Service Providers Guide 2011 - A guide to chemicals management and control services - V2 by Enhesa Product

Service Providers Guide 2011 A guide to chemicals management and control services

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ReachCentrum, created in June 2006 by Cefic (the European Chemical Industry Council) helps companies all through the value chain to prepare and implement REACH.

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ReachCentrum assists chemical manufacturers and importers in complying with all three aspects of the REACH legislation: dossier preparation for registration and support through the phases of evaluation and authorisation by providing our main services, which are consortia and lead registrant support services, consultancy and workshops.

Overall Project Management Settled Around 4 Core Fields of Expertise Secretarial and administrative support – Meeting organisation – Monitor technical service provider – Follow up actions & deadlines – Archiving

Legal support – REACH legal advice – Contract advice and management – Declarations of accession – Legal remedies

SIEF support & communication – Acting as contact person – Creation and maintenance of LINKinSIEF, our SIEF communication platform – Surveys – Reporting – Generic communication – Data collection

Financial and data management – Preparation and control of budget – Letter of Access and token management via LoA shop – Obtaining Letters of Access from data holders – Performing data

Training and Events To become acquainted with the REACH requirements, we offer webinars, be-spoke trainings, and workshops as well as self learning tools online or via CD. Our events help keep you up to date with REACH, its tools and its impacts on businesses, and bring you practical advice, ready to be implemented in your company. We also provide specific consultancy and in-company trainings. Consortia services – www.reachcentrum.eu/en/consortium-management.aspx SIEF support services – www.reachcentrum.eu/en/sief-support.aspx LINKinSIEF – www.reachcentrum.eu/en/sief-support/linkinsief.aspx Upcoming events – www.reachcentrum.eu//en/workshops/reach-events.aspx ReachCentrum Avenue E. van Nieuwenhuyse 6 B-1160 Brussels Belgium Page b

Tel: +32 2 676 7400 Fax: +32 2 676 7499 info@reachcentrum.eu www.reachcentrum.eu Chemical Watch | Service Providers Guide 2011

foreword Welcome to Chemical Watch’s first service providers guide and directory. It was driven by our readers’ needs for information about the breadth and depth of the service providers market for REACH and other chemicals management activities. The guide is in three parts. The editorial is based on a survey of some 372 respondents based in service provider and client companies across the world. The guide represents a snapshot of the current state of play but in analysing the survey data our author Cynthia Challener also conducted numerous interviews with providers and clients to obtain an understanding of what they think current and future trends are, resulting in some important insights. The core body of the guide comprises the corporate profiles of 53 global service providers, including consultants, lawyers, laboratories, information providers, IT solutions and training companies – more than 30 organisations have opted for two-page spreads, while more than 20 have quarter-page profiles. Each profile presents information about the company in a harmonised

and visual way providing detail that can often be time consuming to gather concerning staff employed, global office details, corporate history, services provided, clients, testimonials, case studies and key staff. Our aim is to save you time and take you in closer to help you draw up short-lists of service providers for your new projects or to confirm the credentials of those service providers you already work with. The last section of the guide is an A-Z listing of these organisations together with other service providers around the world, providing key details in a comparison matrix as a further tool to make the process of finding the right organisation more efficient than ever before. This guide would not be possible without the considerable effort and support of the service providers represented. Chemical Watch would like to thank them all for their help in compiling the editorial and profiles. Mamta Patel Editor

About Chemical Watch Chemical Watch publishes news and intelligence to help companies meet 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. Our services include: Chemical Watch Monthly Briefing Monthly pdf newsletter containing in-depth analysis of chemical regulatory issues, with expert contributions

Europe News Global News Daily news channel covering REACH, CLP and Daily news channel covering global chemical regulations, other European chemical news policy and implementation

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Webinars and workshops A series of Chemical Watch webinars and workshops offering expert insight into the specifics of chemical regulations

Managing CLP Compliance – The Essentials for Business Packed with case studies, this report offers a step-by-step guide to CLP compliance

REACH consortia Database of over 200 REACH consortia. Search by substance or CAS or EC number

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Jobs Vacancies worldwide for chemical regulatory specialists, toxicologists and other professionals working with chemicals

Forum Events database Discussion forum for the Chemical Watch Extensive database of hundreds of events worldwide for community to inform each other, ask questions those engaged in chemicals management and debate the issues of the day

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Chemical Watch | Service Providers Guide 2011

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contents The chemical service providers market: editorial............5 Profiles............................................................. 28

REACHReady.......................................................................95

3E Company.........................................................................28

Reach Only Representative Ltd...........................................96

ACTA.....................................................................................30

Reach Registration Services Ltd.........................................96

Apeiron-Team.......................................................................32

ReFaC...................................................................................96

ARCADIS..............................................................................34

SIEF-IT..................................................................................96

ARCHE.................................................................................36

Stewardship Solutions Ltd...................................................97

REACHWise, chemSIX.........................................................95

bibra toxicology advice & consulting..................................38

Tox Focus, LLC.....................................................................97

BioQuanta............................................................................40

A-Z Listings........................................................ 98

B-Lands Consulting.............................................................42 Brixham Environmental Laboratory.....................................44 CEHTRA...............................................................................46 Chemservice........................................................................48 Compliance Services International (CSI)............................50 CS Regulatory Ltd................................................................52 DHI.......................................................................................54 EcoMundo............................................................................56 ENVIRON..............................................................................58 Exponent International Limited............................................60 Harlan...................................................................................62 ICF International ..................................................................64 IHS (including Atrion)...........................................................66 Dr Knoell...............................................................................68 LG CNS.................................................................................70 Penman Consulting..............................................................72 ReachCentrum.....................................................................74 ReachSpektrum, s.r.o...........................................................76 REACHsuite .........................................................................78 Royal Haskoning..................................................................80 Sumika Chemical Analysis Service (SCAS)........................82 Smithers Viscient..................................................................84 TNO Triskelion......................................................................86 wca environment..................................................................88 Wildlife International Ltd.......................................................90

Niche firm profiles............................................... 92 AW-ChemAdvice..................................................................92 Caleb Management Services..............................................92 Chris Braun Consultancy.....................................................92 EggCentris NV.....................................................................92 Emveo...................................................................................93 H2 Compliance....................................................................93 IGCON..................................................................................93 International Cosmetics & Regulatory Specialists, LLC......93 Jongerius Consult ...............................................................94 Linmark Consulting..............................................................94 LKC Switzerland Ltd.............................................................94 REACH Chemical Consulting (UK) Ltd................................94 REACH24H Consulting Group.............................................95

Chemical Watch | Service Providers Guide 2011

The Service Providers Guide 2011 is compiled and published by CW Research Ltd, publishers of the Chemical Watch news service and other information products for chemical regulatory experts worldwide. CW Research Ltd, 140B Longden Coleham, Shrewsbury SY3 7DN, UK Tel: +44 (0)1743 818 101 Fax: +44 (0)1743 818 121 email: cw.enquiries@chemicalwatch.com  www.chemicalwatch.com Editor: Mamta Patel  mamta.p @ chemicalwatch.com Contributing Editor: Cynthia Challener  cynthia.c @ chemicalwatch.com Head of Sales and Marketing: June Meagher  june.m @ chemicalwatch.com Sales Executive: Will Marner  will.m @ chemicalwatch.com Business Development Director: Stuart Foxon  stuart.f @ chemicalwatch.com Managing Director: Julian Rose  julian.r @ chemicalwatch.com Proof-reading: Nick Hazlewood 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 The Complete Product Company, Malmesbury. Printed on 9 Lives 80 recycled stock. Front cover image ©iStockphoto.com/dra_schwartz First published 2011 Copyright and Database Rights © 2011 CW Research Ltd. All rights reserved Page 3

Introduction Chemicals management and control requirements continue to increase as both regulatory and nonregulatory pressures expand. The growing complexity of regulations and additional non-regulatory drivers are leading to changes in both the service provider market and the range of clientele they assist. Not only chemical companies, but all downstream users of chemical products must work to be in compliance with the EUâ&#x20AC;&#x2122;s Registration, Evaluation and Authorisation of Chemicals (REACH) Regulation, new chemicals control legislation in other nations and their programmes to implement the UN Globally Harmonised System of Classification and Labelling of Chemicals (GHS) while also dealing with changes in sector-specific regulations (eg biocides, pesticides, cosmetics, food contact materials, etc) and new hazardous materials transport rules. Even large chemical companies that have in-house teams with REACH experience can sometimes feel overwhelmed with the scope of chemicals management and control requirements. Furthermore, many SMEs donâ&#x20AC;&#x2122;t yet realise what is expected of them. As a result, demand for sophisticated services that support not only client compliance efforts but general business activities throughout the organisation and along the entire supply chain will increase. Successful suppliers will invest in building strong relationships and emphasise effective communication, innovative, value-added services based on in-depth knowledge and expertise and rapid responses to the evolving regulatory climate. To find out more about these trends and other related issues, Chemical Watch recently conducted a survey asking its unique community of both providers and their customers how they perceive the current chemical management and control service providers market and what their predictions are for the future. The survey explored such topics as how customers rate their service providers and the prices they charge, where contractors exceed or fall short of client demands and what level of outsourcing can be expected in 2011 Chemical Watch | Service Providers Guide 2011

and during the next five years. Over 370 individuals participated in the survey, the results of which are presented below along with a discussion of the service providers market based on interviews with various market participants.

Service provider market description The chemicals management and control service provider market encompasses very small to very large companies offering a wide range of services that can be generally categorised as follows: consultancy/advisory, management/administrative, training, legal, laboratory, information/IT/software and other (lobbying/advocacy, marketing/PR, human resource management/recruiting, insurance provision). These services are provided predominantly to chemical manufacturers and their key customers. Consultancy/advisory groups provide guidance on issues such as regulatory interpretation, strategies for product compliance and registration, testing and general business as well as supply chain communication and risk assessment. Consultants include Bibra Toxicology Advice & Consulting, B-Lands, Chemservice, Compliance Services International (CSI), CS Regulatory, Dr Knoell Consult, Environ, Exponent International, ICF International, Intertek, Linmark Consulting, Penman Cnsulting, REACH Chemical Consulting, REACHReady, Stewardship Solutions, TNO Triskelion, TUV SUD and WCA Environment. Firms primarily active in the management/ administrative category provide substance registrations, dossier preparation and safety assessments, notifications, and for REACH in particular, lead, only and third party representation as well as SIEF and consortium management services. A sample of organisations includes B-Lands, Chemservice, Consortia Management, H2 Compliance, Penman Consulting, Miami Chemical, PricewaterhouseCoopers, ReachCentrum, REACHLaw and REACHReady. Page 5

The chemical service providers market

Clients looking for advice on competition law, protection of confidential business information, supply chain contract law or help with substance harmonisation claims and gaining fair treatment in consortia turn to legal service providers such as Field Fisher Waterhouse, Keller & Heckman, Mayer Brown and REACHLaw. They may also turn to these firms, or a specialist such as PricewaterhouseCoopers, for assistance with finance and tax issues. Many consultancies and companies offering management and legal assistance also provide training services to their clients. These services can range from webinars to short workshops to extensive courses held at the service provider or custom designed presentations given in-house at the client. Most chemical management and control regulations, and particularly substance based regimes, require extensive environmental, health and safety (EH&S) data on specific chemicals. While some of these data are often already available, many data gaps remain and most regulated entities rely heavily on laboratory and technical service providers to help generate the needed information. Chemir Analytical Services, Harlan Laboratories, Intertek, LAB Research, NOTOX, SGS and TNO Triskelion provide services in various areas such as human health toxicology, exposure, ecotoxicity, conduct environmental fate and degradation, physicochemical property and analytical, environmental monitoring and SVHC (substance of very high concern) assessments and other testing protocols. Case study

Linmark Consulting â&#x20AC;&#x201C; managing the value chain Problem: a European specialist textile company had a problem with a chemical purchased from outside Europe, which was then processed and used in a medical product by their client. The chemical was becoming increasingly regulated in many territories. Continued supply of the raw material (which had high hazard but low exposure) was under question. Solution: Linmark Consulting plotted out the entire value chain at its five levels in the ten countries involved and defined the current regulations and predicted those coming in the next five years. A compliance review (hazard analysis, CLP, SDS, chemical control inventory, transport and use regulations) was carried out and a stakeholder analysis, exposure assessment, position papers and appropriate communication tools were developed. After a successful advocacy programme over two years at the EU member state and wider level, the continued use of the raw material was secured with the agreement of the stakeholders. The business value for the client and value chain involved some â&#x201A;Ź100 million. The approach was to work very closely as part of the client team, checking at all stages that the client was in agreement with and took ownership at each step in the project. An independent consultant was needed by the client to bring together all levels in the value chain.

Page 6

In some cases, companies purchase data from information providers like 3E Company and IHS. These firms provide information including managed regulatory content, chemical hazard information and safety data sheets (SDSs) and also provide regulatory and policy tracking services to help clients stay current with changing compliance requirements. SDI (Selective Dissemination of Information) services to track emerging hazard data help to keep companies up-to-date and highlight when dossiers may need to be updated in the longer term. Software and IT firms develop and/or maintain programmes designed to facilitate the management of both the massive amounts of data and the complex interactions between business software systems that are required today for effective chemical management and control. Companies such as 3E Company, Accenture, Actio Corporation, Environmental Science Ltd, Foresite Systems, H2 Compliance, IHS, SAP, Safeware Quasar and Trasys offer systems for managing substance inventories, SDSs, general EH&S programmes, regulatory information, supply chain and communication issues, laboratory data and consortia/ registration obligations. Not surprisingly, with the bulk of the demand for such services being generated by regulations in Europe and the US, the majority of service providers and their clients are currently headquartered there. In fact, 74% of respondents to the Chemical Watch survey are located in Europe, with 16% coming from North America and just 8.3% in Asia Pacific (Figure 1). Figure 1 Geographic distribution of survey participants Asia Pacific 8.3%

Others 0.4%

North America 16.2%

Europe 74.4%

Survey results also confirm that the highest percentage of customers are involved in the chemicals (commodity, specialty, agro, pharma, etc) and manufacturing (automotive, aerospace, electronics, etc) sectors. Among respondents, 46% belonged in the chemical industry with manufacturing accounting for the next largest group at just over 13% (Figure 2). There is, however, Chemical Watch | Service Providers Guide 2011

Case study

CS Regulatory – advising on data-waiving opportunities Problem: in early 2010, CS Regulatory was approached by a client with a series of related UVCB substances that were produced, supplied and used in the presence of a carrier solvent essential to maintain their structure and substance integrity. The substances had previously been reviewed by a consortium-appointed consultant that had determined an absence of physico-chemical study endpoints and advised a test package on each substance in the range. Solution: CS Regulatory quickly determined that the physico-chemical tests would be technically unfeasible and/or meaningless due to the effects of the solvent. Working with the client's process chemicals, CS Regulatory was able to prepare a detailed justification for waiving physico-chemical study and developed quantitative structure-activity relationships (QSAR) for many of the environmentally significant endpoints by assessing multiple variations of each of the UVCB structures to establish a weight-of-evidence approach for the purposes of risk assessment. With the IUCLID 5 registration dossiers prepared by CS Regulatory incorporating this strategy, the client successfully completed the lead registration for the 2010 deadline for all the substances including the waivers and QSAR endpoints.

Figure 2 Sector distribution of survey participants

Figure 3 Percent of chemical management work performed by in-house teams at survey participant firms 0-20% 15% 80-100% 35% 20-40% 10%

40-60% 13% 60-80% 27%

Of those services outsourced to service providers, consultancy work was retained most often, followed by administrative/representation and laboratory services (Figure 4). Regardless of service type, participants preferred to outsource chemical management projects on an occasional basis, with consultancy and laboratory services used most often overall and more often on a frequent basis. In addition, both consultancy and laboratory, along with IT/software services, were the most likely to be permanently retained (Figure 5). Figure 4 Distribution of services retained by survey participants

Other 22.6% Oil and gas 2.6% Chemicals 45.9%

Environmental 3.3% Energy 3.7% Consulting 8.5%

an organisation-wide level. For the 183 participating companies that answered this question, that extrapolates to a total yearly investment of €1.345 billion in outsourced chemical management and control services. Alongside this significant expenditure on external services, over a third of respondents also reported that 80-100% of chemical management work was completed by in-house teams. In fact, on average, in-house teams accounted for 62% of the chemical management efforts of respondent companies (Figure 3).

Training 7.0%

Other services 8.6% Consultancy 29.6%

Information 3.8% IT & software 12.8%

Manufacturing 13.3%

Notably, chemicals management and control teams within client firms spent on average €2.5 million annually, with €7.4 million per year being spent at Chemical Watch | Service Providers Guide 2011

Laboratory 16.0%

Legal 4.1%

Admin/ represent. 18.1%

Page 7

The chemical service providers market

growing demand from consumer product and retail markets as new regulations come into force around the world. There is also growing use of service providers by other services providers as smaller, focused firms form networks with other providers with different areas of core expertise. Others, such as ReachCentrum, maintain flexibility in their offerings through established relationships with consultants that can provide additional expertise on an as-needed basis, according to its head of consortia management services Mark Meesters. Of the participants in the survey, consultants represented 8.5% of the total.

C O M P L I A N C E

As an integrated business partner we provide the insight and expertise for companies to comply with market Chemical and Environmental Regulations • Representative Services • Registration & Inquiry • Regulatory Business Support • Articles & SVHC • GHS,CLP & SDS • Chemical Mgmt. Software

www.h2compliance.com powered by:

Figure 5

Figure 6 Overall satisfaction of survey participants with provided services

Consultancy/advisory 7%

30%

51% Neither satisfied or unsatisfied 9.0%

Administration/management/representative 34%

3% 16% Legal services 2% 15%

Unsatisfied 2.5%

Very unsatisfied 0.5%

Very satisfied 15.9%

44%

Laboratory 7%

31%

38%

Satisfied 72.1%

IT and software solutions 7%

35%

16%

Information services 5%

18%

41%

Training 2% 15%

53%

Other services 1% 3%

100%

% of participants Permanent

Frequent

Occasional

Never

On the positive side, however, a strong majority of participants (81%) were satisfied with the personal relationships they have with their contractors. The most important relationship factors for survey participants include building long-term relationships with individual staff members, adherence to project protocols and having service level agreements in place. Our respondents cited these factors well ahead of â&#x20AC;&#x2DC;suppliers keeping costs as low as possibleâ&#x20AC;&#x2122; (Figure 8). Figure 7 Satisfaction of survey participants with specific service aspects

While satisfaction with the overall chemical management and control services received by survey participants is high (88%, Figure 6), only 48% of respondents are satisfied with the prices they have had to pay (Figure 7). In addition, while 83% of participants believe that service providers are meeting their briefs, only 64% feel that providers are providing value for their money and just 44% feel that their contractors are adding value beyond contractual obligations. Of real concern is the relatively low level of satisfaction (56%) respondents expressed with the experience/knowledge that their service providers demonstrate in all of the countries in which the client operates.

Meeting your brief 15% 2%

83% Delivering on schedule

19%

72% Price of service

10%

42%

48% Providing value for money

31%

64% Technical knowledge

13%

82%

Adding value on top of agreed deliverables 13%

44%

44% Offering flexibility

25%

67%

Experience/knowledge in all countries in which you operate

Case study

CSI: consortium administrative support Problem: the Organotitanates and Zirconates Consortium required administrative support services for the 2010 REACH deadline. Solution: Compliance Services International (CSI) successfully provided chemical registration services, including consortia management and SIEF communications, study monitoring and registration dossier preparation, for a substance subject to the 2010 REACH deadline.

Chemical Watch | Service Providers Guide 2011

15%

30%

56% Personal relationship

16% 3%

81% Availability

19%

74% 0%

% of participants Satisfied

Neither

7% 100%

Unsatisfied

Page 9

The chemical service providers market

Frequency of service retention by survey participants

Figure 8

communication and an understanding of their specific needs, a good level of knowledge and timely responses as reasons for retaining existing providers. Participants that are considering finding an alternate supplier indicated that poor response times, the need to receive greater value for money, capacity issues, a lack of global expertise and changing business requirements as important factors driving this decision.

Most important relationship factors for survey participants Building long-term relationships with individual staff

The chemical service providers market

43% Strict adherence to project protocols 42% Service level agreements in place 39%

Figure 9

Suppliers keeping costs as low as possible

Distribution of survey participants interested in changing suppliers

29% Regular face-to-face meetings

Yes 5.7%

24% Regularly reviewing (and at times changing) suppliers No 45.8%

20% Paying more to get better value

Possibly 48.4%

11% Use of penalty clauses 3% Other 18%

10%

20%

30%

40%

50%

% of participants

Case study

Exponent: worldwide chemical notification strategies Problem: development of efficient and cost-effective worldwide chemical notification strategies for large numbers of industrial chemicals. Solution: Exponent International carefully considered the requirements of the countries concerned followed by review and evaluation of any available information to complete a data gap analysis. Intelligent testing strategies were used to minimise the requirement for new studies and at the same time the study design was considered to ensure that any necessary testing protocols were drawn up to meet all of the different regulatory requirements worldwide. The studies required were placed and monitored and this included the in-country studies required for China and Japan. Once all the data were available, the technical registration dossiers and risk assessments were prepared, including when necessary, development of exposure scenarios, risk characterisation and risk management measures. Following submission, any competent authority questions or testing proposals were addressed.

Competition in the chemical management and controls sector is heating up in response to the expanding regulatory environment. Service providers who can provide consistently high quality work at competitive prices are likely to be the most successful regardless of size or location of the company, according to Alec Willis, REACH regulatory specialist with consultancy company Exponent International. Many smaller companies are finding that staying smaller in size enables them to build strength in core areas of expertise and develop more intimate relationships with clients and thus gain a greater understanding of their needs. Working with scientists with proven experience and reputation can help in keeping the project package to a manageable scale and within reasonable budget, adds Philip Copestake, a senior toxicologist at Bibra Toxicology Advice & Consulting. â&#x20AC;&#x153;The skill sets needed to provide many of the aspects of what is required to an acceptable standard are not something that can be picked off the shelf at a whim.â&#x20AC;?

Despite the high overall satisfaction rating and perhaps because they donâ&#x20AC;&#x2122;t perceive that service providers offer any added value above the specified services, 54% of respondents are considering switching suppliers (Figure 9). Those respondents that will not be switching cite the development of strong relationships, excellent Page 10

Chemical Watch | Service Providers Guide 2011

Given the complexity of requirements for chemicals management and control, selection of an effective and efficient service provider is critical. Key factors to consider: • proven experience/reputation/delivery history • expertise/technical competence of staff • competence in regulatory and business practices • country knowledge • chemical industry sector knowledge • substance knowledge • global capability • availability/capacity • relevant accreditation/certification • in-house IT and equipment • size • longevity • cost • quality of proposal • established expert network Additional specifics: Management/administrative: Project management skills, ad hoc knowhow, negotiating skills Legal: scientific knowledge; breadth of capabilities Laboratory: recognised measurement techniques; knowledge of in vitro methods; GLP compliance Information/data: aggregate disparate data and information to provide robust solutions Software/IT: evolving technology; in-house and off-site support; integration with legacy systems; formats that are easy and practical to use Respondents to the Chemical Watch survey indicated that the expertise of key staff and proven experience on similar projects are the top two factors they consider when evaluating service providers (Figure 10). It is important to note that much of a project’s success depends on the client, too. “The client must have a clear idea of the goals of a project and the realisation that there is much that must be done in-house even when working with service providers,” notes Dr Richards from Linmark Consulting. “There is also need for the client to allow time early in the process for evaluating different consultants in order to properly determine which provider will best meet the needs for any given project. Furthermore, it is particularly important not to assume that simply because a consultant is large or has a high cost that it must be the best at what it does. It is essential to start consideration of service providers early to allow adequate time to review the provider’s true capabilities,” adds Mr Green from CS Regulatory.

“We believe that investing in truly understanding customer requirements and needs for global chemical management and control services is the platform for success in the coming years and serves as a strategic opportunity to identify future new customer requirements,” says Grant Kinsman, ceo with H2 Compliance. Understanding regulatory affairs as an opportunity for clients and not a threat can provide a real competitive advantage, according to Dieter Drohmann, managing director of Chemservice. “Business success in this sector is driven largely by strong customer loyalty as reflected in ongoing renewals and long, strong, and deep customer

Chemical Watch | Service Providers Guide 2011

Figure 10 Most important factors considered by survey participants when choosing a service provider Expertise of key staff

The chemical service providers market

Choosing a service provider

82% Proven experience on similar projects 79% In-depth knowledge of country specific regulations 61% Comprehensiveness/accuracy of proposal 52% Availability 48% Contract price 42% Ability to operate on a global scale 30% Appropriate accreditation/certification 30% Recommendation from peers 25% Independence of supplier organisation 24% ISO9001 or equivalent (quality management) 18% In-house equipment/software 15% ISO14001 or equivalent (environmental management) 15% Proximity to your office 6% Large size of supplier organisation 5% Other 22% 0%

20%

40%

60%

80%

100%

% of participants

relationships,” adds Robert S Christie, ceo and president of 3E Company. To be able to provide a wider array of services, smaller organisations like technical services provider TNO Triskelion are building networks with other providers offering expertise in the areas they do not focus on, according to industrial chemicals programme manager Doeke van der Schaaf. “The successful company strategy will be one that offers good managerial support and training across a robust team of individuals who are flexible, energetic and willing to engage with new demands,” confirms Bibra Toxicology’s Mr Copestake. For Martin Richards, principal consultant with Linmark Consulting, Page 11

Recent mergers and acquisitions Merger and acquisition activity in the service providers market seems to be concentrated in the laboratory and IT segments. Recent deals include SAP/Technidata, IHS/Atrion and Intertek/Ciba Expert Services. TNO also created the independent company TNO Triskelion including the activities of the Life Sciences Quality & Safety Business Unit in the fields of toxicology research, analytical chemistry and chemical risk assessment. As clients observe the service provider landscape change with this merger and acquisition activity, they want a comfort level knowing that they can buy and receive support from a business that employs the leading domain experts in the field, and that the business unit they depend on represents a meaningful part of a larger but still highly relevant company, according to Mr Christie of 3E Company. “M&A activity that strengthens core data and expertise, and brings new relevant and valuable skills and benefits to the existing offerings, is highly appreciated by corporate clients,” he notes. While a larger size for IT/Software and testing firms does not seem to be an issue for suppliers, it appears that clients prefer to work with smaller organisations when seeking advisory, management or legal services. ReachCentrum’s experience confirms this trend, according to Mr Meesters. “We have a staff of about 15 effectives and are able to offer services tailored according to the needs of our clients, including overall management and financial, communication and legal services. In fact, as of December 2010 we have managed 105 consortia.” Even so, Chemservice’s Dr Drohman believes that medium-sized regulatory affairs consulting companies with presence in different regions (Europe, Americas, and Asia) that can already support clients on a global scale will be attractive acquisition candidates for big testing house companies or global management consulting firms. Other reasons for possible M&A activity include expanding geographical reach, technical expertise or access to new markets.

Market forces: key regulatory drivers Clearly much of the chemical management and control activity taking place around the world is driven by regulatory compliance requirements. REACH has been Chemical Watch | Service Providers Guide 2011

the dominant force, and while the first registration deadline has come and gone, much work remains as the 2013 deadline looms. Significant efforts have also been directed towards compliance with the EU’s new Classification, Labelling and Packaging (CLP) Regulation, compliance with which will take a number of years given its transitional arrangements. But at the same time, attention is steadily being drawn towards other parts of the world as additional countries work to develop and implement their own chemical control and GHS-related regulations. The possibility of changes to the Toxic Substances Control Act (TSCA) in the US and other activities by the US Environmental Protection Agency (EPA) and individual state governments has significant implications. There are also numerous legislative changes that target specific industry sectors such as biocides, agrochemicals, electrical and electronic goods, packaging and cosmetics. Case study

Chemservice: tracking indirect EU-imports Problem: REACH does not distinguish between direct and indirect imports into the EU. Therefore, non-EU business followed by export to the 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 compositions. In a multilevel, 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 essential for traders and formulators to keep product component and supplier/customer information secret (CBI). 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. Solution: Chemservice has developed a software-based solution to track indirect EU-export even for multi-level supply chains while protecting CBI.

For 2011, 77% of Chemical Watch survey respondents still identify REACH as the global driver, followed by GHS (58%of respondents), other global chemical notifications (57%), CLP (53%) and the recently amended Chinese chemicals notification measures (42%) (Figure 11).

REACH and CLP Even though there has been a level of experience and understanding of the REACH Regulation gained by clients during the run up to the first deadline, the second phase involves many more registrations – up to four times as many substances according to Dr Drohmann of Page 13

The chemical service providers market

sustainable and effective service providers understand intimately the industry in which they work and where they can really add value to the client and define well the problem that the client has, even when it may not realise it has a problem. Good service providers, therefore, also become actively involved in educating their clients and feel responsible to them, believes Chris Eacott, managing director of advisory/management firm Stewardship Solutions. CSI president and ceo Bernalyn McGaughey commented “We understand that clients seek scientifically sound, cost-effective, and timely approaches to environmental assessment and regulatory compliance – and we recognise the need to approach all projects with a strong commitment to responsible science, to the environment and to risk management.”

Chemservice – that will require more extensive testing to fill in data gaps. More sophisticated services will also be required by clients that have gone through the first process to deal with European Chemicals Agency (ECHA) evaluations and draft decisions on dossiers. Separately, a great deal of companies not involved in the first phase will be affected by the 2013 deadline, and a majority of these firms are small-to-medium enterprises (SMEs) that may have little idea of the scale of the task in front of them and the complex nature of REACH registration. “Unlike a few years ago, there is a broad spectrum of understanding of REACH throughout industry, from the most sophisticated stakeholders to novice first-starters, and this variation impacts demand for support from service providers,” remarks Marcus

begin enforcement activities because they believe their compliance with REACH will give them a competitive advantage.

Navin-Jones, a senior aassociate with Keller & Heckman

Nanomaterials regulations

The chemical service providers market

Figure 11 Leading regulatory drivers for survey participants REACH 77% GHS 58% Global chemical notifications 57% CLP 53% Chinese chemicals notification law 42% 27%

Case study

Stewardship Solutions: handling late REACH submissions Problem: needing to successfully complete a 2010 substance registration after 1 December 2010 deadline which was late due to the failure of a non-EU manufacturer to cover indirect export to the EU of the substance (even though the substance was in fact already REACH-registered). Solution: in its capacity as only representative acting on behalf of a non-EU client, Stewardship Solutions immediately notified the UK REACH authorities when the non-compliance became apparent. The UK REACH authorities accepted evidence that Stewardship Solutions and its non-EU client were not at fault, and a timetable to complete the necessary registration was agreed without an enforcement notice being applied. The proper registration was completed ahead of schedule and below budget.

TSCA 26% Dangerous Substances and Preparations Directives 23% EU biocidal products Directive 18% International Carriage of Dangerous Goods by Road 16% International Maritime Dangerous Goods (IMDG) Code 13% EU cosmetics Directive 11% China cosmetics regulations 11% Agrochemical registrations 9%

In addition to registering substances that are eligible for the 2013 deadline, companies that submitted registrations in 2010 will also find themselves dealing with ECHA regarding those first filings. Service providers will be asked to provide assistance with incomplete first registrations and ECHA decisions on testing proposals and the updating of registration dossiers in response to any changes in composition, quantities, users/uses or risk identification, according to Sophie Dow, solicitor at Eversheds. “Enforcement may also raise prominent legal issues including the precise analysis of enforcement actions and practices applied in the EU by national competent authorities, including for example, level of fines and criteria for sales bans or product recalls,” notes Marc Thouin, regulatory services, Intertek. “The question,” says Hans Schoolderman, director with PricewaterhouseCoopers, is how individual member states will enforce the regulations.” Some companies are eager for agencies to Chemical Watch | Service Providers Guide 2011

Veterinary Medicinal Products Directive 5% Other 4% 0%

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To best serve SME clients with limited resources, adaptability will be critical for service providers. “An essential approach from service providers is to reduce costs to the absolute minimum combined with much more hands on assistance,” says Steven Green, director of regulatory consulting firm CS Regulatory. Simple communication pathways, training and seminars will support SME requirements, as will important options such as possible reduced fees and government funding or partnership programmes, according to Joel Pekay, global marketing and business development director, Intertek. Page 15

The chemical service providers market

Increased support for non-EU manufacturers can also be expected in the next phase of REACH implementation. Only representatives are the voice for these producers and, according to Chemservice, accounted for about 20% of 2010 registrations. “The OR is the bridge between non-EU manufacturers and the EU market and actually represents the fig leaf for the EU against any WTO/TBT claims,” Dr Drohman says. There is also concern about fair treatment of SIEF and consortia members as SMEs become involved. SIEFs have in some cases not provided the level of access they should to smaller companies, according to Bill Allmond, vice president of government relations for the Society of Chemical Manufacturer’s and Affiliates (SOCMA). “Looking towards 2013 registrations, lead registrants and consortium managers should be careful to provide proper justifications of letter of access costs, in full transparency, if they want to avoid facing discrimination claims that lead registrants or consortia are using their position to prevent smaller players from competing and new players from entering the market,” says Jean-Philippe Montfort, partner with law firm Mayer Brown. As Leslie Scott MacDougall of Bergeson & Campbell consulting affiliate The Acta Group EU notes, data sharing disputes have been filed with ECHA. Based on responses received, however, it appears that ECHA perceives its role to be somewhat limited. As a result, companies can find themselves needing to pursue resolution in the European court system, which is not a very satisfying or efficient option. In the short term, cost will also continue to be a huge challenge for both large and small chemical suppliers and increasingly for downstream users. “REACH is a supply chain issue,” states Mr Schoolderman of PricewaterhouseCoopers. “Companies need to stay in contact with both direct and indirect suppliers and how raw materials move through the supply chain, especially for substances of very high concern (SVHC).” A lot of effort will also need to be directed to guaranteeing downstream continuity all the way to the retailer, and the problem is magnified for non-EU suppliers, points out David Owen, scientific and regulatory affairs manager with Shell Chemicals. To date, however, according to Joost Dekker, business development manager with chemSIX, service providers have mostly focused on ‘point solutions’ such as questionnaires, but response rates from customers are very poor, and the customers are also not getting the information they need. Dr Eacott of Stewardship Page 16

Solutions is particularly concerned about exporters to Europe who presume they have no significant REACH obligations when they source substances from nonEU suppliers who have registered those substances under REACH. “In fact, most non-EU suppliers are not maintaining REACH records about their indirect customer shipment volumes to the EU – in effect acting as only representatives on behalf of their non-EU customers – and it is probably unreasonable to expect them to do so, particularly for very large chemical manufacturers with large numbers of complex supply chains. Unfortunately, though, non-EU companies may find they are out of compliance as a result. Simply sourcing a REACH-registered substance does not guarantee REACH compliance for exporters to the EU, and this is still not widely understood. Significantly, I don’t think even ECHA realises this problem, yet it could have massive implications,” he observes. For BioQuanta’s business development manager Alexandre Ismail, REACH is engendering questions beyond toxicity characterisation: “Companies are focusing on finding the right substitutions and getting supply chains and industrial processes to work with them. The real value added will be in integrated testing strategies that can be translated into cost-efficient changes. REACH will impose a burden on everyone; those who come out ahead will be the ones who transition the most smoothly.” REACH has been challenging for IT/software providers as well. “The objective of the REACH legislation is simple, but its application is very complex, with harmonisation of implementation in businesses of varying maturity levels, expertise, knowledge, business systems and perspectives nearly impossible,” believes IHS product manager Francis Trudeau. “Going forward, as REACH is applied in practice, guidelines, best practice, business practice and eventually business systems will mature and trends will emerge, but this will take time to come to fruition.” There is still much to do to meet CLP requirements in the EU. SDSs are the next high effort task, according to Mr Kinsman of H2 Compliance. Here again he notes that the need to provide SDSs in the correct language will require a culture change in industry. And while the vast majority of substances are not subject to a harmonised classification, where a substance is proposed for a harmonised classification, manufacturers, importers and downstream users will be working to ensure that the hazard classification of the substance is not unnecessarily high, according to Camilla Buchanan, a senior associate with Field Fisher Waterhouse. Chemical Watch | Service Providers Guide 2011

ReachCentrum – finding efficient paths to data access Problem: In the preparation of the registration dossier for a consortium, certain data owned by a third party outside the consortium and outside the SIEF community were needed to complete the dossier. The position of the data owner was that each individual registrant needed to ask for legitimate access to the data via a data licence agreement. In the situation of a small consortium with not that many co-registrants, this approach may be manageable. In the case of a consortium with a significant number of members and a huge number of co-registrants, however, this becomes an unmanageable administrative burden. Solution: ReachCentrum recognised that this data owner was also the owner of other data for substances it supported in the registration process. ReachCentrum therefore approached the data owner, taking a more global approach and suggesting a data access right for the lead registrant (LR) as well as the right to sub-license the access right to all following co-registrants. This approach would reduce the administrative burden and make it possible to grant access to all studies at one time for all registrants of that specific substance. At the end, the data owner agreed with the global approach from ReachCentrum. The result was a win-win situation for all stakeholders: The LR was able to submit a dossier where all data access was arranged for the LR dossier as well as for all co-registrants. The data owner had to undertake only one data access agreement instead of multiple agreements. ReachCentrum was able to arrange access rights for the LR using only one contract and one agreed cost for the LR and all coregistrants instead of multiple individual contacts with individual bank transfers.

Other chemical management and GHS laws As implementation of REACH and CLP moves forward, many other countries, particularly emerging economies, are following the direction of the EU and adopting chemical management and control regulations that are often quite similar in structure. More mature nations are modifying their existing rules. The Turkish Chemicals Inventory and Control Legislation is attracting significant attention as it requires importers and manufacturers to notify the Turkish authorities about their chemical substances by the end of March 2011. In addition, the notification must be in Turkish using IT tools provided by the Turkish authorities. China is on most service providers’ radar as well. “China in particular will be a big focus for industry,” notes Exponent International’s Dr Willis, “and the revision made to their guidelines in 2010 will place an extra burden on companies.” The country’s Environmental Management Measures on New Chemical Substances now requires companies wishing to manufacture or import a new substance (one not on Chemical Watch | Service Providers Guide 2011

the Chinese inventory of around 45,000 substances) to submit a notification that requires specific data and risk assessment information. The Provisions on Safety Management of Dangerous Chemicals represent the country’s implementation of GHS. The regulatory framework for the cosmetic industry in China has also been modified to be closer to regulations in the US and the EU. Taiwan has also been active, issuing draft guidelines for existing chemical substance nomination and new chemical notification with the intent of establishing a national chemicals inventory. And Japan amended its Chemical Substances Control Law (CSCL) to include a volume tracking notification requirement for existing chemicals and a risk assessment and prioritisation programme to identify substances of most concern. Amendments to South Korea’s laws on new chemicals notification exempt chemicals of low concern but increase ecotoxicity testing requirements. Voluntary implementation of Malaysia’s Environmental Quality (Notification and Registration of Environmentally Hazardous Substances) Regulation has been extended until the law has been finalised. Malaysia, South Korea, Brazil and India are also either amending existing regulations or adopting new ones to ensure alignment with GHS requirements. Service providers are responding to the growing activity around the world by ensuring that that they have support staff in Turkey, the US, Asia and South America who can speak the local languages and are familiar with the specifics of each regulation. “Filing registrations in other countries will also likely require the renegotiation of data access rights acquired under REACH, often for REACH purposes only, while the same data will be needed to ensure compliance in other countries,” comments Mr Montfort of Mayer Brown. While other countries are using REACH as a benchmark, the problem with this is that the success of the EU law, however it is defined, remains unknown as it is very much a work in progress and there are many aspects of REACH that remain unfulfilled, according to Lynn L Bergeson, a partner in law firm Bergeson & Campbell PC. Governments’ implementation of the GHS also poses compliance challenges given that it is not a prescribed legal text. “Every jurisdiction has had the freedom to interpret the [GHS] Purple Book and since it was only based on recommendations there is no leverage to dictate local implementation, again leading to the need for local experts,” Mr Pekay of Intertek remarks. Page 17

The chemical service providers market

Case study

The chemical service providers market

Suppliers are definitely concerned about the growing regulations around the world. “The unequal regulatory framework is problematic for global movement, including re-importing,” notes Dr Owen of Shell Chemicals. Adds Ms Bergeson of Bergeson & Campbell: “The growing number of independent regulations around the world will have a significant impact as the movement of chemicals will be much more dependent upon premarket approval. “Many worry about the potential impact of REACH and GHS-based initiatives on product development due to phase out of certain substances based on regulatory considerations and in some cases, public pressure that is not necessarily based on good science.” It is not surprising, therefore, that there is growing interest in increasing international cooperation on safe chemicals management. Harmonisation of data requirements, testing methodologies and data control systems could lead to increased efficiencies, reduced costs and elimination of trade barriers. To that end, ECHA signed a memorandum of understanding with Canada’s federal environment and health departments and is in discussion with the US EPA. There is concern in developing countries, however, that expanded REACH programmes could negatively affect their trade levels as they do not have the resources to implement such initiatives. Case study

Bibra – safety-in-use assessments Problem: a formulator of a multi-component formulation used in a food contact product required an independent assessment of safety-in-use as part of its product stewardship procedures. Solution: Bibra Toxicology Advice & Consulting routinely provides this service to companies, acting as a third party able to discuss, in strict confidence, composition with suppliers and exposures with the client.

Uncertainty in the US With the Republican-dominated House of Representatives, little action is expected on TSCA reform in 2011 but the topic has not been completely removed from the table. Shell is working through the American Chemistry Council (ACC) because the company anticipates an industry push to support reform, and believes it can best be served by the advocacy efforts of the trade group. SOCMA is also actively working to achieve positive changes to the TSCA legislation that will benefit small and medium sized chemical producers, their customers and the public, according to Mr Allmond. Page 18

Responding to customer needs…

Webinar training series ReachCentrum training webinars focus on topics such as REACH authorisation, Turkish legislation compliance and downstream user issues, allowing participants to instantly interact with the presenters and ask questions on specific issues. Existing customers make use of webinars covering the continuation of the REACH process for 2010 registrants, namely the evaluation and authorisation processes that will begin in 2011. Webinars are also offered as part of ReachCentrum’s intensive training boot camp, which is designed to help newcomers to REACH obtain the practical help they need to prepare their registrations over the coming years.

REACH mediation Mayer Brown’s REACH team offers a mediation service to resolve disputes between SIEF and consortium members, in particular on access to information, data sharing and compensation issues.

Tracking TSCA developments Keller and Heckman’s TSCA Reform Center is a website dedicated to tracking legislative and regulatory efforts to reform TSCA and is a legal resource that compiles in a central virtual location the laws, bills and regulatory documents on the subject of chemical regulatory reform as well as green chemistry trends and their possible impact on federal policy initiatives.

Supply chain communication chemSIX SIEF Management and Downstream Communication solution functions as a marketplace/hub where buyers and sellers can connect, eliminating the need to wait, at every supply chain link, for all information to be complete. All companies contribute a membership fee, reducing the overall cost for supply chain communication.

SDS delivery REACH Delivery is a secure online SDS delivery service that enables the electronic delivery, receipt, control, update, audit and tracking of SDSs in line with REACH, providing a single point of access for latest versions.

Separately, the Occupational Safety and Health Administration (OSHA) has issued a proposed rule to align the Hazard Communication Standard with GHS provisions. And the US Department of Transportation (DOT) will phase out the use of existing exemptions (ORM-D, ORM-D-Air) for shipping consumer commodities in order to harmonise the current Hazardous Materials Regulations (HMR) with international standards. In the meantime, more than 30 states have introduced independent chemical policy bills, and service providers need to monitor these actions and be prepared to provide clients the support necessary to ensure compliance. Bergeson & Campbell’s Ms Bergeson notes, “the California Green Chemistry Initiative is a game changer and is likely to have global implications regardless of its final form.” The EPA is also expected to aggressively pursue new test rules by using the full extent of its current authority.

Chemical Watch | Service Providers Guide 2011

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- ECHA requests re REACH Evaluation - Challenging Article 118 REACH access to document requests and Article 119 REACH rejection of confidentiality requests - Rebuttal of proposed REACH Restrictions, etc.

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The chemical service providers market

Ms MacDougall of Bergeson & Campbell adds that many substance hazards lists in state chemical policies and directives are based on lists originating in other countries where the process for nominating and listing chemicals may be quite different, non-transparent and perhaps based on considerations unrelated to science and health hazard. “Care should thus be taken in adopting chemical lists without a de novo review of the basis for listing, or at the least providing an opportunity for delisting, which many state programmes do not do.” Because the US is an enormous market for supplies and purchases, the delays and uncertainties increase the pressure on service providers to be able to adapt and to hit a moving target, and will undoubtedly have consequences for non-US industry, according to Dr Drohmann of Chemservice.

Market forces: influence of non-regulatory factors

Figure 12 Leading non-regulatory drivers for survey participants Economic growth 47% 25% Customer pressure 44% 24% Governmental policies/spending 41% 30% Downsizing of in-house chemical management and control teams 29% 25% Non-statutory ‘voluntary’ corporate initiatives/CSR 28% 18% NGO pressure 28% 15% Outsourcing of business support functions (by client organisations)

While regulatory drivers have the greatest effect on the chemical management and control service providers market, Chemical Watch survey participants did identify several additional non-regulatory factors that have an influence on the sector. They believe that economic growth (47%), customer pressure (44%) and government policies and spending (41%) will have the greatest impact (Figure 12). Case study

FFW: challenging ECHA on appeal Problem: a registration dossier was rejected by ECHA. Solution: Field Fisher Waterhouse, with technical support from The Acta Group EU, filed and won the first appeal before the ECHA Board of Appeal by challenging the decision. Following the appeal, ECHA’s executive director accepted the registration dossier as complete, retroactively, so the client could continue to market its products in the EU.

Case study

Intertek: helping to reduce letter of access costs Problem: letter of access costs for a client were unacceptably high. Solution: Intertek’s Regulatory Services Group in the EU reduced the client’s letter of access cost from €300,000 to €80,000. This result was made possible by leveraging a thorough understanding of the science behind REACH in addition to the business practices surrounding the implementation. As a neutral service provider, Intertek was able to challenge the valuation of studies based on science, fairness and transparency.

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21% 15% increased commercialisation/better management of service provider business 16% 10% Other 0% 3% 0%

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Your country

“How the people on the street balance the perceived risks of chemicals with their benefits in terms of jobs and life styles determines what regulations the elected politicians develop. The perception of risk among the populace is therefore the main driver,” asserts Dr Richards of Linmark Consulting. In addition, NGOs are probably more active and better publicly recognised than ever before and have become effective professional lobby groups, according to Dr Drohmann. Voluntary industry initiatives such as Product Stewardship, Responsible Care, the Long Range-research Initiative and the Global Product Strategy also play an important role. Here again, stresses Bibra’s Mr Copestake, robust SDI services to track emerging scientific issues relating to the hazard of specific substances, or groups of substances, can allow companies to foresee developing areas of concern and manage them in a coordinated and proactive way. Chemical Watch | Service Providers Guide 2011

Case study

Problem: Raytheon Company, a diversified technology company specialising in defence and government electronics, space, information technology, technical services, business aviation and special mission aircraft, needed to identify its chemical management costs and the potential savings that could be afforded by introduction of a chemical management system. The project actually began as a pilot programme at a Hughes Aircraft facility at Air Force Plant #44 in Tucson, Arizona (which was acquired by Raytheon during the process). The objective of the programme was to identify chemical use reduction opportunities and consider CMS as a means to reduce costs, outsource areas that were not included in core competencies and achieve improved data management for environmental reporting. Solution: the Chemical Strategies Partnership (CSP) helped Raytheon determine that adopting a chemical management services approach would provide significant savings. CSP, according to executive director Jill Kauffman Johnson is a non-profit organisation seeking to reduce the use of toxic chemicals in US manufacturing, working with companies to help redefine the way they purchase and manage their chemicals. “In this new CMS model, manufacturers shift away from a traditional supplier relationship to a strategic alliance with a chemical service provider. Instead of purchasing chemicals, the manufacturer purchases chemical services: assistance in purchasing, managing, and tracking chemicals,” she explains. This shift to chemical services often aligns the incentives of the service provider and manufacturer to reduce chemical use and costs. A cross-functional team mapped the process flow for chemicals through the facility and estimated the quantifiable ‘hard’ costs of chemical management to be nearly equal to the purchase costs. The costs of waste and potential opportunities for production process efficiency gains were estimated through a materials and cost accounting analysis for two production processes. At that point Hughes Aircraft merged with Raytheon. Corporate-wide teams were established to combine the companies’ operations and develop plans for cost reductions. The ChemTech team realised that pursuing an integrated purchasing program did not have the same potential for long-term cost and risk reduction as the CMS model. The chemical service approach also aligned well with Raytheon’s upper management mandate for chemical cost and use reduction, integrated nationwide management systems and total life-cycle management. CSP helped develop a cost analysis for the top ten chemical using facilities, as well as two representative smaller facilities to provide an average estimate for Raytheon’s 100+ sites and present the business case to senior management. As a result, the ChemTech team was authorised to issue a request for proposal (RFP) seeking a CMS provider. CSP also assisted with determination of the CMS program scope, RFP preparation and design of compensation mechanisms in the final contract, which was awarded to Radian International (since acquired by Haas TCM). About 20,000 chemicals and gases and 1,000 waste profiles are managed in the programme. The result: >60% gross savings over five years, with ontime delivery above 96% and inventory scraps reduced by >90%. Chemical purchase price was reduced by 15-45% with payback in six months. More than 75 full-time employees were reallocated to higher-value activities. Order cycle time was reduced from 3-7 days to 2 days and chemical storage space decreased by 93%. Over-purchase waste was cut by 85% Notably, this was the third attempt at implementing a chemical services programme at the Tucson facility and there was much scepticism at the outset of the collaboration. Union labour was also opposed to the idea and there were cultural issues leading to resistance. Many on the team acknowledged that CSP’s role as a third party facilitator gave the programme concept the credibility among Raytheon personnel it needed to be seriously considered. CSP’s facilitation of a tour of a competitor facility using CMS was also critical.

Companies that are serious about incorporating product lifecycle management processes into their product portfolio and manufacturing processes must take a holistic view of how information management needs impact product development, according to Mr Trudeau of IHS. “The only way to ensure proper product lifecycle management is through an integrated software platform that can communicate and exchange critical data across a wide spectrum of EHS concerns, including energy and carbon management, environmental compliance, operational risk management, health and safety management, and corporate responsibility reporting, in addition to chemical management.”

Other trends and issues While demand for chemical management and control services will be driven largely by the regulatory environment and enhanced by consumer perception and

Chemical Watch | Service Providers Guide 2011

other government policies, there are other trends and issues that will also impact service providers. In the area of legal support, for instance, legal firms will have to be careful to provide services at the appropriate price. “A new or niche area of law often means higher demand for assistance from service providers, particularly law firms. As advice on the same area of law becomes standardised, the challenge for firms is reacting to that change and continuing to deliver value-for-money support. Delivering a mixture of ‘offthe-shelf’ solutions and more tailored, client-specific advice is one answer. More significant is whether service providers are able to advise on multi-faceted issues at the same time, such as application of the law, scientific reality and impact on commercial practices,” asserts Mr Navin-Jones of Keller & Hechman. Intertek’s Mr Pekay stresses that understanding and defining the potential product liability associated with chemical, or perceived chemical, risk and how to manage such risk from a legal and corporate responsibility angle will also affect Page 21

The chemical service providers market

CSP reducing chemical use through CMS

Chemical Watch | Service Providers Guide 2011

Case study

IHS: targeting lower toxicity and lower cost chemicals Problem: Canadian-based Mosaic Mining wanted accurate regulatory reporting for their chemicals while achieving lower toxicity and cost of chemical inventories maintenance and increased worker safety. Solution: with Dolphin Software from IHS, the company targeted selection of lower toxicity and lower cost in their inventory, leading to improved compliance, an expected 60% reduction in toxicity and substantial cost savings.

The desire to reduce animal testing also remains an issue as greater numbers of substances must undergo evaluation. Initiatives are underway in the EU and the US, but implementation is still quite far off. “The best way forward is the development of integrated testing strategies that use predictive approaches upstream to guide the design and execution of experimental verifications downstream,” notes Bioquanta’s Mr Ismail. Case study

3E: mass authoring of MSDSs Problem: KMG Electronic Chemicals, a supplier of acids, solvents and other chemicals used to manufacture semiconductors, needed to develop material safety data sheets (MSDSs) for over 200 products acquired through the purchase of the High-Purity Process Chemicals business of Air Products and Chemicals. Approximately 520 MSDSs needed to be authored, for products shipped in the US, Canada, Japan, Korea, Malaysia, Taiwan, Singapore, China and more than 25 other countries in Europe and elsewhere in just four months. Solution: 3E Company’s multi-lingual staff authored KMG’s MSDSs using its MSDgen system, which is populated with the company’s Ariel chemical regulatory data, and ensured that they were globally compliant with regulatory and language requirements for each country. A custom hosted MSDS pull distribution web site was then created so that KMG’s customers could have direct, live access to the MSDSs. 3Es MSDS Push Distribution service was implemented to ensure that KMG’s customers received new MSDSs in accordance with local regulatory requirements. A data export system was also developed to populate KMG’s labelling software application.

Expectations for the future Chemicals management and control is moving from the domain of the regulatory department to becoming an integral part of business strategy development and implementation. “Chemical management is fundamentally a competitive issue as we are way beyond compliance,” Ms Bergeson (Bergerson & Campbell) asserts. “Managing chemicals in ways that are resistant to risk and enable global competition at reduced risk are critical for success in the future,” she Page 23

The chemical service providers market

providers of legal services. Mayer Brown’s Mr Montfort adds: “With the publication of registration information on the ECHA website, including new hazardous classification for substances that have been produced and used for years, we are likely to see a search for new liability cases, in particular from the US plaintiff bar, which will require experienced legal support.” SOCMA members, according to Mr Allmond, also note growing concern regarding the handling of confidential business information (CBI) as new testing programmes and data requirements come into force, particularly in Asia. Tax issues may also come to the forefront as service providers deal with a wider geographic scope of regulations. “REACH is an issue of financial transactions as much as it is about chemical management,” observes Mr Schoolderman of PricewaterhouseCoopers, “and often the tax and related implications are ignored.” With REACH, new VAT rules in Europe will affect cross border services and cost sharing activities. Awareness of individual country tax laws and corporate financial reporting requirements is essential. Service providers also need to be aware of the potential impact that the changing regulatory environment might have on insurance needs. For instance, REACH does not cover accidents and spills but only the normal use of substances. Therefore companies manufacturing or using chemicals still require insurance to cover these risks, according to Mr van der Schaaf of TNO Triskelion. Insurance may also be necessary to cover potential product liability cases brought by consumers using REACH as leverage. Tracking new areas of regulatory concern is important as well. Nanomaterials and endocrine disrupters are two topics receiving significant attention. “Service providers can help determine the future success or failure of nanomaterials by enabling proper risk assessment and by influencing the discussion about these materials at many levels,” says Ms Bergeson (Bergeson & Campbell). She highlights development and standardisation of testing protocols as well as conducting and evaluating tests. Testing capacity, however, may become an issue itself. “There are potentially not enough CROs who meet the standards and so planning of testing will need to start early in the registration process for 2013 and 2018,” Dr Willis of Exponent International believes. Providers can help with the high demand, though, by fully exploring the possibility of data gaps using intelligent testing strategies and by pushing chemical companies to move forward more quickly with registration of substances for the next deadline.

The chemical service providers market

adds. “Chemical management, especially those aspects related to EH&S compliance have become clearly mission critical and strategic,” agrees Mr Christie (3E Company). “The risks of non-compliance are hugely significant, and successfully navigating the complexities requires resources, domain expertise, and vigilance, and the need for data, applications and experience is vital.” Such an integrated approach requires integrated software systems and information resources. “Information collected to meet compliance obligations is the same data that is leveraged to drive higher level operational excellence, corporate responsibility reporting and strategy analysis. As a result, companies are transforming their compliance data into information that enables strategic sustainability management decisions. Implementing an integrated information management software platform is therefore now regarded as a best practice to address compliance for complex chemical management regulations,” observes IHS’s Mr Trudeau. The biggest challenge going forward, he also notes, will be for companies to find effective ways to stay in compliance with new constraints while at the same time improving their financial bottom line. Service providers will play an important role. Mr Meesters of ReachCentrum believes that service providers with specialist expertise will be needed by clients that have gained experience through the first registration phase of REACH but now need more advanced support. “There is a real chance for service providers to differentiate themselves,” he asserts. The demand for chemical management and control services will certainly increase, but the question is in what way, according to Bioquanta’s Mr Ismail. “Initial demand for basic tactical services will be followed by a growing need for strategic service offerings that will help companies deal with the supply chain issues that regulatory driven substitutions will force. Streamlining the transition will be a very real competitive advantage.” Educational services will be particularly important in the coming months, according to Dr Eacott of Stewardship Solutions. ReachCentrum has already noted that a growing number of clients are sending a wide range of business people – purchasing, sales, product managers, etc – to its training courses. “Our clients now realise that everyone in the business needs to be aware of the requirements and implications of REACH and other regulations on both upstream and downstream relationships,” says training and workshops manager Vincenzo Girardi.

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Testing and data evaluation will also be crucial. “Having a global presence combined with knowledge of local regulations will be necessary for optimising testing strategies so that clients can maximise use of study reports in multiple jurisdictions,” states Interek’s Mr Thouin. So what will this all mean for service providers? Pre-tax profitability, which has been running anywhere form 10-25%, should remain stable for those firms that have prepared for expansion into new markets, regions and segments. Software/IT providers can be expected to do very well as demand for integrated solutions increases. Those companies that only offer very basic administrative services, however, are likely to suffer as IT solutions are introduced.

SME perspective Although Alcan International Network (AIN) is a small division of Rio Tinto, this distributor functions independently and completes its REACH and other regulatory compliance efforts on its own. For the first REACH deadline, Kate Cummiskey on AIN’s REACH task force said they had a hard time choosing a SDS software supplier because of the huge range in prices. “Price is a big issue because we have a limited budget, and it is difficult to tell what is reasonable and how much is too much when there is such a wide variation.” She also worked with a larger law service provider that provided extensive materials but now wonders whether working with a smaller firm would help them implement more practical steps. She will be keeping that in mind when the team selects a management consultant to help with REACH 2013 deadlines and other expected additional regulatory compliance efforts.

The attractive profits are likely to mean increased competition. While expertise definitely acts as a barrier to entry for many, there are a growing number of people experienced in EH&S, REACH, CLP and other related issues that are leaving companies in order start their own consultancies, according to Mr Meesters. “Even so, established providers do have a certain edge, particularly with their current clients. And on the positive, side, with more experienced consultants available, ReachCentrum has a larger pool of experts with a wider knowledge base to tap into on a case-bycase basis, which fits with our strategy of expanding through organic growth.” Results of the Chemical Watch survey confirm this positive outlook. Only 11% of clients indicated they would decrease the use of service providers in 2011 (Figure 13), while 77% expect to increase their requirements over the next five years. They also anticipate greater use of in-house staff (Figure 14).

Chemical Watch | Service Providers Guide 2011

Figure 13

Figure 15 Anticipated need for external sector services by survey participants in 2011

Next 12 months 7%

41%

8% 3%

Consultancy/advisory 46%

44%

10%

Administration/management/representative

Next 5 years 17%

60%

12%

27%

11% 1%

61%

12%

Legal services 0%

Increase significantly

29%

100%

% of participants Increase

63%

Laboratory

Static

51%

37%

12%

IT and software 42%

Figure 14

10%

Information

Anticipated future use of in-house staff by survey participants

48%

Next 12 months 8%

48%

47%

Training 40%

46%

48%

Other(s) Next 5 years 13%

6% 51%

27%

94%

0% 0%

100%

% of participants Significantly more

Static

8% 100%

% of participants Increase

Static

Decrease

Less

Figure 16

For those companies outsourcing to service providers, 51% expect to increase the use of laboratory providers in the next 12 months, while 46-48% also expect to rely more on consultancy, training and information services during 2011 (Figure 15). Over the next five years, use of consultancy (63%) and laboratory services (61%) is anticipated to increase the most (Figure 16). Figure 17 demonstrates the need for specific services within each discipline over the next five years.

Anticipated need for external sector services by survey participants over the next five years Consultancy/advisory 30%

63%

Administration/management/representative 9%

51%

39% Legal services

46%

46% Laboratory

32%

61%

IT and software 8%

47%

45% Information 54%

43%

53%

45%

Training

Other(s) 94%

% of participants Increase

Chemical Watch | Service Providers Guide 2011

Static

100%

Decrease

Page 25

The chemical service providers market

Anticipated future need for external services

Figure 17

The chemical service providers market

Anticipated need for specific external sector services by survey participants over the next five years Supply chain communications

74%

Guidance on regulation interpretation

73%

23%

Product compliance

72%

25%

Environmental risk assessment

70%

27%

Consultancy/ advisory

SVHC advisory services

53%

Registration strategies

51%

Assessment of data quality

46%

47%

Corporate strategy/strategic planning

44%

49%

7% 5%

66%

29%

10%

33%

57%

Management (SIEF, Consortium etc)

49%

37%

14%

GHS notification

49%

37%

14%

Registration services

46%

44%

10%

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

44%

48%

CLP notification

69%

22%

(Material) safety data sheets

19%

79%

Chemical hazard database

Information

16%

43%

41%

Business process outsourcing (BPO)

66%

Managed regulatory content

2% 1%

28%

70%

Regulatory/policy tracking

32%

65%

31%

Ecotoxicology

66%

29%

Environmental fate & degradation

65%

31%

Human health toxicology

63%

Laboratory

32%

39%

Environmental monitoring

59%

Exposure testing

58%

38%

SVHC testing

57%

39%

Physical & analytical chemistry

46%

Supply chain management/ communications systems

24%

74%

(Material) safety data sheet systems

69%

26%

Regulatory information management

67%

30%

Substance inventory management systems

Other

66%

25%

Lobbying/advocacy

47%

43%

CPD/CES certified training

31%

66%

Bespoke/inhouse training

63%

33%

Training courses/webinars Training

47%

Laboratory information management solutions

39%

56%

Consortia/registration management solutions

31%

65%

EH&S solutions

Insurance

39%

Legal representatve

39%

59%

56% % of participants

Increase

49%

45%

Page 26

42%

Testing strategies

Dossier preparation & safety assessment, including CSA/ CSR

IT solutions

46%

49%

Chemical transport and warehousing advice

Admin/ management

23%

Static

100%

Decrease

Chemical Watch | Service Providers Guide 2011

STRATEGIC CONSULTING & DOSSIER PREPARATION KNOELL GROUP consists of DR. KNOELL CONSULT GmbH and 6 majority-owned subsidiaries in Germany, Switzerland, Great Britain and China. KNOELL GROUP is providing full-services in the areas of regulatory affairs, product safety and consulting. Whether you need complete registration dossiers, risk assessments or safety data sheets –– we are perfectly prepared to support you and your business.

DR. KNOELL CONSULT GmbH Dynamostraße 19 68165 Mannheim, Germany Phone: +49 621 71 88 58-0 info@knoellconsult.com

www.knoellgroup.com

Agrochemicals Biocides Industrial Chemicals REACh Pharmaceuticals Cosmetics Trainings

REACH einfach gemacht

ReFaC – the REACH Facilitation Company – simplifies REACH compliance by providing the experienced and expert support you need.

REACH più semplice

Delivering its services throughout the chemical supply chain, ReFaC acts on behalf of chemical producers, distributors, service providers, and downstream users based in the European Union and elsewhere.

REACH simplificado

Managed by the industry for the industry, ReFaC provides cost-effective solutions focusing on three main aspects of REACH compliance: REACH Registration – the complete preparation of registration dossiers, including data-gap analysis, exposure scenarios and Chemical Safety Reports (CSR’s);

REACH plus simple

ReFac – REACH made simple ReFaC REACH Facilitation Company

Lyme Building, Westmere Drive, Crewe Business Park, Crewe, Cheshire, CW1 6ZD. Telephone +44 (0)1270 258530 e-mail manager@refac.eu website: www.refac.eu

Only Representative – for companies based outside the European Union, ReFaC assumes all REACH compliance obligations to ensure continued market access;

REACH Management Services – providing companies with a full outsourcing service for compliance obligations as well as REACH administration, including new format Safety Data Sheets and requirements under the new classification, labelling and packaging regulations.

To learn more about ReFaC’s services and the help available, contact Dr Darren Staniforth for an initial, no-obligation discussion on 01270 258530 or e-mail manager@refac.eu

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

PROFILE: 3E Company

CONTACTS Web site

3ecompany.com

E-mail

info@3ecompany.com

Head office

1905 Aston Ave

Carlsbad, CA 92008

USA

Tel

+1 760 602 8700

Fax

+1 760 602 8852

Directors

Robert S Christie, President and CEO

Jytte Syska, President, Ariel Operations

Jeffrey Starr, Vice President, Marketing

SERVICES PROVIDED Access and delivery: regulatory decision support Ariel WebInsight™ – a subscription-based online reference tool for researching and tracking how chemicals and substances are regulated ArielLogic™ for Food & Flavors – 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® EHS Management – integrated chemical, regulatory, toxicity and eco-toxicity data, vendor MSDS data, expert rules, multilingual phrases, document and label templates, and data loading tools for managing EH&S compliance activities in SAP EHS Management

Greg Merwin, Vice President, North American Sales Al Voskian, Vice President, Asia-Pacific Sales

Andrea Verspay, Director, European Sales

Ownership

Owned by public company, Verisk Analytics

Locations

US, Canada, Europe, Asia

Founded

1988

OVERVIEW 3E Company is the trusted global provider of chemical, regulatory and compliance information services. Our vision and commitment is to serve as a global strategic partner for EH&S compliance data to our customers across the supply chain and throughout the lifecycle. 3E provides its customers with the premier knowledge-base of substance level regulatory data and product level MSDS data, round-the-clock global coverage and customer support; data accuracy, quality and integrity; a breadth of solutions covering upstream product stewardship and downstream workplace safety; and unparalleled experience and domain expertise. Services include reference and integrated regulatory data; MSDS authoring systems and services: MSDS distribution and management; transportation, emergency response, regulatory reporting and hazardous waste management. VITAL STATISTICS

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN IT & software 10%

Other 5%

Consultancy/ advisory 5%

MSDS authoring services – provides outsourced or co-sourced assistance with authoring MSDSs via 3E’s own fully-dedicated, in-house staff of highly qualified, multi-lingual authors MSDS distribution – facilitates the dissemination of MSDSs through multiple channels, including web hosting, or a scheduled delivery via fax, email, or post Professional services REACH – 3E can work collaboratively with a company to submit and collect data for late pre-registration, and also as a third party representative GHS – classification services and consulting to companies who need assistance with understanding the implications of 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 (classification, labelling and packaging) Regulation European product registration – 3E can determine which products need to be registered, perform the registration process, the maintenance of the registration and any necessary updates to MSDSs and labels DGSA (Dangerous Goods Safety Adviser) – 3E can serve as a company’s DGSA EH&S supply chain data and sustainability tools

Information 80%

Page 28

MSDgen® MSDS Authoring Software – an enterprise software solution suite designed for companies’ in-house EH&S staff

3E Online Supplier Portal – facilitates efficient supply chain communication by offering a streamlined process for users to obtain EH&S and regulatory information from their suppliers 3E Green Product Analyzer – provides powerful regulatory and toxicology analysis of products MSDS Management – a variety of products and services for the management of vendor supplier MSDSs Transportation – 24-7-365 global hotline access for guidance and classification of shipping hazardous materials for any mode

Chemical Watch | Service Providers Guide 2011

documents. We have been using their authoring service for several years now and we have been very pleased with the results. The team at 3E is very professional, helpful, and knowledgeable and we trust their work completely.” CASE STUDY 2: Momentive Performance Materials is fired up on 3E's rock solid regulatory data

2002- Five-time winner Environmental Business Journal Business 10 Achievement awards Winner of two Occupational Health and Safety product of the year awards Nine-time winner Commitment to Worker Safety awards from Compliance Magazine

Industry: manufacturer providing material solutions through siliconbased products, and fused quartz and ceramics Challenge: manual research performed by three separate teams. Not only was it time-consuming, but it was difficult to identify new regulations versus changed regulations; it resulted in inconsistent practices; there was no sharing or centralisation of information; and no integration with the company's SAP system Solutions: Ariel Solutions for SAP EHSM Results: enabled team to easily track regulatory changes over time; increased operational efficiencies; increased levels of compliance "We chose 3E because we needed a reliable content provider that could provide direct integration into SAP EHSM and download updates and changes to regulations automatically. Choosing a trusted, experienced and established outsourced regulatory content provider eased the integration between the content and SAP and allowed us to focus on more strategic functions. As a result of using Ariel data in our SAP EHSM system, we feel we are better able to comply with the myriad of regulations affecting our company. We trust 3E's Ariel regulatory content and are confident that we are basing our business decisions on the most comprehensive, accurate regulatory data available."

ACCREDITATIONS

STAFF SELECTION

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2010

Acquired by Verisk Analytics

2009

AMR Research (now Gartner) publishes report, “3E moves its way to outsourced MSDS management leadership”

2008

REACH and GHS initiatives

2007

Acquisitions: HSE Systems and MSDS Solutions

2004

Acquisition: Ariel Research Corporation; international expansion

1998

Company founded; pioneered MSDS management services business

CHMM, CSP, DGSA, CPEA, CSBA, REA, IATA, more PARTNERS SAP, Japan Chemical Daily, ChemSW, SciQuest, Source 44, RegScan, Redstone, SOCMA ChemStewards CLIENTS Brenntag, Shell Oil, GrafTech International, Eastman Chemical, Sumitomo Chemical, Cabot Microelectronics, Menasha Corp, Costco Wholesale, Southwest Airlines, DTE Energy, Cabela's, Bostik, Momentive Performance Materials, Novelis, JM Huber, Supreme Chemicals, AMCOL International TESTIMONIALS "We are continually impressed by the scope of 3E's authoring services. We have not found another service that can rival the depth of 3E's knowledge and real world experience" – GrafTech International "MSDgen gave us the platform to improve the quality of our MSDS data, and manage the process of generating and distributing MSDS. We selected MSDgen because of the team's straightforward, honest approach and their understanding of our needs" – AMCOL International "Being able to outsource that stress and burden [authoring MSDS] has been a tremendous relief" – JM Huber CASE STUDY 1: Supreme Chemicals utilises 3E outsourced authoring services with optimal results Industry: consumer and industrial cleaning product manufacturer Challenge: limited internal resources or expertise for authoring MSDSs, constantly changing regulations Solution: outsourced MSDS authoring services Results: compliant MSDSs for entire product line “Working with 3E really does give me peace of mind. The documents that 3E produces reflect their professionalism and their expertise has been proven time and time again. Thanks to 3E, we are now able to provide our distributors and users with top-notch hazard communication information. I would recommend 3E to any company that is currently searching for an MSDS authoring service. I chose 3E because of their excellent reputation for producing high-quality, globally compliant hazard communication Chemical Watch | Service Providers Guide 2011

Jytte Syska – President Ariel Operations Syska has more than 20 years of experience as an EH&S regulatory expert. She is responsible for all 3E business units dedicated to regulatory research and services. Syska previously held the position of director of occupational health and toxicology for the Danish Toxicology Centre where she enjoyed scientific, financial and managerial responsibilities for the centre's 25 consultants. She is regularly published in industry magazines and is a highly sought-after speaker at industry events. Sookie Hong – Senior Regulatory Research Analyst Hong is responsible for researching, analysing and monitoring overall chemical and other EH&S related governmental legislation and regulations of the Asia Pacific region. She has nearly 15 years of regulatory expertise focusing on the Asia-Pacific region, including work in Japan, Hong Kong and the US. Hong holds a MA in International Affairs, Asia political economy from American University in Washington DC, and graduate certificate of East Asian Studies from Harvard University. Margarethe Jaroszewski – Regulatory Consulting and Applied Toxicology Jaroszewski has more than 25 years' experience in chemical management and chemical legislation through her employment with authorities in Denmark and in the EU. She has participated in the legislative process through authoring and negotiations of national and international regulations on chemicals. She is an expert in the field of toxicology, safety and health in use of chemical substances and materials at work including toxicological assessments. Karin Baron – MSDS Author Baron has more than ten years' experience, working as an R&D chemist for a coatings and polyesters chemicals manufacturer and working in their EH&S group as a toxicologist. Baron served as senior hazard communications specialist supervising SDS authoring and TSCA activities and as a consultant for FDA compliance. She is certified in 49CFR, IATA, IMDG, TDG and ADR and has extensive GHS experience. She holds a MSPH in environmental health sciences and a BS in biology with a minor in genetics.

Page 29

PROFILE: 3E Company

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, analyzing, tracking, completing and submitting required disclosures, permits and reports Hazardous Waste Management & Classification services that support customers’ hazardous waste management obligations, including proper storage and disposal

SERVICES PROVIDED General consulting services 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.

SUSTAINABLE CHEMICAL PRODUCT INNOVATION AND DEVELOPMENT

PROFILE: Acta Group EU Ltd

CONTACTS Web site

www.actagroup.com

E-mail

lmacdougall@actagroup.com

Head office

23 New Mount Street

Manchester, M4 4DE

United Kingdom

Tel

+44 (0) 1612127405

Contact

lbergeson@actagroup.com

Directors

Lynn L Bergeson and Lisa M Campbell

Ownership

Private company

Affiliated with The Acta Group LLC

Affiliated with Bergeson & Campbell PC

Global product registration and agent services (only representative services) Regulatory chemical product notification, registration, and technical defence under the framework of global chemical programs. Acta and Acta EU concentrate on obtaining, maintaining, and supporting product approvals and efficiently overcoming commercial or regulatory impediments to the successful and profitable marketing of approved products. The multi-disciplinary skills offered by Acta and Acta EU professionals are essential to obtaining cost-effective and timely product approval. Jurisdictions that we active in are: North and South America, European Union, Switzerland, Turkey, and Pacific Rim.

Affiliated with B&C Consortia Management LLC 2004

Founded

Data compensation support services and trade infringement/ competition issues

OVERVIEW The Acta Group EU Ltd (Acta EU) and its affiliate The Acta Group LLC (Acta) are leading international specialists in chemical product approval, support, and regulatory defence. Acta EU and Acta are affiliated consulting firms established to control the spiraling costs and inefficiencies encountered by clients seeking approvals to market chemicals, biocides, products of biotechnology and nanotechnology, and medical devices in global markets. Acta and Acta EU manage products from concept to approval, utilising the skills and experience of professionals who have worked in the specific product areas in government and industry. The Acta EU regulatory team provides project management for fast-track product approval by building support and defence packages for product portfolios. VITAL STATISTICS

2009

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

>25

Staff, group

>25

Staff, chemical service provision

>25

SERVICE AREA BREAKDOWN Training 5%

Other 5%

Consultancy/ advisory 30%

Legal 25%

IT & software 5%

Page 30

Acta EU and its affiliates are 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 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation, many clients continue to evaluate and pursue competition-related issues. We are actively engaged in data compensation and competition-related disputes. Technical document preparation activities Undertaking the appropriate document preparation and coordination to support a 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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1998

Parent company, Bergeson & Campbell PC formed in Washington DC, USA

2000

Bergeson & Campbell PC establishes consulting affiliate, The Acta Group LLC in Washington DC, USA

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, USA

GLOBAL OFFICES

Information 10%

Admin/ management 20%

The Acta Group LLC; Bergeson & Campbell PC; and B&C Consortia Management LLC 1203 Nineteenth Street, NW Suite 300 Washington, DC 20036

Chemical Watch | Service Providers Guide 2011

ACCREDITATIONS

STAFF SELECTION

Occupational Health and Safety Assessment Series 18001; International Organization for Standardization (ISO) 9001; ISO 14000

Lynn L Bergeson – Principal/Director

Caleb Management Services Ltd.; B&C Consortia Management LLC CLIENTS Acta EU’s clients are involved in many businesses, including basic, specialty, agricultural, and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; pharmaceuticals, medical devices, and diagnostic products; fibres; paints and coatings; printing and publishing; and plastic products. TESTIMONIALS Our client list is maintained on a confidential basis. We do not publish client names/testimonials. CASE STUDY 1: Successful 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 the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In other roles, we perform analysis of data valuation in association with the data rights to be granted.

Leslie Scott MacDougall – Director of Regulatory Affairs Ms MacDougall has more than two decades experience in various chemical-related matters. She spent a significant portion of her career as a programme manager for the US EPA. In her current role, Ms MacDougall is the managing director for Acta EU with emphasis 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 – Regulatory Specialist Ms Downes specialises in REACH registrations and worldwide notifications. Ms Downes is experienced in performing REACH related submissions as well as document preparation to support international registration activities. Ms Downes has strong links with national competent authorities and communicates with competent authorities frequently. She participates in substance information exchange forums (SIEF) and consortia supporting registration activities. Kevin N Goulden – Senior Regulatory Specialist Mr Goulden is a trained lead auditor for Occupational Health and Safety Assessment Series 18001 and successfully managed the implementation of a system accredited under ISO 9001 and ISO 14000. Mr Goulden serves as an expert in the classification of chemicals, generation of material safety data sheets (MSDS) and has many years of experience as an appointed dangerous goods safety advisor.

CASE STUDY 3: Import tolerance Provided strategic regulatory counselling on 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 US Environmental Protection Agency (EPA) and 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 | Service Providers Guide 2011

Page 31

PROFILE: Acta Group EU Ltd

PARTNERS

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

SERVICES PROVIDED Corporate strategy/advice

Web site

www.apeiron-team.eu

E-mail

info@apeiron-team.eu

Tailor made advice for a cost efficient implementation of regulations, taking into account the global business strategy and required flexibility of our clients; interpretation of the regulations; position papers and communication with authorities; SVHC (substances of very high concern) tracking. In general, Apeiron-Team can assist you in chemicals management and product stewardship.

Head office

Pluyseghemstraat 69

Dossier preparation − scientific advice

2550 Kontich

Belgium

Tel

+32 3 808 20 69

Contact

Elke Van Asbroeck

Substance identification; risk assessments; PBT (persistent, bioaccumulative and toxic) assessments; REACH registration and notification dossiers; CLP notification dossiers; classification of substances and mixtures; representation of our clients in consortia.

Directors

Elke Van Asbroeck

Hiram Moerman

Ownership

Private company

Locations

Kontich, Belgium

Founded

2009

PROFILE: Apeiron-Team

CONTACTS

Audit programme Compliance audit (preparation to authorities’ inspection audit); system audit (evaluation of current status and possible improvements); supply chain audit (risk management measure to avoid supply chain disruption); project audit; due diligence audit; audit on implementation of strictly controlled conditions. Project management and training Consortium management; pro-active project management with focus on in-time and in-budget delivery. Apeiron-Team can deliver in-house training on various aspects of the REACH implementation process.

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 all 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 eight 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

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

2009

Start of Apeiron-Team NV

2010

Management of consortium of a highly specialised chemical

2010

Move to the new location in Kontich

2010

REACH training for Belgian federation of chemical industry

2010

Development of a client portfolio of SMEs and multinationals in chemical and polymer industry

2010

Successful registration of more than 100 substances for REACH

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

2011

Hands on toxicology training

Staff, group

2011

eSDS course for DUs

Staff, chemical service provision

2011

Extension of client portfolio in food and pharma industry

2011

Participation in Smithers conference in Atlanta with presentation on development of exposure scenarios

SERVICE AREA BREAKDOWN Training 15%

Information 10%

Admin/ management 10%

Other 5%

ACCREDITATIONS Consultancy/ advisory 60%

• Certified toxicologists • Environmental advisor (Milieu Coordinator) • Strategic advisor SME PARTNERS • • • • •

IRIS Lutea ProMil CjConsult PTK Ltd Burgess Regulatory Services Ltd

CLIENTS Chemical industry: petrochemical, toll manufacturing Food industry Polymer industry Refinery Tyre industry Pharma Industry Page 32

Chemical Watch | Service Providers Guide 2011

TESTIMONIALS

STAFF SELECTION

"Our experts, together with the experienced Apeiron-Team, successfully implemented the complex EU regulations REACH and CLP. We appreciate the know-how exchange and professionalism on both sides” − Borealis "Apeiron-Team is a no-nonsense company delivering their services on time, in full and in budget" − Monument Chemical

Elke Van Asbroeck – Managing Director

To support the registration of a high volume rubber chemical, ApeironTeam has built for this substance the complete REACH dossier and prepared the registration for the lead registrant. The multi-constituent substance was evaluated by Apeiron-Team in all relevant physicochemical and toxicological aspects both human and environmental. Exposure was assessed for all stages of the lifecycle including the waste stage. Apeiron-Team also provided the C&L classification and composed the eSDS, including the annex. Within the consortium Apeiron-Team provided the cost evaluation of the studies and has set up the cost-sharing model for the consortium and SIEF members.

ir (Bio-)chemical engineer Polymer chemistry/ waste Cost-efficient regulation implementation Auditing/ GPS Supply chain communication (eg SVHC) Import/ export strategy

Hiram Moerman – Managing Director • • • • • •

ir chemical engineer Specialised in process chemistry Product stewardship and GPS Auditing Regulatory IT systems (eg IUCLID) Consortium/ project management

PROFILE: Apeiron-Team

CASE STUDY 1: REACH dossier preparation

• • • • • •

CASE STUDY 2: Development of product stewardship programme A large, global chemical company was looking to strengthen its product stewardship programme. Apeiron-Team was able to support this company in developing a multi-year chemicals management programme. Apeiron-Team has implemented here its concept where existing data, projects and organisational structures, often put in place for REACH registration purposes, are recovered and re-focused. The new approach was to extend the scope of the team towards the implementation and management of all chemical regulations throughout the entire lifecycle of the products. Within this scope a risk-based method was implemented to select the projects within the product stewardship programme. CASE STUDY 3: Strategic advice to align REACH registrations with the business objectives Although REACH registration is a scientific exercise involving a lot of communication throughout the supply chain, REACH is also very much a business driven effort. Apeiron-Team has helped several multinationals to develop their REACH registration strategy taking into account the markets and import/export strategies which the business had already in place. By doing so, a cost effective registration strategy could be developed avoiding unnecessary registration cost while securing optimal business continuity and flexibility.

Chemical Watch | Service Providers Guide 2011

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GLOBAL OFFICES Our 300 offices around the world provide global support. Centres of excellence for our global product stewardship practice: ARCADIS Belgium Citylink, Posthofbrug 12, 2600 Antwerpen-Berchem, Belgium Contact: Alain Vassart, 0032 3 328 62 48, a.vassart@arcadisbelgium.be ARCADIS US Inc 4665 Cornell Road, Suite 350, Cincinnati, Ohio 45241, USA Contact: Jim Kain, 001 513 860 8700, jim.kain@arcadis-us.com

PROFILE: Arcadis

CONTACTS Web site

www.arcadis.com

E-mail

jim.kain@arcadis-us.com

Head office

Gustav Mahlerplein 97-103, 1082 MS Amsterdam

PO Box 7895, 1008 AB Amsterdam

The Netherlands

Tel

+31 020 2011011

Fax

+31 20 2011 002

Contact

Jim Kain, Alain Vassart

Directors

Jim Hill, Operations Leader

Kristof Peperstraete, Executive Director Environment

Ownership

Public company

Locations

300+

Founded

1888

SERVICES PROVIDED Our services In order to produce exceptional value for our clients, employees and shareholders, we organise our services into four main business lines, each with its own area of strength and strategies, ie infrastructure, water, environment and buildings. At the same time, these segments are naturally and inextricably woven together, inspiring us to work across disciplines and geographies to deliver exceptional solutions to complex issues. One of the services in the business line environment is global product stewardship and will be highlighted in this briefing. Global product stewardship

OVERVIEW ARCADIS is an international company providing consultancy, design, engineering and management services in infrastructure, water, environment and buildings. We enhance mobility, sustainability and quality of life by creating balance in the built and natural environments. ARCADIS develops, designs, implements, maintains and operates projects for companies and governments. With more than 15,000 employees and €1.8 billion in revenues, the company has an extensive international network supported by strong local market positions. VITAL STATISTICS

2009

Turnover, group

€1,7856m

Turnover, chemical service provision

€5m

No of offices

324

No of countries represented

Staff, group

15,500

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 10% IT & software 5%

Other 5%

Consultancy/ advisory 30%

Laboratory 5%

Information 20%

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Admin/ management 25%

The mission of our global product stewardship (GPS) practice is to enable our clients to efficiently manufacture and market their products and manage their supply chains in a safe, responsible, and globally compliant manner. Our global team is lead by a blend of corporate-bred senior scientists and regulatory affairs managers from Fortune 100 companies and best in class technical experts that are widely recognised by significant stakeholders around the world. We stay abreast of the international chemical regulatory challenges confronting industry with significant concentrations on the US, European Union and Asia-Pacific regions. Our product stewardship team is actively providing strategic and technical services for corporate organisations, their individual business units and international industry associations conducting lifecycle assessments with an extensive staff actively preparing technical dossiers to comply with the requirements of the European Union’s REACH Regulation and the UN’s globally harmonised system for hazard classification and labelling (GHS). CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1888

Parent company Heidemij formed in the Netherlands

1993

Geraghty & Miller merges with Heidemij

1998

Global company becomes ARCADIS

2002

BBL (est 1984) establishes a global product stewardship (GPS) practice with Cincinnati as its centre of excellence

2005

ARCADIS merges with BBL

2006

ARCADIS Belgium is established as a second GPS centre of excellence

2009

ARCADIS takes the lead in consortia management

2010

ARCADIS provides support and advice in nearly 100 dossiers in the framework of REACH registrations

Chemical Watch | Service Providers Guide 2011

ACCREDITATIONS

STAFF SELECTION

EuroTox Federation of European Toxicologists; European Societies of Toxicology; European Chemist Registration Board; Diplomat of the American Board of Toxicology.

Ranulfo Lemus-Olalde ScD – Human Health Toxicologist

ARCADIS works for top tier clients around the world. We focus on clients in these market sectors: aerospace, automotive, chemical, conglomerates, consumer goods, pharmaceuticals, power and utilities, oil and gas, public authorities/port and transit, government (all levels), financial, insurance, tech/telecom/electronics, brownfields/developers/real estate, and others. CASE STUDY 1: Product stewardship services for a home and personal care product producer ARCADIS has been providing ongoing services to a Fortune 100 company to support its REACH registration efforts. Our team helped this industry giant review thousands of studies for quality and completeness for regulatory submissions. These data were then indexed into the company’s internal data management system and entered into IUCLID for sharing among all the companies that pre-register the same substance in an effort to reduce duplication of testing. In addition to REACH support, ARCADIS has been providing general regulatory and product safety services to multiple businesses within the company. Key activities include human and environmental safety assessments, updating product material safety data sheets, US TSCA import/export review, scientific manuscript preparation, developing website content, support for green certification, and global product registrations.

JM Cardinaals – Chemist Risk Assessor J.M Cardinaals holds a BSc in analytical chemistry and an MSc in human nutrition. He gained significant experience in performing and evaluating physical chemical properties of substances by managing the chemistry department of a contract research organisation for seven years. Over the next 15 years, he became a regulatory specialist by contributing to the preparation of dossiers for different regulatory frameworks (including plant protection products, biocides and industrial chemicals). Nele Deleebeeck PhD – Ecotoxicologist Dr Nele Deleebeeck holds the academic degrees of MSc in biology, MSc in environmental sciences and technologies, and a PhD in applied bio-engineering sciences (environmental technology). Nele has ten years' experience in environmental risk assessment and has worked for the Belgian government, academics, industry and consultancy. She is experienced/familiar with all aspects of environmental risk assessment and this for a wide variety of chemicals, with her main specialty being metals/metalloids.

CASE STUDY 2: Management of professional organisations

Kate Sellers, PE – Environmental Engineer

The large diversity of expertise within ARCADIS allows administrative and legal as well as financial support in the management of task forces and professional organisations. Another service offered by ARCADIS in this context is the development of position papers on various issues for discussion between industry organisations and with regulatory authorities. The aim of this type of documents is to set standards on behalf of industry, with the issue of health and safety being one of the main examples. Other aspects related to management of professional organisations are communication and education. Various tools developed by ARCADIS have added to the success factor in both these areas.

Kate Sellers edited and co-wrote Nanotechnology and the Environment (Taylor and Francis Press, 2008), which explores the implications of this new technology. She has presented seminars and short courses based on this book to professional societies and multinational clients, and has advised clients on issues ranging from the consequences of nanoparticle exposure to the nuances of regulatory registration. Ms Sellers holds a BS in chemistry, a MS in environmental engineering.

CASE STUDY 3: REACH consortia management ARCADIS is currently providing management and technical support to various international consortia under REACH. Consortium management generally involves communication with SIEFs and other stakeholders, budget and cost tracking, and cost sharing among consortium members. ARCADIS' experience in regulatory affairs is especially valuable for this kind of support. Technical support includes the evaluation of experimental study reports and the preparation of the registration dossier, and is supported by a team of experts in chemistry, toxicology and ecotoxicology.

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PROFILE: Arcadis

CLIENTS

Dr. Lemus-Olalde is focused on assessing human health risks to support clients in implementing the GHS and REACH. He has provided toxicological assessments and has supervised non-clinical GLP studies. He has published papers in journals such us Food and Chemical Toxicology and Environmental Health Perspectives. He is a recipient of the NIOSH’s Alice Hamilton award for Occupational Safety and Health, a member of the Society of Toxicology; and a diplomat of the American Board of Toxicologists.

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

PROFILE: ARCHE

CONTACTS Web site

www.arche-consulting.be

E-mail

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

Patrick Van Sprang

Ownership

Private company

Locations

Gent and Leuven

Founded

2009

REACH The REACH regulation is the biggest 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 and (g) REACH dossier submission, updating and follow-up. Classification of substances and complex mixtures under CLP/ GHS

OVERVIEW ARCHE was founded in 2009 by key experts from EURAS who hold a unique track record (15 years) 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 on these topics. Other key services include the classification of substances and complex mixtures (GHS/CLP), setting and/or evaluation of (site-specific) environmental quality standards, and the assessment of pharmaceuticals in the environment, plant protection products and biocidal products.

In order to remain compliant with all the current legislation related to the hazard classification of substances and (complex) mixtures, ARCHE provides the following services: (a) identification of obligations under CLP and REACH, (b) re-classification of substances/mixtures to meet the new CLP requirements, (c) SDS creation/updating and assignment of classification according to CLP and REACH requirements, (d) support the required hazardous declaration to the European Chemicals Agency (ECHA), (e) preparation of CLP notification dossier to the classification and labelling (C&L) inventory utilising IUCLID 5 software, (f) implementation of GHS Water Framework Directive (WFD) and Environmental Quality Standard (EQS) Directive

Turnover, group

The WFD and EQS regulations directly impact the operation of industrial sites; one of its goals is to assess/protect the chemical status of water bodies (eg impact of effluents). ARCHE provides tailor-made plans to increase the realism of the compliance assessment: (a) translation of generic EQS, (b) derivation of site-specific EQS using bioavailability/ background corrections, (c) implementation of probabilistic techniques covering temporal variations, (d) development and management of full-scale monitoring programmes (biological and physicochemical characterisation), (e) modelling and risk/exposure assessment of the effluent mixing zone.

Turnover, chemical service provision

Biocides and plant protection products (PPPs)

No of offices

No of countries represented

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 the active substances and products, (b) identification of data gaps and design of higher-tier studies, (c) exposure modeling (FOCUS suite of models, EUSES, USES, CONSEXPO, EASE), (d) higher-tier exposure scenario development, (e) CLP, (f) dossier preparation, submission and follow-up, (f) client representation in meetings with regulatory authorities, (g) product stewardship

VITAL STATISTICS

2009

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN IT & software 5%

Training 5%

Consultancy/ advisory 90%

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Chemical Watch | Service Providers Guide 2011

2009

Foundation of ARCHE (staff: five people)

2010

Expansion of the team to 12 people, with offices in Ghent and Leuven.

PARTNERS EBRC Consulting GmbH, Hannover CLIENTS

CASE STUDY 3: Monitoring pesticides in Bulgaria Our experts assisted the Bulgarian government in optimising their monitoring strategy for pesticide residues in groundwater for eight selected regions. The work consisted of setting up a database on the hazard profile and application rates of pesticides used in Bulgaria. In order to prioritise, both EU pesticide risk indicators as customised Pearl modelling was used. STAFF SELECTION

Industrial clients and consortia related to the following chemical substances: • Metals: Mo, Pb, Ni, Cu, Zn, Hg, V, Co, Fe, Mn, Se, Sr, Ba, Mg, Bi, Te, Ti • Organic compounds: Chlorinated flame retardants, organic acids, plasticisers, amines • Complex materials: Cu slags, Ti slags • Other inorganic substances: Ca, B, NaOH, KOH, sulphur dioxiderelated substances (SO2, sulphites, thiosulphates, dithionites), lime, nitric acid, phosphoric acid

Patrick Van Sprang − Managing Director ARCHE

TESTIMONIALS

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, www. imoa.info CASE STUDY 1: Development of soil screening values for total petroleum hydrocarbons (TPH) The people currently working at ARCHE assisted the United Kingdom Environment Agency in the derivation of ecological sound soil screening values (SSV) for complex contaminants, such as total petroleum hydrocarbons (TPHs). In comparison with the aquatic environment, the derivation of reliable environmental quality standards for soil for TPH is hampered by the lack of experimental toxicity data for soil organisms. This was solved by integration of knowledge of the fate and behaviour of chemicals in the environment and data on their toxicity to eg aquatic organisms.This novel modelling approach used the equilibrium partitioning (EqP) and the narcosis target lipid model (nTLM) developed for aquatic organisms. This model was further refined using the hydrocarbon blocks method as developed originally by CONCAWE.

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

Frederik Verdonck − Senior Science Project Manager Dr. Frederik Verdonck obtained his PhD degree in bio-engineering on probabilistic risk assessment at Ghent University (Belgium). At ARCHE his main expertise area comprises the implementation and application of statistical and modelling approaches in exposure, effects and risk/safety assessment. Currently, Dr Frederik Verdonck is the leading expert in developing and implementing new tools in the field of exposure 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: MeClas − metals classification tool Most complex materials in the metals sector contain a spectrum of different metals (compounds) and minerals, which therefore requires extensive physico-chemical, toxicity and ecotoxicity reference data sets. The MeClas tool offers a unique web-enabled classification tool that is always updated to the latest classification rules. The tool comprises several tiers, aimed at the progressive refinement of classification through recognition of speciation, specific mineral content and the availability of test data on the complex material in question. A licence is needed in order to use the tool (register and obtaining a login account at www.meclas.eu in order to access the MeClas tool and all supporting information). The MeClas tool has been developed jointly by EUROMETAUX and ARCHE based on initial developments in collaboration with the European Copper Institute, ICMM and Euromines.

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PROFILE: ARCHE

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

SERVICES PROVIDED

PROFILE: Bibra Toxicology Advice & Consulting

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 Directive, 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 acceptable risk-based levels of exposure. 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.

CONTACTS Web site

www.bibratoxadvice.co.uk

E-mail

info@bibratoxadvice.co.uk

Head office

Cantium House, Railway Approach,

Wallington, Surrey, SM6 0DZ

Tel

+44 (0)20 8544 4150

Fax

+44 (0)20 8544 4151

Contact

Peter Watts

Directors

James Hopkins, Managing Director

Peter Watts, Director of Toxicology

Graham Hunt, Commercial Director

Ownership

Private company

Locations

United Kingdom

Founded

1960, acquired by current management 2005

Human health hazard and risk assessment The bibra 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, food and food contact, consumer products and pharmaceutical 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

OVERVIEW Bibra toxicology advice & consulting is the brand name for two sister companies working together in the field of chemical hazard and risk assessment – Toxicology Advice & Consulting Ltd and Bibra Information Services Ltd. The result is an organisation that combines 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. VITAL STATISTICS

2009

Turnover, group

£1.3m

Turnover, chemical service provision

£1.3m

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Information 7%

Training 3% Consultancy/ advisory 40%

Admin/ management 50%

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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 taking weight-of-evidence approaches to fill data gaps. If further testing is deemed necessary we advise on testing strategies to minimise both the use of animals/overall costs to the client, while maintaining scientific integrity. We assess the impact of the results of new tests conducted and provide ongoing expert guidance on what is really needed. Extensive in-house toxicological database and databank For more than 50 years, bibra toxicology advice & consulting has been scrutinising emerging toxicological literature, expert reviews or pronouncements, and indexing these in a systematic endpoint and chemical-specific way. Much of this scientific literature is held in-house in our technical library and quickly accessed using its associated database, TRACE. This unrivalled resource allows instant access to relevant documents and is critical in helping us produce the finest hazard and risk assessment work for our clients, in the most timely and cost-effective manner. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1960

Formation of BIBRA

1960

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 datasource of its type, worldwide

2003/5

Toxicology Advice & Consulting Ltd and Bibra Information Services Ltd established as vehicles to facilitate management buy-out of Information and Advisory Department, including TRACE and its associated databank

2005

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

2010

Relocated to new, larger offices in Wallington, Surrey

Chemical Watch | Service Providers Guide 2011

Our senior toxicologists are all Society of Biology/British Toxicology Society and EUROTOX registered toxicologists REACHReady Approved Supplier PARTNERS Campden BRI Group Leatherhead Food International Ltd wca environment Ltd 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: Actavis Group ptc; CSL Behring Biotherapies for Life; Environment Agency (UK); Health Canada; IPCS, World Health Organization; Groupe Danone; Infineum UK Ltd; Innospec Active Chemicals; IRSST (Canada); Johnson Matthey plc TESTIMONIALS “Reliable, responsive and adept at applying their toxicology expertise to REACH, our experience of working with bibra has been very positive” – Infineum UK Ltd "In my opinion the toxicologists at bibra/toxicology advice & consulting are able to provide a very high-quality service by applying a combination of many years of experience and a high level of efficiency, in relation to scientific toxicological literature reviews and risk assessment" – Marc Baril PhD, Conseiller scientifique, IRSST 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. CASE STUDY 2: Urgent request for help with chemical safety report We are very happy to take on smaller projects and have been working with a number of clients to help out with specific areas of their REACH registration dossiers. In one case we were asked at short notice to help improve an existing IUCLID 5 dossier on a petrochemical additive manufactured in the EU at greater than 1000 tpa. This urgent request involved the peer-review 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.

Chemical Watch | Service Providers Guide 2011

CASE STUDY 3: Provision of alerting service to keep industry upto-date on emerging issues Bibra toxicology advice & consulting was asked by an industry sector group to provide an ongoing service to track the emerging toxicological literature on a range of chemicals of particular interest to their members. Using a range of carefully tailored search and alerting strategies (SDI – selective dissemination of information), the bibra team receives daily notification of newly published or pre-published papers, abstracts or comment and alerts the sector group members to keep them abreast of the scientific literature and developing areas of possible concern. The service allows the industry to successfully foresee and manage arising issues in a co-ordinated and proactive way. STAFF SELECTION James Hopkins – Managing Director James was a toxicologist of high repute at Bibra International before leading the management buyout in 2003. The new company, bibra toxicology advice & consulting, has performed impressively under James's guidance, reporting record results in 2010. 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 30 years. His vast experience includes reviewing and critically evaluating toxicological data and providing risk assessments on numerous chemicals for government depts 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. Philip Copestake – Senior Toxicologist Philip has more than 24 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 team of toxicologists to support a number of client companies and consortia with their registration submissions. The rest of the team We have another 11 highly-competent toxicologists, all of whom are professionally qualified (the majority are SB/BTS & EUROTOX registered toxicologists) and, barring our two graduate trainees, range in practical experience from eight to 25 years. All are extremely skilled in chemical hazard and risk assessment and have been heavily involved in REACHrelated work during the past 24 months.

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PROFILE: Bibra Toxicology Advice & Consulting

ACCREDITATIONS

GLOBAL OFFICES USA BioQuanta Corp 2851 South Parker Rd. (S) 720 Aurora, CO 80014 – USA Japan Y's STAGE 8-4-4 kamikizaki Urawaku Saitama Shi – Japan

PROFILE: BioQuanta

CONTACTS Web site

www.bioquanta.net

E-mail

romain.guidon@bioquanta.net

Head office

BioQuanta SA

5 rue de l’Abbé de l’Epée

75005 Paris – France

Tel

+33 6 25 14 17 66

Contact

Romain Guidon

Directors

Remi Rabeuf, CEO

Thierry Gerardi, Dir Marketing, Communication, HR

Thierry Delvienne, Business Development, Europe LGC

Francois Hamon, Finance and Marketing

Ownership

Private (founder owned)

Locations

Paris, France; Aurora, Colorado, USA;

Saitama Shi, Japan; Bangkok, Thailand

Founded

2003

SERVICES PROVIDED MultiDIP − in silico toxicity prediction and characterisation MUltiDIP is our next-generation virtual screening service. Unlike many other in silico products, the MultiDIP service is based on a detailed molecular modelling approach. This enables us to achieve a high level of accuracy in our toxicity predictions − higher than the three leading in silico solutions combined. These toxicity predictions are rendered on specific REACH endpoints. These predictions are annotated with bibliographic references (including basic research as well as toxicology studies), which can be used in the weight-of-evidence approach required by REACH. The bibliography can also be used to fill data gaps. We have also developed a secure client module which brings another feature unmatched by other systems: the ability to render these predictions and characterisations without the need for disclosure of your chemical entity. Mitoxis − in vitro characterisation of oxidative stress

OVERVIEW BioQuanta provides services in toxicity prediction and characterisation. We have developed two new technologies for this: an in silico system called MultiDIP, and an in vitro system called Mitoxis. MultiDIP is a virtual screening system based on a novel pharmacophore definition. It outperforms the three leading in silico solutions combined. It has high accuracy in predictions on specific endpoints, and a high quality bibliography for understanding mechanisms of toxicity. Mitoxis is an automated in vitro system for characterising oxidative stress and mitochondrial dysfunction. It can detect low-level or chronic toxicity more reliably and more rapidly than conventional microplate based assays. VITAL STATISTICS

2009

Turnover, group

€714,000

Turnover, chemical service provision

No of offices

No of countries represented

Mitoxis performs automated measurements to quantify key metabolic parameters such as oxidative stress, electron-transport chain disorders, the energy status of the cell, inflammation, and cell death. Mitoxis is different from systems based on microplate technology, and delivers results with a much greater level of precision. A multi-parametric analysis allows 30 measurements to be made at once on a single sample, with sample volumes as low as five microlitres. This technology eliminates variations between samples so you can focus on differences between parameters. This provides valuable complementary information to standard in vitro studies. The Mitoxis test panel consists of more than 70 assays, and our expert team will help you select the ones most relevant to your concerns. Because of its sensitivity, Mitoxis is especially suitable for uncovering long-term, chronic, and sub-acute toxicity. This can be an important advantage, depending on the exposure scenarios of your substances.

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Laboratory 100%

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Chemical Watch | Service Providers Guide 2011

STAFF SELECTION

2009

Listed on the Euronext-Paris exchange

Remi Rabeuf − CEO

2008

Medicen partnership established

2008

Universite de Louvain partnership established

2007

APHP partnership established

2007

Genopole partnership established

MSc, MBA Mr Rabeuf spent 20 years at Roche, where his last position led him to deploy a comprehensive international approach involving the diagnostics and pharmaceuticals divisions. He brings a strategic vision and expertise to guide BioQuanta's development.

2006

UEVE partnership established

Philippe Manivet − Scientific Advisory Board, co-founder

2006

INSERM partnership established

2005

Universite de Mahidol partnership established

2004

Univeriste Paris Descartes partnership established

PhD Polytechnique, PharmD Professor Manivet is an expert in computational chemistry and biochemical modelling. He has designed the tools and methods of the MultiDIP platform. He has also coordinated the intensive use of in silico tools in the development of several molecules for our clients and diagnostic-kit projects with the aim of achieving a more efficient molecular design and production process.

PARTNERS AP-HP, Genopole, Medicen, INSERM, UEVE, Universite Paris Descartes, Universite de Louvain, Universite de Mahidol CLIENTS Our clients have requested that their names not be disclosed. TESTIMONIALS Our clients have requested that their names not be disclosed. CASE STUDY 1: A major French automobile manufacturer A major French automobile manufacturer needed to predict and characterise the toxicity of several hundred compounds used in its production chain. The client already had an internal toxicity classification scheme, which would eventually serve to guide substitutions. The client needed better toxicity characterisations of its compounds to prioritise its substitution schedule. The MultiDIP team was able to develop a results format that satisfied the client's needs. The long-term substitution challenge is an important one, with two major consequences. One is to be able to continue production with minimal interruption, and with minimal adaptation to the substitute compound. The second is in correctly choosing the substitute compound. The substitute may have a more manageable risk profile, but this new compound must also not appear on future SVHC or similar listings. The substitutions must be chosen correctly the first time, and this is where the fidelity of our molecular modelling system shows its true value.

Chemical Watch | Service Providers Guide 2011

Marc Conti − Scientific Advisory Board, co-founder PhD, PharmD Dr Conti is a leader in the biochemistry of oxidative stress. As a clinical biologist, he oversees hundreds of thousands of tests each year, both for patients and industrial clients. His experience in diagnostics enables BioQuanta to identify unmet needs in the clinical field and contributes greatly to the development of innovative biomarker assays. Romain Guidon − Business Development Romain Guidon is the head of business development for the in silico toxicity prediction service (MultiDIP). Mr Guidon works with clients to determine their needs, (especially in the regulatory context) and match them with MultiDIP service offerings.

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PROFILE: BioQuanta

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

SERVICES PROVIDED REACH compliance • REACH only representative, REACH late pre-registration and full registration • Generation of the technical dossier and chemical safety report (CSR) under IUCLID 5 • Supervision of physico-chemical, toxicological and eco-toxicological testing (via GLP certified labs) • QSAR modelling qualitative/quantitative structure activity relationship, bridging and waiving • Generation and update of (extended) safety data sheets (SDS and eSDS) in compliance with REACH and CLP • REACH dossier submission, updating and follow-up

PROFILE: B-Lands Consulting

CONTACTS Web site

www.reachteam.eu

E-mail

services@reachteam.eu

Head office

5 Place Robert Schuman, BP1516, Grenoble

France

Tel

+33 476 295 867

Fax

+33 476 295 870

Contact

Dr Michael J Kilner (UK)

CLP/GHS notification • Available data collection and assessment. Testing proposals for classification of the substances and mixtures • Double classification for substances in accordance with both CLP and DSD (Directive 67/548/EEC) • Automated generation of CLP compliant labels for substances and mixtures • Submissions of the C&L notifications to the European Chemicals Agency (ECHA)

Dr Jean-Marie Prat (France) Dr Giovanni Prota (Italy) Ownership

Private company

Locations

Grenoble, France

Beijing, China

Founded

2007

EU cosmetic products compliance

OVERVIEW B-Lands Consulting offers worldwide regulatory compliance solutions with a strong focus on the EU and Asia. Since 2007 B-Lands has been developing expertise in the fields of REACH/CLP, biocides and cosmetics and delivers compliance solutions to a worldwide client base. B-Lands Consulting has been operating a strong regional office in China since 2008 and provides Asia compliance solutions for clients who seek to gain in China’s lucrative market. B-Lands is staffed with multi-lingual experts able to address compliance issues worldwide. VITAL STATISTICS

2010

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

>40

Staff, group

Staff, chemical service provision

GLOBAL OFFICES B-Lands Consulting, 5 Place Robert Schuman, BP1516, Grenoble, France Chemken Consultancy, 2nd Floor, 6 London Street, London, W2 1HR, UK B-Lands Beijing,YiZhuang Business Development Area, 100176, Beijing, China SERVICE AREA BREAKDOWN Training 5%

Other 8%

Consultancy/ advisory 30%

IT & software 15% Laboratory 2% Information 10%

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• Safety evaluation for cosmetics and fragrances • Generation of ingredient dossiers and submission to SCCP • Generation and update of cosmetic product safety reports and product information files • Monitoring of toxicological studies required for dossiers • Reviewing labelling of cosmetics for compliance with EU requirements • General regulatory support for cosmetic products EU biocidal products registration • Identification of biocidal products and their uses • Generation and submission of inclusion dossiers for active substances in Annexes I or IA • Generation and submission of authorisation dossiers (first authorisation, mutual recognition) • Study monitoring in required areas (toxicology, ecotoxicology, environment, residues, efficacy…) • Coordination of task forces or consortia • General regulatory support for biocidal products CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007

B-Lands first premises opens in Grenoble, France

2007

B-Lands launches QuickREACH, automated preregistration tool

2008

B-Lands launches REACHChecker, instant online REACH verifications

2008

B-Lands second premises opens in Beijing, China

2008

Over 17,000 pre-registrations completed

2009

B-Lands launches biocides, cosmetics compliance services

2010

220 full registration dossiers submitted

2011

Ongoing CLP notifications

2011

Registration for late comer companies who missed the 2010 deadline

Admin/ management 30%

Chemical Watch | Service Providers Guide 2011

CASE STUDY 4: Assistance with China REACH registration

China Chamber of Commerce of Metals Minerals & Chemicals Importers & Exporters (CCCMC) Infodyne Nexreg Phycher Bio Développement

Following the entry into force of the revised version of the Measures on Environmental Administration of New Chemical Substances “China REACH” (15 October 2010), one of our clients faced significant challenges with non-compliance and financial losses due to supply chain disruption. In the process of assisting this client, inquiries were made into the status of chemical substances in the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC). We proceeded to notify new chemical substances to the Chinese Chemical Registration Centre (CRC). The completion of this project relied on a joint effort by our European and Chinese regulatory teams.

CLIENTS B-Lands Consulting has an extensive portfolio of clients ranging from global multinational organisation to small sized enterprises. Due to confidentiality, the identity of our clients cannot be disclosed as we represent different parties through data sharing processes. CASE STUDY 1: Integrated REACH/CLP compliance solutions B-Lands undertook a wide-ranging REACH-compliance project covering an extensive product portfolio of more than 600 unique chemical substances on behalf of a US-based multinational-company. This project included an extensive REACH pre-registration programme that covered more than 30 separate EU legal entities, as well as the timely submission of REACH registration dossiers prior to the 2010 deadline. We participated in the relevant substance information exchange forums, handling all SIEF communication and interactions with consortia. In addition to REACH, this project integrated key obligations under CLP. This included the classification and notification of all chemical substances within the portfolio. As well as this, we collaborated with a major international accounting firm to offer a tax-streamlining solution which yielded significant cost savings and full compliance for our client. Currently we are assisting this company with various requirements under the Measures on Environmental Administration of New Chemical Substances (China REACH). CASE STUDY 2: Takeover of existing compliance programmes B-Lands was approached by an EU-based importer having failed in its submissions of several REACH dossiers to ECHA. After a thorough assessment of the client’s compliance status, we were able to successfully submit updated versions of the failed dossiers. As a result of our work, we were able to ensure that our client did not lose the substantial ECHA fees associated with the initial submissions. Similarly, B-Lands has successfully taken over regulatory compliance work from a significant number of REACH only representatives initially appointed by non-EU companies. As part of this process, B-Lands performs a full assessment of the existing compliance programme, including an extensive assessment of supplier compliance and an evaluation of the SVHCs in articles. CASE STUDY 3: Instant online REACH verifications Responding to demands from the field, B-Lands has developed several IT tools aimed at tackling compliance challenges via smart automation. As REACH compulsory measures are being increasingly adopted by industry players, B-Lands has recognised the necessity for recipients to quickly and accurately qualify REACH compliance justifications passed through the supply chain. REACHChecker provides our clients with instant verification support for any ECHA issued REACH reference number (Registration number, preregistration, inquiries, notifications, etc) passed from higher up the supply chain. REACHChecker provides the confidence (and peace of mind) that erroneous references are screened out one step ahead of enforcement authorities.

Chemical Watch | Service Providers Guide 2011

CASE STUDY 5: Assistance in achieving global environmental compliance A major French multi-national hotel chain contacted B-Lands to help address its regulatory compliance obligations covering REACH, CLP, WEEE, RoHS, biocides. From our ongoing work, we identified a number of regulatory compliance optimisation strategies. This led to the renegotiation of several corporate contracts for the purchase of multimedia and IT equipment resulting in significant cost savings for the client across its worldwide operations. STAFF SELECTION Dr Jean-Marie Prat − Regulatory Chemist PhD analytical chemistry at the University College Cork, Ireland Diplôme D’Ingénieur at Ecole Nationale Supérieure de Chimie de Montpellier, France Fields of expertise: • Analytical chemistry, chromatographic phases and method development • R&D project management Dr Michael J Kilner − Regulatory Chemist Post graduate diploma in law at the Nottingham Law School, UK PhD organic chemistry at the University of Manchester, UK MSc chemistry at the University of Manchester, UK Fields of expertise: • European law • Organic synthesis and product characterisation Dr Giovanni Prota − Regulatory Chemist PhD pharmaceutical sciences at the University of Pisa, Italy Fields of expertise: • Occupational health and safety • Organic synthesis Dr Declan Cusack − Regulatory Chemist PhD organic chemistry University College Dublin, Ireland BA Mod, 1st class honours degree in medicinal chemistry, Trinity College Dublin, Ireland Field of expertise: • Organic synthesis • Analytical techniques (product characterisation)

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PROFILE: B-Lands Consulting

PARTNERS

PROFILE: Brixham Environmental Laborator y

Industrial chemicals (REACH) Brixham Environmental Laboratory is part of a global testing alliance and as such can offer a complete REACH service. We can provide both the routine studies required for REACH and the studies required for substances of very high concern (SVHC). The laboratory is able to conduct all of the studies required to assess a substance against the PBT or vPvB criteria and complete all of the aquatic studies listed within the OECD conceptual framework for the testing and assessment of endocrine disrupting chemicals.

CONTACTS Web site

www.brixham-lab.com

E-mail

infomaster.brixham@astrazeneca.com

Head office

Freshwater Quarry, Brixham

Devon

England

Tel

+44 1803 884400

Fax

+44 1803 882974

Contact

Enquiry co-ordinator

Ownership

AstraZeneca UK Ltd (parent company)

Locations

Brixham, Devon, England

Founded

1948

Plant protection products Brixham Environmental Laboratory has worked extensively for the plant protection products industry for more than 30 years, generating both ecotoxicological and environmental fate data. As well as working directly with agrochemical companies, the laboratory also works on behalf of consultancies who are preparing registration or re-registration submissions. Biocidal products Brixham Environmental Laboratory is experienced in designing the appropriate testing strategy for a particular biocidal product and in agreeing that strategy with the regulatory authorities. We are able to deliver all studies required for the environmental component of the submission, including various studies listed on the Directive.

OVERVIEW Brixham Environmental Laboratory deliver fit-for-purpose environmental support to the chemical industry worldwide, providing assessments of the environmental fate and effects of new and existing products and intermediates. The laboratory can also offer environmental support for the manufacturing processes that produce those products. Throughout its history the laboratory has worked for both its parent company and external clients, who have included a wide range of companies from within the international chemical industry. Because of that wide customer base the laboratory has strict processes and procedures in place to ensure client confidentiality. The laboratory has good laboratory practice (GLP) accreditation. VITAL STATISTICS

2009

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Consultancy/ advisory 20% Admin/ management 5% Laboratory 70%

Information 5%

SERVICES PROVIDED We offer laboratory based assessment of the environmental effects, ecotoxicity and environmental fate of new and existing substances. Our services can be easily classified according to the following industrial sectors:

Page 44

Veterinary medicines Directive 2001/82/EC, as amended by Directive 2004/28/EC on the community code relating to veterinary medicinal products, includes provision for an assessment of environmental risk. Brixham Environmental Laboratory can provide the Phase I assessment and all of the Phase II testing. Human pharmaceuticals An environmental risk assessment (ERA) is required for all new marketing authorisation applications for a medicinal product through a centralised, mutual recognition, decentralised or national procedure. We can provide all phases of the risk assessment. Pharmaceuticals are unique in that the ERA takes place towards the end of a development process that will have already included a great deal of in vitro and in vivo testing of efficacy, safety, metabolism and pharmacokinetics. Brixham Environmental Laboratory has experience of interpreting these data and using them to design an intelligent environmental testing strategy. Environmental modelling Modelling the environment, its process and the impacts from discharged contaminants, has been an integral part of the work of Brixham Environmental Laboratory for more than 30 years. This long history has resulted in a committed and skilled modelling team with the capability to provide clients with appropriate solutions, from simple analytical models to complex mathematical models using either off-the-shelf or bespoke packages. These skills, combined with the knowledge of other teams at the laboratory, provide the client with unrivalled solutions to model environmental processes and the fate and effects of contaminants in the environment. Research and development Solution driven, we work at the forefront of environmental research often acting as a central hub on cross disciplinary collaborations with a range of research institutes, funding bodies, industrial and academic partners, ensuring realism and a pragmatic application of science. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1948

Established as a marine research station for ICI Paints

1960s70s

Environmental science began to dominate the laboratory's function

1979

First environmental laboratory to be OECD GLP compliant in Europe

Chemical Watch | Service Providers Guide 2011

Major expansion with growing reputation for high quality and value environmental science

1993

The laboratory transferred to Zeneca Limited following the demerger of ICI

1999

The laboratory became part of AstraZeneca Pharmaceuticals

2007

£12 million laboratory refurbishment and expansion to include state of the art facilities

STAFF SELECTION

19482011

BEL continues to work at the forefront of environmental science, with a large publication output every year

—

Our expertise and testing helps to produce guidelines such as OECD, ISO, ECHA and many more

—

We continue to provide ecotoxicology and environmental fate testing for a very wide variety of compounds

—

More than 30 successful ERA submissions conducted since EMA guidelines published in 2006

Grace Panter is an ecotoxicologist with more than 12 years' laboratory experience in aquatic ecotoxicology and fish reproductive health. She has extensive experience of several areas of fish testing, especially endocrine disruption, gonadal histology and chronic tests. Grace is an active member within several international ecotoxicology organisations, including the ILSI-HESI on animal alternatives and endocrine disrupting chemicals committee; and the OECD fish drafting test guideline group. She has published extensively on the issue of endocrine disruption in fish, both as papers and technical reports.

—

Please refer to our website for our latest news, achievements and publications

ACCREDITATIONS Good Laboratory Practice (GLP) CLIENTS Due to client confidentiality individuals cannot be named but we work with various clients such as top pharmaceutical and chemical companies, government agencies, consultants, third parties, local authorities, petrochemical industries, specialty chemicals and many more. CASE STUDY 1: Persistence testing Through research funded by the UK government (Defra and EPSRC) and the CEFIC long range research programme, project teams lead by Dr Jason Snape established the proof of concept studies for a new generation of biodegradation test that have been recently included within the technical guidance for REACH. These include the modified biodegradation tests for poorly water soluble chemicals and the enhanced biodegradation studies for persistence assessments. Dr Jason Snape is currently a co-contractor on ECO11, a CEFIC LRI project validating enhanced biodegradation methods. CASE STUDY 2: Environmental modelling A client from the petroleum industry had to provide an assessment of the impact of a potential accidental spill of oil to the estuarine environment in order to meet the Control of Major Accident Hazards (COMAH) regulations. The Brixham Laboratory software, BELPLUME, was used to simulate the potential discharge to the estuary and the subsequent dispersion and dissolution of the oil. The model was used to predict the areas of impact from the spill for different tidal and meteorological conditions. Furthermore, an ecological impact assessment was carried out to assess whether the spill would constitute a major accident to the environment (MATTE). CASE STUDY 3: BEL’s intelligent approach marks an important milestone for 3Rs in fish full life cycle testing A request was made by a regulator to provide fish full lifecycle (FFLC) data for an active pharmaceutical ingredient. An FFLC test is deemed to be the gold standard for evaluating the potential environmental impact of human pharmaceuticals. It covers all life stages and measures long-term effects, taking 12 months to complete. However, following discussions with the regulator, an alternative test design to the FFLC was agreed. It used existing mammalian, human and environmental data for the active pharmaceutical ingredient to identify test concentrations, sensitive life stage(s) and the appropriate choice of experimental design. The alternative test design did not require a rangefinding study. It required less than half the number of fish and completed in half the time compared to a FFLC. Chemical Watch | Service Providers Guide 2011

The alternative test design, and the data provided by this study, have been accepted by the competent regulatory authority. Importantly, this also represents a significant milestone for incorporating intelligent testing within chronic fish testing and will potentially lead to significant reductions of animal usage in the future. Dr Grace Panter − Ecotoxicologist

Dr Jason Snape − Environmental Foresight Business Manager Jason is an environmental microbiologist and biochemist with 18 years' laboratory and field experience in the biodegradation and persistence of chemical products in the environment. He uses this extensive empirical experience at the interface between science and science-based policy and the development of pragmatic environmental regulations for exposure and persistence assessment. Jason is actively involved in chairing/cochairing committees, task forces and working groups. His expertise has also provided many published papers. Dr Gary Roberts − Senior SHE Specialist, Environmental Fate Gary has worked at the Brixham Environmental Laboratory since 1985 and is a specialist in studying the environmental fate of biologically active chemicals. Gary's current research interests include the biodegradability of volatile and poorly water-soluble substances; the partitioning of pharmaceuticals in biosolids, soil and sediment; and the anaerobic degradation of pharmaceuticals. Gary is responsible for the supervision of students registered for a PhD degree. Recently Gary chaired the organising committee for the ECETOC workshop: Significance of bound residues in environmental risk assessment, and currently chairs the ECETOC taskforce on this topic. Gary manages several projects studying the fate of chemicals in wastewater treatment, soil, sediment and the aquatic environment. He is actively involved in projects both within AstraZeneca and in collaboration with other industry and academic partners Martin Vaughan − Ecotoxicologist/Study Director Study director with 20 years of experience of ecotoxicology and environmental research techniques in GLP accredited laboratories. Ecotoxicology expertise in the aquatic, sediment and terrestrial compartments and the risk assessment of chemicals in the environment. Experience of testing with various species including fish, invertebrates, algae, macrophytes and mesocosm studies and analysing the results generated from such tests. Specific expertise in the bioaccumulation of chemicals in the environment. Active contributor to international working groups such as OECD and ILSI HESI bioaccumulation groups. Other staff BEL currently employs 84 people, from all over the world with a wide range of professional qualifications. These include internationally acclaimed scientists with doctorates and established publication records as well as individuals with professional business and management qualifications. Our 34 bench scientists, most with a degree in an environmental/analytical science, make up our largest cohort. As with any large modern employer, the site also requires a range of service and support staff to ensure efficiency.

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PROFILE: Brixham Environmental Laborator y

1980s

GLOBAL OFFICES CEHTRA Lyon – 80, rue Condorcet, 38090 Vaulx Milieu, 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 – 2A Vandana Building, 11 Tolstoy Marg, New Delhi-110001, India CEHTRA NA – 24 Ivy Lea Crescent, Toronto, Canada

PROFILE: CEHTRA

CONTACTS Web site

www.cehtra.com

E-mail

cehtra@cehtra.fr

Head office

43, rue Laroque

SERVICES PROVIDED

33560 Saint-Eulalie

Regulatory dossier services

France

Tel

+33 5575610

Fax

+33 5575610

Contact

Paul Thomas

Directors

Pierre-Gérard Pontal, President

Michel Guilhem, CEO

Philippe Adrian, Director CEHTRA Europe

CEHTRA provides clients with bespoke services for the production of regulatory dossiers, be that in the field of general chemicals, cosmetics, biocides, pesticides or pharmaceuticals. We have all the competencies inhouse to do all or any part of a project requested. We have contributed to or realised over 1,000 dossiers since CEHTRA was founded and we have produced more than 100 REACH dossiers, all of which were successfully submitted on time. We use, verify and validate the algorithms of software such as ECETOC TRA, PEARL or ART or improve on existing tools (eg adding a module to allow speedy formatting of final dossiers).

Paul Thomas, Director CEHTRA Lyon

Industrial hygiene and worker exposure studies

Peter Jenkinson, Director CEHTRA UK Ownership

Private company

Locations

Bordeaux FR, Brussels BE

With more than 10 years of culture and experience in different industrial sectors, from pesticide to general chemicals, and a complete understanding of the tools and 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.

Lyon FR, Nottingham UK, Delhi, India

Consortium management

Toronto, Canada

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.

Jason Nugent, Director CEHTRA NA

2001

Founded OVERVIEW

CEHTRA is a regulatory toxicology and environmental consultancy specialising in all areas of regulatory toxicology and particularly in dossier preparation for pesticide, pharmaceutical, biocide, chemical and cosmetics legislation. We also have an OR subsidiary company. VITAL STATISTICS

2009

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Legal 2% IT & software 2% Information 5% Admin/ management 10%

Training 2%

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 sate 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 via its subsidiary company LTS REACH-OR SAS. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Other 4%

Consultancy/ advisory 75%

2001

Company established

2003

Opening of UK office

2008

Opening of Brussels office

2008

Opening of Lyon office

2009

Start of the Indian Joint venture

PARTNERS Chris Braun Consultancy, Lisam Systems, Science & Environment, LTS REACH OR

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Chemical Watch | Service Providers Guide 2011

Michel Guilhem, CEO

Chemical companies, flavours and fragrances, plant protection industry, biocides, veterinary products, pharmaceuticals

Michel has 3 master’s degrees in chemical, environmental and safety engineering and 30 years of experience, from R&D and regulatory affairs project management at Dow Chemical to management positions in worldclass consultancies (ERM, ENVIRON) and in the pharmaceutical industry EHS services (Janssen-Cilag). He joined CEHTRA in 2009 and, beyond his key management responsibilities, he is in charge of expology and occupational health services.

CASE STUDY 1: REACH dossier rescue Late summer 2010, CEHTRA was asked to help on a problematic incomplete and flawed R50/53 dossier. Issues: • Environmental and HH studies of limited value • Re-work needed for environmental ES • Failed consumer and environment RCR CEHTRA response: • Total review of available studies, WOE approach, July • Short-term Ecotox. study performed to declassify, Aug • All ES completely re-worked and taken to Tier 2, Aug/Sept • Dossier compiled, draft CSR sent early Sept • Consortium comments addressed, submitted end Sept.

PROFILE: CEHTRA

CLIENTS

CASE STUDY 2: Declassification of a carbamate insecticide Based on sparse findings in the toxicology dossier and an open literature publication, the substance was proposed to be classified as R60, R62, R63, R64. The toxicology data were reviewed and a position paper written to demonstrate the lack of relevance of the finding for reproductive toxicity. An ad-hoc study was designed and conducted which demonstrated that the alleged findings in the publication were flawed. Our expert had face-to-face or telephone discussion with several MS experts from the C&L commission. Our expert attended the C&L meeting at ISPRA to present the case and answer to expert questions. At the end of the meeting, all R6X classifications were cleared. STAFF SELECTION Paul Thomas − Director and Manager of Lyon Office Paul Thomas has a PhD in aquatic Ecotoxicology and 15 years' experience with industrial chemicals, agrochemicals and biocides. 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 including several fragrance molecules. Peter Jenkinson − Director and Manager of UK Office Peter Jenkinson has a PhD in reproductive toxicology and 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. Philippe Adrian − General Manager of Brussels Office Philippe Adrian has a PhD in soil science and 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 Agrochemie and FMC. In 2001 he created CEHTRA with Pierr-Gerard Pontal and manages the environmental fate team and has developed the modelling expertise for pesticides according to current models as well as biocides using relevant TGDs. Pierre-Gérard Pontal − President of CEHTRA Pierre-Gérard Pontal is a medical doctor and has 26 years of experience with industrial chemicals, agrochemicals and biocides. He has worked for Rhone-Poulenc Chimie and Aventis cropscience in the product safety and risk assessment group. He has been a member of numerous task forces such as ECPA, ECETOC and UIPP and since 1994 a member of the EUROPEM group. He is a recognised expert for operator exposure, having conducted more than 20 worker exposure studies.

Chemical Watch | Service Providers Guide 2011

Page 47

GLOBAL OFFICES Chemservice GmbH, Worms, Germany Chemservice SA, Grevenmacher, Luxembourg Chemservice Asia Co Ltd, Seoul, Korea Chemservice Ltd Sti, Bodrum/Mugla, Turkey Chemservice EHNS GmbH, Worms, Germany Consortia Management GmbH, Worms, Germany

PROFILE: CHEMSERVICE

CONTACTS Web site

www.chemservice-group.com

E-mail

info@chemservice-group.com

Head office

Chemservice GmbH

SERVICES PROVIDED

Von-Steuben-Str. 13

Global regulatory affairs consulting

D-67549 Worms, Germany

Tel

49 (0)6241-95480-0

Fax

49 (0)6241-95480-25

Contact

Karl-Heinz Reis

Directors

Dr Dieter Drohmann

Managing Director

Ownership

Privately owned group of companies

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, plant protection products, cosmetics, and compile dossiers for food contact clearances and food and feed additive petitions.

Locations

Germany, Luxembourg, Korea, Turkey

REACH and GHS/CLP

Founded

2007

We provide our clients with strategic and technical support to be prepared 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 IUCLID5 assistance, CLP notification, safety data sheet and label creation.

OVERVIEW The Chemservice vision is to be the leading global regulatory affairs consulting company by supporting our clients around the world in gaining competitive advantage through the regulatory process. 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, env scientists, agronomists, biologists, veterinarian, regulatory specialists, etc) enables broad issue addressing. VITAL STATISTICS

2010

Turnover, group

ca €3m

Turnover, chemical service provision

ca €3m

Consortia, SIEF and letter-of-access management 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 tool provides an efficient LoA management for SIEF members to acquire access rights for a specific substance for the submission of the joint REACH dossiers. Moreover, it will help to reduce resources at lead registrant and consortia level and offers professional accounting support – including trustee account management.

No of offices

Only representative and third party representative

No of countries represented

We act for manufacturers outside the EU as only representative and cover fully the registration and pre-registration obligations. The importers of that non-EU manufacturer would no longer have duties as importers, 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.

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 5% IT & software 10%

Information 15%

Admin/ management 20%

Page 48

Other 5%

Consultancy/ advisory 45%

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

Office opening in USA is scheduled for Quarter 4

Chemical Watch | Service Providers Guide 2011

ACCREDITATIONS

STAFF SELECTION

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.

Dr Dieter Drohmann – Managing Director

Our partner companies are visible 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 ca 100 notifications to the Turkish inventory and 300 nominations to the inventory in Taiwan. For one client we supplied a global inventory strategy for a new polymer, and for multiple clients we conducted notifications to chemical inventories like Australia (AICS), Canada (DSL), China (IECSC), Korea (ECL), New Zealand (NZIOC), Philippines (PICCS) and USA (TSCA). CASE STUDY 2: REACH-Code-Model REACH does not distinguish between direct and indirect imports into the EU. Therefore, non-EU business followed by export to EU is more complicated – in particular if several non-EU steps along the supply chain are involved and substances have been formulated into preparations with confidential composition. In a multi-level non-EU supply chain the manufacturer of a substance usually does not know through which channels, in which products and finally how much volume of his substances is being imported into the EU. It is an essential business secret (CBI) of traders or formulators what the components of their products and who their suppliers and customers are. Neither the nonEU 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 and many companies with multi-step non-EU supply chains have signed up to this system already. This software can be used as well by only representatives to track their volumes and importers and is commercially available.

Dr Neslihan Altinbas – Managing Director of Chemservice Ltd Sti., Turkey • PhD in Chemistry • 10 years of experience in GLP and GMP quality assurance in the field of pharmacology and plant protection products, and nanoparticles Dr Günter Spang – Senior Regulatory Affairs Advisor • PhD in agronomy • 15 years of experience in regulatory affairs consulting, including risk assessments and dossier preparation Natalia Jansen-Bouriatchenko – Regulatory Affairs Advisor • Master in biochemistry • 15 years of experience in analytical and ecological chemistry, ecotoxicology and toxicology Karl-Heinz Reis – Senior Regulatory Affairs Advisor • Master in biology • 20 years of experience in the field of risk assessments, PBT assessments and CRO study director Thomas Schaefer – Manager Data and System Services • IT specialist • 20 years of experience in IT and data systems Yong Jiang – Regulatory Affairs Advisor • Master degree in chemistry • seven years of experience as chemical specialist, consultant and compliance manager Ah-Reum Seo – Regulatory Affairs Advisor • Chemist • six years of experience in R&D and regulatory affairs

CASE STUDY 3: REACH dossier work Chemservice has experience with ca 100 Tier 1 REACH dossiers, including member and lead dossiers. Moreover, a significant number of new substance registrations (non-phase ins), inquiry dossiers, PPORDS and chemical safety reports and extended safety data sheets were successfully completed. Furthermore, we have acted on behalf of our clients in more than 350 CLP-notifications.

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PROFILE: CHEMSERVICE

PARTNERS

• PhD in Environmental Sciences • Founder of the Chemservice Group • 20 years of experience in the chemical industry as regulatory affairs manager

PROFILE: Compliance Services International (CSI)

GLOBAL OFFICES

Web site

www.complianceservices.com

E-mail

info@complianceservices.com

CSI-Europe, Pentlands Science Park, Penicuik, Nr Edinburgh, EH26 0PZ, United Kingdom CSI-Europe (France), 18 Rue Guy de Combaud Roquebrune, La Saint Nicolas, 13007 Marseille, France US regional offices in Washington, Virginia, Massachusetts, North Carolina, Missouri and Georgia

Head office

7501 Bridgeport Way West

SERVICES PROVIDED

Lakewood, WA 98499-2423

Registration dossier preparation

USA

Tel

+1 253 473 9007

Fax

+1 253 473 2044

Contact

Bernalyn McGaughey

Data gap analysis, data waiver preparation, intelligent testing strategy development, placement and monitoring of studies at contract research organisations, good laboratory practice compliance consulting. Preparation of registration dossiers, including supporting IUCLID databases.

Directors

Bernalyn McGaughey, President and CEO

Hazard, exposure and risk assessment

Ownership

State of Washington, USA

Locations

USA, France and UK

Founded

1988

Physico-chemical, human health and environmental hazard assessment, exposure assessment and risk characterisation and reporting (eg chemical safety assessments/chemical safety reports). Use of exposure modelling tools, eg ECETOC TRA, EUSES, OECD ESDs, ART model, ConsExpo, etc.

CONTACTS

OVERVIEW CSI is a leading regulatory consultancy providing innovative solutions for organisations faced with regulatory and environmental challenges. Established in 1988, our diverse staff of experienced regulatory scientists develop strategies to meet specific needs for a global client base. CSI approaches all projects with a strong commitment to responsible science, to the environment and to risk management. Our mission is to serve our clients with scientifically-sound, cost-effective, and timely approaches to environmental assessment and regulatory compliance. VITAL STATISTICS

2009

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN IT & software 5% Laboratory 5% Information 5% Admin/ management 5%

Legal 5%

Only representative/third party representative Only representative services for non-EU manufacturers which (under REACH) cannot directly pre-register/register the substances that are exported to the EU. Third party representative services for companies not wishing to disclose their interest in a particular substance for reasons of commercial confidentiality. Consortia/task force management Scientific, technical and administrative support for consortia/task forces, including all aspects of communication and coordination. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1988

CSI formed in Washington State, USA.

1990s

Introduced innovations in the application of spatial technologies to environmental assessment.

1990s

Three times named one of the USA's fasting growing private companies (inc 500).

2000

CSI-Europe launched

2010

Winner of the AGROW award for Best Supporting Role.

ACCREDITATIONS Consultancy/ advisory 75%

Winner – 2010 AGROW award for Best Supporting Role European Registered Toxicologist on staff PARTNERS CSI operates independently and has no formal partners, but utilises a network of contract research organisations, legal companies and specialist providers as appropriate to supplement our consultancy services. CLIENTS CSI works with a wide variety of clients from multinationals to familyowned businesses based in our domestic EU and USA markets and throughout the world.

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TESTIMONIALS

PROFILE: Compliance Services International (CSI)

Welmoed Clous, Dow Europe GmbH, Switzerland John Cummings, FMC Corporation, USA Jennifer Shaw, Syngenta Crop Protection Inc,USA CASE STUDY 1: Chemical registration services Compliance Services International (CSI) successfully provided chemical registration services, including consortia management and SIEF communications, study monitoring and registration dossier preparation, for a substance subject to the 2010 REACH deadline on behalf of the Organotitanates and Zirconates Consortium. CASE STUDY 2: Biocidal Products Directive Compliance Services International (CSI) stewarded the first new active ingredient onto annex I of the Biocidal Products Directive and has attained mutual recognition of biocidal products containing the active ingredient throughout Europe. CASE STUDY 3: Plant Protection Products Directive Compliance Services International (CSI) stewarded two existing plant oil-based active ingredients onto annex I of the Plant Protection Products Directive. STAFF SELECTION Bernalyn McGaughey – President/CEO Bernalyn has more than 30 years of data evaluation, chemical research, study monitoring, and project management experience in the properties, use, toxicology, and environmental fate of pesticides and other chemicals. Her activities have included original and regulatory research, report design and composition, and international technical assistance on toxicology investigations and risk assessments. She has been manager of the FIFRA Endangered Species Task Force for more than 12 years. Frank Galloway – Manager, CSI-Europe/Principal Consultant Frank has regulatory, commercial and research experience spanning more than 30 years. He has worked extensively with consortia and task forces supporting existing crop protection and biocidal product active substances and industrial chemicals. As a past regulator with the former UK Pesticides Safety Directorate, Frank conducted operator, consumer and environmental risk assessments for agricultural pesticides and prepared recommendations for consideration by government departments. Alison McGuire – Deputy Manager, CSI-Europe/Principal Consultant Alison has extensive regulatory and research experience spanning over 19 years. Alison performs exposure and risk assessments for biocides, industrial chemicals and pharmaceuticals, and is actively involved in the technical aspects of REACH, in addition to working on biocide dossiers. Alison is an experienced analytical chemist and prior to joining CSI spent seven years managing and developing residue chemistry services at a major contract research organisation. Warren Scott – REACH Programme Coordinator/Senior Consultant Warren has more than 20 years' experience in laboratory contract research studies and business development for contract research organisations. He serves as CSI’s REACH programme coordinator and has accumulated considerable REACH experience fronting CSI’s activities as an only representative, third party representative and consortium secretariat.

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SERVICES PROVIDED Registration of chemicals in the EU The CSR regulatory team provides project management to ensure product approval and registration, and to build support and defence packages for product portfolios. We compile supporting data packages, including literature searches, reviews, and risk assessments. Services include: assistance with late pre-registration; establishing REACH IT accounts; preparation of registration dossier in IUCLID 5 format; preparation of chemical safety report, including exposure scenarios and risk characterisation; production of CLP compliant MSDS, including extended format; submission to and liaison with ECHA.

PROFILE: CS Regulator y Ltd

CONTACTS Web site

www.csregulatory.com

E-mail

helpline@csregulatory.com

Head office

The Old Courthouse, St. Peters Churchyard

Derby

Tel

+44 1332 380692

Fax

+44 1332 380692

Contact

Mr Steven Green

Directors

Mr Steven Green

Mr Craig Deegan

Ownership

Private company

Locations

Head office only

Founded

2007

Worldwide notification of chemicals Staff at CS Regulatory are extremely familiar with the requirement for the notification of chemicals to all notification schemes around the world, having worked with every national registration scheme and benefiting from a global network of independent regulatory experts to ensure that we are in possession of the very latest expert information. CS Regulatory has experience of preparing the notification dossier in the appropriate format to achieve notification, submitting the notification and corresponding with the appropriate regulatory authority directly from the UK or with the assistance of local expert consultants where necessary. Representative and support services

OVERVIEW CS Regulatory is an independent, privately owned organisation accredited to ISO 9001:2008 successfully providing regulatory assistance to suppliers of industrial chemicals throughout the world. Staff at CS Regulatory offer a combined experience of more than 30 years of professional experience within the industrial environment; we have the expertise to assist you with whatever chemical requirements you may have. With a network of strategic partnerships throughout the globe we can assist with EU registration for REACH and CLP purposes, worldwide notification of chemicals, representation of clients within Europe, production of associated chemical safety documents, liaison with authorities and product defence, advice on testing strategies and project management of data packages, acquisition of existing data and product stewardship. VITAL STATISTICS

2009

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Information 10% Admin/ management 15%

It can often be a competitive advantage to allow CS Regulatory to represent your company in Europe. Acting as only representative for non-EU suppliers or the third party representative for EU entities, CS Regulatory can undertake duties in a consortium and/or SIEF and efficiently manage the supply chain interactions, as needed. Acting as the representative, CS Regulatory can work in the SIEF and consortium on behalf of our customer, representing their best interests, minimising our customers workload and maintaining and retaining our customers' confidential business information. Data packages CS Regulatory has a wealth of expertise in providing regulatory consultancy services to industry. We can offer our clients detailed advice on provision of their chemical products into the worldwide marketplace. We ensure that provision of your products to your customer base within Europe and around the world is progressed rapidly to meet your business needs. We offer: product evaluation and gap analysis; literature and inventory searching; application of QSAR and in silico modelling to chemicals; read-across and grouping of chemicals; provision of expert reports for data waiving. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007

CS Regulatory established as an LLP

2007

Established a global network of expert regulatory consultants

2008

Incorporated as a private limited company

2009

Established the preferred partner agreement with LAB Research Inc

2009

First achieved the ISO 9001:2008 accreditation for all services, including registration

ACCREDITATIONS ISO 9001:2008 Consultancy/ advisory 75%

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CASE STUDY 3: Regulatory update reports

LAB Research Inc; preferred partner

During 2009 CS Regulatory received a number of enquiries from one of its clients on a wide variety of regulatory aspects. During a meeting with the client, CS Regulatory had an opportunity to discuss many of these regulatory issues with a view to obtaining a greater understanding of the client's business activities and the relevance of these various regulations to the variable product portfolio. It became clear from the discussions that one of the principal constraints on the client was its ability to conduct adequate product stewardship due, in part, to the diversity of the product range. Taking account of budgetary constraints, CS Regulatory's solution was to prepare a monthly overview of regulatory activity from a number of sources, providing only a short synopsis and a link to further information. The client could then simply review the brief synopsis and follow the link to obtain further information if the article was of particular interest or relevance. This allowed the client a quick and cost-effective solution to a diverse regulatory requirement.

CLIENTS Due to strict terms of confidentiality and the nature our business, CS Regulatory does not release the identity of customers. CS Regulatory work with and assist international blue chip companies and household names, as well as small and medium enterprises with their regulatory requirements. TESTIMONIALS Specific references can be provided to potential clients upon request CASE STUDY 1: Audit to determine compliance procedures CS Regulatory was approached by a client in the process of acquiring a going concern in the EU that supplied a broad range of products. As part of the purchase and for the purposes of due diligence, the client needed to understand business structure of the going concern and determine how readily the business could be incorporated into our client's business structure. The EU entity had an extremely diverse product portfolio with a wide range of products falling under a broad raft of EU regulations. CS Regulatory proposed a site audit of the EU entity, reviewing the product portfolio and systems in place followed by further investigations of the upstream and downstream supply chain, the status of product registration and hazard communication associated with the product line. CS Regulatory then prepared a report detailing the business structure of the going concern, the product lines and the regulatory and business aspects of the company. By means of a bespoke coding system that CS Regulatory included in the report, the client was able to easily and quickly understand the intricacies of the business and determine the regulatory priorities, the activities required in the future and optional activity as recommended by CS Regulatory. CASE STUDY 2: REACH registration and the use of QSAR to replace testing In early 2010 CS Regulatory was approached by a client with a series of related UVCB substances that were produced, supplied and used in the presence of a carrier solvent essential to maintain the structure and substance integrity. The substance had previously been reviewed by a consortium appointed consultant that had determined an absence of physico-chemical study endpoints and advised a test package on each substance in the range. Due to the extensive experience of CS Regulatory's staff, we very quickly determined that any of the physicochemical tests would be technically not feasible and/or meaningless due to the affects of the solvent. Working with the client's process chemists, CS Regulatory was able to prepare a detailed justification for waiving physico-chemical study data along with preparing QSAR for many of the environmentally significant endpoints by assessing multiple variations of each of the UVCB structures to prepare a weight of evidence for the purposes of risk assessment. With the IUCLID 5 registration dossiers prepared by CS Regulatory incorporating this strategy, the client successfully completed the lead registration for the 2010 deadline for all the substances including the waivers and QSAR endpoints and saved almost €1 million of testing costs.

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STAFF SELECTION Steven Green − Director Over a period of 19 years, Mr Green has successfully completed chemical registration submissions throughout the world, having negotiated with many regulatory authorities including EU member state authorities, NICNAS, JMETI, MHLW, JMAFF, KMoL and CRC SEPA. Mr Green is expert in regulatory strategy with an almost unique blend of regulatory assessment with clearly defined business principles which is essential to compliance with REACH. Craig Deegan − Director Mr Deegan has been working in the field of international regulatory affairs and health, safety and environmental consultancy for 17 years, incorporating development of testing strategies based on risk hierarchy, evaluation and interpretation of client specific requirements to ensure best value for clients with an interest in REACH. With detailed experience of practical application of risk management, Mr Deegan offers experience and knowledge that many regulatory consultancies lack. Claire Lowe − Registration Officer Mrs Lowe has been preparing regulatory documentation for eight years, preparing registration dossiers in appropriate formats for global compliance purposes, including IUCLID 5 format for REACH. Prior to joining CS Regulatory, Mrs Lowe worked in forensic compliance procedures, including the spectral analysis of drug formulations. Mrs Lowe now assists CS Regulatory's customers with regulatory compliance documentation for compliance with REACH. Ruth Green − Office and Administration Manager Mrs Green brings around 12 years of professional experience of document management and project coordination, having previously worked with two international chemical manufacturers. Mrs Green manages CS Regulatory's ISO 9001:2008 quality management system, whilst overseeing many of its only representative duties in compliance with REACH Article 8 and CS Regulatory's regular reporting programmes.

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PROFILE: CS Regulator y Ltd

PARTNERS

GLOBAL OFFICES Australia, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, India, Italy, Japan, Malaysia, New Zealand, Norway, Poland, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Thailand, UK, United Arab Emirates, USA, Vietnam.

PROFILE: DHI

CONTACTS Web site

www.tox.dhigroup.com

E-mail

dhi@dhigroup.com

Head office

Agern Allé 5

DK-2970 Hørsholm

Denmark

Tel

+45 4516 9200

Fax

+45 4516 9292

Contact

Jens Tørsløv

Directors

Asger Kej, CEO

Ownership

Not-for-profit organisation

Locations

Worldwide offices and operations

Founded

1964

SERVICES PROVIDED REACH registration services DHI offers REACH technical services, facilitation and moderation of consortia and SIEF activities, secretariat function, accounting/ bookkeeping, assessment and valuation of studies and preparation of testing proposals. In addition we act as an only representative (OR) for non-EU companies and fulfil all legal requirements pertaining to the registration process and updating. We further provide services related to authorisation, assessment of alternatives and SEA (via subcontracted specialist). Regulatory services and IT based support tools

OVERVIEW DHI is a global and independent research and development organisation dedicated to work within the fields of water, environment and health (including toxicology). Within these fields we provide a wide range of consulting, research and policy services as well as leading edge technologies and products. VITAL STATISTICS

2010

Turnover, group

€107m

Turnover, chemical service provision

€ 8.9m

No of offices

No of countries represented

Staff, group

950

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 3% IT & software 18% Laboratory 3% Admin/ management 1%

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Other 3% Consultancy/ advisory 72%

DHI facilitates company specific GHS strategies for global companies, and classification and labelling of chemical substances and mixtures. Preparation of safety data sheets and REACH exposure scenarios and IT tool for exposure scenarios. Training courses and webinars in CLP, SDS and consolidation of exposure scenarios. Provider of regulatory data for SDS software and chemical management systems including individual lists on classification, substance names, exposure limits, CAS and EINECS no, phrase modules with 3000+ phrases in more than 35 languages and translation of company specific phrases. Environmental and toxicological services Environmental and toxicological risk and safety assessments are applied in a large number of fields including the chemical industry, pharmaceuticals, biocides and pesticides, cosmetics, food and feed, consumer products, and medical devices. DHI provides technical services to cover all fields required for preparation of technical dossiers. This includes setting up test programme, conducting tests or liaison with CRO, study monitoring, interpretation of results, hazard assessment, exposure estimation and risk assessment. Environmental laboratory DHI offers laboratory services including: acute and chronic toxicity studies with organisms in water, sediment and soil; bioaccumulation and biodegradation studies including simulation tests; land-based testing for type approval of ballast water management systems; pigment and toxin standards for monitoring the composition and biomass of algal groups and the occurrence of toxic algae; analyses for monitoring phytoplankton; studies of leaching from waste and contaminated soil; wastewater studies related to physical/chemical and biological treatment processes. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1964

Danish Hydraulic Institute (DHI) founded

1973

Approved as Authorised Technological Service Institute by the Danish Minister of Sci, Tech and Innov

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

2001

Merge with Institute for the Water Environment (VKI)

2004

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

2004

Designated the World Health Organisation (WHO) Collaborating Centre for Water and Health

2005

Merge with Danish Toxicology Centre (DTC)

2007

Established the Environment and Toxicology unit

Chemical Watch | Service Providers Guide 2011

CASE STUDY 3: Derivation of environmental quality standards

Ecotoxicology tests: • accredited by DANAK, the Danish accreditation and metrology fund • OECD principles of GLP compliancy

To fulfil the regulatory requirements for a discharge permit of wastewater to the recipient, a Danish company asked DHI to derive environmental quality standards (EQS) for a number of known substances in the wastewater according to Technical Guidance for Deriving Environmental Quality Standards, draft September 2009. The derivation of EQS is based on information about water solubility, toxicity to aquatic organisms, toxicity to birds and mammal, human toxicology, biodegradability and natural occurrence. To fulfil the data requirements, DHI first performed a literature review. Further ecotoxicological data were obtained by testing the substances in the laboratories at DHI. The laboratory is authorised to carry out studies in compliance with the OECD principles of good laboratory practice (GLP), therefore tests were prepared and reported in compliance with the GLP principles. For substances not commercially available, a read-across approach was used to infer the properties of the substances based on the properties of closely related tested analogues. Finally, all the obtained data was used to derive the EQSs to be used in the discharge permit application.

PARTNERS Software: • Safeware Quasar Ltd • ECOonline Member of the GCC Network CLIENTS REACH: Novo Nordisk A/S, Danisco A/S, FeF Chemicals A/S, Chevron Products Company, Nickel Institute, Danish Environmental Agency, ECHA, Brenntag AG, Novozymes A/S, Rockwool A/S, Saint Gobain, Paroc Group, URSA insulation, Johns Manville, Halliburton, Owens Corning, Knauf Insulation SDS: Magna Industrial Company Ltd, Hong Kong; Statoil AB, Leo Pharma

STAFF SELECTION

CASE STUDY 1: REACH registration of MMVF note Q fibres, E-glass microfibre and non note Q fibres

Jens Tørløv, PhD (Ecotoxicity) – Head of Projects

DHI has successfully carried out the REACH registration of three different fibre types, namely MMVF note Q fibres, E-glass microfibre, and non note Q fibres. These registrations included preparing the lead registrant dossiers and company specific dossiers as well as submitting them to REACH-IT and following up on the registrations. Several spontaneous dossier updates have also been carried out when needed. Within these projects DHI has carried out all administrative and secretarial duties such as facilitation and moderation of consortia and SIEF activities; accounting/bookkeeping; and legal advice via sub-contractor. Furthermore, all the legislative as well as technical requirements of the registrations were done by DHI. The work included carrying out data-gap analysis; preparing robust study summaries; entering data to IUCLID; preparing chemical safety assessment and chemical safety reports; and creating exposure scenarios.

Karl-Heinz Cohr, MSc Biochemistry – Chief Toxicologist

CASE STUDY 2: e-SDS, extended safety data sheets DHI prepared e-SDS for a French company manufacturing substances. Data from the CSR provided by the client were analysed and incorporated directly into the customer’s SDS system. DHI prepared generic exposure scenarios to the CSR for 12 individual registration dossiers on nickel and nickel compounds. The ES was prepared in a format for communication in the supply chain. DHI is currently assisting a Danish company with preparation of consolidated exposure scenarios for preparations. The service is provided as a combination of training and workshop.

2004-2007 employed by the European Commission at European Chemicals Bureau, Italy, where he participated in the development of the technical guidance and tools assisting industry in complying with REACH. • extensive experience as project manager with references within REACH registration, risk assessment of chemicals, regulation of chemicals, industrial pollution control, capacity building, preparation and chairing of workshops and training programmes General experience in human toxicology, toxicological evaluations, exposure scenarios and risk assessments, and development of proposals for limit values (C-values, OEL, PDE, TDI). Special knowledge: • expert reports for the pharmaceutical and medico industries; • REACH including IUCLID, notification of new chemical substances, assessment and control of risks from existing substances; • mathematical modelling, eg QSAR and read across in risk assessment. Henriette Christiansen, BSc Chemistry – Business Area Manager With more than 13 years working with chemicals compliance Ms Christiansen has extended knowledge of the regulation of chemicals worldwide and software systems for chemicals compliance. Special knowledge: • extensive experience as project manager with reference to classification and labelling of chemicals, company specific GHS strategies, preparation of safety data sheets, chemical management and preparation and chairing of workshops and training programmes. Anja Kamper, MSc Biology – Laboratory Manager • ecotoxicological and biodegradability testing of chemicals in aquatic and terrestrial systems; • performance of laboratory studies according to OECD principle and good laboratory practice (GLP); • quality management, quality assurance and quality control of laboratory activities; • environmental risk assessment of chemicals and products; • development of environmental quality standards.

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PROFILE: DHI

ACCREDITATIONS

GLOBAL OFFICES Brussels Office (Belgium), At Beci – Brussels Enterprises Commerce and Industry, 500 avenue Louise, 1050 Brussels, Belgium SERVICES PROVIDED

PROFILE: EcoMundo

CONTACTS Web site

www.ecomundo.eu

E-mail

contact@ecomundo.eu

Head office

215 rue Jean-Jacques Rousseau, 92136 Issy-lesMoulineaux Cedex, France

Tel

+33 (0)1 83 64 20 56

Fax

+33 (0)1 34 29 60 35

Contact

Pierre Garçon

Directors

Pierre Garçon, Founder and President

Jean-Raphaël Miron, Associate

Private company

Issy-les-Moulineaux (France)

Locations

Brussels (Belgium)

Founded

September 2007

OVERVIEW EcoMundo is a consulting firm dedicated to compliance with chemicals regulations. Staff skills are mainly chemical engineering, toxicology and ecotoxicology, materials engineering, ecodesign and IT. Based in France, with a representative office in Brussels, the firm generates 80% of its turnover abroad. Our main activity is the preparation of technical dossiers under REACH. We act as only representative for exporters to the EU and manage several SIEFs and consortia. Other services include CLP compliance, safety data sheets management and SVHC traceability in the supply chain. Our specificity is the development of web-based tools adapted to companies’ needs. EcoMundo is an affiliate member of MMTA and SOCMA. We have established a solid network of relations with large international federations and official representations. VITAL STATISTICS

2010

Turnover, group

€1.5m

Turnover, chemical service provision

€1.5m

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 5% IT & software 20%

Consultancy/ advisory 40%

REACH Quality Assurance Manual www.ecomundo.eu/img/quality_assurance_manual.pdf CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Information 15% Admin/ management 20%

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REACH registration − REACH registration is the core activity of EcoMundo. We have dedicated teams made up of REACH managers, toxicologists and ecotoxicologists. They ensure the administrative and financial management of SIEFs/consortia and respect clear internal procedures that are compiled in a REACH quality assurance manual made available to the client. EcoMundo offers several REACH registration services: • SIEF/consortium manager: formation of SIEF and consortium, assistance to the LR, collection of data, registration strategy, optimisation through read across, constitution of joint and individual dossiers and chemical safety report if necessary. Full management up to 2018. • Individual dossier: representation of the registrant to the SIEF/ consortium, purchase of the letter of access, constitution of the individual dossier in IUCLID 5.2 format, creation of the individual chemical safety report if necessary. • Continuity manager: management of an existing consortium or SIEF until 2018: transfer of data to third parties, management of new required tests, attribution of letters of access, administrative and cost sharing tasks between registrants. CLP compliance − EcoMundo offers a two-step process: • Classification of substances and mixtures: data generation and reclassification if necessary. • CLP notification of substances: creation of the notification dossier in XML or IUCLID format and submission to the classification and labelling inventory of ECHA. CLP Factory − is a web-based tool developed by EcoMundo. It allows the classification of substances according to the CLP regulation and provides a IUCLID 5 notification dossier ready for upload to ECHA. SDS creation and management − The safety data sheet (SDS) is the main communication vehicle within the supply chain. EcoMundo offers complementary services: update of SDS to a REACH and CLP compliant format, creation of extended SDS based on expert assessment and official translation into any European language. SVHC management − EcoMundo helps downstream users detect possible SVHC in their products through efficient communication with their suppliers, inform their clients if necessary, anticipate substances that are most likely to be added to the candidate list, and substitute SVHC by less hazardous substances. SVHC Factory: is a web-based tool developed by EcoMundo that may be adapted to a company’s specific needs. It allows efficient communication with up to thousands of suppliers and ensures the calculation of SVHC concentration in concerned products. SDS Factory − is a web-based tool developed by EcoMundo that may be adapted to a company’s specific needs. It allows one to track and record SDS thanks to storage in a unique database, to transmit SDS throughout the supply chain via a secured internet access and to receive alerts for necessary updates.

2001

Pierre Garçon participates in the EDIT European project (Eco Design Interactive Tools) for the automotive sector

2003

Pierre Garçon participates in the ECODIS European project for electronics, mechanics and plastics industries

2007

Creation of EcoMundo by Pierre Garçon, Founder and President

Chemical Watch | Service Providers Guide 2011

Launch of the X-MAT and X-PRO , software for the management of environmental data and ecodesign

CASE STUDY 2: Creation and management of consortia for orphan substances: lead and nickel compounds

2008

EcoMundo develops high quality services to assist companies with REACH registration

2009

Diversifies services and launches REACH Factory, a suite of complementary web-based tools coupled with a dedicated expertise to make REACH compliance process easier for industrials: REACH communication, SVHC management, SDS updates and CLP compliance

2010

EcoMundo becomes a key actor in matters of REACH and CLP compliance at a European level

2010

EcoMundo realises 80% of its turnover abroad

2010

Submits more than 150 REACH registration dossiers and about 10,000 CLP notification dossiers

2011

Opens up to the global market with targeted actions in USA and Canada, Eastern Europe and India

In the context of REACH registration, numerous families of substances often end up being ignored by large consortia for economic reasons. Solicited by several industrials, EcoMundo created the Lead Across Platform (LAP) as well as the Nickel Across Platform (NAP) both aiming to assist companies with the REACH registration of lead and nickel compounds. As all lead compounds and some nickel compounds are classified CMR category 1 or 2, they had to be registered in 2010. EcoMundo managed the relevant SIEFs and drafted the associated REACH technical registration dossiers for ten substances and as many companies. Sharing of data and read-across strategies were optimised in collaboration with both the lead REACH consortium and the Nickel Institute. Finally, EcoMundo has been entrusted by metal industry leaders to handle the administrative and technical operation of the SIEFs up to 2018.

PARTNERS • Technical expertise to international law firms • Member of Minor Metals Trade Association (MMTA) • Partnership with CETIM, the Technical Center for the Mechanical industry • Liaised with the CRIQ, industrial Research Center from Québec in Canada • Member of the US Society of Chemicals Manufacturers & Affiliates (SOCMA) CLIENTS Both SMEs and large industrial groups trust EcoMundo as a reliable partner for their REACH compliance. Cosmetics: L'Oréal; Pharmaceuticals: San ofi-Aventis; Chemicals: Chemtura, Novasep; Electronics: Schneider Electric, Hager Group Metals trading: Steelinvest; Manufacturing: Fosbel Ceramic Technologies, Vishay, Anhybel, Steelcase, Glass Service; Aerospace: Lisi Aerospace Automotive: Plastic Omnium TESTIMONIALS "From the day we started our collaboration, EcoMundo took care of absolutely everything and we were very happy with the minimum involvement that was necessary from our side. All REACH registration dossiers were successfully drafted, respecting all deadlines and without any hidden costs" − Steelinvest "The expertise and constant effort shown in completing our submissions were extremely timely and without flaw" − Fosbel Ceramic Technologies CASE STUDY 1: Reduction of studies costs in the context of REACH registration The cost of studies is often the largest expenditure in REACH registration. In one instance, EcoMundo was confronted with costs approaching €2 million for the purchase of private data. Prolonged negotiations, conducted in parallel with the build up of a detailed strategy to reduce costs for the client, succeeded in bringing down the original demand to less than one fourth of the original cost. This negotiation demonstrated one of EcoMundo’s valuable assets: the ability to negotiate and act as an efficient and trustful intermediate. For the generation of data required for the registration dossier, EcoMundo experts’ objective is always to fill the gaps in information while minimising cost and time. For toxicological and ecotoxicological properties, readacross and waiving opportunities are investigated before considering new tests in laboratories.

Chemical Watch | Service Providers Guide 2011

CASE STUDY 3: Development of a specific web platform for SVHC management Article manufacturers are to inform their clients of the presence of SVHC in articles if the concentration is superior to 0.1%. This implies that all manufacturers of articles must check the composition of their components by contacting their suppliers. In the case of a large multinational company in the electronics sector needing to contact all of its suppliers regarding sensitive information, EcoMundo took care of the entire communication process at an international level. Interacting with IT and engineering staff, EcoMundo developed a specific web platform giving suppliers the means to communicate data upon the client’s request. Substances were classified into categories of industrial applications. The suppliers’ response rate was more than satisfying as 90% of them responded to EcoMundo’s SVHC request. To optimise results, EcoMundo also guided the company in identifying critical components to rapidly reduce the risks of having SVHC. Finally, EcoMundo is able to anticipate the substances that will soon be added to the candidate list 18 to 24 months in advance, to avoid contacting suppliers every six months. STAFF SELECTION Pierre Garçon – Founder and President Before creating EcoMundo, Pierre Garçon held senior positions in software publishing companies and founded the West Valley Company which was successfully introduced on the free stock market in France. He directed multidisciplinary teams in large European research projects. Today as president of EcoMundo, Pierre Garçon focuses on building international partnerships in North America, Eastern Europe and India. Jean-Raphaël Miron – Technical Director As a senior consultant, Jean-Raphaël Miron has been involved in ecodesign and multimedia IT development for more than 15 years. Today he supervises the information technology team at EcoMundo and ensures the development of web-based platforms and software specifically conceived for clients. André Clodong – European Union Representative After a 15 year career in a large US industrial corporation in Canada and Europe, André Clodong became a European affairs adviser in the aerospace, chemical, energy and transport sectors. Today he is head of EcoMundo’s office in Brussels, and is dedicated to building a solid network with European federations and official representatives. Rinus Bogers – PhD Toxicologist A member of Eurotox for over ten years, Dr Rinus Bogers has more than 20 years of research experience in environmental toxicology and risk assessment. Today he manages EcoMundo’s team of experts in toxicology and ecotoxicology, in charge of the entire REACH registration process: registration strategies, read-across proposals, exposure and risk assessment, chemical safety reports management, etc. Page 57

PROFILE: EcoMundo

2007

GLOBAL OFFICES Australia, Belgium, Brazil, Canada, China, Finland, France, Germany, Hong Kong, Italy, Malaysia, Poland, Russia, Singapore, Spain, The Netherlands, United Kingdom, United States

PROFILE: ENVIRON

CONTACTS

SERVICES PROVIDED

Web site

www.environcorp.com

E-mail

sbullock@environcorp.com

Head office

5 Stratford Place

London

W1C 1AX, UK

Tel

+44 20 7478 9800

Fax

+44 20 7478 9801

Contact

Sue Bullock

Directors

172 partners worldwide, including

Jose Fernandez (F), President Europe

Sue Bullock (UK), Aidan Turnbull (UK)

Henk Verhaar (NL), Joseph Rodricks (US)

Comprehensive consultancy support for REACH, and parallel European chemical regulation (CLP, biocides, agrochemicals, cosmetics, medical devices, etc) Expertise and experience: technical dossier and CSR preparation; strategy development and implementation; SVHC support for identification and regulation; only representative; third party representative; supply chain management and communication (including ext-SDS); downstream user compliance; consortium management; product audit and due diligence; vigilance and tracking policy development; classification and labelling, management of laboratory testing. Risk assessment troubleshooting, preparation of dossiers and product authorisation (plant protection products and biocides). ENVIRON: balancing technical, regulatory and commercial interests. Innovative solutions and integrated testing strategies. Independence from testing facilities.

Martina Vosteen (DL) Ownership

Private limited company

Locations

Over 80 offices worldwide

Founded

1982

Global chemical notifications and regulatory compliance support

OVERVIEW An international health, environmental, safety and sustainability consultancy, ENVIRON works with clients to resolve their most demanding environmental and human health issues. Our global product safety and regulatory compliance team helps companies gain regulatory approval for products to comply with chemical regulations around the world. Beyond this, we assist industry leaders and innovators alike to provide effective product stewardship programmes to manage risk, reduce liability and enhance support from stakeholders. Striving always to be 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

2010

Turnover, group

€177m

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

1,200

Staff, chemical service provision

Expertise and experience: evaluating regulatory obligations across Asia-Pacific, America, Europe and Africa; assessing new market opportunities; substance notification and regulatory obligations; classification and labelling (GHS); packaging. ENVIRON: established global network including Argentina, Australia, Brazil, California, Canada, China, Europe, India, Japan, Korea, Malaysia, Mexico, New Zealand, Philippines, Russia, Singapore, Switzerland, Taiwan, Turkey, US. Product stewardship, expert technical support and troubleshooting Expertise and experience: toxicology; epidemiology; exposure modelling; exposure measurement (and exposure reconstruction); toxicokinetic modelling; ecotoxicology, chemistry, environmental fate, regulatory affairs, risk mitigation (industrial wastewater treatment, air emission management); industrial hygiene; supply chain management; product vigilance and advocacy. ENVIRON: client-focused solutions. Internationally recognised expertise and reputation as leader in risk management. BOMCheck Substances declarations web database for REACH, RoHS, batteries and packaging compliance to facilitate supply chain management. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2010

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

SERVICE AREA BREAKDOWN Admin/ management 10%

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Laboratory 5% Consultancy/ advisory 85%

Chemical Watch | Service Providers Guide 2011

Industrial and specialty chemical industry Petrochemical industry Agrochemical industry Food and food packaging industry Cosmetic industry Medical devices industry Electronics industry Manufacturing industry TESTIMONIALS “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 rapidly integrated into our global REACH team to add excellent technical expertise, and provide timely REACH knowledge for registration, CLP and SIEF management. ENVIRON is very well organized to be efficient, cost effective and delivers results as expected” – James E Mumby PhD, Global Director Product Stewardship and Regulatory Affairs, Elementis Specialties Inc “Philips has decided not to receive REACH compliance information individually from each of our suppliers each time a new list is published. Instead, we require all of our suppliers to comply with these REACH obligations by joining ENVIRON’s www.BOMcheck.net web-based substance declaration system” – Jan-Willem Scheijgrond, Senior Director Environment, Health and Safety at Philips Corporate CASE STUDY 1: REACH dossier and CSR preparation for a group of SVHCs ENVIRON prepared REACH dossiers and CSRs for a group of high profile hazardous organic substances with potential endocrine disrupting properties and a wide use pattern. ENVIRON provided robust and comprehensive dossiers while balancing the effort associated with registration through use of read-across, weight-of-evidence, QSAR and waiving (including exposure-based waivers). ENVIRON developed and implemented original methods to refine chemical fate and exposure parameters (eg dermal penetration, biotic degradation, dissociation coefficient). CSAs were prepared using ECETOC TRA and CHESAR based on carefully defined exposure scenarios developed with regard to available exposure data and information from downstream users to provide CSRs that were accessible and useful to both registrants and their customers alike. CASE STUDY 2: Global regulatory compliance for a new consumer product ENVIRON evaluated regulatory obligations in more than 50 counties – considering chemical notification, packaging and labelling requirements – for a company wishing to market a product globally. The review allowed identification of key market opportunities. ENVIRON then prepared notifications for priority countries, including identification and management of local representative to file documents, as needed. CASE STUDY 3: New exposure data drives increased regulatory scrutiny Several biomonitoring studies have reported detectable levels of perfluorooctanoate (PFO) in the blood of the general population. This has led to increased regulatory scrutiny of potential exposures to PFO in the environment and in consumer articles. As part of its product stewardship programme, a multinational company asked ENVIRON to evaluate the contribution of exposure to PFO from certain consumer articles (including treated carpets, clothing, upholstery and non-stick cookware) to total PFO exposure for the general population. Based on an analysis of data generated to support the exposure assessment, ENVIRON quantified the magnitude of potential

Chemical Watch | Service Providers Guide 2011

PFO exposure for consumers of these products in the home, in school or at work. Our assessment concluded that, based on the toxicity criteria derived by our expert toxicologists, exposure to these products in the consumer environment is not expected to contribute appreciably to PFO levels in the blood of the general population, or to cause adverse human health effects. CASE STUDY 4: Responding to the threat of regulatory action related to product contamination Our client, a food packaging producer, faced possible regulatory action associated with residual levels of a contaminant (a potential carcinogen) in a key product. Using an integrated approach – involving expert determination of a safe intake level (DNEL), analysis of available exposure information and development of refined exposure models – we demonstrated that consumer exposure to the contaminant from handling the packaging and ingesting the packaged foods were within safe levels. Through partnership with our client and thoughtful evaluation of the problem, we provided a robust and defensible approach that informed important strategic decisions for the business, including product viability, consumer perception and communications, as well as supporting product regulatory notifications STAFF SELECTION Sue Bullock – Principal, Product Safety and Regulatory Compliance Leading ENVIRON's product safety and regulatory compliance services, for 20 years Sue has provided strategic, regulatory and technical assistance to industry relating to presence of chemicals in the environment, the workplace and consumer products. A physicist, she has an extensive knowledge of REACH and helps companies around the world comply with global chemical regulations, assess and manage health and commercial risks, and deliver effective product stewardship across the supply chain. Dr Henk Verhaar – Principal, Chemist and Ecotoxicologist 20 years' experience in modelling the fate of chemicals in the environment and assessing and predicting their ecotoxicity. His work on predictive aquatic toxicology has been widely used in Europe and the US during the development of hazard assessment models for chemicals in the aquatic environment. His fields of expertise also include derivation of safe exposure levels and environmental statistics. Dr Verhaar has extensive experience as a troubleshooter on chemical and ecotoxicological matters. Dr Martina Vosteen – Principal, Chemist and Product Safety Dr Vosteen has more than ten years of experience as a consulting chemist, including coordination and management of hundreds of risk assessments regarding product and environmental liability (financial losses) particularly for the chemical, pharmaceutical, medical devices and food industries. She has acted as technical/scientific expert in several product liability cases and advises the industry in relation to REACH and other product regulatory relations (cosmetics, pesticides, etc). Dr Joe Rodricks – Principal, Toxicologist An internationally recognised expert in the field of toxicology and risk analysis and their uses in chemical regulation, management and stewardship. Since 1980 he has consulted for hundreds of manufacturers, for government agencies and for the World Health Organisation. He has served on 15 boards and committees of the National Academy of Sciences and the Institute of Medicine.

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PROFILE: ENVIRON

CLIENTS

GLOBAL OFFICES Global head office (Exponent Inc): 149 Commonwealth Drive, Menlo Park, CA 94025, USA Other UK office: 1 Pride Point Drive, Pride Park, Derby, DE24 8BX, United Kingdom Switzerland office: Aeschenvorstadt 57, Basel, 4051, Switzerland

PROFILE: Exponent International Limited

CONTACTS Web site

www.exponent.com

E-mail

jreddy@uk.exponent.com

SERVICES PROVIDED General REACH services

Head office The Lenz, Hornbeam Business Park Â

Harrogate, North Yorkshire, HG2 8RE

United Kingdom

Tel

+44 (0)1332 868000

Fax

+44 (0)1332 868099

Contact

Julian Reddy

Directors

Head of REACH and Chemical Notification Services

Ownership

Wholly owned subsidiary of Exponent Inc.

Locations

Derby, UK; Basel, Switzerland

Founded

2002

Exponent's consultants have significant experience in the provision of a wide range of REACH support to our clients. These services include initial work such as regulatory strategy and advice, data evaluation and the use of intelligent testing strategies. We can also place and monitor studies, prepare and submit registration dossiers and chemical safety reports and provide post-submission support during evaluation and authorisation. Exponent has significant experience in programme and project management and SIEF and consortia management and we can also act as your only representative or third party representative. Preparation of REACH registration dossiers and chemical safety reports

OVERVIEW Exponent Inc 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 unparalled technical expertise with the ability to focus this knowledge to meet our client's 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

2009

Turnover, group

US$7million

Turnover, chemical service provision

US$3million

No of offices

Exponent prepared in excess of 45 complete lead registrations for phase-in substances during 2010. We can complete all aspects of the process such as data evaluation and data gap analysis, determination of substance identification, use of intelligent strategies to address data gaps and study placement and monitoring. We can complete all of the IUCLID 5 dossier and the chemical safety report including exposure assessments, using ECETOC TRA and higher tier models if necessary, and risk characterisation. Once the assessments have been completed we can produce the final exposure scenario and produce extended safety data sheets. Global chemical notifications Our consultants have considerable experience in compiling and submitting chemical notifications worldwide; utilising our team of consultants we are capable of preparing and submitting chemical notifications to all countries that have a relevant scheme. We can prepare and submit dossiers for Australian, Canadian, New Zealand and Swiss registrations and use our Swiss office to act as a sole representative. We have a network of local agents to help with the preparation and submission of regulatory documentation in China, Japan, Korea, Philippines, Taiwan and Turkey and can utilise the experience of our US colleagues for TSCA notifications.

No of countries represented

Other regulatory regimes

Staff, group

Staff, chemical service provision

Exponent's consultants have significant experience in assisting clients with EU agrochemical, biocide and food regulatory requirements. For agrochemicals and biocides 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 for food additives, contact materials, novel foods and health claims.

SERVICE AREA BREAKDOWN Training 2% Information 5%

Other 3% Consultancy/ advisory 55%

CORPORATE DEVELOPMENTS & ACHIEVEMENTS Admin/ management 35%

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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

Chemical Watch | Service Providers Guide 2011

ISO 9001 accreditation 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 over 5,000 clients and Exponent International has undertaken work for over 300 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 a number of industries including industrial chemical, speciality and fine chemical, petrochemical, agrochemical, cleaning and maintenance products, metals, organometallics and plastics. 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 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 established specifically for REACH. Exponent performed the initial technical work required for the 16 substances that needed to be registered in 2010 such as the identification of data gaps, use of intelligent testing strategies to address gaps and, where necessary, placing and monitoring of studies. Exponent was also responsible for the production of the registration dossiers (both lead and non-lead) in IUCLID 5 including appropriate data waivers and testing proposals. For the production of chemical safety reports, Exponent took responsibility for working with consortium members to identify downstream uses that needed to be considered and proposing use descriptor codes for exposure assessments and the production of exposure scenarios. Liaison with a number of companies, both inside and outside the consortium, was necessary to obtain vital information to ensure that all uses were considered and that appropriate safe uses were demonstrated. Creative, but pragmatic, solutions were sometimes necessary to demonstrate safe use. Exponent's technical capabilities and support ensured that all 2010 consortium substances were registered ahead of the deadline. CASE STUDY 2: Product stewardship service for a SME Exponent has provided ongoing product stewardship support for a catalyst manufacturer, covering REACH and other global chemical regulatory regimes, for three years. Taking a holistic approach, we provide global regulatory strategy and advice to ensure that regulatory requirements from a number of countries can be effectively overlapped. Exponent also provides more technical support by preparing and submitting regulatory documentation for REACH and other chemical notifications, preparing and reviewing European safety data sheets and determining 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.

Chemical Watch | Service Providers Guide 2011

By being able to consider all global areas at once and not in isolation, we are able to ensure that our client’s regulatory requirements can be effectively met and ensure that their regulatory burden is kept to a minimum. CASE STUDY 3: Vulnerability analysis for cleaning and maintenance product manufacturer Exponent assisted a global cleaning and maintenance product manufacturer with their REACH preparations by performing a vulnerability analysis on the company's raw materials to identify their REACH obligations and responsibilities. Using the company's own database, each of their raw materials was assessed against a number of criteria to determine their position in the REACH process and whether they could be considered as being out of scope of registration and if so why. Substances that were considered to be in scope were then assessed against a number of criteria established to determine what obligations the company may have under REACH, what the priority of those obligations should be and the risk that failing to comply with REACH would have to the company's business. These criteria were rated using a scoring system developed by Exponent and our client and recorded and analysed using a relational database. Actions and conclusions were proposed by Exponent for the company to consider and implement to ensure its REACH compliance and reduce the risk to the business from the REACH legislation. 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 has published papers on a range of subjects including dietary risk assessment, infant and child exposure to pesticide residues and risk perception. She 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. Julian Reddy – Head of REACH and Chemical Notification Services Mr Reddy is an experienced regulatory project manager and has supervised complex testing and regulatory programmes undertaken on industrial chemicals and biocides. In addition, he has particular experience of Asian chemical notification schemes. Mr Reddy manages Exponent’s Derby office which specialises in REACH and the global notification of industrial chemicals. He is responsible for the management of individual projects as well as overall programme management for clients and consortia. John Hislop – REACH Regulatory Specialist Mr Hislop specialises in REACH and particularly the registration requirements for phase-in substances. He also has more than 16 years of experience working on global notifications of new chemical substances. Mr Hislop has considerable experience in development of testing programmes for chemicals for regulatory purposes, specialising in the use of an 'intelligent approach' to safety testing and is a leading advocate of the principle of read-across approach. Dr Alec Willis – REACH Regulatory Specialist Dr Willis leads Exponent’s capabilities for chemical safety reports and exposure scenarios. He has experience in SIEF management, production of registration dossiers and SIEF and consortia representation for client. He has also helped clients across a range of industries prepare for REACH by providing regulatory strategy and advice and performing vulnerability analysis. Dr Willis is an experienced project manager, managing a large number of multi-disciplinary REACH projects.

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PROFILE: Exponent International Limited

ACCREDITATIONS

PROFILE: Harlan

CONTACTS Web site

www.harlan.com

E-mail

crs.uk@harlan.com

Head office

8520 Allison Pointe Blvd Suite 400

Indianapolis, IN 46250

USA

Tel

+44 1332 792896

Fax

+44 1332 799018

Contact

Suzi Hill

Directors

Hans Thunem

Dr Kuno Sommer

Ownership

Private company

Locations

France, Germany, Israel, Italy, Japan, Korea,

Mexico, Netherlands, Spain, Switzerland, UK

Founded

1930

OVERVIEW Harlan Laboratories is a global leading provider of essential, nonclinical contract research, research models, animal diets, and services to the pharmaceutical, biotech, medical device, agrochemical, and chemical industries, as well as to academic and government research organisations. Our focus is on providing customers with products and services to optimise the discovery and safety of new medicines and compounds. Understanding the value of close relationships and collaboration with our costumers we act locally. Stability, reliability, consistency, and quality are what Harlan Laboratories offers with decades of proven expertise in both research models and services, and contract research services. As important as good customer service and relationships are, though, it’s really all about scientific excellence. Today, research is increasingly being outsourced, and researchers need to have confidence in their supplier partners. Stability, reliability, consistency, and quality are all essential. That’s what Harlan Laboratories offers with our passion for science and decades of proven expertise in both research models and services, and contract research services.

Products and services Harlan is made up of two major business units offering local expertise, presence, service, and state-of-the-art facilities in all of the countries it serves. Contract Research Services provides non-clinical and pre-clinical laboratory research services supported by state-of-the-art facilities worldwide. Our core capabilities are in: • discovery services; • toxicology, genetic toxicology, and ecotoxicology services; • drug metabolism and pharmacokinetics; • regulatory affairs, consulting, and programme management; • analytical chemistry; • chemical and agrochemical registration; • environmental fate and modelling; • in vitro alternative testing. Research Models and Services provides high-quality research models such as rodents and large animals, and support services worldwide. • research models; • animal diets; • bedding and enrichment products; • surgical services; • transgenic services; • genetic testing services; • health monitoring services; • custom antibody production; • flexible film isolators; • transportation services. VITAL STATISTICS

2009

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

2,800

Staff, chemical service provision

800

SERVICE AREA BREAKDOWN Consultancy/ advisory 30% Laboratory 50%

Admin/ management 20%

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Chemical Watch | Service Providers Guide 2011

GLOBAL OFFICES Harlan Laboratories Ltd, Shardlow Business Park, London Road, Shardlow, Derbyshire, DE72 2GD, UK SERVICES PROVIDED REACH testing Harlan Laboratories can offer all standard and higher-tier studies in the fields of physical chemistry, toxicology, genotoxicology, ecotoxicology, environmental fate and alternative testing. All tests required by REACH Annex VII to X are conducted by our experienced study directors in modern testing facilities. Registration

PROFILE: Harlan

In a world of an ever-increasing number of chemical control schemes, our registration services team plays a vital role in the registration of our clientsâ&#x20AC;&#x2122; products. Our turnkey service, from the initiation of a project to preparation of the final dossier, ensures regulatory compliance. With nearly 3,000 regulatory projects successfully completed in the last 20 years, Harlan Laboratories has extensive experience of chemical control schemes worldwide. This experience, plus an excellent rapport with the regulatory agencies, ensures a successful outcome for your project. Physico-chemical testing Harlan Laboratories is a leading provider of physico-chemical and storage stability testing services. We are able to offer a full range of services, including full hazardous properties and explosive testing services that meet internationally recognised guidelines required for the chemical, agrochemical, biocidal and pharmaceutical industries. Our facilities operate to GLP requirements but can conduct studies without GLP compliance. We are able to operate in a principal investigator role with multi-site studies, if necessary. Ecotoxicology Located in purpose-built facilities, the Harlan Laboratories environmental science team has extensive experience and expertise in a wide range of ecotoxicity (aquatic and terrestrial), biodegradation, analytical and physico-chemical tests, environmental fate (lab and field), animal (ADME, DMPK, PK screening and toxicokinetic testing) and plant metabolism studies for the chemical, agrochemical and pharmaceutical industries.

Chemical Watch | Service Providers Guide 2011

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GLOBAL OFFICES London, United Kingdom; Brussels, Belgium; Moscow, Russian Federation; Rio de Janeiro, Brazil; Ottawa and Toronto, Canada; Beijing, China; New Delhi, India; Fairfax, Virginia, USA SERVICES PROVIDED REACH business strategy consulting

PROFILE: ICF International

CONTACTS Web site

www.icfi.com/reach

E-mail

reach@icfi.com

Head office

9300 Lee Highway

Fairfax, VA 22031

USA

Tel

+1 703 934 3000

Fax

+1 703 934 3740

ICF International’s experience in helping major organisations meet the December 2010 registration deadline gives us the perspective to help you decide if and how to participate in REACH. Given information on the number and types of products you currently or would like to market in the European Union, ICF can provide you with an understanding of the scope and cost of meeting REACH requirements and the downstream impacts on your business processes. In addition, we can help you understand and implement confusing and complicated REACH requirements and help organisations participate in substance information exchange forums (SIEFs) or consortia.

Contact

Stephanie Barrett +32 485 319 961

Operational support to SIEFs and consortia

Directors

Sudhakar Kesavan, Chairman and CEO

John Wasson, President and COO

Isabel Reiff, Executive Vice President

Ronald Vargo, CFO

Ownership

Public company (NASDAQ:ICFI)

Locations

UK, Belgium, Russian Federation, China,

India, Brazil, Canada, USA

REACH requires companies to share available information, and many have formed REACH consortia to leverage resources and collaboratively evaluate classes of chemicals. ICF International has award-winning experience supporting active REACH consortia and SIEFs, helping to ensure each programme is well organised and all the details and challenges are addressed using state-of-the-art IT tools. ICF and our partners focus on achieving the most important objective: complying with the REACH requirements as efficiently, accurately, and quickly as possible.

Founded

1969

Science support ICF International has more than 30 years of experience and more than 200 scientific staff focused on toxicology, chemistry/environmental fate, exposure assessment, risk characterisation, and risk management. Our experts have applied this knowledge and experience in preparing chemical dossiers and safety reports that meet the specific requirements of REACH. Examples of support we can provide include assisting with classification and labeling, preparing dossiers including chemical safety assessments/reports, helping with safety data sheets, conducting exposure scenarios. See our website for more services provided.

OVERVIEW ICF International partners with government and commercial clients to deliver professional services and technology solutions in the energy and climate change; environment and infrastructure; health, human services, and social programmes; and homeland security and defence markets. The firm combines passion for its work with industry expertise and innovative analytics to produce compelling results throughout the entire programme lifecycle, from research and analysis and design through implementation and improvement. Since 1969, ICF has been serving government at all levels, major corporations, and multilateral institutions. More than 3,500 employees serve these clients worldwide. VITAL STATISTICS

2009

Turnover, group

US$674m

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

3,700

Staff, chemical service provision

SERVICE AREA BREAKDOWN Consultancy/ advisory 100%

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Business process improvement Economic challenges combined with the new REACH requirements are leading organisations to streamline their operations. Organisations complying with REACH have opportunities to improve existing business processes and develop new ways to respond to new and emerging REACH data requirements. ICF International can help determine the most effective strategies for dealing with these changes and align business processes, resources, and people to support your organisational mission. ICF has worked with clients for years to evaluate, design, reengineer, and implement business processes and information management strategies. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2010

Environmental Finance Market Survey – Best Advisory/ Consultancy EU Emissions Trading

2010

Environmental Finance Market Survey – Best Advisory/ Consultancy Kyoto Project Credits

2010

Environmental Finance Market Survey – Best Advisory/ Consultancy North American Mandatory Markets

2010

Environmental Finance Market Survey – Best Advisory/ Consultancy Renewable Energy Finance North America

2010

Environmental Finance Market Survey – Runner Up Best Advisory/Consultancy Renewable Energy Europe

2010

Environmental Finance Market Survey – Runner up Best Advisory/Consultancy SO2 and NOx Markets

Chemical Watch | Service Providers Guide 2011

Environmental Finance Market Survey – Best Advisory/ Consultancy Voluntary Markets

2010

REACH outstanding project contributor by a major European consortium

2010

Rank #76 on Forbes America's Best Small 100 Companies

2010

Companies As Responsive Employers (CARE) award

2010

Northern Virginia Technology Council green award

2009

Software Engineering Institute (SEI) Capability Maturity Model Integration (CMMI) Level 3 designation

ACCREDITATIONS CMMI Level 3 designation Project Management Institute global executive council Project Management Institute registered education provider PARTNERS Penman Consulting BVBA ICF’s partnership with Penman Consulting enables us to provide an even more complete range of REACH services to our clients. CLIENTS A major American chemical industry trade association Several petrochemical and refining industry REACH consortia (subcontractor to Penman Consulting) A major REACH consortium in the metals industry A major international chemical company and many more... TESTIMONIALS Recognised on REACH project as Outstanding Contributor by a REACH consortium for a major European trade association in December 2010 Recognised in December 2010 by a major REACH consortium for excellence in operational management on the 2010 REACH registrations from 2008-2010 CASE STUDY 1: REACH consortium operational and SIEF support ICF International has provided comprehensive program management and SIEF management support for several major REACH consortia since 2008. These consortia represent hundreds of member companies and high-volume substances. ICF's operational support includes supporting and managing communication among consortia members, providing meeting support, managing consortia websites and data portals, and managing the dossier production and consortium review and approval processes. ICF also provides SIEF management services, addressing thousands of technical, policy, regulatory, and process enquiries from SIEF participants. ICF International also supported consortia in setting data sharing and data access costs and policies and communicating these and technical information to SIEF members for each substance within the scope of the consortia and working with the consortia legal teams and technology platforms to provide, disseminate and collect revenues from letters of access. CASE STUDY 2: IUCLID data entry and dossier preparation ICF International has provided comprehensive technical support for dossier preparation in advance of the 2010 substance registration deadlines for several European-based chemical consortia. ICF managers, toxicologists and exposure scientists worked collaboratively to produce hundreds of dossiers for REACH registration in 2010. Substances included organic chemicals and metal compounds. Each dossier includes summary information on production, use, physical and chemical properties, environmental fate, ecological effects, human health effects, exposure, and risk management. ICF provided detailed technical support for more than 100 dossiers and other support for more than ten percent of the dossiers submitted for the 2010 REACH registration. ICF’s technical Chemical Watch | Service Providers Guide 2011

responsibilities included data collection, literature review, data preparation and entry into IUCLID, mapping of lifecycle stages for industrial chemicals, identification of exposure scenarios, exposure modelling using REACH-IT tools such as ECETOC TRA, risk characterisation, and preparation of various other documentation needed for registration. ICF also reviewed articles to determine if a substantial human sensitisation response could be anticipated following exposure to high-volume substances. CASE STUDY 3: Classification and labelling ICF International has made classification and labelling recommendations for hundreds of industrial chemicals for several European-based chemical consortia and international chemical companies. ICF’s experience using read-across strategies and weight-of-evidence arguments has provided our clients with recommendations in accordance with CLP and GHS regulations. ICF’s classification and labelling recommendations have been used to populate safety data sheets in the United States and Europe and have also been incorporated into REACH chemical registration dossiers. ICF reviews previous classifications under other regulations combined with references from comprehensive literature searches and proprietary studies supplied by the client. Toxicokinetic, acute, subchronic, chronic, irritation, sensitisation, carcinogenicity, mutagenicity, reproductive toxicity, developmental toxicity, physicochemical, environmental fate, and ecotoxicity data are then objectively analysed to identify critical effects, data deficiencies, and NOAELs or LOAELs. When reliable data on a specific substance are lacking or the available data reports conflicting results, ICF scientists have used expert judgment and weight-of-evidence arguments to make classification recommendations. STAFF SELECTION Robert Hegner, PhD – Senior Vice President Dr Hegner has more than 35 years of experience in programme management, risk analysis, and original research. His risk analysis experience includes developing the Air Toxics Risk Assessment reference library for the US EPA and assisting in the agency's initial efforts to develop a framework for ecological risk assessments. He has published more than 20 peer-reviewed research papers on the endocrine and environmental regulation of complex vertebrate reproductive cycles. Jay Hadley – Vice President Mr Hadley has more than 16 years' experience implementing environmental, health and safety (EHS) policies, programmes, and related information management and compliance solutions. He has led numerous technology projects with multinational organisations, including ExxonMobil, Chevron, and Shell. At ICF, Mr Hadley oversees the delivery of information technology (IT) projects in areas such as sustainability, climate change, REACH, regulatory compliance, and product stewardship. Stephanie Barrett – Senior Manager Ms Barrett, based in ICF's Brussels, Belgium office, has almost 15 years of experience in environmental policy and regulatory analysis and project management. Ms Barrett's educational background includes environmental policy, environmental law, and geology coursework. Her professional experience includes REACH consortium project officer and SIEF facilitation support. Ms Barrett manages projects, budgets, and staff to ensure that client needs are met on time and within allocated resources. Rebecca Kauffman – Manager Ms Kauffman, based in Malmö, Sweden, has more than 12 years of professional experience in project management, environmental science, technical analysis, and communications. She served as the project officer for the LOA REACH consortium from 2008-2010, and was responsible for managing the day-to-day operations for the members and service providers and thus was on the forefront of developing solutions to complex technical, legal, and operational issues for REACH. Page 65

PROFILE: ICF International

2010

PROFILE: IHS (Atrion has been acquired by IHS)

GLOBAL OFFICES 4777 Levy Street, St. Laurent, Quebec, Canada H4R 2P9 Oranjesingel 34, 6511 NV Nijmegen, The Netherlands 9 Monroe Parkway, Suite 150, Lake Oswego, Oregon 97035, USA

IHS has acquired Atrion International

SERVICES PROVIDED

CONTACTS

Solutions for enterprise sustainability management

Web site

www.ihs.com/ehs-sustainability

E-mail

productcompliance@ihs.com

Head office

15 Inverness Way, East

Englewood, Colorado 80112

USA

Tel

+1 5033036544

IHS has been helping organisations achieve their EHS and sustainability goals for decades by delivering a unique combination of software, content and expertise in a comprehensive suite of enterprise sustainability management solutions. These solutions address critical business challenges around product stewardship and compliance, environmental compliance, health and safety compliance, energy and greenhouse gas management, risk management and corporate responsibility.

Fax

+1 5036353824

IHS product stewardship and compliance solution

Contact

Trish Jones

Directors

Jerre Stead, Chairman and CEO

Eugene "Woody" Ritchey, Vice President, Environment, Health, Safety and Sustainability

Scott Lockhart, Vice President, EHS and Sustainability Solutions

This powerful solution helps companies ensure supply chain continuity, while protecting access to key markets. In today’s increasingly complex regulatory landscape, companies need to take a strategic approach to regulatory management. IHS solutions for product compliance and regulatory document authoring enable organisations to comply with current and future regulatory challenges while recognising cost savings and reducing risks.

Ownership

Publicly traded company (listed on NYSE)

Managed regulatory content

Locations

Offices in 30 countries

Founded

1959

OVERVIEW IHS is a leading source of information and insight in pivotal areas that shape today’s business landscape: energy, economics, geopolitical risk, sustainability and supply chain management. IHS is also the leading provider of information management solutions for environmental, health and safety compliance and sustainability reporting. As part of our commitment to help organisations comply with regulations such as REACH, GHS and RoHS, IHS acquired Atrion, a marketleading company that combines expertise and technology to streamline hazardous materials communication, to strengthen its existing product stewardship offerings. Integrating Atrion software and services into IHS industry-leading solutions enables our clients to efficiently address product stewardship and chemical management issues, as part of a broader programme to achieve enterprise sustainability management. VITAL STATISTICS

2010

Turnover, group

US$1.075bn

Turnover, chemical service provision

n/a

No of offices

165

No of countries represented

Staff, group

4,400

Staff, chemical service provision

n/a

SERVICE AREA BREAKDOWN

IHS also delivers managed regulatory content, which provides unparalleled support to our enterprise sustainability management solutions. IHS content consists of information on more than 300,000 chemical substances, 15,000 regulatory phrases in more than 44 languages, 7,500 proprietary rules, and 100 templates spanning 50 plus countries. Regulatory expertise Our team of implementation consultants possesses a wealth of domain knowledge and has proven experience at global implementations that ensure alignment with our clients' key goals. Our team brings a clear vision of industry requirements with practical expertise in chemical regulations such as REACH, GHS and RoHS. IHS regulatory experts continuously monitor and track legislation changes in order to constantly refine our solutions, which support industry best practices that enable organisations to contain costs while reducing business risks. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1959

IHS founded as Information Handling Services Inc

2004

Information Handling Services becomes IHS Inc

2005

IHS becomes a publicly traded company

2007

IHS acquires EnvironMax

2008

IHS acquires Environmental Software Providers (ESP) and Dolphin Software

2009

IHS acquires Environmental Support Solutions (ESS)

2010

IHS acquires Atrion International and Syntex Management Systems

ACCREDITATIONS Information 100%

Microsoft Gold Certified Partner PARTNERS SAP, Microsoft, Oracle, IBM Global Services, Deloitte, Accenture, ERM, OSIsoft, CH2MHill, Trinity Consulting, URS, E2 ManageTech, Osys, Citation Technologies CLIENTS GE Healthcare, KAO Chemicals, Enthone, RT Vanderbilt , Vesuvius, Valspar

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Chemical Watch | Service Providers Guide 2011

STAFF SELECTION

“Thanks to IHS, we can now add new products and expand our business across multiple countries without worrying about the impact of MSDS/ SDS compliance. For us, the primary factor in choosing IHS over the competition was its global coverage. Everything we need to grow our business, as it relates to hazard communication compliance, is available to us thanks to the IHS Product Stewardship Solution” – Mark Christenson, Vice President, Ecolab

Sue Barton – Senior Regulatory Analyst

CASE STUDY 1: Ecolab The challenge: Ecolab was seeking a solution to centralise business processes, ensure consistency of product safety hazard communication, efficiently manage frequent changes in requirements, and provide consistent product safety information to its customers. The goal was to eliminate manual authoring of safety documents, thereby reducing risk, and ensuring timely global product MSDS/SDS compliance for new products. Company officials were looking to implement a common approach to handle authoring worldwide, and they wanted to use a standard 16-section format, which is in line with the globally harmonised system (GHS). The solution: Ecolab implemented an IHS enterprise solution for product stewardship and compliance that provides consistent product safety information to its customers in Europe, Canada, and the US. The result: Ecolab gained considerable benefits from cost reductions related to MSDS/SDS consulting and translation. In addition, Ecolab can easily generate multilingual documents and give its customers around the world MSDS/SDSs in a consistent format. CASE STUDY 2: Americhem The challenge: Americhem is a global organisation that brings polymer products to life with custom-crafted colour and additive solutions. Americhem needed to stay abreast of the ever-changing legislative environment and maintain a high level of expertise in interpreting legislative changes and their impact on the company. The solution: Americhem implemented a global compliance from IHS solution that enabled the company to streamline its processes and support its globalisation efforts. This software and regulatory content suite of products provides seamless raw materials management, auto creation and authoring of MSDS/SDS in more than 44 languages. The results: the IHS solution greatly improved Americhem’s ability to manage compliance automatic data link updates providing the latest developments on regulatory changes and requirements on all chemicals. This has enabled the company to focus on its core business rather than compliance issues.

Sue Barton brings more than 20 years' experience in the regulatory compliance arena to help IHS customers navigate the ever-changing regulatory landscape in the chemical management arena. Her expertise in research and development, interpreting regulations and developing system customisations, helps IHS customers meet their compliance challenges. Barton works extensively with the IHS user community and plays a prominent role with customer task forces and user groups. Mark Blainey – Senior Regulatory Analyst Mark Blainey has been involved in EU chemicals legislation for more than 13 years and is considered one of the foremost authorities on REACH legislation. He is widely published and his work experience includes the development of REACH from its inception to agreement, as well as the myriad of guidance documents, reviews of the REACH annexes and contributions to the European Commission’s CLP (classification, labelling and packaging) Regulation proposal. Mary Rudolph – Senior Manager, Global Content Mary Rudolph has more than 25 years of international environmental, health and safety experience, including technical and business implementations of authoring services. She offers IHS customers an indepth and often sought after understanding of the needs of global EHS departments. She has also managed the development of EHS-related databases, including RTECS®, a recognised toxicology database. Francis Trudeau – Product Manager Francis Trudeau has worked for more than 12 years in product compliance and chemical management. Trudeau has significant experience in IT, regulations and industry guidelines enforced worldwide. He has worked on a wide variety projects that support IHS integrated information management solutions, and address legal compliance challenges of environmental, health and safety professionals and the implementation of regulations in databases and software applications.

CASE STUDY 3: Kao Chemicals Europe Kao Chemicals Europe SL (KCE) is a group company of Kao Corporation with headquarters in Tokyo, Japan. Kao Corporation manufactures and sells consumer products and chemical products. The challenge: Kao needed an application with mature functionality, global content and scalable technology that was easy to integrate with its current Baan and BPCS business software. Kao was also looking for a company with a proven record of fast, flexible and enterprise-level implementation. The solution: IHS Materials Compliance Solution was interfaced with both Baan and BPCS within Kao Chemicals Europe. This has enabled SDS distribution, as well as on-demand label printing (label print interface, LPI) per shipment. The result: since its implementation, Kao has experienced improved efficiency and reduction in costs with respect to the creation and distribution process for MSDS/SDSs and labels, and is now able to produce and distribute consistent documents proactively from one central database in more than 30 languages.

Chemical Watch | Service Providers Guide 2011

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PROFILE: IHS (Atrion has been acquired by IHS)

TESTIMONIALS

GLOBAL OFFICES Dr Knoell Consult GmbH, Mannheim, Germany Dr Knoell Consult GmbH, Leverkusen, Germany Dr Knoell Consult GmbH, Wageningen, The Netherlands Dr Knoell Consult Ltd, Cardiff, United Kingdom Dr Knoell Consult Shanghai Ltd, Pudong, Shanghai, China Dr Knoell Consult Schweiz GmbH, Basel, Switzerland FORIM GmbH, Mannheim, Germany Cyton Biosciences Ltd, Bristol, United Kingdom Knoell Academy GmbH, Mannheim, Germany

PROFILE: DR. KNOELL CONSULT GmbH

CONTACTS Web site

www.knoellconsult.com

E-mail

info@knoellconsult.com

Head office

Dynamostraße 19

68165 Mannheim

Germany

Tel

49 (0)621718858-0

Fax

49 (0)621718858-100

Contact

Dr Michael Cleuvers

Directors

Dr Hans-Emil Knoell, Managing Director

Dr Runar Eberhardt, Managing Director

Ownership

Private company, majority-owned by Dr Knoell

Locations

Germany, UK, Switzerland, China, Netherlands

Founded

1996

SERVICES PROVIDED Registration of industrial and specialty chemicals Strategic advice and consulting, literature search, data evaluation, data gap analysis, study monitoring Testing and registration strategies, in silico methods (QSAR), read-across and waiving strategies Dossier preparation, eg IUCLID5-files for REACH, hazard and risk assessment, exposure modelling Post submission support, communication with authorities, OR- and TPRservices, full consortia management Registration of agrochemicals and biocides

OVERVIEW Provider of full-services in the areas of global regulatory affairs, product safety and consulting for agrochemicals, biocides, industrial/specialty chemicals, human and veterinary pharmaceuticals, medical devices and cosmetics. Chemical business is a global business, and all around the world new chemical legislation is appearing! Working with Dr Knoell Consult means that you can be sure to be in compliance with the latest developments, not only in the European Union, but also in Switzerland, Turkey, USA, Canada, South America and the entire Asia-Pacific region. With a global network of cooperation partners we match our services to support your business needs. VITAL STATISTICS

2009

Turnover, group

> €20m

Turnover, chemical service provision

> €20m

No of offices

No of countries represented

Staff, group

234

Staff, chemical service provision

213

SERVICE AREA BREAKDOWN Information 7%

Training 5%

Other 1%

Strategic advice and consulting, dossier preparation, literature research, data evaluation, biological efficacy, residues and metabolism, dietary safety, human exposure, environmental modelling and ecotoxicology, strategic advice and consulting, GAP analysis, CADDY-dossiers, exposure modelling, PEC-reports, risk assessments, study management and monitoring, liaison with authorities, post-submission report Human pharmaceuticals, medical devices, cosmetics Non-clinical/ pre-clinical services (study management, toxicology, pharmacology, metabolism, pharmacikinetics, bioanalysis, biosafety testing) Clinical services (design, initiation and management of phase I, II and IV clinical trials and PASS), medical writing (eg expert opinions, study reports) Pre- and post-marketing pharmakovigilance, PSUR, summary of product characteristics (Core SmPC), summary bridging reports (SBR) and post authorisation safety studies (PASS), classification of medical devices, CEmarking, authorisation of cosmetics (INCI-listing, labelling etc), food and food additives Animal health (veterinary drugs, feed additives) Strategic advice, project management, auditing, managing and writing of registration submissions, expert reports, successful marketing authorisations All routes, all therapies, all species Management of pharmacological, toxicological, residues and ecotoxicological studies for feed additives Management of pre-clinical and clinical studies for feed additives, several services for vaccines and neutraceuticals CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Admin/ management 25%

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Consultancy/ advisory 62%

2010

Knoell Group has been appointed as institution for the training of experts in toxicology

2010

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

2010

Set up of Dr Knoell Consult Shanghai Ltd in China

2010

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

2010

Acquisition of Cyton Biosciences Ltd, Bristol, UK

2010

Opening of a new office in Wageningen (NL)

Chemical Watch | Service Providers Guide 2011

2010

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

STAFF SELECTION

2009

Knoell contributed to more than 100 dossiers for plant protection products

> 30 toxicologists

2009

Set up of Dr Knoell Ltd in Cardiff, UK

2009

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

2007

Foundation of FORIM GmbH, Mannheim

2007

Foundation of Dr Knoell Consult, Switzerland GmbH, Basel

2002

Office in Leverkusen, Germany

1996

Foundation, Mannheim, Germany

CEFIC – partner

Regulatory affairs agrochemicals/biocides 11 specialists Ecotoxicology

PROFILE: DR. KNOELL CONSULT GmbH

ACCREDITATIONS

Toxicology

> 30 ecotoxicologists Dietary safety 12 specialists Product safety specialists for MSDS preparation > 10 specialists Global regulatory affairs chemicals > 10 specialists

PARTNERS

Consortium management, OR, TPR

SCAS Japan, SCAS Europe, BSL Bioservice, Ibacon, Currenta, Ceres International, Ruio Technology

Eight consortium managers

CLIENTS

Efficacy, biological dossiers

Our clients are mainly the big international companies, but also SMEs

> 10 specialists

TESTIMONIALS

Human pharmaceutical experts

Residues and metabolism > 10 specialists Environmental fate and risk assessment > 40 specialists

The Spanish Ministry of Environment informed us that "our dossier for a wood-preservative was the best organised and well-done dossier in comparison with the rest of dossiers received from other companies" Additional testimonials can be provided on request.

CASE STUDY 1: REACH: consortium management and dossier preparation

Dr Michael Cleuvers – Head of Industrial Chemicals, Regulatory Affairs

As one example of our performance, Knoell has managed a huge consortium covering 370 substances in 10 sub-categories and submitted 55 successful registrations for this consortium in 2010. To achieve this, we established a team of more than 20 scientists dedicated to this project (chemists, toxicologists, ecotoxicologists, QSAR-specialists) who prepared the entire testing and registration strategy, including category and analogue approach, QSARs and exposure based waiving. CASE STUDY 2: Agrochemicals Knoell successfully submitted an AIR-I (Annex-I renewal procedure) dossier for a big international R&D company in 2008. The project was well recognised by the authorities, in particular bearing in mind that neither industry nor authorities had experience with such projects. More than 20 people based all over the world were involved in this project. CASE STUDY 3: Biocides

Vet. pharmaceutical experts 20 Selected staff

Torsten Hauck – Head of Agrochemicals and Biocides, Human & Environmental Safety Dr. Edith Kurzmeier – Head of Agrochemicals and Biocides, Regulatory Affairs Dr. Marika Suhm-Tintelnot – Head of Industrial Chemicals, Human & Environmental Safety Dr. Elisabeth Wekel – Head of Industrial Chemicals, Customised Projects Dr. Iain A. MacKinnon – Managing Director, Dr Knoell Consult Ltd. Dr. Jan Tuinstra – Senior Expert REACH, Wageningen office Conrad Scheidegger – Senior Expert REACH, Dr Knoell Consult Schweiz GmbH

Biocidal product registration in Spain: the Spanish Ministry of Environment informed us that “our dossier for a wood-preservative was the best organised and well-done dossier in comparison with the rest of dossiers received from other companies."

Chemical Watch | Service Providers Guide 2011

Page 69

GLOBAL OFFICES

Web site

www.lgcns.com

E-mail

vijaya.kumar@lgcns.com

Head office

Prime Tower, 10-1 Hoehyeon-dong 2-ga,

LG CNS China Co Ltd – Beijing, China LG CNS Japan Co Ltd – Tokyo, Japan LG CNS India Pvt Ltd – Bangalore, India LG CNS America INC – NJ, USA Pt LG CNS Indonesia – Jakarta, Indonesia LG CNS Europe BV – AE Almere, The Netherlands LG CNS Subsidiary in Brazil – Sao Paulo, Brazil LG CNS Middle East – Dubai, UAE

Jung-gu, Seoul,

SERVICES PROVIDED

Republic of Korea

Consulting

Tel

+82 2 6363 5000

Fax

+82 2 6363 5118

Contact

Vijaya Kumar

• Strategy consulting • Business process consulting • IT consulting

Directors

Mr Dae Hoon Kim, CEO

Ownership

Public Limited Company

Locations

Japan, China, India, Brazil, Indonesia

Europe, USA, Middle East

Founded

1987

PROFILE: LG CNS

CONTACTS

System integration

LG CNS is an US$3 billion IT arm of LG Group with its head office in Seoul, South Korea. LG CNS has offices in nine countries, with four subsidiaries and five branch offices. Business scope: consulting; system integration; outsourcing, ERP/BI; IT infra-solutions; and IT convergence.

• • • • • • • • • • • • •

VITAL STATISTICS

Outsourcing

OVERVIEW

2009

Turnover, group

US$3 billion

Turnover, chemical service provision No of offices

4 subsidiaries and 7 overseas branches

No of countries represented

Staff, group

7,000

Staff, chemical service provision

73 (+88 outsourcing resources)

SERVICE AREA BREAKDOWN Training Other 2% 2% Legal 2% IT & software 30%

Laboratory 2%

Page 70

Consultancy/ advisory 10% Admin/ management 10%

Information 42%

• • • • • • • • •

Judiciary/registry service Postal logistics service Online lottery ticket service Patent administration service Electronic passport service Weather information service Financial service Civil petition service Maritime safety service National tax service Police information service Disaster management service Command and control service IT outsoucring Desktop services Service desk service Data centre service Disaster recovery service Network service Security service Application service Cloud service

ERP and infrastructure solutions • • • • • •

ERP (enterprise resource planning) Cloud computing BI (business intelligence) Security solution AMO (application management outsourcing) Data centre

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1987

Established and registered a joint corporation, STM (System Technology Management)

1990

Operated the second integrated data processing centre (Munrae-dong, Yeongdeungpo-gu)

1992

Completed an information technology centre (ITC) – first in Korea

1994

ISO9001 Quality Certificate and TickIT

1997

Partnered ERP with Oracle and CMM Level 2 certification for four business places (the first in Korea)

1999

Acquired LG Electronics Soft OBU

2003

CMM Level 4 (Finance), CMM Level 5 (Public Sector) and CMM Level 3 (Defence sector)

Chemical Watch | Service Providers Guide 2011

Established subsidiary in Indonesia, Brazil/ BS 15000 certification

2006

CMMi Level 5 for India and China subsidiary, ISO20000 certification (China)

2007

Merged LG N-SYS Inc as a subsidiary company; opened LG CNS Sangam IT Centre

2009

CMMI Level 4 certification for post logistics system and Level 5 for China development centre

2010

ISO14001; opened mobile cloud centre; signed LG CNSSAP China channel partnership

ACCREDITATIONS CMMi Level 5 ISO 9001:2008 ISO 27001:2005 NICE (National Information and Credit Evaluation) Group – A1 rating PARTNERS SAP, Oracle , IBM, Microsoft, CLIENTS ERP clients (Partial List) – LG Chemicals, Dongyang Electronics, SeAH Steel, Shinhan Bank, LG Logistics, LS Cable Banking industry – Hana Bank, Korea Exchange Bank, BC Card Public sector – Korea Rail, KIPO, NTS Manufacturing – LG Electronics, Honam Petrochemicals, LS Industrial Systems, Eugene TESTIMONIALS

CASE STUDY 3 : Dongbu Hannong Chem PI ERP project • Methodology: PI project + ERP development project • Implemented module: implement all modules except HR (SD, MM, PP, QM, FI, CO, BW, EIS) • Project details: ERP development and select HW, development and TEST • Project scope: enterprise level for account and logistics for fertiliser unit only STAFF SELECTION Vijaya Kumar – Sales and Marketing Manager, UK and Europe Highly accomplished and results oriented busness development manager with proven success in the establishment, development, and direction of leading sales accounts while continually increasing market share in dynamic sales environment. Vinay Rao – DM, Asst Sales Manager Experience in direct marketing across various geographies including Europe. Akash Agrawal – SAP Practice Manager Extensive experience in SAP and compliance solutions by using SAP EHS and SPRC. Core expertise is in programme management and large projects deliveries. Kaustuv Basu – Project Manager/Architect, REACH and SAP Extensive experience in SAP and REACH compliance solutions across various geography and industries. Worked on large chemical company compliance solution implementation.

“The content project was the first for RS, as was the use of an offshore supplier for a such a major piece of work. The experience has been very positive with the relationship developed” – Berit Larrson, Head, Content Management, RS Components “Premier Farnell has been dealing with LG CNS India since July 2004 for a variety of content project. We found LG CNS India very efficient in terms of delivering to commitment” – David Brown, Head, -eCommerce, Premier Farnell, EU and APAC CASE STUDY 1: Reach implementation for LG Chemicals • One of the largest chemical manufacturers with revenues of more than US$11 billion and more than 13,000 employees • Twenty five business locations in 15 countries • More than 9,000 registered patents worldwide • Manufacturers of batteries, electronic materials, optical materials, technofilms, polyolefins, PVC and acrylates • Focused on building a sustainable future with environment friendly initiatives CASE STUDY 2: Honam Petrochemicals • •

Methodology: ERP development project Implemented module: big bang type development except PM (SD, MM, PP, QM, FI, CO, BW, EIS) • Project details: ERP development and HW selection, development, TEST

Chemical Watch | Service Providers Guide 2011

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PROFILE: LG CNS

2005

GLOBAL OFFICES Brussels, Belgium Oxfordshire, UK SERVICES PROVIDED

PROFILE: Penman Consulting

CONTACTS

Regulatory toxicology, environmental and exposure sciences Based on their industrial, health and environmental science and regulatory experience, Penman Consulting provides companies with expert strategic advice that is relevant to their businesses. It develops strategies to collect toxicological and environmental data for use in hazard assessment and risk assessment, to ask and answer questions on chemical safety.

Web site

www.penmanconsulting.com

E-mail

info@penmanconsultong.com

Head office

Penman Consulting BVBA

Sint Hubertuslaan 25

3080 Tervuren, Belgium

Tel

+ 32 (0)2 305 0698

Contact

info@penmanconsulting.com

Directors

Mike Penman, Managing Director

Suzanne Penman, Director

Ownership

Private limited company

Locations

Belgium, UK, Netherlands

Penman Consulting provides a full range of services to consortia and companies alike. It can plan and execute all the actions that are required in the complex process including: managing the entire process and liaising with businesses; document production – gathering and preparing all materials, the data set and CSR, (eco)toxicology to classification and exposure scenario, using their science skills; ensure substances get registered in the required format and on time.

Founded

2007

Regulatory IT tools and data

REACH and GHS

OVERVIEW Penman Consulting is a company with its origins in the petrochemical industry that has rapidly gained recognition for its ability to deliver on regulatory issues and especially on REACH. Serving both companies and consortia it has managed some of the largest REACH projects and numerous individual registrations. Clients recognise the leadership and expertise that it brings to such projects. Penman Consulting has been involved in managing the business process and/or overseeing the technical work for literally hundreds of substances that have been used in thousands of registrations. They have also designed software tools to cope with complexity of registrant and SIEF management. It has a track record of projects that are on time and within budget. VITAL STATISTICS

2009

Turnover, group

> € 2m

Turnover, chemical service provision

> € 2m

For the consortia registrations it manages, Penman Consulting has developed the SIEF management strategy which was then turned into an IT tool to enable communication with SIEFs in the most cost effective way. It also encompassed contract signature and dossier dissemination. Penman Consulting can use these tools to provide services to any SIEF. Penman Consulting is developing new active stewardship systems to encompass global product stewardship needs in the invigorated regulatory climate, for example in Korea and future TSCA reform. Training Penman Consulting provides tailored training in regulatory affairs, product stewardship, regulatory toxicology and environmental sciences. Penman Consulting provides essential training for those who must use LUCLID 5. It runs each training session as an online webinar or in person and on site. It has a hosted training instance of IUCLID which trainees can use during and after the training; it is always complete with the latest plug-ins from ECHA, including technical completeness check (TCC) tool and Chesar which is used for exposure estimation, risk assessment and CSR preparation.

No of offices

No of countries represented

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Staff, group

2007

Founded in Brussels

2008

Expansion to UK

2010

Successful REACH registrations of almost 300 substances for nearly 50,000 SIEF members

Staff, chemical service provision SERVICE AREA BREAKDOWN IT & software 15%

Information 10%

Admin/ management 25%

Training 5%

ACCREDITATIONS Consultancy/ advisory 45%

PRINCE2 project management REACH Ready certified training PARTNERS ICF International WCA Environment CXR Biosciences bibra Hunton & Williams – Brussels office CLIENTS Penman Consulting's clients range from some of the largest consortia containing the world’s leading petrochemical and chemical companies, those companies directly, to a number of small and medium sized enterprises. They have also worked directly for trade organisations.

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Chemical Watch | Service Providers Guide 2011

TESTIMONIALS

STAFF SELECTION

Lower Olefins and Aromatics Consortium – award "for leadership on the 2010 REACH registrations." CONCAWE – "has been recognised as a REACH project outstanding contributor" From SIEF members – "Your system is the most easy to follow and simple to use. You’ve also put a lot of simple guidance out which is quick and easy to reference (like the May webinar presentations)."

Mike Penman MBE

Penman Consulting successfully built a team consisting of legal, financial, toxicological, and environmental and exposure professionals to set up and manage the consortium for the lower olefins and aromatics industry. Covering both operational and technical aspects for some of the highest volume substances to be registered in 2010, it included both data rich substances with a history of regulatory scrutiny, to complex categories of streams. The scope of the project was large – over 140 substances nominated into the process, with over 50 worldwide consortia members. There were more than 47,000 SIEF members that were communicated with on a regular basis, so that they could be informed as to progress and potential costs. The technical challenge was also considerable and required coordination and detailed review by experts both in and outside of member companies. The engagement with the executive and technical committees were essential to the successful registrations. All members' substances were successfully registered by the 2010 deadline. www.loareach.com Penman Consulting managed two other consortia in a similar holistic fashion. Although both were smaller in terms of substances and consortia members, each had its own challenges and special needs. CASE STUDY 2: Registrations for a petrochemicals company with a short lead time A petrochemical supplier to major petrochemicals companies found themselves short of time to begin the 2010 REACH registration process for a number of substances. They brought in Penman Consulting for their dossier preparation and registration processes just a few weeks before the 2010 deadline. Registration materials were needed from three consortia. All registrations were made successfully and in good time, and the plant was able to continue an uninterrupted supply to clients. Penman Consulting continues to manage the customer's ongoing responsibilities as lead registrant.

Chemical Watch | Service Providers Guide 2011

Helen Penman Helen manages the SIEF process for the largest petrochemical SIEF consortia in Europe. She joined Penman Consulting Ltd in 2008 for this role. Helen is qualified to PRINCE2 Practitioner level; her professional background is project management and she has successfully managed major projects in the UK National Health Service and the print industry. Her experience includes designing information management and content management systems and database structures. Graham Robb Graham graduated in physics from Magdalen College, Oxford in 1974. After starting his career with the UK Central Electricity Generating Board, in 1977 Graham joined Digital Applications International, the well known London-based IT services company delivering process control and manufacturing solutions to the chemical and other industries. Graham now brings these years of scientific IT project and management experience to Penman Consulting. Thomas Penman Thomas is REACHReady's preferred IUCLID trainer. He provides training in REACHsuite and IUCLID to companies and consortia. Penman Consulting clients have hundreds of substances under management and Thomas is responsible for managing IUCLID, including troubleshooting for users and producing IUCLID data sets. Before being involved in REACH, Thomas worked in the communications industry training staff in how to use company specific databases and meet regulatory requirements.

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PROFILE: Penman Consulting

CASE STUDY 1: Large REACH consortium

Founder Mike Penman has more than 30 years' experience in managing toxicology, regulatory affairs and information technology within major companies (ICI 1976 – 1997; ExxonMobil 1997 – 2007) and associated trade associations. He was awarded an MBE for “Services to environmental safety”. Mike worked for ExxonMobil as senior toxicology advisor for Europe, and subsequently as the technical REACH/GHS implementation manager.

SERVICES PROVIDED Overall project management

Web site

www.reachcentrum.eu

E-mail

info@reachcentrum.eu

Head office

Avenue E. van Nieuwenhuyse 6

B-1160 Brussels

Belgium

Tel

+32 26767400

ReachCentrum’s overall project management to achieve registration and beyond (evaluation, authorisation) has settled around four core fields of expertise: 1) Secretarial and administrative support; 2) Financial and data management support; 3) SIEF support and communication; 4) Legal support. As for administrative support, ReachCentrum‘s experienced and dedicated staff organise and oversee meetings, check upon actions and the progress of technical dossiers, and take care that deadlines are respected. Our clients benefit from a secure document exchange platform, where all relevant files are either shared or can be stored as archives.

Fax

+32 2 6767499

Admin, financial, data management and legal support

Contact

Francesca Furlan

Directors

Leo Appelman, Managing Director

Ownership

Private company

Locations

Brussels, Belgium

Founded

2006

PROFILE: ReachCentrum

CONTACTS

OVERVIEW ReachCentrum was created in June 2006 by CEFIC (the European Chemical Industry Council) to help companies all through the value chain to prepare and implement REACH. ReachCentrum helps chemical manufacturers and importers to comply with all three aspects of the REACH legislation: dossier preparation for registration and support through the phases of evaluation and authorisation by providing our main services, namely consortia and lead registrant support services, consultancy and workshops. Our services and support tools are designed for European and nonEuropean companies working on their own or in close collaboration with other companies. Currently we manage about 120 consortia and lead registrant support projects, comprising very large and complex groups of 80 substances and 45 members to very specific and specialised onesubstance projects. VITAL STATISTICS

2009

Turnover, group

Turnover, chemical service provision

No of offices

All financial issues related to a project are handled in-house (budget control, invoicing, access to data, balance sheet). Support is backed-up by our own financial department. Besides, ReachCentrum has set up a flexible data management system, allowing us to execute even complex data-related cost sharing calculations. Experienced staff analyse and process the data and an IT support team runs the actual calculation. ReachCentrum has a powerful tool in place to manage the sales of letters of access, the LoA shop. ReachCentrum provides REACH legal advice and solutions, and contract support as well as contract management. SIEF support and communication − LINKinSIEF In order to support industry for collaboration in SIEFs, ReachCentrum has launched LINKinSIEF, a SIEF communication platform offering a solution for communication and collaboration between companies in a SIEF. As a user-friendly and secure platform it is easy to share documents, to post information and to create surveys as well as to give feedback on their outcome. Each project has the possibility of opening a website and having its own e-mail address. ReachCentrum acts as the focal point for all requests concerning a substance covered by a project. Training and workshops To become acquainted with the REACH requirements, ReachCentrum organises training courses, workshops and webinars. These events help keep you up to date with REACH, its tools and its impact on businesses. ReachCentrum also provides specific consultancy and in-company training courses, bringing you practical advice ready to be implemented in your company. To increase awareness or show the business opportunities of REACH, ReachCentrum can organise in-company workshops for each association as well as bespoke training and boot camps for REACH awareness, and it also offers a self-learning tool online or via CD.

No of countries represented

Staff, group

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Staff, chemical service provision

2006

Founded by CEFIC (the European Chemical Industry Council)

2007

Partnership with CentroReach for offering REACH workshops and training courses

2008

Doubled number of staff employed

2009

ReachCentrum SIEF Communication launched

2010

LoA e-shop successfully launched

2010

105 managed consortia

2010

Over 400 lead dossiers successfully registered

2010

Through the LoA e-shop 342 SIEFs allowed their SIEF members to access the registration dossier

2010

About 900 people attended ReachCentrum events (about 90 events)

2010

LINKinSIEF, the ReachCentrum SIEF communication platform was launched

2011

10 lead registrant support projects

SERVICE AREA BREAKDOWN Consultancy/ advisory 10% Training 25%

Legal 10% Information 10%

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Admin/ management 45%

Chemical Watch | Service Providers Guide 2011

Partnership with TNO Triskelion for offering REACH workshops and training courses

2011

Partnership with Zieta Technologies for offering REACH workshops and training courses

PARTNERS Zieta Technologies; REACH Global Services (RGS); CentroReach; TNO Triskelion CLIENTS ReachCentrum offers its services to a wide range of chemical companies, from all major multinationals to SMEs and only representatives (OR) from all over Europe. TESTIMONIALS "Very good and compact course with different kinds of examples” − Dr Stephan Liebsch, Zschimmer & Schwarz "I liked the course, it was very interesting even though my knowledge was very low and I think I learned a lot in a few hours. The tempo was very good too for me to follow” − Ms Kim Jolie, Dubal “After having attended the ReachCentrum boot camp, I wanted to testify of my high satisfaction. I think that my entry to the REACH world could not have been better: during one week, we could understand the whole process, and had accurate overviews of every topic with highly skilled facilitators. They were able to answer all questions in a positive and open-minded attitude. Even the case studies – homework for most of them – were built in such a way that the learning was enjoyable. Last but not least, I also enjoyed the brilliant food cooked by a chef, and dinners in a friendly atmosphere” – Patrick Karpe, quality, regulatory and HSE manager, Axcentive CASE STUDY 1: A consortium case In 2008 a group of companies started to organise themselves into a consortium, whose formation and development involved ReachCentrum. The consortium was set up by six companies, covering around 40 substances which needed to be registered in 2010, 2013 and 2018. Over the course of about a year the consortium prepared the actual work, and, due to the potential to read across certain data between the substances, a lot of costs were saved. Also read across to other consortia and even partly merging of consortia was used to further push down the costs as much as possible. The writing of the dossier and the testing started about a year and a half before the registration deadline. A large number of studies were commissioned to a service provider who also prepared the registration dossiers. The consortium successfully submitted 20 dossiers in September 2010. For 2013 substances, the work has started and a lot of the data is already available due to read-across and efficient testing. The consortium expects to be ready about a year before the next registration deadline. For the selling of LoAs the consortium used the ReachCentrum LoA shop, easily retrieving about 50% of the investment. CASE STUDY 2: In-company workshops and IUCLID5 training courses ReachCentrum created a programme for SIEF management for companies who were planning to become lead registrants to understand how the SIEF would evolve and how to manage the SIEF. The companies put their REACH team through this programme together with other departments so that each group fully understood the impact that SIEF decisions would have on a company for business continuity and not just compliance. The companies in question were better prepared to manage themselves internally and could communicate effectively within the SIEF.

Chemical Watch | Service Providers Guide 2011

IUCLID5 training has been a successful course demonstrating how important good knowledge is to completing a REACH dossier. The training courses for joint submission members were focused on creating a dossier in IUCLID ready to send to ECHA. Some companies were in a position to submit dossiers at the end of the day having followed the training with the data they had brought with them. For the participants, having trainers who were able to respond to IUCLID5 as well as understand the REACH process, ensured practical questions could be answered immediately. CASE STUDY 3: Lead registrant support When approached by a customer in 2009 about the registration in 2013 of a specific multi-constituent "substance A" without any data available, a problematic situation arose when it became clear that the two main constituents of "substance A" needed to be registered in 2010 as they were imported into Europe in volumes bigger than 1,000 tons. However, until March 2010 there was not yet a lead registrant. ReachCentrum accompanied the companies concerned in the search for the best possible solution – finally two different consortia were found that were either already considering registering or could do so based on substance similarities. As no data was available for "substance A", the project was also engaged in contracting a suitable technical service provider to conduct all relevant phys-chem tests in 2010 so they were able to propose a common C&L to the SIEF. STAFF SELECTION Leo Appelman – Managing Director A toxicologist by profession, before joining ReachCentrum as managing director in 2007 he had worked for nearly 17 years in a global paint manufacturing company dealing with all health, safety and environmental issues. He was the REACH facilitator for the coating business, and head of the HSE department servicing its business units worldwide in their marketing approach. He was also involved in the registration of biocidal products and notifications for new chemical substances. Mark Meesters – Head of Consortium Management Mark had worked as a regulatory affairs manager in the chemical industry for seven years before joining ReachCentrum in 2007. His principle responsibilities have included product safety, compliance with chemicals legislation and preparation for REACH. He is a chemist and lawyer by training. He joined ReachCentrum to head the consortia management services. In this role, he is responsible for managing consortia and coordinating the activities of the ReachCentrum consortia managers. Vincenzo Girardi – Head of REACH Training and Workshops Vincenzo has more than 20 years of experience as a professional trainer. He has amassed experience in the information technology, consumer goods, banking and pharmaceutical industries. As a professional trainer, Vincenzo has advised on, managed and delivered numerous training projects. At ReachCentrum his role is to develop and deliver training workshops and webinars on all REACH IT tools as they are released to industry. He is a member of the Institute of IT Training. Vincent Navez – Senior Legal Advisor After completing his studies in European and economic law in Belgium, he has consolidated his legal training with six years practical experience as legal advisor at the European Consumer Centre in Barcelona, working for the European Commission ECC-network, mainly on consumer issues and internal market issues. He joined ReachCentrum to deal with REACH legal interpretation and application and give legal advice and guidance regarding data sharing and consortia formation.

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PROFILE: ReachCentrum

2011

SERVICES PROVIDED REACH consultancy The ReachSpektrum team provides consultancy in the complex area of the REACH Regulation. Our consultancy service includes business impact assessment and liabilities, regulation interpretation in different areas in order to determine proper registration strategy and supply chain communication.

PROFILE: ReachSpektrum

CONTACTS Web site

www.reachspektrum.eu

E-mail

info@reachspektrum.eu

Head office

Dělnická 12

170 00 Prague

Czech Republic

Tel

+420 266 793 590

Fax

+420 266 794 578

Contact

Jan Holomek

Directors

Jan Holomek, chief executive director

Ownership

Private company

Locations

Prague, Czech Republic

Founded

2007

REACH services Preparation of registration dossier for lead registrants and for joint submission members, advice on information requirements for registration, compilation of data in IUCLID5, completion of dossier and submission to ECHA. REACH lead registrant technical secretariat services. Late pre-registration. Literature search, data gathering, testing services in partner GLP laboratory. SIEF management. Helpdesk for REACH. Only representative activities for manufacturers settled outside EU. CLP consultancy and services

OVERVIEW ReachSpektrum was founded in 2007 by the Association of Chemical Industry of the Czech Republic. Since then, ReachSpektrum has provided excellent knowledge and high quality service to all industries dealing with chemicals manufacture and management. VITAL STATISTICS

2009

Turnover, group

5m CZK

Turnover, chemical service provision

5m CZK

No of offices

No of countries represented

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 20%

Consultancy/ advisory 40%

Training, workshops We organise workshops on REACH and CLP Regulation, IUCLID5 training sessions. The sessions can be tailored to your needs and conducted in your company or in the form of webinar. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007

Founded by Association of Chemical Industry of the Czech Republic

2008

Partnership with major laboratories to provide high quality standards in testing

2009

Lead registrant secretariat for four substances under REACH

2010

More than 50 REACH registrations for major players in the Czech Republic's chemical industry

PARTNERS Research Institute for Organic Syntheses, Rybitví, Czech Republic (GLP laboratory)

Legal 10%

CLIENTS

IT & software 10% Information 10%

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ReachSpektrum is ready to help you understand the new classification, labelling and packaging obligations, and help you to meet these requirements. We will investigate the implications, set up a time schedule for meeting deadlines, and identify roles. Moreover, we can reclassify your substances and mixtures, prepare new labels and notify the classification and labelling of your substances to ECHA. We can also prepare new MSDS and e-SDS of your products.

Admin/ management 10%

BorsodChem MCHZ, Czech Republic; UNIPETROL RPA, Czech Republic; GOJO Industries Europe, UK; Humatex, Czech Republic; MAGNA Interiors and Exteriors Bohemia, Czech Republic; PRECIOSA, Czech Republic; AGRA Group, Czech Republic; Ministry of Industry and Trade of the Czech Republic

Chemical Watch | Service Providers Guide 2011

CASE STUDY 1: BorsodChem MCHZ, lead registrant support

PROFILE: ReachSpektrum

Client requested ReachSpektrum to act as technical secretariat and supporting consulting company in the role of the lead registrant under REACH. ReachSpektrum offered BorsodChem MCHZ to become a SFF, conducted SIEF management and election of the lead registrant. ReachSpektrum then provided literature search evaluation, supported preparation of dossier, coordinated work with partners and ensured communication within SIEF and potential members of joint submission. The registration was finished in October 2010, well before the deadline and accepted by ECHA as complete. All members of joint submissions successfully submitted their individual dossiers (partly pre-created by ReachSpektrum) in time. CASE STUDY 2: Ministry of Industry and Trade of the Czech Republic, impact assessment study In 2008, ReachSpektrum provided, at the request of the Ministry of Industry and Trade, an impact research study on GHS Regulation against costs of manufacturers producing chemical substances and preparations/ mixtures according to the GHS Regulation. CASE STUDY 3: MAGNA Interiors and Exteriors (Bohemia), REACH status analysis The client from the automotive industry with three manufacturing sites in the Czech Republic, asked ReachSpektrum to analyse its role under the REACH Regulation, to determine its obligations and prepare follow-up actions based on the analysis. The work of ReachSpektrum consisted of complex procedures. During the study inputs to manufacture as well as the products were analysed from the REACH Regulation point of view, liabilities and obligations were determined and solutions and processes to assure compliance were recommended to the client. Also several hundred MSDS were revised and corrected to match the REACH Regulation requirements. STAFF SELECTION Jan Holomek Jan formerly worked for the Association of Chemical Industry of the Czech Republic as its chemical regulatory affairs secretary. He became ReachSpektrum CEO in 2010. and in his first year he brought in numerous clients and developed a strong relationship with current customers. Jan has a masters degree in chemistry from Technical University Brno, and represents the Czech Republic on CEFIC's REACH Experts Network. He continuously provides support to the Czech chemical industry on REACH and CLP issues. Eliška Lorencová Eliška holds a masters degree in environmental sciences at Wageningen University, Netherlands, and gained professional experience in South Africa and Belgium. Eliška is now fully responsible for delivering REACH and CLP expertise to company clients as well as participating in projects led by ReachSpektrum.

Chemical Watch | Service Providers Guide 2011

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SERVICES PROVIDED REACH consortium, SIEF and lead registrant substance management, and SIEF communications IT solutions Substance management with information requirements and costs, supporting documents, proprietary data management, task force security, uses, and unique or common project process steps for each substance, all integrated with the centralised action tracking to maintain project progress and oversight. SIEF Management and Communications uses the REACH-IT pre-SIEF files with custom data to target SIEF communication emails, custom forms and surveys, all of which are reusable from the library, with surveys and other information being easily posted into SIEF member portals as well as contracts, files and deliverables/letters of access.

PROFILE: REACHsuite

CONTACTS Web site

www.REACHsuite.com

E-mail

reach@baytouch.com

Head office

Ribble Court, 1 Mead Way

Padiham, Burnley BB12 7NG

Tel

+44 1282 687000

Fax

+44 1282 687009

Contact

Sales

Directors

Malcolm Pollard, CEO

Ownership

Private company

Locations

UK, Belgium, The Netherlands

Founded

2005

REACHsuite Advantage − enhanced, content-ready version of REACHsuite A powerful combination of REACHsuite's sophisticated substance, project management and SIEF interaction functionalities and the expert content of the Jongerius Consult REACH Registration and SIEF Milestone Planning tool providing a complete, flexible and ready to use registration and SIEF management solution for companies. REACH only representative services and supply chain communications IT solutions

OVERVIEW Baytouch Ltd is the leading independent provider of REACH management IT solutions for companies, consortia and SIEFs of all sizes striving for REACH compliance, and is currently working successfully with large numbers of leading consortia and SIEFs throughout Europe. At the end of 2010, REACHsuite was supporting over 1,100 substances and regularly communicating with more than 110,000 SIEF contacts for some of the most critical substances. With IT solutions and services for consortia and SIEFs of all sizes, for companies that find themselves as lead registrants or want to manage their product portfolios down to substance level, for supply chain communications, or for organisations undertaking only representative responsibilities, REACHsuite provides cost effective, top to bottom integration through a consistent and modular database-driven approach. VITAL STATISTICS

2009

Turnover, group

€0.7m

Turnover, chemical service provision

€0.7m

No of offices

No of countries represented

All EU and North America

Staff, group

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 5%

Consultancy/ advisory 10%

IT & software 85%

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Communicate with downstream users and distributors (DUs) and suppliers, capture and consolidate EU import volumes, communicate exposure scenarios and end uses and other supply chain communication activity using a simple to set up and use online forms capability and structured email communications. A database-driven approach that integrates with spreadsheets and enterprise resource planning systems REACH management IT solutions − company product portfolio and substance management Manage products and components down to substance level for both manufactured / imported and EU-supplied substances (bill of substances), track registration and supplier status, identify uses, information requirements and costs and monitor SVHCs all within a comprehensive process-driven framework tracking deadlines. A database-driven approach that integrates with spreadsheets and enterprise resource planning systems CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2005

IT solutions business launched focusing on regulatory compliance management issues, primarily EH&S

2007

REACHsuite launched, first clients for manufacturers/ importers and downstream user substance modules

2007

REACHsuite Supply Chain Communication launched, significant wins ahead of pre-registration start

2008

August – REACHsuite Consortium Management launched, first REACHsuite consortia signed up

2008

December − REACHsuite SIEF Management/ Communications launched and clients signed up

2009

REACHsuite version to help service providers manage multiple clients launched

2010

First to market with online contracts module, billing and deliverables/LoA distribution

2010

1,113 multi-substance/multi-legal entity contracts generate €10,526,675 of revenue from 2010 registrations

2011

REACHsuite only representative management version launched for service providers and companies

Chemical Watch | Service Providers Guide 2011

CASE STUDY 2: Service provider management

Caleb Management Services Ltd Jongerius Consult BV Penman Consulting Managed Services

As well as Baytouch Ltd working directly with some of the larger consortia, there is also a version of REACHsuite available to enable service providers to support and manage their own clients within REACHsuite. Smaller consortia and SIEFs that are perhaps more in need of a range of REACH-focused services get the best of both worlds, the expertise, skill and experience of Baytouch's service provider network and the knowledge that the operations, SIEF management and communications are being handled by the best portfolio of REACH IT management solutions on the market through a single point of contact. Caleb Management Services is a key REACHsuite service provider partner which not only manages a number of smaller SIEFs and consortia directly in its own REACHsuite version, but works with Baytouch on other major projects such as the CALICIO/ ATC consortium. Other partners include Jongerius Consult and Penman Consulting Managed Services, who manage SIEFs with smaller member numbers for their clients in REACHsuite.

CLIENTS Consortia – Lower Olefins and Aromatics, European Aluminium Association, Higher Olefins and Poly Alpha Aromatics, European Precious Metals and Rhenium, European Association of Mining Industries, European Carbon & Graphite Association, Calicio / Petrol Additives, Polyester Monomers Consortium, and others Companies − Kemira, Shell Chemicals, Kimberly-Clark, DuPont TJF, StatoilHydro Service Provider Partners using REACHsuite − Caleb Management Services, Jongerius Consult, Penman Consulting Managed Services TESTIMONIALS "We are using the REACHsuite SIEF Management tool for all the SIEF surveys and communication. We would not have managed to organise this with so many SIEF members without an efficient communication tool to follow up the process" − Eirik Nordheim, European Aluminium Association “REACHsuite is easy to use and supports managing the SIEF communication superbly. Unlike other software, it also seems to be easy to maintain and is highly user friendly" − Helena Huttenen, Kemira Principal REACH Specialist “It has been clear from the outset that effective IT solutions are needed to manage this and to reduce the significant admin overhead. Without the right IT in place, meeting the 2010 deadline would have become almost impossible" − Mike Penman, Lower Olefins Consortium executive project manager CASE STUDY 1: Large consortium management REACHsuite was used to support some of the largest consortia in the run-up to the 2010 registration deadline where it helped teams of consortia members and service providers to work collaboratively on individual substances or across categories/ super-SIEFs within an overall plan targeting registration. REACHsuite stored documents and proprietary data as well as information requirements and costs and it enabled large numbers of SIEFs and often many thousands of SIEF members to be effectively managed and communicated with. In addition, several consortia took advantage of the contracts, billing and deliverables functionality to efficiently manage their contract/LoA distribution operations. Some of the leading consortia using REACHsuite included Lower Olefins and Aromatics, Higher Olefins, Aluminium, Precious Metals and Rhenium and Euromines. Approximately 17% of 2010 substance registrations were managed in REACHsuite.

Chemical Watch | Service Providers Guide 2011

CASE STUDY 3: Company lead registrant substance management and SIEF management/ communications Companies often find themselves as lead registrants by default in substances which are strategic to them, and also as a SIEF member for many more substances for which they are not the lead. There is a REACHsuite version that helps companies to not only undertake their lead responsibilities, but also to monitor and keep track of the LR's plans and activity for the other SIEFs they have an interest in. The same ease of use, process-oriented action planning and large scale communications capability in the REACHsuite consortium solution is oriented towards a company with the additional option to extend this to only representative and supply chain communication capabilities. A major client who recognised REACHsuite's capabilities early in this area is Kemira Oyj, the €2bn Finnish company that established that emails and spreadsheets were not the answer to long term REACH communications and data management and who, working with Jongerius Consult and Baytouch, adopted REACHsuite early in 2010 to effectively manage their REACH operations.

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PROFILE: REACHsuite

PARTNERS

GLOBAL OFFICES Haskoning Nederland BV (Global headquarters): Barbarossastraat 35, 6522DK Nijmegen, Netherlands Haskoning UK Ltd: Rightwell House, Bretton, Peterborough, PE3 8DW, United Kingdom Haskoning Belgium SA, Schaliënhoevedreef 20D, B-2800 Mechelen, Belgium Haskoning France sarl, 2, Rue Jacques Prévert, F-59650 Villeneuve d' Ascq, France

PROFILE: Royal Haskoning

CONTACTS Web site

www.royalhaskoning.com/processandchemicalindustry

E-mail

chemicalsmanagement@environment.royalhaskoning. com

Head office

Haskoning Nederland BV

P.O. Box 151 – 6500 AD Nijmegen

Netherlands

Tel

+ 31 (0)243 284135

Fax

+31 (0)243228170

Contact

Mr Christiaan van Daalen / Mr Tjeerd Bokhout

Directors

Mr Rob Schonk, Director Process and Chemical Industry

Ownership

Private company

Locations

Locations worldwide. Key locations: Nijmegen (Nl) – Peterborough (UK) – Mechelen (Be) – Lille (Fr)

Founded

1881

SERVICES PROVIDED REACH

REACH driven engineering

OVERVIEW The firm was founded in 1881 in the Netherlands. At present, our 3,900 employees combine a wide range of knowledge and experience. Rooted in a technical background, our consulting services focus on the broad field of the 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. VITAL STATISTICS

2009

Turnover, group

€370m

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

3,900

Staff, chemical service provision

SERVICE AREA BREAKDOWN

IT & software 5%

Legal 5%

Training 8%

Laboratory 2% Information 15%

Consultancy/ advisory 50%

Royal Haskoning provides a full range of REACH services, varying from consortium management to preparation of the technical dossier and the chemical safety report. Royal Haskoning 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 Haskoning does not provide laboratory services, it provides support in laboratory selection and study monitoring. As a result of REACH the risk management measures 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. Royal Haskoning provides a unique combination of knowledge on chemicals management and engineering to deliver lean and mean organisational and technical solutions. GHS/CLP Royal Haskoning 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. Safety data sheets Royal Haskoning provides a full safety data sheet service including the preparation of the annex of the extended SDS (eSDS). Other Services Royal Haskoning provides a wide range of services that provide solutions for multidisciplinary challenges to industry. To find out more, visit: www. royalhaskoning.com CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1881

Founding fathers Johan van Hasselt and Jacobus de Koning start their business in Nijmegen.

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 legislations all over the world

1994

Royal Haskoning developed Rosetta, one of the first programs able to produce multilingual safety data sheets.

2005

RIP 3.10 on characterisation and checking of substance identity is prepared by Royal Haskoning.

2007

Royal Haskoning joins the organisation of ChemCon Conferences

2011

130th birthday

Admin/ management 15%

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Chemical Watch | Service Providers Guide 2011

ACCREDITATIONS

STAFF SELECTION

ISO 9001 ISO 14001 OHSAS 18001

Mrs Froukje Balk Msc – Senior Expert Ecotoxicology

ChemCon Conferences CLIENTS The clients of Royal Haskoning are located in many different industries. Because Royal Haskoning provides many more services than chemicals management alone, it has service relations with clients covering a wide variety of solutions. Clients are eg 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 Haskoning 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 Haskoning 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.

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 Mrs Dr Ingrid Sterenborg – Senior Expert Toxicology Ingrid Sterenborg studied environmental hygiene and obtained her PhD degree on the physiological mechanism of metal tolerance in springtails, she started her career in environmental consulting, with particular expertise in regulatory toxicology. In 2011 Ingrid will complete her postdoctoral education to become a EUROTOX registered toxicologist. She prepared several dossiers for biocidal and plant protection products as well as REACH dossiers and prepared data gap analyses, proposed testing strategies and prepared expert statements for several toxicological endpoints. Ms Conny Hoekzema Msc – GHS/CLP and SDS Expert Conny Hoekzema has five 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 IUCLID5, safety data sheets and classification and labelling for a variety of audiences. Mr 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. Mr 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 is a board member for chemical safety of the Dutch Industrial Hygiene Association. Mr 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. Beside 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 Haskoning

PARTNERS

PROFILE: Sumika Chemical Analysis Service Ltd

GLOBAL OFFICES Japan: Ryumeikan-2nd BLDG, 3-20, Kanda Ogawamachi, Chiyoda-ku, Tokyo, 101-0052, Japan Will move in May 2011 to: Sumitomo Fudosan Hongo BLDG, 3-22-5, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan China: 6F, No.163, Jiangchang 3rd Rd., Shanghai, 200436, China Singapore: 2 Jurong East Street 21, #04-02 IMM Building, Singapore 609601

CONTACTS Web site

www.scas-eu.be

E-mail

scaseurope07@scas-eu.be

Address

Lambroekstraat 5a

B-1831 Diegem

Belgium

SERVICES PROVIDED

Tel

+32 (0) 2 719 0475

Chemicals compliance services

Fax

+32 (0) 2 719 0480

Contact

Kazumi Yuki (President)

Directors

Kazumi Yuki

Dr Naohiro Takahashi

Ownership

Private company

Locations

Japan (Head Office), China, Singapore,

SCAS conducts assessment and evaluation of risks and hazards, and environmental impact related to chemical substances and offers consulting services related to these. SCAS also assists in the application for registration related to chemicals regulations and contributes to the appropriate risk management of chemicals in the EU, USA, and AsiaPacific region including Japan, Korea, China, Taiwan, Australia, and New Zealand.

Belgium

Founded

1972 (Sumika Chemical Analysis Service)

Global MSDS Services

OVERVIEW Sumika Chemical Analysis Service (SCAS) was founded in 1972, being formerly the Analytical Division of Sumitomo Chemical Co. Since then, SCAS has been consistently satisfying the analytical-related requirements of its customers by providing the best solutions for the environmental, electronic, pharmaceutical, chemical and several other industrial sectors. Safeguarding its main principle of customer confidentiality, SCAS provides highly dependable technologies and very detailed services to its customers under its business concepts, those being: innovative attitudes, scientific approaches, data quality assurance and customer satisfaction. SCAS can become your total solution partner for analyses, measurements, and evaluation and consultation of chemicals legislation: to pioneer the future with a solid foundation of trust. VITAL STATISTICS

2009

Turnover, group Turnover, chemical service provision No of offices

about 1,500m yen

SCAS manufactures and markets world-leading HPLC columns. SCAS contributes to global requirements by developing and marketing various kinds of analytical instruments.

1,500

Staff, chemical service provision

SERVICE AREA BREAKDOWN Other 1%

Consultancy/ advisory 10% Information 2%

Laboratory 87%

SCAS laboratories offer a wide range of analytical services. This includes total support in the area of environmental research including analysis of various matrices as well as environmental assessments and remediation. SCAS possesses the best technology in Japan for the evaluation of ultra-micro contaminants in the areas of semiconductors and flat panel displays, used in industrial and consumer sectors like electronics. SCAS keeps up to date with the latest amendments in the regulations, and the analytical needs that arise from these regulations, usable in all stages of product research and development in all sectors. Others (chromatography columns and scientific instruments)

more than 10

Staff, group

Analytical services

about 15,000m yen 13

No of countries represented

SCAS generates and formats globally-compliant MSDSs for GHS and regional jurisdictions covering more than 40 countries, operating in the regions and countries mentioned above. We also create product labels and offer translation services for more than 30 languages. All services are fast, low-cost, and superior in quality, drawing upon highly qualified authors and extending to close monitoring of regulatory revisions and prompt updating of authored MSDSs.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1972

SCAS was established

1986

The analysis and consulting services corresponding to CSCL were started

1997

SCAS Singapore was established

2007

Chemicals Compliance Division became independent

2007

Sumika Analysis and Evaluation Service (Shanghai, China) was established

2007

SCAS Europe (Belgium) was established

2007

REACH consulting services were started

2010

Consulting services corresponding to amended chemical substance law in China were started CSCL: the Chemical Substances Control Law in Japan

ACCREDITATIONS Approved member of the Only Representative Organisation (ORO) ISO9001, 14001, 17025 (not all laboratories)

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Chemical Watch | Service Providers Guide 2011

STAFF SELECTION

Consultants and law firms acting globally in respective fields

Ad J Oosterling – Regulatory Affairs Manager (SCAS Europe)

CLIENTS From various sectors eg chemical, petrochemical, electronics, pharmaceutical, automotive, paint, inks, rubber and fibre industries. CASE STUDY 1: Notification services SCAS has provided notification services over decades in various regions/ countries such as Japan, Korea, China, Taiwan, USA, Canada, the EU, Switzerland, Turkey, Australia, and New Zealand. Each notification service is made in accordance with the latest regulations, eg the REACH Regulation in the EU, a new regulation corresponding to GHS in Taiwan, and amendments of the Chemical Substances Control Law (CSCL) in Japan in 2010 and 2011. In Taiwan SCAS notified around 10,000 substances under the Existing Chemical Substance Notification, which is the largest number of notifications handled by a single representative. SCAS will continue to provide consultation services regarding the new regulation concerning new chemical substances, which comes into force in June 2011. SCAS started its notification services corresponding to the Amendment of Environmental Management of the New Chemical Substances in China in October 2010. SCAS will continue to provide its consultation services corresponding to New Chemicals Regulation in Korea in 2014. The extensive knowledge and experience, based upon regulations such as CSCL and REACH, will enable SCAS to confidently support its clients in their global chemicals strategies management. CASE STUDY 2: Representative services In some countries and regions like the EU or China, manufacturers or exporters shall appoint their representatives in the relevant country to manage chemicals, ie for notification/registration and for the obligations followed. SCAS has provided legal representation services by establishing new subsidiaries in the EU and China, or by cooperating with our local partners. In the EU SCAS has successfully submitted a number of dossiers under the REACH Regulation as only representative or third party representative. SCAS is developing its relationship with consultants in Malaysia, Vietnam, Indonesia, the Philippines and Thailand. SCAS supports the management of chemical substances in these countries by appointing highly experienced specialists.

Dr Oosterling, holding a masters degree in chemistry from State University Leiden, the Netherlands, offers approximately 15 years of experience in the field of environmental, health and safety regulations, including transportation and storage for the chemical industry (paints, flavours and fragrances, detergents). Specialist in chemical legislations and a contact for European clients. Ritsuko Furuta – Senior Manager (SCAS Europe) Dr Furuta has a doctor’s degree in pharmaceutical sciences from Osaka University, Japan, and a masters in environmental management from the University of Nottingham, UK. With more than 20 years of experience working as an analytical and regulatory scientist in pharmaceuticals and agrochemicals R&D divisions in the chemical industry, she specialises in the REACH and CLP Regulations and is a contact for European clients. Masato Sudo – Manager (SCAS) Mr Sudo has 25 years’ experience as a specialist in toxicological and ecotoxicological studies including bio-degradation, bio-concentration, acute toxicity, and repeated dose toxicity. He also has experience in the sales department concerning safety studies of chemical substances. Being located in Japan, he specialises in the CSCL. Makiko Hayashi – Manager (SCAS) Ms Hayashi is a global manager and a consultant of chemicals registration for a variety of countries and regions such as the EU (REACH), China, Korea and Japan, and has great expertise in formulating strategic approach for multi-regional registrations and risk assessment. She has a strong background in pharmaceutical and regulatory sciences, and also has vast experience in consulting on industrial chemicals, cosmetics and plant protection products.

CASE STUDY 3: Multi-regional notifications and consulting Multi-regional approach is one of SCAS’s chemical substances consulting services, based on its know-how and experiences through the services mentioned above. By using the multi-regional approach tailored to clients’ specific registration needs, ie designing test protocols so that the studies can be used in various countries, it is possible to reduce costs and to save time. SCAS supports chemical registrations in compliance with local chemical jurisdictions around the world. Regions and countries covered include Japan, the EU, USA, Canada, Australia, China, Korea, Taiwan, the Philippines, New Zealand, and Switzerland. With in-depth experience and a robust global network of highly regarded partners, SCAS has helped its clients achieve their goals at minimum cost with maximum results. Full-quality service and support are guaranteed, from designing test protocols to preparing dossiers for complete notification or registration.

Chemical Watch | Service Providers Guide 2011

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PROFILE: Sumika Chemical Analysis Service Ltd

PARTNERS

GLOBAL OFFICES Smithers Viscient Europe Horn, Switzerland Tel: +41 (0) 71 8468989 Shawbury, UK Tel: +44 (0) 1939 250383 Smithers Viscient North America Wareham, MA USA. Tel: +1 508 2952550 (Global Headquarters) Snow Camp, NC USA. Tel: +1 336 3760141 Smithers Viscient Asia Saitama, Japan Tel: +81 (0) 90 35999277 Shanghai, PR China Tel: + 86 (0) 21 51160674

PROFILE: Smithers Viscient

CONTACTS Web site

www.smithersviscient.com

E-mail

info@smithersviscient.com

Head office

Shrewsbury

Shropshire SY4 4NR

United Kingdom

SERVICES PROVIDED

Tel

+44 (0) 1939 250383

Registration strategy

Fax

+44 (0) 1939 251118

Contact

Dr Ben Gandhi

Directors

Dr Ben Gandhi, Global Leader of Consultancy

Dr Steffen Erler, Technical Director of Consultancy

Stefanie Schick, Director Business Development (Horn)

Ownership

Private company

Within the REACH activity, Smithers Viscient can provide guidance based on a combination of market share, tonnage band, chemistry and product end-use to assure appropriate timeliness of dossier submission and assure continued business revenue. This includes reviewing data to determine the most appropriate hazard and exposure assessment factors as well as risk management strategies to ensure safety while avoiding market disruptions from unnecessary risk management measures or over-stringent classifications.

Locations

Wareham, MA USA

Substances of very high concern (SVHCs) management.

Horn, Switzerland

Founded

1969

Partnering with Smithers Viscient to perform data reviews and chemical analysis helps mitigate the risk of relying on suppliers for accurate due diligence data. It can also provide intelligent strategies to meeting the REACH requirements, such as avoiding unnecessary product testing. Smithers has a firm grasp on managing the considerable uncertainty surrounding the procedure of SVHC candidate list substances, as well as what obligations must be met during implementation.

OVERVIEW The consulting division of Smithers Viscient based in the UK assists companies through regulatory issues such as REACH, cosmetics regulations as well as regulatory submissions and notifications worldwide. Smithers Viscient AG performs trusted studies that satisfy all major regulatory requirements. We specialise in applying integrated testing strategies for studies in toxicology, ecotoxicology and environmental fate. Since 1969, Smithers Viscient has served as a contract research organisation (CRO) for the agricultural, pharmaceutical, and chemical industries. Our regulatory expertise and laboratory experience enable us to provide REACH testing, including analytical support, safety assessment, and a range of registration solutions to help you meet your business objectives. VITAL STATISTICS

2009

Turnover, group

Turnover, chemical service provision

No of offices

No of countries represented

Staff, group

130

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 6% IT & software 2%

Consultancy/ advisory 20% Admin/ management 7% Information 5%

SIEF data review As a cost saving approach to SIEF data review, using a third party to review the data will provide an independent solution to selecting data and performing a data gap analysis. Comparatively, the cost of each SIEF member company reviewing the data and attempting to agree on which data to select will use time and labour which is too valuable in today's economic climate. Smithers Viscient can assist in selecting the best data for use in the registration strategy, and can accurately assess the data value and interpret the results based on our 40 years of regulatory testing services. Material replacement and dossier preparation Through extensive laboratories and testing facilities, Smithers Viscient can create lists of replacement options and assist with new product prototypes for testing to assure performance remains at a high level to satisfy the client and its customer base. With our history of creating dossiers for various industries on a global basis, we can assist chemical companies with this new process to assure deadlines are met. Environmental testing and regulatory services Smithers Viscient, formerly Smithers Springborn, is a global contract research organisation (CRO) providing environmental testing and regulatory services for the crop protection, pharmaceutical, industrial chemical, and the consumer and household product industries. With laboratories located in North America and Europe, Smithers Viscient has performed standard guideline and higher-tiered environmental studies for more than 40 years. We conduct studies to satisfy all regulatory requirements globally.

Laboratory 60%

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Chemical Watch | Service Providers Guide 2011

CASE STUDY 3: SVHCs

Adhering to regulatory requirements, as well as to company policy, is vital for strategic growth with minimised risk. Our consulting team supports new drug application (NDA) risk assessments and registration submissions. Additionally, Smithers Viscient specialises in environmental manufacturing risk assessments strategies designed to ensure that the use of a chemical is appropriately managed to create value while reducing environmental impact.

In collaboration with polymer experts at Smithers Rapra, a client’s plastics and non-woven product portfolio was reviewed with regards to the potential for hazardous ingredients being present. Each potential SVHC was examined in terms of its use during manufacture and processing of a material type. Particular consideration was given as to the chemical compatibility of each substance with the polymer chemistry. Through this approach, a targeted methodology was developed to enable supplier communications and product safety assessments to be conducted, the benefit to our client a global consumer products manufacturer was reassurance that hazardous ingredients were not involved in the use of the packaging or non-woven products and compliance to SVHCs requirements were met.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2010

Smithers Viscient expands to include RSG and SSL as one brand

2010

Smithers acquires PIRA International

2008

Smithers forms REACH Services Groups (RSG)

STAFF SELECTION

2008

Smithers Viscient established

Dr Ben Gandhi – Global Leader of Consultancy

2006

Smithers acquires Rapra Technology

2005

Smithers Pharma Services established

2002

Smithers acquires Springborn Laboratories (SSL)

1994

Smithers Quality Assessments established

1992

Smithers Laboratories Europe formed

1969

Springborn Laboratories founded in Wareham MA USA

Ben brings to Smithers Viscient a strong management background built over the last 20 years having held senior positions in the chemicals industry and service providers, the last six years specialising in the regulatory consultancy environment. Ben understands the clients need for efficiency and service and wanting value from consultancy. Ben also has experience in project management, consortia management, information through the supply chain, and contract negotiations.

1925

Smithers Scientific Services established

ACCREDITATIONS Member of the Only Representative Organisation (ORO). SETAC – Global Partners. PARTNERS Smithers Rapra, Smithers Quality Assessment (SQA), PIRA. Smithers Pharma Services. iSmithers CASE STUDY 1: Read-across expertise Smithers Viscient use of read-across resulting in cost savings of approximately 20% to our client. It also ensured full compliance with the REACH legal text to avoid animal testing. Specifically, a set of readacross substances were identified. Justification of the read-across was provided through an analysis of existing data, with QSARs to fill data gaps. Then, predictions of metabolism and degradation were made, with toxicological and ecotoxicological comparison of key metabolites/ degradants. This provided a strong basis for proceeding with the approach, which was accepted by all parties. This resulted in a saving of approximately €150,000 for the client (a chemical manufacturer), and the other SIEF members. CASE STUDY 2: Exposure-based waiving While REACH allows exposure-based waiving, potential application often depends on exposure assessment. For a substance where a critical process required a detailed exposure assessment, Smithers Viscient identified the relevance of existing exposure data on a surrogate substance. Our client had monitoring data for the surrogate, which is used in the same processes. By a comparison of the physicochemical properties, tonnage used, method of use and the chemistry involved in the process, a set of robust data on estimated exposure was obtained. When combined with conservative DNELs based on the existing data set, the exposure assessment provided a basis for the waiving of further studies. For the environmental assessment, an investigation of the downstream use and end-use allowed setting prescriptive risk management measures that also avoided the need for testing proposals. This provided approximately a €50,000 saving for the registration of our international chemical manufacturer.

Chemical Watch | Service Providers Guide 2011

Dr Steffen Erler – Technical Director of Consultancy Dr Erler gained a PhD on REACH and has been involved with REACH for more than 12 years, he is recognised as one of the leading authorities on the subject. He supports technically all of the REACH projects which include testing and test proposals, exposure assessments, SVHC reviews, hazard assessments, compliance standards, R&D plus the provision of REACH integrated solutions packages including inventory analysis, scientific assessments, consortia formation and compliance monitoring. Christopher Smith – Senior Consultant Chris has recently joined Smithers Viscient from Pfizer Inc. Chris now heads up our North America office and as well as REACH consultancy he is focusing on providing a service for environmental and manufacturing risk assessments. Chris also has extensive practical experience in registration of crop protection products and biocides according to international standards. Stefanie Schick – Director Business Development (CRO, Horn) Stefanie has worked in the life science industry for over 25 years. Her career started in the pharmaceutical industry in R&D, she then moved into global regulatory affairs, with clients in North America, Europe and Asia in preparing dossier and risk assessments. For the last ten years Stefanie has been in business development at CROs or service providers. Understanding the clients global need to meet regulatory requirements and working with agencies worldwide to ensure compliance is Stefanie's true strength.

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PROFILE: Smithers Viscient

Pharmaceutical consulting

GLOBAL OFFICES Headquarters group: TNO, Delft, The Netherlands, Headquarters TNO Triskelion: Zeist, The Netherlands Sales Office: Tokyo, Japan SERVICES PROVIDED

PROFILE: TNO Triskelion

CONTACTS

Risk assessment and registration of chemical substances

Web site

www.triskelion.nl

E-mail

chemistry@tno.triskelion.nl

Head office

Utrechtseweg 48, PO Box 844

3700 AV Zeist

The Netherlands

Tel

+31 88 866 2800

Fax

+31 88 866 6970

Contact

info@tno.triskelion.nl

Ownership

Private company, wholly-owned by TNO

Locations

Zeist, Netherlands

Founded

TNO, 1933; TNO-Triskelion 1/1/2011

Our focus is on REACH (registration, authorisation, exposure scenarios, audits) and biocides as well as health impact assessment (HIA) and nano-particles. Health risks as a result of exposure to chemical products in the workplace or the home often go unnoticed. TNO has developed a range of assessment tools, to help evaluate exposure of workers and consumers and to avoid and reduce health risks. Our clients are major chemicals manufacturers and trade associations but also include small and sized enterprises. Experimental toxicology

OVERVIEW TNO Triskelion is a new 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 services characterised by strong communication with a personal touch that larger CROs cannot match. VITAL STATISTICS

2010

Turnover, group

€650m

Turnover, chemical service provision

€30m

No of offices

No of countries represented

Staff, group

4,500

Staff, chemical service provision

230

SERVICE AREA BREAKDOWN IT & software 5%

Training 5%

Consultancy/ advisory 30%

Laboratory 45% Admin/ management 10% Information 5%

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Our toxicological research centre is a specialised centre of excellence for new and improved methods in toxicology, especially inhalation, reproduction and immuno-toxicology (see below). We have developed novel methods for testing nanomaterials and have actively been developing novel methods to reduce, refine and replace animal testing for nearly two decades. We are proud of our performance record in this field, especially combined in vivo studies such as repeat-dose, repro screening an in vivo gentox in the same study. TNO's focus on in vitro alternatives led to the ICE test, replacing in vivo eye irritation and corrosion tests. 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: • mechanistic studies of toxic compounds in vivo using sophisticated analytical techniques; • 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 sharpen 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 your 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 | Service Providers Guide 2011

1932

TNO The Netherlands Organisation for Applied Scientific Research is founded

1946

Founding of the Central Organic Chemistry Institute in Zeist

1960

Development of the first organic antifouling paints

2004

Completion of five-year HPV programmes on various chemical groups including: organotins

2005

TNO Business Unit Quality & Safety formed to offer safety services to the chemical industry

2006

Participated in REACH implementation projects (data requirements, exposure assessment)

2007

Commenced REACH partnership with Sabic Europe.

2008

REACH phase I takes off: a long deep dive

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

ACCREDITATIONS In compliance with GLP (toxicology and analytical chemistry); ISO 9001 certified; Some analytical services under ISO 17025 PARTNERS TNO Quality and Safety (R&D) ReachCentrum (workshops and training) EPPA Consulting (advocacy) 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, polyols and isocyanates, silicates and mineral oxides (micro and nano grades), coal chemicals, fragrances. TESTIMONIALS "In the past three years TNO Triskelion has steered us safely through the difficulties and uncertainties of REACH registration. It is a thorough, scientifically reliable and pro-active partner for the risk assessment and registration of chemicals" – Harrie Camps, SABIC CASE STUDY 1: Successful registration within REACH, post-2010 follow-up and 2013 preparations Successful registration of Annex X substances on 1 December 2010 was the primary goal of chemical companies for several years. However, it is now time to focus on managing the next phases of REACH, ie ensuring timely follow-up of ECHA’s response to Annex X registrations as well as ECHA’s decisions on 540 test plans and equally importantly, for specialty chemicals manufacturers, the preparation of the next wave of Annex IX registrations for 100-1000 tonnes substances. Depending on ECHA’s report to the European Commission, this could possibly also include nanomaterials. Our experience in developing exposure scenarios is leading in the European field and includes methodologies for dealing with complex mixtures (UVCB).

Chemical Watch | Service Providers Guide 2011

By 1 June 2013, companies should have completed the registration of substances in the 100-1000 tonnage band. Does your substance have sufficient data or do you need to carry out a testing programme first? The time for dossier preparation is quite limited. TNO Triskelion can help you plan the registration, guide you through the process, and/or work with you to ensure timely and successful registration. CASE STUDY 2: ECHA test proposal evaluations – what to do? REACH requires that for substance volumes of 100-1,000t and >1,000t, higher tier safety studies be included in the registration dossier in the form of a test proposal; ECHA will evaluate these proposals and publish a decision. ECHA has informed the chemicals industry that Phase I of REACH yielded 404 test proposals. Each will be published on the ECHA website and is open for public comment for several weeks. In the two months from 1 January to 28 February 2011, a total of 32 testing proposals covering 59 studies were published by ECHA at weekly to fortnightly intervals. • Our advice to clients faced with an ECHA test-proposal evaluation is to first relook at the read-across arguments used and to strengthen these with comparative physico-chemical and biological data on similar molecules. TNO can help develop and support the scientific justification for read-across. • Should testing be approved, 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. CASE STUDY 3: REACH compliance auditing TNO Triskelion has the REACH expertise and the compliance audit experience to support you in dealing with this critical compliance and business-continuity issue. We will work with you to develop compliance review programmes that best meets your needs, and can undertake pilot and/or full-scale REACH reviews at your EU legal entities, reporting on gaps and recommending prioritised remediation steps. We can help you answer the following questions: • how do you set up an effective REACH compliance programme that meets the specific needs of your business, and those of the EU member state REACH enforcement authorities? • how do you ensure your only representatives are meeting your compliance obligations on your behalf? • how can you incorporate REACH into your existing internal audit programme, in line with your corporate quality standards and internal audit methodology? • how can you ensure that you communicate effectively with your clients and suppliers to optimise extended safety data sheet development? 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

GLOBAL OFFICES Northern and southern England, Scotland and Italy SERVICES PROVIDED Limit values and environmental quality standards

PROFILE: wca environment

CONTACTS Web site

www.wca-environment.com

E-mail

solutions@wca-environment.com

Head office

Brunel House

Volunteer Way

Faringdon, UK

We are expert in the development of environmental and human health quality standards and limit values for soils, sediments and fresh and marine waters for regulatory organisations and industry. wca environment has extensive experience in reviewing, analysing and synthesising environmental ecotoxicology and monitoring data, including for biota, in order to provide support to regulatory decision-makers, particularly under the Water Framework Directive.

Tel

+44 (0)1367 246026

REACH and CLP services

Fax

+44 (0)1367 246041

Contact

claire.massey@wca-environment.com

Directors

Graham Merrington, Managing Director

Dawn Maycock, Finance Director

David Taylor, Strategy Director

Ownership

Private company

Locations

United Kingdom, Italy

Founded

2005

We have considerable experience with all aspects of the REACH Regulations, with activities ranging from initial data review and assessment, through to IUCLID5 file preparation and final registration. We have experience in completing the physico-chemical, environmental fate and ecotoxicity hazard sections (including the PNEC derivations), and environmental exposure assessment. wca environment works for a number of clients across a variety of industries, and has been involved in over 400 successful registrations. These chemicals included metals, organics and substances of unknown and variable composition. We have prepared classification and labelling proposals as part of CLP notifications and REACH projects, and can assist clients in preparing updates to these if new data become available.

OVERVIEW wca environment limited (www.wca-environment.com) is an independent research and consultancy company established in 2005 by highly experienced chemical risk assessors. We provide assistance to industry and government agencies in the field of environmental toxicology and risk assessment. wca environment is expert in preparing chemical risk assessments under REACH; in the derivation of environmental quality standards and limit values for substances in waters, soils, sediments and wastes; and in producing hazard and exposure assessments for active substances in pesticides, biocides and human and veterinary medicines. VITAL STATISTICS

2009

Turnover, group

£1.5m

Turnover, chemical service provision

£1.5m

No of offices

No of countries represented

Staff, group

20+

Staff, chemical service provision

20+

SERVICE AREA BREAKDOWN Admin/ management 8%

Socio-economic analysis We assist government and commercial clients to develop methods for performing SEAs, with an emphasis on the use of quantitative and semiquantitative evidence. We have also developed and used multi-criteria decision analysis techniques to allow the consistent combined use of both quantitative and qualitative evidence in SEA. We are currently engaged in developing SEA methodology for metal compounds that may be subject to authorisation under REACH in the near future, refining exposure scenarios to quantify and evaluate risks to human health and the environment and to undertaking analysis of alternatives. Biocides and active substances We advise commercial clients when dealing with regulatory agencies and when preparing dossiers for marketing authorisation applications. We have expertise in the environmental risk assessment of pesticides, biocides and medicines, including interpretation of higher tier tests (eg mesocosms) and use of probabilistic approaches. We have developed prioritisation frameworks for human and veterinary medicines and advised on environmental toxicology, monitoring and modelling strategies for government clients. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Training 2% Consultancy/ advisory 90%

2005

Company established

2008

Established head office in Faringdon

2009

Doubled number of staff employed

2010

Successfully registered over 400 REACH dossiers

2011

Established new management structure and recruited staff to offer greater depth in assessment of bioactives

ACCREDITATIONS wca environment is certified to ISO 9001:2008. We are also certified to ISO 14001:2004 PARTNERS Regulatory Science Associates (RSA), Penman Consulting, Bibra

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Chemical Watch | Service Providers Guide 2011

BASF, Bayer Crop Science, Biogen, Catalent Pharma Solutions, CEFIC, CONCAWE, ConocoPhillips, DEFRA, Environment Agency, EuroChlor, ECMA, ECETOC, European Commission JRC, Frit REACH Consortium, HOPAT REACH Consortium, ITRI, i2A, IMnI, ICA, Johnson Matthey, LOAT REACH Consortium, Luxembourg Environment Agency, Medscreen, NiPERA, Novartis, Penman Consulting, Pfizer, Precious Metals REACH Consortium, Reckitt Benckiser, Rio Tinto, Scottish Salmon Producers’ Organisation, Scottish Aquaculture Research Forum, Spelthorne Borough Council, Syngenta TESTIMONIALS "wca environment is a first class consultancy and its pro-active, collaborative style has been pivotal in helping Johnson Matthey to develop exposure scenarios and deliver chemical safety assessments as part of our ongoing REACH initiative. I cannot recommend wca enough as the first port of call should you require unrivalled risk assessment expertise" − REACH Manager, Johnson Matthey Catalysts CASE STUDY 1: Higher Olefins and Poly Alpha Olefins (HOPA) REACH registration project Client: HOPA REACH Consortium. Approximately 80 substances that fall into the categories of linear alpha olefins, olefins branched and linear, and poly alpha olefins needed to be registered under REACH and CLP by December 2010. wca environment were part of a consortium of legal, financial and technical experts who formed the HOPA REACH Services Team. wca environment were responsible for the preparation of the physico-chemical, environmental fate and ecotoxicity sections of the REACH submissions. Successfully undertaking this project involved: • conducting literature searches and reviewing all available data; compiling and organising data for all categories/substances; • selecting key studies for robust and supporting summaries; identifying data gaps and designing testing strategies; • preparing robust and supporting summaries in IUCLID; deriving predicted no effect concentrations (PNECS); • conducting environmental exposure assessments; conducting PBT and vPvB assessments; • proposing classification and labelling; and producing the relevant sections of the CSA and CSR. CASE STUDY 2: Literature reviews for endocrine disrupting properties of plant protection product active ingredients The recently revised European legislation on plant protection products (Regulation (EC) No. 1107/2009) sets out new, stricter, criteria for approval of active substances and includes the assessment of endocrine disrupting properties. One way of determining whether a substance is an endocrine disrupter is to use a weight of evidence (WoE) approach to evaluate all available data. wca were engaged by our client to establish a WoE approach, which makes use of endpoints available in standard regulatory toxicity and ecotoxicity studies required for dossier submission and any relevant information in the open literature, and evaluate these for indications of endocrine effects. Two published WoE frameworks for the assessment of the endocrine disrupting properties of chemicals were evaluated and elements of each combined into a practical WoE evaluation for PPP active substances. The combined framework consists of four evaluation steps: 1) study reliability − quality of work undertaken; 2) study relevance − endpoint relevance to endocrine disruption; 3) study significance − based on the earlier assessments made for reliability and relevance; and 4) balance of the weight of evidence, coherence and gap assessment. A report for each active substance was produced for the client.

Chemical Watch | Service Providers Guide 2011

CASE STUDY 3: Development of a code of practice for using recycled organic materials in land reclamation in the UK Client: SNIFFER (Scotland and Northern Ireland Forum for Environmental Research). This project produced a code of practice on the use of wastederived organic amendments in land reclamation. This was aimed at relevant stakeholders in Scotland and Northern Ireland, but is also of value to equivalent stakeholders in other parts of the UK and potentially elsewhere in Europe. Available codes of practice and relevant scientific research were summarised in a literature review, and interviews with key stakeholders were undertaken to gauge their views on the format and content of the final document and help to structure the outputs. A draft version of the code was prepared along with an accompanying technical document, which provided supporting scientific evidence to justify the recommendations and guidance within the code itself. Both of these documents were based on the literature review, the views of stakeholders and the advice of the project technical advisory group (TAG), made up of representatives from SEPA, Scottish Water, NIEA, the Environment Agency, the Forestry Commission and WRAP. The draft code was sent out for open public consultation and was published in its final version at a launch event in Edinburgh in March 2010. STAFF SELECTION Dr Graham Merrington – Managing Director Graham has more than 15 years' experience of terrestrial risk assessment, waste regulation, and the behaviour and effects of metals in the environment. Graham joined wca from the Environment Agency of England and Wales where he led an R&D programme focused on environmental quality standards in soils, waters and sediments. Key projects included the incorporation of Biotic Ligand Models into compliance assessment and the implementation of ecologically based soil standards for metals. Dr David Taylor – Strategy Director David is an environmental chemist with 40 years' experience of the evaluation, management and resolution of environmental issues in the heavy chemical, speciality chemical, agrochemical and pharmaceutical industries. He is a fellow of the Royal Society of Chemistry where he is chair of the Environmental, Safety & Health Policy Group. Until June 2008 he was the global director of environment and sustainability for the pharmaceutical company AtraZeneca. Ed Stutt – Principal Consultant, Marketing Executive Ed has more than 14 years' experience as an environmental scientist working in academia and consultancy. His areas of expertise include the fate and transport of chemicals in the environment and human health risk assessment. Ed has also worked in the assessment of contaminated land and contributed to several items of national technical guidance in this area. Dr Claire Massey – Principal Consultant Claire is an environmental toxicologist with more than seven years of experience in environmental regulation and consultancy. Claire has particular expertise in assessing the fate and effects of chemicals in the environment, deterministic and probabilistic modelling of risks to wildlife and data analysis. Claire manages the environmental aspects of REACH registration projects for wca which successfully contributed to the registration of more than 400 chemicals in 2010.

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PROFILE: wca environment

CLIENTS

GLOBAL OFFICES European Office of Wildlife International Ltd; Waterstraat 5, 7201 HM Zutphen, The Netherlands Japanese Agent: LSG Corporation; S&S Buildling 6-36 ShinOgawamachi; Shinjuku-ku, Tokyo 162-0814; Japan SERVICES PROVIDED

PROFILE: Wildlife International Ltd

CONTACTS

Biodegradability testing and environmental fate

Web site

www.wildlifeinternational.com

E-mail

aleopold@wildlifeinternational.com

Head office

8598 Commerce Drive

Easton Maryland 21601

USA

Tel

+1 4108228600

Fax

+1 4108220632

Biodegradation screening and testing (OECD 301, 310, 314, 303, etc). Environmental fate testing (OECD 307, 308, 309, 106). Specific expertise in the context of REACH is in the field of biodegradability screening and simulation testing. The director of our Biodegradation and Environmental Fate Department was one of the authors of OECD guideline 314, Simulation tests to assess the biodegradability of chemicals discharged in wastewater. This study can be used as a less expensive alternative to the Continuous Activated Sludge Test (OECD 303A).

Contact

Annegaaike Leopold

Endocrine disruptor screening and testing

Directors

Mark Jaber, CEO

Jim Miraldi, CFO

Dave Palmer, Director of Business Services

Annegaaike Leopold,

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

Director of European Business Development Ownership

Private company

Locations

USA, The Netherlands

Founded

1976

We offer testing and study design expertise in terrestrial and aquatic plant testing and evaluation of products to sediment dwelling organisms. A 9,000 m2 greenhouse provides ample space for testing multiple species and advanced study designs. Sediment testing includes freshwater and marine acute and chronic tests. Ecotoxicology testing

OVERVIEW Wildlife International Ltd is a leading contract research organisation (CRO) specialising in ecotoxicology, environmental fate and chemistry. Established in 1976, we serve and provide support to a global clientele with GLP studies to meet global regulatory requirements for the testing of agrochemicals, industrial chemicals, pharmaceuticals, biocides and animal health products. Our highly experienced and talented team of scientists and technicians focuses on quality, timeliness, innovation and flexibility to meet the complex needs of diverse markets, each of which are confronted with ever more complex regulations.

Wildlife International Ltd maintains a modern aquatic toxicology laboratory. It has been open since 1990. The facilities are designed to accommodate a wide range of acute and chronic aquatic tests, and are capable of supporting a large number of concurrent studies. Testing is performed in walk-in environmental control chambers with built-in reconfigurable diluter systems (capable of holding up to 64 replicate test tanks), or in smaller test systems each consisting of an integrated temperature controlled water bath and diluter, enclosed in an isolation chamber.

VITAL STATISTICS

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

2009 US$13.6m

1976

Established as an avian toxicology facility with a staff of five

US$1.5m

1983

Company acquired by current ceo and partner

No of offices

1986

No of countries represented

Opened laboratory designed for full service avian toxicology testing

1990

Opened 2800m2 aquatic toxicology and chemistry laboratory

1990

Expanded avian toxicology laboratory to 3600m2

1992

Established biodegradation department to offer ready, inherent and specialty biodegradation testing

1997

Opened the European office of Wildlife International Ltd in The Netherlands

2000

Opened 1,300m2 environmentally controlled greenhouse facility

2006

Expanded biodegradation and e-fate department to include 300m2 of new laboratory space

2010

Began construction on 1100 m2 expansion to aquatic and chemistry labs.

2010

Acquired by the Riverside Company

2011

Opened up 1100m2 expansion designed to conduct aquatic endocrine testing

Turnover, group Turnover, chemical service provision

Staff, group

105

Staff, chemical service provision

SERVICE AREA BREAKDOWN Training 3%

Other 2%

Consultancy/ advisory 5%

Laboratory 90%

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Chemical Watch | Service Providers Guide 2011

Good Laboratory Practice (GLP) − multiple inspections by EPA with no findings PARTNERS Wildlife International Ltd works with many other contract laboratories and consultancies with the aim of optimally serving our clients. We do not have a partnership with any one company. CLIENTS • Agricultural chemicals – Dupont, Syngenta, DowAgro, BASF, Bayer, Makteshim-Agan, Sumitomo, Nihon Nohyaku, Valent, Gowan, Agrichem • Industrial chemicals – Dow Chemical, Albemarle, ICL, Bayer, Dupont, Akzo Nobel, Procter and Gamble • Pharmaceutical – Pfizer, Sanofi-Aventis, Eli Lilly, Merck • Animal health – Intervet, Eli Lilly TESTIMONIALS "Wildlife International has always had a highly competent staff that produces high quality reports with attention to detail. The reports meet or exceed our needs for REACH and other regulatory requirements. Wildlife is also flexible and will attempt to meet timelines on key projects if at all possible. We have enjoyed working with Wildlife International Ltd personnel for over 15 years and will continue to do so in the future" − The Dow Chemical Company CASE STUDY 1: Minimised bioaccumulation test design − developed by Dr T Springer and Dr H Krueger at Wildlife International Ltd. Bioaccumulation testing: minimised design using fewer animals and fewer resources. Wildlife International Ltd has developed a minimised bioaccumulation test design as alternative to the existing OECD 305 guideline study (Springer et al 2008). This minimised design has been taken up in the REACH guidance under section R7C Key aspects of the minimised design include: • sampling of fish tissues twice − only twice − during depuration; • the goal is to determine kinetic definition (BCF=uptake rate constant/ depuration rate constant), and therefore a steady-state of the chemical in fish tissue concentrations need not be achieved; • animal use is reduced by at least 75% relative to the standard OECD 305 test if the minimised design is used (eight instead of 36 animals minimum per concentration tested); • taken up in the modified OECD 305 guideline as part of a tiered approach. If well above or below trigger values of concern, this can be accepted as final study. CASE STUDY 2: Evaluation of fate of arzoxifene − work performed at Wildlife International Ltd. Poster presented at SETAC 2010, Perkins et al. Arzoxifene is a selective estrogen receptor modulator in development for the treatment of osteoporosis in humans. To evaluate fate in a sewage treatment plant, 14C-arzoxifene was incubated with sewage sludge in three systems: static, porous pot, and anaerobic digestion. In a 28-d static aerobic system, less than 1% of the applied radioactivity (AR) was converted to 14CO2 and the total amount of transformation products at each sampling interval ranged from three to 15%. In a porous pot, 14C-arzoxifene was introduced continuously in the influent into a mixedliquor system. Less than 0.1% AR was converted to 14CO2 and HPLC/ RAM indicated that the radioactivity in the mixed liquor was all arzoxifene. The effluent contained only about 10% of the radioactivity in the influent, and of that radioactivity, only about half was arzoxifene.

Chemical Watch | Service Providers Guide 2011

The remaining radioactivity was bound to solids. In anaerobic sludge digestion, less than 0.1% AR was converted to 14CO2 or 14CH4. Transformation products ranged from 10.5 to 13.8% of the extractable radioactivity. The fate of 14C-arzoxifene was evaluated in two static, aerobic water sediment systems for 100 days. Lastly, the fate of 14C-arzoxifene in the terrestrial compartment was evaluated in four soils under aerobic conditions for 120 days. In summary, there is inherent biodegradation potential of arzoxifene in the environment as evidenced by transformation products and some 14CO2 evolution. However, the majority of depletion of arzoxifene from the environment will be due to strong and unextractable sorption to solids, both sewage solids and those in sediment and soil. CASE STUDY 3: Results of aquatic and terrestrial invertebrate studies with a brominated flame retardant. Poster presented at SETAC 2010, Hardy et al. Using the water accommodated fraction method due to DBDPEthane’s low water solubility (0.72 ?g/L), the No Observed Effect Load Rates in fish (O. mykiss, 96 h), daphnia (D. magna, 48 h), and freshwater algae (S. capricornutum, 96 h) were >110 mg/L, the highest doses tested. The 28-d No Observed Effect Level in two sediment dwelling species, the midge C. riparius and the oligochaete L. variegates, using spiked sediment with 2% organic carbon was 5,000 mg/kg dry sediment. In an earthworm (E. fetida) survival and reproduction study, the 28-day No Observed Effect Concentration (NOEC) for survival was 3,720 mg/kg dry soil. The EC50 for reproduction was 3,180 mg/kg dry soil while the NOEC for reproduction was 1,910 mg/kg dry soil. Seedling emergence and growth of six species of plants (Z. mays, C. sativa, A. cepa, L. perenne, G. max, L. esculentum) was not effected at doses >=1,563 mg/kg. Nitrification by soil bacteria was not adversely affected (6% inhibition) by a 28-d exposure to 2,500 mg/kg soil. Sewage sludge respiration was not inhibited at the limit dose of 10 mg/L. All studies were conducted under good laboratory practices, according to OECD and/or US EPA OPPTS guidelines, and used material representative of the commercial product as test article. STAFF SELECTION Henry O Krueger, PhD – Director of Aquatic and Non-Target Plant Testing · Director of aquatic toxicology since 1995. Responsible for all aspects of the Wildlife International Ltd aquatic toxicology programme including fish and amphibian endocrine disrupter studies · Expert aquatic toxicologist. Timothy Springer, PhD – Director of Special Projects · Manager of special projects and technical support. Responsible for the development of all amphibian testing programmes including endocrine disrupter development tests with Xenopus sp. · Expert in study design and statistical evaluation of toxicology data · Development of alternative testing systems with fish and amphibians including design, conduct, data analyses and reporting · Key membership in EPA/OECD test method development committees. Edward Schaefer – Director of Fate and Biodegradation Mr Schaefer has more than 20 years of experience in the area of degradation and environmental fate testing. Responsible for study design and oversight of testing programs. Key contributor to development of EPA/OECD test guidelines. Willard Nixon, PhD – Director of Chemistry Dr Nixon has more than 25 years of experience in analytical chemistry. He received his degree in analytical chemistry from UNC Chapel Hill. He has worked in the area of environmental chemistry for over 20 years and his group provides analytical support for the WLI ecotoxicology group.

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PROFILE: Wildlife International Ltd

ACCREDITATIONS

CONTACTS

NICHE FIRM PROFILES

Web site E-mail Head office Tel Fax Contact Ownership Founded

www.aw-chemadvice.eu awchemadvice@xs4all.nl Looierslaan 8, 2264 AA Leidschendam, The Netherlands +31 703204891 +31 847517808 Arnold van der Wielen Private company 2010

OVERVIEW A small consultancy specialising in the legal and technical implementation of REACH and CLP, providing advice to companies and governmental organisations. SERVICES PROVIDED Advice on legal and technical implementation of chemical management policy, especially in the implementation of European chemicals legislation such as the REACH and CLP regulations. Advice on risk and hazard assessment of chemicals, on classification and labelling of chemicals and preparations, also gives advice needed to fulfil the requirements of the European CLP regulation. Offers a great network of contacts in the European Commission, ECHA and EU member states. CLIENTS National Institute for Public Health and the Environment, Moxba Metrex, KMR Stainless, Forest Metal Group, BSEF

Web site E-mail Head office Tel Contact Ownership Founded

www.cbconsult.nl clj.braun@kpnplanet.nl Alteveer 26, 6881BK Velp, The Netherlands +31 26 3612136 / +31 6 16312139 Chris Braun Private company June 2009

OVERVIEW Chris Braun has more than 30 years of experience in the chemical industry, of which the last ten were dedicated to the introduction and implementation of REACH in one of Europe's major chemical companies. Previous experience was in notification of new chemicals, RAR and SIDS dossiers, mammalian toxicology, occupational hygiene, health and safety auditing and occupational medicine. Working independently, CBC's wide network will serve you well in selecting testing laboratories and other service providers. SERVICES PROVIDED Advice to companies, consortia and SIEFS on how to organise the registration process; coordination and monitoring of outsourced activities such as testing, dossier compilation etc; dossier review and approval; assistance in REACH and CLP registration; actual dossier compilation for human toxicology and epidemiology; advice to companies on REACH compliance and the post-registration process; consultancy on substance toxicity, medical aspects and handling, especially in the occupational area. CLIENTS For confidentiality reasons, clients cannot be named. However, testimonials may be provided upon request. CBC advised four major consortia, covering eight different substances, and participated in the dossier compilation of two more substances. All registrations were successful and in time.

CONTACTS Web site E-mail Head office Tel Fax Contact Ownership Locations Founded

www.calebgroup.net john@calebgroup.net The Stables, Somerset House, Church Road Tormarton, Badminton, Gloucestershire, UK +44 (0)1454 269330 +44 (0)1454 216030 John Yates Private company UK, Germany 1994

OVERVIEW Caleb Management Services Ltd is a policy and regulatory consultancy that has been active in the field of chemical regulation since 1994. Caleb’s clients range from governments, multi-national companies and world-wide 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. • Consortium management • REACH dossier development and registration • SIEF management • CLP compliance management • SDS authoring and management • OR and TPR services 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.

Explanation Service providers that have taken a niche profile have annual revenues of less than €700,000.

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CONTACTS Web site E-mail Head office Tel Fax Contact Ownership Locations Founded

www.EggCentris.com Rita.Cortvrindt@EggCentris.com Z1; Research park 310, 1731 Zellik Joseph Wybranlaan 40, 1070 Anderlecht Belgium +32 (0) 2/529 58 69 +32 (0) 2/529 51 04 Rita Cortvrindt Private company Belgium 2002

OVERVIEW EggCentris is a contract research laboratory with expertise in reproductive function and its toxicity. We have developed a unique battery of innovative and proprietary in vitro bioassays which mimic different target organs, allowing the investigation of effects on male and female fertility, embryo development, and endocrine disruption. These tests can be applied for screening, hazard characterisation, and mechanism of action elucidation of chemicals, biologicals, and materials. SERVICES PROVIDED EggCentris offers testing services (ISO 17025) and knowledge-based project research. Our multi-parametric bioassays, which mimic in vivo physiology, generate quantitative and qualitative datasets which allow the prediction of fertility issues, pre- and postimplantation embryo toxicity, and endocrine disruption at the functional level. These in vitro tools are ideal for determining toxic concentrations, screening, ranking, and comparing compounds for their toxic profile. CLIENTS EggCentris targets companies concerned with safeguarding reproductive functions in general and with gamete and embryo quality in particular. Such companies may be drawn from the pharmaceutical, chemical, or cosmetic industries. In addition, we can help fertility centres and their suppliers as a quality assurance laboratory for their medical devices and labware used for the handling of gametes and embryos.

Chemical Watch | Service Providers Guide 2011

CONTACTS

CONTACTS www.emveo.be mvo@emveo.be Route de Meux 58 – B 5031 – Gembloux Belgium +32 497475366 +32 81640024 Mireille Van Overstraeten Private company 2010

OVERVIEW Chemical management: REACH implementation and monitoring – supply chain development – environmental risk assessment – lifecycle analysis. International experience in consulting, business association management, project management and EU affairs. SERVICES PROVIDED The chemical management services of Emveo include REACH as a core service, with guidance on regulatory obligations, audit of the product compliance and management of the compliance project. We stimulate strategic thinking within the supply chain and evaluate the consequences of non-compliance. Additionally we provide advisory services for SVHC and project management for successful registration strategies.

Web site E-mail Head office Tel Contact Ownership Founded

www.igcon.nl ineke.gubbels@igcon.nl Booglaan 4, 5348JJ Oss, The Netherlands +31 412854594 Ineke Gubbels Private company 2011

OVERVIEW Ineke Gubbels founded IGCON in February 2011. She will assist clients with services related to regulatory compliance. Extensive knowledge on EU regulations combined with years of experience in toxicology and risk assessment guarantee that you will receive high quality advice on REACH, biocides and food. This will facilitate your access to the market and will lead to sustainable business solutions. You do not need to gather knowledge on massive legislation like REACH or become a toxicologist yourself. SERVICES PROVIDED Strategic consultancy: regulatory impact on business case; independent trustee; consortium management. Technical consultancy: testing strategies; interpretation of (test) results; alternatives to testing; risk assessment. Toxicology: toxicological review; monitoring services; dossier preparation; alternatives to animal testing. REACH: SIEF and consortium management; interpretation and strategic advice; robust study summaries; CSR.

CLIENTS Clients' companies are in the following sectors: mining; industrial chemicals; advisory in environmental management, chemicals management, biotechnology.

CLIENTS Clients come mainly from chemical industry, governmental organisations and others. Identity of individual clients and the nature of the work performed will only be disclosed after formal approval by the client. Confidentiality is key to the services delivered.

CONTACTS

Web site E-mail Head office Tel Contact Ownership Locations Founded

www.h2compliance.com ursula.hayes@h2compliance.com Unit 4A Nutgrove Office Park Rathfarnham Dublin, Ireland +353 1 2989146 Ursula Hayes Private company Ireland (Dublin, Cork), USA (New York) 2006

Web site E-mail Head office Tel Fax Contact Ownership Founded

www.intlcosmetics.com janet@intlcosmetics.com 947 Manhattan Beach Bl, Suite A, Manhattan Beach, CA 902665135, USA +1 310 545 3223 +1 310 546 6204 Janet Winter Blaschke Private company 1997

OVERVIEW H2 Compliance provides chemical and environmental regulatory sustainability services that support company compliance, market access and competitive advantage goals in the market place. By utilising a highly qualified core team and a network of partners and associates in the USA, Europe, China and Canada, H2 Compliance can ensure broad access and local support when required.

OVERVIEW Worldwide regulatory specialists from Argentina to Zimbabwe − full regulatory support for cosmetics in Europe, the USA and Canada as well as South America and Asia. The principal and staff bring to their clients more than 60 years of experience in this field via contract manufacturing, brand manufacturing as well as direct sales. Let us show you how easy launching a product in these markets can be, while meeting the regulations and country requirements for product compliance.

SERVICES PROVIDED

Dossier preparation and data management; GHS and CLP support; NONS conversions; Articles and SVHCs; Only Representative; (pre-) registration services; SIEF facilitation; corporate strategy and advice; supply chain communication; workshops.

We are experts in providing: US FDA electronic registrations – US labelling compliance – OTC drug facts labelling – facility audits to FDA GMPs worldwide – European product information files (PIFs) with qualified safety assessment (recast − compliant) – assistance in meeting retailers requirements including QVC and Sephora – European notifications (Member States) – Canadian notifications and DINS – European office for non EU companies – services for EMEA countries and more

CLIENTS Confidential clients including those in the following sectors: lubricants; dyes/inks; medical devices; pharmaceutical; fragrances; metals/minerals; chemicals; polymers; and IT.

Chemical Watch | Service Providers Guide 2011

CLIENTS We serve a variety of clients, both large and small… from micro enterprises to multinationals. Clients you might recognise: Johnson & Johnson Consumer Products – Henkel Consumer Goods – Juvena / La Prairie – NuSkin – Frederic Fekkai – Rock and Republic – Sexy Hair – Smashbox – TIGI – and others

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NICHE FIRM PROFILES

Web site E-mail Head office Tel Fax Contact Ownership Founded

CONTACTS

NICHE FIRM PROFILES

Web site 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 offers strategic and practical support of high quality to the various stakeholders working towards an efficient and successful implementation of REACH, CLP and related EU chemicals legislation. We combine our thorough legislative knowledge, joy in strategic and practical consultancy, enthusiastic facilitation and training of group processes, affinity for IT and creative, innovative and process oriented thinking ("out of the box") up to working solutions, good results and satisfied customers. SERVICES PROVIDED Sparring partner for company (REACH) teams, organising efficient REACH compliance strategy and practical solutions in the company. Providing specific training and workshops (generic and in-company). Providing powerful support tools, eg REACHsuite Advantage, a web based registration and SIEF management tool that will ease your lead registration and non-lead registration management tremendously. Check our website for more detailed services and references! CLIENTS Umicore (B), SACHEM Europe BV (NL), LyondellBasell (EU), Kemira (FI), Huntsman (B), Halliburton (NO), Firmenich (CH), Eastman Chemical (NL), DEME (B), Ankerpoort (NL), Allied Carbon (Ukraine) and many satisfied participants on our REACH compliance training programme 2011

CONTACTS Web site 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, advocacy and communications for the chemical, food and pharmaceutical industries. Linmark Consulting is headquartered in Basel, Switzerland, a major European centre for the life sciences and chemical industries, with good communications within Europe and wider. Its French subsidiary, Linmark Consulting Europe SARL, offers only representative services under REACH, for chemical importers into Europe. SERVICES PROVIDED Particular skills are in generating new business or protecting client businesses through using regulatory knowledge and practice, stakeholder analysis, problem-solving and communications with stakeholders. Offerings are based on over 25 years' senior operational experience in management of regulatory affairs and product development functions in multi-national chemical, agricultural biotechnology and biopharma companies in UK, USA and Switzerland. Skills are relevant to substances of very high concern and SEA.

Web site E-mail Head office Tel Fax Contact Ownership Locations Founded

www.LKC-ltd.com LKC@lkc-ltd.com Postfach 167 Hauptstrasse Switzerland +41 61 906 8500 +41 61 906 8509 David Kane Private company Switzerland and UK 2001

OVERVIEW LKC Switzerland Ltd provides registration and development management services to the international chemical industry. SERVICES PROVIDED LKC provides a full range of regulatory services to achieve the successful registration of our clients' products in the fields of plant protection, biocides, veterinary medicines and industrial chemicals. CLIENTS LKC's clients are specialty chemical manufacturers who benefit from LKC's technical support in sectors of agrochemical, biocide, animal health and general chemicals.

CONTACTS Web site E-mail Head office Tel Fax Contact Ownership Locations Founded

www.reachchemical.com info@reachchemical.com Unit 5, Polygon Business Centre, David Road Colnbrook, Berkshire SL3 0QT UK +44 (0)1753 68980 +1 310 546 6204 Janet Winter Blaschke Private company UK, USA 2007

OVERVIEW REACH Chemical Consulting Ltd is a sister company to International Cosmetics & Regulatory Specialists LLC USA. We have experienced staff that have completed REACH management post-graduate certificate programme at the University of Hull. In addition to pre-registrations in 2008, we were among the first 300 successful full registrants in 2009. We continue with representing our clients for new substance registrations, and qualified late pre-registrations. SERVICES PROVIDED REACH full service for – only representative services – late pre-registration – full substance registration – new substance registration – CLP and REACH compliant safety data sheets – classification, labelling and packaging (CLP) compliance – CLP notifications – CLP classification and labelling for hazardous substances and mixtures – chemical safety reports (CSR)/chemical safety assessment (CSA) – supply chain communication – in-house training – accountability – management of testing programmes. CLIENTS We serve a wide variety of clients, from micro enterprises to large companies throughout the chemical and cosmetic industries.

CLIENTS Client confidentiality is guaranteed. Recent contracts include working as non-exclusive sub-contractor to CEFIC's ReachCentrum in the management of six Reach consortia, where 2010 registration deadlines were successfully met. Some consortia are also continuing to meet 2013 and 2018 deadlines. Linmark Consulting has successfully managed global and EU chemical advocacy programs for industrial chemical and biocide clients. It also operates as third party representative for US clients in EU and Switzerland.

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Chemical Watch | Service Providers Guide 2011

Web site E-mail Head office Tel Fax Contact Ownership Locations Founded

CONTACTS www.reach24h.com info@reach24h.com 306 The Capel Building, Mary’s Abbey, Dublin 7, Dublin +353 1 889 9951 +353 1 6865 683 Jim Wei Limited company Ireland, China, Canada 2008

OVERVIEW The REACH24H Consulting Group provides global chemical compliance solutions to assist the industry to effectively manage their REACH responsibilities. Our objective is to facilitate the most efficient and cost-effective access to the marketplace for our clients’ products through utilising our strong commercial experience and technical expertise in the chemical industry. SERVICES PROVIDED REACH24H is truly a global chemical compliance company. We provide compliance solutions in the following geographical and regulatory areas: Europe – REACH, cosmetics, CLP; China – REACH, cosmetics, GHS; USA – TSCA, FDA; Canada – TSCA, CEPA, NSN; Japan – CSCL; South Korea – TCCA; Taiwan – NCSR. Our new RSCC system facilitates enhanced supply chain communication for EU REACH stakeholders. We also regularly hold workshops to provide practical solutions to European and Asian chemical compliance issues and we specialise in providing English translations of Chinese chemical regulations. CLIENTS Confidential clients in the following industry sectors: chemicals, food, energy, electronics, healthcare, home and personal care.

CONTACTS Web site E-mail Head office Tel Fax Contact Ownership Locations Founded

www.reachready.co.uk enquiries@reachready.co.uk Kings Buildings, Smith Square, London +44 (0)20 7901 1444 +44 (0)87 1813 0304 Trent Weber Chemical Industries Association London 2006

Web site E-mail Head office Tel Contact Ownership Locations Founded

www.reachwise.eu info@reachwise.eu 22 St Albans Avenue London W4 5JP United Kingdom +44 20 87470873 Peter Douben Private United Kingdom, Netherlands, Germany 2007

OVERVIEW REACHWise, as a one-stop-shop, provides clients with tailor made services. Peter Douben, Director, was head of environmental protection in Unilever and director REACH in Cefic before founding REACHWise. He has extensive knowledge of REACH and its consequences for businesses. REACHWise's specialty is REACH and associated legislation. After many years of experience in a range of sectors all over Europe our expertise is extensive in providing companies with solutions. REACHWise works with chemSIX for online collaboration. SERVICES PROVIDED SIEF support: we provide the whole spectrum of SIEF and consortium management, starting with SIEF formation, organisation and structure, data and cost sharing, preparation of dossiers incl IUCLID and CSR, all the way to submission of lead and joint registrations. We adopt a modular approach to support companies that prefer to carry out some of the individual tasks in-house. Throughout the process we focus on keeping the cost of registration activities to a minimum by employing pragmatic SIEF and consortium management practices. We use the chemSIX platform for efficient SIEF and supply chain communication support. Impact of REACH and CLP: we advise companies on how to best approach their REACH “problem” to remain compliant at all times. REACH support: for individual and group of companies requiring more than SIEF management support, covering data evaluation and sharing, preparation of all aspects of the technical dossier, use and exposure requirements, chemical safety assessment and report, and exposure scenarios. Supply chain communication: using the chemSIX platform we enable SIEF participants to set-up and manage the communication with downstream customers in a way that is fast and efficient for both supplier and customers. CLIENTS 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 colourants sector, speciality chemicals industry

OVERVIEW REACHReady offers a dedicated one-stop shop for REACH and CLP services. A wholly-owned subsidiary of the Chemical Industries Association, our strong reputation and extensive experience of the chemical and downstream industries makes us the best choice for REACH and CLP services. Our thorough understanding and knowledge of the legislation stems from more than a decade of in-depth involvement in their development at every stage. We offer a flexible, value-for-money service for all your REACH and CLP compliance needs. SERVICES PROVIDED We offer a specialist helpdesk staffed by technical experts who can provide a rapid response to your REACH and CLP questions. Our tailored consultancy service can be used to develop or review a strategic approach to compliance, or deliver practical help in tasks such as classification, IUCLID submissions or SIEF support. Our Matchmaker service can match trusted suppliers of REACH and CLP services to your particular need. There is also a comprehensive training programme to help you manage your own compliance. CLIENTS We have a global customer base with clients from all industries affected by the REACH and CLP Regulations. Our services are used by companies from individuals and SMEs to global corporations. Recent clients include: British Adhesives and Sealants Association (BASA), Eli Lilly & Co Ltd, FUJIFILM Imaging Colorants Limited, Minor Metals Trade Association (MMTA), NEXT plc, The Body Shop International, WSP Environmental Limited.

Chemical Watch | Service Providers Guide 2011

Page 95

NICHE FIRM PROFILES

CONTACTS

NICHE FIRM PROFILES

CONTACTS Web site E-mail Head office Tel Fax Contact Ownership Locations Founded

www.refac.eu manager@refac.eu Lyme Building, Westmere Drive, Crewe Business Park, Crewe, Cheshire, CW1 6ZD +44 (0)1270 258530 +44 (0)1270 258444 Dr Darren Staniforth Private limited company United Kingdom 2007

OVERVIEW ReFaC is managed by the industry for the industry. It provides companies with costeffective compliance solutions and, wherever possible, aims to reduce the burden of administration imposed by REACH. ReFaC delivers REACH compliance solutions using its own staff and industry expertise. ReFaC’s services are focused mainly on SMEs − chemical producers, distributors, service providers and downstream users based inside or outside the European Union. SERVICES PROVIDED REACH registration − complete preparation of registration dossiers, including data gap analysis, exposure scenarios, and CSRs. Only representative − for companies based outside the European Union, ReFaC assumes all compliance obligations to ensure continued market access. REACH management services − providing a full out-sourcing service for compliance obligations as well as REACH administration, including classification, labelling, and packaging compliance. CLIENTS Professionalism, efficacy and integrity are core principles in ReFaC's code of conduct and we take pride in our corporate confidentiality. ReFaC does not publish the names of its clients.

CONTACTS Web site E-mail Head office Tel Fax Contact Ownership Locations Founded

www.rorltd.com info@rorltd.com Hippocampus House Hulme Lane United Kingdom +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, and assisting non-European chemical manufacturers, the company also assists EU manufacturers and importers to comply with their REACH obligations. ROR is now recognised as one of the most competent specialist only rrepresentative companies in Europe with the ability to provide compliance services to all members of a 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, safety data sheet authoring, provision and distribution. REACH auditing of companies compliance are among our additional offered services. CLIENTS Countries of clients: China, India, USA, UK, Brazil, Qatar, Egypt, South Africa and other regions.

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CONTACTS Web site E-mail Head office Tel Fax Contact Ownership Locations Founded

www.reach-rs.com info@reach-rs.com PO Box 161 Middlewich, Cheshire United Kingdom +44 (0)1565 724243 +44 (0)1565 723500 Service helpdesk Private limited company Europe 2008

OVERVIEW Reach Registration Services Ltd (RRS) provides first class advice, scientific, technical and administrative support to SIEFs and consortia. Our status as an independent party helps registrants overcome the complexity of EU competition law within the data sharing process. Our assistance allows all parties to ensure registration is completed on time with fair apportioning of costs. In addition to SIEF services we can provide access to registration resources for individual clients. SERVICES PROVIDED REACH registration services include: data management, IUCLID dossier preparation, SDS authoring, SIEF and consortium management, SIEF facilitation and management, corporate training in support of obligations in the supply chain. Other services: support lead registrants with testing proposal strategies and third party risk assessment and laboratory services. Trustee services on request. Auditing service to other SIEFs and consortia to meet their members' requirements. Independent advice in the event of a data or administrative dispute in a SIEF. CLIENTS Countries of clients: European Union (UK, Germany, Spain) China, India, USA, Brazil, Middle East, South Africa

CONTACTS Web site E-mail Head office Tel Fax Contact Ownership Locations Founded

www.sief-it.com info@sief-it.com Zgierska 73, 212 91-462 Lodz Poland +48 42 255 4718 +48 42 255 4719 Dominik Walczak Private Poland 2008

OVERVIEW Established in 2008, SIEF-IT is an information science programme that has been elaborated by the team of specialists being experts on REACH Regulation requirements. It is solely and exclusively intended for running SIEFs according to REACH requirements. SERVICES PROVIDED There are two main pillars of SIEF-IT: • SIEF platform www.sief-it.com; • REACH services. SIEF platform: communication system; activity and SIP surveys; LoA distribution. REACH services: IUCLID documentation support; only representative; dossier preparation; lead registrant support; data holder support; QSAR endpoints search. CLIENTS The worldwide chemical industry: from substance producers and distributors to endusers; and from converters, formulators to article producers.

Chemical Watch | Service Providers Guide 2011

Web site E-mail Head office Tel Contact Ownership Locations Founded

www.stewardshipsolutions.co.uk chriseacott@stewardshipsolutions.co.uk Green Lowe Farm, Shawclough Road Waterfoot, Rossendale, Lancashire BB4 9SA UK +44 (0)1706 220901 Dr Chris Eacott Private company nr Manchester, UK 2003

Web site E-mail Head office Tel Fax Contact Ownership Locations Founded

toxfocus.com barbara.vogt@toxfocus.com 65 Flint Rock Road Stamford, CT 06903 USA +1 203 355 2819 +1 203 355 2819 Barbara Vogt, Ph.D., DABT Private company USA 2008

OVERVIEW Stewardship Solutions Ltd is a small and respected chemicals management consultancy run by a chemical industry professional with over 30 years' experience. A focus of the company is EU chemicals regulatory compliance, with a special emphasis on REACH. We are also leaders in the implementation of chemical industry product stewardship programmes and management systems. Our strength is our ability to translate often complex regulatory and industry obligations into readily achievable compliance strategies and processes.

OVERVIEW Tox Focus, LLC is a specialty consulting practice providing the toxicologic and scientific content of REACH registrations, along with advice on subsequent global chemical management. Principal Barbara Vogt, PhD Toxicology, DABT, has more than 15 years of experience in corporate and clinical toxicology. She has authored REACH registration dossiers and SIEF communications for more than 12 projects for the 2010 REACH deadline, all of which were accepted without challenge by ECHA on the first submission attempt.

SERVICES PROVIDED A comprehensive range of compliance services including: REACH only and third-party representative services; REACH registrations; CLP compliance; REACH authorisations and SVHC management; production of safety data sheets; and exposure scenarios. We advise clients on low-cost regulatory compliance strategies, run training courses, help implement efficient compliance processes and management systems, undertake supplier compliance audits, and offer IT solutions. We thrive on providing solutions to compliance challenges.

SERVICES PROVIDED High-quality toxicology assessments and strategic planning for compliance with REACH requirements, including data gap filling, adaptations to data requirements, analogues, categories, and computer models (QMRF, QPRF), laboratory test monitoring, robust summary authoring, construction of IUCLID5 files with completeness reports, chemical safety reports, exposure scenarios, risk assessments and classification, labelling and packaging (CLP). Evaluation and authorisation support is also available.

CLIENTS Ranging from small enterprises to large multinational corporations our clients span the world, especially North America, Europe, Asia-Pacific region. Industry sectors supported include: chemical manufacturing and distribution; household, cleaning and personal care products; lubricants; pigments and dyestuffs; agricultural chemicals; biotechnology and pharmaceuticals; coatings and adhesives; textiles, consumer articles and consumer retailing. Client testimonials are available on request, and from our website.

Chemical Watch | Service Providers Guide 2011

CLIENTS Cytec Industries Inc, The Redstone Group, Mayer Brown International LLP, Lucite International, Ineos Europe Ltd, The Cyanide Council, Evonik-DeGussa GmbH, Air Products and Chemicals Inc, Vertellus Specialties Inc, Arch Chemicals Inc, Shepherd Chemical Company, Gerber Scientific International, AW Chesterton Company, EnsignBickford Aerospace and Defense Inc, FMI Chemical, Connecticut Business and Industry Association, United States Department of Commerce.

Page 97

NICHE FIRM PROFILES

CONTACTS

 3E Company

Page Headquarters

Other locations

Canada, Europe, Asia 100-500

Accenture

A-Z Listing

 ACTA

USA Belgium

Chemical staff

Further information

100-500

e 3ecompany.com

5,000 plus

i e e www.accenture.com

ggg

e e e a www.actagroup.com

25-50

Actio Corporation

USA

25-50

10-25

AEGIS REGULATORY Inc.

Canada

10-25

www.aegisreg.com

AG-HERA

Spain

www.ag-hera.com

Alberi EcoTech

USA

Alemare Solutions Ltd

2-5

5-10

5,000 plus

25-50

 Apeiron-Team

Belgium

 ARCADIS

The Netherlands

 ARCHE

Belgium

Austen Business Solutions Ltd

 AW-ChemAdvice

Beveridge & Diamond, P.C.

USA

Global staff

Consultancy/advisory Administration/representative Legal services Laboratory services IT & software solutions Information services Training Other(s)

Organisation

300+ offices worldwide

www.actio.net

g g www.alberieco.com g www.alemare-solutions.com e e e www.apeiron-team.eu e e g e a www.arcadis.com

5-10

2-5

e www.arche-consulting.be www.austenbusinesssolutions.co.uk

The Netherlands

www.aw-chemadvice.eu

USA

100-500

10-25

www.bdlaw.com

 bibra toxicology advice & consulting

10-25

 BioQuanta

France

Japan, Thailand, USA 25-50

10-25

 B-Lands Consulting

France

China

10-25

a e e e e www.reachteam.eu

40665

Blue Frog Scientific Limited

Borenius & Kemppinen, Attorneys at law Ltd

e a www.bibratoxadvice.co.uk

www.bioquanta.net

www.bluefrogscientific.com

Finland

100-500

5-10

England

50-100

Buckman

USA

2,000-5,000

1,000-2,000

e g e g e e e www.buckman.com

Burges Salmon LLP

500-1,000

2-5

 Brixham Environmental Laboratory

Burgess Regulatory Services

 Caleb Management Services

UK 94

France

Cambridge Environmental Assessments

 CEHTRA

5-10

10-25

5-10

100-500

10-25

Belgium, India, UK

25-50

mea

www.brixham-lab.com www.burges-salmon.com

Germany

www.borenius.com

www.burgessregulatory.com

m www.calebgroup.net e www.cea-res.co.uk a e a a www.cehtra.com

Centro Reach Srl

Italy

2-5

ige

CFCS-Consult GmbH

Germany

10-25

e e e www.cfcs-consult.de

Germany

Luxembourg, Korea, 25-50 Turkey 25-50

25-50

e e e e www.chemservice-group.com

25-50

 Chemservice

ChemSW, Inc

 Chris Braun Consultancy

USA 94

Clariant compliance2business

The Netherlands

Italy

5,000 plus

100-500

Italy

 Compliance Services International (CSI) 50

USA

France, UK

g www.federchimica.it

e www.chemsw.com www.cbconsult.nl e www.clariant.com

gge

25-50

10-25

e g www.compliance2business.eu

meeeee

www.complianceservices.com

Consortia Management GmbH

Germany

5-10

CoRC

5-10

2-5

www.thecdi.com

www.csregulatory.com

 CS Regulatory Ltd

2-5

DanGoods Training & Consultancy

Defense Logistics Agency

1,000-2,000

10-25

Denehurst Chemical Safety Ltd

2-5

 DHI

 DR. KNOELL CONSULT GmbH Ecolab

g www.dangoods.co.uk g

Denmark

Worldwide offices

500-1,000

50-100

Germany

UK, Switzerland, China, Netherlands

100-500

USA

www.consortia-management.com

gg ae

5,000 plus

50-100

France

25-50

 EggCentris NV

Belgium

5-10

100-500

10-25

mgee

Belgium

 Emveo

a a www.tox.dhigroup.com e e www.knoellconsult.com

 EcoMundo ELC Group

g www.dla.mil i www.denehurst.co.uk

m www.ecolab.com g e e www.ecomundo.eu m

www.EggCentris.com a www.elc-group.com e e a www.emveo.be

Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%

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Chemical Watch | Service Providers Guide 2011

Information

IT solutions

Laboratories

Training

Organisation

3E Company

  

Accenture

                    

ACTA

                    

Actio Corporation

 

AEGIS REGULATORY Inc.

   

     

        

AG-HERA

   

 

   

Alberi EcoTech

      

Alemare Solutions Ltd

       

Apeiron-Team

           

ARCADIS

                    

ARCHE

           

    

Austen Business Solutions Ltd

  



AW-ChemAdvice

 

Beveridge & Diamond, P.C.

           

        

bibra toxicology advice & consulting

 

   

                

   

            

      

 

  



        





 

        

    



 



 

       

 

        



     

 

        





 



                    

               

Blue Frog Scientific Limited

   



Borenius & Kemppinen, Attorneys at law Ltd

      

                             

Brixham Environmental Laboratory

 

   

Buckman

            

Burges Salmon LLP

     

Burgess Regulatory Services

         

Caleb Management Services

           

    

 

            

   

    



   



  

 



 

 

                     

CEHTRA

                       

Centro Reach Srl

           

CFCS-Consult GmbH

      

Chemservice

                 



  

          



          



     

 



 



 

    



      

Clariant

   

compliance2business

                           

            

Compliance Services International (CSI)            

 

        

                 

 



        

Chris Braun Consultancy





     



 

      

Cambridge Environmental Assessments

ChemSW, Inc

    

       

  



 



 



B-Lands Consulting







   

 





 

   

BioQuanta



                

                            

 

  

 

   





Consortia Management GmbH





 

 

     

      



  





CoRC



CS Regulatory Ltd

      

DanGoods Training & Consultancy





 

Defense Logistics Agency



  

Denehurst Chemical Safety Ltd

           



  

DHI

                    

                

DR. KNOELL CONSULT GmbH

           

    

Ecolab

 

       

EcoMundo

                    

EggCentris NV

 

ELC Group

                 

                

Emveo

      





      

          



 

 

      

 

 

 

 





      

 

      

     



   



     





         

        



 



 

 

   



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 | Service Providers Guide 2011

Page 99

A-Z Listing

Admin/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/inhouse training CPD/CES certified training Lobbying/advocacy Insurance

Consultancy/advisory

Other locations

Global staff

Chemical staff

Enthone B.V.

2,000-5,000

10-25

ENTRIX

USA

500-1,000

25-50

1,000-2,000

50-100

 ENVIRON

A-Z Listing

Page Headquarters

Consultancy/advisory Administration/representative Legal services Laboratory services IT & software solutions Information services Training Other(s)

Organisation

Over 80 offices worldwide

www.cardno.com

Environmental Science Limited

2-5

ERM

Germany

2,000-5,000

50-100

Euromines

Belgium

5-10

2-5

Exitss

 Exponent International Limited

Belgium 60

Switzerland

10-25

2-5

500-1,000

25-50

5-10

Foresite Systems, Ltd.

USA

25-50

5-10

Fox Valley Systems

USA

50-100

2-5

Gain Claude

France

Gillies Associates Limited

England

2-5

5-10

 H2 Compliance

USA

Hangzhou RUIO Technology Co. Ltd

 Harlan

China

herbert smith llp

HFL Risk Services Limited

 ICF International

USA

 IGCON

The Netherlands

 IHS (including Atrion)

USA

 International Cosmetics & Regulatory Specialists, LLC

USA

50-100 France, Germany, 2,000-5,000 Israel, Italy, Japan, Korea, Mexico, Netherlands, Spain, Switzerland, UK 2,000-5,000 10-25 UK, Belgium, Russian 2,000-5,000 Federation, China, India, Brazil, Canada 1 Offices in 30 countries

www.erm.com g e e www.exitss.eu

5-10

USA (New York)

e a a www.exponent.com g www.fobig.de g foxvalleysystems.com

m m

e g www.gilliesassociates.co.uk

50-100

500-1,000

2-5 me

50-100

e e www.igcon.nl

2,000-5,000

5-10

ig m

100-500 50-100

Jai Research Foundation

India

100-500

Japan Chemical Safety Institute

Japan

eee

Jean Warshaw, Esq.

USA

2-5

The Netherlands

JSC International Limited

10-25

Konica Minolta Business Expert, Inc

Japan

2,000-5,000

10-25

ggm

LAUS GmbH

Germany

10-25

2-5

 Linmark Consulting

 LKC Switzerland Ltd

Miami Chemical

 Penman Consulting Pinnacle Associates

www.ipo-pszczyna.pl a a www.jrfonline.com

eme www.earthlink.net

e e g www.jongeriusconsult.com www.jsci.co.uk www.konicaminolta.com www.laus.de

UK Switzerland

France

2-5

Switzerland

10-25

5-10

e e e www.penmanconsulting.com

2-5

Belgium

UK, Netherlands

The Netherlands 96

www.intertek.com

50-100

PricewaterhouseCoopers

 REACH Chemical Consulting (UK) Ltd

Japan, China, India, 5,000 plus Brazil, Indonesia, Europe, USA, Middle East 1,000-2,000

USA 72

http://www.ihs.com/ehs-sustainability/ e a www.intlcosmetics.com

50-100

LGC

www.herbertsmith.com www.icfi.com/reach

5,000 plus

Republic of Korea

www.harlan.com

e e www.hflrisk.com

Poland

e e www.reach24h.com

10-25

USA

 LG CNS

a www.h2compliance.com

IPO O/Pszczyna

www.foresitesystems.com

Intertek

 Jongerius Consult

e www.esldatasheets.com www.euromines.be

Germany

Ireland

www.environcorp.com

e i

FoBiG

Further information

www.cooksonelectronics.com

USA

e e a a g i a a www.lgcns.com

50-100

e www.lgc.co.uk

5,000 plus

25-50

5-10

www.linmarkconsulting.com www.LKC-ltd.com

www.miamichemical.com www.pinnacleassoc.com www.nl.pwc.com e e www.reachchemical.com

REACH Facilitation Company Ltd

2-5

REACH Mastery

Italy

5-10

maae

5-10

2-5

g g e e e e e www.rorltd.com

 Reach Only Representative Ltd

Local agents: Asia, Middle East 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 100

www.refac.eu e a www.reachmastery.com

Chemical Watch | Service Providers Guide 2011

Information

IT solutions

Laboratories

Training

Organisation Enthone B.V.

  

ENTRIX

   

ENVIRON

           

       

   

Environmental Science Limited

         

       

      

ERM

                    

Euromines

 

         



       

 

    

  



         

Exponent International Limited

           

    

FoBiG

 

   

Foresite Systems, Ltd.

  

  

 



   





   

  

   



 



  

    



        



     

 

Gillies Associates Limited

          

H2 Compliance

        

 



 

Gain Claude

 



 



  



        



 



 



      

 

 

Hangzhou RUIO Technology Co. Ltd

           

       

  

        

Harlan

           

   



   

herbert smith llp

                     

HFL Risk Services Limited

         



ICF International



 

IGCON

      

IHS (including Atrion)

 

International Cosmetics & Regulatory Specialists, LLC

      



  



 



  



   

Jai Research Foundation

 



 

 

 

Japan Chemical Safety Institute

  

Jean Warshaw, Esq.

  



Jongerius Consult

      

JSC International Limited



Konica Minolta Business Expert, Inc

           

LAUS GmbH



LG CNS

                

 

   

 

    

      

 







   



  



   



 



            





                        

        

LGC



Linmark Consulting

                

LKC Switzerland Ltd

           



 



  

      



  

    

     

          

  



      

 



Penman Consulting

                

Pinnacle Associates

             

     

PricewaterhouseCoopers

  

REACH Chemical Consulting (UK) Ltd

                



REACH Facilitation Company Ltd

                  



REACH Mastery

                     

Reach Only Representative Ltd

           

  

              

                    

 



  

                    



    



IPO O/Pszczyna

 

 

    



 

      

        

  

     

      



 

   

       

Intertek

Miami Chemical



 

  

Fox Valley Systems

    

  

Exitss

   

      



 

 

     



        



    



   

 

          

     

  



 

        



Chemical Watch | Service Providers Guide 2011

Page 101

A-Z Listing

Admin/management

Consultancy/advisory

Page Headquarters

Global staff

Chemical staff

10-25

2-5

g g e e e e e a www.reach-rs.com

50-100

g g e e e e e a www.reach24h.com

Further information

 Reach Registration Services Ltd

 REACH24H Consulting Group

Ireland

 ReachCentrum

Belgium

10-25

eie

e g www.reachcentrum.eu

Finland

25-50

eii

www.reachlaw.fi

5-10

2-5

i e a a a e g www.reachready.co.uk

 ReachSpektrum, s.r.o.

Czech Republic

2-5

iee

e e g www.reachspektrum.eu

 REACHsuite Ltd

5-10

e www.REACHsuite.com

 REACHWise, chemSIX

2-5

e www.reachwise.eu

 ReFaC

REACHLaw Ltd

 REACHReady

A-Z Listing

Other locations

Consultancy/advisory Administration/representative Legal services Laboratory services IT & software solutions Information services Training Other(s)

Organisation

China, Canada

Belgium, The Netherlands Netherlands, Germany

2-5

Regulatus

Ricerca Biosciences, LLC

USA

500-1,000

RimaOne

Germany

25-50

 Royal Haskoning

Netherlands

Locations worldwide, 2,000-5,000 inc: Netherlands, UK, Belgium, France 1

www.regulatus.co.uk www.ricerca.com

www.rimaone.com

50-100

i e e a e e e www.royalhaskoning.com/ processandchemicalindustry

m i

Safety Data Services

SAP AG

Germany

5,000 plus

SAP Japan Co., Ltd.

Japan

1,000-2,000

5-10

SATRA Technology Centre

Science & Environment sarl

Switzerland

2-5

ShawCor

e www.refac.eu

www.sap.com

www.sap.com a a m www.satra.co.uk

m e www.sci-env.ch

Canada

2,000-5,000

2-5

 SIEF-IT

Poland

5-10

 Smithers Viscient

25-50

2-5

a m e a e a a www.spinps.com

Spinnaker Coating, LLC

USA

SSS (Europe) AB

Japan, Switzerland, 100-500 USA 2-5

www.shawcor.com

m a e e www.smithersviscient.com

Sweden

10-25

gge

 Stewardship Solutions Ltd

5-10

 SCAS

Belgium

50-100

Japan (Head Office), 1,000-2,000 China, Singapore

e www.sief-it.com

e e e www.reach-onlyrep.eu e e e e www.stewardshipsolutions.co.uk m

SUSTCHEM Engineering LTD

Greece

5-10

meea

The Sapphire Group

5-10

a www.scas-eu.be e www.suschem.gr

www.thesapphiregroup.com

 TNO Triskelion

The Netherlands

2,000-5,000

100-500

i e e e www.triskelion.nl

 Tox Focus, LLC

USA

2-5

Trasys

Belgium

500-1,000

25-50

TUV Rheinland Hong Kong Ltd.

Hong Kong

5,000 plus

100-500

e e e e www.chn.tuv.com

TUV SUD

Germany

5,000 plus

10-25

TUV SUD Japan

Japan

100-500

2-5

Universit Bordeaux Segalen

France

500-1,000

100-500

e e e g e e e e www.u-bordeaux2.fr

Von Roll REACH GmbH

 wca environment

Germany 88

Weeset Advisors

 Wildlife International, Ltd

Italy

USA 90

USA

The Netherlands

e e toxfocus.com m

e www.trasys.be e www.tuev-sued.de a a www.tuv-sud.jp

2-5

e www.vonroll.com

25-50

a www.wca-environment.com

www.weesetadvisors.com

100-500

50-100

WRc plc

100-500

10-25

e e e www.wrcplc.co.uk

Zanos Limited

2-5

m www.zanos.co.uk

a a www.wildlifeinternational.com

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 102

Chemical Watch | Service Providers Guide 2011

Information

IT solutions

Laboratories

Training

Organisation

Reach Registration Services Ltd

                  

REACH24H Consulting Group

      

   

ReachCentrum

  



REACHLaw Ltd

                     

REACHReady

      

   

    

ReachSpektrum, s.r.o.

           

    

REACHsuite Ltd

  

REACHWise, chemSIX

           

    

ReFaC

      

   

Regulatus

   

      

Ricerca Biosciences, LLC

 

 

 



 





     

   



   

  

         

  

   



        





 

      

  

 

           

            

 

 

RimaOne

 

                 

Safety Data Services

 

SAP AG

  

SAP Japan Co., Ltd.

         

SATRA Technology Centre

         

Science & Environment sarl

      

ShawCor

       



      

SIEF-IT

 



 

Smithers Viscient

           

Spinnaker Coating, LLC

    

      

  





  

      

                    

Sumika Chemical Analysis Service Ltd

     

          

    

   

                    

TNO Triskelion



Tox Focus, LLC

                    

Trasys

      

TUV Rheinland Hong Kong Ltd.

 

         



  

  



  



        



        



    

  

 

 



   

TUV SUD Japan

           

       

        

Universit Bordeaux Segalen

                    

               

  

wca environment



Weeset Advisors

 

 

 

   

 

 

WRc plc

           

Zanos Limited

  







 

Wildlife International, Ltd



 

  

 

        



Von Roll REACH GmbH



                 

  

 



      

                     



 



The Sapphire Group

  



                  

SUSTCHEM Engineering LTD



    

Stewardship Solutions Ltd

TUV SUD

 

 

     

    

    

        

           

 

SSS (Europe) AB

    



   

       



  

 

                  

      

  

 





   

 



          



             

Royal Haskoning



 

                  







          











        



   





 

    

            



Chemical Watch | Service Providers Guide 2011

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A-Z Listing

Admin/management

Consultancy/advisory

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Service Providers Guide 2011 â&#x20AC;&#x201C; A guide to chemicals management and control services