis on reproduction and long term studies. OO WOE (weight of evidence) and data gap analysis; OO testing strategy definition, management and monitoring.
Any persons or companies requesting testimonials or references will be provided with them upon individual written request.
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. OO PIF (product information file) or PSR (product safety report). OO administrative activity, including robust study summaries and substance information sheet (SIS) with ingredient evaluation. OO OO
Petrochemicals We advise our clients on legal aspects of chemical trade worldwide and related chemical control regulations. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
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. CASE STUDY 2: REACH dossier work 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
2001
Start-up in Italy as “a one man” company.
20072008
REACH and OR services offered.
Lawyer, JD in environmental law, with more than 20 years of experience. Environmental, chemical and international law
2009
Biocides and agrochemicals group creation.
Francesca Fasano – Head of Biocides Department
2010
Technical consortia advisers for three international consortia. Staff increase to ten people.
Industrial chemist, with more than ten years of experience. Biocides, agrochemicals and ecotoxicology.
2011
Petrochemicals derivatives, wastes, cosmetics and pharmaceuticals consortia management. Staff increase to 12 people.
Elena Meriano – Head of REACH Registration group
2012
Qatar office opens.
Loredana Savin – Head of CLP/GHS group
ACCREDITATIONS ChemSafe is a full member of ORO, the Only Representatives Organisation. ChemSafe is a member of the Industrial Union of Turin, Italy.
Biologist, with more than 11 years of experience. Technical dossier preparation, study monitoring, Iuclid. Biologist, with more than 11 years of experience. Classification, labelling, GHS.
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.
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PROFILE: ChemSafe
Cosmetics
CASE STUDY 1: REACH testing programme
SERVICE AREA BREAKDOWN Training 5%
IT & software 10%
CONTACTS
PROFILE: Chemservice
Other 5%
Website
www.chemservice-group.com
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
Information 15%
Representation & management 20%
GLOBAL OFFICES
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, Turkey, 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 will be 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
Consultancy/ advisory 45%
2013/14
Turnover, group
~ €3m
Turnover, chemical service provision
~ €3m
No of offices
7
No of countries represented
5
Chemservice GmbH, Worms, Germany Chemservice S.A., Grevenmacher, Luxembourg Chemservice Asia Co Ltd, Seoul, Korea Chemservice Ltd Sti, Bodrum/Mugla, Turkey Chemservice EHNS GmbH, Worms, Germany Consortia Management GmbH, Worms, Germany ChemCEHTRA SAS, Bordeaux, France ChemAdvocacy S.A., Grevenmacher, Luxembourg SERVICES PROVIDED Global regulatory affairs consulting 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 5 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.
Staff, group
30
Consortia, Sief and letter of access management
Staff, chemical service provision
28
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.
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CASE STUDY 2: REACH-Code-Model
We act for manufacturers outside the EU as only representative and cover 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 non-EU manufacturers would no longer have registration obligations, but will be regarded as downstream users. Only one registration is needed by the only representative. Moreover, we act as only representative for non-EU manufacturers of articles, which intentionally release substances and we act as third party representative (of a community entity) according to REACH Article 4.
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.
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 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 Representatives 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 285 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 1.200 C&L notifications. STAFF SELECTION Dr Dieter Drohmann – Managing Director OO OO OO
PhD in environmental sciences founder of the Chemservice Group >20 years of experience in the chemical industry as regulatory affairs manager
Karl-Heinz Reis – Director Global Regulatory Affairs OO OO
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
Dr Neslihan Altinbas – Managing Director of Chemservice Ltd Sti, Turkey OO OO
PhD in chemistry ~15 years of experience in GLP and GMP quality assurance in the field of pharmacology and plant protection products, and nanoparticles
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
master in biochemistry ~20 years of experience in analytical and ecological chemistry, ecotoxicology and toxicology
Ah-Reum Seo – Regulatory Affairs Advisor (Korean) OO OO
Chemical Watch | Global Service Providers Guide 2015
chemist >8 years of experience in R&D and regulatory affairs
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PROFILE: Chemservice
Only representative and third party representative
SERVICE AREA BREAKDOWN IT & software 5%
Other 10%
PROFILE: CHEMTREC
CONTACTS Information 85%
Website
www.chemtrec.com
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
Directors
Chris Reed, Chief Executive Brian Banks, Product Manager Kevin Bryan, Sales Manager
Ownership
American Chemistry Council
Locations
USA
Founded
1971
GLOBAL OFFICES Falls Church, VA, USA SERVICES PROVIDED Emergency response 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..
SDS management 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. 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.
2014/15
2011
CHEMTREC celebrates 40 years of service.
Turnover, group
-
2012
Turnover, chemical service provision
-
CHEMTREC signed an MOU for mutual assistance with the National Registration Center for Chemicals (NRCC) of China.
No of offices
1
2015
No of countries represented
-
CHEMTREC’s SDS digital library reaches the six million SDS milestone.
Staff, group
-
Staff, chemical service provision
-
VITAL STATISTICS
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PARTNERS CHEMTREC has a memorandum of understanding (MOU) for mutual assistance with several emergency response organisations around the world. CHEMTREC has MOU’s in place with organisations located in: OO Canada; OO Mexico; OO South America; OO China; and OO New Zealand.
Chemical Watch | Global Service Providers Guide 2015
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
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. STAFF SELECTION Chris Reed – General Manager Brian Banks – Product Manager Kevin Bryan – Sales Manager
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.
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PROFILE: CHEMTREC
CLIENTS
PROFILE: Chilworth – a DEKRA Company
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
CONTACTS Website
www.chilworth.co.uk
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 Explosion & Process Safety Service Unit
Ownership
Wholly owned subsidiary of DEKRA SE
Locations
UK, USA, India, Germany, France, Spain, Benelux, Scandinavia, Eastern Europe, Japan, Brazil, Northern and Southern Africa, Israel, Japan and China
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. Most importantly, our team is your team. Chilworth’s consulting services can be built around your precise business needs; whether adding to your capabilities or supporting you on a short, medium or a permanent basis through our partnership programmes.
Founded
1925 (DEKRA)
Process safety information – laboratory testing
OVERVIEW Chilworth is a global organisation devoted to helping process industries avoid major fire, explosion and loss of containment events and improve performance to save lives and protect assets. We have globally consistent consultant practitioners capable of delivering consultancy, training and testing in process safety anywhere in the world, and in a wide variety of languages. VITAL STATISTICS
2013/14
Turnover, group
€2.5bn
Turnover, chemical service provision
€700m
No of offices
30+
No of countries represented
80+
Staff, group
35,000+
Staff, chemical service provision
500+
SERVICE AREA BREAKDOWN
Training 5%
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
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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. Chilworth 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 cuttingedge techniques and dedicated laboratory testing teams. We offer more than 300 standard testing procedures, as well as the research capability to conduct unusual or complex customised testing. The result is an expert and trusted service that not only delivers quality controlled results, but removes the pressure on resources, continuity and compliance associated with in-house testing. Material testing Chilworth’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. Laboratory testing Our CPE teams provide laboratory testing data with expert consultancy, for the identification and assessment of exothermic reaction hazards, thermal stability screening, reaction and adiabatic calorimetry, runaway simulation, engineering solutions and emergency vent design (DIERS). Laboratory Testing Services also available from Chilworth 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 Chilworth’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 2015
Regulatory Support DEKRA provides a large range of regulatory support services with regard to chemicals to it’s clients in industry and trade: OO classification and labelling of products according to CLP, ADR, etc; OO preparing MSDS in more than 20 languages; OO notification of products in national inventories and registers; OO REACH: support with registration and authorisation; OO DEKRA fulfils the REACH only representative position for several companies based outside the EU; OO evaluation of product marketability in the EU; OO support with occupational safety, eg risk analysis. Process safety training Sharing knowledge is what we do; it is our guiding principle. By sharing our expertise, Chilworth 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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
CASE STUDY 1: Chilworth’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 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, Chilworth – a DEKRA company has tailored an extensive portfolio of tests of a diverse selection of materials under both REACH and CLP criteria. CASE STUDY 3: Co-operating with a number of service providers from Europe to the Far East, Chilworth 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: 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. STAFF SELECTION Dr Stephen Rowe – Managing Director 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.
1986
Foundation of Chilworth Technology Ltd.
1991
Chilworth Technology Inc established in US.
1995
Received Good Laboratory Practice accreditation.
2001
IChemE safety and environmental awards winner.
2003
Chilworth goes global; capabilities established in France, Italy and India.
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.
2008
Chilworth acquires Spanish facility.
Mr Daniel Baker – Safety Testing Specialist
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.
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.
ACCREDITATIONS Good Laboratory Practice (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.
Chemical Watch | Global Service Providers Guide 2015
Dr David Firth – Business Development and Marketing Manager
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: Chilworth – a DEKRA Company
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 Russia SERVICES PROVIDED Identification
PROFILE: CIS Center
CONTACTS Website
www.ciscenter.ru
info@ciscenter.ru
Head office
Nakhimovsky prospekt, 31/2, 117418, Moscow, 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
Anna Miroshnik
Russian safety passport (RSP)
Directors
Dmitry Skobelev
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 RSP, 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 RSP 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 safety passports.
OVERVIEW CIS Center was founded as a non-profit organisation. It 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 enterprises and regulators regarding chemicals safety across the supply chain and throughout the whole product lifecycle in order to reduce trade barriers. CIS Center’s team includes experts on standardisation, classification and labelling of substances and mixture, expert chemists and REACH and GLP consultants which can help your company find individual solutions. We can offer a wide range of services, including: OO identification of chemicals; OO creation, expert examination and registration of Russian safety passports (SDS in Russia) for chemicals; OO classification and labelling according to Russian national standards; OO SDS creation; OO risk assessment and risk management; OO consulting in the field of Russian regulation on chemicals; OO best available techniques (BAT) implementation; OO REACH, GLP and Russian national regulatory compliance training; OO other (standardisation, IT localisation, ASTM PTP etc). VITAL STATISTICS
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
2
No of countries represented
1
Staff, group
65
Staff, chemical service provision
20
Consultancy/ advisory 45%
IT & software 10%
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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, the US, South Korea, China, Brazil, Australia, Singapore and elsewhere. Risk assessment and risk management CIS Center activities lie in the field of exposure assessment, risk estimation and evaluation of chemicals in order to minimise negative impact of chemicals on human health and the environment in accordance with the best available risk management practices. Additionally CIS Center provides training courses on chemical risk assessment and management for the chemical sector of Russian industry, Customs Union officials and regulatory experts. 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
Laboratory 5% Information 15%
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.
Consulting in the field of Russian regulation on chemicals
SERVICE AREA BREAKDOWN Training 20%
Classification and labelling according to Russian national standards
Representation & management 5%
A new activity 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.
Chemical Watch | Global Service Providers Guide 2015
CIS Center organises training and conferences in the field of chemical control and safety regulations. We run regular training sessions and seminars on classification, RSP 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
OO
OO
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. 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. One of the main activities of CIS Center is standardisation. Our experts are directly involved in the development of the national and interstate (in the territory of Custom Union) standards regarding chemical regulation and safe handling, including the GHS and BAT implementation in the Russian Federation.
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
OO
OO
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.
2010
Organisation of the third annual conference of CIS countries “Safety regulation of chemicals. UN Recommendations and European regulations REACH and CLP” (Baku, Azerbaijan Republic).
2011
Organisation of the fourth annual conference of CIS countries on chemicals regulation (Astana, Kazakhstan).
2012
OO
OO
2013
OO OO
OO
OO
2014
OO
OO
CLIENTS OO
Chemical industry
CASE STUDY: Russian safety passports Until the technical regulation "On Safety of Chemical Products" enters into force (expected to be in 2017), RSPs 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 RSP 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 safety passports, but think that if they translate an existing SDS (eg EU-SDS) into Russian it will be enough. Unfortunately, they are often unaware that although Russian safety chemical legislation harmonised with GHS, it has a number of distinct features (specific format, period of validity, dual classification and ect). This means that direct and even proper translation of an SDS into Russian is not a solution. More than that, each RSP 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, RSP, SDS and labelling creation. Our specialists are directly involved in the development of Russian Federation standards and always have up-to-date information on national and international chemical control legislation.
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 experts participated in the OECD pilot exercises on classifications of chemicals (CoCAM-4, CoCAM-5). CIS Center became an official partner and distributor of ChemADVISOR products in Russian-speaking territory. CIS Center experts participated in the finalisation of OECD pilot exercises on classifications of chemicals. Organisation of the seventh annual conference of CIS countries on chemicals regulation (Moscow, Russia).
PARTNERS OO
ASTM International, ChemAdvisor
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PROFILE: CIS Center
REACH, GLP, GPS and Russian national regulatory compliance training
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
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
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
2013/14
Turnover, group
> 70 M€
Turnover, chemical service provision
n/a
No of offices
5
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 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. General toxicology and expert services 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 6 months. The principal scientist, Inhalation has over 20 years of experience in inhalation toxicology with a range of chemical and pharmaceutical materials, while the other scientific and technical staff in the inhalation group have five years’ experience on average. 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 2015
–– ––
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.
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, zebrafish 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
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 CLIENTS OO
CiToxLAB work with the major players in each industrial sector.
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PROFILE: CiToxLAB
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SERVICES PROVIDED
PROFILE: DHI
REACH registration services including exposure scenarios
Website
www.dhigroup.com www.tox.dhigroup.com
hgf@dhigroup.com
Head office
Agern Allé 5, DK-2970 Hørsholm, Denmark
Tel
+ 45 4516 9200
Fax
+ 45 4516 9292
Contact
Hülya Genc-Fuhrman, Business Development Manager
Directors
Antoine Labrosse, Chief Executive Officer Peter Rasmussen, Chief Financial Officer
Ownership
Not-for-profit organisation
Locations
31 worldwide offices and operations
Founded
1964
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 them 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
2014/15
Turnover, group
€109m
Turnover, chemical service provision
€8.5m
No of offices
31
No of countries represented
49
Staff, group
1,045
Staff, chemical service provision
55
Product stewardship, regulatory services and software tools 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 are 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 acute and chronic ecotoxicological studies with organisms in water, sediment and soil and is specialised in carrying out standardised and specialised tests concerning biodegradability, ecotoxicity, endocrine disrupting effects and bioaccumulation of chemicals. DHI has furthermore experience as test facility for offshore activities using sensitive marine organisms. 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 data search, information retrieval, data gap analyses; OO toxicological evaluations; OO ecotoxicological tests; OO phrasing of claims, notifications and expert reports. Medical devices, pharmaceuticals and cosmetics
SERVICE AREA BREAKDOWN Training IT & software 1% 10%
DHI offers manufacturers and importers of substances following technical expert services: OO guidance and strategic counselling on chemicals legislation and REACH tasks; OO preparation of registration dossiers, CSR and individual testing strategies integrating use of non-test methods (Qsar, read-across, waiving); OO services on authorisation, strategic decision and communication, application for authorisation, analysis of alternatives and SEA. DHI facilitates and manages SIEFs and consortia, and provides third party representation and only representative (OR) services.
Consultancy/ advisory 54%
Laboratory 34%
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). Food and feed safety, drinking water
Representation & management 1%
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, United Kingdom, USA, Vietnam. Page 84
Regulatory advice and safety or risk assessments of novel foods, food packaging materials, dietary supplements, food and feed additives, contaminants, naturally occurring toxins, technical processing aids, whole foods and drinking water. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1964
Danish Hydraulic Institute (DHI) founded
1973
Approved as Authorised Technological Service Institute by the Danish Minister for Science, Innovation and Higher Education
Chemical Watch | Global Service Providers Guide 2015
1982
VKI laboratory accredited by DANAK, the Danish Accreditation and Metrology 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.
STAFF SELECTION
2013
Offices in 31 countries around the world
DHI works in accordance with the quality management system standard: OO ISO 9001 as certified by DNV. Ecotoxicology tests: OO in accordance with ISO 17025; accredited by DANAK, the Danish Accreditation and Metrology Fund; OO in compliance with the OECD and principles of good laboratory practice (GLP).
Extensive experience as project manager with references within REACH eg on registration and CSR, analysis of alternatives, industry strategy on SVHC and application for authorisation. Jens Tørsløv joined the management team of Department of Environment and Toxicology DHI in 2007 and plays a key role coordinating 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.
PARTNERS
Helle Westphal, MSc, Pharmacy – Head of Department
Software: OO ECOonline; OO Safeware Quasar Ltd OO Knauf; OO InterSolia AB.
Expert knowledge of European chemicals REACH legislation and broad knowledge on other parts of the European regulation related to chemical products. More than 20 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. More than 15 years of management experience.
CLIENTS Brenntag AG, Calcium Carbide Consortium, Cargill Inc, Chevron Products Company, Coloplast A/S, Danisco A/S, Danish Environmental Protection Agency, Delta, FeF Chemicals, Ferring Pharmaceuticals A/S, Echa, GE Healthcare, Halliburton, JFE Mineral Company (Ltd), Johns Manville, Knauf Insulation, KIST Europe, Leo Pharma, Magna Industrial Company Ltd (Hong Kong), Nickel Institute, Novo Nordisk A/S, Novozymes A/S, Owens Corning, Paroc Group, Rockwool A/S, Saint Gobain, Statoil AB, Sun Chemicals, URSA insulation. 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 can be granted. An analysis of alternatives therefore plays a key role in the authorisation title of REACH. CASE STUDY 2: assessment of risk management options DHI has conducted a number of analyses of risk management options for industry stakeholders and authorities. The aim is to support decision on possible further regulation, eg candidate list and authorisation, restriction
Chemical Watch | Global Service Providers Guide 2015
Jens Tørsløv, PhD, Ecotoxicology – Head of Projects
Hülya Genc-Fuhrman, PhD, Chemicals – Business Development Manager Has an international background including professional experience from Denmark, Turkey, the Netherlands and Australia. Expert knowledge of REACH legislation including but not limited to preparing lead registrant and company specific registration dossiers, forming and facilitating Siefs and consortia. More than 15 years of academic and practical consultancy experience including global regulatory management of chemicals (in the EU, USA, Canada, Australia) and health and environmental issues (risk assessment for environment and human exposure to chemicals, endocrine disrupting chemicals and water and health). Has also experience in organising and presenting at workshops and training programmes. 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 Environmental Protection Agency. 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 management, quality assurance and quality control of laboratory activities, environmental risk assessment and classification of chemicals and products.
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PROFILE: DHI
ACCREDITATIONS
harmonised classification or non-REACH measures such as deriving an EU OEL. Industry has high interests in providing information and views on this before decisions are made, as do authorities in not making faulty decisions. The RMO papers discuss available information and address concerns of risks to humans or to the environment. Relevant management options for risk reduction are identified and their suitability is discussed from a risk reduction as well as from a socio-economic view. The RMO is a useful way to document implications and benefits of different legislative options and can assist industry in their discussions with authorities.
GLOBAL OFFICES Dr. Knoell Consult GmbH, Mannheim, Germany Dr. Knoell Consult GmbH, Berlin, Germany Dr. Knoell Consult GmbH, Leverkusen, Germany Dr. Knoell Consult GmbH, Wageningen, the Netherlands Dr. Knoell Consult Ltd, Cardiff, United Kingdom 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
PROFILE: Dr. Knoell Consult GmbH
CONTACTS Website
www.knoell.com
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
Directors
Dr Hans-Emil Knoell Dr Runar Eberhardt Torsten Hauck Dr Michael Cleuvers
SERVICES PROVIDED Global registration of industrial and specialty chemicals
Ownership
Private company, majority-owned
Locations
Germany, UK, Switzerland, the Netherlands, Spain, Portugal, France, China, Thailand, US
Founded
1996
OVERVIEW The chemical business is a global business, and new chemical legislations are emerging worldwide! We are a full service provider in global regulatory affairs for agrochemicals, biocides, industrial/specialty chemicals, biopharmaceuticals, veterinary medicine and medical devices. Additionally we offer a wide range of services in the field of product safety (eg preparation of 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 Asia-Pacific region (China, Japan, Korea, Australia, and others). With a global network of subsidiaries and cooperation partners, we match our services to support your business needs.
Dossier preparation and submission: Iuclid 5 files for REACH, TSCA registration including PMN support, toxicological and ecotoxicological hazard and risk assessment, exposure modelling, post-submission support, communication with authorities, OR- and TPR-services, and full consortia management. Data review and analysis: strategic advice regarding testing and registration strategies, in silico methods (Qsar), read-across and waiving strategies), literature searches, data evaluation, data gap analysis, and study monitoring. Product stewardship: classification and labelling under GHS, CLP, and Osha HazCom; development and management of safety data sheets (SDSs) and extended safety data sheets (eSDSs); supply chain management and communication; and management and support of formulators and article manufacturers concerning regulatory compliance in their global markets. Global registration of agrochemicals and biocides
Turnover, group
> €40m
Strategic advice and consulting, literature research, data evaluation, data gap analysis, completeness checks, study management and monitoring. Dossier preparation, biological efficacy, residues and metabolism, dietary safety, toxicology, human exposure, exposure modelling, PEC-reports, environmental risk assessment, ecotoxicology, studymonitoring and management of bee studies, endocrine disruptors and CADDY-dossiers. Regulatory affairs, communication with authorities, post-submission report, full service provider.
Turnover, chemical service provision
> €15m
Medical devices, pharmaceuticals, cosmetics
VITAL STATISTICS
2014/2015
Number of offices
15
Number of countries represented
10
Staff, group
approx. 450
Staff, chemical service provision
380
SERVICE AREA BREAKDOWN Training Laboratory 5% 5% Information 7%
Representation & management 20%
Consultancy/ advisory 63%
Classification 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, Pre- and postmarketing 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.
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Chemical Watch | Global Service Providers Guide 2015
Analytical laboratory services
TESTIMONIALS
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.
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.
knoell managed a huge consortium with 58 companies covering substances in 11 sub-categories and submitted 157 successful registrations in 2013. To achieve this, we established a team of more than 30 scientists who were dedicated to this project, 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. CASE STUDY 2: agrochemicals
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.
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.
2012
Opening of a new Office in Berlin, Germany
2013
Foundation of Knoell Iberia SL, in Madrid, Spain.
STAFF SELECTION
2013
Acquisition of Critical Path Services, LLC, based in Pennsylvania Philadelphia, US.
2013
Acquisition of Shotwell & Carr, LLC, Carrolton, Texas, US.
2014
Opening of a new office in Lisbon, Portugal
2014
Foundation of Knoell France, SAS, Lyon, France
2014
Opening of environmental fate laboratory, in addition to already existing analytical and bioanalytical laboratory, at Critical Path Services, Pennsylvania, US
ACCREDITATIONS Qualified Cefic – partner. PARTNERS SCAS Japan, SCAS Europe, BSL Bioservice, Ibacon, Currenta, Ceres International, Tier3 solutions.
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
Toxicology > 40 toxicologists Regulatory affairs agrochemicals/biocides 20 specialists Ecotoxicology > 40 ecotoxicologists Dietary safety >20 specialists Product safety specialists (C&L, MSDS preparation) > 40 specialists Global regulatory affairs for chemicals > 20 specialists Consortium management, OR, TPR > 20 consortium managers Residues and metabolism > 20 specialists 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
CLIENTS We deliver flexible services to globally acting chemical companies as well as to small- and medium-sized enterprises. We work on- and off-site to support our customers’ specific local needs. Chemical Watch | Global Service Providers Guide 2015
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PROFILE: Dr. Knoell Consult GmbH
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
CASE STUDY 1: REACH consortium management and dossier preparation
PROFILE: EBRC Consulting
CONTACTS Website
www.ebrc.de
info@ebrc.de
Head office
Raffaelstraße 4, 30177 Hannover, Germany
Tel
+49 511 898389 0
Fax
+49 511 898389 10
Contact
Torsten Grewe
Directors
Dr Rüdiger V Battersby
Ownership
Privately owned
Locations
Germany
Founded
1993
OVERVIEW EBRC is a privately-owned consulting organisation based in Hannover, Germany, providing consulting services with a focus on 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
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
1
Staff, group
55
Staff, chemical service provision
33
SERVICE AREA BREAKDOWN IT & software 5% Representation & management 15%
GLOBAL OFFICES EBRC Consulting GmbH Raffaelstraße 4 30177 Hannover Germany
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Training 5% Consultancy/ advisory 75%
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); 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 Agrochemicals Active substance approval and national product registration. EU notification of active substances governed under regulation (EC) No 1107/2009: OO support of existing substances in the context of the renewal programme of the EU (AIR); OO support of new active substances; OO completeness checks, validation of existing studies, literature surveys; and OO full dossier preparation including risk assessments, 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 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, 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. Chemical Watch | Global Service Providers Guide 2015
STAFF SELECTION
1993
Foundation of EBRC (initial staffing: six people)
Rüdiger Battersby – Director
2015
Continual growth, leading to a current staff count of 55
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.
PARTNERS ARCHE, Belgium 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.
Arne Burzlaff – Senior Registration Manager Industrial Chemicals
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.
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.
CASE STUDY 3: RiCoG
Andreas Büsing – Senior Registration Manager Agrochemicals
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.
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
CASE STUDY 4: development of standard handling frequencies of rodenticide baits
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.
CASE STUDY 2: HERAG (Health Risk Assessment Guidance)
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 2015
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
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
SERVICE AREA BREAKDOWN Training 10%
Consultancy/ advisory 10% Information 10%
PROFILE: EcoOnline
CONTACTS Website
www.ecoonline.com
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, RD Manager Ms Martina Jonsson, VP Product Management Mr Luis G Paulsen, VP International Operations
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 3,500 enterprises now using our 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
2013/14 €8.3m
Turnover, chemical service provision
-
No of offices
6
No of countries represented
8
Staff, group Staff, chemical service provision
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67 -
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 2015
CLIENTS
STAFF SELECTION
Small and large, public and private, multinationals and locals, our clients represent most segments and industries. A total of more than 3,500 enterprises connect to the services.
Mr Kjell Hamnes – R&D
We’ll be happy to provide you with referrals that are relevant to you! Please contact us. CASE STUDY 1: automotive industry OO 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
OO
OO
OO
OO
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.
CASE STUDY 3: universities, hospitals, municipalities, public institutions OO
OO OO
OO
OO OO
OO
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. Mrs Christy Whiddon – Product Management Christy is product manager. She has extensive background in the chemicals industry, and a PhD in surface and colloid chemistry. 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 Director of Education and Product Management. He has a long and extensive career within chemical health and safety, and is trained OHS professional at Harvard. Mr Luis G Paulsen – International Operations and Partner relations Luis is responsible for international operations and partner relations. Mr Øyvind Thorsen – CEO Øyvind has extensive background from the software and computer industry.
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
an 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.
Chemical Watch | Global Service Providers Guide 2015
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PROFILE: EcoOnline
TESTIMONIALS
Kjell is the founder and head of R&D at 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.
SERVICES PROVIDED Risk management, strategic support and regulatory compliance (REACH, CLP, biocides, PPP, cosmetics, food contact materials)
PROFILE: ENVIRON
CONTACTS Website
environcorp.com
sbullock@environcorp.com
Head office
Artillery House, 11-19 Artillery Row, London, SW1P 1RT, UK
Tel/ Fax
+44 20 7808 1420 / +44 20 7808 1421
Contact
Sue Bullock
Directors
137 partners worldwide including
Jose Fernandez (FR) Sue Bullock, Dr Aidan Turnbull (UK) Dr Martina Vosteen (DE) Dr Bob De Mott, Dr Joseph Rodricks (US)
Ownership
Private limited company
Locations
93 offices worldwide
Founded
1982
Global chemical notifications and regulatory compliance support 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.
OVERVIEW An international environmental, health, safety and sustainability consultancy, ENVIRON works with clients to resolve their most demanding environmental and human health issues. 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
2013/14
Turnover, group (2013)
$294m (€214m)
Turnover, chemical service provision
-
No of offices
93
No of countries represented
21
Staff, group
1,520
Staff, chemical service provision (dedicated)
50
SERVICE AREA BREAKDOWN Representation & management 10%
For more than 30 years, ENVIRON has worked 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. ENVIRON also acts as consortium manager and only representative, and is independent from testing facilities.
Laboratory 5%
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; and OO advocacy. We are ideally placed to advise clients on problems across the spectrum of product safety and stewardship including product substitution and sustainable chemistry. We couple internationally recognised expertise and a reputation as a leader in risk management with client-focused solutions. BOMCheck and EC4P BOMCheck is a substances declarations web database for REACH, RoHS, batteries and packaging compliance to facilitate supply chain management. Environmental Compliance 4 Products (www.EC4P.com) is a web-based product compliance tool that helps producers of WEEE, batteries and packaging meet their regulatory obligations in Europe. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Consultancy/ advisory 85%
1982
Founded in Washington, DC, USA
2010
Chemical Industry Association (CIA) REACH service provider of the year
2014
Elektra European Electronics Industry Environmental Award for ENVIRON’s Environmental Compliance 4 Products webbased system (EC4P)
GLOBAL OFFICES
CLIENTS
Australia, Belgium, Brazil, Canada, China, Finland, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Myanmar, New Zealand, Poland, Russia, Singapore, South Africa, Spain, the Netherlands, UK, US
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.
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Chemical Watch | Global Service Providers Guide 2015
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 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, 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 2015
Sue Bullock – Principal, product safety and stewardship Leading 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. Dr Aidan Turnbull – Principal, WEEE, RoHS and eco-design Aidan has almost 20 years’ experience particularly in compliance with WEE directive and sustainable product design, integrated pollution prevention and control and environmental management systems. 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 chemical regulation specialist with 25 years’ experience in global regulatory affairs and toxicology for industry and has prepared registrations and applications for authorisation under 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.
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PROFILE: ENVIRON
CASE STUDY 1: REACH registration and evaluation
STAFF SELECTION
SERVICES PROVIDED Regulatory compliance OO
OO
PROFILE: EquiTox
CONTACTS
OO
REACH: data collection, data gap analysis and testing. REACH registration dossiers (Iuclid) and submission to Echa via REACH-IT, chemical safety reports (CSR), Inquiry process, etc. biocides and cosmetics. classification and labelling: notification C&L, classification of substance and mixtures according to CLP, UN GHS, DSD, DPD.
Website
www.equitox.eu
contact@equitox.eu
Regulatory information
Head office
63 rue André Bollier, 69307 Lyon Cedex 07, France
OO
Tel
+33 (0)48 253 9018
Fax
+33 (0)97 231 0242
Contact
Dr Benoit Fraysse
Director
Dr Christine Reteuna
OO
Ownership
Private company
Product advocacy and project management
Locations
Lyon, France
OO
Founded
OO OO OO OO
OO
2011
OO
OVERVIEW
OO
OO
OO
VITAL STATISTICS
2013/14
Turnover, group
€360,000
Turnover, chemical service provision
€360,000
No of offices
1
No of countries represented
1
Staff, group
5
Staff, chemical service provision
5
SERVICE AREA BREAKDOWN Training 19% Information 3%
environmental risk assessment (cosmetics, industrial chemicals, biocides, etc). human health safety assessment (cosmetics, industrial chemicals, biocides, etc). toxicological and ecotoxicological expertise.
Training OO OO
European chemical regulations (REACH, cosmetics, biocides, CLP). toxicology, ecotoxicology, risk assessment.
ACCREDITATIONS OO OO
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product defence strategy . animation and technical representation in consortia and Sief. communication strategy.
Specific and targeted technical support
EquiTox offers a full range of expertise in European chemical regulations (REACH, cosmetics, biocides, CLP…). We can manage your projects from the definition of your duties to the submission of your regulatory dossiers with their follow-up in case of challenge by authorities. We can also train your teams, develop your regulatory strategies, provide technical support for your customer services… The relationships we build with our clients are a reflexion of our core values: excellence, quality, open-mindedness, consideration of client constraints and trust. EquiTox is organised around five highly qualified experts, each with 10-20 years of experience working in toxicology, ecotoxicology and regulatory affairs departments of international chemical and consultancy companies.
Representation & management 10%
literature review, study assessment and validation. model prediction and Qsar. organising and follow-up of laboratory testing. safety data sheet (SDS) writing, update and regulatory audit. extended-SDS: writing, compliance check, auditing. global product strategy (GPS) summary and (eco)toxicological profile.
OO
European registered toxicologists (Eurotox). Members of the French Society of Toxicology (SFT). Members of the Society of Environmental Toxicology and Chemistry (Setac).
CLIENTS Our clients range from multinational companies to SMEs, producing industrial and specialty chemicals, petrochemicals, biocides and cosmetics. Our clients include: Bluestar Silicones, L’Oréal, Roquette, UIC RhoneAlpes. CASE STUDY 1: setup of a regulatory support process for an EU chemical importer/distributor
Consultancy/ advisory 68%
EquiTox supplies technical and regulatory support to an established EU chemical importer/distributor. We have developed a responsive and trustbased relationship. One of the biggest successes of 2013 was the withdrawal of a draft decision from Echa concerning a testing proposal. Working within the tight deadline and in coordination with the client (lead registrant), we were able to bring the Sief members together and define a pertinent strategy arguing for the waiver of the required tests. Then we set up a meeting with Echa’s representatives. Following this, we provided a written and a unanimously agreed response. The outcome was an update of the registration dossier and the approval from Echa not to perform the requested tests.
Chemical Watch | Global Service Providers Guide 2015
In preparation of the 2013 REACH registration deadline, a SME specialised in organic chemistry for the cosmetics and the food markets launched sub-acute toxicological tests with the advice of a CRO. However, due to a lack of in-house expertise in toxicology, the study design wasn’t appropriate for the chemical specificity of the test substance. As a consequence, the study had to be stopped because of several major deficiencies. EquiTox was contacted at that time. The requirements were clear: to produce a registration dossier without missing data that would pass the technical completeness check and was scientifically robust. All of this needed to be done in a short period of time. The strategy we developed was based on the physico-chemical properties of the substance (hydrolysis) and a read-across approach with well-known degradation products. We then completed with a weight-of-evidence using some information from the abandoned sub-acute toxicological study. We submitted, on-time, a reliable and valid registration dossier. CASE STUDY 3: the biocide Regulation: how to anticipate the future The new biocides Regulation (BPR, 528/2012) presents a wider field of application compared to the former one (BPD, 98/8/EC). As an example, active substances generated in situ have to be approved with a closed list of precursors. An international company specialised in the production of minerals for the food, manufacturing and chemical industries, was aware of a non-conventional application of their chemicals, as precursors of active substances generated in situ. They have asked EquiTox to help them to understand the biocidal regulations, and to define a strategy to be in compliance with the applicable regulations (national, European). EquiTox frequently provides them with an up-to-date overview of the current discussions at the EU level one this evolving subject. In addition we guide them in the different tasks to deal with: OO being in compliance with national regulations until the couple precursor/active substance is approved; OO communicating with the leaders of the active substance dossier submitted to the rapporteur member state; OO forming a consortium with the other mineral producers to be in a good position to negotiate a letter of access. STAFF SELECTION Dr Christine Reteuna – Regulatory Ecotoxicologist After obtaining her PhD in environmental toxicology, Christine began her career in the French Ministry of Environment for the implementation of chemical regulations. She then went into industry for 19 years (Rhodia), as an expert in regulatory ecotoxicology. It enabled her to work for both the consumer market (cosmetics, detergents, etc) and the industrial market (metal processing, oil market, etc), and to address environmental issues in a wide variety of products. She was also an Industry representative in several scientific (Ecetoc) and professional organisations (UIC, ASPA, Cefic). Christine has developed specific skills in the assessment of environmental impact of chemical products (eg polymers, surfactants, cosmetics); covering data collection, study monitoring, the establishment of ecotoxicological profiles, product classification and risk assessment. She has taken part in the production of several regulatory dossiers and their support against competent authorities.
Chemical Watch | Global Service Providers Guide 2015
Stéphanie Moulin – Regulatory Toxicologist Stéphanie spent ten years working in the chemical industry for Rhodia, as regulatory toxicologist. She also worked for the CNRS (French national scientific research centre) in the chemical risk prevention unit, and has teaching experience. Stéphanie’s main fields of activities are the development of testing strategies and the use of in vitro methods, the cost optimisation based on analogy and weight of evidence approaches, the selection and qualification of CROs, the registration strategies in Europe and in other zones, and chemical product defence. In addition, Stéphanie is specialised in human health risk assessment, with a focus on the safety assessment of cosmetic products. Dr Marie-Laure Teisseire – Regulatory ecotoxicologist Marie-Laure started her career in research, in the field of ground and surface water pollution, and teaching (six years at the University of Reims) then worked as a regulatory ecotoxicologist for a Chemical Company (Rhodia). The main projects managed by Marie-Laure, such as notification of new substances in EU or China or compilation of REACH dossiers, allowed her to improved her expertise in environmental exposure assessment to environmental risk characterisation and the definition of risk reduction strategies. Several other fields of expertise are environmental and physico-chemical hazard assessment of chemical products, study monitoring and hazard communication (SDS, C&L). Dr Benoit Fraysse – Regulatory (Eco)toxicologist Once he had his PhD, obtained in collaboration with the French Nuclear Safety Institute, Benoit developed expertise with three years in postgraduate positions, mixing teaching and research (French institutes and universities). He joined the French chemical company Rhodia, where he spent six years. Benoit specialises in analysis of the hazardous properties of substances (physical chemistry, environment, health) combining experimental tools with in silico (Qsars) methods. With regard to international issues, Benoit has a particular interest in the fields of developmental toxicity and the assessment of health risk to workers (REACH and biocide exposure scenarios). He also has active discussions with the competent authorities. Céline Goulois – Regulatory (Eco)toxicologist Céline is a regulatory (eco)toxicologist, specialising in REACH regulation. She studied chemistry and has a master in environmental toxicology. Before joining EquiTox in 2014, Céline spent 12 years as a consultant in several international consultancy firms (Altran, SGS) where she was in charge of the preparation and validation of technical documents, hazard classification, and REACH (registration, risk assessment, technical support). Céline’s skills are the technical coordination of REACH registration dossiers, with a substantial experience in Sief communication and dossier compilation. Her experience allows her to work with many product profiles and to propose a REACH compliance strategy suitable for each company.
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PROFILE: EquiTox
CASE STUDY 2: REACH registration dossier: when the clock is ticking and the expertise in toxicology is lacking
OO OO
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.
PROFILE: ERM
CONTACTS
Classification, labelling and packaging (CLP/GHS)
Website
www.erm.com
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 John D’Agostino (US), John Phillips (US), Nuno da Silva (US), Sarah Medearis (US), Jen Whitney (US), Simon Aumonier (UK), Sam Temara (France + Belgium), Rudolf Wilden (Germany), Vijay Gudivaka, Dailey Tipton, Thomas Wienke (Global IT)
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, tracking of emerging legislation bans/restrictions. Downstream product legislation, eg food/food contact, biocides OO OO OO OO OO
food contact notifications compliance with country-specific legislation Fifra / BPD/BPR support national registrations local/ regional registrations labelling and claims support
Ownership
Private limited company
OO
Locations
140
Lifecycle assessment and sustainability
Founded
1971
OO OO
OVERVIEW
OO
Environmental Resources Management (ERM) is one of the world’s leading providers of EHS and sustainability management, technical consulting and IT implementation services, with considerable experience in providing global product stewardship (GPS) services. Global product stewardship is positioned within ERM as a strategic growth initiative. ERM offers integrated product service across all divisions within the company. VITAL STATISTICS
2014
Turnover, group
$680m
Turnover, chemical service provision
$25m
No of offices
150
No of countries represented
40
Staff, group
> 5,000
Staff, chemical service provision
OO OO
carbon footprinting and emission inventories lifecycle management (LCM) also to ISO14040 design for environment (DfE) environmental product declarations (EPDs) lifecycle analysis (LCA)
IT services supporting product stewardship OO OO OO
Global product stewardship implementations IT enterprise sustainability systems Unbiased software evaluations for product stewardship applications
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2012
Technical partnership with ReachCentrum for preparation of the application for REACH authorisation
2013
ERM supports implementation of global chemical compliance programmes (regulatory and IT)
2014
ERM supports compilation of three REACH authorization applications
>150
ACCREDITATIONS
SERVICE AREA BREAKDOWN
ISO 9001 and ISO 14001
Training 10%
PARTNERS Partner of Cefic, ReachCentrum, SAP, Enablon, IHS
IT & software 20%
CLIENTS Consultancy/ advisory 60%
Representation & management 10%
GLOBAL OFFICES We support our clients in all countries globally. SERVICES PROVIDED Registration, evaluation and authorisation of chemicals (REACH) OO OO OO OO OO
socio-economic analyses preparation of applications for authorisation REACH training/ REACH impact assessments preparation of lead and member registration dossiers chemical safety assessments
Page 96
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 technical-scientific 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 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. Chemical Watch | Global Service Providers Guide 2015
“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.
Dr Steven Peterson – Senior Ecotoxicologist
CASE STUDY 1: supporting the REACH team of Momentive Performance Materials (MPM)
Dr Alfred Wiedow – Senior Toxicologist, DABT
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 Stewardship 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 Rudolf Wilden – Product Stewardship 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 – Partner, Global Stewardship and Reg Affairs 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. 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, globally harmonized system (GHS), European classification, labelling and packaging (CLP), TSCA, Fifra pesticide registration, and import /export of industrial chemicals and consumer products. Dr Dave Best – Technical Director PhD in microbial biochemistry, coordinating ERM’s global effort on the provision of REACH. He has 18 years of experience in the chemical industry as an environment, health and safety manager.
Chemical Watch | Global Service Providers Guide 2015
More than 35 years of regulatory toxicology experience from working in the chemical industry, a governmental agency and academic research institutions. He is a recognized 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 Stewardship Lead 20 years of experience in EHS Information Management. Key implementation projects with the European Chemical Agency and founder of a Solvay branch company in the domain of SAP EHSM on demand service. Ashish Deshmukh – Principal Chemist Chemist with over 20 years of experience in the environmental and chemical sciences with expertise in providing regulatory support for industrial chemicals, pesticides, and food contact substances. 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 Eckhard Schäfer – Principal Chemist PhD in chemistry, with more than 20 years’ experience in chemical risk assessment and preparation and implementation of safety plans. Health and safety advisor of the Hoechst Corporation between 1986 and 1994. Dr Elsie Millano – Senior Ecotoxicologist BSc in chemical eng and PhD in civil eng environmental area. Supporting the REACH team in the review and preparation of CSRs and safety data sheets, and review of robust study summaries. Over 25 years of environmental consulting experience in human health risk assessments, including exposure assessments, fate and transport evaluations, and risk calculations. Dr Randy Shuler – Senior Toxicologist Diplomate, American Board of Toxicology Inc, 1996-present, with more than 18 years of experience in toxicology, environmental science and consulting. Randy has evaluated toxicology and epidemiology data, and has provided litigation support in toxic tort and environmental litigation cases. 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. Carolyn Hammer – Senior Ecotoxicologist Before joining ERM Carolyn worked for the US EPA in the fields of ecological risk assessment of pesticides and the development of new Federal rules and regulations related to waste, chemicals and pesticides. 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 Wayne Bergin – Principal Consultant BSc in chemical engineering and BSc in chemistry with over 15 years of experience in international chemical, biocides and electronic equipment laws with specialist experience evaluating compliance issues associated with mergers and acquisitions.
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PROFILE: ERM
MPM required support for its REACH team using ERM’s REACH expertise, including toxicologists, ecotoxicologists and chemists. The ERM REACH project team was fully integrated into the MPM team and early identification and discussions of issues encountered provided timely resolution of such. Benefits and value: OO Successful submission of all registration dossiers in 2010 and 2013 OO comprehensive documentation of approaches and work products to enable MPM to demonstrate compliance to the Echa/CAs; OO alignment of global teams with same company culture ensures highly efficient cooperation; OO cooperation of the team with a view beyond registration (eg on health and safety management) helped solving upcoming issues; OO lessons learned during the first and second registration phase will inform and streamline future REACH management.
PhD in biological sciences with 20 years of experience in risk assessment, ecological research, environmental science with consulting firms, academic institutions, and government.
SERVICES PROVIDED
PROFILE: Exponent International Limited
REACH services 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 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 and higher tier modelling and if necessary risk characterisation. We also provide postsubmission support during evaluation and authorisation phases, 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.
CONTACTS Website
www.exponent.com
jreddy@uk.exponent.com
Head office The Lenz, Hornbeam Business Park, Harrogate, North Yorkshire, HG2 8RE, UK Tel
+44 (0)1332 868000
Fax
+44 (0)1332 868099
Contact
Julian Reddy
Ownership
Wholly owned subsidiary of Exponent Inc.
Locations
Derby, Harrogate UK; Basel, Switzerland
Founded
2002
Global chemical notifications
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 clients’ 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
2013/14
Turnover, group
Est US$15m
Turnover, chemical service provision
Est US$3m
No. of offices
3
No. of countries represented
35
Staff, group
50
Staff, chemical service provision
30
SERVICE AREA BREAKDOWN
Information 5%
Training 2%
Other 3% Consultancy/ advisory 65%
Representation & management 25%
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. Biocide services Exponent’s biocide group has vast regulatory expertise gained from working as government regulators, in industry, contract research organisations and as independent regulatory consultants. We have significant experience in assisting clients achieve positive Approval/ Annex I inclusion under the biocidal products Regulation (EU) No 528/2012 (BPR) and biocidal products Directive (98/8/EC). This has been achieved by interpretation of core, additional, and PT-specific data, successfully constructing scientifically defensible data waiving arguments and undertaking complex exposure modelling and risk assessments. We are experienced in evaluating and building product/family dossiers under the BPR; we routinely use Iuclid and R4BP; and we have achieved many authorisations under global national regulations. We offer advice on regulatory strategy, product stewardship, portfolio management and are experienced in the management of task forces. 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 ad‐hoc 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
GLOBAL OFFICES Global head office (Exponent Inc): 149 Commonwealth Drive, Menlo Park, CA 94025, US Other UK office: 1 Pride Point Drive, Pride Park, Derby, DE24 8BX, United Kingdom Switzerland office: Aeschenvorstadt 57, Basel, 4051, Switzerland Plus numerous other offices in the US, Germany and China
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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 2015
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 400 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 “Thanks for all your help and support throughout the (biocides) project. This certainly would not have been possible without your brilliant support. It has been an absolute pleasure to work with you. Thanks a lot for your patience, 'can do attitude' and over and above everything- thanks for tolerating my millions of phone calls!” – Regulatory Affairs Associate, global consumer goods company. 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 and in 2013 and wecontinue 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. To complete the CSRs, we work with the consortium members and external parties to identify downstream uses that need to be considered and proposing use descriptor codes for exposure assessments and the production of exposure scenarios. Due to the properties of the substances, creative yet pragmatic solutions have been necessary to demonstrate safe use. In addition we have also provided support for post registration activities and have been involved with compliance checks as part of a dossier evaluation and also substance evaluations. CASE STUDY 2: product stewardship service for an SME Exponent has provided ongoing product stewardship support for a catalyst manufacturer, covering REACH and all other global chemical regulatory regimes for over five years. Taking a holistic approach, we
Chemical Watch | Global Service Providers Guide 2015
provide global regulatory strategy and advice to ensure that legislative requirements from a number of countries can be effectively overlapped. Exponent also provides more technical support by preparing and submitting regulatory documentation for worldwide chemical notifications, including higher tier notifications in countries such as China and Japan. We prepare and review European safety data sheets and determine the classification and labelling of the substances for GHS inside and outside of the EU. We also act as a sole representative for their Swiss notifications. 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 postsubmission support for individual clients and task forces. Dr Howard leads the Exponent EU Biocides Business. Mr Stephen Johnson – Head Of Cosmetic Safety & 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 and Regulatory Affairs (Europe) Dr Evans recently 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 99
PROFILE: Exponent International Limited
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
GLOBAL OFFICES OO OO OO OO
PROFILE: Fieldfisher
CONTACTS
OO
Website
www.fieldfisher.com
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
Chemicals
Fieldfisher is a full service European law firm comprising some 150 partners, 220 other lawyers, nearly 70 trainees/paralegals and 300 support staff. Fieldfisher advises international clients on domestic and EU law and has extensive experience advising on large and complex multijurisdictional matters. With five 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 both advisory 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. VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
9
No of countries represented
6
Staff, group
763
Staff, chemical service provision
16
SERVICE AREA BREAKDOWN Consultancy/ advisory 10% Representation & management 10% IT & software 5% Legal 70%
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OO
SERVICES PROVIDED
OVERVIEW
Training 5%
OO
Brussels, Hamburg, Munich, Dusseldorf, Paris, London, Manchester. Palo Alto, Shanghai (partner firm)
With more than 20 years' experience in EU chemical law – compliance 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 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, BPD, PPPD, CLP, GHS, DSD, DPD, WEEE, RoHS, medical devices, cosmetics, food and food contact, and other consumer and industrial products. Agrochemicals/pesticides We advise major pesticide manufacturers on the European reregistration 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 re-submission 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 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 2015
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
2011-2012
The Pesticides team continues to build on its litigation success and currently has approximately ten cases pending before the EU and national courts. In the wake of the Lisbon Treaty, and applicants’ improved rights of access to judicial remedy, industry is likely to benefit from further rights of legal challenge, particularly relating to regulatory restrictions adopted by EU institutions and agencies. The team successfully handled data compensation arbitration proceedings launched in several EU member states
ongoing
The Biocides team manages and serves as legal secretary to several biocide task forces, among which is the EU Silver Task Force. The silver dossier is commonly known as the most complex dossier in the EU review programme, comprising eight different silver forms and 13 participating companies.
2012-2014
The team filed ground-breaking 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).
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. Agrow Awards Fieldfisher won the Agrow Awards 2014 in the "Best Supporting Role" category. The Best Supporting Role award is provided every year to a company that has contributed most to the global crop protection and associated industries through the provision of support services. 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.
Chemical Watch | Global Service Providers Guide 2015
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. 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 a large consortium of chemical companies in relation to the REACH regulation, involving antitrust compliance work and handling of confidential information. CASE STUDY 2: EU Silver Task Force The team sets up and manages the European Silver Task Force and defends all notified silver form/product type combinations in the EU review programme. It also provides legal advice on data protection, dossier submission and overlap with REACH Regulation. CASE STUDY 3: Fieldfisher's EU Regulatory team represented several clients in litigation before the EU General Court regarding classification under the CLP, identification of substances as substances of very high concern, candidate listing and inclusion in the authorisation list under REACH Regulation. The substances concerned include borates, coal tar pitch, anhydrides, chromium trioxide, acrylamide, cadmium, n-propyl-bromide and many others. STAFF SELECTION Claudio Mereu – 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
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
SERVICES PROVIDED REACH registration
Website
www.fobig.de
info@fobig.de
Head office
Klarastraße 63, 79106 Freiburg i Br, Germany
Tel
+49 761 386080
Fax
+49 761 3860820
Contact
Klaus Schneider
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 DSD and 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).
Directors
Klaus Schneider, General Manager
REACH authorisation
Ownership
Private company
Locations
Germany
Founded
1992
Together with partner RPA Ltd, FoBiG prepares applications for authorisation with: OO updated CSRs, including a refined exposure assessment to demonstrate acceptable remaining risks; OO analysis of alternatives; OO socio-economic analysis; and OO complete application package (Iuclid 5 dossier).
PROFILE: FoBiG
CONTACTS
OVERVIEW FoBiG is a privately owned consultancy specialising in toxicological 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 prepared the REACH Baseline studies and related reports (part of the REACH review in 2013). 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 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
Turnover, group
-
Turnover, chemical service provision
€1m
No of offices
1
No of countries represented
Europe-wide
Staff, group
12
Staff, chemical service provision
12
SERVICE AREA BREAKDOWN Information 2%
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 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 as well as safety assessments of consumer products including exposure assessment. 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 active substances; 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.
Training Other 4% 2%
Representation & management 2%
Occupational toxicology (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. Consultancy/ advisory 90%
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REACH dossier and substance evaluation and restrictions
Other services FoBiG provides regulatory support and (eco)toxicological risk assessments in various other areas such as food safety, environmental contaminants and effects assessment for industrial plants requiring permissions.
Chemical Watch | Global Service Providers Guide 2015
1989
Founded as personal company by Fritz Kalberlah.
1992
Reorganised as private company (GmbH) with partners Fritz Kalberlah, Klaus Schneider, Martin Hassauer.
2009
New company partner Jan Oltmanns.
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 OO
Chemical and pharmaceutical companies (from multinational to small- and medium-sized). EU institutions (eg Efsa, JRC, Eurostat). (German) federal and other authorities (eg BfR, Baua, UBA). Stakeholder organisations (eg VCI, trade unions).
CASE STUDY 1: read across for filling data-gaps Application of read-across and category approaches for filling data gaps in registration dossiers: Read-across proved to be the most successful strategy during the first two REACH registration phases for filling data gaps. Cases, where FoBiG successfully applied read-across in registration dossiers include: OO category formation/grouping based on structural relationship; OO read-across from metabolites to parent compounds or vice versa; and OO read-across along homologous structural changes. At the same time Echa 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 2: 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 allows developing quantitative estimates also for sublinear dose-response 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 biomonitoring measurements), which may be supported case-by-case byTier II exposure modelling (eg byART, RISKOFDERM, ConsExpo etc.), are key to a successful application.
Chemical Watch | Global Service Providers Guide 2015
CASE STUDY 3: dossier and substance evaluation: refinement of CSR and supply chain information With more and more substances being added to the Corap list, substance evaluation becomes an additional important activity within REACH. Companies, whose substances are concerned, should adopt a proactive position, communicate with the competent authority, and try to reduce existing concerns. 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 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
GLOBAL OFFICES GLTaC, Inc, 4608 North Saginaw Road, Midland, MI 48640 SERVICES PROVIDED Translation services Translations and/or reviews of safety data sheets, labels, phrase libraries, national regulations and more. GLTaC spends considerable effort recruiting and evaluating the most qualified linguists in the EHS industry as well as keeping current on the terminology of the national regulations of the languages into which we translate. Our expertise allows us to offer extremely high technical accuracy with short delivery schedules into over 70 languages.
PROFILE: GLTaC, Inc.
CONTACTS Website
www.gltac.com
info@gltac.com
Head office
4608 North Saginaw Road, Midland, MI 48640, US
Tel
+1 989 839 5804
Fax
+1 989 839 5838
Contact
djstrock@gltac.com
Directors
Hei-Kyong King Douglas J Strock
Ownership
Private company
Locations
US
Founded
1996
Phrase library reviews for: OO OO OO OO
Technical accuracy Correct translation Consistent terminology Compliance with current regulations
SDS reviews for: OO OO
OVERVIEW
OO
As the leading language services provider to the EHS industry, GLTaCâ&#x20AC;&#x2122;s translations appear on over one million safety data sheets each year. Additionally, we translate a plethora of national regulations to support chemical classification and hazard communication worldwide. Our extensive translator recruitment and evaluation process ensures only qualified professionals with the proper industry experience and educational background join our team, and most of our linguists have held EHS roles or have advanced degrees in a closely related field. GLTaC has the capabilities and industry expertise to not only provide you with the most technically-accurate translations possible, but also to serve as a trusted partner in meeting your business goals. GLTaC is a member of the Society for Chemical Hazard Communication (SCHC), the Association of Language Companies (ALC), the Patent Information User Group (PIUG), and the Council on Safe Transportation of Hazardous Articles (COSTHA). We are ISO 9001:2008 certified. EDWOSB certified, and SBA 8(a) certified.
OO
VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
1
OO
Readability Correct translation Technical accuracy Consistent terminology Current regulatory references
Translations of other corporate material such as websites, contracts, patents, Product Data Sheets, policies, manuals, training material and more. Proofreading of source content to ensure technical accuracy, consistent use of terminology and translation efficiency. CLP Phrase Set (234 hazard statements, precautionary phrases, physical properties) in 48 languages based on the current EC and national regulations). CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1996
GLTaC incorporated in Midland, MI
2001
Developed our proprietary, in-house Translation Management System and E-Commerce capability
2009
Awarded contract W911SF-09-D-0002 over 35 competitors
2010
Purchased and renovated our current Corporate HQ location
2010
Received ISO 9001:2008 Certification
2013
Received SBA 8(a) Certification
2013
Passed our ISO 9001:2008 recertification audit
Staff, group
<25
ACCREDITATIONS
Staff, chemical service provision
<25
ISO 9001:2008 (Quality Management System) PARTNERS
SERVICE AREA BREAKDOWN Training 15%
Consultancy/ advisory 10%
Legal 15% Information 40% IT & software 20%
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OO
None
CLIENTS GLTaCâ&#x20AC;&#x2122;s clients are global businesses in a wide variety of industries, including: OO safety data sheet authoring systems; OO chemicals; pharmaceuticals; OO ag-bio; medical device manufacturing; OO paints and coatings; automotive engineering; and OO legal/regulatory specialists.
Chemical Watch | Global Service Providers Guide 2015
TESTIMONIALS
STAFF SELECTION
"I was very pleased with the service and timeliness of my request. A partner company put me in touch and I worked with your project management team from that point. They were very helpful, answered my questions and were prompt with delivery. I am grateful to be in touch with your business and to know that we can turn to GLTaC in the future for translation needs." Erica Speight, Regulatory Affairs Manager, Comax Flavors "Please be assured that I am well pleased with the service provided by the folks at GLTaC. They have gone above and beyond for me on more than one occasion. Their efforts are truly appreciated" John Carter, Senior Information Specialist, Invista S.a.r.l. “Our company has been using GLTaC’s translation services for the past five years and has always been completely satisfied. They do an excellent job, go beyond the call of duty to exceed our expectations, are always punctual and offer very competitive rates. Their professionalism and customer service is outstanding.” Nathalie Hon, B.Sc., Project Coordinator, BPO, Product Steward Services, IHS, Inc.
Lisa Greschaw, Senior Project Manager Lisa has been with GLTaC for more than seven years and manages complex projects. Previously she was a manager at The Dow Chemical Corporation. Her organisational skills and ability to focus on the small details while maintaining the “big picture” are a tremendous assets in the work she does for GLTaC. John Robinson, Project Manager
Kaori Manley, Project Manager Kaori has been with GLTaC for more than ten years and manages a wide variety of projects, including the Machine Translation (MT) division. A native Japanese speaker, she brings a unique skill set to GLTaC.
CASE STUDY 1: Extreme project management OO
OO
OO
Problem: Review a large project critical to the customer that was done by a competitor. The project involved over 15,000 SDS phrases in 44 languages. Solution: GLTaC identified over 400 errors in the source text, resulting in over 15,000 changes to the project material. Multiple automated and manual reviews of the resulting XML file of over 660,000 lines produced a substantially improved result. Errors ranged from failing to comply with regulatory requirements, to spelling and grammar, capitalisation and punctuation, to failure to follow instructions. Result: GLTaC reduced the error rate from over 60% down to under 0.01%.
CASE STUDY 2: SAP R/3 implementation OO
OO
OO
Problem: Implement SAP R/3 using customised manuals in multiple languages with minimal impact to the business, while changing client project leader mid-implementation. Solution: While a team of more than ten people authored training documents in English, GLTaC was not only translating, but providing a thorough proofreading of the freshly created content. Due to the GLTaC proprietary Translation Management System, we were able to provide the client a detailed accounting of hundreds of documents within two hours of their audit request, ensuring all parties had correct accountability. Result: The SAP implementation went forward on schedule with training conducted and materials available in native language format.
CASE STUDY 3: Cite the proper reference OO
OO
OO
Problem: Thousands of SDS phrases required identification of the proper regulatory reference in both English and over 40 target languages. Solution: The staff and translators at GLTaC were able to research and identify the correct, current reference material in all languages where such regulation existed. Result: All phrases now have a regulatory reference tied to them, increasing the confidence in the accuracy and compliance of the phrase set as a whole.
Chemical Watch | Global Service Providers Guide 2015
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PROFILE: GLTaC, Inc.
John has been with GLTaC for more than five years and divides his time between project management and business development. John has previous experience as an appraiser and emergency dispatcher, giving him a skill set well suited to doing project management work.
PROFILE: International Cosmetics & 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.
CONTACTS Website
www.intlcosmetics.com
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
Â
Georgia Boehm
Ownership
Private company
Locations
USA, UK
Founded
1997
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 report; 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.
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. VITAL STATISTICS
Only representative (REACH), CLP notifications (sole representative)
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
2
No of countries represented
35
Staff, group
10
Staff, chemical service provision
4
SERVICE AREA BREAKDOWN Training 15%
Representation & management 25%
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. US agent, cGMP audits and training, electronic US FDA registrations 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. Training for GMPs and ISO manufacturing standards
Consultancy/ advisory 60%
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
GLOBAL OFFICES US: International Cosmetics and Regulatory Specialists LLC UK: International Cosmetics and Chemical Services Ltd
Page 106
REACH 2007
Formed REACH Chemical Consulting, Ltd now known as International Cosmetic 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.
Chemical Watch | Global Service Providers Guide 2015
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.
2014
Assisting clients with meeting CLP deadlines and with preparations for the 2018 deadline. 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.
2008
Designated expert Cosmetic GMP and Microbiology workgroup in Paris.
2009
Designated expert Cosmetic GMP and Microbiology workgroup in Baltimore, MD, US.
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. 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
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
PARTNERS Manhattan Repro (graphic design for labelling) CLIENTS
STAFF SELECTION Janet Winter Blaschke, BA, Biology, University Redlands OO OO
OO
OO
OO
OO OO
CEO of International Cosmetics & Regulatory Specialists LLC. CEO and founder US, and managing director of International Cosmetic 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
Georgia Boehm, AA Business Management, Glendale College OO
OO
OO
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.
Deborah Rediet, BA French and Minor in International studies, California State University Long Beach OO
OO OO
OO
regulatory manager – nine 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 .
Harmony Gates, MS Chemical Engineering OO
chemical engineer – 12 years’ experience in regulatory affairs in the US, Canada and the EU; specialising in environmental regulatory issues.
Robert Blaschke, BA, French, Loyola Marymount University OO
OO OO
regulatory affairs specialist.– four years’ experience in FDA compliance in the USA . expert with FDA electronic registrations and IT portal. IT specialist.
Alterna, Arbonne International, California Tan, CB Fleet Co, Circle of Friends, Contem 1g (Brazil), Davi (Mondavi) Skin, Disney Consumer Products Inc, Dermanew, Econet, Inc, Frederic Fekkai, Freeman Beauty, Giorgio Nardi (Italy), Go Smile, Henkel Consumer Goods, ICN Pharmaceuticals (Valeant Pharmaceuticals), Johnson & Johnson Consumer Products Inc, Jordana Cosmetics Corp, Juvena/La Prairie (Switzerland, Germany), Laboratoire Labothene Cosmetique GMbH (Germany), Leaf & Rusher, Mary Kay Inc, Merle Norman, MERCK (MSD), M&K (JK Mueller & Myung Sun), Nu Skin, Ole Henriksen, Pental Soap Products (Australia), Pierre Fabre DermatoCosmetique (France), Pola Cosmetics (Japan), Procter and Gamble, Rock & Republic, Smashbox, TIGI (Toni and Guy), Twincraft Soap Company, Zenyaku USA, as well as other Fortune 100 and Fortune 500 companies.
Chemical Watch | Global Service Providers Guide 2015
Page 107
PROFILE: International Cosmetics & Chemical Services Ltd
2010
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/
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 0161 245 8071
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Contact
Jeremy Ramsden
Directors
Sir David Reid, Chairman, Wolfhart Hauser, Chief Executive Officer, Edward Leigh, Chief Financial Officer
Ownership
Public
Locations
Intertek is the industry leader with more than 36,000 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 127 years, and evolved from the combined growth of a number of innovative companies.
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
2013/14
Turnover, group
£2,054m
Turnover, chemical service provision
£154.8m
No of offices
1,000+
No of countries represented
100+
Staff, group
36,000+
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 ComalongTechnology Service Park, No. 889 Yi Shan Road, Shanghai, China 200233, +86 021 6073 7735 Page 108
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 added granulometry to complement their comprehensive suite of REACH physico-chemical property tests and chemical characterisation.
2013
Intertek expanded commercial materials and surface analysis laboratory capabilities in Australia with the addition of 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.
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: OO Dr Ruud Overbeek – board member of Decernis; OO 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; OO Dr Paul Lambert – committee member of the European Structural Integrity Society (ESIS TC4); OO 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); OO 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), the Color Pigments Manufacturers Association (CPMA), Canadian Paint and Coatings Association (CPCA) and the Canadian Consumer Specialty Products Association (CCSPA). CLIENTS Our clients include: Behr, Bosch, BP, ChevronTexaco, Citgo, ConocoPhillips, Haier, Lubrizol, Petrobas, Siemens.
Chemical Watch | Global Service Providers Guide 2015
TESTIMONIALS
Dr Michael Leise – Senior Expert Consultant
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
Dr Michael Leise is one of Intertek’s senior expert consultants in regulatory affairs whose 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.
CASE STUDY 1: Incorrect definition of substance can lead to unnecessary registration
Helen Xue – General Manager, Chemicals & Pharmaceuticals, China
CASE STUDY 2: Intertek’s global network of experts helps clients achieve cost-effective registrations worldwide As most companies focus more and more on core competencies such as R&D, marketing and production, it is our role as a true service provider to help our clients with exactly those support services no longer considered core. For instance, our analytical, regulatory and environmental compliance services focus on these competencies ensuring that our clients can draw from our global network of experts, particularly in North America, Europe and Asia/Pacific Rim. Due to our in-depth understanding of the regulatory requirements locally we helped a multinational chemical company save €80k by coordinating the testing requirements for China, Japan and Europe. STAFF SELECTION Torben Nörlem, Esq – Chief Counsel Regulatory Services Torben Nörlem, Intertek’s Legal Counsel for Regulatory Services, 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. Naeem Mady, Vice President, Regulatory Services Naeem Mady serves as Vice President of Intertek Regulatory Services. His 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 programs; 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. Chemical Watch | Global Service Providers Guide 2015
Karen Levins serves as Intertek’s Senior Vice President, Global Business Development and Vice President Chemicals Group at Intertek Scientific and Regulatory Consultancy Services. As a regulatory toxicologist with more than 19 years’ experience, Karen helps the chemical industry understand and comply with global regulations controlling the manufacture, importation, distribution, and use of new and existing products. 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 is the Global Business Stream Leader for Healthcare and Beauty Products within Intertek. He 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 Ashley Roberts – Senior Vice President, Food and Nutrition Group, Intertek Scientific and Regulatory Consultancy Dr Ashley Roberts worked in the area of scientific and regulatory affairs for more than 25 years. Ashley is an experienced regulatory toxicologist who has worked in both the food and pharmaceutical industry. He is available to advise and assist our international clients with issues that are scientific, regulatory and toxicological in nature. In addition, he is able to assist those clients wishing to design and develop scientific research programmes and for those developing regulatory strategies for food additives, foods that are generally recognised as safe (GRAS), and novel foods Dr Ruud Overbeek – Vice President, Global Health, Environmental and Regulatory Services Dr Ruud Overbeek leads Intertek’s Global Health and 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, holds advisory roles on environmental business impact within the US health and beauty industry’s governing association and has a doctorate in chemistry. Page 109
PROFILE: Intertek
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.
Karen Levins – SVP, Global BD and Marketing, Intertek Scientific and Regulatory Consultancy Services
GLOBAL OFFICES OO OO OO OO OO
PROFILE: iPoint-systems
CONTACTS
OO
Website
www.ipoint-systems.com
info@ipoint-systems.de
Head office
Ludwig-Erhard-Straße 58, 72760 Reutlingen, Germany
Tel
+49 7121 144 89 60
Fax
+49 7121 144 89 89
Contact
Katie Boehme, Global Marketing
Directors
Joerg Walden, CEO
Hans-Gerhard Lang, Director Sales
Ownership
Private (Germany: GmbH, US: Inc, UK: LLC, Sweden: AB)
Locations
Germany, Austria, UK, France, Sweden, USA, China, Japan
Founded
2001
OO OO OO
Reutlingen, Germany (Headquarters) Dortmund, Germany Vienna, Austria (KERP Centre of Excellence) Manchester, UK Paris, France Växjö, Sweden Southfield, MI, USA Shanghai, China Tokyo, Japan
SERVICES PROVIDED Software solutions Environmental product compliance and sustainability: ELV, IMDS, RoHS, REACH/CLP, LCA, DfE, RRR, conflict minerals, GHG, sustainable open innovation, SDS, dangerous goods management. Consulting Sustainability strategies, business and process analysis, impact analysis, EH&S consulting, sustainable products and brands, sustainable supply chain, sustainable manufacturing, circular economy. Training Training events in the field of environmental product compliance and sustainability.
OVERVIEW iPoint is an expert in environmental product compliance and sustainability, specialising in software, consulting and training for managing, tracking and reporting throughout the supply chain from product concept to completion. iPoint delivers adaptive and comprehensive software solutions that give the visibility and control customers seek in managing sustainability. iPoint’s solutions ensure compliance with requirements and regulations such as Dodd-Frank 1502 (Conflict Minerals), ELV, REACH, RoHS, or RRR, at the same time supporting companies in increasing the sustainability of their products. VITAL STATISTICS
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
9
No of countries represented
Sustainability services for handling data from companies’ supply chain. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2001
iPoint-systems gmbh founded in Reutlingen/Germany.
2002
Sales office in UK opened.
2007
Office in North America opened.
2008
Sales office in China opened.
2010
Acquisition of KERP GmbH in Austria.
2012
OO OO
OO
8 2011: 55; 2012: 70, 2013: 80, 2014: 90
Staff, group
Data care services
Staff, chemical service provision
20
2013
OO OO
SERVICE AREA BREAKDOWN Training 10%
2014
OO
2015
OO
Consultancy/ advisory 20%
Information 10% IT & software 60%
Gartner recognises iPoint-systems as Cool Vendor. Quality seal “Top 100”: iPoint-systems is Innovator of the Year. Launch of iPoint Conflict Minerals Platform (iPCMP). iPCMP is an on-demand software solution which enables companies to collect, manage, aggregate and report Conflict Minerals information and meet the requirements of their customers and regulatory. New offices in China and Japan opened. Gartner “Sample Vendor” in the areas “Sustainable Sourcing and Procurement” and “Life Cycle Assessment Tools”. IPC “Distinguished Committee Award” for contributions to the development of the Conflict Minerals Data Exchange Standard IPC-1755. With 25,000+ registered companies, the iPoint Conflict Minerals Platform (iPCMP) becomes the cross-industry, market-leading standard solution for Conflict Minerals reporting.
ACCREDITATIONS ISO 9001 ISO 14001 PARTNERS OO
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AIAG, IHS, NTT, TetraTech, Microsoft, Oracle
Chemical Watch | Global Service Providers Guide 2015
CLIENTS OO
OO
OO OO
OO
OEMS: Ford, Harley-Davidson Inc, GM, Hyundai/Kia, Jaguar Land Rover, Nissan, Renault, Scania Suppliers: Automotive Lighting, Hella, Johnson Controls, Lear, Magna, Mahle, Meritor, Valeo Electronics: Arçelik, AKG, Bosch, Tridonic Machinery and plant engineering: ABB, Florida Production Engineering, Pentair, Rexroth, Voith Other industries: Caterpillar, ITW, Eugster/Frismag, MTU, Roche Diagnostics, Tesa
STAFF SELECTION Management consulting Chemical and material experts Software engineering Support and services Sales and marketing
TESTIMONIALS
OO
OO
“State of the Art in Compliance Management” – Günter Braun, GETRAG “iPoint is a very responsive and trusted partner who listens to our ideas, wishes, or requirements and then proposes a suitable solution. For me, the brand iPoint stands for trust, business competence, and reliability.” – Erik Höppö, Scania CV AB “For me, iPoint stands for innovation, competence, and flexibility” – Fred Twardon, PhD, Automotive Lighting Reutlingen GmbH
PROFILE: iPoint-systems
OO
CASE STUDY 1: Automotive Lighting OO
OO
OO
iPoint-systems optimises global ELV processes at Automotive Lighting with Compliance Agent’s IMDS Solutions. Closing the floodgates on data: AL has to create about 750 in-house material datasheets (MDS) for annual average of 75 new products – about two per day. This means that on top of our own MDS, we receive about 20 times as many again from suppliers – which makes for a flood of data. Finding the light at the end of the tunnel by ensuring that delivered data was both on time and correct was therefore the main priority for the new IT-solution http://www.ipoint-systems.com/en/newsroom/brochures/#c1369
CASE STUDY 2: MagnaSteyr Legally compliant and sustainably designed products for MAGNA STEYR: OO main motivation for the project: use of a software tool that facilitates compliance with regulations governing material recycling and recovery. A steadfast commitment to the environment begins with the development of green products while considering each individual life cycle stage OO in a joint effort with MAGNA STEYR, we have successfully developed iPoint RRR. This tool greatly reduces the time needed to calculate recycling and recovery rates, allowing simulations of different recycling scenarios while emulating novel recycling technologies. OO http://www.ipoint-systems.com/en/newsroom/brochures/#c1369 CASE STUDY 3: iPoint-systems equip Turkish household goods sector leader with new software solution OO
OO
OO
In the EU, houseware producers are faced with innumerable regulations. In particular, surface properties and pure substances of imported products are closely monitored. In order to maintain profitability and ensure a complete overview of the country-specific standards, the Turkish leader in the household goods sector has chosen the iPoint Supplier Entry Portal (SEP) and the Compliance Agent (module SAM-M). www.ipoint-systems.com/en/newsroom/news/
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SERVICES PROVIDED Hazardous substance consulting Safety data sheets
Website
www.kft.de; www.kft-academy.com; www.kft-ebook24. com; www.kft-chemdoc24.com
mail@kft.de
Head office
Im Leuschnerpark 3, 64347 Griesheim, Germany
Tel
+49 6155 86829 0
Fax
+49 6155 86829 25
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, USA, all of Asia, South America and South Africa. We generate SDS in all EU languages, also in Russian, Thai, Malay, and Mandarin Chinese. We also support specific national certifications as required in Turkey. A comprehensive concept of SDS maintenance packages has been successfully introduced allowing customer’s permanent updating of safety data sheets (SDS) pursuant to statutory requirements. The total care service is completed by the latest innovation KFT SDS Control & Care, covering the management of supplier SDS.
Contact
Karl-Franz Torges (PhD), Karin Schmidt
Raw materials management
Directors
Karl-Franz Torges (PhD), Managing Partner
Ownership
Private company
Locations
Griesheim (near Darmstadt), Germany
Founded
1995
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.
PROFILE: KFT Chemieservice
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
Generation and maintenance of exposure scenarios
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
1
Staff, group
17
Staff, chemical service provision
13
SERVICE AREA BREAKDOWN Training Legal 12%
Other 8%
1%
IT & software 1% Laboratory 2% Information 14% Representation & management 12%
Consultancy/ advisory 50%
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. 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 registration Registration pursuant to §16e of the German chemicals Act (ChemG), the German Federal Institute for Risk Assessment (BfR), the German detergents and cleaning agents Act (WMRG) and product registrations 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 Iuclid 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.
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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. Emergency numbers Emergency numbers are important in two respects. First, they must be provided in safety data sheets according to the REACH Regulation (1907/2006/EG). 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 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.
ACCREDITATIONS VCH (association of chemical suppliers) subsidiary of FECC (European Association of Chemical Distributors) Member of ENES (European network on exposure scenarios) 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) 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.
Chemical Watch | Global Service Providers Guide 2015
GmbH that all documents and labels conform to legal regulations. KFT Chemieservice checks the requirements and legal conformity with regard to: OO chemical legislation; OO ordinance on detergents; OO cosmetics regulations; OO biocide regulations; OO environmental regulations; OO commodities regulations; OO transport law (hazardous materials) etc; and OO and ultimately issues approval for marketing. CASE STUDY 2: marketability study 2 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. 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 cargo, 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
Seminars,training and coaching
PROFILE: National Chemical Emergency Centre (NCEC)
SERVICES PROVIDED Software
Website
www.the-ncec.com/
Chemdata® – clear and concise chemical hazard information on more than 50 000 substances, at your fingertips. Pocket Chemdata® – Chemdata® for pocket PCs and smartphones running Windows Mobile, Android and iOS operating systems. ChemeDox® – document management system, with functions for COSHH compliance and distribution.
ncec@ricardo-aea.com
Emergency response
Head office
Ricardo-AEA Limited
Shoreham Technical Centre, Old Shoreham Rd, Shoreham-by-Sea, West Sussex, BN43 5FG, UK
Tel
+44 (0) 1235 753654
Fax
+44 (0) 1235 753656
Contact
ncec@ricardo-aea.com
Directors
Jonathan Gibbard
Locations
UK
Carechem 24 – for MSDS, labels and packaging, legal compliance and the gold standard of responsible care. Carechem Marine – for transport by sea, guarding your cargo... and your reputation. CERS – for keeping your business running, protect your employees and reduce the risk of business downtime. Chemsafe – 24-hour support for the UK's emergency services. Haulsafe 24 – for UK road transport, guaranteed specialist advice to keep your wagons on the road.
Founded
1973
CONTACTS
SDS services
OVERVIEW The National Chemical Emergency Centre (NCEC) offers a 24-hour emergency response service that provides fast, trusted and up-to-theminute advice to both the emergency services and businesses around the world, including 50% of the world’s top 100 chemical companies. For over 40 years NCEC’s exceptional products and services have set global standards on emergency response and compliance, helping its customers to manage risks associated with working with chemicals. In addition, its commercial emergency response services have helped companies to provide and obtain specialist advice and information when dealing with chemical emergencies. NCEC can help with all aspects of chemical risk management and offers a number of services including training; REACH consultancy; crisis notification and SDS authoring.
NCEC's SDS authoring services and SDS management software. SDS Authoring – keeping your safety data sheets legal and compliant with REACH and GHS. ChemeDox® – document management system, with functions for COSHH compliance and distribution. Training Chemical training to help you comply with legislation and to help you and your staff deal with chemical emergencies. Bespoke training courses – including hazmat 1st response and chemical spill response. Open training courses – including chemical hazard awareness and making COSHH assessments. Online training courses – including chemical hazard awareness and first aid for chemical exposure Consultancy
No of offices
21
Classification, labelling, information and advice on chemical safety legislation as well as chemical risk management. REACH Services – help with your responsibilities under REACH and GHS. REACH Glossary – a list of REACH-related terms and abbreviations.
No of countries represented
11
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
VITAL STATISTICS
2013/14
Turnover, group
£229.7m
Turnover, chemical service provision
£2.7m
Staff, group
2,300
Staff, chemical service provision
32
SERVICE AREA BREAKDOWN Training 10% IT & software 10%
Consultancy/ advisory 20%
Information 10% Representation & management 50%
GLOBAL OFFICES
2012
NCEC receives over 4,500 calls per year, approximately 10% of these are through our Chemsafe role advising the UK emergency services.
2012
Chemsafe – providing chemical emergency response services to UK fire, police and ambulance for 39 years through the Chemsafe scheme on behalf of UK government.
2012
Chemdata – chemical emergency response software for emergency responders around the globe from public and private sector. Over 55,000 products listed and available on laptops, PCs, Apple devices and Android phones.
2013
NCEC marks its 40th anniversary with a regulatory conference and celebration event.
2014
NCEC launches crisis management services including crisis notification, exercising/crisis testing, training and consultancy
2015
NCEC hosts Global Chemical Crisis – chemical regulation and crisis management conference
UK, China, Czech Rep, Germany, India, Italy, Japan, Korea, Russia, USA, Malaysia, South Africa
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PARTNERS
CASE STUDY 2: overheated lithium battery incident
NCEC is part of Ricardo-AEA and also part of: 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 who include UMCO (Germany), DHI (Denmark), INERCO (Spain), REACH Global Services (Turkey), NSSS (India), REACH24H (China), Chemtopia (Korea) and JCDB (Japan). CLIENTS NCEC’s client list includes governments, trade associations and over 800, industrial customers. NCEC has a wide and deep understanding of the issues facing the global chemical industry. We take client confidentiality seriously and do not routinely publish or promote individual client relationships. TESTIMONIALS Chemsafe “All requests for information and advice were handled quickly and information explained concisely.” Group Manager David Somerville, Fife Fire and Rescue Service Emergency Response “Carechem 24, like all the services provided by National Chemical Emergency Centre [NCEC] at Harwell, 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 “This is the first time we have used the NCEC for emergency response training and we found it really beneficial to our employees. We had mock incidents planned where our employees had to physically deal with the scenario. It made us think more of our surroundings and the possible incidents we could be faced with – we are going to continue this training with NCEC so that employees are kept focused on their environment.” Sue Clegg, UOP Ltd
A lithium battery measuring 25 x 20 cm was undergoing testing at an electrical equipment testing company. It overheated on a workbench and released smoke and fumes. The fire and rescue service was in attendance and had evacuated the building. A firefighter contacted NCEC for advice on the level of PPE required to enter the building and isolate the battery, and the decomposition products. Solution: the NCEC emergency responder explained that different types of lithium battery would produce different decomposition products, but inhalation of metal oxides can cause metal fume fever, which has a delayed onset and causes flu-like symptoms. The emergency responder recommended suitable PPE including breathing apparatus, in accordance with the emergency action code (4W) for lithium batteries. Furthermore, the emergency responder advised the firefighter that dry agents, such as sand, should be used to smother the battery fire and that the area should be thoroughly ventilated before employees were allowed back into the building. Expertise: NCEC can provide guidance to companies on the safe handling and transportation of lithium batteries, and offers an emergency telephone advice service that is dedicated to providing advice on lithium batteries. CASE STUDY 3: barn fire incident NCEC received a call from a Fire Station Manager who was dealing with a barn fire late in the evening. The barn was constructed of asbestos and contained two tonnes of ammonium nitrate fertiliser. The Station Manager was concerned about the environmental impact of the fire water due to the ammonium nitrate fertiliser. Solution: the NCEC emergency responder advised the caller that ammonium nitrate is not toxic to the aquatic organisms, but caused eutrophication (an algal bloom that uses all of the oxygen in the water as it decomposes, causing fish and other aquatic organisms to die). When asked if ammonium nitrate was toxic in fire, the emergency responder explained that nitrogen oxides would be produced, which pose a risk of pulmonary oedema, and that firefighters should be monitored for 48 hours after exposure. Expertise: NCEC emergency responders are available 24 hours a day, 365 days a year to provide chemical advice to the emergency services, helping them to protect people, property, and the environment. STAFF SELECTION
CASE STUDY 1: polyurethane foam manufacturing fire incident
Dan Haggarty – Emergency response
NCEC received a call from a fire and rescue service station manager who was dealing with a major fire at a factory where polyurethane foams were manufactured. Police and ambulance service personnel were also in attendance. The station manager was concerned about the chemicals used in the process – isocyanate solutions, polyols and solvents. He wanted advice about the hazards, thermal decomposition products, personal protective equipment (PPE) and decontamination. Solution: The NCEC emergency responder advised the station manager that the isocyanate solutions posed the greatest hazard and explained that they were flammable, toxic, irritant, skin sensitising and hazardous to the environment, and that they may be absorbed through the skin. The emergency responder also explained that hydrogen cyanide and nitrogen oxides were likely products of thermal decomposition. The emergency
Bethan Davies – Chemsafe
Chemical Watch | Global Service Providers Guide 2015
Maria Stearn – Chemdata Chris Sowden – SDS authoring Mike Kent – SDS management – ChemeDox Caroline Raine – REACH Paul Rast-Lindsell – Training David Key – Crisis management
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PROFILE: National Chemical Emergency Centre (NCEC)
Quality assurance As part of Ricardo-AEA, the NCEC is recognised via Lloyd's Register Quality Assurance (LRQA) which has issued the certificate of approval to RicardoAEA for the Environmental and Quality Management System Standards below. OO BS EN ISO 9001: 2008 OO ISO 14001: 2004 OO The TickIT Guide Issue 5 (Overall business certificate) Certificate expiry: 30 November 2014
action code for isocyanate solutions is 2X. Therefore, the emergency responder advised the use of liquid-tight chemical protective clothing with breathing apparatus and explained that soap and water should be used for decontamination of equipment. In addition, our emergency responder liaised directly with the manufacturer of the products to provide the most up-to-date safety data sheets to the fire and rescue service. Expertise: NCEC’s chemists work closely with the emergency services and the chemicals industry to provide impartial expert advice in the event of a chemical incident.
ACCREDITATIONS
SERVICES PROVIDED REACH services OO
PROFILE: REACh ChemAdvice GmbH
CONTACTS
OO OO
Website
www.reach-chemadvice.com
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 OO
OVERVIEW
OO
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.
OO
VITAL STATISTICS
2013/14
Turnover, group
c â&#x201A;Ź1.5m
Turnover, chemical service provision
c â&#x201A;Ź1.5m
No of offices
6
No of countries represented
6
Staff, group
10
Staff, chemical service provision
10
SERVICE AREA BREAKDOWN Training 10%
OO OO OO OO OO OO OO OO
OO
CLP services OO OO OO OO OO OO
OO OO
OO OO
OO OO OO
Information 20%
OO
Consultancy/ advisory 60% Representation & management 5%
OO OO OO OO
GLOBAL OFFICES REACh ChemAdvice GmbH, Germany Regional offices: Portugal, Sweden, USA, India, China
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
Other 5%
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 5 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 5 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
identification of obligations under the BPR implementation of strategy for BPR compliance preparation of Iuclid 5 dossiers (approval of active substances and authorisation of biocidal products) and submission in the R4BP 3 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 REACH compliant safety data sheets BPR and Iuclid 5 workshops
Cosmetics services Once you select REACH ChemAdvice as your consultant, we will be pleased to provide a comprehensive range of services customised exactly for your needs. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
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2007
Start up in Frankfurt am Main, Germany
2007
Opening regional office in USA
2008
Opening regional office in India Chemical Watch | Global Service Providers Guide 2015
Relocation to new offices in Kelkheim/Taunus
2011
Start cosmetics consultancy
2011
Opening regional office Sweden
2012
Expansion into the Iberian peninsula (Portugal and Spain)
2012
Opening regional office in Portugal
2013
Opening regional office in China
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. REACH ChemAdvice, as an ERPA-member (European Cosmetics Responsible Person Association), supports the cosmetic industry in all REACH-difficulties during the whole complex cosmetics supply chain, as the cosmetic industry needs to comply with the new cosmetics Regulation and REACH. 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: 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: Cosmetics industry We are a member of cosmetics associations and are actively involved as project managers for the development of guidelines. We help especially SMEs in the cosmetics industry to manage the interface between REACH and the new cosmetics Directive. 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 2015
Carlos Fazendeiro – Director Regulatory Affairs (Head Office and 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. He is a licentiate in industrial chemistry (five years degree, University of Beira Interior, Portugal) and has practical education and training on REACH, CLP/ GHS, biocidal products Regulation, Iuclid 5, REACH-IT, R4BP 3 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. Prof Dr Dieter Mayer – Toxicologist Professor Mayer s extensive research experience having worked at the Institutes of Human Genetics, University of Heidelberg, and Environmental Health, University of California, Davis. He was scientific director at the Centre International de Toxicologie, Evreux, France, and professor at Frankfurt’s Johann Wolfgang Goethe University, Institute of Pharmaceutical Technology. He has been a guest professor at Johannes Gutenberg University, Mainz, Institute of Toxicology, Risk Assessment, Methods in Modern Toxicology and also at the German Society of Pharmacology and Toxicology. His industrial career includes having been a toxicologist, and global head of toxicology Hoechst AG, Hoechst Marion Roussel, Aventis SA. 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
2009
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 Strategic implementation of European regulations Participation to consortia, co-registrants agreements, data sharing, deadline and tonnages for registration are decisions that are managed in order to find the most cost-effective solution and the most convenient choice on the market. OO Chemical management and product stewardship The market will constantly evolve over time. Companies will face new challenges to strategically select secure suppliers and to identify growing sector markets. Our business development experts will support companies with the most effective advice, in compliance with the provisions of the regulation. OO Implementation of IT systems for chemical management Companies will internally develop new management systems to integrate existing tools to monitor the presence of chemical substances, including deadlines, total amounts, risk management measures etc.
PROFILE: REACH master y
OO
Web site
www.reachmastery.com
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 is 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
2014/15
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
1
Staff, group
11
Staff, chemical service provision
11
SERVICE AREA BREAKDOWN Training Legal Other 1% 2% 5% Information 2% Representation & management 15%
Consultancy/ advisory 75%
REACH services 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 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. 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 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 expert persons are managing Iuclid compilation. 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 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. OO Authorisation dossiers REACH mastery acquired the expertise to develop authorisation dossiers complete with analysis of alternatives and socio-economic analysis OO
CLP/GHS services OO OO OO
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data collection and assessment of classification and labelling CLP notification MSDS compilation
Chemical Watch | Global Service Providers Guide 2015
OO OO OO OO
dossier preparation risk assessment test monitoring assistance to customer for Efsa calls for data
BPD services OO
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
PPP services OO
OO OO
OO OO OO OO OO
support of existing substances in the context of the EU review programme, re-submission of dossiers for active substances Annex III dossiers for re-registration of products post-Annex I inclusion Annex III dossiers for new products or to support label changes and/ or formulation changes testing strategy development study monitoring risk assessment finalisation and discussion with national and EU authorities. post-submission support
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
2009
Restructuring of REACH mastery as independent company
2010
About 120 successful registrations for the 2010 deadline
2011
Implementation of the group with operative members
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
PARTNERS RTC, QSAR group of Bicocca University, Vitroscreen, REACH & Colours, CAAT Europe as preferred cooperations. CLIENTS We are working for about 50 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 2015
CASE STUDY 1: TIER 2 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 CASE STUDY 2: Echa compliance check During 2014 Echa finalised a thorough compliance check on many dossiers submitted in 2010. None of the dossiers submitted by REACH mastery received up to now requests for new tests or better justifications.. REACH mastery was involved into the revision and update of about 17 dossiers prepared by other consultants CASE STUDY 3: Application for authorisation In 2014 REACH mastery prepared and submitted the application for authorisation for trichloroethylene, with deadline 20 of October, on behalf of two Italian companies, complete with analysis of alternatives and socioeconomic analysis, in co-operation with the company Danger&Safety s.r.l. The application was so far positively commented by stakeholders and Echa. 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
FEED and FOOD registration
SERVICES PROVIDED Business solutions
Website
www.reachcentrum.eu
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
Craig Barker, Managing Director
Ownership
Private company
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. Moreover, ReachCentrum has set up a series of transversal services beyond REACH regulation: OO CLP Regulation; OO non-European chemicals regulations; OO biocidal products Regulation (BPR), where it works to promote joint submission for product families with same active ingredients.
Locations
Brussels, Belgium
Project management
Founded
2006
ReachCentrum has extensive experience in managing consortia 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.
PROFILE: ReachCentrum
CONTACTS
OVERVIEW ReachCentrum, created in June 2006 by the European Chemical Industry Council (Cefic), 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 services and support tools are designed for European and non-European companies working on their own or in close collaboration with other companies. VITAL STATISTICS
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
-
Staff, group
17
Staff, chemical service provision
17
SERVICE AREA BREAKDOWN Training 20%
Consultancy/ advisory 30%
IT & software 5% Representation & management 30%
GLOBAL OFFICES European Union supported by partners for global coverage.
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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. 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. Consortia management for biocides ReachCentrum is initiating biocides consortia for 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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Legal 13%
Information 2%
Authorisation support
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).
2011
Partnership with TNO Triskelion and with Zieta Technologies
2012
Set up of three authorisation consortia.
2013
Technical partnership with ARCHE for biocidal products Regulation.
2014
Submission of the first joint application for authorisation (HBCDD).
2014
Creation of the first biocidal product family (BPF) preconsortium, sodium hypochlorite Chemical Watch | Global Service Providers Guide 2015
OO OO
LPI accredited as authorised training assessment centre. LPI accredited as authorised training organisation.
PARTNERS REACH Global Services (RGS) for Turkey; national association service providers; SCAS Europe; ARCHE 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. "I had the chance to participate to the REACH Awareness Bootcamp in December 2014. During this training session, teachers used, for some presentation, Prezi tool. I found this tool very powerful: with the use of few key words, it pictures the concepts in a very interactive way. For me, it is how we have to use a presentation. It was just a support for the teacher completed by the speech, and it's exactly the goal of this kind of presentations. Congratulations to ReachCentrum because it's rare to attend a training session during which the presentation is focused on the speech instead of the text on the powerpoint!" – Marion Bichot, Saint Gobain. CASE STUDY 1: biocidal product family (BPF) pre-consortium A first biocidal product family (BPF) pre-consortium for sodium hypochlorite as an active substance has been set-up by ReachCentrum and ARCHE (as technical service provider) in November 2014. About 40 companies have joined the BPF pre-consortium to be compliant with the biocidal products Regulation. ReachCentrum, as Secretariat of the preconsortium, has collected the questionnaires containing information on the uses, product types (PTs) of interest and composition of formulations from companies. ReachCentrum is currently working on the organisation and structure of pre-consortium/consortium bodies: technical committee, steering committee and Secretariat. Also, it is performing its tasks regarding the creation of a model for data and cost sharing, which will then be presented to consortium members for revision and approval in the first steering committee meeting. CASE STUDY 2: substance evaluation Substance evaluation can be a real challenge due to extremely short timing when for instance answers on draft decision are expected to be given back to Echa. As this is preferably been done by the lead registrants on behalf of all co-registrants, an efficient communication strategy with clear and unambiguous messages is developed together with the lead and the consortium. In case of a substance with many co-registrants ReachCentrum makes sure that the contact list is up to date and registrants coming during the process are also included in the information flow. ReachCentrum also provides regularity advice throughout the process, accompanies and minutes meetings with the evaluation member states’ competent authority and serves as central point of contact again to facilitate the communication or acts as trustee for data in case the member states request more information during the decision-making process.
Chemical Watch | Global Service Providers Guide 2015
STAFF SELECTION Craig Barker – Managing Director Managing Director of ReachCentrum, Craig previously worked for Cefic, where he was Director, Product Stewardship and in Regulatory Affairs for AkzoNobel NV, in the Netherlands. Prior to that, he held the position of Global Head Regulatory Affairs and Advocacy with Ciba Inc, Basel, Switzerland. With more than 30 years working in the area of product stewardship and regulatory affairs Craig played an active role in the development of the REACH regulations and has participated in developing many of the chemical requirements around the globe. 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. Leondina Della Pietra – Project Manager Leondina is in charge of consortia management both for REACH and biocidal products Regulation (BPR), where she is developing ReachCentrum’s strategy for consortia. Having an industrial chemical background, she started her career in R&D moving to manufacturing and chemical industry as a consultant. In this field she assisted companies to adapt to requirements and obligations imposed by European regulations in health and safety in the workplace and environment. A postgraduate MSc in REACH and CLP Regulations, she gained experience as project manager in London. Caroline Bertein – Project Manager Caroline is in charge of REACH consortia management. Having a legal background she started her career as legal advisor on REACH and other EU regulations in a trade association. In this field she assisted companies to adapt to the requirements and obligations imposed by European regulations in health and safety in the workplace and environment. She was also in charge of REACH implementation in an international industry for several years. Marc Aerssens – Project Manager Marc joined ReachCentrum in October 2014 as project manager. With a background in chemistry, he worked for over twenty years in industry in various positions (R&D, production and operations). Since late 1999 he has been working as regulatory affairs manager taking care of registrations of biocides and plant protection products. He has been involved in REACH as from its inception. Marc has been a member of a number of Cefic sector groups and has managed REACH consortia since 2007.
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PROFILE: ReachCentrum
ACCREDITATIONS
SERVICES PROVIDED Tailored customer services
PROFILE: REACHLaw
CONTACTS Website
www.reachlaw.fi
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
Contact
Mr Ville Mäkelä, Sales Director
Directors
Mr Lasse Kurkilahti, Chairman of the Board Mr Lasse Musakka, CEO, Partner Mr Frederik Johanson, Head of Environmental, Partner Mr Jouni Honkavaara, CFO, Partner Dr Mathias Berner, Partner Mr Riku Rinta-Jouppi, Head of Global Compliance, Partner Dr Ying Zhu, COO, Partner Mr Ville Mäkelä, Sales Director
Ownership
Private company
Locations
Finland, Belgium, India, Turkey
Founded
2006
In many cases REACHLaw customer assignments start with a management consulting assignment with a well-defined and limited scope. On the longer term new service areas are identified and the tailored services portfolio is provided on a continuous basis. Typically compliance services are among the first ones to be assessed; for which market areas and regulations it makes sense for the company to buy services from a single specialised service provider rather than from multiple sources or use own service organisation. The EHS function often contains a lot of heterogeneous, small and compulsory tasks requiring specific competences; it makes sense to out-task these. In some of the cases the company ambition level may lead into broader EHS outsourcing services. The continuous service delivery will need IT solutions to integrate with customer organisation. REACH authorisation services Authorisation is one of the most complex challenges for companies under REACH. REACHLaw combines the best expertise and deep understanding of the business and regulatory requirements to provide companies with a full set of services towards authorisation. Our support covers the issues from defining the overall strategy and scope of the authorisation to performing the work needed in all the stages of the authorisation process (eg analysis of alternatives, socio-economic analysis, chemical safety report and full authorisation application). With two applications already submitted, and several ongoing projects, REACHLaw has already gained significant practical experience in authorisation. Biocidal products regulation services
OVERVIEW REACHLaw provides first class solutions in global market access related regulatory compliance, outsourcing and out-tasking in EHS and related digital solutions. We partner with our clients in these three fields, ensuring their global market access by meeting regulatory requirements, but also by identifying their business opportunities in the market place. With the outsourcing and out-tasking solutions our customers are able to focus on the core activities of the company. Likewise, additional digital solutions provide much needed efficiency in the EHS function. Having a multicultural team, REACHLaw is able to serve its clients in the following languages: English, Finnish, French, German, Spanish, Swedish, Chinese, Hindi, Russian and Turkish.
REACHLaw supports companies that produce and/or make available biocidal products, active substances or treated articles on the EU market in all the stages of the new biocidal products Regulation – BPR. Our services cover stages from defining the overall strategy, a roadmap towards BPR to performing all of the work needed to obtain the biocidal product authorisation. Furthermore, we support companies in building up a consortia to reduce overall costs and in the active substance and alternative supplier application process. REACHLaw also acts as an EU representative for the non-EU companies.
VITAL STATISTICS
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 SDS’s for mixtures. Providing IT management solutions especially related to supply chain compliance and risk management.
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
4
No of countries represented
40+
Staff, group
30+
Staff, chemical service provision
25+
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
SERVICE AREA BREAKDOWN Training 5% Consultancy/ advisory 30%
Legal 20%
IT & software 10% Laboratory 5% Information 5%
Representation & management 25%
GLOBAL OFFICES Helsinki, Brussels, New Delhi and Istanbul. Page 122
Chemical Watch | Global Service Providers Guide 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
ACCREDITATIONS Internationalisation award from the president of Finland in 2009. AAA financial rating in 2010. 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 Selected partners: Chemtopia, ChemRisk, Chemitox, Dynamic Orbits, Mourao Henrique Consultores Associados, AIDA, Chamber of Chemical and Petrochemical Industry of Argentina – CIQyP, CICM. CLIENTS More than 300 customers from 40+ countries, from Fortune 100 companies to SMEs. Major industry sectors served: oil, chemicals, specialty chemicals and metals. Our customers are manufacturers, importers, traders, downstream users, retailers and governmental organisations. TESTIMONIALS “Over the years REACHLaw has advised OMG 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, OMG Kokkola Chemicals Ltd. CASE STUDY 1: authorisation Since 2010 REACHLaw has been helping the European Space Agency (ESA), Eurospace and space system manufacturers address the challenges posed by REACH. Obsolescence of space-qualified materials and processes due to REACH-induced alterations upstream is the key risk to be managed. REACHLaw’s continuous activities include authorisation task force management and technical support, presently for hydrazine and chromates, and regulatory updates. REACHLaw has also been chosen by ESA to perform materials and processes analysis for critical items – together with VTT Technical Research Centre of Finland – and develop the requirements for a web-based ESA obsolescence management tool in the course of 2015. CASE STUDY 2: biocidal products Regulation The biocidal products Regulation-BPR- creates a complex and heavy regulatory environment on the European biocides markets. For companies and especially SME’s the first burden is not to create a deep understanding of the regulation but try to create an overall understanding on what kind of business actions the company should do in the short and long term. REACHLaw consulting assignments typically start in jointly clarifying the customer strategy and then proceed to the technical areas, such as work to assure supply of needed active substances and authorisation of biocidal products. The BPR implementation requires a long time so REACHLaw usually delivers customers a continuous BPR monitoring and consulting service beyond the technical work CASE STUDY 3: outsourcing One of REACHLaw’s more holistic services is its “Outsourcing service”, where companies can choose to outsource specific tasks or whole functions, such as chemical regulatory compliance assurance. This has been the case with an international and publicly listed inorganics company that was looking to simplify their corporate structure and increase the efficiency of their business by outsourcing bulk of its chemical regulatory compliance work to REACHLaw. The service entails managing day-to-day compliance tasks as well as strategic and product stewardship
Chemical Watch | Global Service Providers Guide 2015
issues together with the customer chemical team on a continuous basis. The work was initiated with a setup phase where all relevant tasks and functions were identified and implemented. After the setup phase when all the work processes and responsibilities had been defined, it has simply been a matter of following those processes together with the client to ensure compliance of all chemicals manufactured, procured and placed on the market, as well as guide workers on the safe use of chemicals. The assignment continues and is regularly updated to accommodate for any changes in the operations and strategy of the customer. STAFF SELECTION 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 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 of 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, COO-Partner 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. 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. Mrs Sari Kuosmanen, MSc (Env Sc), LicPhil (Appl Animal Sc) – Senior Specialist Sari is working as a senior specialist of the biocidal products Regulation (BPR). She has been involved in developing and carrying out REACHLaw’s BPR services. She has extensive experience in the biocides industry and she has also worked in the pharmaceutical and biotechnology sectors with responsibilities in toxicology. Before joining REACHLaw, she was working with TUKES, the Finnish competent authority for BPR and REACH. Her responsibilities included: evaluation of biocidal active substances, especially the efficacy and authorisation of the products. 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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2015
SERVICES PROVIDED
PROFILE: Regulator y Services International Ltd
Chinese new chemical notifications
CONTACTS Website
www.rsireg.com
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 USA
Founded
2010
OVERVIEW With Regulatory Services International (RSI) our focus is on gaining you compliance with new chemical legislation 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 focused on Chinese chemicals legislation and have long-term and extensive experiences and expertise with a huge range of new substances for different industries. VITAL STATISTICS
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
3
No of countries represented
3
Staff, group
14
Staff, chemical service provision
14
SERVICE AREA BREAKDOWN Information 5%
Consultancy/ advisory 15%
Representation & management 80%
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, 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, 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. Study arrangement and monitoring The notification of new substances in China requires a wide range of studies and inevitably leads to data gaps being found. We take care of arranging and supervising the performance of these data gap studies. We work with a range of laboratories involved in all study types as required under new chemicals legislation, including specialist in-country testing. We understand your requirements and needs, compare these with a range of labs to identify a compatible match and then take care of all the operational arrangements and study monitoring activities to deliver the completed study package. Chinese hazardous chemical services 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 and MEP Order No 22. 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). CORPORATE DEVELOPMENTS & ACHIEVEMENTS
GLOBAL OFFICES China: Suite 1009 Tongguang Tower, 12 NongzhanguanNali, Chaoyang District , Beijing, 100125. UK: P.O. Box 1280, Peterborough, PE2 2NG, UK USA: 1024 Iron Point Road, Folsom, CA 95630, USA
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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
Chemical Watch | Global Service Providers Guide 2015
STAFF SELECTION
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.
Andy Burgess â&#x20AC;&#x201C; Managing Partner
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. 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.
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. Renke Dai, PhD â&#x20AC;&#x201C; Chief Scientist Extensive and wide ranging experience in chemistry, biosciences and environmental toxicology. He has been previously employed at the US National Cancer Institute, Chinese academy of Sciences Guanzhou Institute of Biomedicine and Health as well as industry experience. He acts as technical adviser for the scientific related issues of regulatory projects. Manna Tang â&#x20AC;&#x201C; Regulatory Specialist Four 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 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.
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PROFILE: Regulator y Services International Ltd
PARTNERS
SERVICE AREA BREAKDOWN Training 5%
PROFILE: Risk & Policy Analysts (RPA)
CONTACTS Website
rpaltd.co.uk
post@rpaltd.co.uk
Head office
1 Beccles Road, Loddon, Norfolk, NR14 6LT, UK
Tel
+44 1508 528465
Fax
+44 1508 520758
Contact
Panos Zarogiannis
UK
Directors
Pete Floyd Meg Postle
SERVICES PROVIDED
Ownership
Private
Locations
UK
Founded
1990
Consultancy/ advisory 95%
GLOBAL OFFICES
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. Building on our experience in preparing risk reduction strategies under the Existing Substances Regulation, we are now assisting a range of industry organisations in meeting their obligations for REACH authorisation and restriction, and preparing the SEAs needed to justify continued use of a substance. RPAâ&#x20AC;&#x2122;s multi-national staff routinely undertakes detailed analysis and consultation with industry and regulators in most European languages. VITAL STATISTICS
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
2
No of countries represented
Focus on EU-28, EEA and candidate countries
Staff, group
32
Staff, chemical service provision
16
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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.
2012
RPA completes three studies for DG Environment reviewing the first years of REACH implementation.
2013
RPA leads the market in supporting seven applications for authorisation of SVHCs under REACH.
2014
RPA clients obtain the first granted REACH authorisations.
PARTNERS RPA works with FoBiG, Ă&#x2013;kopol, TNO Triskelion, Denehurst, Milieu, DHI, RIVM, ARCHE, Cranfield University, BiPRO, ReachCentrum and EPPA among others.
Chemical Watch | Global Service Providers Guide 2015
OO
OO
OO OO
OO
European Commission (including DG Enterprise (now DG GROW), DG Environment, DG Employment and DG Justice and Consumers). National authorities (including those in the UK, Germany, Denmark, France and the Netherlands). European Chemicals Agency. Numerous European/international industry/trade associations (including AISE, APEAL, Cefic, Cosmetics Europe (Colipa), 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.
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 in relation to the direct and indirect impacts of proposed restrictions and other controls on the use of hazardous chemicals within the EU. As a leading expert on socio-economic analysis (SEA), she guides the preparation of SEAs to support authorisation applications for a range of industry clients as well as providing training to both RAC and SEAC members of Echa.
TESTIMONIALS
Panos Zarogiannis – Technical Director, Chemicals Policy
“RPA has played the major role throughout this process. At all times they provide excellent advice, based on their leading knowledge of the Regulation and the regulators, and on their impressive track record in all aspects of socio-economic analysis and the chemicals industry. Their fundamentally valuable professional experience and solid, hands-on expertise were fully dedicated to the process of developing and delivering the application for authorisation.” – 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
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.
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 socio-economic analyses of the impacts of the loss of the SVHC. As part of this work, we are using the services of specialist toxicology and risk assessment consultants to further up-date the chemical safety assessment and to provide additional interpretation of toxicological data for both the substance and the alternatives. CASE STUDY 2: assistance to the European Commission in reviewing the first five years of REACH RPA assisted the European Commission with preparing a high level report on the implementation of the REACH Regulation. The work included a detailed review of reports carried out on impacts and activities including those by competent authorities (in 30 EU and EEA Member States) and by Echa. The reports cover REACH (registration, evaluation, etc) and CLP, as well as the associated training activities, communications and operation of helpdesks. The full report was published by DG Enterprise in May 2012. 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 has 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 is due for completion in 2015.
Tobe Nwaogu – Principal Consultant, EU Policy Tobe has degrees in biochemistry, pollution and environmental control as well as an MBA. Since 2003, Tobe has been involved in EU chemicals policy and chemical risk management and has managed studies for the UK, Dutch, French and Danish authorities. Tobe has also managed studies for the EC and Echa to assess the impacts of (potential) restrictions on chemicals and/or the development of Annex XV dossiers. 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 companyspecific SEA outputs for applications for authorisation. Anthony Footitt – Principal Consultant, Chemicals Anthony has 18 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 has been involved in numerous studies looking at different aspects of the REACH and CLP Regulations. He is currently the project manager of two different studies aiming to assess the impacts of further regulation of nanomaterials at European level. Paul Ylioja – Consultant, Chemicals Paul comes from a background of organic and medicinal chemistry industrial research projects. He is now working on several Applications for Authorisations. His work involves extensive literature review and assessment of the current state of knowledge to develop robust Analysis of Alternatives (AoA) reports. Thomas Persich – 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 supported clients at meetings with Echa and its committees.
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PROFILE: Risk & Policy Analysts (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
secretariat.pci@rhdhv.com
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 Process and Chemical Industry
Ownership
Private company
Locations
100 Locations worldwide. Key locations Europe: 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 REACH strategy and day-to-day practical questions. 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 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.
OVERVIEW The firm was founded in 1881 in the Netherlands. 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 many legislative programmes. In 2012 Royal Haskoning and DHV merged to the current organisation. VITAL STATISTICS
2013
Turnover, group (2013)
â&#x201A;Ź651m
Turnover, chemical service provision No of offices
100
No of countries represented
35
Staff, group
7,000
Staff, chemical service provision
80
Laboratory 2% Information 15%
Representation & management 15%
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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 As a result of REACH the risk management measures and operational conditions of both manufacturers and downstream users may be affected due to the changed insights in hazards and risks arising from the use of their products and communications in the supply chain. Royal HaskoningDHV provides a unique combination of knowledge on chemicals management, safety and engineering to deliver lean and mean organisational and technical solutions. 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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
SERVICE AREA BREAKDOWN Legal IT & software 5% 5%
Safety Data Sheets
Training 8% Consultancy/ advisory 50%
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
1994
Royal Haskoning developed Rosetta, one of the first programs able to produce multilingual safety data sheets.
2005
RIP 3.10 on characterisation and checking of substance identity is prepared by Royal Haskoning.
Chemical Watch | Global Service Providers Guide 2015
Royal Haskoning joins the organisation of ChemCon Conferences
2012
Merge between Royal Haskoning and DHV
2013
Royal HaskoningDHV completes a 3-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
and to refine the risk assessment and demonstrate safe use using highertier 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. STAFF SELECTION Froukje Balk, Msc – Senior Expert Ecotoxicology
ChemCon Conferences, EPPA SA, The Wercs
Froukje Balk is a biologist by training and a Eurotox registered toxicologist specialising in ecotoxicology and environmental fate and behaviour of chemicals with more than 25 years of experience, including seven years in the laboratory. She is involved in the risk assessment (both effects and exposure) of chemical substances, mainly related to the European chemicals legislation on existing chemicals and biocides.
CLIENTS
Joanne Salverda, PhD – Senior Expert Toxicology
ACCREDITATIONS ISO 9001/ ISO 14001/ OHSAS 18001 PARTNERS
The clients of Royal HaskoningDHV are located in many different industries. Because Royal HaskoningDHV provides many 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: Optimal use of alternative methods to reduce animal testing and costs A group of manufacturers and importers of natural complex substances cooperated with Royal HaskoningDHV to prepare a series of REACH registration dossiers for related substances. For the preparation of dossiers for these specific substances all parties committed to the optimal use of alternative methods to testing. Royal HaskoningDHV created a category of the substances and used information on both the substances and their many constituents to complete the technical dossiers. To cover the data gaps, Qsars were applied for several physico-chemical and ecotoxicological properties and RH provided guidance on in-house testing to efficiently generate adequate data for physico-chemical properties. The exposure assessment and risk characterisation were performed by using Chesar and applying higher tier modelling like the Advanced REACH Tool (ART) for worker exposure and the higher tier possibilities EUSES offers to reduce the estimated releases to the environment and to achieve realistic maximum use levels on a site. This approach allows the industry to remain flexible within its current operational environment. CASE STUDY 2: Tailor-made interim risk management measures To a consortium on inorganic substances with registration deadlines in 2010 little information was available on repeated dose toxicity and developmental toxicity. To save costs and time the Annex VIII studies were waived and higher tier tests were proposed. Until these higher tier tests can be conducted interim risk management measures (RMMs) had to be implemented. An alternate derived no effect level (DNEL) for the substances was established using an expert insight in existing occupational exposure limits (OEL) for surrogate substances. Where the Chesar exposure assessment led to rigorous RMMs, or incompliance, we used experts tools, eg higher tier modelling using ART and ConsExpo. We also devised an occupational exposure measurement program to be able to compare safe levels of use with the actual industry situation and reduce uncertainties. This approach enabled us to generate a realistic exposure assessment with a minimal set of RMMs. CASE STUDY 3: 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 a broad set of specialist uses throughout the 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
Chemical Watch | Global Service Providers Guide 2015
Joanne Salverda studied nutrition and health/toxicology, followed by a PhD degree on the role of stem cells in skin in the development of skin cancer. Afterwards she worked at the National Institute for Health and the Environment on the risk assessment of cosmetics ingredients, emerging risks, REACH/CLP, consumer safety and safety aspects of nanotechnology. Joanne is a Eurotox registered toxicologist. Conny Hoekzema, Msc – GHS/CLP and SDS Expert Conny Hoekzema has six 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 5, safety data sheets 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 20 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 Haskoning in September 2002. 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 and he is teamleader of the advisory group in Nijmegen.
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PROFILE: Royal HaskoningDHV
2007
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
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, Cosmetics, Consumer Products, Feed & Food)
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, Cosmetics, Consumer Products, Feed & Food) Dr Hans-Josef Leusch (Biocides)
Ownership
Private company
Locations
Germany and Japan
Founded
1989/ regulatory experts for 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, pharma pre-clinical and veterinary medicinal products. VITAL STATISTICS
2014
Turnover, group
-
Turnover, chemical service provision
-
No of offices
3
No of countries represented
2
Staff, group
120
Staff, chemical service provision
45
SERVICE AREA BREAKDOWN
Training 1% Other 1%
IT & software 2% Information 10%
Representation & management 18%
SCC has prepared hundreds of chemical notifications for new chemical substances (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 upcoming REACH deadline and regarding international jurisdiction; 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); OO eSDS including Annex; OO scientific/regulatory support at EU expert meetings; OO Qsar tools. 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
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.
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Registration of feed and food additives
CLIENTS
The SCC Feed and Food Additives department successfully delivered 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.
Small to large (global) companies in the areas of chemicals and consumer products, agrochemicals and biopesticides, biocides, feed and food additives and veterinary medicine.
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, UV-filter, preservatives, nanomaterials, botanicals and CMR categorised substances. Registration of veterinary medicinal products SCC established the Veterinary Medicine department already in 2007. In the past years, SCC handled a variety of issues related to veterinary science, often in the borderline-area between materials, feed additives, biocidal products and veterinary medicinal products. Recently SCC hired a senior expert with a long-standing and handson experience in the registration of veterinary pharmaceuticals. The combination of his excellent reputation and our already established expertise will help you even more to overcome upcoming challenges. GLP and regulatory/scientific archiving SCC has 25 years’ 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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Many of our clients have been customers for a long time, some going back to the start of our company. New clients are often recommended to us via existing clients. CASE STUDY 1: General remark 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, Cosmetics, Consumer Products, Feed and Food 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, Cosmetics, Consumer Products, Feed and Food. 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 the chemical world. Isabel Kirbach Mrs Kirbach has a master’s degree in chemical engineering. She has been with SCC since 2004 and her focus is on Sief, Iuclid 5 and consortia management since 2006. 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 MSDSs.
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 and Veterinary Medicine group
2014
25 years of SCC
Dr Leusch has a PhD in agronomy. He has been with SCC since 2000 as head of Biocides.
2014
Establishment Office Berlin
Dr Emmanuel Metz – Head of Veterinary Medicine
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
GLP archive (since 2004)
Dr Metz has a Doctorate in Veterinary Medicine. He joined SCC in 2014 and is head of Regulatory Affairs and Product Development, Veterinary Medicine group.
PARTNERS
Dr Bernd Brielbeck – GLP Archive
ACCREDITATIONS
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.
Chemical Watch | Global Service Providers Guide 2015
Dr Brielbeck has a PhD in chemistry. He has been with SCC since 2001 and is responsible for our GLP-certified archive.
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PROFILE: SCC
Registration of consumer products
TESTIMONIALS
PROFILE: Sustainability Support Services (Europe) AB
VITAL STATISTICS
2014/15
Turnover, group
€3.5m
Turnover, chemical service provision
€3.2m
No of offices CONTACTS Website
www.ssseurope.org
sk@reach-onlyrep.eu
Head office
Ideon Science Park, Scheelevägen 17, Beta 5, 223 70 Lund, Sweden
Tel
+46 46 2850418 and +46 46 2114615
Contact
Shisher Kumra
Directors
Shisher Kumra and Mukta Kumra
Ownership
Private Limited Company
Locations
Sweden, India
Founded
2008
OVERVIEW SSS was set up exclusively to provide technical assistance and regulatory compliance services to the companies interested in accessing European markets. Today, SSS has diversified its service portfolio to also include conformity assessment and compliance management services. Within this, SSS provides a one stop solution to assess conformance with various product based technical regulations; REACH being one of the most prominent. SSS also provides Global Regulatory Compliance Services. SSS group company is now accredited for an internationally recognised standard for inspection bodies, making SSS probably the only organisation providing accredited regulatory compliance services. All regulatory compliance activities of SSS are processed through this group company. SSS also proposes to provide 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); OO China International Electronic Commerce Center (CIECC); and OO Randis ChemWise (Shanghai) Co.,Ltd, China Through these MoU, SSS offers the complete regulatory compliance services related to the chemical regulations in the Asian continent and is also actively contributing towards the finalisation of India’s national chemical policy (NCP) and hazardous substances (classification, packaging and labelling) rules sometimes referred to as India GHS. SSS and its group company in India are all geared up to help companies comply with the Indian regulations when they become a law. SSS has a client base of over 1,000 companies across the world and has dealt with 9,000 pre-registrations, the successful registration of more than 35 substances by the first REACH registration deadline of 30 November, 2010 – including being the lead registrant. SSS successfully registered around 225 substance; including 125 substances as the lead registrant by the end of 2014. SSS also: OO organised LPR for over 1680 substances; OO CLP notification of approximately 1700 substances; and OO developed MSDS for 2,304 substances (including 600 MSDS translation in various European languages).
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2
No of countries represented
20
Staff, group
35
Staff, chemical service provision
25
SERVICE AREA BREAKDOWN Training 10% Legal 10%
Consultancy/ advisory 50%
IT & software 10% Laboratory 10% Representation & management 10%
GLOBAL OFFICES Sweden and India SERVICES PROVIDED Late pre-registration (LPR) 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 1675+ substances, with many 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 to date successfully completed over 1,700 CLP notifications. Registration Since 2011-12, SSS is constantly working to help its client companies successfully meet the second registration deadline of 31 May, 2013. SSS successfully registered around 225 substance; including 125 substances as the lead registrant by the end of 2014 and is working for its clients to help them meet the last REACH registration deadline of 31st May’ 2018. REACH 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: since it is obligatory for the exporter of chemicals to provide to his buyer, SDS, originally prepared in English, in the local language, 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 to date prepared over 2,300 REACH compliant SDS. SVHC applicability analysis 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
Chemical Watch | Global Service Providers Guide 2015
SSS also provides compliance assistance for the following: OO OO OO OO OO OO
GHS; K-REACH Proposed – Indian National Chemical Policy & India GHS China REACH; and Compliance with chemical management in Malaysia (EHSNR) 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.
PARTNERS OO OO
OO OO OO OO
Confederation of Indian industry (CII), India China Chamber of Commerce of Metals Minerals and Chemicals Importers and Exporters (CCCMC), China 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 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. TESTIMONIALS On the service quality criteria, 92% of our client companies have rated the REACH compliance assistance services being offered by SSS as very good.
CASE STUDY 2: providing guidance to a non-EU manufacturer having own legal entity in Europe on preparation for a REACH audit Problem: A non-European company sought the technical assistance of SSS to guide them in their preparation for a REACH audit proposed by one of REACH enforcement agency Solution: SSS provided guidance to the company in terms of the various documentations and records that the European office of the non-EU company should have in place before the audit, including compliance with the CLP notification as well as provision of safety data sheets (SDS) and translated safety data sheet (wherever applicable). Accordingly company verified its compliance status prior to the Audit. CASE STUDY 3: Providing 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 REACHIT by joining the joint submission (JS). Some of these requests were received very close to the deadline and the timely inputs from SSS helped companies meet their registration deadline. STAFF SELECTION Mr Shisher Kumra – 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 Dr Shruti Ralegaonkar Area of expertise includes REACH and Articles, SVHC assessment and REACH compliance verification Dr Martina Holst Responsible for evaluation of toxicological reports and for dossier quality assurance for toxicological endpoints and CSR Ms Ewa Dahlgren A toxicological executive and study assistant working with Dr Martina Holst. Ms Camelia Petriu Manages the database of the client companies of SSS as well as responsible for IT & Communication related activities.
CASE STUDY 1: SSS group company in India is accredited for an internationally recognised standard for inspection bodies With a view to provide quality regulatory compliance services to its client companies, SSS has helped prepare its Indian group company in getting accredited to an internationally recognised standard for the competence of inspection and certifying bodies. This is probably a first of its kind global achievement for any OR service providing organisation wherein all its compliances shall be inspected and validated prior to completing the compliance process request of its clients. This shall ensure accurate regulatory compliance and conformance with the technical product standards. Chemical Watch | Global Service Providers Guide 2015
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PROFILE: Sustainability Support Services (Europe) AB
solution is in line with the guidance provided by Echa. So far, SSS has provided around 100 companies exporting articles/substances to Europe with the most cost-effective REACH SVHC compliance certification. For all the above mentioned services, a systematic and detailed conformity assessment of all the data to be used for regulatory compliance is done. This ensures conformity assessment with the relevant regulatory and product standards.
SERVICES PROVIDED 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 TNO Triskelion 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.
PROFILE: TNO Triskelion
CONTACTS Website
www.tnotriskelion.com
chemistry@tno.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@tno.triskelion.nl
Ownership
Private company, wholly-owned by TNO
Locations
Zeist, The Netherlands
Founded
TNO, 1933; TNO Triskelion, 1/1/2011
Experimental toxicology 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 gentox (also Comet assay) in the same study. We can offer the new OECD 443 guideline for an extended one-generation reproduction toxicity (EOGRTS) study, with one study already ongoing in our laboratories, as well as the OECD 488 transgenic rodent test.
OVERVIEW TNO Triskelion is a company born out of a rich history of TNO R&D achievements. 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. We excel in worker exposure assessment, in inhalation and in reproduction toxicology, including nanomaterials. We offer our customers high quality registration and chemicals testing and analysis services characterised by strong communication with a personal touch that larger CROs cannot match. VITAL STATISTICS
2013/14
Turnover, group
€600m
Turnover, chemical service provision
€30m
No of offices
30
No of countries represented
5
Staff, group
3,900
Staff, chemical service provision
200
SERVICE AREA BREAKDOWN Training 5%
IT & software 5%
Consultancy/ advisory 30%
Laboratory 45% Representation & management 10% Information 5%
GLOBAL OFFICES Headquarters group TNO: The Hague, The Netherlands Headquarters group TNO Triskelion: Zeist, The Netherlands Sales Offices: Japan, USA, UK, Turkey
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Analytical chemistry TNO Triskelion’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; OO 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 TNO Triskelion 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 Project management – your assignment with TNO Triskelion 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 TNO Triskelion, who will help you find the right solution. Chemical Watch | Global Service Providers Guide 2015
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 TNO Triskelion as a private company.
2011
ReachCentrum and TNO Triskelion join forces to offer REACH workshops and training courses.
2012
Extensive application of our exposure experience to the evaluation of risk management options for SVHCs.
2013
AAALAC accreditation obtained; REACH 2013 dossiers submitted on time!
2014
First EOGRTS study accommodated in our laboratory.
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. ReachCentrum: workshops and training 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 12 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 “TNO Triskelion 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 TNO Triskelion 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.
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 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 the 2013 experience, TNO Triskelion 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 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, TNO Triskelion 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 have validated OECD 443 in our laboratory and are currently performing a full size study. 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: TNO Triskelion
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
SERVICES PROVIDED With our core team of industry-experienced toxicology, environmental and regulatory affairs consultants and analysts, ToxMinds serves companies from the chemical, biocides, agrochemicals and consumer products sectors worldwide. Our strategic and technical support centers around 3 service areas: OO chemical and product safety; OO regulatory strategy and compliance; OO product stewardship. Through our presence in Brussels, we are up-to-date on latest EU developments and regulatory changes that may affect our clients. We have good access to the respective experts in the European Institutions and members states, allowing us to represent the interests of our clients.
PROFILE: ToxMinds
CONTACTS Website
www.toxminds.com
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 Mireya Camino Jurado
Directors
Dr Thomas Petry Dr Francesca Tencalla
Ownership
Private company
Locations
Belgium, Germany
Founded
2006
Chemical and product safety
Turnover, group
-
Turnover, chemical service provision
-
(Eco)toxicology, environmental fate and risk assessment: our scientific services include retrieval, organisation, interpretation and presentation of accurate information on the (eco)toxicological effects of chemical substances; data gap analysis under consideration of nontesting approaches; identification of intelligent testing strategies, design and management of testing programmes. Qsar, analogue- and grouping-based chemical assessment: we have established a transparent and rule-based process that evaluates the suitability of Qsar, analogue- or grouping-based chemical assessment approaches in support of business strategies, regulatory submissions or for general product safety and stewardship purposes. Exposure modelling: in the context of our risk assessment and registration support work, we have substantial experience in using human and environmental exposure assessment models including those required by EU chemicals , plant protection product, biocides, food contact and consumer/ cosmetics product product legislations Establishing safe exposure levels: we integrate the principles of toxicological risk assessment in our daily thinking and practice – the science of hazard identification, characterising the hazard through assessment of dose-response, thorough internal and external exposure assessment and quantitative risk assessment.
No of offices
2
Regulatory strategy and compliance
No of countries represented
4
Chemicals and commodities: strategic consulting, technical registration and post-submission support to ensure success under the REACH as well as compliance with the CLP Regulation. Biocides and agrochemicals: pre-registration/registration support including literature search, data gap analysis, human and environmental risk assessment as well as dossier assembly and post-submission support. Food contact materials: we assist our clients in assessing and screening FCM from a toxicological and in developing supporting documentation required in context of the EU FCM approval process. Cosmetics: identification and evaluation of non-testing approaches including chemical similarity analysis and SAR-/analogue-based hazard assessments; preparation of Regulation (EC) No 1223/2009 compliant cosmetic safety assessment and preparation of product information files (PIFs); preparation of SCCS submissions. Plant biotechnology: development of regulatory submissions as well as scientific post-submission support (eg development of responses to queries from regulatory authorities).
OVERVIEW ToxMinds BVBA is a Brussels-based product safety and regulatory affairs consulting firm. Our motivation and passion is the use of good science, but we also understand the reality of our tightly regulated chemicals world. We combine state-of-the-art hazard and risk assessment science with pragmatic regulatory solutions and business practice. 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
Staff, group
10 – 25
Staff, chemical service provision
10 – 25
SERVICE AREA BREAKDOWN Information 5%
Training 5% Consultancy/ advisory 75%
Representation & management 15%
GLOBAL OFFICES Head office: Avenue de Broqueville 116, 1200 Brussels, Belgium.
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Product stewardship ToxMinds supports companies by helping to characterise the human and environmental risks associated with the manufacture and use of their products. We further develop the documentation required to communicate all information necessary to assure safe chemical handling and use. In this context, ToxMinds services include the generation of ICCA-compliant product safety summaries; development of REACH-compliant extended safety data sheets; convening and moderating scientific expert panels; and the development of science-based strategies and documentation to support chemicals or products under regulatory or public scrutiny for scientifically unjustified reasons.
Chemical Watch | Global Service Providers Guide 2015
2006
Foundation of ToxMinds BVBA
2009
Opening of ToxMinds office in Brussels
2014
Collaboration with Deskin Associates LLC to provide more direct support to US-based clients
CLIENTS ToxMinds is providing its (eco)toxicology, product safety and regulatory compliance services to a wide range of multinational fortune 100 companies, SME, and industry associations from the chemical, biocidal, plant protection, metal/mining, consumer product, biotechnology and pharmaceutical sectors. 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 required by our company. We continue to rely on ToxMinds as experts in the fields of toxicology, ecotoxicology and regulatory compliance.” – Senior manager, Global Product Regulatory Compliance, international specialty chemical company CASE STUDY 1: consortium management and technical support to REACH consortia ToxMinds provides technical REACH support for a number of REACH consortia and individual chemical companies covering more than 80 chemical substances, predominantly UVCBs. Our technical work includes: OO desktop search 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 applications for authorisation, strategic and technical support during authorisation phase. CASE STUDY 2: human and environmental risk assessment ToxMinds (eco)toxicology consultants have long experience in conducting human and environmental risk assessments of commodity and specialty chemicals for our clients as part of regulatory or voluntary industry programmes or for internal safety assurance purposes. 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 ecotoxicicty 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). The process allows for example the prioritarisation 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 prioritarisation. 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). Daniela Jeronimo Roque, MSc Ms Jeronimo Roque is a consultant at ToxMinds BVBA. Daniela specialises in and leads our efforts 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. 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 in 2006. Monica Autiero, PhD Dr Autiero is a Consultant at ToxMinds BVBA. Monica specialises in and leads our efforts in the area of non-animal based safety assessments with particular focus on Qsar modelling and identifying analogue and groupingbased 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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PROFILE: ToxMinds
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
GLOBAL OFFICES The Netherlands SERVICES PROVIDED
PROFILE: Trade Wind B.V.
CONTACTS
Chemicals management software
Website
www.twnl.com
info@twnl.com
Head office
Haagsche Hof, Parkstraat 83, 2514 JG Den Haag, Netherlands
Tel
+31 70 214 3040
Fax
+31 84 747 24 99
Contact
Mrs Marijke Slok Soede
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
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 in 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 document like labels and work instruction cards or overviews can be created with just a few mouse clicks. Our internet solution DeDoks helps companies to distribute their SDSs in pdf-format or linked to URLs without any software 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-related work to Trade Wind. We will assess your raw materials and on the basis of your formulations we will draft your SDSs, translate them and even distribute them to your customers. VITAL STATISTICS
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
1
Staff, group
7
Staff, chemical service provision
6
Our internet (SAAS) solution will take care of your SDS-distribution to your downstream users. It can be documents in pdf-format, or links to your SDSs already on your website. According 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 the recipients that have received the previous version less than 12 months before. DeDoks will also allow you to publish your SDSs on your website where they can be downloaded. This will be registered in order to be able to resend new versions. SDS outsourcing 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 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)
PARTNERS OO OO
CLIENTS OO
SERVICE AREA BREAKDOWN Consultancy/ advisory 30% IT & software 50%
Lisam Systems Belgium Lisam Telegis, Paris
OO
Dutch Paint Association (VVVF), AKZO, PPG, 3M, Lâ&#x20AC;&#x2122;Oreal, Total, P&G, 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).
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 (Vereniging van Verf- en Drukinktfabrikanten, VVVF) has more than 81 company members who employ a total of 5,200 people. As such the trade association represents approximately 95% percent of the Dutch paint and printing ink industry. 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 members (paint 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 FTP-service, or through a completely automated web service. At the same time, it allows the 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 Lubricants outsources SDSdrafting 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 Laetitia van der Heiden (Analytical chemical analyst) – Consultant Marijke Slok Soede – 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 choose 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.
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PROFILE: Trade Wind B.V.
TESTIMONIALS
GLOBAL OFFICES TSG USA – Washington, DC; Sacramento, California TSG Canada – Ontario TSGE – United Kingdom; Ireland, Regional Offices – Germany; Spain; France; Slovenia; Poland; Slovakia
PROFILE: TSG
CONTACTS
SERVICES PROVIDED
Website
www.TSGUSA.com
Science and technical
info@tsgusa.com
Head office
1150 18th Street, NW, Suite 1000, Washington, DC 20036, USA
Tel
202-828-8988
Toxicology; ecotoxicology and environmental fate; human health and ecological risk assessment; product chemistry; residue and metabolism; product efficacy; data waiver rationales; study design, monitoring, analysis and interpretation.
Fax
202-872-0745
Contact
info@tsgusa.com
Directors
Dr Arthur Lawyer, President, TSG Oleta Melnicoe, Vice President, TSG Erin Tesch, Vice President, TSG Dr Louis Wyness, Managing Director, TSGE
Ownership
Wholly owned subsidiary of McKenna Long & Aldridge LLP
Locations
United States, Canada, United Kingdom, Ireland, Germany, Spain, France, Slovenia, Poland, Slovakia
Founded
1990
Pesticides Regulatory compliance – antimicrobial/biocide, biopesticide, microbial and conventional pesticides; strategic positioning and advocacy; registration – federal, state, multinational; product maintenance and renewals; import/export compliance; inert ingredient approvals; pesticide tolerance/ maximum residue levels; consortia management. Industrial chemicals US – TSCA/Osha Premanufacture notices (PMNs); LVEs, LoRex, TMEs, polymers; notice of commencement (NOC); section 5(e) consent orders; import/export compliance; risk assessment; compliance audits; chemical data reporting and recordkeeping; GHS and SDSs. California – Proposition 65 and safer consumer products Regulatory guidance and compliance; risk assessment; chemical delisting, safe harbour level determinations; litigation support; alternatives analyses. EU REACH Iuclid dossier preparation, submission and follow-up; chemical safety report (CSR); data gap analysis (completeness check); risk assessment; consortia and Sief management. Canadian Environmental Protection Act (Cepa) New substance notification (NSN); notice of manufacture/import (NOMI); notice of excess quantity (NOEQ); Domestic Substance List (DSL) issues; WHMIS-compliant SDSs.
OVERVIEW Technology Sciences Group (TSG) is a multinational consultancy that provides expertise on a wide range of scientific and regulatory chemical issues. With experts in regulatory affairs, chemistry, toxicology, ecotoxicology, residue and metabolism, environmental fate, efficacy and risk assessment, TSG provides services in support of the registration, compliance and defense of chemically related products. With a staff of more than 100 consultants located in offices throughout North America and Europe, TSG offers multinational services to chemical, pesticide, fertiliser, consumer product, food, personal care and animal health companies, as well as industry groups, trade associations and law firms. VITAL STATISTICS
2013/14
Fertilisers, plant and soil amendments, biostimulants
Turnover, group
-
Label development; compliance assistance; registration, renewals and tonnage reporting.
Turnover, chemical service provision
-
Food and drugs
No of offices
11
No of countries represented
38
Staff, group
110
Staff, chemical service provision
110
SERVICE AREA BREAKDOWN Training 5% Information 5% Representation & management 10%
Food contact notifications; GRAS determinations; threshold of regulation determinations; food additive and colour additive petitions; topical overthe-counter antiseptics. Medical devices 510(k) premarket notification submissions. Cosmetics Safety assessments; ingredient and labelling compliance; voluntary cosmetic registration programme (VCRP).
Other 5% Consultancy/ advisory 75%
Audits and training Chemical compliance and due diligence. China China business liaison and advocacy; sourcing assistance; product registration with Ministry of Agriculture (MoA) and National Health and Family Planning Commission (NHFPC); label and SDS technical translations; market intelligence.
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STAFF SELECTION
1990
TSG founded in Washington, DC, USA
Erin Tesch – Vice President (TSG)
1991
TSG launched office in California, USA
2000
TSGE founded in the United Kingdom
2003
TSG began offering services in China
2007
TSG Canada founded
Ms Tesch leads TSG’s US federal regulatory affairs division. She is a pesticide expert with particular expertise in antimicrobials, including a strong emphasis on material preservatives, hard surface sanitisers, disinfectants and other novel products with public health claims. She has been a key figure in pesticide policy issues over the years, both individually and as a participant, in several industry coalitions. Ms Tesch is the executive director of the Silver Task Force North America and Zinc Task Force North America, and serves on the American Chemistry Council Biocides Panel.
ACCREDITATIONS TSG actively participates in a broad range of industry associations such as CropLife America, Western Plant Health Association, Council of Producers and Distributors of Agrotechnology, Consumer Specialty Products Association, Biocides Panel of the American Chemistry Council, Personal Care Products Council, Canadian Consumer Specialty Products Association, Biopesticide Industry Alliance and International Biocontrol Manufacturers’ Association. CLIENTS Our clients include chemical, pesticide, consumer product, food, personal care and health care companies, as well as industry groups, trade associations and law firms. CASE STUDY 1: Silver Task Force North America and the EU Silver Task Force TSG/TSGE works efficiently and effectively to develop and manage coalitions of companies with similar interests to address complex regulatory and scientific issues across several regulatory agencies. An example of this effort is the creation of the Silver Task Force North America and the EU Silver Task Force. TSG/TSGE was instrumental in the formation of the task forces and the advancement of science as it relates to the use of silver as a biocide. The two task forces represent over 50 companies in the silver biocidal market. CASE STUDY 2: multinational registration TSG has successfully developed regulatory strategies and facilitated joint review between multiple jurisdictions, including the United States and Canada. Joint review allows for data evaluation to be split between the jurisdictions which leads to timely evaluations and registration simultaneously in multiple jurisdictions. TSG has developed regulatory strategies that address both North America and the EU to identify studies that can be generated to fulfil the requirements in multiple jurisdictions thereby reducing the overall cost of data generation and enabling the company to pursue multinational registrations utilising data generated to meet requirements in the various jurisdictions. CASE STUDY 3: proposition 65 delisting On behalf of a chemical manufacturer, TSG successfully petitioned California’s Developmental and Reproductive Toxicity Identification Committee (DART IC) for delisting of a chemical that was previously identified as a reproductive toxin. Chemicals are listed under California’s Proposition 65 as known to the state to cause cancer or reproductive toxicity. TSG requested delisting of a chemical from all three categories of reproductive toxicity (developmental, female and male) based on new data and new conclusions of the US EPA. TSG was allowed to present scientific evidence to the DART IC and it agreed with TSG’s findings that the chemical should be delisted from the Proposition 65 list for all reproductive toxicity endpoints.
Chemical Watch | Global Service Providers Guide 2015
Oleta Melnicoe – Vice President (TSG) Ms Melnicoe leads TSG’s US state regulatory affairs division. She is a recognised expert in pesticide regulation and state registration. As a former California state regulator, her experience and close working relationships with government officials helps her provide clients with unique insight into product development, regulatory strategy and product registration and defense. Ms Melnicoe serves on the Pest Management Board for the Consumer Speciality Products Association and the Regulatory Affairs Committee for the Western Plant Health Association. Dr Hong Chen – Director of Asia-Pacific Affairs Dr Chen leads TSG’s efforts in the Asia-Pacific region, with a strong emphasis in China. With over 30 years of experience in Chinese regulatory affairs, she has an intimate knowledge of the Chinese system and strong connections with government officials. Dr Chen’s practice is focused on assisting companies to successfully conduct business in China, and provides a variety of services including client representation and advocacy, sourcing assistance, product registration and market intelligence. Dr Saadia Eltayeb – Senior Managing Scientist Dr Eltayeb is a senior scientist that leads TSG’s industrial chemicals efforts in North America, which focuses on compliance with the US Toxic Substances Control Act (TSCA) and the Canadian Environmental Protection Act (Cepa). In this capacity, she routinely assists clients with product chemistry issues, chemical notifications, testing, inventory interpretations and import/export guidance. She also has significant experience working with polymers and testing them for exemption eligibility. Dr Louis Wyness – Managing Director (TSGE) Dr Wyness is a Managing Director at TSGE with many years of experience in the preparation of overviews, dossiers and risk assessments for the registration of chemical products in the agricultural, industrial and biocidal sectors in the EU, as well as providing expert advice and guidance to industry on registration requirements. He has specialised in environmental risk assessments and has recently acted as manager for several REACH consortia.
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PROFILE: TSG
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
GLOBAL OFFICES Japan, Singapore, China, India, Croatia, Indonesia, Thailand, Vietnam, Serbia, Russia, Ukraine, South Korea, USA
PROFILE: TÜV SÜD Industrie Service GmbH
SERVICES PROVIDED Only representative Website
www.tuev-sued.de/plants_buildings_technical_facilities
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
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.
Contact
Dr Dieter Reiml
REACH initiative for mid-sized and small companies
Ownership
TÜV SÜD Holding AG
Locations
TÜV SÜD Group employs more than 22,000 people in 80 countries in ca. 850 locations
Founded
1866
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.
CONTACTS
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 come 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
2014/15
Turnover, group
€1,940m
Turnover, chemical service provision No of offices
850
No of countries represented Staff, group
80 20,200
Staff, chemical service provision
80
SERVICE AREA BREAKDOWN Training, 10%
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
Laboratory 5% Information, 10%
Authorisation
Consultancy/ advisory , 40%
1866
Established in Mannheim
1926
Introduction of the “TÜV SÜD mark / stamp” in Germany
1960
Establishing chemical services
1990
Conglomeration of TÜVs from the southern part of Germany to form TÜV SÜD and the expansion of business operations into Asia Best brand of technical services, testing, consulting, training, certification in all industries worldwide – energy producers and providers, nuclear power plants, chemical industry
2006
Expansion of services in ASEAN by acquiring Singaporebased PSB Group
Representation & management, 35%
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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 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.
CASE STUDY 4: Testing strategies and testing
Ing. Rupert Scherer
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.
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.
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 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. Chemical Watch | Global Service Providers Guide 2015
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.
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PROFILE: TÜV SÜD Industrie Service GmbH
2007
SERVICES PROVIDED REACH and product safety
Website
www.tuv-sud.es
info.es@tuev-sued.es
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).
Head office
C Lope de Vega, 22-24, 08005 Barcelona, Spain
Laboratory testing
Tel
+34 933 036 612
Fax
+34 933 036 612
Contact
Montserrat Fernández (REACH Business Group Leader) Alex Arévalo (Business Unit Manager)
Directors
Jordi Campos (Business Director)
Ownership
TÜV SÜD
Locations
Spain, Switzerland, Taiwan
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 Swissi Process Safety GmbH 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).
Founded
1945
PROFILE: TÜV SÜD Process Safety
CONTACTS
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.
OVERVIEW TÜV SÜD Process Safety (legal entity name Instituto Suizo para el fomento de la Seguridad, Swissi-España SLU) is member of the international group TÜV SÜD since 2013. 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
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
2013/14
Turnover, group
€5.2m
Turnover, chemical service provision
€1.5m
No of offices
2
No of countries represented
Global
Staff, group
20
Staff, chemical service provision
18
SERVICE AREA BREAKDOWN
Legal 8%
Training 8%
Laboratory 12%
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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 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.
ACCREDITATIONS Our Swiss laboratories are certified in accordance with ISO/IEC 9001 and our test laboratories are accredited under ISO/IEC 17025. Consultancy/ advisory 72%
GLOBAL OFFICES 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.
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CLIENTS
Dolors Vinyoles – REACH, ORP and environment consultant
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 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.
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 – REACH and Crisis Management consultant 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. Jordi Espinilla – Responsible for testing Jordi Espinilla is responsible for managing all laboratory tests. He also performs safety data sheets. Espinilla holds a degree in physics and worked as a head of an important physico-chemical laboratory in Spain.
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. Dr Alexis Pey – Business Unit Manager – Process Safety Dr Alexis Pey has a PhD in chemical engineering and is specialised in electrostatics, process safety, accident investigation and risk analysis. He is a permanent member of EFCE. Alex Arévalo – Business Unit Manager – Product Safety Alex Arévalo has a degree in chemistry (Organic) and is specialised in REACH, product safety, occupational risk prevention 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 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 and web service. Joan Marc Juncosa – REACH and Machine Directive consultant Joan Marc Juncosa is chemical engineer. He is a consultant specialising in REACH, classification, labelling and packaging (CLP), explosive atmospheres (Atex) and machinery safety.
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PROFILE: TÜV SÜD Process Safety
CASE STUDY 1: REACH IT tool and customer care
GLOBAL OFFICES Germany: Hamburg, Cologne, Rottweil SERVICES PROVIDED Chemicals management
PROFILE: UMCO Umwelt Consult GmbH
CONTACTS
OO
Website
www.umco.de
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
Jens Fisser
Directors
Hubert Oldenburg Peter Duschek Ulf Ch. Inzelmann
Ownership
See directors
Locations
Germany
Founded
1982
OO
OO OO
OO
OO
OO
OO
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 for the last 30 years. Our customers benefit from complete and high quality advisory services for substances, plants, organisations and transports. Our 45 employees in Hamburg, Cologne and Rottweil provide consultancy for over 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
OO
OO OO OO
REACH management
2013/14
Turnover, group
–
Turnover, chemical service provision
–
No. of offices
3
No. of countries represented
1
Staff, group
45
Staff, chemical service provision
25
SERVICE AREA BREAKDOWN Legal 5%
Training 5%
Information 10%
determination of the status of all the substances used or traded by your company with regard to their worldwide merchantability; auditing and advising regarding chemicals management at the company or corporate level and the integration of responsibilities and documentation into management systems; worldwide registration together with our network partners; general advice concerning questions and applicability of the biocidal products Regulation, including support in the 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); 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 for the automatic import and export of data in standard XML format into/from UMCO SDS software UHCS; web services for customer specific evaluations, e.g. 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; and compliance service for restricted / banned substances in mixtures / articles.
Registration management for co-registrants: OO support for the participation in joint registration, including ordering the letter of access (LoA), substance sameness discussion and the review of Sief agreements; OO compilation and submission of dossiers to the European Chemicals Agency (Echa); and OO only representative (OR) according to article 8 of the REACH Regulation. Comprehensive support for lead registrants: OO registration management including Sief process, preparation of contractual arrangements for data and cost sharing, as well as assistance in the collection and evaluation of information; 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.
Representation & management 5% Consultancy/ advisory 75%
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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 approval procedures; advice on storage of dangerous materials; consultations on explosion protection; 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; check lists, working and operating instructions; verification of correct classification and labelling; instruction and training courses; preparing and checking documents; information about legislative changes; and project organisation.
CASE STUDY 1: chemical product management OO
OO
compilation of SDS for different chemical traders and producers of chemical mixtures; approx. More than 60,000 SDS compiled and updated permanent.
CASE STUDY 2: business process outsourcing OO
OO
assumption of product stewardship and legal chemical product service for paint companies, incl. determination of classification and labelling for products in all EC 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 45 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
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 GCCN
UMCO is co-founder of the international network “Global Chemical Consulting Network (GCCN)” for additional services dealing with foreign legal regulations.
2009
With our proprietary software and service “Compliance Solution”, you are able to achieve legal and liability compliance in environmental protection and occupational safety. You can delegate, monitor and document your specific operator obligations very easily and clearly.
2012 UHCS
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.
PARTNERS OO OO OO
NCEC GIZ GCCN
CLIENTS Our clients include 1,000 national and international companies all along the chemicals value added chain. Our clients come from the chemicals and pharmaceutical industry, traders, warehouses and logistics companies as well as from the manufacturing industry.
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PROFILE: UMCO Umwelt Consult GmbH
Safety health environment management
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 facility 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.
PROFILE: WIL Research
CONTACTS
SERVICES PROVIDED
Website
www.wilresearch.com
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
Privately owned
Locations
Main offices: US, the Netherlands and France. Support offices in the UK, Japan and Switzerland.
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 the WIL Research team remains dedicated and its objectives clear. REACH compliance
OVERVIEW WIL Research consists of over 1,200 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. WIL Research Europe 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). VITAL STATISTICS
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
9
No of countries represented
40-50
Staff, group
1,250
Staff, chemical service provision
-
SERVICE AREA BREAKDOWN
REACH safety testing To help you comply with the regulations WIL Research has set up a tenstep 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. Full service portfolio for Annex 7-8-9-10 Registration chemicals worldwide WIL Research provides 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% Laboratory 80%
REACH consultancy and Sief management and full testing portfolio
OO
OO
OO
OO
WIL Research has achieved good laboratory practice (GLP) compliance status for more than 20 years, with the most recent GLP endorsement statement signed in May 2013. WIL Research publication was referenced in the guidance document 117 for OECD 443 guideline. WIL Research published 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.
CLIENTS Non-disclosure agreements prohibit this level of information.
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STAFF SELECTION
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.
Wilbert Frieling, DVM – Senior Vice-President, European Operations
CASE STUDY 2: biocidal registration WIL Research’s regulatory affairs department provides a complete service for the registration of biocides under the BPR EU-528/2012. 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.
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).
CASE STUDY 3: complete hazard and exposure assessments WIL Research’s 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. 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, 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.
Chemical Watch | Global Service Providers Guide 2015
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CASE STUDY 1: WIL Research ten steps to REACH compliance
CHEMTREC® Provides Dynamic Solutions for our Registrants
6,000,000 SDSs
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A 24/7 communications center staffed by the most trained and experienced emergency service specialists in the industry
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Immediate access to thousands of chemical product specialists and hazardous materials experts through CHEMTREC®’s proprietary network of over 30,000 manufacturers, shippers, carriers, public organizations and private resources
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A state-of-the-art telecommunications system supporting a virtual emergency response team, seamlessly linking on-scene responders with chemical experts, hazmat professionals and medical specialists
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An expansive electronic library of over six million Safety Data Sheets (SDS)
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Immediate access to medical experts and toxicologists who provide emergency medical treatment advise/assistance to onscene medical professionals
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Interpretation capabilities for more than 200 languages
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In-country dial telephone numbers in more than 50 key countries around the world
30,000 Registrants 200 Foreign Languages 40+ Years Experience 24/7 Support 2900 Fairview Park Drive Falls Chruch, VA 22042 1-800-262-8200 (within the U.S.) +1-703-741-5500 (outside the U.S.)
www.chemtrec.com
www.3s-chem.gr info@3s-chem.gr 133, El Venizelou Str, 16343 Athens, Greece +30 2109901150/ +30 2109901151 Panos Drougas Private 2/01/2007
OVERVIEW
3S–SafelyServingScience is a distinctive company providing specialised advice and guidance at each stage of 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 +22y experience in the global supply of chemicals, matched with a certified knowledge onTransport-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/registrations and notifications); 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
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 clients in determining what their role and obligations are, the complete registration process from A to Z (including CSA/CSR), notifications (C&L and SVHC in articles), communication up and downstream (compilation of ext-SDSs, REACH compliancy letters, 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 for non-identified uses. Recently BIG has added the registration of biocides to its field of expertise. CLIENTS BIG is only representative for many global players, providing customised services to large international companies and SMEs. Clients are active in various sectors, such as: raw chemicals, fine chemicals, polymers, adhesives, plastics, healthcare, pharmaceuticals, coatings and paints, article manufacturers.
Incorporating
Incorporating
CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.calebgroup.net and 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, USA 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. Caleb’s clients range from governments, multi-national companies and worldwide consortia to small companies with a single substance. 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 CLIENTS 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. Caleb also supports more than ten REACH consortia as managers and advisors.
Chemical Watch | Global Service Providers Guide 2015
CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded
www.boeijeconsulting.com boeijeconsulting@telenet.be Meersstraat 44, B-9830 Sint-Martens-Latem, Belgium +32 468 15 41 08 Geert Boeije Geert Boeije Belgium 2012
OVERVIEW Boeije Consulting provides tailor-made solutions in the areas of safety-related product stewardship, regulatory compliance, environmental science and sustainability. Dr Geert Boeije is an environmental engineer with over 15 years of experience in product stewardship, risk assessment, regulatory affairs and organisational management. SERVICES PROVIDED OO Product stewardship: assessment and management of vulnerabilities for products as well as chemical substances; stakeholder engagement and advocacy; scientific as well as layman communication; expert panel coordination, etc. OO Regulatory compliance: strategic advice and practical execution for: classification and labelling (eg CLP); registration of chemical substances or products in the EU (eg REACH, BPR) and beyond; artwork compliance. OO Environmental science and sustainability: environmental risk assessment; lifecycle assessment; holistic review of environmental and sustainability related opportunities / vulnerabilities; environmental claim strategies and claim support; product qualification for eco-labels, or other environmental credentialing, including dossier preparation. CLIENTS Since 2012, Boeije Consulting has mainly provided services to the detergents sector – for several individual companies (eg on CLP classification and on artwork compliance), as well as at the industry association level (eg product stewardship of laundry capsules; sustainability and hygiene of low temperature washing). Examples of work outside of this sector are environmental risk assessment of pesticides and, with the European Commission, the development of new ecolabel criteria.
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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 Contact Ownership Locations Founded
www.chementors.fi info@chementors.fi Hulikanperä 2, FI-37570 Lempäälä, Finland +35 8407473393 Dr Jan Nylund Private Lempäälä, Tampere, Raisio, Kokkola 2012
OVERVIEW Chementors provides chemical safety services to companies under 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, Iuclid5, Chesar, R4BP and REACH-IT expertise. We assist customers to comply with the CLP Regulation on classification, labelling and packaging of chemical substances and preparations and to prepare appropriate and correct safety data sheets (SDS) and other documents required by law. Our SDS service also includes SDS translations to all EU and other languages. We offer qualified dangerous goods safety adviser services including consultation and preparation of all reports as required by the transport of dangerous goods Regulation (safety adviser). We help companies exporting chemicals to China with regulatory services in China. SERVICES PROVIDED OO REACH and biocide registration and consultancy OO China REACH and exporters to China OO cosmetic safety assessments and responsible person services OO safety data sheet preparation and translation OO data search and assessment OO human health and environment assessment OO R&D-services – substance replacement OO qualified dangerous goods safety adviser (DGSA) OO laboratory and testing CLIENTS Metso Minerals Ltd, Oriola Ltd, Mayer Industries, REACH, biocides, cosmetics, CLP: manufacturers/importers
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.
Chemical Regulatory Affairs – Israel CONTACTS E-mail Head office Tel Fax Contact Ownership Locations Founded
Shimshon.roth@gmail.com 8, Eliezer Hagadol Street, Jerusalem, Israel 9359008 +972-506233143 +972-2-6781377 Shimshon Roth Sole proprietorship Israel 2012
OVERVIEW I provide Israeli chemical regulatory affairs services. My twenty-five years of experience in government and services provided to international clients, helps me deliver accurate and cost-effective products tailored to your needs. SERVICES PROVIDED OO Translation of SDS and label phrases from English into Hebrew; OO Monitoring of the Israeli chemical control regulations; OO Classification and labelling of chemicals according to GHS and CLP; OO Authoring of SDSs and labels according to the requirements in Israel. Clients Companies developing regulatory databases, and SDS and label authoring software.
CLIENTS Manufacturers, importers or downstream users of industrial chemicals, veterinary drugs, plant protection products or cosmetic ingredients.
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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 build-in CLP-calculation. 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 a build-in CLP-calculation and intelligent selection of phrases. AlphaOmega includes comprehensive chemical management functions, control functions and automatic update functions. SDS output is available in more than 20 languages. AlphaOmega can also be used for authoring of chemical safety documents like APB (DK), COSHH (EN), Skyddsblad (SE) Betriebsanweisungen (DE) etc. Furthermore CHYMEIA provides consultancy including lectures and seminars on chemical legislation. Please note that the AlphaOmega CLP-calculator is one of the most advanced of its kind in the world – and is used by the Danish authorities. 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.
CONTACTS Website E-mail 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 Steven L Hanft, MA, President (private ownership) Aachen, Germany 1995
OVERVIEW CONUSBAT is an internationalisation regulatory service provider with expertise dealing with European Union legislation for cosmetics, personal and consumer health products, household cleaning agents and fine chemicals. Working with our 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: strategic planning PIF preparation, CPSR, CPNP notification; OO Regulation (EC) No 1907/2006 (REACH): strategic planning and all compliance steps, SIEF participation, automated-/substance inventory (SI) management; OO Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP): classification of substances and mixtures; OO international representation: responsible person (RP) for cosmetic products, only representative (OR) for cosmetic ingredients and other chemicals. Global knowledge for cosmetic ingredient compliance: regulatory frameworks for cosmetics, borderline products and chemicals, GHS. Strategic regulatory partnerships: US/Canada, Brazil/South America, Japan, South Korea, Taiwan, ASEAN, India, Israel, Turkey, South Africa, Russia. Training (online/onsite): EU / global cosmetics regulatory affairs workshops.
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 +390571367427 +390571382829 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.
CONTACTS Website E-mail Head office Tel Fax Contact Ownership Locations
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.
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.
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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.
CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
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, founded in 2011 as a Solvay spin-out. eSpheres is a global leader in delivering cloud health, safety, environment (HSE) and corporate sustainability 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. Consultancy services expertise: product safety and safety datasheet management implementation and maintenance; incident and accident management implementation; safety datasheet distribution; global label management; dangerous goods. eSpheres EHS SAAS: eSpheres has developed a private cloud solution based on SAP EHS and non SAP software containing regulatory content data bases. This platform offers EHS information management, but also regulatory compliance management. eSpheres products delivered by our software: SDS authoring; chemicals inventory management for substances and products; regulatory compliance checks; incident/accident management; safety working instruction cards.
CONTACTS Website E-mail Head office Tel Fax Contact Ownership Locations Founded
www.eurideastranslation.com translation@eurideastranslation.com 475 Avenue Louise, 1050 Brussels, Belgium +32 (0)2 669 7701 / +32 (0)2 669 77 87 +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 legislation. We have great experience in translating MSDSs, exposure scenarios, and other chemistry, environment and health related 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 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. This way we ensure the highest quality of translation and that the correct terminology is used. CLIENTS We have worked on REACH, BPR and other chemical related projects for Cefic, REACHCentrum, ISOPA, EuPC, Glencore International Imports, Rio Tinto, ReachLaw, FEFCO, Codelco, Molymet, the International Molybdenum Association, the International Lead Association, the Nickel Institute, Aurubis AG, DonauChem, Euromines, EcoMundo, Chemtopia, and many more.
CONTACTS Website E-mail Head office Tel/ Fax Contact Locations Founded
www.hdtschemicals.com service@hdtschemicals.com 4145 North Service Road, Suite 200, Burlington, Ontario L7L 6A3, Canada +1-905-336-4355/ +1-289-288-5201 Dave Saucier Canada 2001
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. 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. HDTS Chemicals Inc. also provides label design and material safety data sheet authoring services uing TECIS® software developed by Trivalent Data Services to meet Canada’s workplace hazardous materials information system (WHMIS) worker right to know regulations. We are also preparing for the Global Harmonized System (GHS) and will be ready to help your organisation meet specific Canadian GHS compliance requirements. CLIENTS Nexeo Solutions Inc, ADLI Logisticcs Inc, Chemroy Canada Inc, Ethox Chemicals LLC, Madison Chemical Industries Inc, Pro Form Products Ltd, Tri Art Canada, Vivier Pharma
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, cosmetic, automotive industry.
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Tel Contact Ownership Locations Founded
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 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 & 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 offers strategic and practical support to the various stakeholders working towards a successful and efficient implementation of REACH, CLP and related EU chemicals legislation. We combine our extended network, thorough legislative knowledge, joy in strategic and practical consultancy, enthusiastic facilitation of group processes and affinity for IT, with our creative, innovative and process-oriented thinking (“out of the box”) up to working solutions, good results and satisfied partners and customers. SERVICES PROVIDED We act as a sparring partner for companies and partners (like Caesar Consult and Apeiron-team), organising efficient REACH compliance strategies and practical chemicals management solutions in companies and industry sectors. Highly appreciated starting point is our “REACH Compliance Review”, mirroring a REACH compliance inspection on site. Let us think with you what is the possible impact and best implementation strategy dealing with REACH and CLP in relation to your specific business case. We are appreciated for our “out of the box” advice and practical training and workshops. Check our website for more detailed services and references. 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.
Chemical Watch | Global Service Providers Guide 2015
CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded
www.kreatis.eu contact@kreatis.eu 23 rue du Creuzat, 38080 L’Isle d’Abeau, France +33 (0) 4 28 19 01 06 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, France 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 French subsidiary, Linmark Consulting Europe SARL, offers only representative 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.
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Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
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 and UK 2001
OVERVIEW LKC provides European registration and development services to the international chemical industry. The LKC team is multifaceted, offering technical skills, regulatory experience, project management proficiency and strategy planning expertise. Chemical manufacturing clients can benefit from a full range of regulatory services to achieve the successful registration of products in the fields of crop protection, biocides, veterinary medicines and industrial chemicals. SERVICES PROVIDED Services for crop protection products, biocidal products, veterinary medicines and industrial chemicals include: Regulatory sciences: data gap analysis, data evaluation, contracting and managing of higher tier studies, study monitoring of chemistry, analytical, toxicology, ecotoxicology, environmental fate and efficacy studies, PEC-reports, GLP multi-site residue studies. Conducting risk assessments and modelling for dietary, human and environmental exposures. Dossiers: dossier preparation for active substance submissions for Annex I inclusion, product dossiers for national registrations, provisional authorisations and mutual recognition. CADDY. XML-dossiers, IUCLID dossiers, re-registrations, renewals, label extensions,extensions, setting EU import tolerances/MRL’s, REACH, CLP and JMAFF dossiers. Regulatory support: pre and post submission meetings with regulatory authorities, negotiation communications, estimating data package compensation for data-sharing and product defence. CLIENTS LKC’s clients are specialty chemical manufacturers who benefit from technical support in sectors that include crop protection, biocides, animal health and general chemicals.
CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership Locations
www.mckennalong.com dcornil@mckennalong.com / ncroquet@mckennalong.com 2 Avenue de Tervueren, 1040 Brussels, Belgium +32 2 278 12 11/ +32 2 278 12 00 Dominique Cornil, REACH Consortium Financial Manager and Office Administrator, Nicolas Croquet, Associate, Peter Gray, Partner, Robert A Matthews, Partner. Partnership US, Brussels
OVERVIEW Chemical regulation is one of MLA’s marquee practices. Lawyers in our Brussels office counsel and litigate on all aspects of EU chemical regulation, including REACH, biocides, pesticides and cosmetics. MLA handles the administrative and financial management of REACH consortia. MLA has significant experience with REACH related issues concerning mergers and acquisitions (See www.mlalaw.eu). SERVICES PROVIDED Anti-trust and unfair competition; chemicals, pesticides and product regulation; corporate; energy; environment, energy and product regulation; EU competition; EU environmental; EU food; financing and lending; government contracts; green chemistry; hazardous waste management; litigation; mergers and acquisitions; private equity, hedge funds and venture capital. CLIENTS Confidential.
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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 15 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 Chinese companies to the EU market, and supporting international companies to comply with Chinese regulations and custom clearance. We have extensive experience with a number of industry sectors and government policymakers in EU and China. Our outstanding capability lies in supply chain communication and product stewardship SERVICES PROVIDED We help prepare regulatory license documents for market entry into the EU and China. These include, in the EU: REACH, CLP, EMEA, water framework Directive, biocidal products Regulation, cosmetic products Regulation, RoHS, health / nutritional claims and eco-labels; in China, China REACH and MEP Order 7; China hazardous chemical registration (Decree 591, Order 53 and Order 22); disinfectants regulation, food safety and health related regulations. We also provide technical documents translation and policy interpretation. Our featured service areas include: 1) intelligent testing strategies – helping design environmental and health testing strategies that save money and meet regulatory requirements; 2) hazard and risk assessment – PBT, CMR, exposure assessments and chemical safety reports; 3) representation and advocacy – representing clients to REACH consortia; and 4) SVHC and supply chain management. CLIENTS Government and industry clients in a wide range of sectors, such as industrial chemicals; 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 2015
Tel/Fax Contact Ownership Locations Founded
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 2004
OVERVIEW Although not big but very professional, Randis is managed by a team of experts with dozens years of experience working for famous multi-national chemical companies in China, provide timely and cost-effective services on regulatory compliances for China. SERVICES PROVIDED OO full regulatory support for China IECSC registration (China REACH), including being the notification agent (OR), 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 registration of Environment Microbe Microbial Inoculum. 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 Richard L Roden Istanbul Chemicals and Chemical Products Exporters’ Association (IKMIB) 95% and Steel Exporters’ Association (CIB) 5%. Two divisions of Istanbul Minerals and Metal Exporter’s Association, a joint venture between Turkish private industry and the Ministry of Economy. 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 the European Chemicals Agency (Echa) in Helsinki. 2008
OVERVIEW REACH Global Services SA (RGS) is a professional regulatory consulting company advising private and public sector clients in the chemicals and allied industries to comply with European Union and Turkish Republic chemicals legislation. RGS’s experienced staff, based in Europe and Turkey consults to a diverse array of chemical and cosmetic companies, international and Turkish operating across a range of industrial sectors. SERVICES PROVIDED REACH audit and related services including only representation to non-EU manufacturers. Responsible person EU cosmetics Regulation compliance services for Turkish exporters to the EU. Turkish chemicals legislation compliance including by-law on chemicals inventory and control, Seveso II, food and biocides regulatory compliance. CLIENTS RGS’s client portfolio range from multinational blue chip and leading Turkish chemical and allied industry companies to small and medium enterprises.
Chemical Watch | Global Service Providers Guide 2015
CONTACTS Website E-mail Head office Tel Fax Contact Ownership Locations Founded
www.rorltd.com info@rorltd.com Hippocampus House, Hulme Lane, UK +44 (0)1565 724241 +44 (0)1565 723500 Client services Private limited company Europe, local agents: Asia, Middle East 2006
OVERVIEW Reach Only Representative Ltd (ROR) was one of the first commercial Only Representatives established in Europe. UK based, assisting non-European chemical manufacturers, and EU manufacturers and importers to comply with their REACH obligations. ROR is recognised as one of the most competent specialist Only Representative companies in Europe with the ability to provide compliance services to all members of the supply chain. SERVICES PROVIDED Only Representative services for non-EU manufacturers to export to the EU. Third party representative services for EU manufacturers, importers and internal Only Representatives so they comply with their obligations. Lead registration representation in consortia, within the Sief or on committees. Document preparation: Iuclid technical dossier, chemical safety report (CSR), safety data sheet (SDS) authoring, provision and distribution. Additionally we can offer auditing services to ensure your company remains compliant with REACH. CLIENTS Countries of clients: China, India, USA, UK, Brazil, Qatar, Egypt, South Africa, South America and other regions.
CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded
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. SERVICES PROVIDED Impact of REACH, CLP and BPR: in finding comprehensive solutions for companies, we advise you on the best way to approach your REACH and CLP “problem” and to remain compliant; similarly for biocides. 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.
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CONTACTS Website E-mail Head office
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www.refac.eu Technical.manager@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, primarily to suppliers of industrial chemicals etc, both within Europe and from across the world, who seek to comply with REACH. 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 REACH and CLP 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, Harlan, Intertek and LSM 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 who require management, consultancy and study monitoring services.
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 Belgium. 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 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 Steve Kent 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, metabolism and metabolite profiling: micro-organisms, aquatic macrophytes, and microalgae, aquatic invertebrates, aquatic vertebrates to international guidelines (OECD, ISO etc). Fate of substances and contaminants (distribution, accumulation, biodegradation and metabolism). Indoor soil, aquatic and sediment mesocosms with simulation of urban, agricultural and natural climatic conditions. Validation and implementation of analytical methods with biomarker identification and Metabolomics, proteomics and enzymatic assays and MALDI imaging, substance and metabolite profiling, monitoring of contaminants (environmental biota, biofluids). CLIENTS General chemical industry, research institutes and universities, government bodies NGOs, human and animal pharmaceutical industry, biocides industry, plant protection products industry, plastics industry, personal care products industry, flavours and fragrances industry.
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Website E-mail Head office Tel Contact Ownership Locations Founded
www.scivera.com pbeattie@scivera.com SciVera LLC, 300 Preston Avenue, Charlottesville, VA 22902, US +1 434 974 1301 betterproducts@scivera.com 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 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 over thousands of chemical, component, and productlevel 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 and market requirements such as California Prop 65, REACH CSA/CSR, EU Toy Safety Directive Conformity Assessment. 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 manufacturers and suppliers in: automotive, electronics, footwear/ apparel, household goods, office furniture, toys, textiles, and specialty chemicals.
Chemical Watch | Global Service Providers Guide 2015
E-mail Head office Tel Ownership Locations Founded
Website: www.siam-it.net Product website: www.chemeter.eu info@chemeter.eu Ortega y Gasset 17 bajo, 26007 Logroño, Spain +34 941286749 Limited society 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. Our clients come from the following chemical sectors: cleaning products, coatings, paints, rubber, adhesives, etc.
Spring Trading Company CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded
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, thoughtfully 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 includes 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.
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: high-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 and 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, 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.
Chemical Watch | Global Service Providers Guide 2015
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CONTACTS Website E-mail Head office Tel / Fax Contact Ownership Locations Founded
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, labelling and notification. BPR Regulation: data sharing agreements, dossier development for active substances approval and biocidal products authorisation. Cosmetic products: safety assessment, product information file, notification. Medicines: CTD, genotoxic impurities assessment, environmental risk assessment. Occupational medicine: risk assessment and management (Directive 98/24/EC). Other: training for companies, universities and institutions. CLIENTS Toxicon assists large companies and SMEs. Moreover, Toxicon works in partnership with institutions, industries and associations for R&D and compliance projects.
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 and to promote safer products. ToxServices excels at providing toxicology, regulatory, sustainability, and risk assessment consulting services. SERVICES PROVIDED ToxServices specialises in assessments of industrial chemicals, pharmaceuticals, cleaning products, cosmetics, dietary supplements, building materials, food additives/food contact materials, GRAS ingredients, medical devices, and consumer products, among others. ToxServices is an authorised third-party profiler/assessor for the US EPA Design for the Environment (DfE) programme, GreenScreen® for Safer Chemicals, CleanGredients®, Health Product DeclarationsTM (HPDs), and the Cradle to CradleTM certification programme. Core competencies include: quantitative exposure and risk assessments; MOS/MOE;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 we also 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 are smaller companies and multinational corporations with extensive portfolios, including manufacturers, suppliers, and distributors of dietary supplements, personal care products, medical devices, textiles, food contact materials, household and consumer products, foods and beverages, and pharmaceuticals and over-the-counter drugs.
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CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.wrcplc.co.uk solutions@wrcplc.co.uk Frankland Road, Swindon, UK 01793 86 5000/ 01793 86 5001 Annette Ewence 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 European Chemicals Agency (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. CLIENTS A wide variety of clients ranging from single industrial chemical manufacturers to multinational consortia.
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Contact ReFaCâ&#x20AC;&#x2122;s team now to find out how our Regulatory Professionals can assist your company in complete confidence with a wide range of cost-effective regulatory compliance solutions includingâ&#x20AC;Ś Consortium & SIEF management
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www.refac.eu +44 (0)1270 258530
A
Company
A-Z LISTING
Page Headquarters Germany UK 48 USA
3S-SafelyServingScience Accenture ACTA Actio Corporation Advinus Therapeutics Limited Aegis Regulatory Inc AG-HERA Alan Best Alberi EcoTech Alchemy Compliance Ltd Alemare Solutions Alster Consulting > Chemical Compliance Altox a/s AMEC Environment and Infrastructure
151 Greece Belgium 50 UK USA India Canada UK UK USA UK UK Germany Denmark UK
Annray Test Co., Ltd. Antea Group
China USA
Anthesis-Caleb APC
151 UK 52 UK
Apeiron-Team NV ARCADIS
54 56
Belgium The Netherlands
ARCHE Argentum Environment ASCHEM Chemical Consulting Assent Compliance
58
Belgium Sweden Poland Canada
ATOUT REACH Austen Business Solutions Ltd AW-ChemAdvice Baytouch Ltd Beijing BoardingCard Chemical Consulting Co., Ltd. Beveridge & Diamond, PC 60 bibra toxicology advice & consulting BIG vzw 151 BioQuanta BIOVIA, Dassault Systemes Bird & Bird LLP 62 Blue Frog Scientific Limited Boeije Consulting 151 Bootman Chemical Safety 152 Borenius & Kemppinen, Attorneys at law Ltd BSL BIOSERVICE Scientific Laboratories GmbH 64
Buckman Bureau Veritas Bureau Veritas HSE Denmark A/S Burges Salmon Cambridge Environmental Assessments Cardno ENTRIX
France UK The Netherlands UK China USA UK Belgium France USA Belgium UK Belgium UK Finland Germany
USA France Denmark UK UK USA
CEHTRA
66
France
Centro Reach
68
Italy
Other locations China, Italy, USA Australia Denmark, Canada, Asia
USA, China
Germany, Netherlands, USA
Chemical staff 2-5 50-100 100-500
2-5 5,000 plus 25-50 25-50 100-500 2-5 2-5 1 1 1 2-5 1 2-5 2,000-5,000
2-5
25-50 The Netherlands, 5,000 plus France, Belgium, Colombia, Africa, Germany Germany, USA 100-500 France, Poland, 25-50 Czech Rep, Australia, Brazil 5-10 Belgium, USA, 5,000 plus Switzerland 10-25 UK 100-500 1 USA, Germany, UK, 100-500 Taiwan, India, Kenya 2-5 2-5 1 USA 5-10 10-25 50-100 10-25 25-50 Japan, Thailand, USA 25-50 25-50 500-1000 5-10 1 2-5 100-500 Representatives in 100-500 Switzerland, Japan, India, Poland, Sweden, Italy and other countries 2,000-5,000 5,000 plus 5,000 plus 500-1000 5-10 South America, 1,000-2,000 Canada Belgium, Canada, 50-100 India, 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%
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Global staff 10-25 50-100 100-500
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Organisation 1cc GmbH 24-7 Response 3E Company
Further information e www.1cc-consulting.com g g g www.24-7response.org em e www.3ecompany.com
ieg gg e
www.3s-chem.gr www.accenture.com www.actagroup.com www.actio.net www.advinus.com www.aegisreg.com www.ag-hera.com www.alanbestsustainability.com g g www.alberieco.com www.alchemycompliance.com i g e a www.alemare.co.uk g alster-consulting.eu e e g www.altox.dk e e e www.amec.com/reach.htm
25-50 10-25 50-100 2-5 2-5 1 1 1 1 1 2-5 25-50
mg ge ggg m m m mg e i gg gg m m e ig e
e iee eeee m
10-25 100-500
e me
www.annraytest.com/eindex.asp e e e e e www.anteagroup.com
5-10 25-50
mg m
5-10 25-50
me me
10-25 25-50 1 10-25
me ge i e gg
2-5 1 1 5-10 10-25 10-25 10-25 25-50 10-25 25-50 2-5 5-10 1 2-5 5-10 50-100
ig g ii m e m gg i e m me aa iee ege m ii m
www.atoutreach.fr www.austenbusinesssolutions.co.uk
100-500 50-100 5-10 5-10 25-50
egegeee eg geee i g g m ii e m
www.buckman.com www.bureauveritas.com www.bvhse.dk www.burges-salmon.com www.cea-res.co.uk www.cardnoentrix.com
50-100
mea
aee
2-5
iee
eg
m
e
e www.calebgroup.net a www.apc.eu.com
e e e www.apeiron-team.eu e a a a www.arcadis-us.com e e gge ge gg
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 www.accelrys.com www.twobirds.com mg e a www.bluefrogscientific.com www.boeijeconsulting.com me e ig e e e www.bootmanchem.com www.borenius.com m www.bioservice.com g m
www.cehtra.com www.centroreach.it
Chemical Watch | Global Service Providers Guide 2015
Information
IT solutions
Laboratories
Training
3S-SafelyServingScience Accenture ACTA Actio Corporation Advinus Therapeutics Limited Aegis Regulatory Inc AG-HERA Alan Best Alberi EcoTech Alchemy Compliance Ltd Alemare Solutions Alster Consulting > Chemical Compliance Altox a/s AMEC Environment and Infrastructure
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 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 Boeije Consulting Bootman Chemical Safety Borenius & Kemppinen, Attorneys at law Ltd BSL BIOSERVICE Scientific Laboratories GmbH
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: Core service Service that is occasionally provided Service provided by partners and third parties
Chemical Watch | Global Service Providers Guide 2015
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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
Consultancy/advisory
A-Z LISTING
ChemService Srl Controlli e Ricerche CHEMTREC Chemwatch
CHESSOL, chemical safety sheets online Chilworth – a DEKRA Company Chris Braun Consultancy Chymeia ApS CIS Center CiToxLAB CJV Consulting Ltd Clariant Complianca LLC Compliance & Risks Compliance Footprint AG Compliance Services International compliance2business Consortia Management GmbH CONUSBAT CRAD Crowell & Moring CS Regulatory Ltd CTT Currenta GmbH & Co. OHG Cyprotex PLC Danger and Safety srl DanGoods Training & Consultancy Datalab David Ryberg Defense Logistics Agency DEKRA Assurance Services GmbH DEKRA Consulting GmbH Dell Tech Laboratories Ltd. Delphic HSE Solutions Limited DHI DIPHEX Ltd Distefano Law Office DR MACH Chemical Compliance & Competence Dr Prerna Shinde Dr. Andrea Volpato
Page Headquarters 152 Germany 70 USA Switzerland USA Luxembourg 152 Finland Finland Ireland USA 152 Israel UK Finland UK USA 72 Italy 74 Germany, Luxembourg Italy 76 USA Australia
The Netherlands UK The Netherlands 153 Denmark 80 Russia 82 France UK 78
Italy USA Ireland Switzerland USA Italy Germany 153 Germany Turkey USA UK China Germany UK 153 Italy UK USA Norway USA Germany Germany Canada UK 84 Denmark UK 153 Belgium 154 Germany
Global staff 5-10 5,000 plus 10-25 50-100 5-10 5-10 2-5 1 1 1 2-5 1 2-5 50-100 Qatar 10-25 South Korea, Turkey, 25-50 France Agent in China 25-50 25-50 UK, US, Australia, 100-500 Netherlands, Turkey, Poland, Italy, Egypt, UAE, Mongolia, Malaysia, China, Japan 5-10 80+ globally 5,000 plus 1 10-25 50-100 Hungary 1,000-2,000 1
Other locations Italy UK Germany Belgium
India, Kenya USA, UK, Belgium global offices UK
UK, Belgium
USA
France, Hungary, Turkey, UK
5-10 Hong Kong 10-25 31 worldwide offices 1,000-2,000 5-10 2-5 1
India Italy
Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%
Page 164
5,000 plus 5-10 25-50 5-10 10-25 1 2-5 5-10 10-25 1,000-2,000 5-10 100-500 100-500 100-500 5-10 1 2-5 10-25 1,000-2,000 25-50 100-500
1 1
Chemical staff 5-10 50-100 5-10 50-100 5-10 2-5 2-5 1 1 1 2-5 1 2-5 50-100 5-10 25-50
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Organisation CFCS Charles River Chem-Academy ChemADVISOR ChemAdvocacy S.A. Chementors Ltd Chemest Ltd. ChemHaz Solutions Chemical Consultant, Joseph E. Sabol, PhD Chemical Regulatory Affairs – Israel ChemPharmaServe Ltd Chemphex ChemRegs (UK) Ltd ChemRisk Chemsafe Chemservice
me
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www.chempharmaserve.com www.chemphex.com www.chemregs.co.uk www.chemrisk.com www.chemsafe-consulting.com e e e e www.chemservice-group.com
ig
25-50 25-50 100-500
g
2-5 100-500 1 10-25 10-25 100-500 1
g g m e i e m
100-500 2-5 10-25 5-10 10-25 1 2-5 2-5 10-25 25-50 5-10 100-500 25-50 25-50 5-10 1 1 2-5 10-25 5-10 50-100
i gg e i ge ee e ii i i e meeeee gge eg m m ge gi e e m mg ee g m ee
2-5 10-25 50-100 2-5 2-5 1
i g i ig e ee ia ge a e e g m aa me e
1 1
m m
m
e
e e
Further information www.cfcs-consult.com www.criver.com www.chem-academy.com www.chemadvisor.com www.chemadvocacy.com www.chementors.fi www.chemest.fi www.chemhazsolutions.com chem-consult.com
e www.chemservice.it em e www.chemtrec.com m e www.chemwatch.net
gge e e m e e eeeg m ee ee i
e e
www.chessol.nl www.chilworth.co.uk www.cbconsult.nl www.chymeia.com www.ciscenter.ru www.citoxlab.com cjvconsultingltd.wix.com/ cjvconsultingltd www.clariant.com www.complianca.com www.complianceandrisks.com www.compliance-footprint.com www.complianceservices.com www.compliance2business.eu www.consortia-management.com www.conusbat.com www.crad.com.tr www.crowell.com www.csregulatory.com www.cttlab.com www.analytik.currenta.de www.cyprotex.com www.dangerandsafety.it www.dangoods.co.uk www.datalabsj.com
geei aa me me eeg g ig m g g i g gg g www.dla.mil mg e www.dekra.de/reach me e e www.dekra.de/en/reach
g ee
e
www.delltech.com www.delphichse.com www.tox.dhigroup.com m www.diphex.com e www.distefanolawoffice.com www.mach-chemguide.com
ee www.andreavolpato.it
Chemical Watch | Global Service Providers Guide 2015
Information
IT solutions
Laboratories
Training
ChemService Srl Controlli e Ricerche CHEMTREC Chemwatch
CHESSOL, chemical safety sheets online Chilworth – a DEKRA Company Chris Braun Consultancy Chymeia ApS CIS Center CiToxLAB CJV Consulting Ltd
Clariant Complianca LLC Compliance & Risks Compliance Footprint AG Compliance Services International compliance2business Consortia Management GmbH CONUSBAT CRAD Crowell & Moring CS Regulatory Ltd CTT Currenta GmbH & Co. OHG Cyprotex PLC Danger and Safety srl DanGoods Training & Consultancy Datalab David Ryberg Defense Logistics Agency DEKRA Assurance Services GmbH DEKRA Consulting GmbH
Dell Tech Laboratories Ltd. Delphic HSE Solutions Limited DHI DIPHEX Ltd Distefano Law Office DR MACH Chemical Compliance & Competence Dr Prerna Shinde Dr. Andrea Volpato
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 2015
Page 165
A-Z LISTING
Organisation CFCS Charles River Chem-Academy ChemADVISOR ChemAdvocacy S.A. Chementors Ltd Chemest Ltd. ChemHaz Solutions Chemical Consultant, Joseph E. Sabol, PhD Chemical Regulatory Affairs – Israel ChemPharmaServe Ltd Chemphex ChemRegs (UK) Ltd ChemRisk Chemsafe Chemservice
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
Consultancy/advisory
A-Z LISTING
Page Headquarters 86 Germany Germany South Africa 88 Germany Canada Belgium USA The Netherlands France 90 Norway
Ecotox Services International Edupalli Ramakrishna eftec EggCentris EHS Strategies, Inc EHSCareers.com, Inc elc group
Australia India UK Belgium USA USA UK
Elemica
USA
Emveo Enthone BV ENVIRON Environmental Science Limited EnviroPlanning AB EquiTox ERA Technology Ltd ERM ES4chem eSpheres ETC Eupoc Eurideas Linguistic Services Euro Safety and Health Eurofins Air Toxics
Belgium The Netherlands 92 UK UK Sweden 94 France UK 96 UK The Netherlands 154 Belgium Slovakia Germany 154 Belgium UK USA
Eurofins Product Testing A/S
Denmark
Euromines Eversheds LLP
Belgium UK
Exitss Exponent International Limited f_OXYDE GmbH Fanwood Chemical, Inc Field Fisher Waterhouse LLP
98
Belgium UK Austria USA Belgium
Fieldfisher
100 UK
FinnREACH Flashpoint srl FoBiG Food and Environment Research Agency (Fera) Foresite Systems Fraunhofer ITEM GAB Consulting GmbH Gain Claude
Finland Italy 102 Germany UK USA Germany Germany France
Other locations
Canada Sweden, Finland, Denmark, Switzerland
Belgium
Chemical staff 100-500 1 1 25-50 1 5-10 50-100 2-5 25-50 5-10
5-10 500-1000 10-25 5-10 1 5-10 50-100
Czech Republic, India, Romania Germany, UK, The 100-500 Netherlands, Japan, Singapore, China, South Korea 1 2,000-5,000 93 in 21 countries 1,000-2,000 2-5 5-10 2-5 50-100 Worldwide offices 5,000 plus 1 Finland, Germany, 25-50 France, Netherlands 10-25 1 5-10 2-5 Denmark, Germany, 5,000 plus France, China Belgium, China, 5,000 plus France, Germany, Italy, The Netherlands, Spain, Sweden, USA 5-10 Europe, Middle East, 2,000-5,000 Asia 10-25 USA, Switzerland, 500-1,000 China 5-10 Germany 2-5 UK, Germany, 500-1000 France, Italy Belgium, France, 100-500 Germany 2-5 10-25 10-25 5-10 25-50 100-500 Spain 50-100 1
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 166
Global staff 100-500 1 2-5 50-100 2-5 5-10 5,000 plus 5-10 25-50 50-100
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Organisation Dr. Knoell Consult GmbH Dr. Philipp Langenbach GmbH Eagle Environmental EBRC Consulting ECD Compliance ECETOC Ecolab Ecomatters EcoMundo EcoOnline
m m i m i
g g
ee
e
a m ii e
m e e eee m m e e e a mee
5-10 100-500 10-25 5-10 1 2-5 10-25
m i
100-500
1 10-25 50-100 2-5 2-5 2-5 5-10 100-500 1 25-50
i m i m m m m i e
5-10 1 5-10 2-5 2,000-5,000
me gie ie g
m
100-500
e
m
2-5 25-50
2-5 50-100
gge mg
2-5 2-5 10-25
me m eem
10-25
eem
2-5 5-10 10-25 5-10 5-10 25-50 25-50 1
g m m m e g m m
e g
e
www.ecotox.com.au www.bhu.ac.in www.eftec.co.uk www.EggCentris.com m www.ehsstrategies.com m www.ehscareers.com e a e a www.elc-group.com
m e m ii
m e e
m
ge e
e e g e
e e i e ae eaee g e g ig ee ee m ee
m
e a
e a
Further information www.knoell.com www.dr-langenbach.de www.eagleenv.co.za www.ebrc.de www.ECDcompliance.com www.ecetoc.org www.ecolab.com www.ecomatters.nl www.ecomundo.eu www.ecoonline.com
www.elemica.com
www.emveo.be www.cooksonelectronics.com www.environcorp.com www.esldatasheets.com 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.airtoxics.com
www.eurofins.com/galten
www.euromines.org www.eversheds.com
e e e e www.exitss.eu e a a www.exponent.com g www.foxyde.com www.fanwoodchemical.com e www.ffw.com e
e g
g
e g aaa e m i ee a
www.fieldfisher.com www.finnreach.com www.flashpointsrl.com www.fobig.de www.fera.defra.gov.uk www.foresitesystems.com www.item.fraunhofer.de www.gabconsulting.de
Chemical Watch | Global Service Providers Guide 2015
Information
IT solutions
Laboratories
Training
Ecotox Services International Edupalli Ramakrishna eftec EggCentris EHS Strategies, Inc EHSCareers.com, Inc elc group
Elemica
Emveo Enthone BV ENVIRON Environmental Science Limited EnviroPlanning AB EquiTox ERA Technology Ltd ERM ES4chem eSpheres
ETC Eupoc Eurideas Linguistic Services Euro Safety and Health Eurofins Air Toxics
Eurofins Product Testing A/S
Euromines Eversheds LLP
Exitss Exponent International Limited
f_OXYDE GmbH Fanwood Chemical, Inc Field Fisher Waterhouse LLP
Fieldfisher
FinnREACH Flashpoint srl FoBiG Food and Environment Research Agency (Fera) Foresite Systems Fraunhofer ITEM GAB Consulting GmbH Gain Claude
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 2015
Page 167
A-Z LISTING
Organisation Dr. Knoell Consult GmbH Dr. Philipp Langenbach GmbH Eagle Environmental EBRC Consulting ECD Compliance ECETOC Ecolab Ecomatters EcoMundo EcoOnline
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
Consultancy/advisory
A-Z LISTING
Page Headquarters The Netherlands Canada Hungary UK UK 104 USA Italy
GreenSoft Technology, Inc
USA
Greenwich Chemical Consulting H2 Compliance Haley & Aldrich Hangzhou RUIO Technology Co. Ltd Harlan Laboratories
USA Ireland USA China USA
HAZMAT Ltd HDTS Chemicals Inc. herbert smith llp HFL Consulting Ltd 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 K J Bray & Associates K&L Gates LLP Kathrin Lanz Keller and Heckman KFT Chemieservice Konica Minolta Business Expert, Inc KREATiS LAUS GmbH LG CNS
LGC Linmark Consulting Linnunmaa Oy
Israel 154 Canada UK UK Germany USA Germany China The Netherlands USA 155 Portugal 106 USA 108 UK UK Poland 110 Germany South Korea India Japan USA Belgium 155 The Netherlands India UK UK Belgium Germany USA 112 Germany Japan 155 France Germany South Korea
UK 155 Switzerland Finland
Other locations
Chemical staff 1 1 1 2-5 5-10 50-100
iiee g m m g e m e i gg e e gie mg
Further information www.gentrochema.nl www.ghstc.com www.GHS-expert.com www.gilliesassociates.co.uk www.globalmsds.co.uk www.gltac.com www.golder.com
50-100
www.greensofttech.com
1 10-25 5-10 50-100 500-1,000
m me me em g
10-25 2-5 2-5 2-5 100-500 50-100
mg ee ie g e m m g m m
2-5
m
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 aag meeee m g mee
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 10-25 1 25-50 10-25 25-50 10-25 10-25 2-5 25-50 50-100
iee e mg ii m e m iea ggm
50-100 2-5 5-10
Offices in over 20 countries Taiwan, Japan, China, 50-100 Spain 1 USA 10-25 500-1000 50-100 France, Germany, 2,000-5,000 Israel, Italy, Japan, Korea, Mexico, The Netherlands, Spain, Switzerland, UK UK 25-50 2-5 2,000-5,000 25-50 100-500 Belgium, Brazil, 2,000-5,000 China, Russia, India 2-5
Worldwide UK UK 110+ Countries Singapore AT, CN, FR, JP, SV, USA, UK China, Vietnam
50-100 2-5 1 2-5 USA, Mexico, France, 5,000 plus Germany, Italy, Spain, UK, Japan 1 USA, UK 100-500 25-50 1 1,000-2,000 10-25 Belgium China 100-500 10-25 2,000-5,000 2-5 25-50 Japan, China, India, 5,000 plus Brazil, Indonesia, Europe, USA, Middle East 1,000-2,000 France 2-5 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%
Page 168
Global staff 2-5 1 1 2-5 5-10 10-25 5,000 plus
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Organisation Gentrochema BV GHS Training & Consulting GHS-expert Ltd Gillies Associates Limited GlobalMSDS GLTaC, Inc. Golder Associates
ii e ee m
www.grcci.com www.h2compliance.com e e www.haleyaldrich.com e e www.reach24h.com www.harlan.com
g ggge ee ige e e
www.hazmat.co.il www.hdtschemicals.com www.herbertsmith.com hflconsulting.uk www.ibacon.com www.icfi.com www.idrg.eu www.igcon.nl www.ihs.com/ehs-sustainability www.infotox.pt www.Intlcosmetics.com www.intertek.com www.iom-world.org www.ipo-pszczyna.pl www.ipoint-systems.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 a a e e e www.kft.de www.konicaminolta.com www.kreatis.eu ii m e e a a g i a a www.lgcns.com
ii igg
e
m
m
g
e www.lgc.co.uk e www.linmarkconsulting.com www.linnunmaa.fi
Chemical Watch | Global Service Providers Guide 2015
Information
IT solutions
Laboratories
Training
GreenSoft Technology, Inc
Greenwich Chemical Consulting H2 Compliance Haley & Aldrich Hangzhou RUIO Technology Co. Ltd Harlan Laboratories
HAZMAT Ltd HDTS Chemicals Inc. herbert smith llp HFL Consulting Ltd 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 K J Bray & Associates K&L Gates LLP Kathrin Lanz Keller and Heckman KFT Chemieservice 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 2015
Page 169
A-Z LISTING
Organisation Gentrochema BV GHS Training & Consulting GHS-expert Ltd Gillies Associates Limited GlobalMSDS GLTaC, Inc. Golder Associates
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
Consultancy/advisory
A-Z LISTING
Page Headquarters UK
LKC Switzerland Ltd LSR Associates MB Research Laboratories McKenna Long & Aldridge LLP Mercer
156 Switzerland UK USA 156 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) 114 UK Neuralog, LP USA NimkarTek Technical Services Pvt. Ltd India Noerr LLP NovaTox 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
Germany Canada USA UK USA Belgium UK 156 UK Belgium UK Finland Hungary
Pöyry Finland Oy Prefusion LLP Proactima AS ProductIP
Finland 156 UK Norway Netherlands
Prosacon GmbH PwC Randis ChemWise (Shanghai) Co., Ltd. REACH Advice GmbH REACh ChemAdvice GmbH
Germany The Netherlands 157 China Germany 116 Germany
REACh ChemConsult GmbH Reach Chemical BV REACH Delivery REACH Global Services REACH mastery REACH Monitor Reach Only Representative Ltd
Germany The Netherlands UK 157 Belgium 118 Italy Spain 157 UK
Reach Registration Services REACH24H Consulting Group ReachCentrum REACHLaw REACHReady Ltd ReachSpektrum, s.r.o. REACHWise
UK China 120 Belgium 122 Finland UK Czech Republic 157 UK
Redeker Sellner Dahs Rechtsanwälte ReFaC
Germany 158 UK
Global Other locations staff Belgium, Germany, 50-100 France, Japan, China, Brazil, US and Canada UK 10-25 USA, Japan 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 Canada 25-50 Sri Lanka, 10-25 Bangladesh 1,000-2,000 Ireland, UK 2-5 50-100 1 Canada, UK, India 10-25 UK, Netherlands 5-10 100-500 10-25 1 2-5 1 Belarus, Kazakhstan, 10-25 Moldova, Russia, Ukraine 2,000-5,000 China 2-5 100-500 China, Hong Kong, 25-50 Germany, UK 5-10 Global presence 2,000-5,000 10-25 1 Portugal, Sweden, 5-10 USA, India, China UK 5-10 1 USA, Japan 25-50 Turkey 10-25 5-10 10-25 Agents: Asia, Middle 5-10 East 10-25 Ireland, USA 100-500 EU, Asia-Pacific, USA 10-25 Belgium, India, Turkey25-50 5-10 2-5 The Netherlands, 2-5 Germany Belgium 100-500 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 170
Chemical staff 50-100
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Organisation Lisam Systems
e
Further information e e www.lisam.com
m
10-25 25-50 25-50 10-25 2-5
me ig
1,000-2,000
ee
5-10 1 100-500
em
10-25
eieaege
10-25 10-25
www.LKC-ltd.com www.lsr-associates.com www.mbresearch.com a e www.mckennalong.com www.mercer.com m
m
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m
e
e
geg
m m
e
www.merieuxnutrisciences.com
www.miamichemical.com www.particletesting.com www.mts-global.com www.msds-europe.com
e e e a the-ncec.com www.neuralog.com m m g www.nimkartek.com
gi g
10-25 2-5 50-100 1 5-10 5-10 10-25 10-25 1 2-5 1 5-10
10-25 2-5 10-25 25-50
m ie m e e
5-10 25-50 5-10 1 5-10
m i m i m
5-10 1 25-50 10-25 5-10 2-5 2-5
m m e m m m g
2-5 50-100 10-25 25-50 2-5 2-5 2-5
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5-10 2-5
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www.noerr.com www.novatox.ca aai e www.pacelabs.com/regulatory www.peeraspect.com m e e e www.penmanconsulting.com www.peratechnology.com e e e www.ecotoxchem.co.uk e www.pietconsulting.eu www.pinnacleassoc.com i www.polgar-acro.eu g
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www.poyry.com www.prefusion.co.uk www.proactima.no/en www.productip.com
www.prosacon.eu www.pwc.nl/nl/reach www.randis.cn, www.randischem.com www.reach-advice.com g e e www.reach-chemadvice.com
e i eee gg e
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www.reach-chemconsult.com www.reacheu.nl www.reachdelivery.com m www.reach-gs.eu ea a a e www.reachmastery.com e e www.reachmonitor.org g e e e e e www.rorltd.com a e e
g
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www.reach-rs.com www.reach24h.com/en-us www.reachcentrum.eu www.reachlaw.fi www.reachready.co.uk www.reachspektru.eu www.reachwise.eu
www.redeker.de e e www.refac.eu
Chemical Watch | Global Service Providers Guide 2015
Information
IT solutions
Laboratories
Training
LKC Switzerland Ltd LSR Associates MB Research Laboratories McKenna Long & Aldridge LLP Mercer
Mérieux Nutrisciences
Miami Chemical Micromeritics Analytical Services Modern Testing Services (Global)
MSDS Europe
National Chemical Emergency Centre (NCEC) Neuralog, LP NimkarTek Technical Services Pvt. Ltd
Noerr LLP NovaTox 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 Randis ChemWise (Shanghai) Co., Ltd. REACH Advice GmbH REACh ChemAdvice GmbH
REACh ChemConsult GmbH Reach Chemical BV REACH Delivery REACH Global Services REACH mastery REACH Monitor Reach Only Representative Ltd
Reach Registration Services REACH24H Consulting Group ReachCentrum REACHLaw REACHReady Ltd ReachSpektrum, s.r.o. REACHWise
Redeker Sellner Dahs Rechtsanwälte ReFaC
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 2015
Page 171
A-Z LISTING
Organisation Lisam Systems
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
Consultancy/advisory
A-Z LISTING
Chemical staff 10-25 1 500-1,000 25-50 10-25 1 1 10-25
Page Headquarters 124 China UK USA Germany 126 UK UK South Africa Ireland
Other locations UK and USA
Roisin McEneany Rovaltain Research Company Royal HaskoningDHV RTC – Research Toxicology Center SAFENANO Safety Data Services Safeware Quasar Ltd
Ireland 158 France 128 The Netherlands Italy UK UK UK
1 10-25 100 offices worldwide 5,000 plus 100-500 Singapore 100-500 1 USA, Ireland, Greece, 50-100 Japan, Turkey, 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 China, France, 5,000 plus Germany, Hong Kong, UK, USA All countries 5,000 plus 2,000-5,000 10-25 2,000-5,000 France, Italy, Greece, 5-10 Portugal, Poland, Romania, Finland, Ireland, UK, EL 5-10 2-5 25-50 2-5 UK 100-500 Russia, Ukraine 5-10 2-5 5-10 India 25-50 1 Belgium, China, UK 1,000-2,000 2-5 2-5 Japan, China, 1,000-2,000 Singapore 10-25 5-10 Denmark 2-5 1 5-10 10-25 The Netherlands 1 Germany, Canada, 5,000 plus UK USA, Italy, Japan 10-25 Netherlands 10-25
SAP AG SAP Japan Co, Ltd SATRA Technology SCAS Europe SCC Science & Environnement SciVera Selcia SGS SGS UK Limited ShawCor SHES Chemical Consulting Co., Ltd Shridhar Rajappanavar Siam S.L.
SIEF-IT Siletz SPRL SiteHawk Sitmae Reach Services BV Smithers Viscient Spetsinterproject Oy Spinnaker Coating, LLC Spring Trading Company, LLC SSS (Europe) AB Stefanie Merenyi Steptoe & Johnson LLP Stewardship Solutions Ltd Subvise Sumika Chemical Analysis Service Ltd (SCAS)
Germany Japan UK 158 Japan 130 Germany Switzerland 158 USA UK Switzerland UK Canada Korea India 159 Spain
Poland Belgium USA The Netherlands USA Finland USA 159 USA 132 Sweden Germany USA UK Germany Belgium
Surface Science Western SustChem Engineering Ltd Syska Voskian Consulting Ted Simon LLC TEI Analytical, Inc Telematic srl Tenviro Tetra Tech
Canada Greece USA USA USA Italy Sweden USA
The REACH Centre Ltd The Redstone Group
UK USA
USA, Spain and Japan
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 172
1 50-100 100-500 25-50 1 10-25
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Global staff 10-25 1 500-1,000 25-50 25-50 1 2-5 10-25
Organisation Regulatory Services International Ltd Regulatus Ricerca Biosciences, LLC RimaOne Risk & Policy Analysts Ltd (RPA) Risk Control Services Ltd Riskchem Rivendell International
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www.ricerca.com www.rimaone.com www.rpaltd.co.uk www.linkedin.com/in/rossfielding www.riskchem.co.za www.rivendell.ie rovaltainresearch.com www.royalhaskoningdhv.com www.rtc.it www.safenano.org www.safeware.co.uk www.sap.com www.sap.com www.satra.co.uk www.scas-eu.be www.scc-gmbh.de www.sci-env.ch www.scivera.com www.selcia.com www.sgs.com/reach
i www.sgs.com www.shawcor.com e e i i e www.cae.com e m e e www.chemeter.eu g
i ii
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Further information www.rsireg.com
m e meae e e eeee g em g e m e m
aa e e g ee e a
e www.sief-it.com www.siletz.eu www.sitehawk.com g www.sitmaereachservices.com m www.smithersviscient.com www.spetsinterproject.com www.spinps.com Springtradingcompany.com a www.ssseurope.org www.merenyi.net www.steptoe.com e www.stewardshipsolutions.co.uk www.subvise.com a www.scas-eu.be
www.surfacesciencewestern.com www.sustchem.gr www.sysvoskconsulting.com www.tedsimon-toxicology.com www.teianalytical.com www.epyplus.com www.tenviro.eu www.tetratech.com
e e e e www.thereachcentre.com g e e www.redstonegrp.com
Chemical Watch | Global Service Providers Guide 2015
Information
IT solutions
Laboratories
Training
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 SGS
SGS UK Limited ShawCor SHES Chemical Consulting Co., Ltd Shridhar Rajappanavar Siam S.L.
SIEF-IT Siletz SPRL SiteHawk Sitmae Reach Services BV Smithers Viscient Spetsinterproject Oy Spinnaker Coating, LLC Spring Trading Company, LLC SSS (Europe) AB Stefanie Merenyi Steptoe & Johnson LLP Stewardship Solutions Ltd Subvise Sumika Chemical Analysis Service Ltd (SCAS)
Surface Science Western SustChem Engineering Ltd Syska Voskian Consulting Ted Simon LLC TEI Analytical, Inc Telematic srl Tenviro Tetra Tech
The REACH Centre Ltd The Redstone Group
Key: Icons above represents the extent to which the company provides the service as follows: Core service Service that is occasionally provided Service provided by partners and third parties
Chemical Watch | Global Service Providers Guide 2015
Page 173
A-Z LISTING
Organisation Regulatory Services International Ltd Regulatus Ricerca Biosciences, LLC RimaOne Risk & Policy Analysts Ltd (RPA) Risk Control Services Ltd Riskchem Rivendell International
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
Consultancy/advisory
Page Headquarters USA 159 USA
A-Z LISTING
The Windsor Consulting Group, Inc. TJS Technical Services Inc. TNO Triskelion Tox Focus, LLC toXcel Toxicon Toxikon ToxMinds ToxServices TraceGains Trade Wind B.V. Tradebe UK TRASYS TSG TSGE Consulting
USA Canada The Netherlands USA UK Italy USA 136 Belgium 160 USA USA 138 Netherlands UK Belgium 134 159 159 160
140 USA UK
TUV Rheinland
USA
TUV Rheinland Hong Kong Ltd TÜV Rheinland LGA Products GmbH
Hong Kong Germany
TÜV SÜD Industrie Service GmbH
142 Germany
TUV SUD Japan TÜV SÜD Process Safety UL
Japan 144 Spain UK
UMCO Umwelt Consult GmbH Universit Bordeaux Segalen Verdant Law, PLLC Vidaris, Inc. Von Roll REACH GmbH VRS Regulatory wca environment Weeset Advisors Wercs Professional Services
146 Germany France USA USA Germany UK UK USA 158 USA
WIL Research Wildlife International, a Division of EAG, Inc Wilmer Tox Consulting WRc plc WSP UK Ltd
148 USA USA Switzerland 160 UK UK
WTConsulting Xiaodan Pei YASH Technologies
Switzerland China USA
Zanos Limited
UK
Other locations France, Belgium, UK, China, Germany, Japan
Page 174
Global staff 5-10 100-500
Chemical staff 5-10 100-500
m i
5-10
2-5
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1 100-500 2-5 10-25 5-10 5-10 10-25 10-25 25-50 2-5 500-1000 50-100
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10-25
g
100-500 50-100
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50-100
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2-5 10-25 500-1000
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25-50 100-500 2-5 2-5 2-5 2-5 10-25 1 10-25
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100-500 50-100 1 10-25 50-100
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5-10 100-500 50-100
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1
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2-5 Japan (sales office) 2,000-5,000 2-5 USA 10-25 5-10 Belgium 100-500 Germany 10-25 25-50 25-50 5-10 Spain, USA, France 1,000-2,000 Greece, Luxembourg, 500-1000 Spain, UK, France, Switzerland 100-500 Ireland, Spain, 50-100 Germany, France, Slovenia, Poland Germany, China, 5,000 plus Japan, India, Taiwan, Korea 5,000 plus China, India, 500-1000 Bangladesh, Turkey Japan, Singapore, 2,000-5,000 China, India 100-500 Switzerland, Taiwan 10-25 USA, Switzerland, 5,000 plus Bangladesh Germany 25-50 500-1,000 2-5 100-500 2-5 5-10 10-25 1 Belgium, Germany, 100-500 China, Japan The Netherlands 1,000-2,000 The Netherlands 100-500 1 100-500 Africa, Asia, Europe, 5,000 plus Middle East, Oceania 5-10 USA 100-500 Europe, Asia, 2,000-5,000 Australia 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%
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Organisation The Sapphire Group The Wercs
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Further information www.thesapphiregroup.com www.thewercs.com
e g g windsgroup.wix.com/ windsconsultingroup www.tjstechnical.com e e www.tnotriskelion.com a a toxfocus.com e a a www.toxcel.com e e a www.toxicon.it www.toxikon.be e e www.toxminds.com e e e www.toxservices.com www.tracegains.com www.twnl.com g www.tradebe.co.uk e www.trasys.be e e e www.tsgusa.com www.tsgeurope.com
ie
e
m m
g
www.tuv.com/us/green-solutions www.chn.tuv.com www.tuv.com
www.tuev-sued.de/technical_ installations/reach a a www.tuv-sud.jp e a www.tuv-sud.es e e e ul.com/consumer-products ee
www.umco.de www.u-bordeaux2.fr www.verdantlaw.com www.vidaris.com www.vonroll.com www.vrs-regulatory.net www.wca-consulting.com www.thewercs.com
www.wilresearch.com a www.wildlifeinternational.com www.reachwilmer.com www.wrcplc.co.uk e www.wspgroup.com
a e ee ee
m www.zanos.co.uk
Chemical Watch | Global Service Providers Guide 2015
Information
IT solutions
Laboratories
Training
The Windsor Consulting Group, Inc.
TJS Technical Services Inc. TNO Triskelion Tox Focus, LLC toXcel Toxicon Toxikon ToxMinds ToxServices TraceGains Trade Wind B.V. Tradebe UK TRASYS
TSG TSGE Consulting
TUV Rheinland
TUV Rheinland Hong Kong Ltd TÜV Rheinland LGA Products GmbH
TÜV SÜD Industrie Service GmbH
TUV SUD Japan TÜV SÜD Process Safety UL
UMCO Umwelt Consult GmbH Universit Bordeaux Segalen Verdant Law, PLLC Vidaris, Inc. Von Roll REACH GmbH VRS Regulatory wca environment Weeset Advisors Wercs Professional Services
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: Core service Service that is occasionally provided Service provided by partners and third parties
Chemical Watch | Global Service Providers Guide 2015
Page 175
A-Z LISTING
Organisation The Sapphire Group The Wercs
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
Consultancy/advisory
n Co em h C
e Th
cas i r e Am
ChemCon Europe Che mC on
As ia
REACH 2018 Authorisation
GHS 2015 Dossier update Evaluation
More Challenges Ahead You have successfully managed REACH 2013? Congratulations! So maybe for the time being you can cross off the R (Registration) on your list. But have you had the time to contemplate what the next 2 letters could mean for your business and what you have to consider for 2018? Further challenges may lie ahead requiring your attention. Evaluation is going on and also Authorisation has started for the first set of substances. The implementation of GHS for mixtures is due mid of 2015 and it is never too early to prepare for the next REACH deadline. knoell has prepared more than 800 lead dossiers in REACH phases I and II and offers comprehensive and tailor-made services to support your business in Europe and beyond:
Literature search and data evaluation Data gap analysis and development of registration strategies Non-testing approaches (read-across, QSARs, WoE, waiving) Study management and monitoring Classification & Labeling of substances & mixtures Technical Dossiers (IUCLID) and Chemical Safety Reports Extended Safety Data Sheets (eSDS) SIEF and consortium management Worldwide registration of chemicals
Agrochemicals Biocides Industrial Chemicals Veterinary Medicine Medical Devices Lab Services Training
We have been an independent service provider for the chemical and pharmaceutical industries since 1996, with currently over 450 employees at sites within the EU, Asia and the USA. For further information visit www.knoell.com or call us.
Dr. Knoell Consult GmbH Dr. Michael Cleuvers Managing Director Industrial Chemicals & Biocides Tel +49 214 20658-170 68165 Mannheim Germany www.knoell.com