chemical watch global service providers guide 2013

Global Service Providers Guide 2013

A guide to chemicals

management and

control services

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Chemical Watch | Global Service Providers Guide 2013 Page 1

ForewordI’m very pleased to welcome you to

� � � � � � � � � � � � �third annual service providers guide and directory. When we launched this publication series, we were responding to our readers who wanted information about the service providers out there, who they are, what they do and also some context in terms of the overall market and what everyone else is saying and doing. This combination of intelligence has proved to be a winning formula with copies of our guide going like hot cakes at conference and exhibitions.

Continuing to respond to reader feedback, in this third edition we have split our survey of opinions into three separate surveys in order to improve response rate still further – to over 1,300 respondents – and get a grainier picture.

A star feature is our first review of the jobs market, including a survey to find out how much various personnel in chemicals regulatory compliance and related service industries actually earn, and to see how satisfied they are with their jobs! Can you a#ord not to take a look?

In addition, we provide a first in-depth article written by our author Cynthia Challener examining the policies and politics concerning chemicals regulation and risk management in the US. And, of course, we bring you the findings of our annual survey, looking at the drivers, issues and progress with regulatory compliance, looking at what service providers and their clients dealt with in 2012 and their predictions for 2013.

We are also continuously improving the directory section of the guide to ensure it provides companies with a quick and unbiased review of the di#erent services o#ered by each provider to save them time and money, and give them a robust selection of firms to choose from to meet their compliance needs.

We hope you enjoy reading our longer-than-ever guide and look forward to your feedback for next year.� � � � � � ��

· Chemical Product Stewardship

· Chemical Regulation under

TSCA & REACH

· Pesticides and Biocides

· Global Chemical Notification

· Nanotechnology

· Biobased Chemicals and Biofuels

· Food Contact Chemicals

· Metals

· Cosmetics

· Risk and Exposure Assessment

Beijing, China

86-10-84534538

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+44 (0) 161 212 7405

Washington, D.C.

(202) 266-5020

www.actagroup.comGlobal Chemical Product Innovation and DevelopmentTM

A scientific and regulatory consulting firm

providing experts that assist companies

making or using chemicals to market and

sustain their products globally.


ContentsChemical service providers editoral ..... 5Increasing complexity extends throughout the supply chain .................. 5

US chemical manufacturers and users dealing with GHS implementation and an EPA looking to extend its authority ................................................ 16

Key country regulatory highlights in 2013 ................................................. 21

A look at the chemical management and control jobs market ....................... 22

Using service providers and future market trends ....................................... 27

Profiles .......................................3624-7 Response ..................................... 36

3E Company ........................................ 38

ACTA .................................................... 40

ARCADIS .............................................. 42

ARCHE ................................................. 44

bibra toxicology advice & consulting .. 46

Bioagri .................................................. 48

Blue Frog Scientific .............................. 50

Brixham Environmental Laboratory ..... 52

BSL BIOSERVICE Scientific Laboratories GmbH ............................. 54

Bureau Veritas ...................................... 56

CEHTRA ............................................... 58

Centro Reach ....................................... 60

Chemsafe ............................................. 62

Chemservice ........................................ 64

ChemService Srl Controlli e Ricerche . 66

Chilworth – a DEKRA Company .......... 68

CS Regulatory Ltd ................................ 70

CURRENTA GmbH & Co.OHG ............ 72

DHI ....................................................... 74

Dr. Knoell Consult GmbH ..................... 76

EBRC Consulting ................................. 78

ECOonline ............................................ 80

ENVIRON ............................................. 82

Equitox ................................................. 84

ERM ...................................................... 86

Exponent International Limited ............ 88

Harlan Laboratories ............................. 90

ICF International .................................. 92

IHS ........................................................ 94

International Cosmetics & Chemical Services ............................... 96

Intertek ................................................. 98

iPoint-systems gmbh .......................... 100

JSC International ................................ 102

KFT Chemieservice ........................... 104

National Chemical Emergency Centre (NCEC) ................................... 106

Pace Analytical - Regulatory Services ............................................. 108

REACh ChemAdvice .......................... 110

REACH Mastery ................................. 112

ReachCentrum ................................... 114

REACHLaw ......................................... 116

Risk & Policy Analysts ........................ 118

Royal HaskoningDHV ......................... 120

SCC .................................................... 122

Selcia .................................................. 124

SGS .................................................... 126

Reach Only Representative Ltd ......... 128

SSS (Europe) AB ................................ 128

Swissi Instituto Suizo de Seguridad .. 130

TNO Triskelion .................................... 132

ToxMinds ............................................ 134

TÜV SÜD Industrie Service GmbH .... 136

WIL Research ..................................... 138

Wildlife International, a division of EAG .................................................... 140

WTConsulting ..................................... 142

YASH Technologies ............................ 144

Niche firm Profiles ....................... 147AG-HERA ........................................... 147

ALTox .................................................. 147

BIG vzw .............................................. 147

Caleb Management Services ............ 147

CFCS-Consult .................................... 148

ChemSW ............................................ 148

CONUSBAT ........................................ 148

Crowell & Moring ................................ 148

Danger and Safety srl ........................ 149

DR. MACH Chemical Compliance & Competence ................................... 149

Ecotox Services International ............ 149

ES4chem ............................................ 149

eSpheres ............................................ 150

Eupoc ................................................. 150

Eurideas Linguistic Services ............. 150

FinnREACH ........................................ 150

FoBiG.................................................. 151

GHS Expert Ltd. ................................. 151

Greenwich Chemical Consulting ....... 151

IGCON ............................................... 151

Jongerius Consult BV......................... 152

JRF Global ......................................... 152

Linmark Consulting ............................ 152

LKC Switzerland Ltd ........................... 152

McKenna Long & Aldridge LLP ......... 153

Peter Fisk Associates ......................... 153

REACH Delivery ................................. 153

REACH Global Services .................... 153

Reach Only Representative Ltd ......... 154

REACHReady .................................... 154

REACHWise ....................................... 154

ReFaC ................................................ 154

Regulatory Services International ..... 155

Steptoe & Johnson LLP ..................... 155

The Wercs .......................................... 155

Tox Focus, LLC ................................... 155

toXcel International Ltd ...................... 156

Toxservices LLC ................................. 156

Verdant Law, PLLC ............................. 156

wca environment ................................ 156

Wercs Professional Services, LLC ..... 157

WRc plc .............................................. 157

WSP Group ........................................ 157

A-Z Listings ................................ 158

CW Research Ltd, trading as Chemical Watch, publishes news and intelligence to help companies achieve sound chemicals management that responds to the many non-regulatory drivers as well as meeting responsibilities under chemicals legislation worldwide, including regimes such as REACH, CLP, GHS and TSCA. We keep you abreast of policy and business trends across the EU, North America, Asia and the rest of the world. Because we are not tied to any trade associations, government or campaign group, we are able to offer objective news and analysis for all sectors.

CW Research Ltd, 140B Longden Coleham, Shrewsbury SY3 7DN, UK Tel: +44 (0)1743 818 101 Fax: +44 (0)1743 818 121 email: [email protected] www.chemicalwatch.com

Editor Mamta Patel, [email protected]

Contributing Editor Cynthia Challener, [email protected]

Nick Hazlewood, [email protected]

June Meagher, [email protected]

Kerry Williamson, kerry @ chemicalwatch.com Lotte Spencer, lotte @ chemicalwatch.com Glen Marechal, glen @ chemicalwatch.com

Richard Butterworth, richard @ chemicalwatch.com

Stuart Foxon, [email protected]

Julian Rose, [email protected]

Copying of this document including electronic circulation is not permitted without consent of the publisher.

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 2013 Copyright and Database Rights © 2013 CW Research Ltd. All rights reserved

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Chemical serviceproviders

IntroductionE#ective chemicals management and control programmes cover the full lifecycle of chemicals manufactured, processed, used as raw materials or sold. As such, they touch all aspects of a company’s operations from new product development to purchasing to customer selection and support. They also require an extensive skill set, including, but not limited to, regulatory, administrative, project and information management, legal, chemistry, toxicology, laboratory and software expertise. Much of this work can be completed in-house at larger firms, and has

been done, even as budgets have shrunk due to declining sales, but is generally outsourced by SMEs. Even for large companies, however, there are many times that specialist skills or a particular type of experience are required to ensure successful project implementation. Firms o#ering consultancy/advisory, management/administrative, legal, training, laboratory and technical, information/data management and software/IT services fill these needs.

In the following pages, we take a closer look at some of the key drivers, discussions, issues and solutions ongoing in this dynamic market.

CHEMICALS MANAGEMENT AND CONTROL

Increasing complexity extends throughout the supply chain

EU REACH, country-specific chemical management regulations, country-specific GHS requirements and product-specific legislation on biocides, agricultural chemicals and cosmetic products place growing burdens on not only chemical manufacturers and processors and their distributors and direct customers, but all firms that produce or handle products containing chemicals identified as presenting some risk or hazard. Simply staying abreast of these various regulatory requirements is a real challenge for companies selling in multiple countries and regional markets, and often a new process for many downstream users. Compliance requires both significant resources and extensive knowledge, which, in the current di%cult economic climate, can be overwhelming even for larger organisations to access, and may not be possible for smaller- and medium-sized enterprises (SMEs) to obtain. Many companies, therefore, are delaying activities or taking minimalist approaches to compliance, while others remain unaware of their responsibilities. Some of the impacts of this situation on the chemicals management and control service providers market were observed in 2012, and more are expected to come to the fore in 2013.

Leading driversNot surprisingly, REACH and GHS compliance requirements helped continue to drive the workload of chemicals management and control professionals in 2012. The results of the

� � � � � � � � � � � � survey confirm that

REACH is a major regulatory driver (Figure 1). In fact, an overwhelming 89% of survey participants cited REACH as the main global driver, followed by the EU CLP Regulation (65%), and other national schemes for the Globally

Harmonized System (GHS) for chemicals classification and labelling (46% of respondents). Other drivers include US TSCA inventory reporting requirements and biocides regulations. Notably, 27% of respondents specifically mentioned China’s new chemical notification (MEP order 7).

The next REACH deadline is 31 May 2013, and forward-thinking companies were preparing. Others were dealing with ECHA decisions on phase one registrations and beginning the authorisation process. Work also continued on extended safety data sheets (eSDSs) and exposure scenario development as required by REACH and CLP. In addition, reflecting work in industry, many service providers experienced higher workloads related to product-specific regulations, and all of these regulations drove demand for laboratory testing services and increased the need for more extensive software and data management capabilities. A leading fragrance and flavour company, for example, has a large EU portfolio of manufactured and imported chemicals and continues to invest in new and developing markets that are introducing increasingly challenging regulations, for example, in Asia. The changing global registration environment and chemical management and control issues have focused greater regulatory attention on such markets for the company, according to a company spokesperson. For another multinational, Eastman Chemical Company, meeting the requirements of the new US Chemical Data Reporting (CDR) Rule was a major concern in 2012, along with REACH and Asian regulations. While Jan Schüller, director REACH & regulatory a#airs for Eastman Chemical EMEA B.V., expects GHS requirements will be big in 2013.

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Page 6 Chemical Watch | Global Service Providers Guide 2013

Figure 1

Leading regulatory drivers for survey participants

89%

65%

46%

29%

28%

27%

25%

23%

22%

21%

20%

20%

19%

16%

15%

15%

15%

13%

13%

11%

11%

10%

9%

8%

4%

4%

0% 20% 40% 60% 80% 100%

REACH

CLP

National GHS classification, labelling and inventorynotification regulations

Biocides regulations

US TSCA inventory reporting

China new chemical notification (MEP order 7)

Nanomaterials regulations

China: registration of general hazardous chemicals(SAWS Order 53)

Food contact material regulations

China: registration of hazardous chemicals for environmentalmanagement (MEP Order 22)

Other country new chemical notifications

Cosmetics regulations

Packaging regulations

International Carriage of Dangerous Goods by Road (ADR)

Korea: Notification under TCCA

International Maritime Dangerous Goods (IMDG) Code

Other country chemical manufacture/import inventoryreporting

Agrochemical regulations

Japan: notification and annual reporting under CSCL

Taiwan: nomination to existing chemicals inventory

Taiwan: registration of designated substances under TCSCA

Turkey: notification under CICR

Pharmaceutical regulations

Medical devices regulations

Veterinary product regulations

Other

% of participants

Several survey respondents also provided more specific comments regarding the regulatory drivers that are impacting their chemical management and control activities. Some were very specific, such as the Australian OHS regulation, Canada’s chemical regulations, the US state of California’s green chemistry initiative, and the EU’s Directives on the restriction of hazardous substances in electrical and electronic equipment (RoHS) and on toy safety. Others were concerned with additional programmes that have international scope, including the Chemicals

Weapon Convention and updates to protocols, the International Carriage of Dangerous Goods by Air (IATA), and the Stockholm Convention.

Non-regulatory drivers can have a significant impact on the growth of the chemicals management and control sector as well. Not surprisingly, 49% of participants in the � � � � � � � � � � � �

survey identified economic growth as the major factor (Figure 2). Not far behind were customer pressure (42% of respondents) and governmental polices/spending (37% of participants). Other non-regulatory

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drivers noted by one in five or more respondents included NGO pressure and voluntary corporate initiatives. In addition, several very specific and interesting issues were pointed out by survey respondents, including green chemistry initiatives, the advancement of electronic monitoring and detection devices, the integration of science within the regulatory framework, the knowledge and expertise loss due to retirement, the need to demonstrate e%ciency and discontinuation of products in the supply base.

Figure 2

Leading non-regulatory drivers for survey participants

49%

42%

37%

27%

22%

19%

14%

11%

3%

0% 20% 40% 60%

Economic growth

Customer pressure

Governmental policies/spending

NGO pressure

Non-statutory ‘voluntary’ corporate initiatives/CSR

Downsizing of inhouse chemical management and control teams

Increased commercialisation/better management of service

provider business

Outsourcing of business support functions

(by client organisations)

Other

% of participants

Key trends and issues in chemicals management and controlRequests for REACH support varied significantly for many service providers, but continued to account for a good portion of business in 2012. The main activities included preparation for the second registration deadline for substances with sales volumes of 100-1000 tonne, responding to ECHA decisions on substances submitted during the first phase, and the beginning of activities related to authorisation.

For example, the majority of work for independent registration and development management services firm LKC involved administration of data sharing in advance of the May 2013 registration deadline,

including communication obligations within the supply chain, according to COO, Matthew Kane. Others have found, however, that the global recession has taken a toll on REACH activity. Where possible, notes Stephen Van Heerden, Sales Director at REACHLaw Ltd, many companies have switched the 2013 REACH registrations to the 2018 REACH deadline due to the impact of the economic recession on resources.

José V. Cantavella Cabedo, project manager for Sief/Consortia/Business Development at Chemsafe Srl, adds that not many large companies are taking the Lead Registrant role, which may mean that a number of chemicals will not be registered. Dieter Reiml, with TÜV SÜD Industrie Service GmbH, agrees that many companies are delaying the process despite experiences from 2010, and there is as yet little action in many substance information exchange fora (Siefs). Even those who are taking action and have first phase experience are finding it di%cult, because there is less data available on the substances involved, testing labs are at least partly overloaded, and the ‘rules and conditions’ continue to change, including an update to the IUCLID software and the publication of new guidance from ECHA, according to Klaus Schneider, general manager, Forschungs-und Beratungsinstitut Gefahrsto#e GmbH (FoBiG).

“We are concerned that many substances remain unsupported, and that a last minute rush to submit dossiers will swamp both testing houses and regulatory consultancy firms,” concludes Samantha Wright, regulatory a#airs: REACH, with JSC International. Beyond that, she is also concerned that substances that are not supported could be taken o# the market, which would have a knock-on e#ect on a range of di#erent products.

In addition to preparing for the second phase of REACH, companies have also had to begin dealing with the consequences of the first phase of the programme. Companies have had to respond quickly to ECHA’s draft decisions on evaluation of 2010 submitted dossiers in order to prevent them from becoming final, according to Barbara Vogt, a principal with Tox Focus LLC. “Some involved clarification and refinement of scientific positions, while others were simply corrections of administrative errors. However, resubmission of a corrected dossier was made more complex due to the need to gain consensus among Sief participants and to upgrade the dossier from IUCLID 5, version 3 to version 4. As a result, the time and cost was often higher than anticipated,” she comments. Some updates had to be made, according to Karl-Franz Torges, managing partner of KFT Chemieservice GmbH, because other registrants wanted to join and were only prepared to join if the quality of the dossier was improved.

Test proposals from the first phase of REACH and spontaneous dossier updates were also a bigger proportion of business for consultancy CEHTRA. “ECHA has begun to challenge testing proposals, categories and read-across strategies, with potentially expensive consequences for registrants,” says Paul Thomas, senior ecotoxicologist and director of its Lyon Agency � Meanwhile law firm McKenna Long & Aldridge LLP was involved in the legal assessment of several ECHA compliance check decisions and brought two cases before the Board of Appeal. The consequent workload from REACH registrations is not likely to lessen any time soon, our respondents feel. REACHLaw’s Mr Van Heerden adds that a lot of companies that submitted intermediate registrations as an easy way out have found that they must redo their dossiers, which has doubled their costs. “As time goes on,

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we are convinced that ECHA will dig deeper into dossier quality and the current industry policy of minimising Annex IX and X test proposals will probably be scrutinised,” predicts CEHTRA’s Mr Thomas.

Authorisation activities picked up as well in 2012. McKenna Long & Aldridge LLP and ReachCentrum each established authorisation consortia for the preparation of joint authorisation applications (chromium trioxide and miscellaneous chromium compounds for McKenna Long & Aldridge LLP and di(2-ethylhexyl)phthalate (DEHP) hexabromocyclododecane (HBCDD) and sodium dichromate for ReachCentrum). In addition, individual companies are monitoring the presence of SVHCs in their processes and supply chain and developing mitigation strategies related to these substances: identifying in which processes SVHCs are used, which uses need to be covered in an application for authorisation and for which chemicals, alternatives are available, explains Maaike Bilau with the REACH & Product Stewardship Services business of ARCADIS Belgium nv. “Consortia are now working with the members to make sure that these applications for authorisation are robust and can be submitted on time. However, we are also more and more in contact with singular downstream users that seek an authorisation for their very specific downstream use,” adds Leo Appelman, managing director of ReachCentrum. In light of the growing REACH candidate list of substances of very high concern (SVHCs), clients of SGS-CTS are taking a closer look at risk assessment rather than doing a complete screening of the list, according to Dr Anne Kleinkauf, a Reach consultant with the firm.

This process has actually had a positive aspect, according to NCEC REACH consultancy manager, Robert Whiting. “Companies have been forced to work together and look openly at the issues that specific substances present. Many have also taken a proactive and considered approach to managing risk and how the logistics within their own production processes work,” he remarks. “We believe the result of such an approach will have a positive impact on how risk is managed, with an increasing emphasis placed on the use of safer alternatives.” However, communication is absolutely vital and there are still many in the downstream user category that don’t fully understand the regulation or how they are covered, such as those in the cosmetic industry, according to Janet Blaschke, managing director of International Cosmetics & Chemical Services, Ltd. UK.

For those companies that are not taking their REACH responsibilities seriously, both service providers and their clients would like to see ECHA and Member States become more aggressive with their enforcement activities. Companies that have invested significant resources want to protect their investments and keep ‘free-riders’ away. “We saw some enforcement activities under REACH, but they were focused on eSDSs and others did not end in any measurable citations. While ECHA has done a remarkable job and is very responsive, it must take seriously its role as an enforcement agency and issue real violations for significant deficiencies if the legislation is to be viable,” KFT Chemieservice’s Mr Torges asserts.

Extended safety data sheetsExtended safety data sheets (eSDSs) and exposure scenarios created much work for all types of service providers. Not only did eSDSs require updating with new data and a new format, but the annexes summarising exposure scenarios had to be developed and

manufacturers had to incorporate use information for raw materials based on the eSDSs received from suppliers, according to Benoit Fraysse, an eco-toxicologist with Equitox. NCEC’s Dr Whiting notes that it has been di%cult in some cases to ensure that the given scenarios match a company’s actual uses. Publication of the classification and labelling inventory on ECHA’s website also reportedly caused headaches, because many downstream users thought it was an ‘o%cial’ classification that would require changes to eSDSs.

One of the biggest challenges has been the hesitation by companies to prepare or to order eSDSs. There is still a lot of uncertainty whether this approach will be the solution for the future, according to KFT Chemieservice’s Mr Torges. He notes that most large international clients that initially supplied the annexes as separate PDF documents in English are planning to supply legally compliant eSDSs during 2013. “Developing comprehensive, compliant, and accurate exposure scenarios and eSDSs is incredibly time-intensive and can burden a company’s in-house product stewardship and regulatory compliance resources,” asserts Je#rey Starr, vice president of marketing for 3E Company. “As such, companies are increasingly partnering with reliable outsourced solution providers. While there is no single ‘REACH Solution’ that can be purchased that takes care of all aspects of REACH, there are reliable providers, who are well-versed in data and information as it relates to global Environmental Health and Safety regulations, and who thoroughly understand the EU regulatory environment that are available to help.”

For Agnes Botos, REACH, GHS, ADR, and EHS consultant with GHS Expert, mixture classification also became a noticeable issue in 2012, as companies began looking toward the June 2015 CLP deadline. In fact, about 25% of KFT Chemieservice’s clients ordered eSDSs for mixtures according to CLP requirements. Mixtures present a complex issue, however. “Our clients do have some concerns about how substances and exposure scenarios from the REACH process translate into data for mixtures at the production and safety data sheet stage,” NCEC’s Dr Whiting indicates. “We hope that industry will work together to take a pragmatic approach on this element, although it may prove the case that adopting CLP for mixtures highlights a number of data gaps in the process, and filling those gaps will be a key task in 2013.”

Testing labs were particularly a#ected by CLP requirements and found clients needing help with testing of compounds to determine the substance classification, the development of ad-hoc testing strategies and eSDS preparation once the testing data was obtained, according to Carlotta Casalegno, regulatory & development specialist with ChemService Srl Controlli e ricerche. The tests in most demand in 2012 were aquatic long-term tests on invertebrates (OECD 211 on Daphnia) and biodegradation tests, which she expects will remain popular in 2013.

Building GHS alignmentImplementation of the GHS is another complex issue, largely because while there is an international UN framework, each country had adopted its own version, and thus the requirements still di#er from country to country. “As much as GHS is meant to drive global harmonisation, individual countries are allowed to select the physical hazards, the health and environment classes and the associated categories within each class that they wish to adopt, and most countries that have implemented

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GHS have chosen to keep some of their existing hazard classification and communication that is not yet part of the GHS. As a result, there will be far less harmonisation between countries and regulatory authorities within each country than originally anticipated. We anticipate this lack of harmonisation will continue to be a source of concern for companies with global operations, necessitating – in many cases – access to proven regulatory data and compliance tools to help support conformance processes,” observes 3E’s Mr Starr.

Even simple translation from the former EU system to the new GHS system hasn’t been as easy as , sometimes assumed, notes Ineke Gubbels, director of IGCON. “Many mistakes have been made in simple translations by the automated programs that are commercially available, and as more countries implement GHS, this issue will continue to be a problem.”

Software and data management companies have thus focused on leveraging their products for this application. “GHS has been the single strongest driving force for companies around the globe to reevaluate how they are handling their hazard communication compliance. With so many regions/countries around the world making slight to major changes to the proposed UN GHS standard, companies are finding that compliance with these regulations is not possible without strong, configurable automation tools,” states Ste#an Kilmer, International Business Manager for The Wercs. Companies who have a desire to expand into new markets will find it increasingly di%cult to comply and thus ship their products. Having powerful software to help handle this growing demand is no longer a ‘nice-to-have’, he says, but a necessity for enabling the continuation of global business.

GHS implementation has moved to the forefront in the US, where the country’s new Hazard Communication Standard (HCS) was adopted by the Occupational Safety and Health Administration (Osha) in 2012. The new standard requires significant changes to labelling and documentation processes, practices and systems, according to Francis Trudeau, senior product manager for product stewardship solutions with IHS. “We expect this law will have the greatest impact on companies operating solely in North America, as most global companies have already adopted GHS-based processes in support of operations where GHS has previously been adopted.” However, he adds that the impact of GHS will continue to be felt beyond the US and EU. “New implementations of GHS, as well as GHS revisions by countries that have already adopted the UN Purple Book, were driving the current regulatory compliance agenda last year and will continue to do so in 2013.”

Honeywell Performance Materials and Technologies is a good example of a company faced with extensive GHS requirements in the US. “The US Osha GHS ruling is a significant issue that will add real complexity to the chemical management and control requirements that we already face, including compilation of eSDSs, preparation for 2013 REACH registrations, substance notifications in China and following up on GHS implementations globally,” says Guy Verbiest, PMT EMEA product stewardship leader for the company. “These items are of particular interest to our company, as our product portfolio is very extensive and targeted to a global market. Any REACH-like regulation or GHS implementation is of significant interest to Honeywell.”

There are many possible strategies for dealing with GHS compliance, according to Mr Starr from 3E Company. Many companies choose to use reference tools that centralise all global chemical regulatory information into a robust,

searchable, easy-to-use database that provides quick access to o%cial GHS classifications, including substance classifications published by the relevant authorities, as well as translated GHS classifications, labels, full text, and phrases. Such regulatory data tools or integrated regulatory content should also include expert rules that take into account national deviations as well as UN Purple Book rules, templates for key hazard communication documents, and multilingual phrase libraries. This system can be integrated with an authoring platform for the in-house generation of hazard communication documents, and can even be integrated with the purchasing system for management of in-bound vendor eSDSs. The other major option is, of course, to outsource these activities to a service provider.

Global compliance effortsDemand for help in compliance with national chemicals regulatory requirements, particularly in Asia, continues to be keeping many busy. “An increasing number of our clients have realised that compliance with REACH alone is not su%cient because they have global activities and thus have to deal with, often new, regulations in non-EU target markets,” notes Michael Cleuvers, head of industrial chemicals – global regulatory a#airs for Dr. Knoell Consult GmbH. There has been enough of an increase in demand that the company has established subsidiaries in China and Thailand and enhanced its cooperation with partners in Japan and South Korea. Linmark Consulting also had requests for support with the Korean Reach pilot programme, and its principle consultant, Martin Richards, expects to see more activity from China and Korea in 2013, particularly relating to data access. Because rights to data developed by consortia may only be relevant for EU REACH use, companies may need to go back to each original data owner to get new licences. McKenna Long & Aldridge was involved in extensive international product labelling and product composition work in 2012, and partner, Ursula Schliessner, expects more of the same in 2013.

Other companies did not have the same experience with requests for non-EU projects. “While some work was generated from China, Turkey and Russia, it was not significant compared to other business areas, and the amount of projects coming from Turkey was actually disappointing compared to 2011,” observes Dieter Drohmann, managing director of Chemservice GmbH and director of Chemservice Turkey. However, even if projects weren’t initiated in 2012, Steven Green, director of CS Regulatory Ltd believes that many of his customers have a large interest in staying abreast with updates on country-specific regulations, and he expects that these national regulations are likely to be of greater importance in 2013, once the REACH deadline has passed.

US regulations have kept companies that manufacture and sell products in that country on their toes (see section below for details). Along with GHS requirements, which Ashland expects will become an important issue in the next 24 months, Bernie Lindquist, a senior toxicologist with Ashland, is also paying close attention to Canada’s inventory update and is watching whether or not Mexico will bring its inventory online in 2013.

US firms also faced issues from the EPA related to risk assessment reform, prioritisation of chemicals to be subject to risk assessment, questions regarding confidential business information, increasing product deselection activity on the state level and whether or not any progress

CHEMICAL SAFETY

--- Toxicological Testing

(Inhalation, Repro, Gentox, .….)

-- Registration

(REACH, Authorisation,

Food Contact Materials, …..) &

Chemicals Management

(Exposure, eSDS, Audits, …..)

--- Analytical Chemistry

(Methods, Migration,

Product Identity, …..)

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P +31 88 866 16 20

[email protected]

Extended One Generation Reproduction Toxicity Study (EOGRTS)

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will be made on modernisation of the country’s ageing Toxic Substances Control Act (TSCA) legislation.

Product legislationProduct-specific regulations, on the other hand, required significant attention in 2012 and are expected to have an even bigger impact in 2013. “In general, the various changes to product-specific regulations that came into force in 2012 have contributed to making it ever harder for industry to continuously stay in compliance with all applicable product regulations,” remarks Dr Kleinkauf of SGS-CTS. She anticipates that product testing as a measure of quality control will continue to gain further importance as companies work to minimise product liability claims and maximise product safety. In addition to cosmetics, biocide, and food contact legislation, ADR/RID (hazardous goods regulations) will bring further changes in 2013.

In 2012, according to Christine McAlinden, Director of toXcel International Ltd, there was a growing awareness among cosmetic producers regarding their obligations to compile a comprehensive safety assessment and product file in compliance with the new EU Cosmetic Regulation. “For smaller companies with no regulatory experience or resources, however, meeting these requirements is particularly challenging. There is minimal understanding of the safety assessment requirements and the production of o%cial guidance by the European Commission’s Scientific Committee on Consumer Safety has been slow, with the latest released just in December 2012,” she says.

The new Cosmetics Regulation, which will be fully implemented in July 2013, is expected to have a significant impact on the industry. “The electronic notification system will help the Competent Authorities rapidly determine the state of compliance for a company and its products, and we are therefore expecting a big jump in enforcement,” states Ms Blaschke of International Cosmetics & Regulatory Specialists. She adds that the Product Information File (PIF) requirement is more detailed than was previously required under the old Cosmetics Directive, and the requirement for a ‘responsible person’, similar to a requirement under EU legislation on medical devices, is new and also needs to be addressed by most SMEs. “All of which will no doubt lead to an increase in the cost of doing business in the EU,” she concludes. As an example, a significantly higher amount of

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cosmetic ingredients dossiers, according to Jean-Luc Garrigue, director scientific a#airs – Europe for BIOAGRI, a Mérieux NutriSciences Company. “Many companies have anticipated the animal testing and marketing bans that take e#ect in March 2013, and have accelerated their safety evaluation programmes for strategic ingredients,” he says.

The new biocidal products Regulation (BPR), which replaces the current Directive (BPD) in the EU, is also proving to be a challenge for industry and regulator alike, according to JSC International’s Richard Elsmore, regulatory a#airs: biocides & REACH. The legislation was published in June 2012 and takes e#ect at the beginning of September 2013. Companies are currently still working under the BPD, and the inclusion of more active substances on Annex I is triggering the requirement for any biocidal products containing these active substances, which is many more than have been required in the past, to apply for product authorisation in order to stay on the market. The changes in legislation will further impact active substance manufacturers, formulators and producers of

articles that have been treated with biocides (even those treated outside the EU).

Several other requirements of the BPR are challenges for industry as well. “The regulation impacts data protection and data sharing with third parties, which is of real concern for our clients,” notes LCK’s Mr Kane. CEHTRA’s Sara Kirkham, senior regulatory a#airs consultant, adds the involvement of ECHA within the process, new dossier formats and data requirements, and labelling of articles to the list. He also notes that several anomalies have been found in the Regulation that must be addressed in order for the market to continue to function after the application date. “Even so, we have observed that most a#ected companies are slowly starting to move forward to ensure that they are compliant when the BPR goes into e#ect. Service providers like CEHTRA are helping these firms develop strategies to keep their products on the market in the face of high product authorisation costs,” she says.

The food processing and packaging industry will be challenged in 2013-14, according to Ms Laurence Gasnot, food additive and contact expert at CEHTRA. The French Agency of Food, Environmental and Occupational Health and Safety (Anses) will be reassessing the ‘technological aids’ necessary to process foods (antifoaming agents, enzymes, mineral oils, etc) listed in Annexe IB of the French Arrêté, which are authorised until the end of 2014. Furthermore, demand for food contact services has increased since publication in 2011 of the EU’s Regulation on materials and articles intended to come into contact with food.

Another new issue is that Regulation EC N° 1223/2009 on cosmetics requires the assessment of the safety of possible migrants coming from the packaging that is in contact with the cosmetic product, without giving any guide for such assessment. The mechanisms that determine the extent of this interaction (migration, permeation) has been fully studied for food packaging; therefore, a similar approach may be developed for cosmetic products, according to Ms. Gasnot.

All of these changes to product-specific regulations in the EU are taking place at the same time that REACH authorisation requirements must be met. “It is very important that companies seeking alternative substances as a result of REACH requirements make sure that they stay abreast of these other product regulations,” stresses Linmark Consulting’s Mr Richards. It is certainly possible that some alternative substances may require registration under the various product-specific regulations.”

Training needsNot surprisingly, the growing requirements under EU and non-EU regulations have spurred interest in various types of training programmes as well. “We have seen a growing demand for training on technical topics, such as exposure scenarios and their implications for the preparation of eSDSs, administrative issues, including Sief or supply chain management, and compliance with non-EU regulations,” notes Dr. Knoell Consult’s Mr Cleuvers.

REACHLaw has observed an increase in the need for awareness building on several aspects of REACH authorisation and biocides regulations, due to the fact that deadlines are approaching and companies are concerned about losing the ability to market their products and, consequently, also losing revenue streams, according to Mr Van Heerden. ReachCentrum, meanwhile, has also experienced strong interest in two of its most extensive

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training programmes - REACH Awareness bootcamp and Risk Assessment week. These programmes are very successful, according to Vincenzo Girardi, head of training with the firm, because participants receive in just five days a complete overview of the topic with a combination of practical hands-on exercises and theory. “For 2013, we are also expecting more demand for tailored training programmes related to REACH registration and authorisation, including onsite sessions as well as webinars and online solutions that allow participants to follow the training from many di#erent locations, continues Mr Girardi. Aside from regulatory training, there is always the ongoing need for training in basic emergency response activities, such as practical spill response, the UK’s

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1st Response, according to NCEC’s technical consultant, Mr Paul Rast-Lindsell. “We expect interest in these courses to continue to rise. However, we do find that requests for training often come after an incident, problem or audit that has highlighted the need.”

Of course, there are some specialist skills and areas of expertise that cannot easily be obtained through training courses, and providers that have these capabilities, including legal, testing and software and information management services, have and will continue to benefit.

Legal servicesKey services provided in 2012 by ReachCentrum and ReachLaw included preparation for Only Representative (OR) inspections; addressing issues associated with the registration of substances outside of joint registrations; drafting of authorisation consortium agreements; legal assessment of opportunities for appealing ECHA adverse decisions; support for understanding the ECHA dissemination policy and drafting confidentiality claims: studies on exemptions from authorisations and the article status of objects plus substance exemptions; support for implementing or interpreting rules of consortia and Sief agreements; and ongoing merger & acquisition and OR change of identity activity.

Ms Isaline van der Straten, a legal advisor for ReachCentrum, expects that in 2013 the firm will see the greatest demand for legal support related to the authorisation process (relationships with DUs, competition law compliance); updates of registration dossiers, read-across and fair cost sharing; and REACH-like legislation adopted or under development in non-EU countries. For REACHLaw, many of the same issues will be relevant, according to Mr Van Heerden, as well as SME determination for ECHA fee calculation, compliance clauses in supply contracts and industry obligations under the new EU biocidal products Regulation

With respect to legal decisions, Mr Van Heerden points to two cases of particular note in 2012, including the determination that ORs can apply for authorisation, which levelled the playing field for non-EU and EU manufacturers, and the withdrawal of ECHA registrations due to incorrect SME determination, which may lead to supply chain disruptions and provides an indication of potential enforcement issues.

The evolving case law of the Board of Appeal (BoA), including on substance identity, is also of significance, according to McKenna Long & Aldridge’s Ms Schliessner, because it will determine how active companies will be in challenging ECHA decisions. She notes that the NV Elektriziteits case (http://echa.europa.eu/documents/101

62/13575/a_001_2010_decision_en.pdf) was reassuring, because it confirmed the BoA’s broad power of review. Important cases to look out for in 2013, according to ReachCentrum’s Ms van der Straten, include the expected final decisions of the BoA on two appeals related to evaluation (case A-005-2011 lodged by Honeywell on testing involving animals, and case A-001-2012 lodged by Dow on read-across), as well as the court case ChemSec/ClientEarth vs. ECHA before the EU Courts, which may have an impact on the interpretation of REACH and other regulations. Meanwhile, REACHLaw’s Mr Van Heerden believes that ECHA and Member States’ REACH-EN-FORCE-3 project, enforcement on unjustified intermediate registrations, and possible challenges of candidate list inclusions should be watched in 2013.

Ms Schliessner also believes that it will be interesting to see whether any BoA decision is appealed in the EU General Court – considered to be an unlikely event because of the lack of suspensive e#ect in the General Court, and because the General Court does not generally get entangled with technical questions. She is uncertain if the 2013 REACH Review will have any substantial e#ect, and wonders if publication of registrant names by ECHA will lead to more national court cases. “We anticipate that companies may claim unfair trade practices against registrants who submitted low quality registration dossiers that are not actively pursued by ECHA or are using data not compensated for, and hence are e#ectively ‘free-riding’,” she adds.

Testing timesThe second registration deadline for REACH approaching as it does, at the same time that data requirements for other country regulations, GHS, and many product-specific regulations must soon be met, has ensured continued high demand for testing services. “Many of these test requirements have been the result of ‘data gap analyses’ and are needed to determine the properties of substances that were not known or impossible to gather from the supply chain,” SGS-CTS’s Dr Kleinkauf observes.

ChemService Controlli e ricerche experienced a 20% increase in the number of ecotoxicological studies completed in 2012 compared to 2011, with tests on aquatic organisms (algae, Daphnia, fish and aquatic plants), terrestrial organisms (soil microflora, earthworms) and biodegradation testing, being the most common. Ms Casalegno points to REACH, the BPR, the EU veterinary products Directive, and CLP as the major drivers. In 2013, once ‘last-minute’ REACH testing is completed, new requirements for cut-o# criteria (persistent, bioaccumulative, and toxic (PBT) and endocrine disruption properties) for the BPR will keep ecotoxicological testing as the key growth area in 2013 as well. Meanwhile BIOAGRI’s Mr Garrigue reports that the EU cosmetics Regulation, with its ban on animal testing beginning March 2013, led to more than a 110% increase in the number of

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studies completed in 2012 over 2011, including genetic toxicity studies, local lymph node assays, developmental toxicity studies, 28-day and 90-day oral toxicity studies, and screening for developmental toxicity studies (OECD 421).

There have been some additional challenges with respect to the more recent data requirements that are driving such tests. For one thing, it has been more challenging to fill data gaps with non-test data and by using read-across for the second phase REACH substances, according to Tox Focus’s Ms Vogt. She

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notes that lab availability has been an issue, but not an insurmountable one. Smaller companies have also often found it di%cult to obtain data about the uses and conditions of sold substances and mixtures, according to KFT Chemieservice’s Mr Torges. “Most medium-sized companies are not capable of retrieving this data, and we expect to see a growing demand for this type of support in the future.”

Such extensive data requirements have also led to the need for more e#ective data management within companies. Perhaps the most challenging issue today though is the need to address management of chemical risk throughout the supply chain. “Organisations face accelerating regulations with more stringent reporting requirements. These protocols now require companies to collect data across the value chain, from product design to manufacturing,” IHS’s Mr Trudeau states. “Achieving this goal is a significant challenge for companies that rely on single-function systems and manual processes that were not meant to handle today’s complex protocols,” he continues.

As a result, companies are struggling to analyse, share and distribute key information related to supplier compliance and corporate risk across various functional groups, according to 3E Company’s Mr Starr. “In 2012, many companies reached the realisation that their data management initiatives were inadequate; once data is acquired, the majority of companies do not have su%cient methods in place for validation or maintenance to ensure data is accurate or kept up to date. Suppliers need help in gaining access to and understanding the global product regulations with which they must comply. The ability to e#ectively ensure supplier product compliance is critical to business continuity and to avoid supply chain disruptions.”

As a result, in 2013, 3E Company expects that the focus on data management as a critical component of e#ective supply chain risk management initiatives will continue, with many companies striving to create a central repository of regulatory and product information to reduce supply chain risk while minimising data management costs. Mr Kilmer of The Wercs also expects that content delivery via ‘cloud’ systems, which was heavily emphasised in 2012, will continue to be an important component of such solutions in 2013, as will more e#ective systems that enable business process outsourcing for regulatory departments.

Communication challengesThere is also a need for information management systems outside of the chemicals regulatory compliance arena that can incorporate information derived as a result of chemicals laws. “New trends in nonfinancial reporting, driven by investors, NGOs and communities, are leading to significant changes across the global business landscape,” observes IHS’s Mr Trudeau. Stock exchanges are now requesting that sustainability information be included in reports to investors, and the International Integrated Reporting Council, a newly formed organisation with significant corporate participation, is calling for organisations to combine nonfinancial information, including product stewardship and sustainability metrics, along with their financial reporting. With respect to the growing need for communication throughout the supply chain, there are mixed feelings as to the level of progress that has been made. Mr Drohmann of Chemservice feels that, at this point, most companies realise that regulatory a#airs activities are a business strategy that can help di#erentiate suppliers from the competition. CEHTRA’s

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Mr Thomas, however, doesn’t believe that the expected improvements throughout the supply chain have really been achieved yet, even though he points out that many clients have indicated that REACH has ultimately strengthened their relationships with their suppliers and customers.

CS Regulatory has also experienced mixed results, according to Mr Green. “Most downstream users still need significant support, and while communication within the supply chain seems to be working fairly well, accurately tracking that communication beyond two or three steps either way of your own perspective on the chain continues to be a challenge,” says Mr Green. He is heartened, though, at the growing knowledge and awareness of regulatory aspects that downstream users seem to be gaining. Ms Blaschke, on the other hand, has seen only minimal improvements in supply chain communication and believes that only an increased threat of enforcement will have a real impact.

The problem for Dean Leverett, principal consultant with wca environment Ltd, is that downstream users are becoming increasingly involved in aspects of chemicals management that they have limited experience with or understanding of. This is particularly so for those involved in the use of substances that are candidates for, or subject to, restriction or authorisation under REACH. “The requirements for socio-economic analysis (SEA) that now frequently accompany such regulatory intervention are not well understood by downstream users, despite their key role in providing compelling supply chain data. Unfortunately, we find that many manufacturers often have limited or no appreciation of the final products their materials are used to produce.”

One downstream user and manufacturer of chemicals says it saw some improvement in communication in 2012, but not nearly enough to satisfy the company. The spokesperson does expect greater communication in 2013 because of the urgency of the 2013 deadlines. “However, this situation is unsatisfactory, with companies leaving such issues to so very late and entering into panic mode.”

Ashland, meanwhile, has not seen any significant change in communication throughout the supply chain. “We are still prising information from suppliers, and the need to do so is a source of frustration. Internet ‘rooms’ are helpful, but there isn’t enough of this type of tool, and there are still a lot of battles over confidentiality,” says Dr Lindquist. Honeywell, on the other hand, did not experience any supply chain disruptions, but has, in response to the growing amount of chemical management and control requirements, reorganised its Product Stewardship department so that services and resources can be deployed globally when needed, according to Mr Verbiest. Eastman also did not su#er supply interruptions in 2012, so has not focused much attention there. “Our suppliers are usually big chemical companies who have their REACH ducks in a row,” Mr Schüller feels.

The important role that downstream users play is becoming more apparent as implementation of REACH progresses, and the possibility of supply chain disruption is growing. While most service providers have not encountered significant problems, some, such as CS Regulatory, have observed cases where suppliers have withdrawn substances from the market or elected to register substances only as isolated intermediates under strictly controlled conditions, whereby the substances can only be handled under any other conditions. “We believe that there is also potential for greater disruption within supply chains as the e#ects of the regulatory process continue to take hold,” Mr Green says.

In general, according to Chemservice’s Mr Drohmann, it seems that larger companies have increased their chemicals management and control activities, but SMEs often are not able or are unwilling to address this issue, particularly given the lack of enforcement. With movement on the REACH authorisation process and anticipated increased enforcement, further participation by all types of downstream users is expected in 2013. Ashland’s Dr Lindquist agrees: “SMEs do not have the resources to comply with REACH and we expect to see some of them drop out.”

Special US section

US chemical manufacturers and users dealing with GHS implementation and an EPA looking to extend its authority

In the US, political gridlock has meant little legislative progress in recent years, and not much is expected to change in 2013. With major financial issues – and battles – to occupy Congress for at least the first half of the year, little legislative action on chemicals management is anticipated. However, companies – both manufacturers and users of chemicals – will be kept quite busy meeting Osha GHS requirements, keeping up to date with actions of a more aggressive EPA, and responding to numerous programmes taking shape at the state level.

GHS complianceOne area of activity that has not been impacted by the political paralysis in Washington has been the adoption of the Globally Harmonized System (GHS) by the US

Occupational Safety and Health Administration (Osha). “Promulgation of Osha’s Hazard Communication Standard (HCS) 2012 indicates that US regulatory authorities are clearly capable of executing sweeping regulatory changes,” notes Mr Starr from 3E Company. According to Osha, changes to the HCS will a#ect over 43 million workers in over 5m workplaces. The biggest changes in the new HCS relate to Hazard Classification, Labels, Safety Data Sheets and training.

In fact, The Wercs’ Mr Kilmer expects that GHS compliance will be a “regulatory cli#” for chemical companies. “We expect many will wait too long to prepare and comply, and that the consumer retail industry, and not the government, will end up being the chief driver for achieving GHS compliance.”

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Both The Wercs and IHS note that, because important training requirements must be met by the end of December 2013, implementation of the Osha HCS is a critical product management issue for chemical companies this year. The new classification procedures follow a very di#erent approach than was previously used and training and implementation will be a big issue for US companies and those selling into the US market. Tom McKellar-Smythe, senior regulatory consultant with Caleb Management Services Ltd, also warns that chemical manufacturers and distributors should not wait to start working to meet the 1 June 2015 deadline for hazard reclassification and the production of GHS labels and SDSs, because these activities require a great deal of time and resources.

TSCA reform and legislationThe need for TSCA reform continues to top the agendas of all of the leading chemical industry trade groups, and is also recognised by members of Congress and other stakeholders. “The safety of chemicals has received a lot of public attention recently, and our national chemical management regulation needs to be updated to address such concerns,” says William E. Allmond, vice president of government and public relations for the Society of Chemical Manufacturers and A%liates (Socma). However, adds Mike Walls, vice president of regulatory & technical a#airs for the American Chemistry Council (ACC), a modernised TSCA must ensure protection of public health and include strict government oversight, while preserving the innovative nature of the chemical industry, which is a major driver of economic growth in the US.

Progress to date has been slow, but as Mark Duvall, a principal with law firm Beveridge & Diamond sees it, much has been achieved; the basic issues have been identified, di#erent approaches have been discussed with various stakeholders, and members of Congress have been educated about the issues.

With two alternative pieces of legislation expected to be proposed in 2013, ACC believes that an important crossroads in the TSCA reform process has been reached. Senator Frank R. Lautenberg (D-NJ) is expected to reintroduce his “Safe Chemicals Act,” which was approved in July 2012 by the Senate Environment and Public Works (EPW) Committee without any support from Republicans. Meanwhile, Senator David B. Vitter (R-LA) has publicly committed to introducing a bill that many in industry believe will take a more reasonable approach and have the potential for gaining bipartisan support. Having two proposals with contrasting legislative language creates the real opportunity for progress, according to Mr Duvall.

It is unlikely, particularly given the major budget and financial issues that must be addressed in the first half of the year, that any legislation will pass the Senate in 2013, but it is not inconceivable. Key points that will need to be addressed include the use of sound science and a risk-based approach to the prioritisation and review of chemicals, collection of data from users of chemicals as well as producers and processors, strengthening of federal pre-emption of state regulations, and appropriate treatment of confidential business information (CBI), which is critical for maintaining the global competitiveness of the chemical industry, according to both ACC and Socma. “We believe that if Democrats and Republicans focus on these areas where there is common ground, targeted, workable solutions can be developed that will improve

the e#ectiveness and e%ciency of the current TSCA law,” Socma’s Mr Allmond says.

In the vacuum created by the lack of actual TSCA modernisation, the EPA and individual states have stepped up their e#orts to manage chemicals risk in other ways. “There has been, and will continue to be, pressure on individual state legislatures to create their own chemical management laws. The EPA is also taking steps to implement programmes designed to keep pace with other regulations, such as REACH, where new chemicals are not necessarily the focus,” observes Jennifer Reed, new business development manager for Caleb Management Services Ltd. “We do not see this state or federal regulation activity slowing down until progress with TSCA modernisation is made.”

Individual states within the US are taking actions, such as issuing bans on specific chemicals like bisphenol A (BPA) and restricting the use of cadmium. Washington’s Children’s Safe Products Act, which requires manufacturers and retailers to notify the state if they sell certain children’s products containing any one of 66 chemicals of high concern to children, required notifications beginning in 2012. Maine has a similar law with a list of 49 chemicals of high concern, and New York, Minnesota, Arkansas and other states have bills pending that have similar provisions, observes SGS-CTS’s Emilie Viengchaleune, global marketing coordinator for Global Sustainability Services. “This trend in emerging regulatory frameworks for the safety of chemicals in children’s products is forcing the industry to re-evaluate its compliance strategy and look at risk-based approaches regarding the materials that go into children’s products,” she remarks.

Adds Ms Vogt of Tox Focus: “With so many varying state laws, interstate commerce is becoming very di%cult for industry.” The state that has been most active is California, which, according to a spokesperson from the California Department of Toxic Substances Control, plans to finalise its Safer Consumer Products Regulations by April 2013. The most troubling aspect of this green chemistry initiative for industry is the restriction of products containing chemicals found on a ‘Candidate Chemicals’ list of an expected 1,200 substances. Initially, a short list of ‘prioritised products’ will be generated that will require reformulation with ‘safer chemicals’ to be determined via an ‘alternative analysis’.

Meanwhile, at the federal level, the EPA has sought to expand its authority under the existing TSCA Regulation to the fullest extent possible. Its focus has shifted to existing chemicals including their risk assessment, wider dissemination of risk information and encouragement of the development of safer alternatives.

One agency proposal that is causing concern to industry is the potential requirement for disclosure of specific chemical identities in health and safety studies submitted to the EPA for chemicals that have not yet been manufactured. According to Socma’s senior manager of government relations, Dan Newton, if such a rule is adopted, some of the trade group’s members would seriously consider not manufacturing new chemicals in the US. “The protection of chemical identities is critically important for preventing competitors from learning key information about new products; without that protection so early in the product lifecycle, it may not be economically sound to invest in new product development,” he explains.

Claiming CBI is further complicated by the fact that requirements are di#erent in the US and Europe. “Industry is entering a new era. Corporate EHS, product stewardship and legal sta# need to decide whether they will proactively

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declassify substances or try to substantiate confidentiality claims. However, rights to CBI may be questioned as the EPA attempts to expand the guidelines of its current statutory authority,” says Bonita Reynolds, senior regulatory specialist with 3E Company.

Both ACC and Socma believe that carefully structured generic names could provide the necessary protection of proprietary information while still enabling public access to safety and hazard information. They have also asked the EPA to require upfront substantiation of the need for CBI in order to prevent overuse of this important aspect of the TSCA regulations. “We would, however, like to see much more guidance from the EPA on how to develop e#ective generic names, and in the meantime, ACC is working on possible approaches that we will share with the agency,” notes Christina Franz, director of regulatory & technical a#airs with ACC.

Prioritisation of particular chemicals for review is also high on the agency’s agenda. In 2012, the EPA launched an ‘Existing Chemicals Strategy’ that, among other things, identified a work plan of 83 chemicals for further assessment. The EPA released five draft risk assessments in January 2013, and is now seeking public comment and they will be subjected to peer review. An additional two draft risk assessments addressing medium- and long-chained chlorinated para%ns should be released soon, and the agency will be conducting another 18 risk assessments in 2013 and 2014. Both Socma and ACC approve of the EPA’s stepwise process for the review of the work plan chemicals and applaud the agency’s focus on actual uses of the chemicals. One unanswered question, however, is what will happen at the end of this process. “No action has been taken by the EPA under TSCA section 6 since 1991. Therefore, extensive discussion is needed to determine what approaches might not only be e#ective, but also possible, under the existing TSCA legislation,” remarks Beveridge & Diamond’s Mr Duvall.

ACC would also like to see the EPA hold another stakeholder meeting on prioritisation in 2013. The organisation has developed a comprehensive, scientifically-based prioritisation system that takes into account both hazard and exposure and has shared this tool with the agency and other stakeholders, according to Ms Franz. She wants to see the EPA make additional progress on its methods for selecting chemicals for review.

Another approach for the agency with respect to existing chemicals is the issuance of Significant New Use Rules (SNURs), over 300 of which were initiated in 2012. Many of these rules were related to aquatic toxicity issues or for chemicals that aren’t very soluble. SNURs are a serious concern for industry because they can impact the entire supply chain; many users of chemicals avoid purchasing such regulated substances, and both Socma and ACC are anxious that the EPA uses its authority appropriately to issue SNURs.

One particular proposed SNUR – polybrominated diphenyl ether (PBDE) flame retardants – has caught a significant amount of attention. In the past, the EPA has avoided using SNURs for articles, and only regulated single articles if it did issue such a SNUR. For PBDEs, however, which are being phased out in the US, the proposed SNUR would cover all articles, and it appears that the agency is attempting to achieve widespread changes, according to Sarah Brozena, senior director of regulatory & technical a#airs with ACC. Mr Duvall notes that this approach is challenging for the EPA and a real concern for industry. The agency has agreed to hold workshops with industry

in 2013 on its decision-making processes for SNURs, and particularly for substances that are di%cult to test and multicomponent products.

It is worth noting that some of the EPA proposals outlined above have yet to receive approval from the O%ce of Information and Regulatory A#airs (Oira) in the O%ce of Management and Budget (OMB), and it is not clear when or if they will be released. For example, the proposal on CBI claims for chemical identities in Premanufacture Notifications (PMNs) has been pending since December 2011, and the final SNUR on PBDEs has not yet been submitted for Oira approval. Others of note include a proposal regarding reporting requirements for nanomaterials under the Federal Insecticide, Fungicide, and Rodenticide Act (Fifra), and a SNUR for nanomaterials and a ‘chemicals of concern’ list under TSCA (from December 2009). President Obama’s appointment as head of the Oira could have an impact on the future of these proposals.

In addition to the larger number of SNURs in 2012, industry also had to comply for the first time with the updated Chemical Data Reporting (CDR) rule, which replaced the Inventory Update Reporting (IUR) rule. Companies had to report an expanded set of chemical production and import volumes using a new online portal and coding system. “The CDR also requires tracking of data for each year, rather than just every five years, so companies, including distributors, need to be sure that they are collecting all of the necessary data that is required,” notes Jennifer C. Gibson, vice president of regulatory a#airs for the National Association of Chemical Distributors (NACD).

The CDR is very important to both industry and the EPA. The agency will be using the information gathered in this programme for its prioritisation of work plan chemicals, among other activities. “Therefore,” asserts Robert Kiefer, director of regulatory & technical a#airs with ACC, “It is imperative that the CDR is implemented correctly. It provides a valuable mechanism for the EPA to screen manufacturing, use and exposure information on chemicals in commerce.” The EPA recently released chemical use, production, and other data collected in 2012 under the CDR rule.

The EPA has also introduced several new interpretations of existing TSCA provisions, particularly for chemicals that have been on the TSCA Inventory for many years. Companies need to stay abreast of these new interpretations, because it is possible that compounds previously considered by industry to be covered by TSCA inventory listings are no longer included from the EPA’s perspective. Simply following established industry practice does not guarantee compliance anymore.

Altogether, these activities are designed to help the EPA address existing chemicals, which is an area of weakness in the current TSCA legislation. “Even in the absence of TSCA reform, existing chemicals will continue to be in the spotlight,” observes Caleb’s Ms Reed. “More now than ever, companies need to ensure that they stay current with and understand new requirements. The days of ‘My chemical is on the inventory, so I don’t need to do anything’ are over.”

Enforcement activitiesAs well as expanding its authority under TSCA in light of the lack of legislative progress in Washington, the EPA has also stepped up its enforcement activity, largely under the General Duty Clause in the Clean Air Act. NACD’s

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Ms Gibson notes that the slowing of the economy, the perception of important regulatory failures in food and product safety, airline maintenance and the financial system, and the democratic administration have also contributed to the increased level of enforcement.

The situation is quite challenging, particularly for small manufacturers and distributors that have limited resources. The fact that the EPA is relying on a very vague regulation makes it even more di%cult. The GDC requires that companies with an undefined set of ‘other extremely hazardous substances’ manage their chemicals safely. “This general regulation gives the EPA tremendous power to require facilities to change their procedures and designs, and the facilities have limited recourse to question the agency’s allegations,” Ms Gibson claims. Even for companies committed to programmes like Responsible Distribution, ChemStewards and Responsible Care and who operate in a responsible manner, it seems not to be di%cult for the EPA to find a problem and issue a citation she says.

Clean Water Act issuesUnder the Clean Water Act, there is anticipation that legislation to remove the requirement for a water permit for Fifra-compliant applications will be reintroduced in 2013, after being defeated by Senate democrats in 2012. The legislation is designed to prevent potential negative impacts of the permitting requirements, which have been reported to lead to increased disease incidence such as West Nile virus, due to higher costs and the fact that pesticide applicators are no longer o#ering certain services in order to avoid permitting issues. With respect to endocrine disruptors, the EPA is planning to complete the review of its initial round of testing in 2014 and issue test orders for Tier 2 testing in Fiscal Year 2014.

Trouble with the Endangered Species ActThe Endangered Species Act (ESA) and its potential impact on the use of agrochemicals will also be an important issue for Congress. There has been much litigation regarding the EPA’s compliance with the ESA with respect to its pesticide approvals. Of note is the lawsuit filed by the Centre for Biological Diversity in January 2011 on over 300 pesticides that could impact growers of all types of crops across the nation. Despite numerous settlement talks in 2012, no conclusions were reached. The EPA files a motion to dismiss and the decision on this motion is expected in 2013.

Specific product regulationsWith respect to specific product legislation on the national level, two di#erent versions of legislation on cosmetics safety that targeted the greater disclosure of substances used in cosmetics were introduced in Congress in 2012, but were not advanced. No other major new rules for consumer products were enacted, either, according to SGS-CTS’s Ms Viengchaleune. The latest development in this area was the Consumer Product Safety Improvement Act (CPSIA), which was implemented from 2008-11 and resulted in a ban on the use of heavy metals (via ASTM F 963) and stricter restrictions on lead in a much broader range of children’s products. However, the US Food and Drug Administration (FDA) did finalise a ban on the use of

BPA in polycarbonate used for baby bottles and beverage containers.

Can the EPA manage it allBased on the above discussion, it is clear that the EPA’s agenda is laden. The fact that a large number of the EPA’s proposals remain held up by OMB while it continues to add new programmes and actions has many in the industry questioning whether or not the EPA will be able to meet its commitments. In many cases, the policy initiatives that the agency is taking on are complex and di%cult issues that would not be easy to address, even if the EPA had unlimited time and resources. On the contrary though, the agency is facing the prospect of funding decline given the current federal budget deficit. How deep any cuts might be is unclear, and thus their impact is also unknown.

US exportsLooking beyond specific US regulations, there are international regulations that have an impact on US chemical manufacturers and downstream users. REACH, of course, is a major consideration for companies that export to the EU. Chemical distributors discovered in the first round of REACH that they are largely responsible for passing information throughout the supply chain, according to Gibson, and most NACD members seem to have a good understanding of their role now.

REACHLaw’s Mr Van Heerden reports that his company has found that most larger US firms have a good awareness of REACH, while SMEs don’t seem to be taking much action. Some of Socma’s members, which are generally smaller, batch manufacturers of fine and speciality chemicals, decided after the first phase of REACH that it was too costly to do business with the EU. Mr Allmond expects that with the second phase of registrations covering smaller volume chemicals, additional members will decide that exporting to Europe is not cost-e#ective.

Trade agreements and regulations?However, he does note that a possible Free Trade Agreement between the US and EU could have an impact on REACH and TSCA both. “The chemical industry could benefit tremendously from such an agreement. In 2011 alone, the industry paid over $1bn in tari#s on chemicals exported to the EU, and $600m of that was for fine and speciality chemicals. Any agreement would have to address TSCA and REACH requirements, and thus could have an impact on these regulations for both US and European manufacturers,” Mr Allmond says.

Beyond complianceVoluntary industry programmes can have a significant impact on individual companies and the industry as a whole. The programmes mentioned above – Responsible Care, Responsible Distribution and ChemStewards – have helped large and small manufacturers and distributors alike in the US – and increasingly around the world – implement employee environmental, health, safety and security management programmes and continuously improve their performance in all of these critical areas. The industry trade associations also continue to develop these programmes. For example, ACC is enhancing Responsible Care with the recent adoption of a new Product Safety Code and expansion of its Process Safety requirements.

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IHS believes that voluntary nonfinancial reporting is another type of industry e#ort that is gaining increased visibility. “Nonfinancial reporting issues have a broad impact that reaches from resource acquisition to the bottom line, and standards now approach the rigour required for financial reporting,” observes Mr Trudeau. He adds that more than 95% of the world’s 250 largest companies now provide nonfinancial reporting. “With sustainability information now widely available in the public domain, companies are aware that environmentally conscious stakeholders and customers can compare sustainability performance among competing companies. Institutional

investors are watching closely, too, as nonfinancial metrics are considered a reliable indicator of risk management.”

Clearly, with the many compliance requirements associated with existing US-based regulations, the EPA looking to expand its authority under TSCA, the Senate expected to propose new TSCA legislation, the second phase of REACH registrations becoming due, and international chemicals management and control regulations growing at a rapid pace, 2013 promises to be another challenging year for US manufacturers, processors, distributors, and users of chemicals and those looking to participate in the US marketplace.

Key country regulatory highlights in 2013

Europe

Application dates for first chemicals to need authorisation under REACH in February and August

Animal testing ban on cosmetics or cosmetic ingredients into force on 11 March

Second REACH registration deadline (31 May) for production/import volumes between 100 and 1,000 tonnes/year

EU Commission to review endocrine disrupting chemicals (EDC) provisions of REACH on 1 June

EU cosmetics Regulation comes into force on 11 July

EU biocidal products Regulation into force on 1 September

EU Commission to propose criteria for identifying EDCs by December

US

EPA publishes first draft risk assessments from 83 existing chemicals prioritised in 2012 for public and peer review, more expected in 2013

Republican and Democrat senators expected to introduce bills to reform TSCA in spring;

California to adopt final Safer Consumer Products rule in the spring

Requirements under Osha’s 2012 Hazard Communications Standard to implement GHS take e#ect, including new training duties by December 2013

Dodd-Frank Wall Street Reform and Consumer Protection Act ‘conflict minerals rule’ requires first disclosure on use of tantalum, tungsten, tin or gold from Democratic Republic of Congo and surrounding countries in 2013. Returns to be filed by May 2014

Canada

Information required to be submitted for 2,700 substances added to Domestic Substances List in December 2012

Amendments expected to hazardous products Act (HPA) and controlled products Regulations (CPR) in spring to align them with GHS requirements for chemicals in the workplace

China

Measures for Environmental Administration Registration of Hazardous Chemicals (MEP Order 22) come into force on 1 March

List of hazardous chemicals for priority environmental management is expected to be issued before the summer

Revised Catalogue of Hazardous Chemicals due to be published in 2013 triggering requirements under several new or recently amended laws

Possible revision of GHS standards to align with fourth revision of GHS

Finalisation of third (and possibly final) batch of food contact additives approved by MOH

Taiwan

Legislation amending the Toxic Chemical Substances Control Act (TCSCA) requiring chemical manufacturers and importers to register designated priority substances expected to be adopted by April

Japan

Schedule set for new chemical notifications from April to December under Chemical Substances Control Law (separate schedule for low-volume substance notifications)

South Korea

Proposed Act on chemicals registration and evaluation, dubbed “K-REACH”, due to be adopted by the summer

Mexico

Proposal for chemicals regulation (policy and legal options) to provide a legal framework for recently published first national chemicals inventory possible

Malaysia

Regulations on classification, labelling and safety data sheets for the use of hazardous chemicals in the workplace and industry (‘CLASS’) due to be issued for consultation

Vietnam

Revision expected of main chemicals management law, Decree 108/2008

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CAREERS AND SALARY SURVEY

A look at the chemical management and control jobs market

For the first time, � � � � � � � � � � � �

asked specific questions about the salaries and career prospects of chemical management and control professionals, those working within industry and those working as service providers. Our first question asked about the changes in the size of these teams, both last year and for the next 12 months. About half of respondents reported no change whatsoever last year, while 37% said there had been an increase (Figure 3). Around 13% said there had been a decrease, which may reflect greater outsourcing by industry, or smaller teams due to the general economic downturn. The range in responses reflects the fact that there are many varied and conflicting factors that influence the job market.

Similar figures are reported for the next 12 months, with around a third of participants expecting to see sta%ng increase and more than half expecting no change during that time. Nearly 9% actually expect a decline. As a whole, it appears that the global market for chemical management and control professionals increased last year, and will continue to do so over the next 12 months.

Figure 3

Sta"ng trends within your employer

37.0% 35.4%

50.1% 55.9%

12.9% 8.7%

Last 12 months Next 12 months

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Decreasing Static Increasing

REACH continues to be a key driver of demand for chemicals management and control skills. For some companies, there are concerns about workloads following the upcoming deadline in 2013, particularly because the next deadline is several years away. “REACH by nature is not a process that is evenly spread out. The three registration deadlines have resulted and will result in some quite extreme peaks and troughs in REACH compliance activity, which creates a volatile job security situation,” says Caleb’s Mr McKellar-Smythe.

Many others, however, feel that the job market remains strong. For example, Linmark Consulting’s Mr Richards expects the job prospects for regulatory professionals to remain good in 2013, within both chemical producers and consultancies. “Due to the importance of REACH in allowing products on the European market and the diversity

of global regulations, the roles of regulatory professionals are becoming increasingly important within the chemical industry,” he says.

The current REACH deadline is just one part of the story, according to Ms Schliessner of McKenna Long & Aldridge. “Companies also have to simultaneously deal with authorisation and compliance check decisions, as well as CLP compliance and enforcement. Hence the workload is ever increasing, not diminishing. Additional employment opportunities should thus be expected, unless current sta#ers continue to work overtime due to the bleak economic outlook. There should certainly be no lay-o#s.”

The results of the � � � � � � � � � � � �

survey support these sentiments. Nearly 96% believe that job prospects are good or stable in the global market and nearly 90% feel the same is true in their local market (Figure 4).

That confidence is also reflected by the fact that nearly 90% of respondents to the

� � � � � � � � � � � � survey

indicated that they feel their job security has either increased or remains the same in their specific role and across all roles, compared to the last 12 months (Figure 5).

Figure 4

Job prospects

42.6%

59.0%

47.2%

37.0%

10.2%4.0%

In your country Globally0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Poor Stable Good

“To my mind,” adds Chemservice’s Mr Drohmann, “jobs are safe. Good regulatory a#airs people are not generally available on the jobs market, and if they are, extraordinary salaries must be o#ered to attract them, at least in Europe. We have started training people newly graduated from universities, even though it is an investment to get them to reach the necessary skill level.” JSC International’s Dr Elsmore sees continued demand for high quality regulatory support for industry driving growth within specialist consultancy firms and shortages in the availability of expert sta#. Dr Knoell Consult’s Mr Cleuvers concludes: “Compliance with global chemical management systems is still an emerging issue, and professionals with expert knowledge in this area are needed. We hired a lot of people in 2012. I consider these jobs to be safe.”

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Figure 5

Job security compared with 12 months ago

19.9% 19.6%

68.8% 66.1%

11.3% 14.4%

In own role Across all roles0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Less secure Similarly secure More secure

In addition to largely feeling secure in their positions, the majority of participants (60%) in the

� � � � � � � � � � � �

survey also felt satisfied with their roles (Figure 6). Of the remaining, 29% do not feel strongly one way or the other, and around one in ten are dissatisfied. This could be due to the fact that many in the sector find themselves faced with high requirements and limited resources to carry out their tasks, according to Mr Van Heerden of REACHLaw.

Figure 6

Job satisfaction

Satisfied59.8%

Neither satisfied or dissatisfied

29.0%

Dissatisfied11.2%

Also on a positive note, many of the � � � � � � � � � � � �

survey respondents (63%) believe that their career progression prospects are good in the wider jobs market. They are, however, less hopeful about the change for advancement within their current employer, with only 38% indicating that they have good opportunities for advancing their careers within the same company (Figure 7).

International Cosmetics & Regulatory Specialists’s Ms Blaschke gives a potential explanation for this finding: To her, it seems that regulatory support sta# are hired at two extremes of the spectrum: basic entry-level and clerical sta# to do compulsory paperwork, and higher-level worldwide upper management specialists in overall compliance. “I have seen very little evidence of mid-level jobs, and it appears that opportunities for advancement for junior sta# members are minimal,” she notes.

Figure 7

Career progression opportunities

38.0%

63.0%

36.7%

31.0%

25.3%

6.0%

In your company Wider jobs market0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

NeitherPoor Good

Salary trendsParticipants in the

� � � � � � � � � � � � survey kindly shared

information on their current positions and salaries. A summary of the results is presented below. For the first time, we provide useful data on salaries, pay rises, and bonus levels in the global chemical management and control community.

The group of survey respondents includes regulatory a#airs experts with a range of titles and positions (Figure 8). The largest groups were project/team managers (29%) and specialists/technicians (29%), followed closely by senior managers (24%). Directors/partners represented 12%, juniors/graduates 3% and government o%cers 3.4%.

The average age of the survey respondents is 45, with just over 44% of them female. The average global salary for chemical management and control professionals is €46,200 (US$61,700), and almost half of the professionals have global responsibilities within their organisations. Unfortunately, the gender gap remains among our sample, with men earning an average €55,700 and women just €44,300.

The average salary is broken down by job title in Figure 8. Surprisingly, regulators receive the highest salaries, and otherwise there is not a tremendous variation in pay levels for the job titles shown in the chart, except for business management/development positions, which earn a little less than the rest, but are likely to receive larger bonuses.

There is, however, some di#erentiation in salaries depending on the type of organisation (Figure 9). Survey respondents working for government agencies earn the most, followed closely by those working for trade associations or professional bodies, both receiving average salaries above €50,000.

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Figure 8

Average salary by job title

37.2

44.6

47.9

49.6

47.9

53.0

46.1

45.3

46.2

0 10 20 30 40 50 60

Business management/development

Consultant

EHS management

Other

Product safety/stewardship

Regulator

Regulatory a"airs management

Toxicologist/chemist/scientist

Average salary

Euros 000s

Those employed by consumer products firms, non-chemical manufacturers and service providers earn average salaries approaching €47,000. In addition, average salaries were fairly close regardless of company size, although participants at larger (over 250 employees) and medium-sized (50-250 employees) firms had a slightly higher average salary (slightly over €46,000) than those at small-sized (less than 50 employees, €44,600) firms.

Basic salaries also vary significantly depending on location (Figure 10).

� � � � � � � � � � � � survey respondents

in Europe earn an average €53,800, which is well above the nearest amount of €35,900 for professionals in North America, and significantly higher than the average salary for survey participants in the rest of the world (€30,700).

Figure 9

Average salary by organisation type

45.4

47.1

44.4

52.7

45.3

46.8

46.6

50.7

0 10 20 30 40 50 60

Chemicals, life sciences and similar

Consumer products, cosmetics and similar

Engineering, automotive, aerospace and similar

Government & agencies

Other

Other manufacturing

Service provider, including consultants, laboratories, lawyers etc

Trade association or professional body

Euros 000s

Figure 10

Average salary by job region

53.8

35.9

30.7

46.2

0 10 20 30 40 50 60

Europe

North America

Rest of world

Average

Euros 000s

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Not surprisingly, salaries also vary according to the age of the survey respondents, with those aged 46-50 earning the most at €54,800, followed by those aged 36-45 (~€50,000) and 51-55 ((~€48,000). The oldest survey participants (over 65) earn the least at €28,800, which probably represents reduced hours, while the youngest respondents receive salaries just over €30,000 (Figure 11).Over two-thirds of the

� � � � � � � � � � � � survey respondents

(70%) were entitled to a bonus. Of those that did receive a bonus, the average bonus was 11.0%, with European bonuses lower at around 9.5%, North American bonuses at 12.4% and those in the rest of the world at 16.7%.

Meanwhile, the average pay rise for those who stayed in the same role was 2.4% and for those that gained a promotion this increased to 7% (Figure 12). Participants in Europe received the smallest pay rises, although those awarded in North America weren’t significantly higher. However, straight pay rises awarded in other parts of the world were as much as three times those given in Europe and North America.

Figure 11

Average salary by age

33.9

33.9

44.3

49.3

49.5

54.8

47.7

40.9

41.7

28.8

0 10 20 30 40 50 60

21-25

26-30

31-35

36-40

41-45

46-50

51-55

56-60

61-65

>65

Euros 000s

Figure 12

Average pay rise

2.0

2.4

6.0

2.4

2.4

3.0

7.1

3.0

5.9

7.6

10.5

7.0

0 2 4 6 8 10 12

Europe

North America

Rest of world

Average

%

Excluding

promotions

Including

promotions

Only

promotions

Jobs and salaries in the UK and EuropeWhile there is a lot of work to be done in the regulatory and product safety areas, many firms are relying more on in-house sta#, as was noted in the

� � � � � � � � � � � � survey.

That trend has also been observed by John Sherratt, business manager with placement firm VRS Regulatory, and he attributes it to the challenging economic environment that companies are facing today. He notes that companies are keeping head counts down and external expenditures limited, and using employees unless the project requires specialised expertise that cannot be found internally.

The good news, according to Mr Sheratt, however, is that for professionals with those specialised capabilities, demand is very strong, and salaries are increasing. In particular, people with REACH and biocide/agchem registration experience, knowledge of testing, and expertise in fate/exotoxicity analyses are in short supply and high demand. In fact, for Nonstop Recruitment, the demand for environmental fate specialists and ecotoxicologists was even higher than expected in 2012, according to Abid Kanji, country manager, toxicology, ecotoxicology, regulatory a#airs & REACH.

For other chemical management and control positions, while the job markets in Germany, Netherlands, and Belgium picked up markedly in 2011, it was the UK that experienced a real increase in demand in 2012, according to Mr Kanji. However, he notes that demand for regulatory sta# to support REACH, biocides and agchem regulations has been greatest for junior to mid-range level positions, and opportunities remain few and far between for director-level positions.

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On the disappointing side, NonStop saw a 70% decline in demand for toxicologists in 2012 as compared to 2011. Interest did increase towards the end of the year, but not in a manner that indicates any urgency. “It is possible that this lack of growth/demand for toxicologists is due to the fact that demand was extremely high in 2011, and the majority of positions were filled. I am optimistic, though, that growth will return in 2013,” Mr Kanji comments.

NonStop also expects demand for regulatory sta# within the flavour and fragrance industry to increase three-fold due to the EU cosmetics legislation. There is a concern about availability of candidates though, according to Mr Kanji. He, therefore, expects that some cosmetic companies will be willing to train people with experience in chemical and/or consumer products regulatory a#airs activities.

Also on the positive side, salaries are, at a minimum, steady and definitely not declining for all positions in this sector, according to VRS Regulatory’s Mr Sherratt. “In fact,” he says, “the overall job market and demand in the chemical management and control sector have been pretty steady in the UK and Europe despite the recent global recession and current economic situation, and the situation is not expected to change in the foreseeable future.”

The US employment sceneWithin the chemical manufacturing and downstream manufacturing sectors, there is real demand for positions at every level now, and in all types of positions, including engineering and chemical risk management, according to Greg Harper, vice president of the industrial practice for Charles Aris Inc, a placement firm in Greensboro, NC USA.

“The economy is recovering, and not only is increased demand for goods driving the need for more highly skilled people, many employees who postponed retirement because of the poor economic situation are now taking that step and leaving additional positions vacant,” Mr Harper notes. Further adding to the demand is the movement to bring manufacturing back to the US.

Specifically for positions in the chemical risk management area, the increasing regulatory requirements around the world are an additional factor that is coming into play. “These positions require specialised skills, and there is a shortage in the US of people with these abilities, because we don’t have that many graduating students that have majored in these areas. So while there are fewer of these types of positions available compared to, for example, process engineers, people with these skills and relevant experience are in higher demand and hard to find.” As a result, his company, which is usually retained only for filling the highest level positions, is currently being hired to fill positions at the $80,000 level.

Another indication of the shortage of talent in the chemical risk management field is the fact that consulting firms in the US are turning to placement companies for help with their hiring. “Usually, consulting firms have no problem attracting people to fill positions. We have been told by several firms that they are at capacity due to human resource limitations. That they are looking for recruitment firms to help find people means that the market is really tight,” Mr Harper says.

The tightness has led to an increase in salaries. In the recent past, he says, companies could di#erentiate themselves from the competition with non-salary o#erings, but that is no longer enough.

The agriculture industry will be another source of new jobs, and not just in the US. “All over the world, the average age of employees in this industry is very high. There are going to be a lot of people retiring over the next several years, and we are expecting to see substantial growth in hiring in this industry just to replace them, let alone the jobs created by growth,” he predicts.

Most importantly, he expects that tight conditions in the chemicals management and control – and general manufacturing – job market in the US will continue for the foreseeable future.

SERVICE PROVIDERS

Using service providers and future market trends

Given that the upcoming REACH deadline covers a far greater number of chemicals with less available data, and that other product-specific regulations will soon come into force that also require extensive product data, it is not surprising that laboratory testing was identified by participants in the

� � � � � � � � � � � � survey as the most-used

type of service at the time of the survey, late in 2012 (nearly 29%, Figure 13). Consultancy services were second in demand (almost 26%), which is also to be expected given the complexity of many of the current regulatory systems and requirements. There was also a real need for IT & software services (12.4%) and training assistance (9.7%).

Figure 13

Services retained by participants

Consultancy25.6%

Representation & management

6.9%

Legal6.4%

Laboratory28.5%

IT & software12.4%

Information7.3%

Training9.7%

Other services

3.2%

Consultancy for Environmental & Human

Toxicology and Risk Assessment

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www.cehtra.fr

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Biocides

Cosme"cs

Food/Feed Contact

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EHS Services

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Regulatory Support

QSARs & Modeling

Regulatory Watchdog

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Training

Other Services

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ent

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Government Organisa"ons and Scien"fic bodies in the field of chemicals, plant protec"on products,

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For over 10 years our strong scien"fic team has been offering strategic, scien"fic, technical and

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Science Beyond Regulatory Compliance

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Expenditures on outsourced chemicals management and control services in 2012 was measured in the % & ' ( ) * + ,- + . * & survey. The 289 respondents who are purchasers of services invested on average approximately €1.3m on outsourced services, which equates to a total yearly expenditure of €370m. Alongside this, an increasing proportion of work is going to in-house teams (Figure 14). In fact, in 2012, 78% of respondents indicated that 60% or more of spending on chemicals management and control activity was for in-house e#orts, which is up from approximately 61% in both 2010 and 2011. In fact, on average, 72% of chemical management and control work was performed in-house in 2012, compared to 63% in 2011 and 62% in 2010.

Figure 14

Percent of chemical management work performed by in-house teams at survey participant firms

2010 2011 2012

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

80-100%

60-80%

40-60%

20-40%

0-20%

This increase in in-house spending most likely reflects the current and challenging economic climate and is therefore not unreasonable. In response to the increasing complexity of global regulatory requirements related to chemical management and control, more companies in 2012 pushed towards establishing separate compliance divisions than towards the integration of their compliance activities with the overall management activities of the company (Figure 15).

Figure 15

Integration changes at survey respondents over the last 5 years

Remained the same

45%

Move towards general

management

24%

Move towards separate

compliance divisions

31%

Interestingly, compared to the fairly significant di#erences in the distribution of services used in 2010 and 2011, only minor di#erences can be seen between 2011 and 2012 (Figure 16). Laboratory testing, as noted above, was in greatest demand in 2012, as was the case in 2011. The level of demand for the other main categories of services was also similar in the last two years. The only di#erences were a slight decline in the use of representation and management, information and legal services, which was counterbalanced by an increase in the demand for training and other services.

Figure 16

Changes in the proportion of spending on provider service types

2010 2011 20120%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Other services

Training

Information

IT & software

Laboratory

Legal

Representation &managementConsultancy

With respect to the frequency with which % & ' ( ) * + , - + . * & survey respondents use external chemical management and control services, regardless of the type of service, they utilise them on an occasional basis (30-53%) far more than on a frequent (10-27%) or permanent (10% or less) basis (Figure 17). Both consultancy and laboratory services are the most likely to be used on a frequent or permanent basis by survey participants.

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Figure 17

Frequency of service retention by survey participants

10%

3%

3%

10%

9%

9%

2%

2%

26%

10%

12%

27%

17%

16%

21%

21%

49%

30%

53%

37%

38%

35%

52%

52%

0% 100%

Consultancy/advisory


Legal services

Laboratory

IT & software solutions

Information services

Training

Other services

% of participants

Permanent Frequent Occasional

Customer perceptions of the service provider marketEven though the preference appears to be to use in-house chemical management and control resources as much as possible, it appears that the continued growth in the number of regulations being developed and implemented around the world will require chemical, consumer product, and other manufacturers and suppliers that participate in global markets, to increase their reliance on external service providers for assistance. There is, however, concern in some cases about the ability of service providers to meet the full extent of their needs.

The specific concerns of end users of chemical management and control services depend largely, of course, on the location of their largest customer bases. For one large downstream manufacturer of speciality products, REACH, CLP, GHS and the changing global registration environment, are at the top of the list because the company has a large EU portfolio of manufactured and imported chemicals, and is also moving into new and evolving markets with developing regulations (e.g. Asia Pacific).

Honeywell Performance Materials and Technologies has a similar focus, with major elements of its chemical management and control programme in 2012 covering compilation of eSDSs, preparation for the 2013 REACH registrations, substance notifications in China and following up on GHS implementations globally, including adapting label systems to the new requirements, according to Mr Verbiest.

For speciality chemical firms Eastman and Ashland, it is not surprising that US-based regulations are high on the list of issues to deal with, followed by REACH and increased country-specific regulations, again particularly those in Asia. Meeting the first reporting requirements of the new US EPA’s Chemical Data Reporting (CDR) rule was a big task in 2012, according to Eastman’s Mr Schüller. Compliance with the new GHS requirements will have a huge impact in 2013 for both companies. Managing conflict minerals and international food contact compliance and staying on top of the Canada inventory update will also be important for Ashland in 2013, says Dr Lindquist.

While these increased regulations have not, for the most part, had any major e#ect on the availability of chemicals, Ashland has experienced some loss of ability to manufacture certain products because certain countries are in the middle of implementing requirements under global chemical conventions. Sourcing raw materials used in products manufactured in the EU has also become an issue for Ashland.

A lack of significant improvement in supply chain communication is not helping the situation. One large downstream producer says it has observed some improvements, but not nearly enough, particularly given the urgency of the 2013 REACH deadline.

Honeywell is also unhappy with the current status of supply chain communication. “Many companies, particularly distributors and SMEs, are requiring statements and/or confirmation that are not required by any regulations, and are thus adding significantly to the workload of our regulatory compliance e#orts.” Mr Verbiest says. “The basis for the requests is largely due to a lack of understanding of the regulations, and the need for eSDSs and a lack of IT technology to cope with them have made clear communication even more di%cult. Unfortunately, we do not expect much improvement in 2013, either; the new registration deadline will mean that a significantly greater number of eSDSs will be requested, and managing the language requirements for the very technical extensions will be challenging.” Eastman, too, would like to see more standardisation of eSDSs across and down the supply chain to make the process more e%cient and e#ective, according to Mr Schüller.

For service providers, however, the increasing work load does mean that these companies anticipate a need for external support. In 2012, a leading flavour and fragrance manufacturer outsourced support for toxicological studies, risk assessment and registration services because the company does not have in-house toxicological facilities and the registration workload was very high. Those workloads are expected to increase further in 2013 due to the need to begin preparations for the REACH 2018 deadline and other global registration demands, and thus the company will be increasing its use of service providers, according to a spokesperson. Honeywell also mainly uses outside consultants for compiling and follow- up of substance notifications and registrations. The intensity of such requirements has increased recently, and Mr Verbiest anticipates that it will continue to do so over the next few years, because more countries have started or planned for substance or product inventories. There will thus be greater need for external support to meet these growing requirements. And while Ashland does not cite any specific services over others, the company’s need for global consultants has become more frequent, and will continue to do so, according to Dr Lindquist.

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All of these users of chemical management and control service providers, however, are very careful about which firms they do business with. Honeywell uses a substantial pool of consultants and has been rather conservative in its choices, according to Mr Verbiest. “We do have the impression that a number of ‘new’ consulting shops are not really experienced or knowledgeable about what they are trying to sell,” he notes “We do not want to spend our time educating new consultants, and have therefore mostly retained the services of long-term and well -established firms; the cost for these providers may be higher, but we still feel that we get value for money with them.”

Ashland, too, tries to work with firms with which they have had past experience and have been satisfied, and particularly those with whom they have established a relationship over time. That is not always possible, of course, and says Dr Lindquist, the company has several projects underway now for which they are evaluating the quality of the service. Meanwhile, a leading flavour and fragrance producer has had some disappointments in 2012, with some service providers overestimating their capabilities. “Some providers appear to lack project management skills and business acumen and have a poor appreciation of strategic goals,” says a spokesperson for the firm. As a result, the overall level of satisfaction with providers has declined in the last year, and the company is looking for providers with a commitment to accuracy, e%cient communications, e#ective working processes and quality.

Our survey suggests that this company is not alone in feeling less satisfied with chemical management and control services recently. In fact, overall satisfaction levels with the work of service providers have decreased from 88% at the time of the first survey at the end of 2010, to 78% last year and 73% currently (Figure 18).

Figure 18

Change in overall satisfaction levels for survey respondents

73%78%88%

25%19%9%

2%3%3%

201220112010

0%

10%

20%

30%

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60%

70%

80%

90%

100%

% of participants

Dissatisfied Neither Satisfied

There has also been a marked drop in satisfaction levels in qualifying characteristics of service providers (Figure 19). For example, just 53% of this year’s participants are satisfied with the availability of the service provider compared to 70% in 2011, while just 62% are happy that their briefs are being met, a drop of 10 percentage points from last year. Satisfaction with personal relationships

between clients and service providers has also declined by 10%.

Figure 19

Satisfaction levels in 2012 and 2011

72%

63%

41%

47%

75%

49%

53%

50%

70%

70%

62%

57%

33%

44%

68%

34%

48%

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60%

53%

0% 100%

Meeting your brief

Delivering on schedule

Price of service

Providing value for money

Technical knowledge

Adding value on top of agreed deliverables

O"ering flexibility

Experience/knowledge in all countries in which you operate

Personal relationship

Availability

% of participants satisfied

2012 2011

Prices, always a point of contention, are becoming a bigger issue; only 33% of clients are currently satisfied with the prices charged by their service providers, which is down from 41% in 2011 (Figure 20).

Given the decline in overall satisfaction, it is interesting that fewer % & ' ( ) * + , - + . * & survey respondents are currently considering changing suppliers (with those saying ‘yes’ or ‘possibly’ down from 61% last year to 53% this year; Figure 21).

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Figure 20

Satisfaction levels of survey participants with prices charged for services

Satisfied

33%

Neither

54%

Dissatisfied

12%

Figure 21

Interest level of survey respondents in changing suppliers

9%10%6%

44%51%

48%

47%39%

46%

2012201120100%

10%

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100%

No Possibly Yes

Nevertheless, more than half of users say they are thinking about changing their suppliers for various reasons and chief among them is value for money. Lack of availability, flexibility and on-time delivery were also cited by several di#erent respondents as major reasons for switching to a di#erent supplier. Some, on the other hand, have developed new needs that their existing suppliers can’t meet, and while satisfied with the support they have received to date, need to find an alternative provider with the relevant expertise.

Honeywell’s Mr Verbiest, for example, while satisfied with his established pool of providers, says he is also looking for new capabilities. “We would like to see service providers, if possible experienced, that can help us look at relatively new regions for our chemicals control portfolio, regions such as Russia, India, South America and the Middle East. With countries in these regions looking at ‘easy-to-implement’ regulations that are copies of REACH or drop-ins for the UN GHS, we anticipate significantly more regulatory needs in the global marketplace.” For similar reasons, translated resources are described as a critical need for Ashland.

% & ' ( ) * + , - + . * & survey respondents also indicated that, as VRS Regulatory’s Mr Sherratt noted for job seekers, having well-established expertise is of critical importance if service providers are to be successful. Sta# with relevant expertise and proven experience on similar projects were cited most often (86% and 79%, respectively) as the top factors when users are selecting a new service provider (Figure 22). In-depth knowledge of country-specific regulations was also important for a significant number of respondents (66%). Other factors of note include availability (51%), proposal quality (51%) and global capabilities (46%).

Figure 22

Most important choice factors for survey participants

86%

79%

66%

51%

51%

46%

37%

35%

28%

21%

19%

17%

13%

5%

4%

0% 20% 40% 60% 80% 100%

Expertise of key sta�

Proven experience on similar projects

In-depth knowledge of country-specific regulations

Availability

Comprehensiveness/accuracy of proposal

Ability to operate on a global scale

Contract price

Appropriate accreditation/certification

Recommendation from peers

Independence of supplier organisation

ISO9001 or equivalent (quality management)

ISO14001 or equivalent (environmental management)

Inhouse equipment/software

Large size of supplier organisation

Proximity to your o�ce

% of participants

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As mentioned by Dr Lindquist of Ashland, companies looking for external support for chemical management and control activities often prefer to work with providers with whom they have developed a relationship. Survey respondents indicated that certain aspects of those relationships are more important than others (Figure 23). Strict adherence to project protocols and having long-term relationships with individual sta# were identified as the top factors by 47% of the survey participants. Having service level agreements in place (37%), keeping costs under control (33%) and conducting regular reviews (27%) were other factors that can have a strong positive influence on the relationship between service providers and their clients.

Fig. 23

Most important relationship factors for survey participants

47%

47%

37%

33%

27%

23%

13%

3%

0% 10% 20% 30% 40% 50%

Strict adherence to project protocols

Building long-term relationships with individual sta"

Service level agreements in place

Suppliers keeping costs as low as possible

Regularly reviewing (and at times changing) suppliers

Regular face-to-face meetings

Paying more to get better value

Use of penalty clauses

% of participants

Implications for the future demand for servicesOverall, participants in the % & ' ( ) * + , - + . * & survey were positive about the health of the services market. With respect to the need for in-house sta#, 47% of survey respondents expect the situation to remain static over the next 12 months, while 45% anticipate need to increase (Figure 24). That increases further in the longer term, with expectations for an increase in the need for in-house sta# rising over the next five years to 59%.

Figure 24

Anticipated future need for in-house sta#

8%

11%

37%

48%

47%

28%

7%

11%

1%

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0% 100%

Next 12 months

Next 5 years

% of participants

Increase significantly Increase Static

Decrease Decrease significantly

The outlook is even stronger for external service demand, according to the survey results. In the next 12 months, while 44% expect demand to remain static, another 49% expect an increase, and that number rises to 59% for the next five years with 8% of respondents predicting a significant rise in demand (Figure 25). One leading manufacturer’s experience matches the results of the survey: the company says it increased its use of external services in 2012 compared to 2011, and expects it will do so again in 2013 due to increasing workloads for REACH 2018 and global registration demands.

Figure 25

Anticipated future need for external services

5%

8%

44%

51%

44%

31%

5%

8%

2%

2%

Next 12 months

Next 5 years

0% 100%% of participants

Increase significantly Increase Static

Decrease Decrease significantly

Of the services that will be used in the next 12 months, the greatest percentage of participants in the % & ' ( ) * + ,- + . * & survey expects demand for training and information services to increase (64% each; Figure 26). Demand for IT & software, consultancy/advisory and laboratory services are, meanwhile, expected to increase by 56%, 51% and 47%, respectively.

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Figure 26

Anticipated need for external sector services by survey participants in the next 12 months

51%

30%

36%

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56%

64%

64%

17%

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59%

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Legal services

Laboratory

IT & software

Information

Training

Other(s)

% of participants

Increase Static Decrease

These numbers change only slightly when looking five years into the future (Figure 27). The largest percentage of survey participants (over 66%) expect that the demand for information and training services, along with IT & software support, will continue to increase, followed by laboratory and consultancy services (~55%). Most importantly, in all of the service categories, respondents were more likely to predict that demand is likely to rise over the next five years than in the next 12 months.

It is interesting to see how the survey results were borne out in our qualitative discussions. Chemical manufacturers Givaudan, Eastman Chemical, Honeywell Performance Materials & Technologies and Ashland have external service needs that fall into the leading categories identified by the survey. Givaudan outsources toxicological and environmental studies, risk assessment and registration services, while Honeywell mainly uses outside consultants for compiling and follow -up of substance notifications and registrations. Eastman, meanwhile, uses a consultant to send Sief surveys for REACH in order to gauge the interest in co-registration when the company is the Lead Registrant, and outsources laboratory testing. Ashland, on the other hand, turns to external consultants as issues arise, and particularly those that can address global chemical management and control requirements.

Figure 27

Anticipated need for external sector services by survey participants in the next 5 years

56%

36%

47%

56%

63%

69%

66%

26%

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Legal services

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Information

Training

Other(s)

0% 100%% of participants

Increase Static DecreaseA breakdown of the anticipated growth in demand for specific external sector services over the next five years, as indicated by respondents to the % & ' ( ) * + , - + . * & survey, is shown in Figure 28. Demand for guidance on how to interpret regulations is expected to increase the most (64%), followed by support for material safety data sheet (MSDS) and chemical hazard database information management activities (60% and 56%, respectively) and product compliance assistance (57%). Over half of survey participants also expect to see increases in the need for training courses, regulatory policy tracking support and IT solutions for regulatory information management and MSDSs.

Concluding remarksIt’s a good time to be in the chemical management and control service market. With increasing country-specific and product specific regulations being introduced around the globe, implementation of individual GHS requirements and all aspects of REACH now moving up to full gear, the compliance workload is increasing. Many companies are striving to rely on in-house sta# as much as possible, but must turn to external service providers with specialised areas of expertise. Therefore, demand for services is expected to increase in both the short and long terms.

Chemical management and control service providers would do well to note, however, that when companies do commission their services, they look for providers with proven expertise and experience, that meet deadlines, manage projects well and generally go beyond the minimum. Providers with a recognised history of excellent performance, an awareness of changing market dynamics and the ability to understand and address client needs, will therefore benefit most from the anticipated growth.

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Figure 28

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

64%

57%

48%

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42%

40%

33%

32%

32%

21%

44%

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35%

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25%

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56%

54%

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46%

39%

23%

20%

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34%

16%

33%

23%

18%

34%

41%

46%

48%

52%

55%

61%

61%

62%

68%

49%

54%

56%

58%

65%

65%

73%

38%

42%

44%

53%

52%

53%

57%

58%

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61%

64%

42%

43%

46%

49%

57%

67%

70%

42%

60%

77%

60%

71%

78%

3%

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6%

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7%

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11%

7%

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9%

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2%

1%

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0% 100%

Guidance on regulation interpretation

Product compliance

Supply chain communications

Environmental risk assessment

Registration strategies

Assessment of data quality

Testing strategies

SVHC advisory services

Corporate strategy/strategic planning

Chemical transport and warehousing advice

Dossier preparation & safety assessment, including CSA/ CSR

Registration services

GHS notification

CLP notification

Management (SIEF, Consortium etc)

Representation (Lead, Only representative, 3rd party etc)

Business process outsourcing (BPO)

(Material) safety data sheets

Chemical hazard database

Regulatory/policy tracking

Managed regulatory content

Ecotoxicology

Environmental fate & degradation

Human health toxicology

Physical & analytical chemistry

Exposure testing

Environmental monitoring

SVHC testing

Regulatory information management

(Material) safety data sheet systems

Substance inventory management systems

Supply chain management/ communications systems

EH&S solutions

Consortia/registration management solutions

Laboratory information management solutions

Training courses/webinars

Bespoke/inhouse training

CPD/CES certified training

Lobbying/advocacy

Legal representatve

Insurance

% of participants


Representation& management

Laboratory

Information

IT solutions

Training

Other

Increase Static Decrease

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CONTACTS

Website www.24-7response.org

E-mail [email protected]

Head o"ce 1 The Courtyard, Denmark Street, Wokingham, Berkshire, RG40 2AZ, UK

Tel/ Fax +44 (0)118 902 9373/ +44 (0)118 977 2147

Contact Caroline Raine

Directors Caroline Raine

Richard Shreeve

Ownership OAMPS

Locations UK based, Worldwide work

Founded 2011

OVERVIEW

Chemical emergency response, incident management, clean up and training for the chemical and fuel industries: from providing

Response has the expertise to help minimise the impact of any chemical incident. Hazardous goods can also pose all sorts of problems when things go wrong, for example:

water courses may become contaminated unless preventative measures are taken.

These are just a few of the scenarios where the 24-7 Response can help. Our Chemical Emergency line is permanently staffed by experienced

helping those facing any type of chemical or hazardous goods incident. They have the resources to rapidly access information on the products involved. Anytime, anywhere in the world, our advice can make a difference. We are uniquely positioned to provide a complete Level 1, 2 and 3 response service – nationwide chemical emergency advice, management and clean up. Level 1 response is emergency advice given over the telephone. For clients of OAMPS petrochemical insurance we can mobilise our in-house team of incident managers – many of whom are ex-Environment Agency – to provide Level 2 (advice at the scene) and, through our nationwide network of UK spill accredited contractors, a Level 3 (clean-up) response.

VITAL STATISTICS 2011/12

Turnover, group <£100,000

Turnover, chemical service provision <£100,000

1

No of countries represented All

Staff, group 10-100

Staff, chemical service provision 10-100

SERVICE AREA BREAKDOWN

Consultancy/ advisory

20%

Representation

& management

20%

Information20%

Training20%

Other20%

SERVICES PROVIDED

Chemical and hazmat emergency line for hazchem placards

With the introduction of REACH, CLP, GHS etc, there is a greater expectation that publicised emergency telephone numbers not only operate, but are directly answered by someone who can provide pro-active advice.More and more, manufacturers and distributors of hazardous goods are subscribing to the standards set by the chemical industry’s Responsible Care initiative. Companies that commit to the programme are required to implement a wide range of health, safety and environmental measures including the provision of a reliable Level 1 response.

Chemical emergency line – 24 hours a day, 7 days a week

All calls to the Chemical and Hazmat Emergency Line are recorded and detailed reports are sent to the client. Contact information for key

usually in the case of a major incident.Using modern communications technology, with extensive back-up functionality, 24-7 Response offers a robust and cost-effective solution to the demands of operating a specialist emergency telephone number round the clock.There has been an increase in the requirements for companies supplying chemicals and hazardous goods to display emergency telephone numbers. There is also a greater focus on how these numbers operate and what type of specialist advice can be accessed by the caller. Some

expectations of industry and those transporting or using the products. For example, all REACH compliant safety data sheets must display an emergency number and, as GHS is rolled out to other regions, this requirement will no doubt increase – as will the need for advice to be provided in local languages. 24-7 Response has developed a robust process that enables advice to those dealing with incidents involving hazardous goods to be given in the language of the caller.The Multilingual Emergency Line number(s) can be displayed on safety data sheets, product labels and transport documentation. Using a unique system devised by 24-7 Response, expert advice is easily accessible and delivered, if necessary via translators, by one of their team of incident advisors. They are all chemists and have, between them, nearly 20 years’ experience of providing expert advice to those dealing with emergencies:

mobile phones not relied on for providing advice.

REACH consultancy compliance help and advice

With an in-depth understanding of the regulations that apply to the transport and supply of chemicals, our consultants can help companies to comply with REACH, CLP/GHS, IATA, ADR, lithium battery transport and other international regulations.24-7 Response offer a number of services based around REACH, the key

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services include:

REACH exposure scenarios advice.

Safety data sheets and supply labels including translations

Safety data sheets (SDS) must be supplied with substances and mixtures that are hazardous to heath. However, anyone being supplied a chemical can demand an SDS even if it is not hazardous if the mixture contains hazardous components above certain thresholds. In addition, the SDS must be provided in the language of the member state it is supplied in. 24-7 Response offers a cost effective SDS translation service.

by December 2010 and mixtures will need to be by June 2015. This will mean updates and changes to both SDS and labels. There will also be a requirement for extended safety data sheets which will need to contain information relating to exposure scenarios. 24-7 Response provides an SDS authoring service, or if you are looking for reassurance that your SDS complies we offer a checking service.

CLP and CLP notifications

processes associated with CLP.

Dangerous goods transport advice (DGSA)

There is a legal requirement under ADR for anyone involved in the loading, unloading or transportation of dangerous goods to appoint a dangerous safety goods advisor (DGSA). 24-7 Response has a team of

Through our sister company, PTF Training, we also run regular SQA accredited DGSA training courses.

Chemical incident management and clean up

Incident management response: situations often occur when the presence of an expert on the scene is required, 24-7 Response can contact an on-call OHES incident manager and arrange for them to attend the scene.

Training

Drawing on our incident advisors’ expertise, we have designed training courses that will give your staff an understanding of the risks when handling chemicals – and mitigate the consequences should things go wrong.

Chemical transport trainingChemical safety trainingCLP (classification, labelling and packaging) training Lithium battery safety and legislation training DGSA training

PARTNERS

Westfarmers, OAMPS, OHES, PTF Training, PTF Consultancy

TESTIMONIALS

“We have found 24-7 has provided us with a completely professional and

professionals and that any advice complies with regulations at all times. As the implications of any incidents relating to fuel spillages etc have the potential to be very serious the experience with the emergency response service has been excellent and we would strongly recommend 24-7 to anyone within the industry.” – Ray Fowler at Goff Petroleum“Our dealings with 24-7 Response have been of a high standard. It is reassuring to both ourselves and our customers to have the back-up of

FAST Exocet

CASE STUDY 1: First aid

A catering assistant got a splash of caustic automatic dishwashing detergent in the eye. His colleague called the emergency number and said that he had rinsed the victim’s eye out for 15 minutes (as per the advice given on the product label and SDS), however he was still in

accident and emergency department. The advice given by our incident advisor was not to take him to hospital, but to continue to rinse the eye and call an ambulance so that it could be irrigated all the way to A&E. This may have prevented irreparable damage to the eye and stopped the incident escalating to a point where the HSE could have been involved.

serious personal injury and the employer’s liability claim, which could

STAFF SELECTION

Caroline Raine – Principal Consultant of 24-7 Response

Caroline assists those managing major emergencies, to help minimise the impact of a chemical incident. Caroline is a chemical legislation expert, with experience of interpreting and implementing EU legislation relating to hazardous chemical substances. This experience has been developed while working directly in the chemical industry and on consultancy

transport of hazardous goods by road and rail. In addition Caroline is a committee member of the Chemical Hazards Communication Society (CHCS) and is a founder member of the British Association of Dangerous Goods Professionals (BADGP).

Richard Shreeve

chemical and hazardous goods emergency response. Richard and Caroline Raine set up 24-7 Response in the spring of 2011, giving OAMPS a complementary service to the established emergency response and incident remediation capability within the group.

Kate Coughlan

Holding a BSc (Hons) in pharmaceutical and forensic analysis, Kate has several years’ experience in chemical emergency response and hazardous goods legislation. Kate joined 24-7 Response in the spring of 2011, where she is responsible for operations for the 24-7 Response Emergency number service. Kate is also heavily involved in delivering 24-7 Response’s consultancy and training services.

Stephen Walker

Stephen has recently joined the 24-7 Response team as an incident advisor and regulatory consultant. He has a strong chemical regulatory background, in particular the production of safety data sheets and labels for a variety of different countries. He also has several years of experience in providing Level 1 emergency advice to those dealing with chemical incidents.

Darryl McLeod

Darryl joined 24-7 Response as an incident advisor in August 2012, with several years’ previous experience of chemical emergency response, chemical hazard legislation and hazardous waste management. Darryl works within the areas of incident response, DGSA consultancy, tanker training and chemical hazard awareness, among others. Darryl is also an Associate Member of the Emergency Planning Society, with a particular interest in HazMat/CBRNe and transport security.

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CONTACTS

Website www.3ecompany.com


Head o"ce 3207 Grey Hawk Court, Carlsbad, CA 92010, USA

Tel/ Fax +1 760 602 8700/ +1 760 930 6662

Directors Robert S Christie, President and CEOLeo Oves, Vice President, Research and DevelopmentJeffrey Starr, Vice President, MarketingGreg Merwin, Vice President, Global SalesAndrea Verspay, Vice President, European SalesAlan Goodman, Director, Asia and Latin America SalesAlex Ortiz, Vice President, Ariel US OperationsClark VanScoder, Vice President, MSDgen Operations

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 product lifecycle. 3E provides its customers with the premier knowledge-base of substance

a breadth of solutions covering upstream product stewardship and

waste management.


Turnover, group -

Turnover, chemical service provision -

6

No of countries represented -

Staff, group -

Staff, chemical service provision -



5%

Information80%

IT & software10%

Other5%

GLOBAL OFFICES

Carlsbad, CA, USA: 3E Company's world headquarters and the world-renowned EH&S Mission Control call centreCopenhagen, Denmark: European headquarters and SDS authoring and related regulatory services centre-of-excellenceMontreal, QC, Canada: SDS management products and services operationsBethesda, MD, USA: Ariel global regulatory data development and operationsKingsport, TN, USA: SDS authoring centre-of-excellenceCanton, OH, USA: MSDgen SDS authoring platform product, operations and support centre

SERVICES PROVIDED

Regulatory data access and delivery – decision support

Ariel WebInsight™ – a subscription-based online reference tool for researching and tracking how chemicals and substances are regulated.ArielLogic™ for food and flavours – a subscription-based online reference

Ariel Data Manager™ (ADM) – seamlessly integrates chemical regulatory

regular updates as regulations change and new ones are released.Ariel Solutions for SAP® – 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 and SAP Material Master.

SDS authoring

MSDgen ® SDS Authoring Software – an enterprise software solution suite designed for companies’ in-house EH&S staffSDS authoring services – provides outsourced or co-sourced assistance with authoring SDSs via 3E’s own fully-dedicated, in-house

SDS distribution – facilitates the dissemination of SDSs to all stakeholders

Professional services

REACH – 3E can work collaboratively with a company to produce exposure scenarios for eSDSsGHSassistance with understanding the implications of GHS has on their businessTSCA – services range from fully outsourcing TSCA compliance to

C&L notification – assists manufacturers and importers with CLP

Union’s CLP RegulationEuropean product registration – 3E can determine which products need to be registered, perform the registration process, the maintenance of the registration and any necessary updates to SDSs and labelsDGSA (dangerous goods safety adviser) – 3E can serve as a company’s DGSA

Supply chain data and sustainability tools

Supply Chain Product Compliance Management – products and service to facilitate compliance with regulatory and market driven requirements related to detailed information about the source and origin of products3E Green Product Analyser – provides powerful regulatory and toxicology analysis of products

SDS management and workplace safety

SDS management: a variety of products and services for the management of vendor supplier SDSs.Transportation: 24-7-365 global hotline access for guidance and

Emergency response: 24-7-365 emergency response to spills, ingestions or exposures, or for dispatching emergency responders to an incident.Regulatory reporting: outsourced services for researching, identifying analysing, tracking, completing and submitting required disclosures, permits and reports.

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Hazardous waste management and classification services: that support customers’ hazardous waste management obligations, including proper storage and disposal.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

1998 Company founded

2004

2007 Acquisitions: HSE Systems and MSDS Solutions

2008 REACH and GHS initiatives

2009 AMR Research (now Gartner) publishes report, “3E moves its way to outsourced MSDS management leadership”

2010 Acquired by Verisk Analytics

2002

-13Seven-time winner Environmental Business Journal Business

safety product of the year awards. Nine-time winner Commitment to Worker Safety awards from Compliance magazine.

ACCREDITATIONS

CHMM, CSP, DGSA, CPEA, CSBA, REA, IATA, more.

PARTNERS

SAP, Japan Chemical Daily, Kyocera, CIRS, ChemSW, SciQuest, Kelaroo, Waste Management, RegScan, Redstone, SOCMA ChemStewards

CLIENTS

Illinois Tool Works, the Linde Group, Kraton Performance Polymers, Inc, Vestas, Banner Health, City of Manassas School District, PJ Food Service, a subsidiary of Papa John's, Spartech Corporation, Perstorp, Cabela's,Shell Oil, Brenntag, Sumitomo Chemical, KMG Chemicals Inc, Supreme Chemicals of Georgia, JM Huber Corporation, City of Amarillo, GrafTech International, Cabot Microelectronics Corporation, Novelis, Southwest Airlines, Eastman Chemical, DTE Energy, Costco Wholesale Corporation, Temple-Inland, Exelon Corporation, America West Airlines, Western Medical Center – A Tenet Hospital, Cleco, Menasha Corporation

TESTIMONIALS

“Working as a team, these companies built a new SAP EH&S platform for Europe, which will also be used as a global SAP template in the years to come. The cooperation between IDS Scheer Consulting and 3E Company created a powerful combination of process know-how, implementation experience and state-of the- art content.” – Linde AG.

coverage that we require to support our regulatory compliance initiatives. The Ariel content found in WebInsight is current, and our team knows and respects that it is a reliable source of information.” – Kraton Polymers.

CASE STUDY 1: Vestas Wind Systems blows away global deployment challenges with 3E Online-SDS

Industry: manufacturing – wind turbinesChallenge:3500 SDSs in multiple languages across its 14 business units.Solution: 3E Online-SDSResults:

and reliable manner. Prior to deploying 3E Online, the updating process was one of our biggest challenges. SDSs were always updated, but weren’t always proliferated to all of our different sites.

CASE STUDY 2: Illinois Tool Works relies on MSDgen to forge accurate, compliant, multilingual SDSs

Industry:and specialty equipment operating 800 decentralised business locations globally, including 200 outside the US.Challenge: each business responsible for developing SDSs using their own method and technology, resulting in inconsistent and sometimes inaccurate SDSs, which propagated throughout the enterprise.Solutions: MSDgen authoring software.Results:regulatory information we require to conform to the regulations and initiatives impacting our business. Authoring SDSs can be quite complex and cumbersome, especially when authoring on a global basis. MSDgen eliminates much of the complexity by always ensuring that we have access to the regulatory information we require – at the click of a button. As a result, the data on our SDSs has become more reliable, and the quality of our SDSs is more consistent.”

STAFF SELECTION

Pernille Brinklov, Managing Director, 3E Company Europe

Pernille Brinklov is responsible for managing 3E’s European operations, interfacing with product management, sales, senior management and customers to ensure operational plans and activities are aligned with business priorities and customer needs. Ms Brinklov has an extensive background in international business, working for several international companies in an environmental, health, safety and sustainability management capacity, including Biogen Idec, CP Kelco & Huber Engineered Materials and Novo Nordisk A/S. She has been responsible for establishing and maintaining EH&S Management Systems and has a Six Sigma green belt. She has her Bachelor of Science degree in chemical engineering and actively participates in several local and international environmental health and safety events.

Kami Blake, Solutions Engineer, 3E Company

Kami Blake is a Solutions Engineer with 3E Company. In this role, she provides technical expertise to assess regulatory requirements, information management technology and analysis of existing HazMat programs to develop compliance solutions. Ms Blake launched her career in 1982 in the United States Marine Corps and is a two time Navy Achievement Medal recipient for small systems implementation and training.Prior to joining 3E in 2002, Ms Blake served in quality assurance, supply chain management and process engineering roles in the biotech and medical device manufacturing industries.As a technical writer, Ms Blake has authored articles on regulatory challenges and compliance solutions that appear in prestigious EH&S journals and publications. She also shares her HazMat related expertise during discussion groups, serves as an expert panelist and presents topics of concerns at national and regional environmental, health and safety conferences.

Scott Stephens, Regulatory Research Analyst

Scott Stephens oversees regulatory research for Western Europe and also for Russia and the former Soviet Union, in support of Ariel products, including WebInsight. Prior to joining 3E Company, Mr Stephens worked in a number of different capacities, including as a corporate governance analyst, a foreign media analyst and an editor for several English language publications in Central Europe. Mr. Stephens earned his master of public administration in 2004 from Maxwell School at

languages and literatures from the University of Kansas.

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CONTACTS

Website www.actagroup.com


Head o"ce 23, New Mount Street, Manchester, M4 4DE, UK

Tel +44 (0)1612127405

Contact [email protected]

Directors Lynn L Bergeson and Lisa M Campbell

OwnershipBergeson & Campbell PCB&C Consortia Management LLC

Locations US, UK and China

Founded 2004

OVERVIEW

The Acta Group LLC is a leading international specialist in chemical product approval, support, and regulatory defence.

encountered by clients seeking approvals to market chemicals, biocides, products of biotechnology and nanotechnology, and medical devices in global markets. Acta manages products from concept to approval, utilising

product areas in government and industry. The Acta regulatory team provides project management for fast-track product approval by building support and defence packages for product portfolios.


Turnover, group -


3

No of countries represented >25

Staff, group >25

Staff, chemical service provision >25



30%

Representation

& management20%

Information10%

IT & software5%

Legal25%

Training5%

Other5%

GLOBAL OFFICES

The Acta Group LLC 2200 Pennsylvania Avenue, NW Suite 100W, Washington, DC 20037-1701Tel: +1 (202) 266-5020The Acta Group China LLC1009 Tongguang TowerNo 12 Nongzhanguan NanliBeijing, China 100125TEL: 86-10-84534538

SERVICES PROVIDED

General consulting services

We represent and counsel individuals, business entities, trade associations, and industry associations. Our fundamental goals are to

We take a multi-disciplinary approach in assisting our clients. Attention must be paid to the interplay of all branches of government and interest

combined with our national and international view on policy and regulatory developments, position us to handle all these tasks with judgment,

Global product registration and agent services (only representative services)

defence under the framework of global chemical programmes. Acta concentrates on obtaining, maintaining, and supporting product approvals

multi-disciplinary skills offered by Acta professionals are essential to obtaining cost-effective and timely product approval. Jurisdictions we are active in are: North and South America, European Union, Switzerland, Turkey, Australia and NZ, Malaysia, China, Japan, South Korea, Taiwan, Philippines, Singapore, and Indonesia.

Data compensation support services and trade infringement/competition issues

Acta is engaged in numerous data compensation and competition-related issues at the global level. Activities range from supporting, evaluating, preparing, and managing data cost on behalf of the data owner as well as for those entities seeking data access. As a result of recent activities in association with the 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,

documents, inquiries, and safety data sheet (SDS) preparation.


1998 Parent company, Bergeson & Campbell PC formed in Washington DC, USA

2000Acta Group LLC in Washington DC, USA

2004 The Acta Group LLC establishes an international consulting

2010B&C Consortia Management LLC in Washington DC, USA

2011 The Acta Group LLC establishes an international consulting

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ACCREDITATIONS

PARTNERS

B&C Consortia Management LLCBergeson & Campbell, PC

CLIENTS

Acta EU’s clients are involved in many businesses, including basic,

consumer product sectors.

TESTIMONIALS

client names/testimonials.

CASE STUDY 1: Successful ECHA appeal

Provided strategic technical support to our European legal counsel,

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.

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.

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.

STAFF SELECTION

Lynn L Bergeson – Principal/Director

Ms Bergeson has for over two decades assisted individual companies and a wide range of trade groups and ad hoc consortia on chemical-

areas include Toxic Substances Control Act (TSCA), FIFRA, REACH,

product defence and product approval litigation matters.

Leslie Scott MacDougall – Director of Regulatory A#airs

Ms MacDougall has more than two decades experience in various

as a programme manager for the US EPA. In her current role, Ms MacDougall is the managing director for Acta 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

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.

Andrew Bourne – Regulatory Specialist

Mr Bourne is distinguished by his experience in both testing and consultation environments, as well as his practical expertise in both environmental modeling and monitoring. He focuses on regulatory compliance for industrial chemicals, biocidal products/substances, and fertilisers. Mr Bourne's services also include guidance in environmental

and safety.

Dr Hayley Clayton, PhD – Regulatory Specialist

Dr. Clayton has a deep understanding of risk assessment, regulatory

Dangerous Goods Safety Advisor and transport specialist, and has over a decade of experience regarding the sale, possession, and transport of restricted chemicals in compliance with UK and European legislation including REACH, RoHS, and WEEE. Dr Clayton received a PhD in

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CONTACTS

Website www.arcadis.com/Global_Product_Stewardship.aspx

E-mail [email protected] [email protected]

Head o"ce Gustav Mahlerplein 97-103, 1082 MS Amsterdam

PO Box 7895, 1008 AB Amsterdam, The Netherlands

Tel/ Fax +31 020 2011011/ +31 20 2011 002

Contact Alain Vassart (Europe), Michelle Langefeld (US)

Directors Kristof Peperstraete, Executive Director Environment (Belgium) and Jim Hill, Operations Leader (US)

Ownership Public company

Locations 300+

Founded 1888

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. The company has an extensive international network supported by strong local market positions. From that position, we help clients around the

bring their products to market in a compliant and safe manner.


Turnover, group €2.4bn

Turnover, chemical service provision €5m

300+ covering all regions of the world

No of countries represented 40

Staff, group 21,000+

Staff, chemical service provision 49



60%Representation

& management20%

Information5%

Laboratory5%

IT & software5%

Training5%

GLOBAL OFFICES

Centres of excellence for our product stewardship services are located in both Europe (Belgium and Switzerland) and the US, with partners in

For Europe, contact ARCADIS Belgium: Citylink, Posthofbrug 12, 2600 Antwerpen-Berchem, Belgium. Alain Vassart, +32 3 328 62 48, [email protected] the US, contact ARCADIS US: 4665 Cornell Road, Suite 350, Cincinnati, Ohio 45241, USA. Michelle Langefeld, +1 513 860 8700, [email protected]

SERVICES PROVIDED

Our global product stewardship (GPS) practice focuses on: product stewardship systems and programmes global regulatory surveillance due diligence reviews sustainability support supply chain management registration support, permitting, and licensing

Examples of our work are provided below.

REACH from A to Z

manufacture and market their products, and to manage their supply chains in a safe, responsible, and globally compliant manner. Currently, a major

managerial support, combined with pragmatic and strategic advice, resulting

supports multinational companies in the chemical and pharmaceutical sector with the development and implementation of their REACH compliance programmes, organises compliance audits and provides on-site employee training. The team develops read-across approaches and intelligent testing strategies, acts as study monitor, performs risk assessments (CSA/CSR), supports communication in the supply chain and evaluates extended safety data sheets. Finally, as consortium manager, ARCADIS is responsible for

act as trustee and guarantee fair, transparent and non-discriminatory cost sharing between members and the Sief.

EU biocidal product authorisation and US FIFRA registration

The Biocidal Product Regulation (EU) 528/2012 enters into force on 1 September 2013. Being compliant with the new requirements of this Regulation is the legal prerequisite to market your biocidal products in Europe and will have an important impact on resources needed and time to market for all companies in this sector. EU BPR and US Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registrations involve time-consuming and costly processes requesting various expertise. ARCADIS can provide regulatory and/or technical support in the complex process of getting your biocidal products authorised in both the EU and the US.

Supply chain management and product stewardship support

ARCADIS has helped our clients to manage supply chains for products as diverse as household consumer products, automotive components, pulp and paper, polymer, metals and their alloys, pesticides, and food storage containers. We work with our clients to create a structured means of informing, managing, and exchanging information throughout a product’s global supply chain. This process can also be used effectively to perform third-party compliance audits and enhance supplier communication. We help our clients to work through language and cultural barriers to receive the assurance they need from their suppliers.

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1888 Parent company Heidemij formed in the Netherlands

1993 Geraghty & Miller merges with Heidemij

1998 Global company becomes ARCADIS / 2002

product stewardship (GPS) practice in the US

2005 ARCADIS merges with BBL

2006 ARCADIS Belgium is established as a second GPS centre of excellence

2008-10 For the 2010 registration deadline, ARCADIS manages several REACH consortia and supports clients on approximately 100 REACH registration dossiers

2011 ARCADIS continues to be engaged by multinational companies, REACH consortia and Competent Authorities as their key service provider for developing and implementing their REACH compliance strategy related to registration, DU obligations and/or authorisation

2011-12 ARCADIS acquires BMG Engineering Ltd in Switzerland, a

REACH. ARCADIS acquires Langdon/Seah in China and EC Harris in the UK, which provides additional strength in key environmental consulting service areas in these regions

ACCREDITATIONS

of the American Board of Toxicology (DABT). The ecotoxicology laboratory of

CLIENTS

ARCADIS works for many multinational clients around the world. We have built sound relationships with clients in following market sectors: chemical production, pharmaceuticals, automotive, rare earth compounds, consumer goods, oil and gas, governments and policy-makers, and others.

CASE STUDY 1: Product stewardship services for a multinational producer of homecare and personal care products

In addition to REACH support, ARCADIS has been providing general regulatory and product safety services to multiple businesses within this Fortune 100 company for years. Key activities include:

global product registrations.

CASE STUDY 2: Regulatory surveillance and auditing for pharmaceutical and biological companies

Multinational companies engage ARCADIS to support their environmental health and safety teams with regulatory compliance around the world.

devices, and biological substances and partner with our clients to develop

compliance. We work with our clients to integrate those strategic solutions into their business processes. Through our thorough understanding of our partners’ existing processes and evaluation of potential compliance gaps, ARCADIS has tailored new product introduction processes so our partners can produce globally compliant products, resulting in a dramatic decrease in new product holds at customs.

CASE STUDY 3: Authorisation under REACH

the preparation of this type of dossiers for consortia. Successful dossiers combine several ingredients: an extensive network of contacts with downstream users, industrial knowledge of processes (beyond what is

and environmental risk and impact assessment, as well as the knowledge to perform a socio-economic analysis. Data collection is crucial: mapping of the supply chain, information on availability and functionality of possible alternatives, additional exposure data for better characterising remaining

consequences of a refusal (non-use scenarios), and most often, additional exposure data to better characterise the remaining risks. ARCADIS

authorisation (non-use scenarios) vs the continued use of the substance.

STAFF SELECTION

Andreas Häner PhD – Microbiologist / Ecotoxicologist

Dr Häner holds the academic degrees of MSc in biology and a PhD in environmental microbiology. Over the last 17 years at BMG Engineering

product stewardship, legal compliance, REACH, GHS) and environmental risk assessment .and has supervised non-clinical GLP studies (aquatic toxicology and biodegradability) in BMG’s own ecotoxicology laboratory.

Nele Deleebeeck PhD – Ecotoxicologist

Dr Deleebeeck holds the academic degrees of MSc in biology, MSc in environmental sciences and technologies, and a PhD in applied bio-engineering sciences. She has worked for academics, industry, the Belgian government and consultancy. She has more than ten years’ experience in environmental risk assessment and this for a wide variety of chemicals, with her main specialty being metals and metalloids.

Kate Sellers PE – Environmental Engineer

Ms Sellers edited and co-wrote Nanotechnology and the Environment (2008) which explores the implications of this new technology. She has presented seminars and short courses to professional societies and multinational clients. In December 2012, she presented the results of

seminar. She has advised clients on issues ranging from the consequences of nanoparticle exposure to the nuances of regulatory registration. She holds a BS in chemistry and a MS in environmental engineering.

Maaike Bilau PhD – Biologist

Dr Bilau is a European registered toxicologist with a proven track record in the development of REACH compliance strategies for chemical and pharmaceutical companies. In this type of projects, stakeholder management and management of change is key. Together with the companies, she works on performing supply chain risk assessment, developing SVHC mitigation

human health hazard assessment and development of exposure scenarios (focus on occupational and consumer exposure), as the basis for the development of chemical safety assessments and reports.

Nathalie Schraepen MSc Eng – Environmental risk assessor

Ms Schraepen holds the academic degrees of MSc Eng in biochemistry and MSc in environmental sciences. She has more than 15 years’ industry experience (Procter & Gamble). She managed issues related to product safety and environmental toxicology, designed environmental testing programmes for a variety of business categories and industrial chemicals (mainly organics and surfactants). She has been active in industry association work (AISE) and key contributor of the HERA environmental risk assessments of several surfactants used in household care products.

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CONTACTS

Website www.arche-consulting.be


Head o"ce 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, Belgium

Founded 2009

OVERVIEW

ARCHE was founded in 2009 by key experts from EURAS who hold a

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

environmental quality standards, and the assessment of pharmaceuticals in the environment, plant protection products and biocidal products.


Turnover, group -


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Staff, group 14




83%


5%

IT & software5%

Training7%

GLOBAL OFFICES

PJ Van Benedenstraat 4, box 2033000 Leuven, BelgiumTel: +32 16 28 49 00

SERVICES PROVIDED

REACH

The REACH Regulation is the biggest piece of chemical legislation ever. ARCHE is well placed to help you set up a REACH implementation plan

distributor and/or downstream user of phase 2 and 3 substances under

follow-up.

Classification of substances and complex mixtures under CLP/GHS

In order to remain compliant with all the current legislation related to the

regard to format, content, and agreement with the information included

operational conditions that are described in he exposure scenarios cover

Water Framework Directive (WFD) and Environmental Quality Standard (EQS) Directive

The WFD and EQS Regulations directly impact the operation of industrial

increase the realism of the compliance assessment: (a) translation of

full-scale monitoring programmes (biological and physico-chemical

Biocides, pesticides and plant protection products (PPPs)

ARCHE has extensive expertise and a proven track record in delivering solutions to environmental problems at all stages in the registration/review of biocides, pesticides and PPPs. Offered services include: (a)

modelling (FOCUS suite of models, EUSES, USES, CONSEXPO,


2009

2010and Leuven

2013 Further expansion to 14 people, and further development of the services on biocides and pesticides

PARTNERS

EBRC Consulting GmbH, HannoverPietConsulting

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CLIENTS

Industrial clients and consortia related to the following chemical substances:

metals including: Cu, Ni, Mo, Pb, Zn, Hg, V, Co, Fe, Se, Sr, Mg, Bi, Te, Ti

plasticisers, amines, biocides, pesticides complex materials: Cu slags, Ti slags other inorganic substances: Ca, B, NaOH, KOH, sulphur dioxide-

related substances (SO2, sulphites, thiosulphates, dithionites), lime, nitric acid, phosphoric acid

TESTIMONIALS

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

CASE STUDY 1: REACH 2010 chemical safety reports for metals and metals compounds

The people currently working at ARCHE assisted several metal consortia in their REACH dossier preparation and chemical safety report generation for their metals and metal compounds that had to be registered by 1 December 2010. Data gap analysis with regard to the

and (eco)toxicological properties were conducted, and where needed testing programmes were designed and managed. The outcome of such research programs was combined with the results of the exposure assessment and relevant exposure scenarios that were also generated by the experts working at ARCHE. These risk characterisation exercises provided the operational conditions under which safe use of metals and metal compounds could be ensured for men and environment. In addition, all information that was used in the CSR was entered into the ECHA data information format (IUCLID).

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.

of test data on the complex material in question. The MeClas tool has been developed jointly by EUROMETAUX and ARCHE based on initial developments in collaboration with the European Copper Institute,

registering via www.meclas.eu

CASE STUDY 3: Environmental risk assessment of a biocidal product for milk extraction systems

Our experts compared two environmental risk assessment methods for a disinfectant for milk extraction systems: 1) the emission scenario document for biocides (ESD) based on local consumption estimates on a

extrapolated from EU/regional tonnage. For the ESD, formulae and default values were implemented into an Excel worksheet. In EUSES

the product type in question and this scenario was the most appropriate alternative. It was concluded that an ESD calculation is useful for a basic evaluation. However, the formulae appear to be very sensitive to

for PT3/PT4 biocides is not yet available, EUSES is preferred due to

great number of characteristics of substances and that the outcomes of EUSES are far more extended than with an ESD calculation. The results of this study were published at the SETAC Special Science Symposium in October 2011.

STAFF SELECTION

Patrick Van Sprang − Managing Director ARCHE

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

Marnix Vangheluwe − Managing Director ARCHE

Marnix Vangheluwe graduated as master of science in engineering (biochemistry) at Hogeschool Gent (1989). In 1991 he obtained a master in environmental sanitation (Ghent University). At Ghent University (1992-2000) 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

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

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.

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CONTACTS

Website www.bibra-information.co.uk


Head o"ce Cantium House, Railway Approach, Wallington, Surrey, SM6 0DZ, UK

Tel/ Fax +44 (0)20 8544 4150/ +44 (0)20 8544 4151

Contact Peter Watts

Directors

James Hopkins, Managing Director

Peter Watts, Director of Toxicology

Graham Hunt, Commercial Director


Locations United Kingdom

Founded 1961, acquired by current management 2005

OVERVIEW

Bibra toxicology advice & consulting, an amalgamation of two sister companies – Toxicology Advice & Consulting Ltd and Bibra Information Services Ltd – is one of the most experienced and successful chemical hazard and risk assessment organisations in Europe. We combine the skills and expertise of a large team of highly experienced and

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

Bibra toxicology advice & consulting has been working successfully with government departments and industry for many years across a broad range of sectors, including industrial chemicals, plant protection products and biocides. We have built an enviable reputation for our ability to handle large, as well as small projects, and to deliver high quality consulting and information services to tight deadlines. We are a leading supplier of REACH compliance services, assisting chemical manufacturers, importers and downstream users with all their REACH regulatory responsibilities. Indeed, we have helped industry successfully register a large number

support companies with their REACH obligations for the 2013 and 2018 deadlines.


Turnover, group £1.4m

Turnover, chemical service provision £1.4m

1


Staff, group 15




79%

Representation

& management12%

Information6%

IT &software

3%

Training1%

GLOBAL OFFICES

London

SERVICES PROVIDED

Dossier preparation, including CSA/CSRs (DNEL/DMEL derivation)

Highly skilled in working directly into IUCLID preparing technical dossiers required under REACH and the Biocidal Products Directive, and in describing

evaluating toxicity studies and working with appropriate assessment factors to derive risk-based levels of tolerable exposure. Accurate input of information into IUCLID facilitates the overall chemical safety assessment and production

REACH. We also provide a IUCLID 5 web-hosting service to our clients.

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

the client, we have worked with companies from the industrial chemicals, agrochemicals, biocides, 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

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

is deemed necessary we advise on testing strategies to minimise both

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

our technical library and quickly accessed using its associated database, TRACE. This unrivalled resource (listed as a valuable data source in ECHA guidance) allows instant access to relevant documents and is

for our clients, in the most timely and cost-effective manner.


1960 Formation of BIBRA

1960 Establishment of Toxicology Information and Advisory Department

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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

2003/5 Toxicology Advice & Consulting Ltd and Bibra Information Services Ltd established as vehicles to facilitate management buyout of Information and Advisory Department, including TRACE and its associated databank

2005 The new combined entity began to trade as bibra toxicology

2010

ACCREDITATIONS

Our senior toxicologists are all Society of Biology/British Toxicology Society and EUROTOX registered toxicologists. We are a REACHReady approved supplier

PARTNERS

TSGEEnviresearch LtdLinmark Consulting Gmbhwca environment LtdReFaCCampden BRI groupLeatherhead Food International Ltd

CLIENTS

are just a small sample of the types of organisations that we work with: Actavis Group CSL Behring Biotherapies for Life Environment Agency (UK) Health Canada International Programme on Chemical Safety World Health Organization Groupe Danone

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” –

"In my opinion the toxicologists at bibra/toxicology advice & consulting are able to provide a very high-quality service by applying a combination

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

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

drafted ESRs and associated endpoint summaries, and the compilation of a chemical safety report (CSR), which included calculation of DNELs and PNECs, a PBT/vPvB and exposure assessment, risk characterisation step, and documentation of the necessary risk management measures and operational conditions (RMMs/OCs). The size and capabilities of our team meant that, despite the late notice and tight deadline, we could incorporate this project into our work schedule and the client was able to successfully submit their registration dossier in time.

CASE STUDY 3: Provision of alerting service to keep industry up-to-date on emerging issues

Bibra toxicology advice & consulting was asked by an industry sector group to provide an ongoing service to track the emerging toxicological literature on a range of chemicals of particular interest to their members. Using a range of carefully tailored search and alerting strategies (SDI – selective dissemination of information), the bibra team receives daily

comment, and alerts the sector group members to keep them abreast

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 senior toxicologist of high repute at BIBRA 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 2011/12. 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 over 30 years. His vast experience includes reviewing and critically evaluating toxicological data and providing risk assessments on numerous chemicals for government departments and industrial organisations. He helped in the preparation of the 0 1 2 3 4 5 6 7 8 9 : ; < = : > : ? = @ A 9 B 7 = :0 < C 6 7 @ < A < : B D , has authored WHO-IPCS CICADS and Environment Agency CLEA reports, acted as a temporary adviser to the WHO, and provides peer-review services for OECD SIAMs (now CoCams).

Philip Copestake – Senior Toxicologist

Philip has more than 25 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 ten highly-competent toxicologists, all of whom are

registered toxicologists) and, barring our graduate trainees, range in practical experience from ten to 35 years. All are extremely skilled in chemical hazard and risk assessment and have been heavily involved in

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CONTACTS

Website www.merieuxnutrisciences.com


Head o"ce Rodovia SP 127 km 24, 13412-000 Piracicaba SP, Brazil

Tel/ Fax + 55 19 3429 7700/ + 55 19 3429 7713

Contact Dr Jean-Luc Garrigue

Directors M. Luis Fernando Torres Maida

Dr Paulo Silva

Dr Milton Vargas

M Edivan Tonhi

M Celso Zaccaria

Ownership Mérieux Nutrisciences

Locations Brazil, France, China

Founded 1991

OVERVIEW

Bioagri is the Brazilian business unit of Mérieux Nutrisciences, the US group headquartered in Chicago (US), dedicated to human public health and owned by INSTITUT MERIEUX. Bioagri is the largest CRO in Latin America (>1000 employees) serving the chemical, cosmetic, food, pharmaceutical and crop protection industries worldwide. Services encompass toxicity, physico-chemistry, ecotoxicity, analytical and microbiological studies, and residues analysis under applicable regulatory guidelines.

International and employ the most current equipment and technologies. Bioagri, within its parent company Mérieux NutriSciences, has the ambition to become the partner of choice of chemical industry leaders, towards the following unique strengths:

reactivity, very short decision-making centres (in Brazil, Europe or

international locations throughout Mérieux NutriSciences, able to

global network and access to key opinion leaders in China, Brazil, USA and Europe.

The acquisition in 2012 by Mérieux Nutrisciences of CHELAB laboratories located in Italy contributed to a global expansion of the services offered (including E F G E H I JOverall, Bioagri (in association with Chelab) offers to the chemical, cosmetic, food, pharmaceutical and crop protection industries one of the best performing turn-key solutions, with high quality standards for a large range of CRO


Turnover, group US $60m

Turnover, chemical service provision US $38m

16


Staff, group 950




15%

Representation

& management5%

Laboratory75%

Other5%

GLOBAL OFFICES

Headquarters Mérieux NutriSciences: Chicago, USAHeadquarters Bioagri Laboratorios: Piracicaba, Brazil

(China)

SERVICES PROVIDED

Toxicology

In Italy the following E F G E H I J studies are conducted: acute skin corrosion – human reconstructed epidermis (EST1000) acute skin Irritation – human reconstructed epidermis (EPISKIN) acute eye irritation/corrosion – human corneal epithelium (HCE)

expression on THP1 dendritic cell line) E FG E H I J micronucleus test phototoxicity – 3T3-NRU test.

In Brazil all classical acute to long-term toxicity studies are conducted in rodents, rabbits, guinea pigs and dogs, by oral, dermal, inhalation or intraperitoneal route, under supervision of an animal welfare ethical committee:

acute dermal or eye irritation study skin sensitisation (LLNA, M&K, BU) repeated dose (7-d, 14-d, 28-d, 90-d) oral or dermal toxicity E F G E G J kinetics and metabolism (ADME) (single or repeated dose for

one radio-labelled substance) genetic toxicity (Ames test, E F G E G J micronucleus test) fertility and early embryonic development to implementation embryo-foetal developmental toxicity one or two-generation reproduction toxicity reproduction and developmental toxicity screening combined repeated dose toxicity study with the reproduction/

development toxicity screening carcinogenicity (alone or combined with chronic toxicity).

Physico-chemistry

Conducts all required studies on physico-chemical properties of products according to OECD, EU and US-EPA guidelines (eg molecular

Ecotoxicology

Evaluates all classical effects of products on aquatic and soil organisms: ready biodegradability inherent biodegradability (aerobic) acute immobilisation (Daphnia magna) algea growth inhibition (Pseudokirchneriella subcapitata) activated sludge respiration inhibition soil microrganisms (nitrogen test) earthworm acute or reproduction toxicity (Eisenia foetida) Daphnia magna reproduction – 21 days Danio rerio, or truta)

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Danio rerio) honeybees acute oral or contact toxicity (Apis mellifera) avian acute oral/ dietary toxicity (Japanese quails) sediment/water microcosm biodegradation aerobic or anaerobic soil metabolism leaching in soil columns adsorption/ desorption

Analytical chemistry

and shorter detection limits: ICP-MS (n = 2) ICP-OES (3)

GC-MS/MS (40) LC-MS/MS (12 ) HPLC (80)

Mass spectrometry

Performs qualitative/quantitative assays of the active ingredients and

biological matrices).

Radiochemistry

Evaluates the behaviour and fate of pesticides in plants, animals and soils, according to OECD and US-EPA guidelines.

Microbiology

association with quality control and analytical chemistry of the active ingredients in the tested formulations.

Pesticide residues

Safety evaluation of cosmetics and detergents in humans

In Italy: patch test (irritation) on volunteers, ophtalmological irritation test on volunteers

E"cacy evaluation of cosmetics and detergents in humans

In Italy: E F G E G J determination of SPF, water resistance, hydratation test, TEWL, assessment of anti-wrinkle and anti-cellulite products, etc...


1991 Bioagri foundation in Brazil by two PhD researchers from the Centre for Nuclear Energy in Agriculture (University of São Paulo).

2000laboratory practices (GLP) in 2000 by INMETRO (Brazil) and 2002 by OECD (Netherlands).

2009 Bioagri is the leading private CRO in Latin America, with 25,000m2 laboratory space, and more than 850

analytical chemistry, physicochemistry, mass spectrometry and microbiology.

2010Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).

2010 Bioagri is part of Mérieux NutriSciences Corporation, With more than 40 years of experience and part of Institut Mérieux, Mérieux NutriSciences helps advance science and solutions for food safety, quality and nutrition with 4,000 professionals in

and provides Bioagri’s clients with the highest levels of quality, customer service and worldwide technical support.

2011 Brazil becomes a full adherent to the OECD Council Acts related to the Mutual Acceptance of Data in the Assessment of Chemicals. Consequently, GLP preclinical safety test data on pesticides and chemicals generated at Bioagri are accepted in OECD countries and adhering non-members.

2012 Mérieux NutriSciences announces the acquisition of Italy-based CHELAB, a market leader in chemical, microbiological and 7 : K 7 B @ = toxicology laboratory services.

ACCREDITATIONS

GLP, OECD, AAALAC, INMETRO, ISO-17025

PARTNERS

Sister companies of Bioagri within Mérieux Nutrisciences: Silliker (food safety) including Chelab-Silliker (7 : K 7 B @ = toxicology), Biofortis (R&D in nutrition, clinical trials and sensory analysis for nutrition and cosmetics) European consulants (regulatory, toxicology), working with Bioagri under

CLIENTS

Leaders from the chemical industry, agrochemical and crop protection industries, cosmetic industry, household products industry, pharmaceutical and veterinary drugs companies

CASE STUDY 1:

Hundreds of GLP pre-clinical safety studies have been conducted in skin sensitisation, genetic toxicity, developmental toxicity or systemic toxicity studies for cosmetic ingredients for leading international companies, matching sponsor’s expectations in >95% as far as time schedule and

CASE STUDY 2:

A-to-Z tailor-made REACH projects have been managed for leaders of the chemical industry, including: global/ local project management, data gap analysis, testing strategy, physico-chemical, toxicological and/or ecotoxicological testing, study monitoring support, IUCLID 5 completion with dedicated hazard assessment assistance, and risk assessment support when necessary (CSA/CSR).

CASE STUDY 3:

At Bioagri, thousands of studies were performed on hundreds of active ingredients and formulated compounds used in agriculture, or chemical compounds throughout the world, and >99% were accepted by the relevant authorities. Today, 70% of GLP studies with agrochemicals done in Brazil are conducted at Bioagri, based on the undisputed reputation of this lab for performing tailor-made, reliable, timely accurate and cost effective studies.

STAFF SELECTION

Our technical staff includes about 300 hundred dedicated and

(including VetD, MD, PhD, EUROTOX toxicologist, expert in immunotoxicology), ecotoxicology, analytical chemistry, physico-chemistry, mass spectrometry and microbiology among others. Bioagri’s testing services are reliable, timely, accurate and cost-effective. Tailor-made custom services are provided to meet all of our clients’ needs.

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CONTACTS

Website

E-mail

Head o"ce 10 York Place, Edinburgh, Midlothian, EH1 3EP, UK

Tel +44 (0) 131 523 1412

Contact Damien Carson

Directors Damien Carson

Tom Hargreaves

Ownership Private Limited Company

Locations UK (Edinburgh and Cardiff)

Founded 2006

OVERVIEW

the chemical industry. Blue Frog’s philosophy is achieving regulatory compliance through the application of good science, innovation and

standard.

experience in chemicals, human pharmaceuticals, veterinary medicines, agrochemicals and feed additives.Based in the UK, our core team of consultants coordinate operations and our comprehensive network of associates (including contract laboratories,

clients in all areas of regulatory compliance. We have particular in-house strengths in chemistry, toxicology, ecotoxicology, environmental fate, and regulatory affairs. We utilise our network of associates when we

issues requiring an expert opinion, statement or report.


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Representation

& management30%

IT & software10%

GLOBAL OFFICES

Edinburgh, Scotland, UKCardiff, Wales, UK

SERVICES PROVIDED

Scientific consultancy

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

Regulatory a#airs

regulatory affairs for chemicals, human medicinal products, veterinary medicinal products, agrochemicals and feed additives

project management product defence consortium and task force management only representation of non-EU chemical companies under REACH

Chemicals (REACH)

registration service for chemical substances under Regulation (EC)

in preparing registration dossiers, chemical safety assessments, coordinating with Siefs and consortia, and liaising with regulatory authorities during and post dossier submission.Key sectors of experience include:

substances of unknown or variable composition, complex reaction

transported isolated intermediates (Article 18).We also provide supply only representative services in accordance with Article 8 of REACH for non-EU companies that manufacture or formulate chemical substances and mixtures.

Consortium/Sief management

and administrative challenges of consortia and task forces. We are currently managing consortia and Siefs under REACH as well as other groups of companies collectively working on research and development projects.Our services include:

extranet.

Environmental risk assessment of human medicinal products (HMPs) and veterinary medicinal products (VMPs)

environmental risk posed by human pharmaceuticals and veterinary medicines.Environmental risk Assessment:

authoring expert reports for inclusion in European marketing

planning and coordinating the necessary activities required in the

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protocol development and environmental testing requirements to

preparing literature based “weight-of-evidence” risk assessments for

multimedia mathematical modelling of the fate of pharmaceuticals in

deterministic and higher tier probabilistic assessment of effects on

preparation of conclusions of risk, with relevance to the “real world”

regarding bioaccumulation and secondary poisoning.Key sectors of experience:

Product defence, particularly for two “priority list” substances.

Agrochemicals

registering plant protection products throughout Europe. Our range of services provides cost effective solutions to support placing your products on the European market.Data gap analysis:

preparation of updating statements.Study management:

Dossier preparation and regulatory affairs:

communication with regulatory authorities within EU 27 to support submissions.

Key sectors of experience include:

Other: semiochemicals and biopesticides.


2006 Formation of Chemical Regulatory Services team within BMT Cordah Limited, part of the BMT group of companies

2007 Development of REACH technical consulting services supporting a global client base

2008 Development of human pharmaceutical and veterinary medicine consulting services supporting a global client base

2010 Management buy-out of Chemical Regulatory Services business by D Carson and T Hargreaves, forming Blue Frog

2010 Development of agrochemical consulting services

2012 Sustained growth leads to major expansion of company with

ACCREDITATIONS

European Partner: Society of Environmental Toxicology and Chemistry (SETAC).

CLIENTS

pharmaceutical, veterinary, agrochemical and feed additive companies, ranging from SMEs to large multinational corporations. We take our

CASE STUDY 1: REACH advisor to a European Defence Agency

parameters of the defence exemption, training staff on the fundamental aspects of REACH, and developing internal procedures for assessing exempt/non-exempt chemical substances and complying with REACH.

CASE STUDY 2: Assessment of the environmental fate and e#ects of the PPARgamma receptor agonist, pioglitazone

The environmental fate and effects of pioglitazone prescribed for the treatment of type 2 diabetes were evaluated in an environmental risk assessment. A predicted environmental concentration (PEC) for surface

-1, triggering a comprehensive battery of laboratory evaluations. Pioglitazone and its major metabolites

not persistent in the aquatic environment, did not bioaccumulate and were non-toxic to aquatic organisms. Pioglitazone does not pose an unacceptable risk to groundwater supplies, with concentrations not anticipated to be a risk to aquatic organisms or human drinking water supplies. Pioglitazone does not pose a risk of secondary poisoning.

STAFF SELECTION

Damien Carson BSc PhD – Director

An expert in chemical hazard and risk assessment with more than ten years’ experience across a wide range of sectors in the industrial and

strategies.

Tom Hargreaves BSc (Hons) – Director

An expert in environmental hazard and risk assessment, with more than 15 years experience in veterinary medicinal products, human pharmaceuticals, agrochemicals and chemicals. Expert in Good Laboratory Practice and testing strategies.

Nigel Halsall BSc PhD – Associate Director

An expert in environmental hazard and risk assessment with more than 25 years experience in the agrochemical industry. Expert in Good Laboratory Practice and testing strategies.

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CONTACTS

Website www.brixham-lab.com


Head o"ce Freshwater Quarry, Brixham, Devon, UK, TQ5 8BA

Tel +44 (0)1803 884400

Fax +44 (0)1803 882974

Contact Enquiry co-ordinator

Ownership AstraZeneca UK Ltd (parent company)

Locations Brixham, Devon, England

Founded 1948

OVERVIEW

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

The laboratory has good laboratory practice (GLP) accreditation, and is licensed to work with radio-labelled materials.


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Information5%

Laboratory70%

SERVICES PROVIDED

We offer laboratory based assessment of the environmental effects, ecotoxicity and environmental fate of new and existing substances. Our

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.

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 Biocidal Products Regulation.

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 E F G E H I J and E F G E G Jsafety, metabolism and pharmacokinetics. Brixham Environmental Laboratory has experience of interpreting these data and using them to design an intelligent environmental testing strategy.

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.


1948 Established as a marine research station for ICI Paints

1960s -70s

Environmental science began to dominate the laboratory's function

1979 First environmental laboratory to be OECD GLP compliant in Europe

1980s 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 £12m laboratory refurbishment and expansion to include state of the art facilities

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2011 BEL was aligned with two research groups nominated, one of which won, within the Outstanding Impact in Public Policy and Services category at the Exeter University inaugural Impact Awards

1948 -2012

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

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

ACCREDITATIONS

Good Laboratory Practice (GLP)

CLIENTS

with a wide range of clients including 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)

Dr Jason Snape established the proof of concept studies for a new generation of biodegradation test that have been recently included

biodegradation tests for poorly water soluble chemicals and the enhanced biodegradation studies for persistence assessments. Dr Jason Snape

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 lifecycle testing

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 range-

in half the time compared to a FFLC.The alternative test design, and the data provided by this study, have been accepted by the competent regulatory authority. Importantly, this

of animal usage in the future.

STAFF SELECTION

Dr Grace Panter − Ecotoxicologist

Grace Panter is an ecotoxicologist with more than 12 years' laboratory

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

both as papers and technical reports.

Dr Jason Snape − Environmental Foresight Business Manager

Jason is an environmental microbiologist and biochemist with 18 years'

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/co-chairing committees, task forces and working groups. His expertise has also produced many published papers.

Dr Paul McCormack – LC/MS and MSn Specialist, Chemistry

Paul has over 12 years’ experience in liquid chromatography and multi-stage mass spectrometry (LC/MSn). His experience includes the

joined Brixham in 2005 as a consultant providing specialist knowledge of data interpretation using MSn. He has been involved with a number of research projects as well as continuing to provide technical expertise in developing LC/MSn

products in aquatic, soil and sediment systems. Recent research includes monitoring of active pharmaceutical ingredients for a number of AstraZeneca manufacturing sites worldwide to help develop environmental quality standards and bioanalysis of the endocrine disrupting chemical Bisphenol-A that has been linked to human health effects.

Dr Gary Roberts − Senior SHE Specialist, Environmental Fate

Gary is a specialist in studying the environmental fate of biologically active chemicals. Gary’s research interests include the biodegradability

degradation of pharmaceuticals. Gary chaired the organising committee

risk assessment, and currently chairs the Ecetoc taskforce on this topic. 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.

algae, macrophytes and mesocosm studies and analysing the results

chemicals in the environment. Active contributor to international working groups such as OECD and ILSI HESI bioaccumulation groups.

Other sta#

BEL currently employs 83 people, from all over the world with a wide

acclaimed scientists with doctorates and established publication records as well as individuals with professional business and management

including ecotoxicology, analytical chemistry, environmental fate and environmental risk assessment, etc.

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CONTACTS

Website www.bioservice.com


Head o"ce Behringstr 6/8, 82152 Planegg / Munich, Germany

Tel +49-89-899 650-0

Fax +49-89-899 650-11

Contact

Directors Dr Wolfram Riedel, CEO

Locations Germany

Founded 1984

OVERVIEW

chemicals, agrochemicals, biocides, cosmetics, medical device, food and pharmaceuticals. The interdisciplinary and internationally accepted

and numerous successful audits (GLP, DIN EN ISO 17025, GMP, FDA) guarantees high-quality biological trials. The laboratories have in the

most recently in 2012, and all tests are performed in accordance with the internationally valid guidelines (OECD, ISO, ICH, EU, EPA, MHW, FDA).With more than 25 years of experience our team of scientists offers a broad spectrum of biological test systems and is dedicated to meet the

high quality standards.

leader in the pharmaceutical, food and environmental testing market and offers also a comprehensive portfolio for the chemical and agrochemical

has over 13,000 employees in more than 170 laboratories across 33 countries.


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No of countries represented 6-10

Staff, group 170+




10%

Laboratory90%

GLOBAL OFFICES

Our facilities are located in Planegg/Munich, Germany.In addition, we have representatives in Switzerland, Japan, India, Poland, Scandinavia, Italy and other countries.

SERVICES PROVIDED

For the chemical, agrochemical and biocides industry BSL BIOSERVICE offers a broad scope of biological safety studies, which meets the international regulatory requirements and includes the following services.

Toxicology for chemicals, PPP’s and biocides

We cover all common toxiclogy services relevant for chemicals, plant protection products (PPP’s) and biocides. This includes the classical E FG E G J studies from acute to repeated dose and DART studies. In addition, BSL puts a high emphasis on alternative E F G E H I J testing strategies with

animal studies. We have established a big range of E F G E H I J assays for all endpoints where this is possible yet.Our services include:

irritation/corrosion ( E F G E H I J / E F G E G J ) sensitisation dermal absorption ( E F G E H I J / E F G E G J ) genetic toxicity ( E F G E H I J / E F G E G J ) acute toxicity repeated dose toxicity reproductive and developmental toxicity (DART) toxikokinetics carcinogenicity neurotoxicity endocrine disruptor testing

Ecotoxicology and physico-chemical properties

Physico-chemical and ecotoxicology services including aquatic and terrestric studies as well as studies on biodegradation and environmental fate and behaviour are also part of our portfolio. These services are

partners and are project managed by BSL BIOSERVICE.

REACH services

With regard to REACH we can offer the full portfolio of studies, required for the different tonnage levels according to Annex VII-X of the REACH directive. Due to the large variety of chemicals tested for the REACH deadlines in 2010 and 2013 we are well prepared to effectively support you also for the upcoming deadlines. Furthermore, as ECHA will continue with the evaluation of the registered substances and testing proposals, we are happy to perform those higher tier studies for you and support you in updating your dossier. Studies like 90-day toxicity (OECD 408) and reproductive and developmental toxicity (OECD 414) are performed at BSL on a routine basis. With regard to the latest discussions we have also established the EOGRTS (OECD 443) as an alternative to the two-generation study (OECD 416).

Endocrine disruptor testing

In response to the EPA announcement of the Endocrine Disruptor Screening Program for Biocides, we have established endocrine disruptor testing services and can offer the full Tier 1 testing battery.

In vitro safety testing

mutagenicity, clastogenicity, carcinogenicity skin and eye irritation/ corrosion – several models dermal absorption photo-induced toxicity reproductive toxicity (embryonic stem cell test) sensitisation – several models under development

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Consulting, testing strategies and individual study designs

With more than 25 years of experience, BSL BIOSERVICE and our team of scientists will provide you with expert advice not only for standard studies, but also for individual study designs and testing strategies, taking into account substance properties as well as interdependency of many studies required for example for REACH. In addition to our internal consulting services we are backed up by an

partners that support us in covering the regulatory issues of chemicals, agrochemicals and biocides.


1984 Foundation under the name Dr Müller Lierheim AG

1992

1995 Within a management-buyout the company was renamed to

1995 Accreditation according to DIN EN ISO 45001/DIN EN ISO

2006 BSL BIOSERVICE becomes a partner laboratory of the

2007 Expansion into an additional building and establishment of a brand new state-of-the-art E F G E G J facility with a laboratory area of 3000 m2

2009REACH Task Force as toxicology partner

ACCREDITATIONS

Good Laboratory Practice (GLP)DIN EN ISO IEC 17025Good Manufacturing Practice (GMP)FDA approvedRadioactive handling permission

CLIENTS

Chemical industry Agrochemical/ biocides industryPharmaceutical/ biotech industryFood industryCosmetic industry

STAFF SELECTION

Dr Wolfram Riedel, CEO

Dr Wolfram Riedel has worked as CEO of BSL BIOSERVICE since 1994. He holds a master’s degree in biology and performed his PhD thesis at the German Cancer Research Centre, Heidelberg, Germany. He has extensive experience in toxicology and regulatory services and is a member in various expert groups.

Dr Achim Albrecht, Scientific Director

With more than 20 years of experience in contract research, Dr Albrecht E F G E G J Pharmacology/ Toxicology at BSL BIOSERVICE. His experience includes biological safety testing, safety pharmacology, safety toxicology and elaboration of expert reports and statements for drugs and chemicals From 1995-2010 he has been working at BSL as Head of E F G E G J Pharmacology and Toxicology, Study Director E F G E G J and was writing biological evaluation reports. Dr Albrecht has a PhD in veterinary medicine and is a member in various expert groups.

Dr Marc Kunze, Senior Toxicologist

Dr Kunze studied pharmacy and toxicology and holds a PhD in medicinal chemistry and a master in toxicology. After several years at the university giving lectures on pharmacology and toxicology, he moved to the pharmaceutical industry. He specialises in non-clinical and clinical toxicology within drug development and risk assessment of chemicals. As senior toxicologist at BSL BIOSERVICE, Dr Kunze is responsible for preparation of study designs and project management of regulatory toxicological studies. Additionally, he acts as an internal and external consultant for all areas of toxicology.

Dr Iris Pfisterer, REACH Manager

to support our clients with all enquiries and questions about REACH and project manages large projects. This may include projects from data gap

holds a master’s degree and PhD in biology and has supported our clients at BSL since 2009.

Other sta#

In total more than 170 people work for BSL BIOSERVICE. Our highly educated and experienced staff comprise a large proportion of scientists with a wide variety of expertise. They will provide you with excellent services and are dedicated to meeting your individual needs with a high

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CONTACTS

Website www.bureauveritas.com


Head o"ce 67/71 Boulevard du Château, 92578 Neuilly/ Seine, France

Tel/ Fax +33 1 5524 7000/ +33 1 5524 7001

Contact Marie-Laure Héraud, Chemical SGP Mgr

Directors Didier Michaud-Daniel, CEO

Sami Badarani, CFO

Ownership Listed private company (Paris Stock Market)

Locations Global geographical coverage (140 countries)

Founded 1828

OVERVIEW

services. We help our clients to improve their performances by offering services and innovative solutions in order to ensure that their products, infrastructure and processes meet standards and regulations in terms of quality, health and safety, environmental protection and social responsibility. Bureau Veritas is recognised and accredited by major national and international organisations. From a global standpoint, Bureau Veritas services are related to:

government services and international trade services.





Staff, group 48,000 employees

Staff, chemical service provision 200+ employees



10%

Representation

& management

30%

Information15%

Laboratory20%

IT & software10%

Training15%

GLOBAL OFFICES

across:

SERVICES PROVIDED

The below are only a selection of Bureau Veritas services, focusing on chemical risks

REACH assistance

Bureau Veritas offers a full range of services to assist manufacturers, importers and downstream users in meeting their requirements for the REACH regulation. Global project assistance is available, with support ranging from training to technical support, such as chemical risk assessment, Sief/consortium management and dossier submission, SVHC and Annex XVII substances management and testing, and REACH authorisation dossiers.

MSDS management – REACH/CLP context

Starting with a chemical risk approach, Bureau Veritas provides MSDS management services, technical assistance for MSDS elaboration and update within REACH and CLP context, especially for extended MSDS. Bureau Veritas also provides training on e-MSDS, in order to assist with programme implementation. Services are supported by a complete set of dedicated tools.

Occupational hygiene and chemical workers exposure

Bureau Veritas delivers chemical risk prevention services, such as employee monitoring, and exposure mitigation recommendations,

approach to chemical risk management.

Dangerous goods safety advisory (DGSA)

such as chemical risk assessment and DGSA assistance, drawing-up of transport documents and packing, packaging, labelling consultancy according to eg ADR, RID, IMDG, IATA… frameworks. Also a complete set of qualifying training courses is provided (eg for drivers... warehouse workers, etc). Indeed “DGdoc.net” business software is delivered on-purpose by Bureau Veritas.


1828 Operations in marine

1910 Operations in industry

1929 Operations in construction

1984 Operations in government services, international trade

1988

Since 1993

Deployment on all continents

2007 Bureau Veritas listed on stock market (Paris)

2008 Mining platform

2010 Commodities platform

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ACCREDITATIONS

Selected credentials:

services by many organisations (UKAS and IRCA in the United Kingdom, ANAB in the United States, JASANZ in Australia and New

machinery, electrical and electronic appliances, lifts, construction

laboratory accreditations in 20 countries, delivered by bodies such as

PARTNERS

To offer further REACH services, Bureau Veritas has developed partnership with other service providers.

CLIENTS

400,000 clients in various markets (aeronautics – agriculture – automotive – construction and real estate – consumer products – food – governments and public organisations – industrial equipment – international trade – IT, telecoms and electronics – maritime industry – mines and minerals – oil and gas – power and utilities – process Industries – chemical industries and chemistries – retail – services – transport and infrastructures)

CASE STUDY 1

substances such as unstable, reactive or inorganic substances. Indeed the exemptions or adaptations foreseen in column 2 of appendices VII to X and the tools for the health and environmental assessment are not always adapted or relevant for these kind of substances. Thus, to implement the integrated testing strategy, OECD guidelines were considered and adapted protocols were developed in collaboration with laboratories. For the CSA (environmental assessment), a Tier 2 with the use of reliable and representative data from measurement campaigns was sometimes necessary to justify the risk control.

CASE STUDY 2

A leading computer industry hardware manufacturer selected Bureau Veritas as its worldwide HSE compliance partner to deliver health, safety and environmental support, as required for manufacturing and administrative sites globally.As major users of chemical materials and products in the manufacture of numerous articles, Bureau Veritas supports all client requirements in meeting its HSE compliance obligations, including the range of chemical management obligations in the UK and Europe associated with REACH, GHS and chemical safety. Service aspects include:

design and delivery of technical training including for chemical

statutory safety compliance assessments and audits.

CASE STUDY 3

to sell chemicals/chemical products at the European marketplace level, Bureau Veritas has acted as an independent third party handling

On this basis, Bureau Veritas has taken care of client labelling,

data sheets (SDS) in various languages.In real terms the company has called Bureau Veritas to ensure that regulation, documentation and other related procedures in this very chemical area were met so that the company can focus on their core business.

STAFF SELECTION

Dr Gautier Vincent – Senior Toxicologist, Practice Leader

Gautier is a pharmacist and a civil engineer. He has 12 years’ experience in regulatory toxicology and risk assessment. He has worked on different regulations (REACH, CLP, Biocide, IPPC, etc). Prior to this, he had been working for INERIS in France (technical agency for environmental ministry) where he determined different toxicological thresholds (accidental and chronic). As a registered toxicologist, he is a member of the French Toxicology Expert Committee for acute exposure threshold levels.

Simon Hodge – Chemical Practice Leader

Simon holds a masters degree in environmental science, backed up by 30 years’ experience delivering health, safety and environmental

commercial sectors. He specialises in hazardous material and chemical risk assessment, management, exposure and control and has led the Bureau Veritas UK chemical management service for the past ten years, developing a range of chemical assessment and consultancy services to assist clients in achieving compliance with regulation.

Jan Henriksen – Chemical Safety Operation Manager

Jan has regulatory, commercial and research experience worldwide spanning more than 26 years. He has worked with risk assessment and dangerous goods related services in a wide selection of industries, spanning from automotive to offshore production and has, based on this experience, developed Bureau Veritas’s dangerous goods safety advisory concept. Working worldwide with focus on implementation of the concept in international companies, he has gained a deep understanding for the logistic and commercial problems that need to be overcome, to be able to move chemicals nationally and internationally. To support the logistic tasks in relation to dangerous goods, he is also the product manager for the unique internet based software solution “DGdoc.net”, that can ensure legal performance when delivering documentation for transport.

Cathy Alvarez – Senior Ecotoxicologist

Cathy is an ecotoxicologist who has seven years’ experience in regulatory ecotoxicology and environmental risk assessment. She worked within the French Competent Authorities, in charge of the risk assessment of new and existing substances and the technical instruction of substances registration dossiers. She was also an active member of the European Stakeholder Experts Group in charge of the development of the CSA/CSR guidance.

Melodie Caraty – Socio-Economic and Sustainability Analyst

Melodie is a socio-economic analyst. She is in charge of developing socio-economic analysis in the frame of REACH authorisation dossiers,

environmental questions for international institutions (World Bank, UNEP, WTO, etc) and on economic and social issues on the West Bank.

Joseph J Fater, CIH – Industrial Hygiene Practice Leader

Joe has more than 35 years’ experience in industrial hygiene consulting and health, safety and environmental (HSE) auditing, with an emphasis on chemical exposures and industrial operations. He is the Bureau Veritas US National Practice Leader for industrial hygiene services and also provides litigation support services and represents clients during contested occupational safety and health administration (Osha) citations.

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CONTACTS

Website www.cehtra.com


Head o"ce 43-45, rue Laroque, 33560 Sainte-Eulalie, France

Tel +33 557775610

Fax +33 557775620

Contact Paul Thomas

Directors Pierre-Gérard Pontal, President

Peter Jenkinson, CEO

Nathalie Ledirac, R&D Director

Michel Guilhem, Director, Business Development

Philippe Adrian, Director CEHTRA Europe

Paul Thomas, Director CEHTRA Lyon

Peter Jenkinson, Director CEHTRA UK

Jason Nugent, Director CEHTRA North America


Locations Bordeaux FR, Lyon FR, Paris FR, Brussels BE, Nottingham UK, Delhi IN, Trivandrum IN, Toronto CA

Founded 2001

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 a subsidiary OR company.


Turnover, group -


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Staff, group 50




75%

Representation

& management

10%

Information5%

IT &software

2%

Legal2%

Training6%

GLOBAL OFFICES

CEHTRA Lyon – 80, rue Condorcet, 38090 Vaulx Milieu, FranceCEHTRA Paris – 25, rue des Bas, 92600 Asnières sur Seine, FranceCEHTRA Europe – 134, rue Saint Germain, 1410 Waterloo, BelgiumCEHTRA UK – 6th Floor City Gate East, Toll House Hill, Nottingham, NG1 5FS, UK

Trivandrum, 695014, Kerala, IndiaCEHTRA India – Cabin No: 245, Level 2, Elegance Building, Mathura Road, Jasola, New Delhi, 25, India CEHTRA North America – 24 Ivy Lea Crescent, Toronto, ON M8Y 2B6, Canada

SERVICES PROVIDED

Regulatory dossier services

CEHTRA provides clients with bespoke services for the production of regulatory dossiers worldwide or together with our partners, be that

pharmaceuticals. We have all the competencies in-house to do all or any part of a project. We have contributed to, or realised over 1,000 projects since CEHTRA was founded and we have produced well over 100 REACH dossiers, all of which were successfully submitted on time. We use, verify and validate the algorithms of software such as ECETOC TRA, FOCUS (for pesticides and ART) and improve on existing tools (eg by

Industrial hygiene and worker exposure studies

With more than ten years of culture and experience in different industrial sectors, from pesticides to general chemicals, and a complete understanding of the tools used in risk-data interpretation, including generation of exposure limits, CEHTRA is able to bring you answers and

Consortium and Sief management

We offer a complete service that can either be used as a stand-alone or may be combined with the technical services provided by CEHTRA. We make sure that the milestones and deadlines of your project are met while ensuring the spirit of fairness and transparency, at the same

your business. We can help you with the preparation of consortium agreements, maintaining contact lists, archiving, billing and all the aspects required for effectively running consortia and Siefs.

Expert services

Our experts have been successful in proposing and supporting complex

other critical substance-related end-points at member state or EU level. We have also successfully used our knowledge in clinical toxicology and epidemiology to support several of our clients in court cases.

REACH OR Services

CEHTRA provides a REACH only representative (OR) service via its subsidiary company LTS REACH-OR SAS.

Authorisation services

authorisation and created a joint venture, ChemAdvocacy, to provide a full service including socio-economic analysis.


2001 Company established

2004

2008

2008

2009 Start of the Indian Joint venture

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2011

2012 Opening of ChemAdvocacy

ACCREDITATIONS

11 ERTs one IOB/UKEMS GT two Chartered chemists (MRSC)

PARTNERS

LTS REACH OR, ChemService GmbH, ECOonline, NCEC, ERM

CLIENTS

companies, plant protection industry, biocides, veterinary products, pharmaceuticals.

TESTIMONIALS

“CEHTRA helped us to submit ten 2010 REACH dossiers as lead registrant. We greatly appreciated their expertise in toxicology and ecotoxicology in particular in cases where the protocols of standard studies needed to be adapted to the test substances. In fact many of our

properties. We have decided to use them again and are once more

CASE STUDY 1: SEA dossier for biocide

The Biocides Products Regulation requires a socio-economic analysis of substances which may be subject to substitution (CMR, PBT endocrine disruptors, etc). ChemAdvocacy has been awarded a study on a national

products, inspired by the available guidance (REACH, etc), and we have presented our proposal to the French Competent Authorities, with

CASE STUDY 2: In silico predictions a priority

In silico methodologies to replace experimental studies are becoming a hot topic, especially with the 2018 REACH deadline approaching. CEHTRA has heavily invested in an in silico toolbox we call i-SAFERAT on the basis of high quality predictions based on best quality experimental data where necessary coupled with a read-across and weight-of-evidence approach. Our aim is to cut the cost of REACH substance submissions for lower tonnage substances without compromising data quality.

STAFF SELECTION

Peter Jenkinson − PhD, GT – CEO and Director of UK O"ce

Peter Jenkinson has a PhD in reproductive toxicology and over 30 years' experience in the CRO industry specialising in genetic toxicology. Latterly he was the director of the Chemical Business Unit at Harlan Laboratories with a primary role of developing the REACH services of the company. In

expert toxicology advice, particularly for study monitoring and data interpretation.

Paul Thomas PhD, ERT − Director and Manager of Lyon O"ce

Paul Thomas has a PhD in aquatic ecotoxicology and 17 years' experience with industrial chemicals, agrochemicals and biocides gained at CIT, ATOFINA and AkzoNobel. He joined CEHTRA in 2008 as director of CEHTRA Lyon specialising in REACH-related services and is manager of the CEHTRA ecotoxicology team. Paul has contributed strongly to numerous successful registrations including several fragrance molecules.

Philippe Adrian PhD − General Manager of Brussels O"ce

Philippe Adrian has a PhD in soil science and over 20 years' experience with agrochemicals and biocides. Prior to his current position he worked as research scientist in Germany. Later he worked at CNRS in France and then Rhone-Poulenc Agrochimie and FMC. In 2001 he created CEHTRA with Pierre-Gerard Pontal and manages the environmental fate team. He has developed modelling expertise for pesticides according to current models, as well as biocides using relevant TGDs.

Nathalie Ledirac PhD, ERT – R&D Director

Nathalie has a PhD in cellular and molecular aspect of biology and 13 years’ experience with agrochemicals. She worked as a research scientist at INRA in France on pesticide toxicity and has also participated in private research on drugs for pharmaceutical industries (HMR, Galderma).She joined CEHTRA in 2006 as a regulatory toxicologist and provides expert toxicology advice in study monitoring and data interpretation. She develops close partnerships with private and academic research

projects (research programmes, publications, model development for pesticides, accreditation, etc).

Pierre-Gérard Pontal MD, ERT− President of CEHTRA

Pierre-Gérard Pontal is a medical doctor and has 27 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 EUROPOEM group. He is a recognised expert for operator exposure, having conducted more than 20 worker exposure studies.

Michel Guilhem MSc – Director, Business development

Michel has three master’s degrees in chemical, environmental and safety engineering and over 30 years of experience, from R&D and regulatory affairs project management at Dow Chemical to management positions in world-class consultancies (ERM, ENVIRON) and in the pharmaceutical industry EHS services (Janssen-Cilag). He joined CEHTRA in 2009 and is in charge of OH&S and product stewardship services.

Charles Alarcon PhD, CIH – Industrial Hygienist

Charles has a PhD in Geochemistry and over 12 years' experience as

CEHTRA in 2009 developing exposure scenario in REACH dossiers and e-SDS. Through audits and other site studies, and using currents models in risk assessment, he has gained a large experience in many industrial sector activities and acquired a unique understanding of health and safety industrial culture.

Jason Nugent MSc – Director of CEHTRA NA

Jason is a highly experienced chemical registration specialist who has worked within the North American chemical industry for more than 15 years. Over the course of his career, Jason has managed and participated in the preparation of more than 400 chemical registrations in Canada, USA, the European Union, China, Australia, and Japan. In recent years he has been heavily involved in assisting North American companies to prepare for and comply with REACH.

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CONTACTS

Website www.centroreach.it


Head o"ce Centro Reach Srl, Via Giovanni da Procida, 11, 20149 Milan, Italy

Tel/ Fax +39 02 8724 5901/ +39 02 3456 5631

Contact Ralf Knauf

Directors Bruno Brianzoli

Sergio Treichler

Ownership Private Company

Locations Milan

Founded 2007

OVERVIEW

Centro Reach was founded on 20 February 2007 on the initiative of Federchimica and Assolombarda. Federchimica, the Italian Chemical Industry Association, controls 53.3 % of the capital stock, the remaining part is held by ten other industrial associations. The company mission is

and downstream users, helping them meet the REACH, CLP and other regulations concerned with the management of chemicals and safety in the workplace. Centro Reach assists chemical manufacturers and importers in the dossier preparation for substance registration either on an individual basis or in consortia and has participated or is participating in almost 20 consortia working on registrations for 2010 and 2013.

training courses, in-company consultancy, legal assistance for chemical regulations, regulatory services for non-EU countries thanks to our

VITAL STATISTICS 2012

Turnover, group ca €1m

Turnover, chemical service provision ca €0.7m

1

No of countries represented All of the EU

Staff, group 6

Staff, chemical service provision 3 (plus wide expert network)



60%

Representation

& management15%

Information5%

Legal5%

Training15%

SERVICES PROVIDED

REACH consultancy

Centro Reach provides in-company support on the REACH Regulation, including impact assessment and liabilities, product portfolio analysis and subsequent REACH compliance actions, supply chain communication assessment up and down, helpdesk consultancy.

REACH services

Centro Reach offers skills in management of registration dossier preparation for individual lead registrants, and/or among consortia, and for joint submission applicants. We provide assistance and information for registration requirements, IUCLID 5 compilation and registration submission, letter of access management, Sief management and late pre-registrations. Consortium management in technical, administration, legal and coordination

CLP and SDS management

Regulation, safety data sheet assistance and management for EU territory as well as extra-EU areas are also basic activities of Centro Reach.

Other chemical regulatory needs

Centro Reach and its network is able to support companies in the

Europe. Our consultants have proven experience in submitting chemical

Korea, India and Australia as well as countries like Turkey, Switzerland

and safety data sheet management is also among the services we offer.

Training courses

Since the very beginning training on REACH and CLP regulation has been a core activity of Centro Reach. Between 2007-2012 more than 3,000 participants have attended our training sessions which are also


2007 Founded by Federchimica (Association of Italian Chemical Industry) and Assolombarda – the largest regional enterprise organisation in Italy.

2008 A further ten industrial associations belonging to the

Partnership with Reach Centrum in Brussels begins

2009REACH registration studies. Set-up of expert network and cooperation agreementsInvolvement in more than 15 national and EU consortia Intensive training activities involving almost 500 professionals, both in-house and in-company courses

2010 Individual registrations for 95 companies successfully submitted. Management and involvement in 20 consortia

labelling. Service for SDS management launched. CLP

2011 Centro Reach served around 310 customers, in large part not Federchimica members about 40% of them being downstream users. More than 50 training course sessions and two national workshops with over 150 participants.Centro Reach supports Italian University Master Reach activities. Cooperation with Reach Global Services (RGS) for

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2012 Centro Reach supported again around 300 customers, many of them not Federchimica members. More than 40 training course sessions and one national workshop with over 120 participants were organised.Centro Reach supports Italian University Master Reach activities and published an updated version of its Inventory

studies.

ACCREDITATIONS

PARTNERS

Reach Centrum, Certiquality, Mario Negri Institute, Assoservizi, Intertek, DGM Italia, Field Fisher Waterhouse, PriceWaterhouseCoopers, Lenviros, ARPA Em Romagna, others

CLIENTS

Mainly SMEs but also companies like MAPEI, BASF Italia, Bracco, Polynt,Clariant Italia, DSM Italia, Polimeri Europa, others as well as non-Italian customers

CASE STUDY 1: EU Project ORCHESTRA

Centro Reach is working in partnership with the M Negri Institute and other Italian and European subjects in the European Union's Seventh Framework Programme “Organising dissemination on results of projects on chemical evaluation, spreading techniques for risk assessment (ORCHESTRA)". Non testing methods (NTM) such as in-silico methods will be very important to 2018 registrations, which will see mostly SMEs involved in the registration of more than 20,000 substances.ORCHESTRA addresses the strategic questions concerned with a broad, systematic dissemination and exploitation of the research

exploitation measures for the different stakeholders – including regulators,

Dissemination towards regulators of all EU member and associated states is ongoing. The project has been concluded at the end of 2012. Further information can be found on the ORCHESTRA dedicated website

CASE STUDY 2: Titaniumdioxide ( TiO2 ) study in nanosize under REACH

Centro Reach in cooperation with ARPA E Romagna has simulated a IUCLID 5 dossier for a volume up to ten tons/year covering the

showing that REACH regulation can handle nanomaterials, and that

are automatically more toxic than those in bulk. Further work under this project is in progress. The study was presented during NANOTECHITALY 2011 in November 2011.

STAFF SELECTION

Bruno Brianzoli – Coordinator

In 1964, after graduating in chemical engineering at Politecnico di Milano, Bruno joined the multinational group Solvay, where he worked until January 2007. As managing director of the Solvay Group from 1997 to 1999 he was in charge of managing the business of the Solvay Sodi Company (the production of sodium carbonate) in Bulgaria. From 2000 2007 he was general manager of the Solvay.

Sergio Treichler – General Director

for the World Bank in Uganda, Ethiopia and Paraguay. Sergio has been

Programme Council and HSE, Logistics and Energy Programme Council. He is a member of the board of directors of Certiquality Srl and an advisor of ICS-UNIDO.

Ralf Knauf – Business Development Manager

AgChem division, where for more than 25 years he was responsible for international business and regulatory coordination in several different Italian AgChem companies. In 2007 he joined Federchimica's product

related regulations. Since 2009 he has been heavily involved in Centro Reach, coordinating training and consortia activities.

Stefano Arpisella – Technical Manager

Graduated in chemistry and pharmaceutical technologies. After his activity in R&S at Università di Ferrara, he worked in the Federchimica technical

practical experience in REACH thanks to more than 300 in-company activities and visits.

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CONTACTS

Website www.chemsafe-consulting.com


Head o"ce Chemsafe Srl, Via Ribes, 5, 10010 Colleretto Giacosa (TO), Italy

Tel +39 0125 538888

Fax +39 0125 538475

Contact José V Cantavella Cabedo

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


Locations Italy, Qatar

Founded 2001

OVERVIEW

and customer care attitude.


Turnover, group €1.7m

Turnover, chemical service provision €1.7m

2


Staff, group 12




45%

Representation

& management20%

Information10%

Laboratory5%

IT & software5%

Legal10%

Training5%

GLOBAL OFFICES

Chemsafe Srl, Colleretto Giacosa (To), ItalyChemsafe International, Doha, Qatar

SERVICES PROVIDED

World regulatory a#airs consulting

Chemsafe can assist its clients with a great range of regulatory affairs services around the world ranging from the legal side to all the technical matters in order to comply with international and national chemical control legislation.Chemsafe technical staff have long experience in all aspects of REACH. Our team has prepared a large number of registration dossiers and chemical safety reports (CSR) and have provided expert advice on

management and Sief and consortia management.

REACH and CLP/GHS

Chemsafe provides its clients with strategic, legal and technical support in order to comply with REACH and CLP/ GHS. Our technical support includes, for example, preparation of full registration dossiers (as lead or joint submissions), data gap analysis, review and analysis of physico-chemical, environmental fate. Ecotoxicology and toxicological data. CSA/CSR preparation, human and environmental exposure scenarios (ES) and risk assessment. Application of alternative strategies to testing such as read across and QSARs.IUCLID 5 preparation and submission to ECHA and pre/post dossier submission contact with the authorities.

Sief and consortia management

We can help our clients with a full/partial Sief and/or consortia management system such as preparation of Sief and consortium agreements, letters of access, data sharing, maintaining contact list, archiving, billing and all the daily aspects of running a successful Sief or consortia.

Only representative (OR) and third party representative (TPR)

Since 2008 Chemsafe has been acting as only representative for non

obligations as prescribed in Article 8 of REACH Regulation. Non-EU companies must either rely on their importers, or retain a person in the EU to represent their interests, these are the “only representatives” (ORs). Appointing your own OR gives your company business freedom and security as you will have regulatory independence from other

provides expertise and third-party review for submissions to the European Chemical Agency (ECHA) and provides representation to both substance information and exchange forums (Siefs) and consortia.

types of companies coming from USA, Switzerland, South America, Middle East and Far East countries.Furthermore we can act as a third party representative (TPR) for companies not wanting to disclose their identity.

Legal advice

We advise our clients on legal aspects of chemical trade around the world and related chemical control regulations.

Biocides and agrochemicals

Our team can prepare and submit dossiers for authorisation of active substances and for registration of formulated products. Also, we can do the technical equivalence for active substances. We coordinate the regulatory strategy with the national and/or international authorities in order to deliver a successful dossier for biocidal products and for agrochemicals.

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Cosmetics

general regulatory support for cosmetic products. competent person designation. data evaluation, data gap analysis, read-across methodology, in silico

method application, testing programme design, and study monitoring/coordination.

administrative activity, including robust study summaries and substance information sheet (SIS) with ingredient evaluation.

Petrochemicals

We advise our clients on legal aspects of chemical trade around the world and related chemical control regulations.


2001 Start-up in Italy as “a one man” company

2004 Staff increase up to four people

2007 REACH services offered

2009 Biocides and agrochemicals group creation

2010 Technical consortia advisers for three international consortia. Staff increase up to ten people

2011 Petrochemicals derivatives, wastes, cosmetics and pharmaceuticals consortia management. Staff increase to 12 people.

2012

ACCREDITATIONS

Chemsafe is a full member of ORO, the Only Representatives Organisation based in Belgium.Chemsafe is also a full member of the Industrial Union of Turin, Italy.

PARTNERS

Chemsafe is 100% privately owned.

CLIENTS

Our clients are manufacturers and importers involved in the market sectors of: chemicals, pharmaceuticals, agrochemicals, biocides, cosmetics, food, medical devices, nanomaterials and petrochemicals from around the world. They vary from multinational companies to SMEs and authorities.

TESTIMONIALS

Any persons or companies requesting testimonials or references will be provided with them upon individual written request.

CASE STUDY 1: REACH testing progamme

Working together with a global supplier of chemicals Chemsafe devised a detailed and comprehensive testing/study programme for REACH registration of a wide range of products.

CASE STUDY 2: REACH dossier work

Our experience in dossier work is over 120 registration dossiers for Phase of REACH, including lead and member dossiers. Some of these dossier were UVCB substances. An important number of CSR and hundreds of safety and extended safety data sheets had been prepared by our team.

CASE STUDY 3: Legal case

Last year Chemsafe successfully settled a legal case with the European authorities, on behalf of one of our clients.

STAFF SELECTION

Dr Antonio Conto – Managing Director

Biology degree, European Registered Toxicologist (ERT).Founder of Chemsafe

Lara De Luca – Head of Technical Department

Industrial chemist, with more than 11 years of experience. Risk assessment, exposure scenarios, CSR/CSA.

Dr José V Cantavella Cabedo – Head of Legal Department

Attorney, JD in environmental law, with more than 17 years of experienceEnvironmental and chemical law

Francesca Fasano – Head of Biocides Department

Industrial chemist, with more than 10 years of experience.Biocides, agrochemicals and ecotoxicology.

Elena Meriano – Head of REACH Registration group

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

Loredana Savin – Head of CLP/GHS group

Biologist, with more than 11 years of experience

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CONTACTS

Website www.chemservice-group.com


Head o"ces Chemservice GmbH /Chemservice S.A.

Von-Steuben-Str 13 /5, an de Laengten

D-67549 Worms, Germany / L-6776 Grevenmacher, Luxembourg

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

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

Contacts Karl-Heinz Reis /Dr Günter Spang

Directors Dr Dieter Drohmann, Managing DirectorKarl-Heinz Reis, Director Global Regulatory AffairsDr Günter Spang, Director Toxicology and Risk AssessmentThomas Schäfer, Director Data and System Services

Ownership Privately owned group of companies

Locations Germany, Luxembourg, Korea, Turkey, France

Founded 2007

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

Different in-house disciplines (chemists, chemical engineers, toxicologists, env scientists, agronomists, biologists, veterinarian, regulatory specialists etc) enables broad issue addressing.


Turnover, group c €3m

Turnover, chemical service provision c €3m

7


Staff, group 30




45%

Representation

& management20%

Information15%

IT & software10%

Training5%

Other5%

GLOBAL OFFICES

Chemservice SA, Grevenmacher, LuxembourgChemservice GmbH, Worms, GermanyChemservice Asia Co Ltd, Seoul, KoreaChemservice Ltd Sti, Bodrum/Mugla, TurkeyChemservice EHNS GmbH, Worms, GermanyConsortia Management GmbH, Worms, GermanyChemCehtra SAS, Bordeaux, FranceChemAdvocacy SA, Grevenmacher, Luxembourg

SERVICES PROVIDED

Global regulatory a#airs consulting

Chemservice provides a broad range of services designed to assist clients in preparing for and in complying with international and national chemical control legislation. The application range for chemistry is extensive. Therefore, chemical control legislation is comprehensive in order to assure product safety, producer liability and consumer and environmental protection to regulate the

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

REACH and GHS/CLP

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

Through our new legal entity, ChemAdvocacy, we provide REACH authorisation services (including SEA), advocacy and product stewardship consulting.

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

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.

Only representative and third party representative

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.


2007 Start-up in Luxembourg

2008

2009 Launch of Consortia Management GmbH as full service provider for consortia and Sief management

2010

2011 Launch of Chemservice EHNS

2011

2012

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ACCREDITATIONS

We are a member of ORO, the Only Representatives Organisation in Brussels and comply with the quality standards of ORO. Dr Drohmann is chairing ORO as president.

PARTNERS

Our partner companies can be viewed 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

nominations to the inventory in Taiwan. For one client we supplied a global inventory strategy for a new polymer, and for multiple clients we

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

chain the manufacturer of a substance usually does not know through

substances is being imported into the EU. It is an essential business secret (CBI) of traders or formulators what the components of their products and who their suppliers and customers are. Neither the non-

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.

CASE STUDY 3: REACH dossier work

Chemservice has experience with around 200 Tier 1 and 2 REACH

number of new substance registrations (non-phase-ins), inquiry dossiers, PPORDS, chemical safety reports and extended safety data sheets were successfully completed. Furthermore, we have acted on behalf of our

STAFF SELECTION

Dr Dieter Drohmann – Managing Director

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

manager

Dr Neslihan Altinbas – Managing Director of Chemservice Ltd Sti, Turkey

PhD in chemistry >10 < 15 years of experience in GLP and GMP quality assurance

nanoparticles

Dr Günter Spang – Director Toxicology and Risk Assessment

PhD in agronomy >15 < 20 years of experience in regulatory affairs consulting,

including risk assessments and dossier preparation

Natalia Jansen-Bouriatchenko – Regulatory A#airs Advisor (Ukrainian)

master in biochemistry >15 < 20 years of experience in analytical and ecological chemistry,

ecotoxicology and toxicology

Karl-Heinz Reis – Director Global Regulatory A#airs

master in biology

assessments and CRO study director

Thomas Schaefer – Director Data and System Services

IT specialist and SDS expert >20 years of experience in IT and data systems

Yong Jiang – Regulatory A#airs Advisor (Chinese)

master in chemistry eight years of experience as chemical specialist, consultant and

compliance manager

Ah-Reum Seo – Regulatory A#airs Advisor (Korean)

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

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CONTACTS

Website www.chemservice.it


Head o"ce Via Fratelli Beltrami 15, 20026 Novate Milanese (MI), Italy

Tel +39 2 3569961

Fax +39 2 38201446

Contact Cristina Marchiori, Sales Manager

Directors Giacomo Ravetta, Managing Director


Locations Novate Milanese (MI), Italy

Founded 1992

OVERVIEW

ChemService Srl Controlli e Ricerche is a contract research organisation (CRO) providing GLP testing and regulatory services for the plant protection, biocidal, veterinary, industrial chemical and consumer product industries. Our mission is to increase our customer’s competitiveness

chemistry, physico-chemistry and ecotoxicology, coupled with a deep knowledge of current regulatory framework and a strong attention to long-term trends makes ChemService Srl Controlli e Ricerche the right partner in regulatory environment. ChemService Srl Controlli e Ricerche collaborates with EU authorities, being selected by Efsa for the assistance

in 2008 (EuropeAid/123060/D/SUP/RO) for building an ecotoxicological laboratory in Romania.


Turnover, group €5m


2


Staff, group 50




35%

Laboratory60%

Training5%

GLOBAL OFFICES

ChemService Srl Controlli e Ricerche – Via Fratelli Beltrami 1520026 Novate Milanese (MI), ItalyChemService agent in China: Ms Ina Cui IGW First Chemical Co Ltd –Suite 352, 3rd Floor, OG Plaza, Building C, No 327 Tian Yao Qiao Road, Xuhui District, Shanghai, 200030, PR China.

SERVICES PROVIDED

Ecotoxicology and biodegradability testing. Analytical methods development and validation, physico-chemistry testing

Short and long term ecotoxicological tests on aquatic (alga, daphnia,

soil microorganisms (OECD 216, 217), aquatic plants (OECD 221 on lemna sp). Biodegradability testing (OECD 301). Tests on terrestrial plants

(FELS, FET). Development and validation of analytical methods for active substances and impurities, 5-batch analysis, physico-chemical testing, spectral analysis (UV, VIS, IR, MS, NMR).

REACH and CLP

Analytical, physico-chemical, ecotoxicological testing and consultancy services for CLP and REACH with data gap analysis, review of existing data and ad hoc testing strategies. Preparation of registration dossiers (lead/joint submissions), CSA/CSR (Chesar), human and environmental exposure scenarios and risk assessment, eSDS. Use of alternative strategies E F G E H I J , in silico (OECD Toolbox, CAESAR, ToxTree, Lazar,

preparation and submission to ECHA. Contacts with ECHA during pre/post (follow-up) dossiers submission.

Plant protection products (PPPs) and biocides

Testing and preparation of dossiers for authorisation of active substances and for registration of formulated products (dRR format). Five-batch analysis in accordance with EU, US, Latin America (Brazil, Argentina) requirements and technical equivalence dossiers of active substances. Data gap analysis and testing strategies. Human (operator, worker, bystander, consumer) and environmental risk assessment, e-fate

trials and preparation of biological assessment dossiers-BAD-for PPP.

consultancy for non-standard studies (operator exposure, dislodgeable residues, radio-labelled material). Use of IUCLID (for PPP), CADDY (for biocides). Dossier submission and follow-up with authorities.


1992 ChemService Srl incorporated as international contract research organisation in Milan, Italy.

1992 Achievement of ISO/IEC 17025 accreditation

1995 Achievement of OECD GLP compliance

2003 Beginning of regulatory services (dossier department)

2004 Erecting of new laboratories (1400 m2) and start-up of GLP ecotoxicological testing facility

2008 Start of collaboration with Efsa and EU authorities

2011 Implementation of tests on aquatic plants (lemna) and soil microorganisms.

2012test), tests on non-target terrestrial plants and non-target arthropods.

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ACCREDITATIONS

Good Laboratory Practice (GLP) and ISO/IEC 17025:2005

PARTNERS

IGW First Chemical Co Ltd , Shanghai – PRC acts as agent of

target of the venture is to handle the increasing demand of GLP testing services from Chinese customers willing to enter EU, Brazil, Argentina and US markets and to advise Chinese companies on global registration requirements.

CLIENTS

Our clients are involved in the market sectors of: agrochemicals, biocides, chemicals, veterinary products, food, medical device and antimicrobial chemicals

TESTIMONIALS

“ChemService Srl Controlli e Ricerche has provided high quality regulatory and testing services to our company for over ten years, having prepared more than ten registration dossiers and having conducted more than 200 physico-chemical and ecotoxicological GLP tests on our agrochemical products” – Makhtheshim Agan Italia Srl

CASE STUDY 1: Inclusion of sulphur in Annex I (91/414/EEC)

ChemService successfully stewarded a fourth list substance, sulphur, onto Annex I inclusion in 2010 after several years of work. Sulphur is a widespread substance that has been used in agriculture for a long

distinguishing the natural background level in the environment, gave rise

study and tests on sediment – dwelling organisms with radiolabelled

several different companies were interested in supporting it in the EU review process. Therefore, ChemService put together a taskforce of 12 companies from all over the world, which was headed by an Italian company and managed from ChemService across the revision process. The technical and management experience of ChemService in coordinating different facilities and the need of the task force members for a common goal was crucial to the success of the project.

CASE STUDY 2: Successful chemical equivalence dossier for an Annex I listed agrochemical

Finchimica, a SME manufacturer of agrochemicals, decided in mid 2010 to submit to the UK chemicals regulation directorate (CRD) a chemical equivalence dossier for Pendimethalin technical, a selective herbicide included in Annex I of Directive 91/414/EEC whose data protection

the newcomers and gain immediate market shares. In a three months timeframe, ChemService performed a preliminary screening of the

the level of quality needed in order to match the technical product

quality and submitted the relevant chemical equivalence dossier to CRD using the fast track option. Non testing data (QSAR and E F G E H I J ) were included in the dossier in order to support the toxicological equivalence of Finchimica’s towards registered source. The dossier was accepted

source of Technical Pendimethalin in Europe after the originator.

CASE STUDY 3: Assistance to the Efsa scientific units on toxicology and ecotoxicology

Since May 2009 ChemService Srl Controlli e Ricerche has been part

toxicology and ecotoxicology (Multiple Framework Service Contract CT/EFSA/AMU/2009/07, budget available €1m) and has been awarded two

in a IUCLID 5 database. In October 2012 ChemService Srl Controlli e

information within the public domain on the toxicity of chromium and nickel in experimental animals and humans (NP.EFSA.CONTAM.2012.01, budget €60,000).

STAFF SELECTION

Giacomo Ravetta – Managing Director

Masters degree in industrial chemistry, 20+ years’ experience in project management in the EU and abroad (China, India, USA), as head of R&D teams for the development of agrochemicals products. He developed a broad network in the global community of chemicals production and legislation and he has a strong focus on customers’ business. Since 2009 he has been managing director of Chemservice Srl Controlli e Ricerche where he has brought his sound management and business oriented background.

Dr Valeria Croce – Head of Regulatory Services

Masters degree in biology and PhD in environmental sciences, ten years’

assessment. Head of the Dossier department she coordinates a team of

ranging from chemistry, agronomy, biology (toxicology/ecotoxicology), e-fate modelling, environmental sciences. Since 2008 she has been involved, as an ecotoxicology and regulatory expert, in EU and EFSA projects.

Chiara Neri – Head of Ecotoxicological Testing Unit

Masters degree in biology, specialised in ecotoxicology and holder of a European scholarship from 2004 to 2006 for a project on endocrine disruption. In 2006 she joined ChemService Srl as study director for aquatic and terrestrial ecotoxicological studies. Currently head of

been involved, as an ecotoxicology expert, in EU and Efsa projects.

Stefano Garofani – Head of Analytical Studies Unit

Masters degree in chemistry, 20+ years’ experience in development and validation of analytical methods, GLP physico-chemical studies, residue

more than 3,000 GLP analytical studies from 2005-2011 (600+ in 2012).

Dr Carlotta Casalegno – Head of Regulatory and Development

Masters degree in biology and PhD in naturalistic and environmental sciences, from 2000 to 2005 she was involved in basic environmental research and EU projects management. In 2006 she joined ChemService Srl as regulatory toxicologist and human risk assessor for PPPs, biocides and REACH. In 2010 she worked for an international ONG (ECEAE-BUAV) commenting on testing proposals for REACH Annex IX and X substances and was appointed as ONG representative to support the use of alternatives during ECHA committee (RAC, MSC) meetings in Helsinki. She came back to ChemService in 2011 as head of Regulatory and Development. Since 2009 she has been involved, as a toxicology and regulatory expert, in Efsa projects.

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CONTACTS

Website www.chilworth.co.uk


Head o"ce Beta House, Southampton Science Park, Southampton, SO16 7NS, UK

Tel +44 (0)23 8076 0722

Fax +44 (0)23 8076 7866

Contact Dr David Firth, Mr Daniel Baker, Mr Mike Weaver

Directors DEKRA Explosion & Process Safety Business Line

Ownership Wholly owned subsidiary of DEKRA SE

Locations UK, USA, India, Germany, France, Spain, Benelux, Scandinavia, Eastern Europe, Japan, Brazil, Northern and Southern Africa, Israel, Japan and China

Founded 1925 (DEKRA)

OVERVIEW

Chilworth – a DEKRA company is the UK’s leading provider of expert

international consulting base, we employ doctorate engineering and

Our GLP/ ISO17025 compliant laboratories offer industrial explosion hazard testing, chemical reaction hazards evaluation and electrostatic testing, as well as a full range of regulatory testing services for REACH, SDS, CLP, UN and other transport applications. Our electrostatic services

problems and electrostatic ignition hazards.

outside the EU, assisting with portfolio optimisation, representing the company in consortia, performing testing and preparing registration dossiers.We have unrivalled expertise in process safety, laboratory testing, consulting, training and instruments with a truly global perspective. Wherever you are, we are close at hand!




30+

No of countries represented 80+

Staff, group 25,000

Staff, chemical service provision 500+



30%

Representation

& management5%

Laboratory50%

Training5%

Other10%

GLOBAL OFFICES

DEKRA Industrial GmbH Handwerkstr. 15 D-70565 Stuttgart Germany

SERVICES PROVIDED

process safety consultancy

chemical reaction hazards material testing laboratory testing regulatory testing process safety training


1986 Foundation of Chilworth Technology Ltd

1991 Chilworth Technology Inc established in USA

1995 Received Good Laboratory Practice accreditation

2001 IChemE safety and environmental awards winner

2003Italy and India

2008 Chilworth acquires Spanish facility

2009 Acquisition of JCI, the UK’s electrostatic measurement experts

2011 Wholly acquired by DEKRA, Europe’s leading safety provider

ACCREDITATIONS

CLIENTS

Chilworth – a DEKRA company provides consultancy and testing services

be named). We work with a number of multi-site blue chip clients in a variety of processing industries including organisations operating in the petrochemical, chemical, pharmaceutical, food, drink, paper and packaging, plastics and rubber, agrochemical, automotive and aerospace and power generation sectors.

TESTIMONIALS

Testimonials can be provided on request.

CASE STUDY 1:

Working closely with a global supplier of metals and minerals, Chilworth – a DEKRA company devised and delivered a comprehensive testing programme for CLP registration of a range of products and formulations.

CASE STUDY 2:

Supporting a global manufacturer and marketer of differentiated chemicals, Chilworth – a DEKRA company has tailored an extensive portfolio of tests of a diverse selection of materials under both REACH and CLP criteria.

CASE STUDY 3:

Cooperating with a number of service providers from Europe to the Far East, Chilworth – a DEKRA company has carried out a range of physico-chemical properties testing for REACH registration of products across a broad range of applications, while acting as study managers for a range of toxicology and exotoxicology test programmes.

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STAFF SELECTION

Dr Stephen Rowe – Managing Director

Managing director – with more than 20 years’ experience in process safety – Steve has particular expertise in chemical reaction hazards testing, exothermic reaction hazards consulting and dust, gas and vapour

Dr David Firth – Business Development and Marketing Manager

Business development and marketing manager – covering all areas of process safety – David has many years of experience working with customers in a variety of industries including chemicals, pharmaceuticals, agrochemicals, paint, polymers, adhesives, electronics, fuel additives,

Mr Michael Weaver – Principal Specialist Process Safety

Principal specialist process safety – bringing more than two decades of testing and consultancy experience to the team – Mike is particularly involved in devising and managing regulatory testing programmes for our customers across the full range of services as well as gas/ vapour and dust explosions.

Mr Daniel Baker – Safety Testing Specialist

Safety testing specialist – responsible for the management of our laboratories – Daniel has more than a decade of experience in testing and project management and brings a wealth of knowledge on regulatory

Dr Andrew Starkie – Principal Process Safety Specialist

Principal process safety specialist – managing our GLP programme and with over a quarter of a century of experience in the sphere of process safety testing and consultancy – Andy has particular expertise in the handling and testing of hazardous and sensitive materials and chemical reaction hazards.

Mr Jochen Dettke – Head of REACH RegistrationTeam in Germany

An expert at DEKRA Industrial GmbH – based in Stuttgart – Jochen heads up the REACH registration team in Germany, providing consultancy and testing advice from portfolio optimisation, through data acquisition and into dossier preparation.

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CONTACTS

Website www.csregulatory.com


Head o"ce The Old Courthouse, St. Peters Churchyard, Derby, UK

Tel +44 (0)1332 380692

Fax +44 (0)1332 380692

Contact Mr Steven Green

Directors Mr Steven Green

Mr Craig Deegan


Locations

Founded 2007

OVERVIEW

CS Regulatory Ltd 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 45 years of

the expertise to assist you with whatever global chemical regulation requirements you may have. With a network of strategic partnerships throughout the globe we can assist with EU registration for REACH

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.


Turnover, group -


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Staff, group 7




65%

Representation

& management20%

Information10%

Training5%

GLOBAL OFFICES

Not applicable. CS Regulatory has a global network of independent expert consultants for global regulatory compliance.

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, conducting a number of QSAR assessments in-house as well as literature searches and reviews to avoid new testing, and prepare the regulatory compliance documents.

scenarios and risk characterisation), production of CLP compliant MSDS (including extended format), submission to and liaison with ECHA.

Worldwide notification of chemicals

network of independent regulatory experts to ensure that we are in possession of the very latest expert information.

corresponding with the appropriate regulatory authority directly from the UK or with the assistance of local expert consultants where necessary.

Representative and support services

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

representative, CS Regulatory can work in the Sief and consortium on behalf of our client, representing their best interests, minimising our

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

in silico modelling to

reports for data-waiving and IUPAC name derivation.


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

PARTNERS

CiTox LAB preferred partner

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CLIENTS

Regulatory does not release the identity of its clients. CS Regulatory works with and assists a broad range of suppliers from international blue chip companies and household names to small and medium enterprises with their regulatory requirements.

TESTIMONIALS

CASE STUDY 1: REACH registration by read across

CS Regulatory has been working with suppliers of related metal compounds. With detailed data for the base metals available CS Regulatory designed a strategy for REACH compliance based on sound

and QSAR assessment to reduce the need for animal testing and

CASE STUDY 2: REACH compliance as OR

CS Regulatory accepted the transfer of OR duties for a substance registered in the EU as an isolated intermediate. On conducting due diligence, however, it became apparent that there was a need to support non-intermediate uses, albeit at lower tonnage bands. Based on OSOR principles advocated by ECHA and expressed within the guidance, CS Regulatory accepted the role of lead registrant to undertake the necessary updates to the dossier and produce suitable chemical safety assessment to ensure the ongoing compliance for the non EU supplier and downstream users.

CASE STUDY 3: DU compliance

CS Regulatory assisted an international supplier of armoury and projectile products with their compliance requirements. The client had dual roles as both a direct importer but also as a downstream user, and was unsure of their compliance position. In seeking to ensure compliance with all EU regulations, CS Regulatory was employed to assess the chemical substances and products and articles from all suppliers to review the REACH status, SVHC content and CLP compliance with a view to

of site audits and review of the various supply chains and associated documentation, CS Regulatory was able to determine the status of products and provide recommendations for ensuring compliance plus suitable documentation for use with downstream users. Assistance with

CASE STUDY 4: Biocidal product review

CS Regulatory was employed by a non-EU organisation to assess the propensity of some niche chemical products for use as potential biocides. Utilising an approach with the member state authorities, it was possible to determine whether the required substances could possibly be evaluated as such (or had been) along with provision of budgets to allow for determination of viability of supporting such products through the biocide registration process. This allowed the client to quickly determine the implications of supporting such products within the EU.

STAFF SELECTION

Steven Green − Director

Over a period of 20 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 SEPA/MEP. Mr Green is an expert in regulatory strategy with an almost unique blend of

essential to compliance with REACH.

Craig Deegan − Director

affairs and health, safety and environmental consultancy for 18 years, incorporating development of testing strategies based on risk hierarchy,

best value for clients with an interest in REACH, CLP and worldwide registration requirements. With detailed experience of the practical application of risk management in the industrial environment, Mr Deegan offers experience and knowledge that many regulatory consultancies lack.

Tracey Thomas – Regulatory Specialist

consultancy for 15 years. Her work within CS Regulatory incorporates

registration dossier preparation, analysing study data information (including trials data) and preparing relevant submissions to regulatory authorities. Ms Thomas also acts as an advisor on CLP issues, preparing evaluations of CLP impact and advising organisations of the viability of their products from a CLP perspective.

Claire Lowe – Regulatory A#airs O"cer

Mrs Lowe has been preparing regulatory documentation for ten 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 clients with regulatory compliance

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Website www.analytik.currenta.de


Head o"ce CHEMPARK, Building K 46, 51368 Leverkusen, Germany

Tel +49 214 30 33777

Fax +49 214 30 61209

Contact Tobias Hedwig

Directors Dr Günter Hilken, Managing Director

Dr Joachim Waldi, Managing Director

Dr Hans Richter, Head of Analytics

Ownership Joint Venture (Bayer AG, Lanxess AG)

Locations Germany

Founded 2008 (for former organisational structure please see Corporate Developments & Achievements)

OVERVIEW

CURRENTA offers an extensive range of analytical services for research, development and production in industry. Companies worldwide rely on the skills of our experts and entrust their samples to our laboratories. Methods range from standardised quality inspections to demanding structural analyses. We help solve all your analytical tasks through a wide range of methods, cutting-edge laboratory technology, the highest quality standards and professional consulting services (REACH).


Turnover, group -


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Staff, group 3.300




35%

Representation

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10%Information5%

Laboratory45%

Training3%

Other2%

GLOBAL OFFICES

CHEMPARK Leverkusen, GermanyCHEMPARK Dormagen, GermanyCHEMPARK Uerdingen, Germany

SERVICES PROVIDED

All services of the REACH regulation in the broadest sense, including: strategic REACH consulting impact analysis

literature searches

recommendation of an intelligent test strategy (category approach, waiving, read-across, QSAR calculations)

planning and performance of studies (physico-chemical and

toxicological endpoints*) preparation of technical dossiers and chemical safety reports performance of exposure estimates and risk assessments PBT and vPvB assessments consulting on SVHC issues submission of registration dossiers and communication with ECHA/

national authorities active product defence, including the evaluation and authorisation

process representation in Siefs/ consortia consortium management


1971

2002

2003

2008 CURRENTA, Analytics

CURRENTA, and its precursor organisations have been dealing with all kinds of product safety issues for more than

BUA reports, OECD SIDS, EU-Risk assessments and many more. In recent years the main focus is targeted at supporting the customers in a successful REACH registration of their products.

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ACCREDITATIONS

GLP, GMP, DIN EN ISO 17025, active member in international working groups e.g. CEFIC, VCI, DIN

PARTNERS

teams within the Bayer AG enterprise in single cases

CLIENTS

customers reaches from industrial sectors (chemistry, agrochemicals, pharmaceuticals, cosmetics, plastics) to various company sizes (big international companies and SMEs) and consortia management

CASE STUDY 1:

CURRENTA successfully accomplished the REACH registration processof more than 170 HPV substances to the satisfaction of its customerssince the REACH legislation is in force.

CASE STUDY 2:

CURRENTA offers broad experience in communication with international authorities targeting on a satisfactory and expedient solution for all involved parties. Currently, this includes in-depth consultancy for product defence strategies of dangerous substances on the CORAP list which are suspected to be PBT/vBvP or endocrine disrupting chemicals.

CASE STUDY 3:

REACH-registrations of nanomaterials.

STAFF SELECTION

Dr Hans Allmendinger – Head of REACH Team

REACH Team:

Dr Regina Schade-Lehn – Consortia Management

Dr Susanne Backens-Hammerschmidt – SMEs, NONs

Dr Lei Shi – Hazard and Exposure Assessment

Dr Jan Wölz – Hazard and Exposure Assessment, Endocrine Disrupters

Dr Julia Schmitt – Hazard and Exposure Assessment, Modelling

Sabine Ranz – Hazard and Exposure Assessment

Further technicians REACH consulting: nine

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CONTACTS

Website www.dhigroup.comwww.tox.dhigroup.com


Head o"ce Agern Allé 5, DK-2970 Hørsholm, Denmark

Tel + 45 4516 9200

Fax + 45 4516 9292

Contact Jens Tørsløv, Head of Projects.

Directors

Ownership

Locations

Founded 1964

OVERVIEW

DHI is a global and independent consulting and research organisation

environment, health and toxicology. DHI supports the chemical industry, working in close relationship with authorities, manufacturers and users, providing excellent expertise within human and environmental risk and safety assessments and documentation. Our integrated approach combines chemical consulting and profound insight in regulatory requirements with leading edge IT solutions and a top professional laboratory.




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Staff, group 981




72%

Representation

& management1%

Information1%

Laboratory7%

IT & software12%

Legal2%

Training3%

Other2%

GLOBAL OFFICES

Australia, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, India, Italy, Malaysia, New Zealand, Norway, Poland, Portugal, Romania, Singapore, Slovak Republic, South Africa, Spain, Sweden, United Arab Emirates, United Kingdom, USA, Vietnam.

SERVICES PROVIDED

REACH registration services

DHI offers manufacturers and importers of substances following technical expert services:

guidance and strategic counselling on chemicals legislation and

preparation of registration dossiers based on development of individual testing strategies and integrated use of non-test methods

analysis of alternatives and SEA pertaining to REACH authorisation.DHI further facilitates and manages Sief and consortia and provides third party representation and only representative (OR) services.

Regulatory services and IT based support tools

Preparation of safety data sheets and REACH exposure scenarios and IT tools 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

phrase modules with 4,500+ phrases in more than 40 languages and

Environmental laboratory

The DHI laboratory conducts acute and chronic ecotoxicological studies with organisms in water, sediment and soil and is specialised in carrying out standardised and specialised tests concerning biodegradability, toxicity, endocrine disrupting effects and bioaccumulation of chemical substances, products and complex mixtures. DHI has experience as test facility for offshore activities using sensitive marine organisms. DHI has further practical expertise in testing for requirements under the scheme for pharmaceuticals according to the European Medicine Agency (EMA).

Biocides and pesticides

DHI offers regulatory assistance for both industry and authorities:

preparation of dossiers on biocidal active substances and biocidal

preparation of dossiers on active substances and plant protection

Pharmaceuticals and medical devices

Within pharmaceuticals, medical devices, medicinal products, veterinary medicine and herbal medicine, DHI supports industrial companies and authorities with human and environmental risk and safety assessments

evaluation of materials/toxicity, QSAR for prediction of toxicological effects of chemical substances, evaluation of biocompatibility, safety assessments and selection of tests in accordance with ISO 10993 and regulatory services (EMEA, FDA, ISO 10993, ICH).

Food and feed safety

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


1964 Danish Hydraulic Institute (DHI) founded

1973 Approved as Authorised Technological Service Institute by the Danish Minister for Science, Innovation and Higher Education

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1982 VKI laboratory accredited by DANAK, the Danish Accreditation and Metrology Fund

1989 VKI laboratory authorised to carry out test in compliance with the OECD principles of GLP

2000 Designated as a resource centre for the Global Water Partnership

2001 Merge with VKI Institute for the Water Environment

2004 Designated the United Nations Environmental Programme (Unep) Collaborating Centre for Water and Health

2005 Merge with Danish Toxicology Centre (DTC)

2007 Establishment of the Environment and Toxicology unit

ACCREDITATIONS

Ecotoxicology tests:

in compliance with the OECD and principles of good laboratory practice (GLP).

PARTNERS

Software: ECOonline, Safeware Quasar Ltd, The Wercs, InterSolia AB Member of the GCC Network

CLIENTS

Brenntag AG, Cargill Inc, Chevron Products Company, Coloplast A/S, Danisco A/S, Danish Environmental Agency, Delta, FeF Chemicals, Ferring Pharmaceuticals A/S, ECHA, GE Healthcare, Halliburton, Johns Manville, Knauf Insulation, KIST Europe, Leo Pharma, Magna Industrial Company Ltd (Hong Kong), Nickel Institute, Novo Nordisk A/S, Novozymes A/S, Owens Corning, Paroc Group, Rockwool A/S, Saint Gobain, Statoil AB, Sun Chemicals, URSA insulation.

TESTIMONIALS

CASE STUDY 1: The chemical management system ChemManager®

Radiometer's own products in the form of safety data sheets. In this way, Radiometer ensures compliance with current chemicals legislation and uniform customers communication – regardless of the 20 languages in use. The DHI databases and phrase libraries and web-based chemical management system, ChemManager®, help ensure the quality. The use of ChemManager® enables Radiometer to screen their products for problematic substances (for example SVHCs) and to take proactive action concerning the use of chemicals.

CASE STUDY 2: A science and technology based AoA to nickel

Since 2011 DHI has provided services on analysis of alternatives (AoA)

The project was initiated by the Nickel Institute in response to questions by the French authorities regarding possible alternatives. Nickel based catalysts are used in many chemical production processes, for example production of fuel, fertilisers and bulk chemicals. Possible alternatives include molybdenum, ruthenium and platin group metals. A careful evaluation of the technical, economic and risk based suitabilities of the alternatives concluded that substitution generally leads to increased capital and process costs and/or inferior products.

STAFF SELECTION

Jens Tørsløv, PhD, Ecotoxicology – Head of Projects

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, environmental and human risk assessment of chemicals, regulation of chemicals, industrial pollution control, capacity building, preparation and chairing of workshops and training programmes.

Lars S Rasmussen, MSc, Chemical Engineering – Business Area Manager IT and Hazard Communication

Expert knowledge of European chemical legislation, in particular

authoring. Broad knowledge on other parts of European chemicals legislation as well as US and Canadian chemical regulation with regards to MSDS authoring and hazard communication. Expert knowledge of international regulations on transport of dangerous goods.

Karl-Heinz Cohr, MSc, Biochemistry – Chief Toxicologist

General experience in human toxicology, toxicological evaluations, exposure scenarios and risk assessments, and development of proposals for limit values (C-values, OEL, PDE, TDI). Specialist knowledge within expert reports for the pharmaceutical and medico industry, REACH

and control of risks from existing substances, mathematical modelling, ie QSAR and read-across in risk assessment.

Poul Bo Larsen, MSc – Toxicologist

Has more than 25 years of experience in regulatory toxicology and human health risk assessment of chemicals/chemical pollutants. Has been employed at the Danish Technological Institute, the Institute of Toxicology at the National Food Agency and for more than 14 years at the Danish Environmental Protection Agency. Participated as a national expert on human health risk assessment of chemicals in various working groups at national level in OECD and the EU including the Risk Assessment Committee at ECHA. Has worked with regulation and assessment of hydrocarbons and with the EU risk assessment document, and regulation and assessment of manufactured nanomaterials within EU and OECD.

Anja Kamper, MSc, Biology – Laboratory Manager

Has extensive experience within ecotoxicological and biodegradability testing of chemicals in aquatic and terrestrial systems, managing and performance of laboratory studies according to OECD principles of good laboratory practice (GLP), quality management, quality assurance and quality control of laboratory activities, REACH, environmental risk

environmental quality standards.

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CONTACTS

Website www.knoell.com


Head o"ce 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, Thailand

Founded 1996

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 Europe (EU and non-EU), but also in the, USA,

Korea, Australia and others).With a global network of cooperation partners we match our services to support your business needs.


Turnover, group approx.> €30m

Turnover, chemical service provision approx.> €26m

10


Staff, group 305




63%

Representation

& management25%

Information8%

Training5%

GLOBAL OFFICES

Dr. Knoell Consult GmbH, Mannheim, GermanyDr. Knoell Consult GmbH, Leverkusen, GermanyDr. Knoell Consult GmbH, Wageningen, The NetherlandsDr. Knoell Consult Ltd, Cardiff, United KingdomDr. Knoell Consult Shanghai Ltd, Pudong, Shanghai, ChinaDr. Knoell Consult Schweiz GmbH, Basel, SwitzerlandDr. Knoell Consult Thai Co Ltd, Chiang Mai, ThailandFORIM GmbH, Mannheim, GermanyCyton Biosciences Ltd, Bristol, United KingdomKnoell Academy GmbH, Mannheim, Germany

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.

ecotoxicological hazard and risk assessment, exposure modelling, extended safety data sheets.Post submission support, communication with authorities, OR- and TPR-services, full consortia management.

Registration of agrochemicals and biocides

Strategic advice and consulting, literature research, data evaluation, data gap analysis, completeness check, study management and monitoring.

dietary safety, toxicology, human exposure, exposure modelling, PEC-reports, environmental risk assessment, ecotoxicology, CADDY-dossiers. Regulatory affairs, communication with authorities, post-submission report, full service provider.

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)

devices, CE-marking, 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.


1996 Foundation, Mannheim, Germany

2002

2007 Foundation of Dr. Knoell Consult Switzerland GmbH, Basel

2007 Foundation of FORIM GmbH, Mannheim

2009 Set up of Knoell Academy for training and in-house seminars

2009 Set up of Dr. Knoell Consult Ltd in Cardiff, UK

2009 Knoell contributed to more than 100 dossiers for plant protection products

2010 Knoell prepared biocide dossiers for 25 active substances (56 products in 15 product types)

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2010

2010 Acquisition of Cyton Biosciences Ltd, Bristol, UK

2010 Extension of regulatory affair services to Japan and Asia/

2010 Set up of Dr. Knoell Consult Shanghai Ltd in China

2010 Successful preparation of more than 400 REACH dossiers and more than 100 chemical safety reports

2010 Knoell has been appointed as institution for the training of experts in toxicology

2012 Set up of Dr. Knoell Consult Thai Co Ltd, in Thailand

2013 Knoell Iberia in Madrid in the course of incorporation

ACCREDITATIONS

PARTNERS

SCAS Japan, SCAS Europe, BSL Bioservice, Ibacon, Currenta, Ceres International, ,Tier3 solutions

CLIENTS

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

TESTIMONIALS

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

As one example of our performance, Dr. Knoell Consult has managed a huge consortium covering 370 substances in ten sub-categories and submitted 55 successful registrations for this consortium in 2010 and more than 120 are expected for 2013. To achieve this, we established a team of about 30 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. Due to thorough

CASE STUDY 2: Agrochemicals

Dr. Knoell Consult successfully submitted a number of AIR-I (Annex-I renewal procedure) dossier for global R&D companies. The projects were well recognised by the authorities, in particular bearing in mind that neither industry nor authorities had experience with such projects. More than 50 people based all over the world were involved in this project.

CASE STUDY 3: Biocides

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.”

STAFF SELECTION

Toxicology

> 30 toxicologists

Regulatory a#airs agrochemicals/biocides

12 specialists

Ecotoxicology

> 30 ecotoxicologists

Dietary safety

>15 specialists

Product safety specialists (C&L, MSDS preparation)

> 30 specialists

Global regulatory a#airs chemicals

> 10 specialists

Consortium management, OR, TPR

> 10 t consortium managers

Residues and metabolism

> 12 specialists

Environmental fate and risk assessment

> 40 specialists

E"cacy, biological dossiers

> 12 specialists

Human pharmaceutical experts

Ten

Vet pharmaceutical experts

20

Selected sta#

Dr Michael Cleuvers – Head of Industrial Chemicals and Biocides, Global Regulatory A#airs

Torsten Hauck – Head of Agrochemicals, Global Regulatory A#airs, Human and Environmental Safety, Environmental Risk Assessment

Dr Volker Mostert – Managing Director Knoell Academy GmbH

Dr Marika Suhm-Tintelnot – Head of Industrial Chemicals and Biocides, Human and Environmental Safety

Dr Elisabeth Wekel – Head of Industrial Chemicals and Biocides – Product Safety

Dr Iain A MacKinnon – Managing Director, Dr. Knoell Consult Ltd

Dr Jan Tuinstra – Senior Expert REACH, Wageningen o"ce

Stefanie Schick– Managing Director,Dr. Knoell Consult Schweiz GmbH

Dr Sylvana P Müller Managing Director FORIM GmbH

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CONTACTS

Website www.ebrc.de


Head o"ce Raffaelstr 4, 30177 Hannover, Germany

Tel +49 511 898389 0

Fax +49 511 898389 10

Contact Torsten Grewe

Directors Dr Rüdiger Battersby

Ownership Privately owned

Locations Germany

Founded 1993

OVERVIEW

EBRC is a privately-owned consulting organisation based in Hannover, Germany, providing consulting services with a focus on chemical, biocidal

in all key disciplines relevant for product safety with respect to human health and environment. Task force management and coordination of industry consortia is another important aspect of our work.


Turnover, group -


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75%

Representation

& management15%

IT &software

5%

Training5%

GLOBAL OFFICES

EBRC Consulting GmbHRaffaelstr 430177 HannoverGermany

SERVICES PROVIDED

Industrial Chemicals – REACH

support on industrial chemicals, including: data gathering, literature searches and evaluation data-gap analysis, closing of data-gaps and study monitoring chemical safety assessment (CSA) and report (CSR) PBT and vPvB assessment technical dossier (IUCLID 5)

development of exposure scenarios for HH and ENV risk characterisation

safety data sheets consortium and Sief management

Agrochemicals

Active substance approval and national product registration.

1107/2009: support of existing substances in the context of the EU review

programme support of new active substances completeness checks, validation of existing studies, literature

surveys, full dossier preparation including risk assessments, submission and defence of dossiers in the review and evaluation process

Product registration dossiers for national authorisations (pre- and post active substance approval) in EU member states including zonal dossiers:

aII dossiers (dRRs) for registration and re-registration of plant protection products, label extensions and formulation changes

our services include the compilation of all required documents, the conduct of exposure and risk assessments, biological dossiers, advice in closing data gaps, the supervision of experimental studies, as well as the submission of the application to competent authorities and attendant contacts / services during the registration process.

previous experience (among others) includes herbicides, fungicides, insecticides, rodenticides and nematicides.

Biocides

EBRC provides experienced support for all key phases of the evaluation and registration process of biocides.Dossier preparation and defence in the regulatory process both for active substances and biocidal products are our primary services.

active substances (Annex I inclusion both of existing and new a.s.) biocidal products (registration/authorisation in EU member states) task force/consortia management

agrochemicals above

Special services

statistical services: statistical (re-)evaluation of data implementation of EU-models and/or scenarios (eg as given in OECD

emission scenario documents) ready-to-use spreadsheet solutions for various applications (eg

probabilistic exposure assessments derivation of species sensitivity distributions Bayesian approaches for (occupational) exposure assessments

Based on long-term involvement in major EU risk assessment projects, EBRC is very familiar with handling extensive databases, including:

importing and (re-)structuring of data online generation status update reports provision of web-interfaces for data-entry and analysis

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2013 Continual growth, leading to a current staff count of 50

PARTNERS

ARCHE, Belgium

CLIENTS

A wide range of companies producing agrochemicals, biocides and industrial chemicals and/or formulated products.

CASE STUDY 1: MEASE

On behalf of EUROMETAUX, EBRC developed a tool for the estimation and assessment of occupational exposure (MEASE) which combines approaches from the EASE expert system, from the TRA tool and from the health risk assessment guidance for metals (HERAG). It represents a

exposure to metals and inorganic substances.

CASE STUDY 2: HERAG (Health Risk Assessment Guidance)

With its extensive background in metals risk assessments, EBRC was contracted from 2005-2007 by the European Metals Industry to compile a guidance document for the human health risk assessment of metals and inorganic metal compounds. The HERAG documents provide guidance

of risk assessment methodology for metals where classic tools developed for organics are not applicable.

CASE STUDY 3: RiCoG

The rigorous containment guide (RiCoG provides guidance to registrants of isolated intermediates on how rigorous containment (RiCo) of their intermediates can be assessed and documented according to the stipulations of regulation (EC) 1907/2006 (REACH). In an integrated assessment of SCC for an entire process (adopted from an approach published by Hirst et al. (2002)), RiCoG can be used to prioritise individual process steps requiring higher tier assessments, and provides an easy and structured way to assess and to document RiCo for the remaining process steps. Experts from various metals' industries have contributed with their practical experience to the development of RiCoG.

CASE STUDY 4: Development of standard handling frequencies of rodenticide baits

frequency of baits by professional pest control operators, EBRC was entrusted by the rodenticides industry to derive a suitable proposal. Data were collected from various (quite heterogeneous) sources (industry and pest control business) and analysed statistically. Based on this analysis, the European Commission and EU member states agreed on default bait

assessment and have been a key prerequisite for including anticoagulant rodenticide active substances in Annex I of Directive 98/8/EC.

STAFF SELECTION

Rüdiger Battersby – Director

Dr Rüdiger Battersby is the founder and director of EBRC. After his PhD in biochemistry, he took up a position as manager of a contract research organisation in Hannover (IBR), from where he switched to EBRC. Apart from his responsibilities as managing director and principal coordinating toxicologist, he acts as supervisor for all of EBRC’s agrochemical, biocidal and industrial chemical risk assessments. His professional expertise encompasses involvement in the German government’s review programme (BUA) on existing chemicals, representation of industry consortia in RA conducted under the ESR programme (793/93) and at EU-TCNES level, as well as the conduct of several dozen occupational exposure surveys in various sectors of the chemical industry. Among other professional activities, he is an appointed member of the German Expert Gremium for Chemicals Safety of the German Chemical Society.

Arne Burzla# – Senior Registration Manager Industrial Chemicals

Dr Arne Burzlaff graduated as a chemist (2000) and obtained a PhD in technical chemistry/biotechnology (2005). He worked for the German Federal Institute for occupational safety and health, Division for Chemicals and Biocides Regulation (2005-2007) on dossier evaluation for biocides, collaboration in EU working groups and scoping issues on borderline cases among legal frameworks. Since 2007 he has been working at EBRC as senior scientist/toxicologist. In this position he has been compiling REACH registration dossiers, with a focus on human health hazard assessment and risk characterisation, and initiation and monitoring of experimental studies on industrial chemicals.

Andreas Büsing – Senior Registration Manager Agrochemicals

Andreas Büsing graduated as a biochemist at the University of Hannover

emphasis on the development and validation of immunoassays, he is working at EBRC as registration manager for agrochemicals since 1999. His main responsibilities at EBRC include the co-ordination and supervision of registration dossiers under Directive 91/414/EEC and subsequent regulations, with focus on ecotoxicological risk assessments, data gap analysis and monitoring of experimental studies on active substances and plant protection products.

Silke Burger – Senior Registration Manager Biocides

Dr Silke Burger graduated as a biologist (2000) and obtained a PhD in molecular biology/toxicology (2004). Since 2006 she has been working at EBRC as registration manager for biocides. In this position she has been compiling dossiers in support of inclusion of active substances in Annex I of Directive 98/8/EC and registration of biocidal products with a focus on human and environmental exposure assessments and risk characterisations, and further initiation and monitoring of experimental studies on active substances and biocidal products.

Daniel Vetter – Senior Consultant Special Services

Daniel Vetter graduated as Dipl-Ing agr at University of Hannover (2003). His main responsibilities at EBRC include the development and implementation of novel statistical techniques in human health risk assessments. He developed MEASE, an assessment tool for

dermal exposure to metals. As part of his current work, he incorporates probabilistic techniques into the HEC (human equivalent concentrations) approach.

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CONTACTS

Website www.ecoonline.com


Head o"ce Trudvangveien 77, N-3117 Toensberg, Norway

Tel/ Fax +47 33 01 68 00/ +47 33 01 68 01

Contact Mr Luis G Paulsen

Directors Mr Øyvind Thorsen, CEO

Mr Kjell Hamnes, CTO

Ms Martina Jonsson, VP Product Management

Mr Luis G Paulsen, VP International Sales

Ownership Privately held, employees

Locations Norway, Sweden, Finland, Denmark, Switzerland

Founded 2000

OVERVIEW

ECOonline is one of the most widely used platforms for SDS authoring, distribution, communication and management in Northern Europe. Originating in the Internet hotspot of Scandinavia, ECOonline has pioneered the SDS industry, and continuously improved the service.Today more than 3,500 enterprises connect to the service online. The platform is ideal for companies in most industries, and it is the perfect

exchanging, communicating and managing data.All parts of the platform are offered online (Cloud, SaaS, ASP). Connecting suppliers and downstream users online reduces time and costs involved in nearly all aspects of handling SDSs and managing substance inventories. A common web browser and internet connection are the only requirements.Available in 23 languages, it is designed to meet your requirements for the REACH area. Our aim is to become the most preferred platform for SDS communication and management in Europe, working with leading consultants and members of industry.

partners, are ready to give a demonstration of the applications and

Please contact Mr Luis Paulsen for more information.




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10%

Information10%

IT & software70%

Training10%

GLOBAL OFFICES

NorwaySwedenFinlandDenmarkSwitzerland

SERVICES PROVIDED

Supply chain communication

SDS/eSDS authoring

SDS/eSDS distribution

SDS/eSDS database

SDS substance/chemical inventory management

Workplace risk assessment

Employee exposure tracking and storing

Up and downstream reporting


2000 Founded by Mr Kjell Hamnes, long time industry professional

platform for SDS communication. HQ in Tønsberg, Norway

2001communication

2007

2011

2011 Launched leading edge solutions for authoring and managing exposure scenarios. Technical documentation and articles covered.Established representation in Germany.

2012 Ready with mobile applications and XML comm modules. Established representation in Denmark, Iceland and Poland.

2013 Enhanced service for building and construction sector.The most widely used service in the Nordic region. We

meet your requirements.

PARTNERS

ECOonline works closely with local, regional and international consulting partners in many different areas, including SDS authoring, substance inventory management, risk assessment, dossier preparations, authority

Please contact Mr Luis G Paulsen if you would like to learn more about opportunities for working together with ECOonline.

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CLIENTS

Small and large, public and private, multinationals and locals, our clients represent most segments and industries.A total of more than 3,500 enterprises connect to the services.

TESTIMONIALS

Please contact us for testimonials. We’ll be happy to provide you with referrals that are relevant to your needs and your industry!

CASE STUDY 1: Automotive industry

a majority of auto dealers are connected to the service a majority of suppliers are connected auto dealers and repair workshops get their SDS directly in their

inventories, and reduce time spent on managing inventory and performing relevant tasks

suppliers reduce time and costs in distributing SDS

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

the diagnostics manufacturer is part of a large international corporation, with production sites and laboratories in many locations

its suppliers upload the relevant SDSs directly to the diagnostics company’s inventory

the diagnostics company can then use all the data from the SDS without having to re-enter them.

all designated staff can work and share information in the same system, from any location

speed, and reduces time spent on relevant tasks no installations are required, no local IT maintenance costs involved

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

a majority of universities, municipalities, schools and hospitals are connected to the service

SDSs are uploaded directly to their inventories all data in the SDS are immediately available for use, and

automatically updated

and the service to customers is greatly improved

no local installations are involved, the entire service is available to all users over the Internet

this saves time and money in the process of authoring, distributing and managing the SDSs and documentation

CASE STUDY 4: Building and construction sector

an automated service enabling direct communication between materials supplier, construction company and building project

SDSs are automatically transferred to the inventory for the project saves time and workload for all parties ensures all correct documentation is in place, including technical

information and workplace safety

STAFF SELECTION

Mr Kjell Hamnes – Norway, International

Kjell is the founder and head of product development at ECOonline. He has pioneered the development of electronic tools for SDS authoring and management in Northern Europe, and is a widely used resource by industry and authorities on the issues of legislation and compliance.

Ms Martina Jonsson – Sweden, International

in Sweden on the issue of REACH and SDS management.

Mrs Christy Whiddon – Sweden, International

Christy is product manager. She has extensive background from the chemicals industry, and has a PhD in surface and colloid chemistry.

Ms Pirjo Kuoppala – Finland, International

Pirjo is product manager. She has extensive background in the electronics industry, and has degrees in mechanical engineering and biochemistry.

Mr Luis G Paulsen – International and Partner relations

Luis is responsible for international operations and partner relations.

Mr Øyvind Thorsen – CEO

Øyvind has extensive background from the software and computer industry.

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Website www.environcorp.com


Head o"ce 5 Stratford Place, London, W1C 1AX, UK

Tel/ Fax +44 20 7478 9800/ +44 20 7478 9801

Contact Sue Bullock

Directors 137 partners worldwide, including

Jose Fernandez (F), President Europe

Sue Bullock (UK), Aidan Turnbull (UK)

Henk Verhaar (NL), Martina Vosteen (DL)

Joseph Rodricks (US)

Ownership Private limited company

Locations

Founded 1982

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 engage with policy makers and regulators, and 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

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.


Turnover, group (2011) €223m


89


Staff, group 1,400




85%

Representation

& management10%

Laboratory5%

GLOBAL OFFICES

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

SERVICES PROVIDED

Risk management, strategic support and regulatory compliance (REACH, CLP, biocides, PPP, cosmetics, food contact materials)

For 30 years ENVIRON has worked in partnership with clients to develop and support product regulatory compliance strategies and prepare robust technical dossiers and risk assessments for substances in industrial, agricultural, biocidal and consumer applications. We balance clients’ technical, regulatory and commercial interests through sound science

regulatory support for SVHC, from an initial proposal for inclusion on the Candidate List to Authorisation, including business impact assessment, socio-economic analysis and alternative analysis. We support communication with the EC, ECHA and MSCA, and development of policy, regulation and guidance. We audit product regulatory compliance systems and support supply chain management. ENVIRON also acts as consortium manager and only representative, and is independent from testing facilities.

Global chemical notifications and regulatory compliance support

ENVIRON evaluates obligations and provides support for regulatory

Europe and Africa. We assess new market opportunities, substance

and packaging. Our established global network covers Argentina, Australia, Brazil, California, Canada, China, Europe, India, Japan, Korea, Malaysia, Mexico, New Zealand, Philippines, Russia, Singapore, South Africa, Switzerland, Taiwan, Turkey, and the US.

Product stewardship and troubleshooting

We have great breadth and depth of expertise in: toxicology (and toxicokinetic modelling) epidemiology exposure modelling, measurement and reconstruction risk assessment and mitigation ecotoxicology environmental fate regulatory affairs chemistry occupational health supply chain issues product vigilance advocacy

This means we are ideally placed to advise clients on problems – from in-depth assessment of animal and human evidence for health effects to concerns regarding measured exposure levels of substances in humans and the environment and managing supply chain issues. We couple internationally recognised expertise and reputation as leader in risk management with client-focused solutions.

BOMCheck

Substances declarations web database for REACH, RoHS, batteries and packaging compliance to facilitate supply chain management.

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1982 Founded in Washington, DC, USA

1996 Acquired UK consultancy EAG

2000

2001

2003 Merged with AEI to bring full range of services in occupational health, environmental health and injury and disability research

2008 Acquired Gustitus Group.

2009 Acquired Arquipélago in Brazil

2010 Chemical Industry Association (CIA) REACH serviceprovider of the year

2012

CLIENTS

Clients in the following industries: industrial and specialty chemicals,petrochemicals, agrochemicals, food and food packaging, cosmetics, medical devices, electronics, manufacturing

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 organised

Mumby PhD, global director product stewardship and regulatory affairs, Elementis Specialties Inc.

this whole process would have been so much cleaner and easier. Thank you for all of your hard work on this and in the short time frame requested” – Michelle T Quinn, associate general counsel, regulatory affairs and general litigation, Catalent Pharma Solutions.

CASE STUDY 1: REACH dossier and CSR for a group of SVHCs

ENVIRON prepared robust and comprehensive REACH dossiers

with potential endocrine disrupting properties and a wide use pattern. This involved use of novel arguments and original methods to better characterise chemical fate, exposure and effects on humans and the aquatic environment. CSAs were prepared using both measured and

accessible and useful to registrants and their customers alike.

CASE STUDY 2: Support for SVHC and Annex XIV REACH

and justify to policy makers a more credible, yet equally effective, risk management option for a chemical than phasing out its use under REACH. We prepared preliminary studies including CSR, alternatives analysis and socio-economic studies to demonstrate impact of inclusion on Annex XIV.

CASE STUDY 3: Global regulatory approval – new consumer product

ENVIRON evaluated regulatory obligations in more than 50 countries,

for a company wishing to market a product globally. The review allowed

CASE STUDY 4: Exposure data drives regulatory scrutiny

the blood of the general population, raising concerns. For a multinational company, we demonstrated exposure to PFO from certain consumer articles (eg treated carpets, clothing, upholstery and cookware) 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, defensibly informing its product stewardship program.

CASE STUDY 5: Regulatory action related to product contamination

A food packaging producer faced possible regulatory action associated with residual levels of a potential carcinogen in a key product. Using an integrated approach we showed that consumer exposure to the contaminant from handling the packaging and ingesting the packaged foods were within safe levels. The work also informed important strategic decisions for the business (eg product viability, consumer perception and

CASE STUDY 6: Review proposed carcinogenicityclassification

An industry association asked ENVIRON to review all available evidence for the carcinogenicity of a product in order to comment on the basis and technical merits of EC proposals to classify the substance as a carcinogen.

STAFF SELECTION

Sue Bullock – Principal, product safety and regulatory compliance

Leading ENVIRON's product safety and regulatory compliance services for over 20 years, Sue has provided strategic, regulatory and technical assistance to industry relating to chemical policy and presence of chemicals in the environment, the workplace and consumer products. She has an extensive knowledge of REACH and helps companies around the world engage with policy-makers, comply with global chemical regulations, assess and manage health and commercial risks, manage liability and deliver effective product stewardship across the supply chain.

Dr Henk Verhaar – Principal, chemist and ecotoxicologist

Over 20 years' experience in modelling the fate of chemicals in the environment and assessing and predicting their ecotoxicity, Henk’s work on predictive aquatic toxicology is widely used in Europe and the US during the development of hazard assessment models for chemicals in the aquatic environment. His expertise also includes 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 15 years of experience as a consulting chemist, including coordination and management of hundreds of risk assessments regarding

chemical, pharmaceutical, medical devices and food industries. She has

advises the industry in relation to REACH and other product regulatory relations (cosmetics, pesticides, etc).

Dr Joe Rodricks – Principal, toxicologist

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 Organization. He has served on 15 boards and committees of the National Academy of Sciences and the Institute of Medicine.

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CONTACTS

Website www.equitox.eu and www.sci-env.ch


Head o"ce 63 rue André Bollier, 69307 Lyon Cedex 07, France

Tel +33 (0)48 253 9018

Fax +33 (0)97 231 0242

Contact Dr Benoit Fraysse

Directors Dr Christine Reteuna, Director EquiTox

Dr Erwan Saouter, Director S&E

EquiTox and S&E are associated since 01.2012


Locations Lyon, FranceGeneva, Switzerland

Founded 2011 (EquiTox), 2007 (S&E)

OVERVIEW

EquiTox and Science & Environnement offer many areas of expertise, which linked together, provide a global and comprehensive approach to worldwide chemical safety regulation and sustainability. From chemical safety and regulatory affairs, life cycle assessment, carbon footprint, eco-design or ecolabel: we offer to companies and organisations a wealth of expertise. EquiTox and Science & Environnement have joined forces in a strong association in order to reinforce their chemical safety offers. It consists

working in human, environmental and regulatory affairs department of big international chemical companies. We can now take care of your regulatory needs worldwide, from Europe to US and Canada, but also for China.


Turnover, group €950,000

Turnover, chemical service provision €750,000

2


Staff, group 6




57%Representation

& management30%

Information3%

Training10%

SERVICES PROVIDED

Regulatory compliance

REACH: data collection, data gap analysis and testing. REACH registration dossiers (IUCLID) and submission to ECHA via REACH-IT, chemical safety reports (CSR), exposure scenario and scaling, etc

biocides and cosmetics

substance and mixtures according to CLP, GHS UN, DSD, DPD registration dossiers (China, US...) ecolabels.

Regulatory information

literature review, study assessment and validation model prediction and QSAR organise and follow-up of laboratory testing safety data sheet (SDS) drafting, update and regulatory audit

Product advocacy and project management

product defence strategy animation and technical representation in consortia communication strategy

Impact assessment and eco-design

environmental risk assessment (cosmetics, industrial chemical, biocides, etc)

human health safety assessment (cosmetics, industrial chemical, biocides, etc)

life cycle analysis (LCA) support in the development and eco-design of new products


2007 Science & Environnement founded

2011 EquiTox foundedS&E approved as REACH Ready supplier

2012 Association between EquiTox and S&E

ACCREDITATIONS

REACH Ready approved supplier European registered toxicologists (EUROTOX) Member of the French Society of Toxicology (SFT)

CLIENTS

Our clients range from multinational companies to SMEs, producing industrial and specialty chemicals, petrochemicals, biocides and cosmetics.Our clients include: Bluestar Silicones, L’Oréal, Procter & Gamble, Roquette, Laboratoires Expanscience, UIC Rhone-Alpes…

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CASE STUDY 1: Use of QSAR for multi-constituent substances

to use QSAR models. In order to provide reliable and robust predictions the project was divided in four steps:

training of the customer’s technical team.

substances of interest. In addition, the selection was driven by the need to comply with REACH data submission requirements and the latest recommendation from ECHA for the submission of QSAR prediction in the frame of a registration dossier. The training session was built for helping the technical team to gain in autonomy in case of comments from ECHA or any competent authority, and to better know the boundaries of the use of QSAR tools for improving their use in regulatory frameworks.

CASE STUDY 2: Extended SDS – analysis and implementation at industrial site levels

More and more raw materials are supplied with an extended Safety Data Sheet describing way to handle the supplied chemicals. EquiTox and S&E were in charge of developing a process for managing this new workload and this new regulatory constraint for European Chemical companies. One of the main requirements was to deliver proposals that can be easily transposed to any European plant. It was needed to work in parallel on:

the training of key people (HSE, product-stewardship, plant management…) on the different drawbacks related to this new set of information (regulatory, administrative, relationship with customers,

the internal IT solutions for tracking a raw material on a manufacturing

the description of the occupational tasks, starting from HSE language to REACH understandable vocabulary, and the comparison with the

the IT solutions for checking the OC and RMM compliance for environment through scaling.

In addition, EquiTox and S&E were asked to deliver a solution limiting the related workload for non-dedicated people and to cover the updating processes.

CASE STUDY 3: Follow-up of testing proposals consequently to REACH 2010 registrations

Many 2010 REACH registration dossiers has been submitted to ECHA with poor understanding of the consequences of the indication of “Annex IX and X testing proposals”. The registrants now face ECHA’s draft decision requesting them to perform animal testing that will cost several €100k, and they are disconcerted. A lack of continuity in service provider

Following the reception of a draft decision, a customer contacted EquiTox for following up the work done by a third party back in 2010. In a very short period of time, it was necessary to review the entire registration

business risks, and to submit comments to ECHA. Once the consensus was reached between the customer, ECHA and the member state

has been contacted for budgeting the studies.

STAFF SELECTION

Dr Christine Reteuna – Regulatory Ecotoxicologist – EquiTox

After obtaining her PhD in environmental toxicology, Christine began her career in the French Ministry of Environment for the implementation of chemical regulations. She then went into industry for 19 years (Rhodia), as an expert in regulatory ecotoxicology. It enabled her to work for both consumer market (cosmetics, detergents, etc) and industrial market (metal processing, oil market, etc), and address environmental issues in a wide variety of products. She was also an Industry representative in several

covering data collection, study monitoring, the establishment of

took part in the production of several regulatory dossiers and their support against competent authorities.

Dr Erwan Saouter – Regulatory Ecotoxicologist and Director of S&E

Founder of the S&E company, Erwan Saouter has more than 20 years of professional experience with private companies (Procter & Gamble), public research organisations (US Agency for Environmental Protection,

media and governments.

Stéphanie Moulin – Regulatory Toxicologist – EquiTox

Stéphanie spent ten years working in the chemical industry for Rhodia, as regulatory toxicologist. She also worked for the CNRS (French national

teaching experience.

strategies and the use of E F G E H I J methods, the cost optimisation based on analogy and weight of evidence approaches, the selection

other zones, and chemical product defence. In addition, Stéphanie is specialised in human health risk assessment, with a focus on the safety assessment of cosmetic products.

Dr Marie-Laure Teisseire – Regulatory ecotoxicologist – EquiTox

and surface water pollution, and teaching (six years at the University of Reims) and continued as a regulatory ecotoxicologist for a Chemical Company (Rhodia).

substances in EU or China or compilation of REACH dossiers, allowed her to improved her expertise in environmental exposure assessment

physico-chemical hazard assessment of chemical products, study monitoring and hazard communication (SDS, C&L).

Dr Benoit Fraysse – Regulatory (Eco)toxicologist – EquiTox

Once he had his PhD, obtained in collaboration with the French Nuclear Safety Institute, Benoit gained in expertise with three years in postgraduate positions, mixing teaching and research positions (French institutes and universities). He joined the French chemical company Rhodia, where he spent six years.Benoit specialises in analysis of the hazardous properties of substances (physical chemistry, environment, health) combining experimental tools or in silico (QSARs) methods. As regards international issues, Benoit

toxicity and the assessment of health risk to workers (REACH and biocide exposure scenarios), and active discussion with the competent authorities.

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CONTACTS

Website www.erm.com


Head o"ce Frankfurt: Siemensstraße 9, 63263 Neu-Isenburg, Germany

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

Contact Dr Rudolf Wilden

Directors 430 Partners globally, including Sal Giolando (USA), Dominique Gangneux (UK), Kathleen Goossens (Belgium), Dirk Nuyens (France), Rudolf Wilden (Germany)


Locations 140

Founded 1971

OVERVIEW

Environmental Resources Management (ERM) is one of the world’s leading providers of EHS and sustainability management and technical consulting services, with considerable experience in providing global product stewardship (GPS) services. With global product stewardship

integrated product service across all divisions within the company.


Turnover, group $572m

Turnover, chemical service provision $10m

140


Staff, group > 4,500

Staff, chemical service provision >50



70%

Representation

& management20%

Training10%

GLOBAL OFFICES

We support our clients in all countries globally.

SERVICES PROVIDED

Registration, evaluation and authorisation of chemicals (REACH)

socio-economic analyses preparation of application for authorisation REACH training/ REACH impact assessments preparation of lead and member registration dossiers

chemical safety assessments

Sief management REACH compliance assessments support advocacy

Toxicology, ecotoxicology and risk assessment

Study placement/ protocol review and development, development of

EHS risk assessments

Classification, labelling and packaging (CLP/GHS)

SDS and label review and improvement

Emerging chemical control laws around the world

Downstream product legislation, eg food/food contact, biocides

FIFRA / BPD/BPR support national registrations local/ regional registration labelling and claims support

Lifecycle assessment and sustainability

carbon footprinting and emission inventories lifecycle management (LCM) also to ISO14040

supply chain management and carbon reduction advice design for environment (DfE) environmental product declarations (EPDs) lifecycle analysis (LCA) sustainable business strategy


2010 Preparation of more than 100 REACH registration dossiers

according to ECHA standards

2011 ERM supports clients with evolving product legislation such as those in Turkey, China, Korea, Japan, Brazil

2011 ERM brings on board the product stewardship team around Sal Giolando

2012 Technical partnership with ReachCentrum for preparation of the application for REACH authorisation

ACCREDITATIONS

ISO 9001 & ISO 14001

PARTNERS

ReachCentrum

CLIENTS

Fortune 100 and more than 50% of the Global Fortune 500 companies.

TESTIMONIALS

"We have been working with the ERM team on REACH for a number of years now, and there are very good reasons to continue and expand this

levels ERM has provided us with active, solid and high-quality support for MSD's REACH programme. We are pleased to observe that our collaboration has turned into a true partnership." – Frits Wielaard, REACH programme manager, Merck Sharp & Dohme

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“ERM have provided support and advice for us throughout the pre-registration and registration phase of REACH and have always been totally professional,

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

CASE STUDY 1: Supporting the REACH team of Momentive Performance Materials (MPM)

MPM required support for its REACH team using ERM’s REACH expertise, including toxicologists, ecotoxicologists and chemists. The ERM REACH

and discussions of issues encountered provided timely resolution of such. Benefits and value:

comprehensive documentation of approaches and work products to

alignment of global teams with same company culture ensures highly

cooperation of the team with a view beyond registration (eg on health

streamline future REACH management.

CASE STUDY 2: Supporting a multinational pharmaceutical company’s new chemical registration in China

An ERM client needed to register a new chemical product with high toxicity

application was rejected in other countries. The Chinese Ministry of Environmental Protection (MEP) was highly concerned about the toxicological properties of this type of product, making registration a challenge. Detailed and comprehensive analysis of product information in order to assess whether the product could be successfully registered was necessary before project commencement. Effective communication with different parties (eg the client, ecotoxicological laboratory, government and experts) was essential.Benefits and value:

to facilitate the approval, full and comprehensive analysis, which was

utilise the laboratory data, analysis results and ERM’s expertise and experience to forego several expensive and time-consuming laboratory tests, saving time and cost for the client.

STAFF SELECTION

ERM’s Global Product Stewardship TEAM (GPS)

able to utilise the full resources of ERM globally to provide full back-up for all GPS-related services.

Dr Rudolf Wilden – Product Sustainability Lead Central Europe

PhD in environmental sciences with more than 12 years’ consulting

Dr Salvatore Giolando – Head of Global Product Stewardship Team

BSc in chemistry and a PhD in environmental health, with 25 years of global industry and consulting experience working for the Procter & Gamble Company. Managing global product safety and regulatory compliance for numerous brands and innovative technologies during tenures in both Cincinnati and Brussels

Dominique Gangneux – Product Sustainability Lead UK

Post-master degree in environmental management with 16 years Sustainability/ EHS consulting and assurance experience across the areas of strategy, risk management, product sustainability, performance improvement, supply chain management, reporting and assurance.

Dr Dave Best – Technical Director

PhD in microbial biochemistry, coordinating ERM’s global effort on the provision of REACH. He has 18 years in the chemical industry as an environment, health and safety manager.

Dr Steven Peterson – Senior Ecotoxicologist

PhD in biological sciences with 20 years of experience in risk assessment, ecological research, environmental science with consulting

Dr Randy Shuler – Senior Toxicologist

Diplomate, American Board of Toxicology Inc, 1996-present, with more than 18 years of experience in toxicology, environmental science and consulting. Randy has evaluated toxicology and epidemiology data, and has provided litigation support in toxic tort and environmental litigation cases.

Kathleen Goossens – Principal Partner

management system programs, performance improvement and assurance projects. Before joining ERM, Kathleen spent ten years in the chemical industry, as a technical commercial engineer with BASF.

Dr Dirk Nuyens – Principal Partner

REACH and risk assessment.

Donna Morrall – Senior Project Manager

20 years of relevant expertise in both industry and consulting with a strong focus on risk assessment, data analysis and computational modelling.

Dr Eckhard Schäfer

PhD in chemistry, with more than 20 years’ experience in chemical risk assessment and preparation and implementation of safety plans. Health and safety advisor of the Hoechst Corporation between 1986 and 1994.

Dr Elsie Millano

BSc in chemical eng and PhD in civil eng. environmental area. Supporting the REACH team in the review and preparation of CSRs and safety data sheets, and review of robust study summaries. Over 25 years of environmental consulting experience in human health risk assessments, including exposure assessments, fate and transport evaluations, and risk calculations. Extensive expertise in contaminated site closures based on controlling exposures.

Carolyn Hammer – Senior Ecotoxicologist

ecological risk assessment of pesticides and the development of new Federal rules and regulations related to waste, chemicals and pesticides.

Dianne Green – Senior Project Manager

stewardship matters (11 of those years at Procter & Gamble), with a focus on chemical and product risk assessment, regulatory compliance, hazard communication, and in-market product safety surveillance.

Tze Shin Goh – Principal Consultant

compliance, management systems and performance improvement and assurance projects in various European and Asian countries.

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CONTACTS

Website www.exponent.com


Head o"ce The Lenz, Hornbeam Business Park, Harrogate, North Yorkshire, HG2 8RE, UK

Tel +44 (0)1332 868000

Fax +44 (0)1332 868099

Contact Julian Reddy

Ownership Wholly owned subsidiary of Exponent Inc.

Locations

Founded 2002

OVERVIEW

Exponent Inc is one of the world's largest regulatory, engineering and

problems. Exponent International Limited is a wholly owned subsidiary of Exponent Inc and is the European arm of the Chemical Regulation and

Basel in Switzerland. Exponent combines unparallelled technical expertise with the ability to focus this knowledge to meet our clients’ needs within short timeframes. Our ability to create multidisciplinary teams of scientists, regulatory consultants and project managers means that we can either

evaluations to provide our clients with the critical information that they need to make day-to-day strategic decisions.


Turnover, group Est US$10m

Turnover, chemical service provision Est US$3m

3

No. of countries represented 35

Staff, group 50




65%

Representation

& management25%

Information5%

Training2% Other

3%

GLOBAL OFFICES

Park, CA 94025, USA

United Kingdom

SERVICES PROVIDED

General REACH services

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

management and Sief and consortia management and we can also act as your only representative registrant or third party representative.

Preparation of REACH registration dossiers and chemical safety reports

Exponent has prepared in excess of 75 complete lead registrations for phase-in substances and is currently working on approximately 50 more for the 2013 deadline. We can complete all aspects of the process such as data evaluation and gap analysis, determination of substance

monitoring. We can complete all components of the IUCLID 5 dossier and the chemical safety report (CSR) including exposure assessments, using Chesar and higher tier models if necessary, and risk characterisation.

exposure scenarios and extended safety data sheets.

Global chemical notifications

Our consultants have considerable experience in compiling and

specialists we are capable of preparing and submitting chemical

prepare and submit dossiers for Australian, Canadian, New Zealand and

preparation and submission of regulatory documentation in China, Japan, Korea, the Philippines, Taiwan and Turkey and can utilise the experience

Other regulatory regimes

clients with EU agrochemical, biocide, cosmetics 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. For cosmetics we provide general

cosmetic product safety reports.


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

2010

ACCREDITATIONS

ISO 9001 accreditation

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PARTNERS

CROs and in-country agents to provide the best service to our clients for

CLIENTS

Exponent Inc has worked with more than 5,000 clients and Exponent International has undertaken work for over 400 clients globally. Exponent has provided regulatory support to a range of companies across many

companies conducting business in all areas of the chemical industry.

TESTIMONIALS

"Exponent International has consistently provided high-quality REACH

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

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. Exponent performed the technical work required for the 16 substances that needed to be registered in 2010 and continues to provide support for the substances to be registered in 2013. The

of data gaps, use of intelligent testing strategies to address gaps and, where necessary, placing and monitoring of studies. In addition Exponent has been and is still responsible for the production of the registration dossiers in IUCLID 5 including appropriate data waivers and testing proposals and for the production of CSRs. To complete the CSRs, Exponent has the responsibility of working with consortium members and external parties to identify downstream uses that need to be considered and proposing use descriptor codes for exposure assessments and the production of exposure scenarios. Due to the properties of the substances, creative yet pragmatic solutions have been necessary to demonstrate safe use. Exponent's technical capabilities and support ensured that all 2010 consortium substances were registered ahead of the deadline and it is anticipated the submissions for the 2013 substances will be completed in advance of that deadline.

CASE STUDY 2: Product stewardship service for a SME

Exponent has provided ongoing product stewardship support for a catalyst manufacturer, covering REACH and all other global chemical regulatory

regulatory strategy and advice to ensure that legislative requirements from a number of countries can be effectively overlapped. Exponent also provides more technical support by preparing and submitting regulatory

and labelling of the substances for GHS inside and outside of the EU. We

the sale of part of this company’s business in 2011, we have handled all of the necessary regulatory and administrative work to ensure that all parties involved continued to maintain regulatory compliance for their products.

CASE STUDY 3: REACH support for the 2013 deadline

meeting their REACH requirements for the May 2013 deadline. The company is a lead registrant for eight substances and we have worked with them to identify gaps in the available data, managed the testing programme that was placed with a global CRO, produced substance

dossiers for these eight substances including completion of CSRs. We have added value as a service provider by managing all this work as one project so that we can ensure that all necessary actions, for ourselves and our client, are progressed within appropriate timeframes, using what we have learnt from one substance to help with others where possible

obligations ahead of the 2013 deadline.

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 regulatory programmes undertaken on industrial chemicals and biocides. In addition, he has particular experience of Asian

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 has almost 20 years of

Mr Hislop has considerable experience in the preparation of regulatory documentation, development of testing programmes for regulatory purposes specialising in the use of an “intelligent approach” to safety testing and is a leading advocate of the principle of the read-across approach.

Dr Alec Willis – REACH Regulatory Specialist

Dr Willis leads Exponent’s capabilities for chemical safety reports, exposure scenarios and Chesar. He has experience in Sief management, production of registration dossiers and Sief and consortia representation for clients. He has also helped clients across a range of industries prepare for REACH by providing regulatory strategy and advice and performing vulnerability analyses. Dr Willis is an experienced project manager, managing a large number of multi-disciplinary REACH projects.

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CONTACTS

Website www.harlan.com/crs


Head o"ce 8520 Allison Pointe Blvd Suite 400, Indianapolis, IN 46250, USA

Tel/ Fax +44 (0)1332 792896/ +44 (0)1332 799018

Contact James Gillespie

Directors Hans Thunem

Manuela Leone


Locations

Founded 1931

OVERVIEW

Harlan Laboratories is a global leading provider of essential, non-clinical 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. Harlan Laboratories is the market leading CRO offering regulatory advice, safety testing and safety assessment of chemicals. Our project leaders

commercial awareness necessary to drive projects forward to completion.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

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 servicesHarlan 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:

E F G E H I J

discovery services.


Turnover, group -


-


Staff, group 2,800




30%

Laboratory70%

GLOBAL OFFICES

France, Germany, Israel, Italy, Japan, Korea, Mexico, Netherlands, Spain, Switzerland, UK, US

SERVICES PROVIDED

REACH testing

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.

Toxicology

Harlan Laboratories offers a full range of toxicological testing to support global regulatory submissions by the agrochemical, chemical, and pharmaceutical industries. All studies are performed according to regulatory guidelines and Good Laboratory Practice. We have extensive experience in all relevant study types.All standard species and routes of administration are offered including specialist routes such as inhalation and infusion. All studies are supported by analytical and clinical diagnostic services, including immunotoxicology and biomarkers.

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

DMPK, PK screening and toxicokinetic testing) and plant metabolism studies for the chemical, agrochemical and pharmaceutical industries.

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.

Alternative and E F G E H I J toxicity

Harlan Laboratories is committed to the principle of the 3Rs of

proactive in the development and use of E F G E H I J and ex vivo methods, partnering researchers and clients in pre-validation and formal validation studies.

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Genetic toxicology

Harlan Laboratories offers a complete range of genetic toxicology studies to support the worldwide registration of pharmaceuticals, industrial chemicals, and agrochemicals, meeting current guideline requirements. We offer consulting services to review data already held, and to advise on further testing requirements/strategies, if required. These services also

risk assessment.

Regulatory services

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 clients’ products. Our turnkey service, from the initiation of a project to

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.


1931 Foundation

2004 Acquisition RCC Ltd

2005 Acquisition Cidasal SA

2007 Acquisition SafePharm Laboratories

2007 Acquisition IMTC (surgical models)

ACCREDITATIONS

Contract Research Services (CRS): AALAC ISO/IEC 17025 EN 45011 GLP GMP GEP

CLIENTS

Chemicals industryAgrochemicals industryPharmaceuticals industry

STAFF SELECTION

John Handley, BSc MSc CBiol FSB – Global Vice President Operations

John Handley is global vice president Operations at Harlan Laboratories Ltd and has some 26 years’ experience of working in the contract research industry. Following the completion of his Masters research in acid rain and the associated toxicity of aluminium to rainbow trout, John worked at the University of Cardiff on a research contract to the EU, developing methods for chemical registration. From there he moved to Huntingdon Research Centre where he worked in the Aquatic Toxicology department for four years.John moved to Safepharm Laboratories in 1989 to design and set up the ecotoxicology facility. In 2005 he became Operations Director for the company while still retaining management responsibility for the department of Ecotoxicology until 2007 when the company was acquired by Harlan Laboratories Ltd and he was made general manager for the UK. In January 2009 he was appointed vice-president Environmental Safety and Metabolism across all Harlan CRS sites. In August 2010 he took control of all operational units in the Harlan CRS structure.John is a member of the Society of Environmental Toxicology and Chemistry and participates on UK shadow OECD discussion panels for ecotoxicology and biodegradation. He is a EUROTOX registered toxicologist.

Ciriaco Maraschiello

Ciriaco Maraschiello is a biochemist and graduated in biological sciences in 1992 with a further DEA in immunology and genetics obtained in Belgium. He moved to Spain in 1993 to gain some work experience under the Erasmus programme and stayed there for six months to do biochemistry investigations applied to nutrition. He obtained his PhD in 1998 and developed his doctoral work within the framework of the European AIR

topic on antioxidants, free radicals and lipid oxidation with a special focus on ageing, atherosclerosis and consumer safety.Ciriaco started his working career as a study director in 1998 with Spanish CRO Cidasal which was acquired in 2005 by Harlan Laboratories Inc.Ciriaco assumed responsibility for the Pharmacokinetics and Analytical

then appointed as the director of Science and Operations of Harlan CRS Spain with a strong focus on toxicology.In August this year Ciriaco was appointed head of Global Toxicology for Harlan CRS.

Robert L Guest Bsc (Hons), C Biol, MSB

Robert Guest has worked within contract research services at Harlan Laboratories Ltd since January 1980.He gained his BSc (Honours) degree in biological sciences at Nottingham Trent University in 1990 and has occupied technical, study director and managerial positions in a GLP-accredited laboratory conducting regulatory short-term toxicology studies on behalf of the chemical, agrochemical and pharmaceutical industries.Robert is currently manager of Alternative and Acute Toxicology based at Shardlow, UK and has been responsible for implementation of the 3Rs in regulatory toxicology by the integration of E F G E H I J and ex vivo tests into tiered testing strategies.

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Website

E-mail

Head o"ce 9300 Lee Highway, Fairfax, VA 22031, USA

Tel +1 703 934 3000

Fax +1 703 934 3740

Contact Stephanie Barrett (+32 2 888 01 28)

Directors Sudhakar Kesavan, Chairman and CEO

John Wasson, President and COO

Isabel Reiff, Executive Vice President

Ownership Public company (NASDAQ:ICFI)

Locations UK, Belgium, Russian Federation, China, India, Brazil, Canada, USA

Founded 1969

OVERVIEW

ICF International partners with commercial and government clients to deliver professional services and technology solutions in the energy and climate

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 4,500 employees serve these clients worldwide.


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SERVICES PROVIDED

Socioeconomic analysis

Socioeconomic analysis (SEA) is a well-established method of weighing the pros and cons of an action for society as a whole and plays an important role in the authorisation process under REACH. For authorisation applications, the applicant will need to determine, for each use of the

human health and the environment. Based on our 40 years of experience

the practical steps and the key objectives for each stage of the process, including analysis of alternatives, impact assessment, and monetisation of impacts. We are currently contributing to an SEA for REACH authorisation.

Operational support to Siefs and consortia

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

information to assist with communication up and down the value chain.

Science support

ICF International has more than 30 years of experience and more than

exposure assessment, risk characterisation, and risk management. Our experts have applied this knowledge and experience in preparing

of REACH. Examples of support we can provide include assisting with

assessments/reports, helping with safety data sheets, and developing exposure scenarios. See our website for more services provided.

REACH Cost Assessment Tool (REACH-CAT) reports

ICF International and our partner Penman Consulting have developed REACH-CAT reports, a tool designed to help your business understand the work and costs associated with 2013 and 2018 REACH registrations. REACH-CAT reports builds on the knowledge and experience gained in successfully preparing the registration materials for hundreds of substances during the 2010 registration process for REACH. For each substance your business might register, our experts can summarise the actions your company would take for successful registration, assess how your business

indicative costs. REACH-CAT reports will help you to make sound business decisions about which substances to register and your registration strategy.


2009 Software Engineering Institute (SEI) Capability Maturity Model Integration (CMMI) Level 3 designation

2010 REACH outstanding project contributor by a major European consortium

2011 Rank #80 on Forbes America’s Best small 100 companies

2011 Environmental Finance Market Survey – Best advisory/consultancy North American markets (All)

2011 Environmental Finance Market Survey – Best advisory/consultancy EU emissions trading

2012 Environmental Finance Market Survey – Best advisory/consultancy North American markets (all)

2012 Environmental Finance Market Survey – Best advisory/consultancy EU emissions trading

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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

(subcontractor to Penman Consulting) major trade associations in the metals and chemical industries

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 programme management and Sief management support for several major REACH consortia since 2008. These consortia represent hundreds of member companies and high production 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 technical 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. We communicated these costs as well as technical information to Sief members for each substance within the scope of the consortia and worked 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. Each dossier included 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 10% of the dossiers submitted for the 2010 REACH registration. ICF’s technical responsibilities included data collection, literature review, data preparation and entry into IUCLID, mapping of lifecycle stages for industrial chemicals,

TRA and other tools, risk characterisation, and preparation of various other

incorporate changes introduced in the latest major version of IUCLID.

CASE STUDY 3: Classification and labelling

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

data sheets in the US and Europe and have also been incorporated into REACH chemical registration dossiers. ICF currently is tracking GHS implementation in 29 jurisdictions worldwide and is updating C&L recommendations in accordance with how jurisdictions are implementing GHS. ICF also has developed a web-based, searchable database to facilitate access to this information.

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 environmental risk assessments. He has published more than 20 peer-reviewed research papers on the endocrine and environmental regulation of complex vertebrate reproductive cycles.

Stephanie Barrett – Senior Manager

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

facilitation support. Ms Barrett manages projects, budgets, and staff to ensure that client needs are met on time and within allocated resources.

Elizabeth Dederick, PhD – Manager

and risk assessment. She led technical teams of toxicologists and exposure assessors in the development of more than 70 registration dossiers in advance of the REACH 2010 deadline. She is currently involved in human health impacts assessments that are part of REACH authorisation applications. With expertise in REACH hazard and exposure assessment, she specialises in designing exposure algorithms for unique pathways of exposure. Dr Dederick has also conducted multiple literature reviews and is familiar with toxicological literature for multiple chemicals including nanomaterials and endocrine disruptors.

Nikki Maples-Reynolds – Senior Manager

Ms Maples-Reynolds has ten years of professional experience, where she specialises in reviewing and analysing public health studies, conducting toxicological risk assessments, and assessing environmental toxicological risks. She is actively involved in several projects classifying chemicals and substances in accordance with GHS as implemented in the European Union and 28 other jurisdictions worldwide. Ms Maples also manages human health and toxicology support to the U.S. Environmental Protection Agency (EPA) National Center for Environmental Assessment.

Louise Assem, PhD – Senior Technical Specialist

Dr Louise Assem has more than six years’ of experience in chemical toxicological hazard, exposure and risk assessment for human health.

global GHS-aligned regulatory systems, and metals toxicology. Dr Assem has provided toxicology, exposure, regulatory, and project management support to assist clients in their REACH registration and registration updates. She also provides technical expertise on UN GHS-implementation in 29

and mineral ores and ore concentrates (mixtures). Dr Assem is also part of a team which is currently preparing a socio-economic analysis for REACH Authorisation. Dr Assem has recently published on the mutagenicity, genotoxicity and carcinogenicity of inorganic manganese compounds, vanadium and vanadium compounds and human biomonitoring.L M N O P Q O N R S T Q P U V Q W X Y S T Q N Z T O [ \ ] S T Z O [ Z ^ PDr Hecht has more than 13 years of experience in economic and policy analysis, research, and education. One particular area of Dr. Hecht’s expertise is in the application of survey-based stated preference methods to estimate the monetary value of “non-market” goods such as public health, environmental quality, safety, and security. Dr Hecht also has extensive experience in revealed preference methods, which use market data to infer

methods, which adapt previous valuation results to match a new analytical context. Dr. Hecht has conducted and directed policy research on a variety of issues, including public health, and drinking water quality, air quality, hazardous waste recycling, and pricing of water services. Dr Hecht has co-authored several publications that have appeared in peer-reviewed journals.

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CONTACTS

Website www.ihs.com/ehs-sustainability


Head o"ce 15 Inverness Way East, Englewood, Colorado 80112, USA

Tel +1 503 303 6544

Contact Trish Jones

Directors Jerre Stead, Chairman and CEO

Arshad Matin, Executive Vice President

Scott Lockhart, Vice President, EHS and Sustainability

Ownership Publicly Traded Company (NYSE: IHS)

Locations Worldwide

Founded 1959

OVERVIEW

Information management solutions for EHS and sustainabilityIHS is a global information company with leading experts in the pivotal areas shaping today’s business landscape, including chemicals, energy, economics, geopolitical risk, sustainability and supply chain management. IHS is also the leading provider of information management solutions – combining software, content and insight – for environmental, health, safety and sustainability. In today’s business climate, corporate executives are under pressure to reduce operational costs, avoid potential disruptions, and meet escalating external demands from investors and other external stakeholders for compliance with government regulations, voluntary sustainability protocols and corporate policies.IHS enables businesses to meet these challenges by adopting an emerging information strategy called enterprise sustainability management. Global industry leaders are increasingly focused on enterprise sustainability management as a key factor in empowering a culture of operational excellence and identifying a new competitive advantage.


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Information35%

IT & software40%

Training5%

GLOBAL OFFICES

Willoughby Road, Bracknell, West Berkshire RG12 8FB, UK78 Shenton Way, Singapore4777 Levy Street, St. Laurent, Quebec, Canada H4R 2P9Oranjesingel 34, 6511 NV Nijmegen, The Netherlands9 Monroe Parkway, Suite 150, Lake Oswego, Oregon 97035, USA

SERVICES PROVIDED

IHS Product Stewardship Solution™

The IHS Product Stewardship Solution™ helps your business maintain access to existing markets while accelerating opportunities to introduce products in new jurisdictions. Powered by industry-leading information management products IHS Intelligent Authoring™, IHS Comply Plus® and IHS DolphinRTK™, this comprehensive solution combines software, content and industry expertise, enabling organisations to

regulatory mandates at every stage of the product lifecycle, from product design through manufacturing. IHS supports your company’s compliance programme with these powerful information management capabilities:

SDS Authoring – Create product hazard communications documents in nearly 50 languages, ensuring your employees and customers will have the information they need to ensure safe use of

Documentation and Labels – Simplify the process of producing labels and regulatory documents while reducing your company’s

Product Compliance Analysis – Minimise risks to your company’s go-to-market strategy by aligning regulatory compliance analysis with your product lifecycle management plan. IHS helps you keep your

Chemical Management – In order to identify opportunities to reduce costs and optimise operational processes while maintaining

Supply Chain Communications – Improve communication between your internal stakeholders and suppliers, so you can

Quality Risk Management

IHS enables your business to make your product stewardship programme

sustainability management, and supported by a single world-class provider.

Managed regulatory content

IHS managed regulatory content provides unparalleled support to our solutions for environmental, health, safety and sustainability. IHS product stewardship content consists of information on more than 300,000 chemical substances, 15,000 regulatory phrases in nearly 50 languages, 7,500 proprietary rules, and 100 templates spanning more than 50 countries.

Enterprise sustainability management strategies

Companies are struggling to address escalating external demands from

issues, including product stewardship, environment, health and safety, risk management, natural resources, social responsibility and governance. An enterprise sustainability management (ESM) information strategy

optimise resources – uncovering opportunities for innovation and growth.ESM establishes a structure for managing sustainability performance by collecting, aggregating and reporting information from the bottom up – from the laboratory to the executive suite – as part of your big data and analytics strategy.

Industry and domain expertise

IHS domain and technology experts possess a wealth of domain knowledge and have proven experience at global implementations that ensure alignment with our clients’ business requirements. IHS regulatory

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experts continuously monitor and track legislation changes in order to

enable organisations to contain costs while reducing business risks.


1959 IHS founded

2005 IHS becomes a publicly-traded company

2007 IHS launches EHS & Sustainability Business

IHS acquires Environmax

2008 IHS acquires Environmental Software Providers

IHS acquires Dolphin Software

2009 IHS acquires Environmental Support Solutions

2010 IHS named Leader in Carbon and Energy Management

IHS acquires Syntex Systems

IHS acquires Atrion International

IHS acquires Chemical and Energy Products

2011 IHS named Enterprise Sustainability Management Solution

IHS acquires Dyadem

2012 Analyst study names IHS a leader in environmental management software

IHS acquires CyberRegs Business from Citation Technologies

IHS acquires GlobalSpec

PARTNERS

CH2MHill, Deloitte, E2 ManageTech, Environmental Resources Management (ERM), EnVizTec, IBM, Kozo Keikaku Engineering (KKE), Microsoft, MicroStrategy, OSIsoft, OSyS, SAP, Trinity Consulting, URS

CLIENTS

For more than two decades, IHS has been trusted by hundreds of enterprise-level clients worldwide across a vast array of industries, including chemicals, pharmaceuticals, energy, mining, manufacturing, transportation, consumer goods, defence and government.

CASE STUDY 1: Americhem

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.Solution: Americhem implemented a global product stewardship solution from IHS that enabled the company to streamline its processes andsupport its globalisation efforts. This software and regulatory content suiteof products provides seamless raw materials management, auto creationand authoring of SDS in nearly 50 languages.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.

CASE STUDY 2: Dow Chemical

Challenge: Dow was looking to replace multiple legacy environmental reporting systems. Previously, Dow used multiple legacy systems for regulatory reporting, but those systems were no longer sustainable, varied between sites, and required duplicate resources for support. The company also was looking to develop and standardise best practices with a single robust reporting system across 200 US facilities.Solution: Dow implemented the IHS Environmental Performance Solution™.

Result:for repetitive support roles and reduced structural costs at multiple sites. Dow was able to save $2m in redundant legacy systems and improve its

STAFF SELECTION

Je# Ladner, Senior Director, EHS and Sustainability Solutions

solutions that enable global organisations to proactively address EHS and

performance. Under Ladner’s leadership, IHS has established a strong reputation for enabling corporations to develop and execute sustainability strategies through a holistic, integrated view of operational performance. He has nearly two decades of experience meeting market demand for

environmental, energy and carbon management, risk management, product stewardship and corporate responsibility programmes.

Francis Trudeau, Solutions Manager

Francis Trudeau has worked for nearly 15 years in product compliance and

management and development, global regulations and industry standards 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.Trudeau is a recognised industry expert, serving both as a featured speaker at international conferences and leading multi-organisation task forces in establishing industry best practices for regulatory compliance.

Mary Rudolph, Senior Manager – Global Content

Mary Rudolph has more than 25 years of international environmental, health and safety experience, including technical and business implementations of authoring services. She offers IHS customers an in-depth and often sought after understanding of the needs of global EHS departments. She has also managed the development of EHS-related databases, including RTECS®, a recognised toxicology database.

Mark Blainey, Senior Regulatory Analyst

Mark Blainey has been involved in EU chemicals legislation for more than 15 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 regulation. Prior to joining IHS, he served as Director at the Policy Analysis and Chemical Evaluation (PACE) SPRL, a consultancy expert in EU chemical policy during which he helped a number of companies with their REACH registration submissions.

Carrie Decatur, Regulatory Analyst

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

Sue Barton, Senior Regulatory Analyst

Sue Barton brings more than 20 years’ experience in the regulatory compliance arena to help IHS customers navigate ever-changing chemical management regulations. Her expertise in research and development, interpreting regulations and developing system customisations, helps IHS customers meet their compliance challenges.

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CONTACTS

Website www.intlcosmetics.com


Head o"ce 947 Manhattan Beach Boulevard, Suite A, Manhattan Beach, CA 90266, USA

Tel +1 310 545 3223

Fax +1 310 546 6204


Directors Janet Winter Blaschke

Georgia Boehm


Locations USA, UK

Founded 1997

OVERVIEW

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


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Information10%

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GLOBAL OFFICES

USA: International Cosmetics and Regulatory Specialists LLC UK: International Cosmetics and Chemical Services Ltd

SERVICES PROVIDED

Responsible person, product information files, and safety assessment, cosmetic product safety report

We provide full regulatory services in Europe, including labelling requirements.Responsible person (RP) services. RP is responsible for:

holding and maintenance of PIFs for legally required access by competent authorities. If a company does not own their formulas, we provide an agreement between the brand owner, the contract

agreement in place we only share information with an EU authority

Only representative (REACH), CLP notifications (sole representative)

Only representative services for companies needing chemical registrations for the EU scheme under REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). Late pre-registration and full registrations have already been successfully provided for many clients.

sheets to meet the requirements of REACH and CLP.

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

Products such as Acne and any product containing SPF ingredients must be registered with the FDA. We can act as the US agent for foreign manufacturers (which is mandated by FDA) and provide the mandatory facility, distributor and product FDA electronic registrations.FDA registrations must now be done electronically, which is a service we provide. We provide cosmetic and over-the-counter drug label review, training and cGMP facility and standard operating procedure audits. Expert witness testimony services in many areas of product development, product liability, and technical services are also available.

Training for GMPs and ISO manufacturing standards

A wide variety of experience facilitates custom services for international needs with the intricacies of each individual organisation in mind. Focus

multiple countries, or for an individual project for one country. We provide GMP training and audits to the newly-required ISO 22716


REACH

2007 Formed REACH Chemical Consulting, Ltd now known as International Cosmetic and Chemical Services, Ltd.-UK

2008 Filed pre-registrations for US and international companies to meet the EU regulation.

2009

2010 deadline. This resulted due to a company who missed

using the ingredient at 1 ton or more the previous three years.

2010 Preparation of safety data sheets (SDS) to meet the REACH and CLP requirements.

2011 Continuing with SDS creations, REACH late-preregistrations, Sief coordination for clients and their chemicals, continue

ISO

2006 Designated expert in the Cosmetic ISO workgroup for TC-217, Cosmetic GMP, Sunscreens and Microbiology in Paris.

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2006 Designated expert in Cosmetic GMP and Sunscreenworkgroup in Den Haag, The Netherlands.

2008 Designated expert Cosmetic GMP and Microbiology workgroup in Paris.

2009 Designated expert Cosmetic GMP and Microbiology workgroup in Baltimore, MD, USA.

2010 Designated expert Cosmetic GMP, Microbiology and Sunscreens workgroup in London

2011 Designated expert Natural and Organic Terminology workgroup in Kyoto, Japan

cGMP audit

ICRS continues to excel in meeting cGMP compliance training and audits in the USA as well as internationally. These activities are designed to meet the individual companies and their unique cultures. Staff use ISO

depending on the market and or country needs.

ACCREDITATIONS

Personal Care Products Council (Formerly CTFA) Society of Cosmetic Chemists (SCC) Regulatory Affairs Professionals (RAPS) American Society for Quality (ASQ).

Chartered biologist, Society of Biology, UK

PARTNERS

Manhattan Repro (graphic design for labelling)

CLIENTS

Alterna, Arbonne International, California Tan, CB Fleet Co, Circle of Friends, Contem 1g (Brazil), Davi (Mondavi) Skin, Disney Consumer Products Inc, Dermanew, Econet, Inc, Frederic Fekkai, Freeman Beauty, Giorgio Nardi (Italy), Go Smile, Henkel Consumer Goods, ICN Pharmaceuticals (Valeant Pharmaceuticals), Johnson and Johnson Consumer Products Inc, Jordana Cosmetics Corp, Juvena/La Prairie (Switzerland, Germany), Laboratoire Labothene Cosmetique GMbH (Germany), Leaf & Rusher, M&K (JK Mueller & Myung Sun), Nu Skin, Ole Henriksen, Pental Soap Products (Australia), Pierre Fabre Dermato-Cosmetique (France), Pola Cosmetics (Japan), Procter and Gamble, Rock & Republic, Sexy Hair, Smashbox, TIGI (Toni and Guy), Twincraft Soap Company, Zenyaku USA, and many others.

STAFF SELECTION

Janet Winter Blaschke, BA, Biology, University Redlands

CEO of International Cosmetics & Regulatory Specialists LLC. CEO and founder US, and managing director of International

Cosmetic and Chemical Services Ltd. in the UK, serving the consumer products and chemical industries.

30 years of experience as a product formulator and regulatory expert has given her unique expertise in both the European and US regulatory schemes.

founder, instructor and lecturer for cosmetic science programme at UCLA (University of California at Los Angeles). Topics include:

quality control of cosmetic products.

contributing author to SCC publications chartered biologist, Society of Biology, United Kingdom

Georgia Boehm, AA Business Management, Glendale College

director Regulatory Affairs - International Cosmetics & Regulatory Specialists LLC, expert in yield and accountability documents for compliance with REACH regulations

30 years of experience in cGMP compliance, regulatory and quality systems, international registrations, FDA registrations, FDA drug compliance for claims and labelling and facility

corporate experience: ten years at Neutrogena Corporation, six years at Herbalife International, and contract manufacturing management

Deborah Rediet, BA French and International Relations, California State University Long Beach

regulatory manager - seven years’ experience in regulatory affairs in Canada, the US, Europe and Asia

expert in labelling compliance and PIF requirements

regulatory affairs, College of Science

Harmony Gates, MS Chemical Engineering

chemical engineer - 12 years’ experience in regulatory affairs in the

issues

Robert Blaschke, BA, French, Loyola Marymount University

regulatory affairs specialist.- four years’ experience in FDA compliance in the USA

expert with FDA electronic registrations and IT portal IT specialist

Monique Chheoun, BA Asian Studies, California State University at Long Beach

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CONTACTS

Website www.intertek.com/green/chemicals/


Head o"ce 25 Savile Row, London W1S 2ES, UK

Tel +44 0161 245 8071

Contact Jeremy Ramsden

Directors Sir David Reid, Chairman

Ownership Public

Locations Intertek is the industry leader with more than 33,000 people in 1,000 locations in over 100 countries.

Founded The Intertek story starts at the inception of the modern testing industry. The history of Intertek spans 126 years, and evolved from the combined growth of a number of innovative companies.

OVERVIEW

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


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10% Information3%

Laboratory55%

Training3%

Other29%

GLOBAL OFFICES

USA: 801 Travis, Suite 1500, Houston, TX 77002, USA, +1-877- 274-0181Germany: Stangenstr 1, 70771 Leinfelden-Echterdingen, Germany, +49 711 27311 152 China: 4/F, Block B, JinLing Business Square, No. 801, Yi Shan Road,

6127 6132

SERVICES PROVIDED

Advisory – services to help you advance your business

Auditing – services to help you control operations

Certification – services to help you reach new markets

Outsourcing – services to help you focus on core activities

Quality assurance – services to help you meet expectations

Training – services to help you improve your performance

Testing – services to help you improve your performance


2004 ASG in Manchester, UK was acquired from Zeneca and Avecia.

2007 MSG in Wilton, UK was acquired from ICI.

2010 Intertek acquires CIBA Expert Services and Cantox Health Sciences International.

2011 Intertek acquires Moody International.

2011 Intertek acquires Analytical Sciences Americas (ASA).

2011 Intertek continued to expand and develop services in the 25-plus industries it operates in.

2011 Intertek is a partner to some of the world’s most loved brands and their suppliers and this work continued in 2011.

2011 Demand for Intertek’s work was fuelled by its clients’ desire for greater quality, safety and sustainability in their products,

expansion into new markets and product innovations.

2011 Intertek’s underlying business grew at a rate of 8% during the year – a strong performance given the pressure of global economic uncertainty on many companies.

2012 Intertek acquires Laboratory Services International BV (LSI) Mineral Laboratory.

Intertek wins UK National Business Awards for exceptional leadership, customer focus, staff engagement and innovation.

Intertek Group plc completes acquisition of NDT Services Ltd.

ACCREDITATIONS

As a company Intertek believes that acquiring the appropriate quality accreditations and maintaining membership (and in many cases) chairing industry regulatory groups and standards organisations is key to not only our development but to providing quality assurance and insight

company on different boards. Examples of these would be: Dr Naeem Mady – industry segment council board member and

a national board council member at the the Plastics Industry Trade

Dr David Bechtel Dr Paul Lambert – committee member of the European Structural

Dr Ian Fletcher Dr Je# Franks Dr Neil Everall – European editor of Applied Spectroscopy journal.

CLIENTS

Our clients include: Behr, Bosch, BP, ChevronTexaco, Citgo, ConocoPhillips, Haier, Lubrizol, Petrobas, Siemens

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TESTIMONIALS

"Working with Intertek Group as our EU REACH only representative has been a rewarding experience. Intertek has provided guidance to CITGO, with respect to legal issues, suppliers, customers and changes of the new EU legislation. CITGO has relied on Intertek's global knowledge and assistance to meet each and every goal within the strict timeline demanded by legislation, suppliers and customers. Intertek continues to help CITGO develop and grow our markets." – Citgo“I would like to let you know that I am surprised with the high speed and high quality of the work you and your team have been doing to generate e-SDS for Braskem. I am very thankful for your special support. You made us feel important and we saw your special effort urgency sense dealing with our requests. Your special effort last month was outstanding and helped us a lot. I also wanted to inform you that Braskem Netherlands BV were inpected by Dutch government in regards to OR scope for all Braskem companies and all e-SDS checked were in compliance with REACH / GHS rules. Thank you so much!” – Braskem SA“NOVA Chemicals Corporation contracted with Intertek in Europe to provide support as our only representative under REACH in Europe enabling us to have the registration dossiers completed and submitted well in-time and ahead of the 2010 deadline under the regulation. Intertek also represents Nova Chemicals interests for certain chemicals having registration deadlines 2013 and 2018 making it possible for us to continue selling our products in Europe without interrupting the supply chain. In addition Intertek

and labeling regulation in Europe supporting us and our EU-customers managing their legal obligations. We have had very good collaboration with Intertek and would like to offer a special thank you for their support, professionalism, and dedication. We look forward to a continued and long excellent relationship with Intertek.” – NOVA Chemicals Corporation

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

dossier for REACH is to ensure the registrant is certain that the substance is

it is to decide on a registration strategy. In one case our client was uncertain

our expert spent several hours discussing the problem. As the descriptions became quite complicated this led to the point that our expert was invited

explanations onsite it became quite evident that the substance in question was not eligible for registration and hence was exempted. Looking back it was good money invested in thinking it through and well worth the trip to the site as

easily saved € 50k in consulting charges and multiples thereof in testing costs.

CASE STUDY 2: Intertek: helping to reduce letter of access costs

Safer health and beauty products: recently the European Commission concluded that REACH has improved the safe use of chemicals both

companies are working with Intertek to meeting their REACH obligation ensuring the safe use of their specialty chemicals in various applications, including health and beauty products. Other legislations require that safety assessments are performed on cosmetics and their ingredients and that their packaging is correctly labelled. Intertek experts globally provide safety solutions to ensure that cosmetic products can be used safely.

CASE STUDY 3: Intertek’s global network of experts helps clients achieve cost-e#ective registrations worldwide

As most companies focus more and more on core competencies such as R&D, marketing and production, it is our role as true service provider to help our clients with exactly those support services no longer considered core.

For instance, our analytical, regulatory and environmental compliance services focus on these competencies ensuring that our clients can draw from our global network of experts, particularly in North America, Europe

requirements locally we helped a multinational chemical company save €80k by coordinating the testing requirements for China, Japan and Europe.

STAFF SELECTION

Dr Andrew Swift – Executive Vice President Chemicals and Pharmaceuticals

Andrew Swift is executive vice president of Intertek's Chemicals and Pharmaceuticals division, which role he assumed in January 2008. Prior to this, he was vice president of global outsourcing within Intertek's Commodities Division. Dr Swift joined Intertek in 2001 as business development manager of the group's laboratory facilities at Sunbury (UK). Both of Andrew's degrees are from UMIST and he is a chartered chemist of the Royal Society of Chemistry.

Dr Ruud Overbeek – Vice President, Global Health, Environmental and Regulatory Services

Dr Ruud Overbeek manages Intertek’s Health and Environmental (H&E) business which includes restricted substances, REACH, and climate change-related services. Ruud and his global team deliver solution-led services to

He is a regular author in respected industry and environmental publications, holds advisory roles on environmental business impact within the US health and beauty industry’s governing association and has a doctorate in chemistry.

Dr Marc Thouin – Vice President, Regulatory Services

Dr Thouin is vice president for regulatory services and bears the operational responsibility globally. He studied natural sciences at the Swiss Federal School of Technology in Zurich and obtained his PhD in toxicology in 1983, followed by a postdoctoral study at GDSearle in Chicago, USA.

Torben Nörlem, Esq – Chief Counsel

Torben Nörlem, Intertek’s senior legal counselor, has a LLM in Law from the legal faculty at Copenhagen University and 15 years’ experience working with product related legislation and regulatory framework. Torben has been working as chief counsel for health and environment with Interek since 2008. Torben was responsible for legal affairs related to the REACH legislative process and was a participant of the Danish government negotiation team during the negotiations in the European Union. He was also responsible for implementation and administration of EU rules regarding chemicals in electronics in Denmark.

Dr Michael Leise – Senior Expert Consultant

Michael Leise is one of Intertek’s regulatory affairs senior expert

strategies for chemicals worldwide, test-programme development,

bodies. He studied at Heidelberg, researched in Boston at MIT and aquired environmental expertise at TÜV Rheinland before he joined Ciba Specialty Chemicals in Lampertheim as head of product safety in 1995.

Dr Manuela Corazza– Global Regulatory Operations Manager

Manuela Corazza is Intertek’s country manager for Italy’s Regulatory Services, Global Operations support manager, and a senior regulatory projects manager.

Karen Levins – SVP, Global BD & Marketing, Intertek Cantox Health Sciences

Karen Levins serves as Interteks’s senior vice president, Global Business Development Cantox and vice president Chemicals Group Cantox. As a regulatory toxicologist with more than 19 years’ experience, Ms Levins helps the chemical industry understand and comply with global regulations controlling the manufacture, importation, distribution, and use of new and existing products.

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CONTACTS

Website www.ipoint-systems.com


Head o"ce Ludwig-Erhard-Straße 52-56, 72760 Reutlingen, Germany

Tel +49 7121 144 89 60

Fax +49 7121 144 89 89

Contact Christoph Junk

Directors Jörg Walden, CEO

Hans-Gerhard Lang, Director Sales

Christoph Junk, Director Marketing

Ownership Private (Germany: GmbH, US: Inc, GB: LLC)

Locations Germany, Austria, Great Britain, France, China, USA

Founded 2001

OVERVIEW

iPoint is an expert in environmental product compliance and sustainability, specialising in software, consulting and training for managing, tracking and reporting throughout the supply chain from product concept to completion. iPoint delivers adaptive and comprehensive software solutions that give the visibility and control customers seek in managing sustainability.

REACH, RoHS, or RRR, and at the same time increase the sustainability of your products (LCA, DfE). Our solutions facilitate easy tracking of your environmental impact, and implementation of your product sustainability goals.


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20%

Representation

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Information10%IT & software

55%

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GLOBAL OFFICES

Reutlingen (Headquarters), Dortmund, Vienna, Manchester, Paris,

SERVICES PROVIDED

Software solutions

Environmental product compliance and sustainability: ELV, IMDS, RoHS,

innovation, SDS, dangerous goods management.

Consulting

Sustainability strategies, business and process analysis, impact analysis, EH&S consulting, sustainable products and brands, sustainable supply chain, sustainable manufacturing

Training

sustainability

Data care services

Sustainability services for handling data from companies’ supply chain


2001 iPoint-systems gmbh founded in Reutlingen/Germany

2002

2007

2008

2010 Acquisition of KERP GmbH in Austria

2012 Gartner recognises iPoint-systems as Cool Vendor Quality seal “Top 100”: iPoint-systems is Innovator of the

Year 2012

2012is an on-demand software solution which enables companies

meet the requirements of their customers and the regulatory authorities.

PARTNERS

AIAG, TetraTech,

CLIENTS

OEM: Daimler, Jaguar/Landrover, Nissan, Renault, Honda, Hyundai/KIA, GM

Supplier: Automotive Lightning, Johnson Controls, Mahle, Valeo, Magna, Lear

Electronics: Bosch, ZUMTOBEL, Electrolux

Manufacturing: Rexroth, Voith Other Industries: Tesa, Lavazza, HP, MTU, Sika

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TESTIMONIALS

Gartner recognises iPoint-systems as Cool Vendor 2012: Why cool?

“Holistic solutions covering a sustainable supply chain management remain absent from the marketplace.

In existence since 2001, iPoint’s solutions however provide a robust and well-tested technology platform for managing environmental compliance and sustainability requirements in complex discrete and increasingly regulated manufacturing environments.

Central to their solution suite is their Compliance and Sustainability Hub which acts as an integration platform for critical compliance, materials and sustainability data”

http://www.ipoint-systems.com/en/newsroom/news/news-details/artikel/weltweit-fuehrendes-analystenhaus-waehlt-ipoint-systems-zum-cool-vendor/

Quality seal “Top 100”: iPoint is one of the three main award winners

“With its integration and compliance solutions, the globally operating software and consulting company has zeroed in on future issues such as resource saving and health and safety.

iPoint-systems convinces by its ability to react to changing circumstances quickly. Due to its excellent monitoring processes, the company can detect new market developments. Moreover, customers are involved in the developing projects. Overall, the company’s management level excels in its extraordinarily strong commitment in innovation management.”

http://www.ipoint-systems.com/en/newsroom/news/news-details/artikel/ipoint-systems-ist-innovator-des-jahres-2012/

CASE STUDY 1: Automotive Lighting

iPoint-systems optimises global ELV processes at Automotive Lighting with Compliance Agent’s IMDS Solutions.

material datasheets (MDB) for annual average of 75 new products – about two per day. This means that on top of our own MDB, we receive about 20 times as many again from suppliers – which

by ensuring that delivered data was both on time and correct was therefore the main priority for the new IT-solution

http://www.ipoint-systems.com/en/newsroom/brochures/#c1369

CASE STUDY 2: MagnaSteyr

Legally Compliant and Sustainable Designed Products for MAGNA STEYR:

main motivation for the project: use of a software tool that facilitates compliance with regulations governing material recycling and recovery. A steadfast commitment to the environment begins with the development of green products while considering each individual life cycle stage

in a joint effort with MAGNA STEYR, we have successfully developed iPoint RRR. This tool greatly reduces the time needed to calculate recycling and recovery rates, allowing simulations of different recycling scenarios while emulating novel recycling technologies.

http://www.ipoint-systems.com/en/newsroom/brochures/#c1369

CASE STUDY 3: iPoint-systems equip Turkish household goods sector leader with new software solution

In the EU, housewares producers are faced with innumerable regulations. In particular, surface properties and pure substances of imported products are closely monitored.

goods sector has chosen the iPoint Supplier Entry Portal (SEP) and the Compliance Agent (module SAM-M).

www.ipoint-systems.com/en/newsroom/news/

STAFF SELECTION

Management consulting

Chemical and material experts

Software engineering

Support and services

Sales and marketing

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CONTACTS

Website www.jsci.co.uk


Head o"ce Simpson House, Windsor Court, Clarence Drive, Harrogate, North Yorkshire, HG1 2PE, UK

Tel +44 (0)1423 520245

Fax +44 (0)1423 520297

Contact Dr Samantha Wright or Dr Richard Elsmore

Directors Lucy Croucher, Managing Director

Denis Kaye, Finance Director


Locations UK

Founded 1992

OVERVIEW

JSC International Limited is a privately owned independent European consultancy company predominantly providing regulatory support to the chemical, agrochemical and biocides industries.At JSC we have a dedicated team of highly motivated people with backgrounds from government, industry and contract research. Our integrated, cross-discipline working practices enable us to provide novel and innovative approaches to problem solving, supported by our excellent


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20%

Training5%

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GLOBAL OFFICES

JSC International Limited, Simpson House, Windsor Court, Clarence Drive, Harrogate, North Yorkshire, HG1 2PE, United Kingdom

SERVICES PROVIDED

REACH services

We have prepared a large number of registration dossiers and chemical

of REACH such as data evaluation and study monitoring. JSC have Sief/consortium management experience and ensure that the deadlines of your project are met. We are able to help with the preparation of consortium agreements, communication within the consortium and ensure an effectively running consortium. JSC are able to help downstream users identify their obligations and provide training to ensure continued compliance.

CLP/GHS

data sheet creation including the extended safety data sheet containing exposure scenarios.

DGSA

JSC can offer dangerous goods safety adviser services for the transport of hazardous goods. Our experts can act as your company DGSA, provide support, auditing and training.

Biocidal products

JSC offers regulatory support for both active substances and biocidal products. We have experience of submitting active substance dossiers for a wide range of product types under the BPD. For biocidal products we routinely submit national registrations and have good contacts with regulatory authorities in all member states within the EU. We are also active in submitting BPD/BPR product dossiers following Annex I inclusion. We are able to offer support to a diverse range of biocidal products.JSC can also offer more general regulatory support to biocide

testing, claim support and risk assessment and the impact of the new Biocidal Products Regulation.

Agrochemical products

JSC has extensive experience in the preparation, submission and regulatory support of EU dossiers and national draft registration reports. We have an excellent track record of successful EUapprovals and national authorisations, and are well placed to assist you in the development of strategies to support your compounds in Europe.


1992

1996

2004 Management buy-out

2005 Biocides expertise consolidated

2006 Development of expertise in REACH

2008 Consolidation of REACH capability

2010 Preparation and submission of a large number of REACH dossiers/CSRs

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ACCREDITATIONS

or PhD). Our senior toxicologists are Society of Biology / British Toxicology Society and EUROTOX registered and our DGSA has current

two fellows of the Society of Biology (FSB).

PARTNERS

Network of locally recognised contacts across the globe.

CLIENTS

Our clients range from large international companies to SMEs located worldwide.

TESTIMONIALS

constraints.

CASE STUDY 1: REACH dossier preparation

JSC has provided REACH dossier preparation for a number of complex and hazardous chemical substances. These substances have required

monitoring of studies. JSC has also been responsible for the production of the registration dossiers for the lead registrants and members of the consortia in IUCLID 5 and for developing the chemical safety report and working with the consortia members to identify downstream user descriptor codes. The project was a success culminating in the successful submission of substance dossiers for the 2010 and 2013 deadlines.During the development of these dossier and safety assessments JSC has had to work with consortia members and downstream users to identify relevant use patterns and in the development of appropriate RRM and in the production of meaningful extended SDS.

CASE STUDY 2: REACH downstream user support

JSC has successfully provided support to downstream users. Through training and consultations, JSC has provided the expertise and knowledge for downstream users to determine their obligations under the REACH Regulation, understand the implications of supply chains and effectively plan their regulatory strategy and compliance.

CASE STUDY 3: New substance registration

a new non-phase in substance. This substance dossier has now been upgraded through the tonnage bands.

STAFF SELECTION

Lucy Croucher – Managing Director

Lucy Croucher has been working in the area of European agrochemical regulatory affairs since 1994. She has managed large scale projects for the preparation, submission and support of EU dossiers for existing active substances, resubmissions and new active substances under Directive 91/414/EEC. To date, JSC has been involved in the successful Approval of 17 active substances.Lucy is currently advising Clients on Annex I renewals and the implications of Regulation (EC) No 1107/2009.

Dr Samantha Wright – Regulatory A#airs: REACH

Samantha Wright is an experienced REACH manager with previous responsibilities for tracking and implementing worldwide legislation to ensure global regulatory compliance. Samantha has experience in the preparation and submission of REACH dossiers and consortium management, as well as a number of years authoring safety data sheets

with strategy planning for business compliance and delivering training for REACH and CLP.Samantha’s background in regulatory affairs was gained through working with clients in the cosmetic, pharmaceutical and industrial sectors.

Dr Richard Elsmore – Regulatory A#airs: Biocides and REACH

Richard Elsmore has held a number of senior roles with speciality chemical manufacturers and formulators and has experience of working

of operating within the global chemical market and with FMCG’s. Richard has worked in technical, regulatory and business management positions and has been involved with a number of industry bodies at EU level. He is also a director of the British Association for Chemical Specialities (BACS).Richard has experience of submitting a number of dossiers under REACH (1907/2006), BPD (98/8/EC) and PPPD (91/414/EEC) as well as submissions to national regulatory authorities. He has been actively involved with a number of industry bodies on the implementation of the

additionally sits on the BSi Technical Committee on disinfectant standards (CH/216) and has represented BSi within CEN. He has also worked on both method development and the assessment of individual chemicals in the human and environmental risk assessments programme (HERA).

Dr Justine Weyman – Regulatory A#airs: Agrochemicals and REACH

Justine has experience of working on REACH projects for a number of years and is responsible for project management, assistance with product dossiers and contacts with ECHA and national regulatory authorities. Her background is both within national regulatory authority, industry and consultancy.

Peter Chapman – Director of Regulatory A#airs

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

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CONTACTS

Website www.kft.de, www.kft-academy.com and www.KFT-ebook24.com


Head o"ce Im Leuschnerpark 3, 64347 Griesheim, Germany

Tel +49 6155 86829 0

Fax +49 6155 86829 25

Contact Dr Karl-Franz Torges, Ludwig Winkler

Directors Dr Karl-Franz Torges, Managing Partner


Locations Griesheim (near Darmstadt), Germany

Founded 1995

OVERVIEW

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


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55%

Representation

& management

16%

Information14%

Laboratory3%

IT & software2%

Legal2%

Training8%

SERVICES PROVIDED

Hazardous substance consulting

Safety data sheets

Generation of EU safety data sheets (SDS) in accordance with current legislation (including GHS) for substances or compounds in all European and other languages ie Turkish, Russian, Malay, Chinese Mandarin and Thai, with particular consideration of national requirements MSDS for US/ Canada according to current local legislation. A comprehensive concept of SDS maintenance packages has been successfully introduced allowing customer’s permanent updating of safety data sheets (SDS) pursuant to statutory requirements. The total care service is completed by the latest innovation KFT SDS Control & Care, covering the management of supplier SDS.

Working instructions

Generating of working instructions pursuant to §14 of the Ordinance on Hazardous Substances (Gefahrstoffverordnung – GefStoffV) and the technical standards for hazardous substances (TRGS) 555.

Labels

Creation of the right labels including individual layouts to adhere to current regulations/ languages with particular considerations of the biocide directive. Labelling for exports to US and Canada to meet their prevailing standards

Research

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

Product registration

Registration pursuant to §16e of the German Chemicals Act (ChemG), the German Federal Institute for Risk Assessment (BfR), the German Detergents and Cleaning Agents Act (WMRG) and product registrations in Switzerland, Greece, the Netherlands, the US and other nations.

REACH

KFT Chemieservice has been working with REACH since 2001. Since that time we have prepared a number of companies for REACH, devised practical solutions by deploying task forces, and have carried out more than 3,000 pre-registrations for our customers. We offer you:

preparations of IUCLID dossiers and CSR (chemical safety reports).Our REACH and management services cover:

impact analysis, strategic and operative REACH consulting, portfolio as well as supply chain communication consultation.

Our Sief management provides:

services, conducting studies and organisation of data sharing , communication with customers, authorities and competitors.

Biocides

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

Seminars,training and coaching

The very popular and much appreciated coaching support has been continuously developed for a broad spectrum of seminars around the compliance aspects of REACH, SDS, GHS / CLP and biocides. The available selection can be found at [email protected] training and customised coaching are available on demand at [email protected]. Monthly webinars can be accessed free of charge.The launch of ebooks on legal aspects around Compliance has started 2013.

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1995 Foundation of KFT Chemieservice in Rellingen , near Hamburg, Germany

1996 First training for the generation of MSDS for Europe and US

1998 First registration according to the existing substances regulation 793/93/EC

2000 Relocation of the company to Griesheim, Germany

2008 First only representative contract with Brazilian company

2010 > 3000 pre-registrations, > 60 substances registered,

2010 Launch of KFT-ChemDoc24.de

2011

2012 Introduction of SDS Control & Care

2013 Launch of KFT-Ebook 24 with legal information worldwide

ACCREDITATIONS

VCH (association of chemical suppliers) subsidiary of FECC (European Association of Chemical Distributors)Member of ENES (European Network on Exposure Scenarios)

PARTNERS

Tradas Translations and Consulting Services (Flexible customised solutions for linguistic and technical needs)

CLIENTS

Chemical manufacturers, distributors, importers of consumer goods, biocide substances, pharmaceutical raw materials, hygiene products for veterinary applications, household cleaner formulations and other products.

CASE STUDY 1: Marketability study

Consumer goods providers must take many legal stipulations into consideration. Particular attention is paid to hazardous materials and hazardous cargo. Usually, these providers are distributors and not manufacturers of the products. Therefore, a few traders have established a partnership with KFT Chemieservice GmbH, in order to verify product compliance. Together with the tender, suppliers of the consumer goods

GmbH that all documents and labels conform to legal regulations. KFT Chemieservice checks the requirements and legal conformity with regard to:

and ultimately issues approval for marketing.

CASE STUDY 2: Marketability study 2

Medium sized chemical companies strategically expand their marketing range. In-house experts are normally familiar with the details of European regulations. But what are the regulations for transport, warehousing and labelling in exotic countries? We check the requirements in this area using the target country list, create checklists and make recommendations for labels. The customer receives detailed and reliable documentation about the requirements.

CASE STUDY 3: REACH lead registrant support

Our strength is the support of the medium-sized industry, whose core competence does not lie within the production or handling of chemical products. The REACH requirements are particularly problematic here.

registrant or Sief facilitator appointed for strategic products, we evaluate the registration capacity of the material by our customers, check the competition situation and identify possible co-registrants. After a positive economic evaluation by our customer, we facilitate the registration of the material. Thus, we cover all steps of the process. We perform the Sief survey with the available data in consideration of the interests of

negotiations with data keepers and contract testing labs to close the

registration with the ECHA. As a result of this, the client receives the registration number. KFT markets the letter of access to other registrants. As an additional service, we create the safety data sheets with appendix (exposure scenarios) in all EU languages. We provide one-stop service for the client.

STAFF SELECTION

Dr Karl-Franz Torges – Managing Partner

Dr Karl-Franz Torges is founder and managing partner of KFT Chemieservice GmbH, heading the business unit REACH and Registrations. Familiar with hazardous materials, hazardous cargo, MSDS and registrations since 1989. Several years experience in working with software companies focusing on compliance software (SAP EH&S). Since 2001 instrumental participation for the development of software tools for

for the development of IUCLID 5.0. Consulting and training projects and workshops for hazardous materials management, registrations, and chemical compliance.

Angelika Torges – Member of the board

Board member and heading the division hazardous materials, marketability study and MSDS. Experience and responsibilities in these

companies. Expertise in toxicology, ecotoxocology, chemical compliance

Restriction Ordinance on Chemicals.

Other sta#

Majority of staff are PhD chemists, biologists and experts in food technology with years of experience for material registrations and MSDS. In-house training is a strong focus and sustainable external training is obligatory.

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CEC


CONTACTS

Website http://the-ncec.com/


Head o"ce Ricardo-AEA, The Gemini Building, Fermi Avenue, Harwell, Didcot, UK, OX11 0QR

Tel +44 (0)870 190 1900

Fax +44 (0)870 190 6318


Directors Daniel Haggarty

Ownership Part of Ricardo-AEA

Locations UK

Founded 1973

OVERVIEW

The National Chemical Emergency Centre (NCEC) offers a 24-hour emergency response service that provides fast, trusted and up-to-the-minute advice to emergency services dealing with chemical incidents. NCEC also offers a number of other commercial emergency response services.Since 1973, NCEC’s exceptional products and services have set global standards on emergency response and compliance, and have helped its customers to manage risks associated with working with chemicals.In addition, its commercial emergency response services have helped companies to provide and obtain specialist advice and information when dealing with chemical emergencies.NCEC can help with all aspects of chemical risk management and

SDS authoring.


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20%

Representation

& management10%

Information20%Laboratory

10%

IT & software10%

Training10%

GLOBAL OFFICES

UK, China, Czech Rep, Germany, India, Italy, Japan, Korea, Russia, USA, Malaysia

SERVICES PROVIDED

Software

Chemdata® – clear and concise chemical hazard information on more

Pocket Chemdata® – Chemdata® for pocket PCs and smartphones running Windows Mobile and Android operating systemsChemeDox® – online, simple-to-use, chemical safety document management system

Emergency Response

Carechem 24 – for MSDS, labels and packaging – legal compliance and the gold standard of responsible careCarechem Marine – for transport by sea – guarding your cargo... and your reputationCERS – for keeping your business running – protect your employees and reduce the risk of business downtimeChemsafe – 24-hour support for the UK's emergency servicesHaulsafe 24 – for UK road transport – guaranteed specialist advice to keep your wagons on the road

SDS Services

NCEC's SDS authoring services and SDS management softwareSDS authoring – keeping your safety data sheets legal and compliant with REACH and GHSChemeDox® – online, simple-to-use, chemical safety document management system

Training

Chemical training to help you comply with legislation and to help you and your staff deal with chemical emergenciesBespoke training courses – including Hazmat 1st Response and Chemical Spill ResponseOpen training courses – including chemical hazard awareness and making COSHH assessments

Consultancy

legislation as well as chemical risk managementREACH services – help with your responsibilities under REACH and GHSREACH Glossary – a list of REACH-related terms and abbreviations


2012 The NCEC receives over 4,500 calls per year, approximately 10% of these are through our Chemsafe role advising the UK emergency services.

2012 Chemsafe – providing chemical emergency response

through the Chemsafe scheme on behalf of UK government

2012 Chemdata – chemical emergency response software for emergency responders around the globe from public and private sector. Over 45,000 products listed and available on laptops, PCs and Android phones.

ACCREDITATIONS

Quality AssuranceAs part of Ricardo-AEA, the NCEC is recognised via Lloyd's Register Quality

AEA for the environmental and quality management system standards below: BS EN ISO 9001: 2008 ISO 14001: 2004

expiry: 30 November 2014

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PARTNERS

NCEC is part of Ricardo-AEA, and also part of: REACH Consultant Network GCC Network

Supported by the Department for Transport (DfT) and the Chemical Industries Association (CIA)

CLIENTS

BASF CPS Colour Group Air Products Flint Hills Chemtura Albemarle Henkel Ltd BP Chemicals Nova Chemicals Yara UK Ltd Wincanton Monsanto BWA Water Additives Leighs’ Paints DKSH

TESTIMONIALS

Chemsafe “All requests for information and advice were handled quickly and information explained concisely.” – group manager David Somerville, Fife Fire and Rescue Service

Emergency Response “Carechem 24, like all the services provided by National Chemical Emergency Centre [NCEC] at Harwell, is a robust solution for people working with Dangerous Goods, be they consignors, consignees, transport

the continual changes occurring in legislation as well as enhanced security and environmental concerns, you need to be supported by credible and internationally recognised technical specialists. NCEC is such an organisation, and Carechem 24 in my opinion, the premier support service for those in the sector. Their technical support is critical in managing The Hazchem Network operation – the UK’s only specialist palletnetwork for the carriage of palletised dangerous goods.” – Ali Karim, managing director, Hazchem Network Ltd

our employees. We had mock incidents planned where our employees had to physically deal with the scenario. It made us think more of our surroundings and the possible incidents we could be faced with - we are going to continue this training with NCEC so that employees are kept focused on their environment.” – Sue Clegg, UOP Ltd

CASE STUDY 1: Polyurethane foam manufacturing fire incident, July 2012

polyurethane foams were manufactured. Police and ambulance service personnel were also in attendance. The station manager was concerned about the chemicals used in the process – isocyanate solutions, polyols and solvents. He wanted advice about the hazards, thermal decomposition products, personal protective equipment (PPE) and decontamination.

Solution: our emergency responder advised the station manager that the isocyanate solutions posed the greatest hazard and explained that they were

and that they may be absorbed through the skin. Our emergency responder also explained that hydrogen cyanide and nitrogen oxides were likely products of thermal decomposition. The emergency action code for isocyanate solutions is 2X. Therefore, the emergency responder advised the use of liquid-tight chemical protective clothing with breathing apparatus and explained that soap and water should be used for decontamination of equipment. In addition, our emergency responder liaised directly with the manufacturer of the products to

Expertise: NCEC’s chemists work closely with the emergency services and the chemicals industry to provide impartial expert advice in the event of a chemical incident.

CASE STUDY 2: Overheated lithium battery incident, July 2012

A lithium battery measuring 25 x 20 cm was undergoing testing at an electrical equipment testing company. It overheated on a workbench

for advice on the level of PPE required to enter the building and isolate the battery, and the decomposition products.Solution: the NCEC emergency responder explained that different types of lithium battery would produce different decomposition products, but inhalation of metal oxides can cause metal fume fever, which has a

recommended suitable PPE including breathing apparatus, in accordance with the emergency action code (4W) for lithium batteries. Furthermore,

thoroughly ventilated before employees were allowed back into the building.Expertise: NCEC can provide guidance to companies on the safe handling and transportation of lithium batteries, and offers an emergency telephone advice service that is dedicated to providing advice on lithium batteries.

CASE STUDY 3: Barn fire incident, May 2012

asbestos and contained two tonnes of ammonium nitrate fertiliser. The station manager was concerned about the environmental impact of the

Solution: the NCEC emergency responder advised the caller that ammonium nitrate is not toxic to the aquatic organisms, but caused eutrophication (an algal bloom that uses all of the oxygen in the water as it

nitrogen oxides would be produced, which pose a risk of pulmonary oedema,

Expertise: NCEC emergency responders are available 24 hours a day, 365 days a year to provide chemical advice to the emergency services, helping them to protect people, property, and the environment.

STAFF SELECTION

Maria Stearn – Chemdata/Hazmat Event

Bethan Davies – Chemsafe

Mike Kent – SDS Authoring

Rob Whiting – REACH Consultancy

Paul Rast-Lindsell – Training

Matt Hawes – Scalecards

Richard Davey – ChemeDox

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Website www.pacelabs.com/regulatory


Head o"ce 1800 Elm St SE, Minneapolis, MN 55414, USA

Tel 612-751-6986

Fax 612-656-1181

Contact Lisa Rettinger

Directors Todd Mitchell, General Manager

Angela Wutz, Regulatory Operations Manager

Lisa Rettinger, New Business Development

Ownership Private Company, division of:Pace Analytical Services, Inc.

Locations USA

Founded 1998

OVERVIEW

The Product Regulatory Services division of Pace Analytical offers the following primary services:

product stewardship.

consulting/project-based expertise requests.


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Information44%

Laboratory1%

SERVICES PROVIDED

Supply chain data collection

Our proactive and streamlined approach to collecting, validating and organising vital regulatory data is a tremendous time and cost savings for our clients. The Pace Regulatory Data Management (RDM) maintains hundreds of technical relationships with suppliers and compiles data

9001:2008 quality system ensuring consistent deliverables. Clients are always provided with metrics so they can rest assured expectations are met.

Hazard communication

Our experts have authored thousands of safety data sheets for both domestic (US) and international markets. Depending on client needs, we can utilise our own software or work within the client’s system to author documents and create label text. Pace can assist you with creation of new SDSs or updating your current documents to meet new requirements. Pace utilises highly skilled hazard communication specialists, AIHA/SCHC registered authors, and toxicologists to create high quality, globally compliant safety data sheets.

Product stewardship

Our product stewardship services are extensive and include: • Regulatory compliance

and/or registrations of products on domestic and international chemical inventory lists such as REACH and TSCA. We review consumer and industrial products for compliance with state, federal and international regulations including, but not limited to, REACH, RoHS, FIFRA, CA Prop 65, CPSC, EU Detergent Regulation, etc. Pace provides guidance on HAPS (Hazardous Air Pollutants) and perform VOC calculations.

• Product assessments – aid in detection of unacceptable liability risk due to potential impacts to public health or the environment. They can also support sustainability goals. The types of assessments we do include, but are not limited to:_____ robust summaries.

• Green label claims support – involves guidance through the requirements involved to obtain desired green product labels.

Process in-sourcing/outsourcing, sta# augmentation or consulting

Our extensive in-house regulatory training system is the driver behind Pace’s ability to offer such unique solutions, including: • Business process outsourcing – Pace can offer dedicated

resources and manage the process at your location (in-sourcing) or at our location (outsourcing).

• Sta# augmentation – Pace employees of all levels are deployed to our client locations and they have the support of our Minneapolis staff and training systems.

• Consulting services – experts are available for project-based

ACCREDITATIONS

ISO 9001:2008AIHA/SCHC Registered SDS authors

CLIENTS

need of complete regulatory guidance to Fortune 50 companies looking for effective strategies to manage their workload.

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CASE STUDY 1: Fortune 50 conglomerate chemical manufacturer

process to allow their regulatory staff to focus core business activities. This company values a proactive regulatory strategy and desired to actively manage their supply chain regulatory data collection. It was

process to collect, validate and organise their data. We implemented internal training programs through our ISO 9001:2008 quality system, ensuring each staff member follows the same process. The result is an

validated data in an organised manner for use in downstream regulatory compliance programmes. Pace also provides the client with monthly metrics to ensure deliverables are met.

CASE STUDY 2: Mid-sized coatings company

With the implementation of OSHA HazCom 2012, it became clear to this client they were in need of a more proactive regulatory strategy to manage their raw materials and products. Pace worked with the client to develop a strategic plan to meet their long term regulatory needs. We aided in the selection of a chemical management software program and then provided an onsite, knowledgeable user to populate their system. Due to the short term nature of the project, the client also chose to outsource the conversion of their SDSs to GHS compliant documents. The client also utilised Pace’s Sr regulatory specialists to meet customer

CASE STUDY 3: Start-up green chemistry company with novel chemistry

Our client developed novel chemistry for the green market, but did not possess expertise necessary to meet regulatory requirements. The client retained Pace to act as their regulatory compliance experts. Pace provided SDS authoring and label text, new chemical registration, testing recommendations, data interpretation, REACH preparation,

on core business activities such as product development, sales and marketing.

STAFF SELECTION

Todd Mitchell – General Manager

Todd Mitchell has more than 25 years’ experience in the environmental chemistry sector. He holds a BS in microbiology from the University of Minnesota and a MBA from the University of St Thomas. Over the course of his career he has led a variety of environmental service programmes

services. At Pace Analytical, Todd is responsible for the professional service business which provides creative in-sourcing and outsourcing

Angela Wutz – Regulatory Operations Manager

Angela Wutz has more than 10 years of direct industry experience in the

has implemented multiple supply chain data collection programmes. She holds a BS in medical microbiology and immunology from the University of Wisconsin and has completed extensive graduate coursework in environmental health and safety at the University of Minnesota. At Pace Analytical, she manages the product regulatory operation and is responsible for the delivery of customised solutions to customers.

John Hutchinson, PhD – Toxicologist

Dr John Hutchinson provides technical consulting support in the areas of human and ecological toxicology. He holds a BS in biology and a PhD in molecular and environmental toxicology from the University of Wisconsin-

cellular signal transduction events resulting from genotoxic stress. With extensive knowledge of toxicological principles, mechanisms, and human health risk assessments, John helps clients interpret and evaluate toxicological data in order to understand the regulatory implications of their business decisions.

Steve Ernst – Sr Regulatory Specialist

Steve Ernst has more than 20 years’ experience in the chemical manufacturing and biotech industries. Steve has been responsible for comprehensive portfolio of regulatory systems and EH&S programmes spanning a variety product chemistries. He holds a degree in chemical engineering from the University of Iowa. Steve is an expert in both domestic and international chemical regulations and hazard communication. His strong chemical industry background, places Steve in a unique position to assess client needs, understand their challenges and implement practical solutions.

Jody Hulne-Strege – Sr Project Manager

Jody Hulne-Strege has more than ten years of industry experience in a variety of environmental and product regulatory capacities. She holds a BS degree in geology as well as graduate level toxicology coursework. Her expertise lies in regulations and issues concerning the development, manufacture and sale of consumer products, including children’s products, OTC monograph drugs, and insect repellents. Her past experience in hazard communication, industrial hygiene, groundwater modeling and remediation make her ideally suited to participate and communicate effectively on cross functional teams. Jody has also been instrumental in the continued development of Pace’s comprehensive internal regulatory training system.

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CONTACTS

Website www.reach-chemadvice.com


Head o"ce Am Marktplatz 5, D-65779 Kelkheim / Taunus, Germany

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

Contact Dr Rudolf Staab

Directors Dr Rudolf Staab, Managing Partner

Ownership Privately owned company

Locations Germany, USA, India, Portugal, Sweden

Founded 2007

OVERVIEW

REACh ChemAdvice GmbH is a sister company of ChemAdvice AG. It was formed by a group of senior executives with decades of experience in the chemical industry, in collaboration with a team of REACH specialists. As an independent representative, with no direct involvement in the production or trading of chemicals, REACh ChemAdvice can act on your behalf without bias. This is very important, especially if you have multiple agents, indirect exports, or want to alter your supply chain into Europe. Founded to help non-EU manufacturers to comply with REACH as only representative, the company now supports EU producers and importers as consultant and/or third party representative, and downstream users as consultant in all REACH matters. Unlike most advisors, we offer the complete scope of REACH-related services: in-house and through our network.REACh ChemAdvice would like to transfer the lessons learned from REACH to the new European Cosmetics Regulation, where the challenge for the cosmetic industry is implementing both regulations at the same time.


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5


Staff, group 10




60%Representation

& management5%

Information20%

Training10%

Other5%

GLOBAL OFFICES

REACh ChemAdvice GmbH, Germany

SERVICES PROVIDED

REACH services

Once you select REACH ChemAdvice as your REACH-consultant, we will be pleased to provide a comprehensive range of services customised exactly for your needs:

creation and submission of IUCLID 5 dossiers (registration, inquiry,

creation and review of REACH-compliant SDS/ e-SDS (safety data

analysis of exposure scenarios and implementation of risk

outsourcing of REACH services.

CLP services

As your CLP-consultant REACH ChemAdvice we provide:

outsourcing of CLP services.

Cosmetics services

Once you select REACH ChemAdvice as your consultant, we will be pleased to provide a comprehensive range of services customised exactly for your needs: regulatory workshops for the cosmetic industry.


2007 Start up in Frankfurt am Main, Germany

2007

2008

2009

2011 Start cosmetics consultancy

2011

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2012 Expansion into the Iberian peninsula (Portugal and Spain)

2012

ACCREDITATIONS

REACH ChemAdvice GmbH is a member of ORO, the Only Representatives Organisation in Brussels and complies with the quality standards of this trade association.REACH ChemAdvice, as an ERPA-member (European Cosmetics Responsible

during the whole complex cosmetics supply chain, as the cosmetic industry needs to comply with the new Cosmetics Regulation and REACH.

PARTNERS

Our partners can be viewed on our website

CLIENTS

Our clients are located in Europe, United States of America, Latin America, Africa, Middle East and Asia

TESTIMONIALS

Testimonials or references will be provided upon individual request

CASE STUDY 1:

The company started offering only representative services for NON-EU Clients in 2007. We represent more than 100 companies with sizes ranging

third party representatives and offer consultancy work under REACH.

CASE STUDY 2: Consortia management

We successfully managed consortia or represented our clients in consortia. We support our clients throughout the whole REACH registration process from registration strategy development, data generation, and dossier preparation to dossier submission.

CASE STUDY 3: Cosmetics industry

We are a member of cosmetics associations and are actively involved as project managers for the development of guidelines. We help especially SMEs in the cosmetics industry to manage the interface between REACH and the new cosmetics Directive.

STAFF SELECTION

Dr Rudolf Staab – Managing Partner

Dr Staab has held many senior jobs in the industry including: senior vice president Masterbatches Clariant International, responsible for the reorganisation and re-engineering of business processes and the introduction of new marketing approaches for key accounts. He was vice president additives within Hoechst AG and Clariant International and vice president specialty chemicals within Hoechst AG in charge of strategy

improvement activities and relocation efforts. He looked after the development of new markets and applications M&A transactions, and has been a member and chairman of the board of several companies within the chemical, food ingredients and plastic processing industry. He has an MSc in inorganic chemistry (Diplom-Chemiker – Saarbrücken, Germany, and a PhD in inorganic chemistry (Dr rer nat – Saarbrücken, Germany).

Carlos Fazendeiro – Regulatory A#airs Consultant (Head O"ce and Portugal)

Mr Fazendeiro has worked in regulatory compliance (CTR Lda, Portugal, and has considerable experience of purchasing and sales of chemical raw

safety data sheets and giving regulatory support to clients and business units (REACH, CLP and biocides). He has worked as a consultant (SGS Portugal SA) and on REACH implementation (petrochemical industry), with extensive experience of pre-registrations and REACH registration dossiers.

Mr Fazendeiro is an expert in safety data sheets (authoring, management and distribution). He worked

administrative issues related to REACH, assessment of test data reliability under the biocidal products Directive and gave support to business development activities.

of Beira Interior, Portugal), and has practical education and training on REACH, CLP/GHS, IUCLID 5, REACH-IT and SDS

Silvia Teige – Finance and Administration

Ms Teige’s experience includes working as a management assistant at both ChemAdvice GmbH and to the head of regional business unit Europe, NME, Africa, Clariant Masterbatches. She has been executive assistant to head of division pigments and additives, Clariant, and executive assistant

same role to the head of division chemicals, Hoechst AG.

Prof Dr Dieter Mayer – Toxicologist

Professor Mayer has extensive research experience having worked at the Institutes of Human Genetics, University of Heidelberg, and Environmental

Centre International de Toxicologie, Evreux, France, and professor at Frankfurt’s Johann Wolfgang Goethe University, Institute of Pharmaceutical Technology. He has been a guest professor at Johannes Gutenberg University, Mainz, Institute of Toxicology, Risk Assessment, Methods in Modern Toxicology and also at the German Society of Pharmacology and Toxicology. His industrial career includes having been a toxicologist, and global head of toxicology Hoechst AG, Hoechst Marion Roussel, Aventis SA.

Dr Sebastian Ho#mann – Scientific Consultant

Dr Hoffman has extensive experience as a REACH consultant (TÜV

consulting and hazard and risk assessment. He is an expert on human health hazards and ` a b ` c d e toxicological methods, having worked as a

Italy). His speciality is assessment (validation) of ` a b ` c d e test methods

reliability and relevance, and has 25 peer reviewed publications to his name.

Jim DeLisi – Regional Head, North America

Jim DeLisi is a president of Fanwood Chemical, Inc, where helooks after the sale of organic intermediates in North America, SouthAmerica and Europe, as well as tariff and trade affairs, monitoring ofimports and exports and REACH. He has been chairman of SOCMA’s International Trade Committee, and chairman of the Industry Trade Advisory Committee on Chemicals, Pharmaceuticals, Health/Science Products and Services.He has a BA in business administration (Rutgers College, USA), and anMBA in chemical marketing (Fairleigh Dickinson, USA).

Barbara Fertl – Regional Head, Sweden

Barbara Fertl has extensive experience having worked at: the Institute

a chemical consultant for Kemikalierådgivare in Sweden and has experience of safety data sheets, registrations, national and international regulations on chemicalsMs Fertl has an MSc in biology (Diplom-Biologin, Ludwig-Maximilians-

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CONTACTS

Web site www.reachmastery.com


Head o"ce Via Giovio 16, 22100 Como, Italy

Tel +39 031 269513

Fax +39 031 2756370


Directors Monica Locatelli


Locations Italy

Founded 2008

OVERVIEW

REACH mastery is a provider of a wide range of services in the area of chemical regulatory affairs. The staff are a highly motivated team,

and environmental toxicology. Our commitment is to assist customers along the supply chain with our industrial experience and to help them

mission is to look for innovative solutions and develop strategies using, when applicable, alternatives to animal testing like ` a b ` c d e and in silico methods, through the high quality of our services and the expert support.


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75%

Representation

& management15%

Information2%

Legal2%

Training1% Other

5%

SERVICES PROVIDED

General consulting services

Supply chain communicationImporters and manufacturers, downstream users and manufacturers/importers of article, are all responsible for the effective communication

standard templates or customised forms to properly manage the

Strategic implementation of European regulationsParticipation to consortia, co-registrants agreements, data sharing, deadline and tonnages for registration are decisions that are managed

choice on the market. Chemical management and product stewardship

The market will constantly change over time. Companies will face new challenges to strategically select secure suppliers and to identify growing sector markets. Our business development experts will support companies with the right advice, in compliance with the provisions of the regulation.

Implementation of IT systems to manage chemicalsCompanies will internally develop new management systems to integrate existing tools to monitor the presence of chemical substances, including deadlines, total amounts, risk management measures etc.

REACH services

Consortia managementA lot of experience has been gained on consortia rules and management. We will provide also legal advice, agreement documents, meeting location, cost calculation, managing of LoAs.

Data gap analysis and data collection

registration dossier, but is not enough. All these data have to be really collected, in respect to the right to use. The latter requires the negotiation of the conditions for use according also to the quality of the data.Each single study is evaluated and rated to check relevance and

Testing strategy development, ` a b ` c d e strategies development, QSAR modelling

building rationale for waiving. International well known partners are helping us in focusing on the right choice.

Our big expertise in analytics and experience in enquiries let us face without problems one of the most critical aspect of REACH regulation.

Tests monitoringIn case new tests are required, REACH mastery will take care of selecting the most appropriate lab, will review the protocol and check the results.

Dossier preparation (IUCLID compilation)Dedicated expert persons are managing IUCLID compilation.

Human health and environmental risk assessmentThe focused experience and the support of high experienced toxicologists let us make of the risk assessment the core part of the developing registration dossier.

CSA-CSRREACH mastery is part of the consultation group of Chesar in ECHA. We followed the development of the tool since the beginning and we are

CLP/GHS services

MSDS compilation

FEED and FOOD registration

dossier preparation risk assessment test monitoring assistance to customer for Efsa calls for data

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BPD services

full dossier preparation for active substances and placing a biocidal product in the market

testing strategy development study monitoring risk assessment

post-submission support

PPP services

support of existing substances in the context of the EU review programme, re-submission of dossiers for active substances

Annex III dossiers for re-registration of products post-Annex I inclusion Annex III dossiers for new products or to support label changes and/

or formulation changes testing strategy development study monitoring risk assessment

post-submission support

EU cosmetic directive

regulatory compliance support

clinical studies: design and monitoring cosmetic product safety reports product labelling review and support


2008 Foundation of REACH mastery within HBJ consultancy group

2009 Restructuring of REACH mastery as independent company

2010 About 120 successful registrations for the 2010 deadline

2011 Implementation of the group with operative members

2012 Implementation of the group to broaden the regulatory area to Biocides and Plant Protection products

PARTNERS

RTC, QSAR group of Bicocca University, Vitroscreen,CAAT Europe as preferred cooperations.

CLIENTS

manufacturers, distributors, downstream users, from SMEs to international

textile, pharmaceuticals, galvanic, food, cosmetic, polymers and many others.

CASE STUDY 1: First tier REACH registration and CLP notification

In 2010 we prepared about ten main dossiers on behalf of lead registrants, complete with exposure scenarios above 1,000 tons and we submitted more that 100 joint dossiers providing complete assistance in retrieving lead registrant identity, letter of access costs, analytic development, inquiry process for non phase-in substances and CSR adaptation.

customers, after extensive bibliographic research, read-across approach and computational predictions

CASE STUDY 2: EPA comments about flame retardant document

In 2012 REACH mastery participated in the public review of the draft report An Alternatives Assessment for the Flame Retardant Decabromodiphenyl Ether (DecaBDE), a document presented by the US EPA (Environmental Protection Agency) within the Design for the Environment (DfE) framework. REACH mastery commented upon and

Final publication is forecast for winter 2013.

CASE STUDY 3: FOOD/ Feed authorisations of dyes

The dossiers for feed use authorisation of three dyes have been followed according to Regulation 1831/2008. This was the beginning of

were all agreed together and in some cases we managed to change the request for ` a b ` b e study into ` a b ` c d e .

CASE STUDY 4: TIER 2 REACH registration

The group is preparing about 20 lead dossiers, many of them with a full study plan ordered and monitored, three of them already submitted in 2012, 40 intermediate dossiers and actually about 40 joint registrations.

STAFF SELECTION

Dr ssa Monica Locatelli – Founder and Director

After a degree in chemistry, ten years in R&D and a specialisation in toxicology applied to risk assessment, she has been working in regulatory and implementation of REACH regulation since 2001, when it was still a proposal. The cooperation with many specialists within international companies and universities let her specialise in consortia management and dossier preparation.

Dr ssa Costanza Rovida – REACH Regulatory Specialist

chemistry, she worked for three years at the European Commission, participating in two groups of RIP 3.3 (REACH Implementation Project, Technical Guidelines to Industries) and as a leader of a work package in a European project focused on integrated development of alternative toxicological methods to animal testing. She is responsible for the management of individual projects and global customer assistance.

Dr Leon Van der Wal – Eco toxicologist

Obtained a PhD in environmental toxicology and chemistry in 2003, and has more than ten years’ experience in the risk assessment of chemicals. He worked as a consultant on risk assessment and risk management for national and international governmental agencies, and evaluated active substances and product dossiers for governmental agencies, as well as private national and multinational companies. For three years he worked at the Joint Research Centre of the European Commission, responsible for the regulatory environmental risk assessment of biocides, the development of guidance documents and exposure scenarios, and the harmonisation of risk assessment strategies between the various EU legal frameworks. He is now responsible for the Biocides and Plant Protection Product Unit and environmental risk assessment for all regulatory frameworks.

Dr Daniele Ferrario – Toxicologist

Graduated in biological science, he earned a PhD in toxicology in 2009. He gained knowledge in cellular and molecular biology techniques, as well as having a strong background in metal toxicity on mammalian

laboratory of European Centre for The Validation of Alternative Method of the European Commission he was actively involved in the validation of CFU-GM as alternative to animal testing to evaluate immunotoxicity. He is now responsible for the evaluation of toxicological outcomes of testing in compliance with REACH Regulation

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CONTACTS

Website www.reachcentrum.eu


Head o"ce Avenue E van Nieuwenhuyse 6, B-1160 Brussels, Belgium

Tel/ Fax +32 26767400/ +32 2 6767499

Contact Francesca Furlan

Directors Leo Appelman, Managing Director


Locations Brussels, Belgium

Founded 2006

OVERVIEW

Chemical Industry Council) to help companies all through the value chain to prepare and implement REACH. ReachCentrum helps chemical manufacturers and importers, as well as downstream users and distributors 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, lead registrant and Sief leadership team support services, consultancy and workshops.Our services and support tools are designed for European and non-European companies working on their own or in close collaboration with other companies.


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Staff, group 14




30%

Representation

& management30%

Information2%

IT & software5%

Legal13%

Training20%

GLOBAL OFFICES

SERVICES PROVIDED

REACH business solutions

REACH requires strategic thinking to get your company ready to pass the various phases of the legislation. ReachCentrum offers REACH expert consultancy to support REACH implementation within companies and other stakeholder groups, in order to help you adopt the most effective strategy. ReachCentrum‘s approach is to listen to and carefully analyse each

registration, evaluation and authorisation phases of REACH.

project management support strategic guidance and support

Sief support and supply chain communication

preparation of application for authorisation, including the SEA.Moreover, ReachCentrum has set up a series of transversal services beyond REACH regulation:

DataCentrum (data brokerage) trustee service for indirect reports CLP for mixtures biocides support nanomaterial support

Admin, financial, data management, audit and legal support

Financial issues for a project are handled in-house. Support is backed-

system, letting us execute complex data-related cost sharing calculations. Experienced staff analyse and process the data and an IT support team runs the calculation. ReachCentrum has a powerful tool to manage the sales of letters of access, the LoA shop. We provide tailor-made REACH audit and legal advice and solutions for REACH and beyond, including support in legal remedies and contract management.

Registration guidance including IUCLID 5 support

ReachCentrum has an extensive experience in assisting companies in registering their substances, including dossier submission as co-registrants and lead registrants. The service is conceived to answer to the needs of any registrants, be it the lead registrant or any Sief member. It targets in particular co-registrants that need to get rid of the burden of a joint submission dossier. For each registration submission, the company and ReachCentrum project manager work together to compile the IUCLID 5 dataset, generate the dossier and submit this to ECHA.

Training, workshops and e-learning solutions

ReachCentrum organises a series of courses covering all aspects of the REACH legislation by offering practical guidance – what to do, when and how. ReachCentrum applies blended learning to its courses to offer

virtual and e-learning. To increase awareness or show the business opportunities of REACH, ReachCentrum can organise tailored workshops for companies and trade associations. From 2012 ReachCentrum has been accredited as a training centre delivering training courses to a recognised standard established by the UK Learning and Performance Institute. ReachCentrum also become an authorised training assessment to offer internal trainers for chemical companies to deliver the same standard of training.

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2006

2010 LoA e-shop successfully launched

2010 Through the LoA e-shop 342 the lead registrant allowed their Sief members to access the registration dossier

2010 About 900 people attended ReachCentrum events (about 90 events)

2011 Partnership with TNO Triskelion and with Zieta Technologies

2011 Partnership with SCAS Europe

2011 Launch of REACH audit service

2012 Launch of virtual learning modules on IUCLID5 and Chesar

2012 Set up of three authorisation consortia

2012 Technical partnership with Environmental Resources Management (ERM) for preparation of the application for authorisation

ACCREDITATIONS

LPI accredited as authorised training assessment centre LPI accredited as authorised training organisation

PARTNERS

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 and beyond, including downstream users and distributors.

TESTIMONIALS

“The conference REACH registration 2013 – where should you be now – showed an excellent mix of very good speakers. Good focus on practical aspects. Well organised, a lot of practical advice and motivation for working on 2013 registration” – Norbert Petereit, Sasol.

instructive when he makes examples of the possible mistakes that one can make while working on IUCLID” – A participant of IUCLID5 virtual online training."Having used the REACH auditing system of ReachCentrum, I can only encourage other companies to conduct an auditing exercise for developing internal REACH management processes. It provides a good overview of the key issues in REACH implementation in various functions in a very concise, cost-effective and inspiring manner. The results are easy to implement and the review process fosters internal dialogue, which is essential for all REACH implementation activities" – Helena Huttunen, Kemira Oyj.

CASE STUDY 1: An authorisation consortium case study

The authorisation process has now really started off and more and more companies approached ReachCentrum in the quest for services around authorisation. One example is a group of downstream users that have combined forces in preparing an application for one particular use of a SVHC as it became clear that their manufacturers are not going to apply for an authorisation as the substance in question will certainly been used beyond the sunset date as a potential alternative will not yet be available. The group is hence now actively preparing the authorisation application and ReachCentrum

communication, as well as all related legal matters, and acts as trustee for the

CASE STUDY 2: Virtual learning for IT tools related to REACH

learning for IT tools related to REACH to the chemical industry. These virtual courses are real-time training conducted by our experts through

knowledge transfer, in a convenient manner anywhere with an internet connection. The virtual training has allowed many more people to attend

from home. The participants were impressed by the fact they did not lose any of the interaction, hands-on experience found in a classroom event.

have had more time to learn and use the tool by spreading the course over several weeks.

CASE STUDY 3: Dossier registration: helping companies fill up the dossier

ReachCentrum has assisted an international company to register their substances. Together with the project manager, a plan was set out to complete tasks over a given period. Tasks were divided between the project manager to compile data from the company while ReachCentrum investigated procedural queries with ECHA. For each registration submission, the project manager and ReachCentrum consultant together compiled the IUCLID 5 dataset, generated the dossier and submitted this to ECHA. The company felt reassured that the advice and guidance given by ReachCentrum was relevant and appropriate at each stage of the process. A level of trust and reliability had been established over the months of working together.

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

Mark Meesters – Manager Support Services

Mark worked as a regulatory affairs manager in the chemical industry for seven years before joining ReachCentrum in 2007. He is a chemist and lawyer by training. He joined ReachCentrum to head Support Services, and he is currently in charge of coordinating the portfolio of tailored business services ReachCentrum is offering to the market. His main expertise is data and cost sharing. He regularly presents best practices to

Vincenzo Girardi – Head of REACH Training and Workshops

Vincenzo has more than 20 years’ experience as a professional trainer, with experience in the various industry sectors and since 2007 in REACH.

managed and delivered numerous training projects. He is actively working with companies to compile and submit their REACH registration dossiers.

Isaline van der Straten W – Legal Advisor

Graduated in law, she has several years of experience on contractual aspects related to registration and on legal aspects and support of evaluation and authorisation processes (tailored support, webinars, workshops). In ReachCentrum she is also in charge of giving legal advice and guidance, as for example on data sharing, consortia formation, competition law and REACH, and legal remedies.

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Website

E-mail

Head o"ce Vanrikinkuja 3, 02600. Espoo. Finland

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

Contact Mr Stephen van Heerden, Sales Director

Directors Mr Lasse Kurkilahti, Chairman of the Board

Mr Lasse Musakka, CEO-Partner

Mr Frederik Johanson, Head of Environmental Services-Partner

Mr Jouni Honkavaara, CFO-Partner

Dr Mathias Berner, Partner

Mr Riku Rinta-Jouppi, Head of Global Compliance - Partner

Mr Stephen van Heerden, Sales Director

Dr Ying Zhu, COO-Partner


Locations Finland, Belgium, India, Turkey

Founded 2006

OVERVIEW

sustainability and EH&S.We partner with our clients ensuring their global market access by meeting regulatory requirements, but also by identifying their business opportunities in the market place. This ensures that our clients achieve competitive advantage, mitigate risks, global compliance, become more capable organisations and improve internal processes. In addition to our in-house expertise, we have local partners in Europe, Asia, USA and Latin America to ensure that our clients get access to specialised competencies and local market knowledge.Having a multicultural team, REACHLaw is able to serve its clients in the following languages: English, Finnish, French, German, Spanish, Swedish, Chinese, Hindi, Russian and Turkish.


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Staff, group 30+

Staff, chemical service provision 25+



30%

Representation

& management25%Information

5%

Laboratory5%

IT & software10%

Legal20%

Training5%

GLOBAL OFFICES

Helsinki, Brussels, New Delhi and Istanbul

SERVICES PROVIDED

REACH and global compliance services

We support companies as their service provider or as their only

consortia, lead registrant projects, regular registrations and REACH authorisations. Furthermore, for companies operating outside of the European Union we assist them in managing the applicable market access regulations by analysing their portfolio of products, monitoring and assessing the impacts of upcoming changes in the regulations.

the authoring of compliant SDSs and labels according to the market requirements in question.

REACH authorisation services

Authorisation is one of the most complex challenges for companies under REACH. REACHLaw combines the best expertise and deep understanding of the business and regulatory requirements to provide companies with a full set of services towards authorisation.Our support

the authorisation to performing the work needed in all stages of the authorisation process (eg analysis of alternatives, socio-economic analysis, chemical safety report and full authorisation application).

www.compliantsuppliers.com

www.compliantsuppliers.com connects buyers and suppliers of compliant

their investments in compliance by providing access to chemical buyers searching for compliant products. For the buyers it reduces risks, number of counterparties and costs by providing access a selection of suppliers

compliance by validating chemicals per regulation per region and takes care of all the required documentation.


2006 Established in Helsinki

2008 Partnerships with 20+ local partners in Asia, Europe, Latin America, USA and India were established. 3000+ REACH pre-registrations submitted

2009 REACHLaw received internationalisation award from the president of Finland. Customers in 40+ countries. Brussels

than 50 events globally, having 1500+ attendees in total

2010 300+ REACH registrations submitted. REACHLaw launched global compliance services outside the EU. The attendees to our events increased considerably reaching the amount of 2500+

2011to ensure compliance with global chemical regulations.

2012 20+ REACH lead registrant cases. First authorisation cases.

shareholder in eSpheres Ltd. REACHlaw established a business partnership with BioSafe – Special Laboratories Services Ltd.

2013 REACHLaw launches www.compliantsuppliers.com Currently supporting several REACH registrations, REACH authorisation cases, 20+ lead registrant cases. Supporting companies with Biocides Regulation

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ACCREDITATIONS

rating in 2010. Innovative – Growth sustainable company by Europe Innova in 2011. Among 200 fastest growing companies in Finland by Kauppalehti in 2011. Young Innovative Growth Company Programme by TEKES completed in 2012.

PARTNERS

Selected partners: Chemtopia, ChemRisk, Chemitox, Dynamic Orbits, Mourao Henrique Consultores Associados, AIDA, Chamber of Chemical and Petrochemical Industry of Argentina – CIQyP, CICM, eSpheres, BioSafe – Special Laboratory Services Ltd.

CLIENTS

More than 300 customers from 40+ countries, from Fortune 100 companies to SMEs. Major industry sectors served: oil, chemicals, specialty chemicals and metals. Our customers are manufacturers, importers, traders, downstream users, retailers and governmental organisations.

TESTIMONIALS

“REACHLaw has provided excellent legal services to our REACH working group. Their business approach and expertise in global compliance

REACHLaw service” – Petrochina.“Over the years REACHLaw has advised OMG on several strategic REACH and CLP issues and in the planning of our 2010 registrations. For one substance REACHLaw managed the whole lead registrant registration process in 2010. We are very pleased with REACHLaw service” – Dr Thomas Slotte, OMG Kokkola Chemicals Ltd. “REACHLaw assisted us in registering our substances as regular registrant and as lead registrant in 2010. We are very pleased with REACHLaw’s services” – Mr Ludo Schyvinck, Minerals Technologies Europe NV.

CASE STUDY 1: REACH – authorisation

REACHLaw acts as the service provider in several authorisation cases on behalf of our customers. Many of the cases are still at an early stage when strategy, participants, scope, uses and required organisational structures have to be decided upon. Some of the cases have already proceeded into a concrete application phase. From a customer perspective these concrete authorisation cases can be extremely critical – the substance to be authorised can form the basis of the customers whole industrial manufacturing process. If the socio-economic route is the only possibility the authorisation projects are even more demanding. REACHLaw has provided the full service

update to socio-economic analysis and project management

CASE STUDY 2: Lead registrant registration

REACHLaw will be lead registrant for numerous substances in 2013 on behalf of our customers. Compared to 2010 the substances are much

case REACHLaw acts as lead registrant for eight substances with similar chemical characteristics such as high reactivity when in contact with water or moisture. Thus there is a need to concentrate on more than 20 degradation products for these substances. Proving that substances that will be registered in 2013 are more demanding and require more expertise

management as well as the technical work required for the registration.

STAFF SELECTION

Mr Riku Rinta-Jouppi, MA (Law), MSc – Head of Global Compliance – Partner

Graduate of Cambridge university. He is widely recognised as one of the leading European legal experts in chemicals regulations. In addition

technology. Mr Rinta-Jouppi is responsible for REACHLaw global compliance services.

Mr Tim Becker, MA (Law) – EU Compliance O"cer

adviser at REACHLaw since 2008. He has also worked previously with ECHA in its guidance team. His main responsibilities in the company include REACH and CLP legal and regulatory expert advice, risk communication and compliance issue management. Since 2011 he has been responsible for advising the European space industry on the impact of REACH on the continuation of launcher and satellite programmes. Mr Becker is strongly specialised in cross-border issues with non-EU countries and the determination of exemptions from the REACH registration and authorisation requirements.

Dr Ying Zhu, PhD (Biochemistry), MSc in Economics, COO-Partner

has also worked in various management positions in industry for more than ten years. Her unique educational background and work experience

REACH authorisation. Dr Zhu has advised companies from four different continents on REACH compliance issues since 2008. In addition, she also has also in-depth knowledge on global chemical regulations and compliance issues.

Dr Kati Vaajasaari, PhD (Technology) – Project Director and Specialist in Risk Assessment

Dr Vaajasaari is working as a leader in REACH lead registrant projects for REACHLaw. Her responsibilities include project management and technical expertise in chemical safety assessment. She specialises in environmental fate, pathways of substances, environmental exposure assessment and risk characterisation of chemicals and products. She has

Mrs Mia Blåfield, MSc (Toxicology) – Toxicologist

She is working as a toxicologist for REACHLaw. Her responsibilities include evaluation of human health hazard of chemicals and human exposure and risk assessment of chemicals. She has several years of

Ms Sini Suomela, MSc (Organic Chemistry) – Technical Project Manager

Ms Suomela is responsible for the REACH member registrant projects. She has an extensive knowledge of different kinds of REACH registrations. She has experience in the physicochemical part of the lead registrant projects. She has also taken care of many REACH inquiries

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CONTACTS

Website www.rpaltd.co.uk


Head o"ce 1 Beccles Road, Loddon, Norfolk, NR14 6LT, UK

Tel +44 1508 528465

Fax +44 1508 520758

Contact Panos Zarogiannis

Directors Pete Floyd

Meg Postle

Ownership Private

Locations UK

Founded 1990

OVERVIEW

Risk & Policy Analysts Ltd (RPA) was established in 1990 as an independent specialist consultancy. RPA has gained extensive experience in undertaking impact assessments and evaluations, including the development of quantitative and qualitative methodologies to assess policy impacts, chemicals policy, chemical risk assessment and management. RPA is particularly proud of its development and application of socio-economic analysis (SEA) to chemical

RPA has been working with industry clients since 2001 on the implications of the new EU regime for chemical risk management. RPA has also been working closely with the European Commission (EC) and the European Chemicals Agency (ECHA) on the development and implementation of REACH and many other directives relating to chemical risk management. Our experience covers a wide range of industry sectors including bulk chemicals, ferrous and non-ferrous metals, paints and coatings, oil and gas, speciality and novel chemicals (including nanomaterials), etc, and this has

experience in preparing risk reduction strategies under the Existing Substances Regulation, we are now advising a range of industry organisations on how to respond to the threat of REACH authorisations and restrictions, and on the scope and detail of the SEAs needed to justify continued use of a substance. RPA’s multi-national staff routinely undertakes detailed analysis and consultation with industry and regulators in most European languages.


Turnover, group £1.4m


1

No of countries representedFocus on EU-27, EEA and

Candidate Countries

Staff, group 27




95%

Training5%

GLOBAL OFFICES

UK

SERVICES PROVIDED

REACH – authorisations

RPA assists industry clients with the development of applications for authorisation under REACH to be submitted to ECHA from 2013. These studies can involve detailed analyses of supply chains, of alternatives and the preparation of SEAs.

REACH – restrictions

RPA assists both industry clients and regulators with the collection and analysis of use/exposure data of chemicals and their alternatives and the preparation of SEAs, which may be used to inform the development of a restrictions dossier.

REACH – registration/compliance

RPA provides advice on all aspects of REACH compliance to companies of all sizes throughout the supply chain.

Regulations and impact assessment

RPA advises industry clients and regulators on the (potential) impacts of regulations and regulatory change. Recent examples include work on REACH, nanomaterials, OELs, mercury, CLP, CMRs at work, cosmetics, biocides and WFD.


1992chemical risk management for the UK authorities

1996 First (of over 40) projects for the EC on chemical risk management

1998 RPA wins major framework contract for the UK authorities on chemical risk management leading to numerous risk reduction strategies

2000 OECD publishes guidance documents on SEA and chemical risk management prepared by RPA

2001 RPA commences work with industry clients and with the EC

Chemicals Strategy which became the REACH Regulation

2004 RPA wins major framework contract for the EC on chemicals

2005 RPA works on REACH implementation projects including leading RIP 3.9 on SEA

2008 RPA is a member of one of the consortia for ECHA REACH framework contract

2009 RPA contracted by industry clients to support applications for authorisation under REACH with a focus on SEA work

2011 RPA leads consortium for the second ECHA REACH framework contract

2012 RPA completes three studies for DG Environment reviewing

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PARTNERS

RPA works with FoBiG, DHI, TNO, RIVM, ARCHE, Hydrotox, Royal Haskoning, Denehurst, ReachCentrum and EPPA amongst others.

CLIENTS

EC (including DG Enterprise, DG Environment, DG Employment and DG Sanco)

National authorities (including those in the UK, Germany, Denmark, France and the Netherlands)

European Chemicals Agency Numerous European/international industry/trade associations

(including AISE, APEAL, CEFIC, COLIPA, ETINSA, Eurocommerce, Eurometaux, ICMM, IMnI, International Zinc Association, Lead Development Association, Nickel Institute and UKWIR)

A range of companies (from multinationals to SMEs) and consortia.

CASE STUDY 1: Provision of analysis of alternative and socio-economic analysis support services

RPA is currently providing REACH authorisation support to a consortium of manufacturers of a SVHC substance. The work includes preparation of an analysis of alternatives (involving an assessment of the technical and economic feasibility of alternative chemicals and techniques), supply chain communication to develop information on uses and users’ responses to the loss of the SVHC in question, and preparation of socio-economic analyses of the impacts of the loss of the SVHC. As part of this work, we are using the services of specialist toxicology and risk assessment consultants to further up-date the chemical safety assessment and to provide additional interpretation of toxicological data for both the substance and the alternatives. RPA will help the consortium submit an application for authorisation in advance of the sunset date for the substance.

CASE STUDY 2: Assessing the health and environmental impacts in the context of SEA under REACH

RPA led this DG Environment study, which was also overseen by ECHA.

technical advice concerning regulatory decisions within the framework of REACH authorisations and restrictions. The key output of the study was the Logic Framework, which was developed to primarily support the ECHA guidance on preparing SEAs for REACH. The aim was not to reinvent a new approach but rather to provide further, more detailed insight into how particular aspects of the overall SEA process for restrictions and authorisation might be addressed. The full report was published by DG Environment in July 2011.

CASE STUDY 3: Annex XV dossier for hydrazine

RPA was contracted by ECHA to collect and provide background information on the markets, uses, releases of and alternatives for hydrazine with the aim to support the development of an Annex XV

The emphasis of the analysis was on uses other than those in which

releases and exposure. The report looked into both the anhydrous and hydrate forms of the hydrazine molecule. The Annex XV dossier was published by ECHA in April 2011.

STAFF SELECTION

Meg Postle – Director

Meg is an environmental economist and policy analyst with more than 20 years’ experience of consultancy. She has led RPA’s work for the EC, the UK government and a range of industry bodies on business, health and environmental impact assessments of REACH and in relation to the direct and indirect impacts of proposed restrictions and other controls on the use of hazardous chemicals within the EU. She led the project for DG Environment on the development of Logic Framework for SEA under REACH and has conducted training on SEA to both RAC and SEAC members of ECHA. More generally, she is overseeing preparation of SEAs to support authorisation applications for a range of industry clients.

Dr Peter Floyd – Director

Risk assessment expert with more than 25 years’ consultancy experience. He has led studies ranging from hazard and risk assessments relating

toxic gases, explosives, oil products and chemicals, to those concerning the establishment of guiding safety criteria at both individual and societal levels. Dr Floyd directs RPA’s framework contract with ECHA.

Phil Holmes – Technical Director, Chemical Science

Phil Holmes is a technical director at RPA with more than 35 years’ experience in toxicology and risk assessment, and has worked extensively on a wide range of chemical classes including pharmaceuticals, agrochemicals, food additives, and industrial and consumer chemicals. He is a registered toxicologist with the Society of Biology/ British Toxicology Society/EUROTOX.

Panos Zarogiannis – Technical Director, Chemicals Policy

Chemist with extensive experience of developing risk reduction strategies for chemical substances under the Existing Substances Regulation as well as SEA-related studies and in the development of TGDs for REACH. He has managed studies in support of the development of Annex XV dossiers by ECHA and is leading our work for major industrial clients on the development of authorisation dossiers.

Tobe Nwaogu – Principal Consultant, EU Policy

Tobe has degrees in biochemistry, pollution and environmental control as well as an MBA. Since 2003, Tobe has been involved in EU chemicals policy and chemical risk management. He has played a key role in the development of the risk reduction strategies and has project managed studies for the UK, Dutch, French and Danish authorities. Tobe has also managed studies for the EC and ECHA to assess the impacts of (potential) restrictions on chemicals and/or the development of Annex XV dossiers.

Paul Ylioja – Consultant, Chemical Science

Paul, who has recently joined RPA, has a background in organic chemistry. After his MChem and experience in process chemistry laboratories, Paul undertook a DPhil and postdoctoral research in organic chemistry. He is currently working on REACH authorisation studies with a focus on the risks associated with moving to alternatives.

Tom Persich – Researcher, Chemicals

Tom has a degree in environmental sciences. Since joining RPA, he has worked on a range of projects both for the EC and for Industry.

physicochemical properties of various chemicals to inform REACH authorisation studies.

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CONTACTS

Website www.royalhaskoningdhv.com


Head o"ce HaskoningDHV Nederland BV, Laan 1914 nr. 35, 3818 EX Amersfoort

Tel +31 24 328 41 35

Fax +31 24 322 81 70

Contact Mr Christiaan van Daalen/ Mr Tjeerd Bokhout

Directors Mr Rob Schonk, Director Process and Chemical Industry


Locations 100 Locations worldwide. Key locations Europe: Nijmegen, Amersfoort (Nl), Peterborough (UK), Mechelen (Be)

Founded 1881

OVERVIEW

combine a wide range of knowledge and experience. Rooted in a technical background, our consulting services focus on the broad

are committed to working enthusiastically with our clients to achieve sustainable solutions in an increasingly complex society. The expertise and experience of our professionals in a variety of disciplines allows us to consider all technical, logistical, legal, organisational, social, environmental and economic aspects of the projects of our clients, in order to subsequently develop sustainable and practical solutions.We have been working with the industry on chemicals management for several decades and contributed to the implementation of many legislative programmes. In 2012 Royal Haskoning and DHV merged to the current organisation.


Turnover, group (2011) €312M and €434M


100


Staff, group 7,900




50%


15%

Information15%

Laboratory2%

IT & software5%

Legal5%

Training8%

GLOBAL OFFICES

HaskoningDHV Nederland BV: Barbarossastraat 35, 6522DK Nijmegen, NetherlandsHaskoning UK Ltd: Rightwell House, Bretton, Peterborough, PE3 8DW, UKHaskoning Belgium SA:Schaliënhoevedreef 20D, B-2800 Mechelen, Belgium

SERVICES PROVIDED

REACH

Royal HaskoningDHV provides a full range of REACH services, varying from consortium management to preparation of the technical dossier and the chemical safety report. Royal 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 HaskoningDHV does not provide laboratory services, it provides support in laboratory selection and study monitoring. Royal HaskoningDHV has good working relations with many laboratories.

Compliance based engineering

As a result of REACH the risk management measures and operational conditions of both manufacturers and downstream users may be affected due to the changed insights in hazards and risks arising from the use of their products and communications in the supply chain. Royal HaskoningDHV provides a unique combination of knowledge on chemicals management, safety and engineering to deliver lean and mean organisational and technical solutions.

GHS/CLP

Royal HaskoningDHV can assist you with services varying from technical support to total solutions for implementation of GHS. The services include, but are not limited to: regulatory consultancy and compliance

substances and mixtures, training on GHS/CLP.

Safety data sheets

Royal HaskoningDHV provides a full safety data sheet service including the preparation of the annex of the extended SDS (eSDS). In addition to these services advice is provided on the organisational and technical implementation of information from the eSDS.

Storage of chemicals and (external) safety

Royal HaskoningDHV can assist you with assessing, designing and permitting of storage facilities for hazardous chemicals, modelling of external safety (SEVESO) and assessing aspects such as explosion safety (ATEX).

Other services

Royal HaskoningDHV provides a wide range of services that provide solutions for multidisciplinary challenges to industry, such as engineering/design of installations and buildings, responsible care and environmental impact assessments.


1881 Founding fathers Johan van Hasselt and Jacobus de Koning start their business in Nijmegen.

1917 Founding fathers Dwars, Hederik en Verheij start their business in 's Gravenhage.

1981 Haskoning is granted the designation 'koninklijk' (Royal) at its 100th birthday.

1991 EaSI is developed by Royal Haskoning: a database with hazard information from legislation all over the world

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1994programs able to produce multilingual safety data sheets.

2005 RIP 3.10 on characterisation and checking of substance identity is prepared by Royal Haskoning.

2007 Royal Haskoning joins the organisation of ChemCon Conferences

2012 Merge between Royal Haskoning and DHV

ACCREDITATIONS

ISO 9001ISO 14001OHSAS 18001

PARTNERS

ChemCon Conferences

CLIENTS

The clients of Royal HaskoningDHV are located in many different industries. Because Royal HaskoningDHV provides many more services than chemicals management alone, it has service relations with clients covering a wide variety of solutions. Clients are, for example, in pharma,

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

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

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

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.

STAFF SELECTION

ir. Froukje Balk Msc – Senior Expert Ecotoxicology

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.

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. Ingrid is 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.

Conny Hoekzema Msc – GHS/CLP and SDS Expert

management. She has extensive knowledge and experience in safety

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

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.

ir. 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.

Christiaan van Daalen Msc – Project Manager

Christiaan van Daalen is trained as an environmental scientist, specialising in both regulatory toxicology and business communication with a focus on REACH. He has been involved in the production of several large dossiers under REACH and advises on various REACH implementation processes. Besides the preparation of technical dossiers Christiaan acts as project manager in many REACH registration projects for individual companies and consortia and he is teamleader of the advisory group in Nijmegen.

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CONTACTS

Website www.scc-gmbh.de


Head o"ce Am Grenzgraben 11, 55545 Bad Kreuznach, Germany

Tel +49 671 298 46-0

Fax +49 671 298 46-100

Contact Dr Werner Koehl (Chemicals, REACH, Consumer Products)

Directors Dr Friedbert Pistel, Owner and President

Dr Albrecht Heidemann (Agrochemicals and Biopesticides)

Dr Monika Hofer (Regulatory Science)

Dr Hans-Josef Leusch (Biocides)

Dr Werner Koehl (Chemicals, REACH, Consumer Products)

Ruud Huibers MSc (Feed and Food Additives and Veterinary Medicine)


Locations Germany and Japan

Founded 1989

OVERVIEW

Friedbert Pistel, and is today one of Europe's largest privately-owned and independent consulting companies for the registration of chemicals, consumer products, agrochemicals and biopesticides, biocides, feed and food additives and veterinary medicine.


Turnover, group -


2


Staff, group 100




70%

Representation

& management

18%

Information10%

IT &software

2%

GLOBAL OFFICES

Bad Kreuznach in Germany (HQ) and Tokyo in Japan

SERVICES PROVIDED

Registration of chemicals – REACH

substances (including high volume products of more than 1,000 t/a) and

REACH. SCC has established a network for the competent authorities within the entire EU and is recognised as a reliable and competent partner by the authorities (eg ECHA) and EU industry organisations (eg

support in prioritisation/advice on required action in your company for

establishment of study requirements as well as organising and

analysis of potential analogous/family approaches and development

exposure modelling (eg EUSES, Risk of Derm, CONSEXPO, EASY-

C&L support (CLH dossier according to Annex XV, eSDS including

QSAR tools.

Registration of consumer products

aspects that may arise for general and overall evaluation of materials or chemicals for intended applications, and has prepared risk assessments for given exposure (direct or indirect) scenarios. We have successfully made numerous dossier preparations for various cosmetic ingredients, eg hair dyes or CMR Cat 3 substances for evaluation by European expert groups (SCCP, SCCNFP), and on cleansing ingredients or formulations for industry associations, such as HERA.

Registration of agrochemicals and biopesticides

The SCC agrochemicals and biopesticides department considers current and future regulatory and legislative needs and developments in the common agricultural policy of the EU, and stays up-to-date on the

biopesticides department is at the forefront in strategic planning and defence, negotiations with authorities, or task force support.

Registration of biocides

The SCC biocides department has successfully submitted dossiers for more than 20 existing biocidal active substances according to the Biocidal Products Directive 98/8/EC, covering nearly all product types. We have established good working relationships with many competent authorities in the EU and have become an acknowledged partner of authorities and industry. Currently, we are involved twofold: defending active substance dossiers already submitted and preparing dossiers for biocidal products.

Registration of feed and food additives and veterinary medicine

The SCC feed and food additives and veterinary medicine department successfully delivered 36 application dossiers for re-authorisation as a feed additive for the 2010 deadline, which is about 10% of all dossiers

statements for your products. These portfolios will be as concentrated as possible and as extensive as necessary.

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Regulatory science

the backbone of the company and the key to its success. SCC unites experts from all regulatory relevant disciplines, such as chemists, physicists, food chemists, biologists, geo-ecologists, toxicologists, eco-toxicologists, environmental fate specialists, agronomists etc. This access to a wide spectrum of expertise ensures that clients of SCC can take

GLP archive

SCC offers a complete GLP-compliant archiving concept for all regulatory

European or worldwide central archive for GLP-compliant storage.


1989 SCC GmbH founded

1989 Establishment of Agrochemical and Biopesticides department

1989 Establishment of Regulatory Science department

1996 Establishment of Chemical and Consumer Products department

2000 Establishment of Biocides department

2004

2007

2007 Establishment of Feed and Food Additives and Veterinary Medicine department

ACCREDITATIONS

GLP archive (since 2004)

PARTNERS

with CROs, governmental institutions, local regulatory experts and scientists. We can help our clients all over the world.

CLIENTS

Small to large (global) companies in the areas of chemicals and consumer products, agrochemicals and biopesticides, biocides, feed and food additives and veterinary medicine.

TESTIMONIALS

Many of our clients have been customers for a long time, some going back to the start of our company. New clients are often recommended to us via existing clients.

CASE STUDY 1: General remark

All names of our clients and projects are restricted under the highest

case studies. Our consultancy has an excellent proven track record in all regulatory areas where we are active. Only one proof of our success is the fact that in the two decades of our existence, we have grown from a small national business to become a global player.

STAFF SELECTION

Dr Werner Koehl – Head of the Chemicals, REACH, Consumer Products Department

toxicology. He has been with SCC since 2001 and is head of the Chemicals, REACH, Consumer Products department. He previously

multinational, and has gained many years of experience in the registration processes of the chemical world.

Isabel Kirbach

Mrs Kirbach has a master’s degree in chemical engineering. She has been with SCC since 2004 and her focus is on Sief and IUCLID 5.

Dr Charlotte Krone

Dr Krone has a PhD in geosciences. She has been with SCC since 2007, where she focuses on general regulatory affairs and consortia management. Also, she is coordinator of all chemical issues involving our

Dr Ingo Walter

Dr Walter has a PhD in food chemistry. He has been with SCC since 2008, focusing on risk assessments, C&L and MSDSs.

Dr Albrecht Heidemann

Dr Heidemann has a PhD in biology. He has been with SCC since 1994 and is head of the Agrochemicals and Biopecticides department.

Dr Monika Hofer

Dr Hofer has a PhD in chemistry. She has been with SCC since 1998 and is head of the Regulatory Science department.

Dr Hans-Josef Leusch – Head of Biocides Department

Dr Leusch has a PhD in agronomy. He has been with SCC since 2000 and is head of the Biocides department.

Ruud Huibers MSc – Head of Feed and Food Additives, Veterinary Medicine Department

Mr Huibers has a master’s degree in agriculture and natural environment. He has been with SCC since 2007 and is head of the Feed and Food Additives and Veterinary Medicine department.

Dr Bernd Brielbeck – GLP Archive

Dr Brielbeck has a PhD in chemistry. He has been with SCC since 2001

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CONTACTS

Website www.selcia.com


Head o"ce0GS, UK

Tel +44 1277 367000

Fax +44 1277 367099

Contact David Carver

Directors Simon Saxby, CEO

Dr Hans Fliri, Chairman

Ownership Private

Locations UK, USA

Founded 2001

OVERVIEW

Selcia is a leading provider of 14C custom radiolabelling and produces 14C radiolabelled compounds and 14C GMP radiolabelled APIs for a global customer base encompassing both the life sciences and chemical industries. Applications of the radiolabelled products prepared by Selcia include: preclinical and clinical drug metabolism, mass balance, and

and environmental fate studies of pharmaceutical, agricultural and industrial chemicals. Selcia’s analytical laboratory is a member of the UK GLP compliance monitoring programme and specialises in GLP NMR.


Turnover, group -


2

No of countries represented Global

Staff, group 75



Laboratory100%

GLOBAL OFFICES

UK, USA

SERVICES PROVIDED

14C custom radiolabelling

Our services include: 14C radiosynthesis including de novo development of synthetic

safe and fast shipment worldwide to multiple destinations.Our team of expert synthetic radiochemists can prepare C-14 labelled small molecules of almost any complexity for use in pre-clinical and clinical metabolism, distribution and mass balance studies, dermal penetration, degradation/environmental fate and other studies.All our products are delivered with a comprehensive analytical data package, including full spectroscopic analysis and experimental

as radiochemical purity by NMR, MS and HPLC accompanies each compound.

GMP radiolabelled API

Regulatory Agency (MHRA) for the preparation and C-14 labelling of active pharmaceutical ingredients (API) for clinical trials.

perform both in compliance with EMEA and the recent FDA Phase I GMP guidance (IQCH Q7A Section 19: Single batches for investigational

labelling of APIs for clinical trials.

GLP analytical services and metabolite synthesis

synthesis and GLP characterisation of impurity, degradation product and metabolite standards. Our analytical department is accredited by the MHRA and we are a full member of the Good Laboratory Practice programme in the UK and specialise in GLP NMR to support regulatory submissions.We provide specialist analytical services tailored to individual needs to support regulatory studies and submissions:

GLP analysis including mass spectrometry and infrared

custom synthesis of compounds labelled with stable isotopes such as

non-routine analytical studies including structural elucidation and

Selcia can act as study director or principle investigator to support your GLP regulatory study

Drug discovery

Selcia Discovery provides integrated small molecule drug discovery to pharmaceutical and biotech clients. Besides general medicinal chemistry and biology capabilities applicable across all target classes, Selcia Discovery has a particular strength in three unique and highly synergistic

(2) capillary electrophoresis-based fragment and natural product

prolyl isomerases (including cyclophilins, FKBPs, Pin1, together called PPIases).

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2012 Selcia celebrates 20 years of radiolabelling at Ongar

2010 Selcia’s radiochemistry facility is granted a Good

of C-14 labelled active pharmaceutical ingredients (APIs) following a successful inspection by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

2009 Expansion of radiochemistry laboratory increases radiochemistry capacity to 30 fume cupboards.

2006 Selcia joins GLP compliance programme

2005 Following the management buyout of Scynexis Europe by Dr Hans Fliri and the incumbent UK management team, the company is renamed Selcia. The company is the only dedicated provider of custom radiolabeling, chemistry and analytics services worldwide. Dr Fliri is appointed managing director.

2001 Aventis’s Ongar facility is acquired by Scynexis Inc. The new subsidiary operation remains on the same site and is called Scynexis Europe. In addition to the existing radiochemistry expertise, Scynexis invests in automated high throughput drug discovery facilities.

1992 Rhone Poulenc (renamed Aventis in 1999) establishes a

and Business Park, Ongar.

ACCREDITATIONS

Selcia has been a full member of the GLP Compliance Monitoring Programme in the UK since 2006.

preparation and C-14 labelling of active pharmaceuticalingredients (APIs) for clinical trials from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).Selcia is an approved service provider under the French Crédit Impôt Recherche (CIR) scheme for the years 2012 to 2014.

CLIENTS

agrochemicals, biocides, veterinary medicines, chemicals as well as life science research and development organisations and contract laboratories.

TESTIMONIALS

References can be provided on request.

STAFF SELECTION

Dr Hans Fliri – Chairman

Hans joined Selcia in 2003 as Managing Director and continued in this position until May 2011 when he was appointed Chairman. During his time as Managing Director he presided over the transformation of Selcia into a major contract laboratory in both custom radiolabelling and integrated drug discovery services. With more than 25 years’ experience in the healthcare sector, Hans has held senior management positions in global pharmaceutical and biotechnology companies. Before joining Selcia he was Vice President of drug discovery at Cetek Corporation (2001-2002) in the US prior to which he was Senior Director of anti-Infective drug discovery and lead generation at Rhone-Poulenc Rorer and later Aventis in Paris (1994-2000). He held research and management positions at Sandoz (now Novartis) in Basel between 1977

in Europe and the US. He holds a PhD in chemistry from the University of

Simon Saxby – Chief Executive O"cer

Simon Saxby joined Selcia as CEO in April 2011 from RecipharmCobra Biologics where he was Vice-President Biologics. His previous roles as CEO include periods at Cobra Biomanufacturing PLC and at Alpha Biologics Sdn Bhd. He has 13 years’ experience as a board director and has led successful M&A activities for two companies. Mr Saxby has a

sciences industry he has been a founder and fundraiser for companies

development of a CMO business for Unisyn Technologies. Prior to that

Quantum Biosystems Ltd, and held senior management positions with KS Biomedix PLC, Xenova PLC and Scynexis Europe Ltd. He is a member of the Institute of Directors’ Policy Voice forum, advising the IoD, legislators and government, on business issues.

Dave Roberts – Business Development Director, Radiochemistry

Dave co-founded Scynexis Europe in 2001 and participated in the subsequent management buyout which led to the creation of Selcia in 2005. For 20 years Dave has held various senior management positions within life sciences R&D at Rhone-Poulenc and Aventis. At Rhone Poulenc an early career as chemical research manager was followed by roles in global project management for academic and internal research programmes. Subsequently, at Aventis, projects included coordinating external chemistry programmes and managing the sale of two former Aventis research sites. Dave studied organic chemistry at King’s College London. He is a co-inventor of the animal health insecticide Fipronil and

Clive Cornell – Chief Operating O"cer

Clive heads up Selcia’s Discovery division and is also responsible for Operations. He previously held the positions of General Manager and Head of Chemistry. Clive was a co-founder of Scynexis Europe in 2001 and participated in the management buyout which led to the creation of Selcia in 2005. Prior to this, Clive spent 25 years in the life sciences industry with Aventis Cropscience, Schering and Fisons where he led multidisciplinary teams progressing early stage research leads into development. At Selcia, Clive has managed collaborative research programmes with customer companies in large pharma, the biotech industry and in academia. He is an active committee member

Hertfordshire as a graduate of the Royal Society of Chemistry (Part II) and subsequently obtained an MSc in synthetic organic chemistry. He is a chartered chemist and member of the Royal Society of Chemistry.

Dr Gill Little – Director, Radiochemistry and Analytics

Gill has headed up Selcia’s 30-strong radiolabelling group and overseen the group’s associated project portfolios since 2006. She was a co-founder of Scynexis Europe and was involved in the subsequent management buyout that led to the formation of Selcia in 2005. With a PhD in natural product chemistry from the University of Wales, she has over 20 years of experience in chemistry initially with Rhone-Poulenc and Aventis, both in the UK and France. She is the co-author of many

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CONTACTS

Website www.sgs.com/reach


Head o"ce 1, Place des Alpes, PO Box 2152, Geneva, 1211, Switzerland

Tel +41 22 739 91 11

Fax +41 22 739 98 86


Directors

Malcolm Reid, Consumer Testing Services EVP


Locations Brazil, China, Finland, France, Germany, Hong-Kong, Spain, UK, US, etc

Founded 1878

OVERVIEW

company. SGS is recognised as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of

Since 2006, SGS has offered a comprehensive suite of services to help customers comply with their obligations under REACH, from initial

services to support ongoing compliance.


Turnover, group 5,578m CHF


1,500

No of countries represented +100

Staff, group 75,000




10%

Laboratory89%

GLOBAL OFFICES

Brazil, China, Finland, France, Germany, Hong-Kong, Spain, UK, US, etc

SERVICES PROVIDED

Seminars and customised training

SGS dedicated REACH experts in the EU as well as our key trading partners can offer seminars and tailor-made training to manufacturers, importers, retailers and their suppliers at various levels (from elementary to advanced) to suit the unique situation of the audiences.

Consultancy/ impact analysis

Our teams assess companies’ role and current compliance status to

Analysis

Laboratory testing: SGS can develop testing strategy and generate required testing data according to the REACH requirements. Testing services are available through our laboratory networks in Europe, Asia and the Americas. Our labs can perform testing according to and in compliance with Good Laboratory Practices (GLP) as required by the regulation for toxicological and eco-toxicological studies.Analysis of restricted substances and SVHC: SGS is a pioneer for consumer products testing. We can meet all requests of product chemical analysis enforced by regulations.

Data collection and volume tracking

SGS has an extensive network in EU and non-EU countries assisting EUimporters and retailers to collect substance data for registration as well as

their own internal IT system, SGS is able to provide alternative solutions which enable effective consolidation of data that can be kept for ten years.

Sief participation and third party representative

Thanks to our large team of experts, including toxicologists, eco-toxicologist, chemists and in-house legal counsel, SGS is able to provide you with valuable advice to negotiate data and cost sharing in the Substance Information Exchange Forum (Sief).

Registration dossier

REACH registration deadline, SGS can assist in preparing and submitting to the ECHA a comprehensive and reliable registration dossier.

Chemical safety data sheet

SGS has many years of experience in preparing SDS and our services are continuously evolving with regulatory development. We can draft SDS under the Globally Harmonized System (GHS) format and according to

Risk assessment and strategy consultation for SVHC notification

obligation.

REACH audit

Around the globe, we have specially trained inspection teams who excel in system audit and have in-depth knowledge in the regulation. We conduct REACH audits for manufacturers in EU as well as non-EU countries. Our audit check list can be adjusted to the unique needs of our clients.


1878 Goldstück-Heinz & Co was founded in 1878 in Rouen as a grain inspection company

1900s Expanded beyond agriculture in early and mid 20th century to:

industrial sector.

1915 Headquarter in Geneva

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1919 The company adopted the name Société Générale de Surveillance

1980s Expanded our activities to:

and life science services.

1981 Publicly listed on the Swiss Stock Exchange

2001 By the start of the new millennium, a wide-ranging corporate restructuring led to the formation of the ten businesses that are now found at SGS.

ACCREDITATIONS

GLP accreditations for our labs in Rouen (France) and Taunusstein (Germany).

TESTIMONIALS

“In 2010 we successfully submitted a REACH registration dossier as lead registrant. We chose SGS as our REACH consultant and laboratory service provider. SGS organised our kick-off consortium meeting and communication throughout the process, developed an intelligent test

business information, and prepared the technical IUCLID dossier and the CSR. At no point during the process, did we regret having chosen SGS as our service partner. In particular, we appreciated the smooth and prompt communication with our SGS key contact and were pleased with the expertise of the SGS staff involved in the project. In retrospect, we can say that we would contract SGS again for the job.” – RUAG Ammotec GmbH

CASE STUDY 1:

A number of retailers positioned as importers of products and suppliers of formulated products required to ensure they were in compliance with REACH regulations. SGS was employed to obtain BOS information and assess chemical substances in products and articles from numerous suppliers many of whom are located outside of the EU. A tailor-made web based data management system was used to collect information enabling

Product testing in independently accredited test laboratories enabled articles that were considered a high risk of containing SVHCs to be evaluated, allowing the client to show a good level of due diligence. SGS were able to reduce testing costs for the client by offering a package of

unnecessarily testing SVHCs that had a low likelihood of being present.

manpower that they were committing to REACH management whilst maintaining a high level of regulatory compliance.

CASE STUDY 2:

Asked by a major player in the cycle industry to verify that their Indian

contained in the products exported to Germany, SGS staff from Germany and India carried out a training and site audit at the Indian supplier’s facility. Despite being aware of the basic facts on REACH and having implemented various compliance procedures, the staff of the Indian company were found by SGS not to have fully grasped all measures possible to comply with their customer’s expectations and EU SVHC requirements. The service by SGS hence proved to not only be well worth the investment for our client to ensure REACH compliance of their imported products, but also turned out to be a valuable opportunity for the Indian company to improve their quality standard procedures.

CASE STUDY 3:

Faced with the question of whether a read-across from the results gained from

applied to the corresponding alkali metal and alkali metal organyles, in absence of the possibility to test the latter substances for their acute oral toxicity potential based on their property of being corrosive, the client approached SGS. By contracting SGS to assess the problem, our client was able to resolve

of the substance was needed. The SGS consultancy report was used by our

STAFF SELECTION

Céline Goulois

Ms Goulois is a regulatory (eco)toxicologist, specialist in REACH regulation.She is in charge of SGS clients’ registration dossiers and also of training and technical procedures.Before joining SGS in 2008, Ms Goulois worked for six years at a multinational chemical company where she was in charge of the preparation and validation of technical documents (safety data sheets,

assessment, technical support).

Anne Kleinkauf

disruption in wildlife, Anne Kleinkauf absolved two further degrees in environmental auditing, impact assessment and management system and in environmental law and economics, while working as an environmental consultant and auditor. In addtion to her extensive knowledge regarding the requirements under the EU REACH regulation, her experience covers aspects of ecotoxicology, toxicology and risk assessment.

Mei Mei Sit

Senior Research Executive Dr Sit obtained her PhD degree in organometallics. Her work focuses on REACH, CLP and POPs regulations. Currently, she is developing chemical assessment service, such as effective risk-control strategy for substances of very high concern (SVHC) management and cost-effective restricted substance testing tool.

Tony Smith

in an analytical quality assurance laboratory developing new test methods and client problem solving for the textile industry. He has been an active member of many British standards committees and has represented the UK at European and International level as the UK principle expert for chemical and composition testing of textiles. A regular public speaker on regulatory affairs to the UK industry and the retail sector providing up to date and easily understood information on REACH and CLP.

Jerome Vandenbroucke

Jerome is a chemical engineer specialised in formulation. He worked two years on chemical legislations applied to mixture: REACH, biocide,

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Website www.reach-onlyrep.eu


Head o"ce Markaskälsvägen 6, Lund – 22647, Sweden

Tel +46 46 2850418

Contact Shisher Kumra

Directors Shisher Kumra and Mukta Kumra


Locations Sweden, India, Hong Kong

Founded 2008

OVERVIEW

SSS was set up exclusively to provide technical assistance and compliance required by non-European manufacturers and exporters of chemicals and chemical containing products to the European Union for compliance with the REACH Regulation (EC No 1907/2006). SSS has an extensive network of European and Indian business intermediaries and has been working to facilitate non-EU businesses to comply with the requirements of REACH and various other European regulations as well as the upcoming chemical regulations in other countries like Turkey, China, Japan, South Korea, Malaysia, Canada, etc. SSS has a memorandum of understanding (MoU) with two major industry associations in China, namely:

China Chamber of Commerce of Metals Minerals and Chemicals

China International Electronic Commerce Center (CIECC).Through these MoU, as well as an exclusive Chinese team, SSS offers the complete regulatory compliance services related to China, such as

substances to the Chinese inventory of existing chemical substances in China (IECSC).SSS has a client base of over 1,000 companies across the world and has dealt with 9,000 pre-registrations, the successful registration of more than

2010 – including being the lead registrant. SSS is now working as lead registrant on over 100 substances for 2013. SSS also:

developed MSDS for 2,000 substances (including 500 MSDS translation in various European languages).


Turnover, group €2.5m


3


Staff, group 30




50%

Representation

& management10%

IT & software10%

Legal10%

Training20%

GLOBAL OFFICES

Sweden, India, Hong Kong

SERVICES PROVIDED

Late pre-registration (LPR)

SSS offers LPR services to help non-European companies, either new

their substances that were not pre-registered during the June-December 2008 period. Since the pre-registration deadline, SSS has successfully completed the LPR for 900+ substances, with many more in the pipeline.

CLP notification

in the capacity of an importer for which the company has to furnish the identity of the substance like the CAS Number, EC Number.

Registration

Since 2011-12, SSS has been constantly working to help its client companies successfully meet the second registration deadline of 31 May 2013. SSS has so far submitted over 70 lead dossiers and propose to submit an additional 40 lead dossiers before the second deadline. In addition, around 250 member dossiers are proposed to be submitted by 31st May 2013.

REACH compliant SDS

SSS is also engaged in compiling the 16 point REACH and CLP compliant SDS for the chemical substances and preparations meeting the

Extended SDS (e-SDS): registered substances with the relevant exposure scenarios that have to be annexed to the SDS.SDS translation: since it is obligatory for the exporter of chemicals to provide to his buyer an SDS originally prepared in English, in the local language, SSS also provides the service of translating the SDS into other languages of European Member states (for example, German, French, Spanish, Dutch, or Italian).SSS has to date prepared over 2,000 REACH compliant SDSs.

SVHC applicability analysis

presence or absence of substances of very high concern (SVHC) and the REACH compliance obligations. SSS offers a very economical and

solution is in line with the guidance provided by ECHA. So far, SSS has provided around 75 companies exporting articles to Europe with the most

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SSS also provides compliance assistance for the following:

Toys Safety Directive (TSD) Directive 2009/48/EC Regulation (EU) No 528/2012 concerning the biocidal products Turkish Inventory and Control of Chemicals Regulations China REACH Compliance with chemical management in Malaysia (EHSNR)


2008 Established and registered as a private limited company

2008 Successfully pre-registered over 7,000 substances within REACH

2009 Professionals trained in IUCLID from REACH Centrum

2009 Trained over 100 industry professionals in use of IUCLID

2010 35 REACH registrations successfully completed

2010 Delivered 1,500 REACH and CLP compliant SDS

2011 Acquired capacity in Chesar and QSAR

2011 Mandated as lead registrant for 50 substances

2012 Mandated as lead registrant for over 60 additional substances

PARTNERS

Confederation of Indian industry (CII), India Apparel Export Promotion Council (AEPC), India China Chamber of Commerce of Metals Minerals and Chemicals

Importers and Exporters (CCCMC), China China International Electronic Commerce Center (CIECC), China Tisamax Technical Co Ltd (Tisamax), Taiwan

CLIENTS

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

TESTIMONIALS

On the service quality criteria, over 90% of our client companies have rated the REACH compliance assistance services being offered by SSS as very good.

CASE STUDY 1: Technical support to a multinational company

Technical support provided to a multinational company having its own European legal entity as their only representative for successful submission of REACH registration dossier.Problem: due to the registration dossier failing the technical completeness check (TCC) at ECHA, the company had only one opportunity for resubmission of the registration dossier without losing its ECHA registration fee.Solution: SSS (Europe) AB reviewed the TCC failure report as well as the IUCLID registration dossier prepared by the company to identify the

then incorporated into the dossier to remove the errors and when the dossier was resubmitted, it cleared the ECHA TCC check resulting in the company being allotted a REACH registration number. This saved the company substantial Euros because it was a large sized company and was registering in the highest tonnage band of greater than 1,000 tons per annum.

CASE STUDY 2: Successful REACH registration for CMR category 2 substance

Problem:registration deadline of 30th November 2010, a company sought assistance for successful registration within the deadline.Solution: SSS took up the challenge and adopted a multi-pronged strategy to successfully meet the deadline. It also made diligent use of computational models for generating certain end points in a cost effective way. SSS coordinated well with various agencies involved in completion of the IUCLID dossier. Due to SSS’s diligence at each stage of the

attempt and the substance was successfully registered.

CASE STUDY 3: Providing guidance to a non-EU manufacturer having own legal entity in Europe on preparation for a REACH audit

Problem: a non-European company sought the technical assistance of SSS to guide them in their preparation for a REACH audit proposed by one of REACH enforcement agency.Solution: SSS provided guidance to the company in terms of the various

company should have in place before the audit, including compliance with

translated safety data sheet (wherever applicable). Accordingly company

STAFF SELECTION

Mr Shisher Kumra – Executive Director

Area of expertise includes specialisation in regulatory affairs, legal expertise, chemical assessment, toxicology.

Dr Rashmi Naidu

Area of expertise includes REACH data inventory, REACH registration process, environmental toxicology, bio-assay and other regulatory affairs.

Mr Shrirang Bhoot

Area of expertise includes specialisation in the software’s like IUCLID, QSAR, ECOSAR, dossier preparation, ecotoxicology.

Dr Chitralekha Datta

Area of expertise includes chemical safety assessment (CSA), chemical safety report (CSR), toxicology, software like IUCLID, Chesar and CLP.

Dr Shruti Ralegaonkar

Area of expertise includes REACH and articles, SVHC assessment and

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Website www.swissiesp.com


Head o"ce C Lope de Vega, 22-24, 08005 Barcelona, Spain

Tel +34 933 036 612

Fax +34 933 036 612

Contact Montserrat Fernández (REACH Business Group Leader)

Directors Dr Alexis Pey (Director Swissi Instituto Suizo de Seguridad, Spain)

Ownership Swissi AG

Locations Spain (Barcelona, Madrid, Murcia), Switzerland, France, Germany, Taiwan

Founded Swissi AG, 1945 – Swissi in Spain, 2004

OVERVIEW

Swissi Instituto Suizo de Seguridad is a subsidiary in Spain of Swissi AG. Swissi works hand in hand with its clients to promote safety in the industry and particularly in the industry dedicated to chemicals and chemical processes. Our commitment to industrial, process and labour safety is our top priority and, as part of it, we participate in research institutes, international safety organisations and standardisation committees. Our activities focus on three main areas: consulting, laboratory testing and training.




10

No of countries represented Global

Staff, group 143




55%

Laboratory23%

Training11%

Other11%

GLOBAL OFFICES

Swissi Instituto Suizo de Seguridad: C Lope de Vega, 22-24. 08005 Barcelona, SpainSwissi AG: Richtistrasse 15, 8304 Wallisellen, SwitzerlandSwissi Process Safety GmbH: Schwarzwaldallee, 215 WRO-1055.5.24, 4002 Basel, SwitzerlandSwissi Process Safety GmbH: An der Leiten 12, 82069 Hohenschäftlarn/ München, GermanySwissi France SARL: 10, Place Charles Beraudier. Immeuble L’Orient. 69428 Lyon Cédex 03, France

807, Taiwan, ROC

SERVICES PROVIDED

REACH and product safety

Swissi assists a number of companies outside the European Union to comply with REACH regulation. We prepare registration dossiers of their substances, submit them to ECHA and provide the necessary documentation to their downstream users. We also act as third party representative, offering consultancy services to European companies, preparing their registration dossiers and SDS adapted to REACH and CLP regulations. We are members of ORO (Only Representative Organisation).

Laboratory testing

GHS and highly active and highly toxic materials. We also offer tests

on Transportation of Dangerous Goods) ie GHS (globally harmonised

laboratories are accredited under ISO/IEC 17025.

Process safety and loss prevention

safety and reactions, ATEX, electrostatics, environment, thermal process safety, occupational risk prevention and machine directive. We apply recognised methodologies such as HAZOP, ZHA, FTA, LOPA and FMA and propose cost-effective solutions. We belong to the EPSC - European Process Safety Centre.

Environment consultancy

We perform environmental risk analysis, quantify the consequences of possible damage, help companies to integrate their activities in the environment, and perform administrative procedures associated to each regulation and to environmental licenses. We also implement safety management systems

Crisis management

We are accredited to prepare emergency plans and also help companies to implement them with training and emergency exercises aimed at both the companies’ management and staff. As part of the global services we give to our clients, we develop crisis management and communication manuals to minimise negative publicity.


1945 Company founded in Switzerland

2004 Company established in Barcelona, Spain

2008 REACH department is set up

2008 Sales company in Taiwan

2011 Delegation in Madrid, Spain

2012 Delegation in Murcia, Spain

2012 SVTI Group acquires Swissi AG

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ACCREDITATIONS

laboratories are accredited under ISO/IEC 17025.

CLIENTS

Our clients are companies that produce or handle chemicals and chemical products. They belong to the chemical, pharmaceutical, petrochemical and agrifood sectors, among others. We work for all kinds of companies, from multinationals to small and medium-sized local companies.

CASE STUDY 1: REACH IT tool and Customer Care

Swissi developed in 2009 an IT tool for our REACH clients so that they are able to manage all the information derived from the registration process. The information is made available both to our clients and to their respective supply chains. That way their European clients can access the IT tool to download relevant documentation related to the substances they

We also have a close relationship with our REACH clients in Asia. We visit them on a yearly basis to provide them with updates on the latest issues related with the registration process. We organise REACH and

needs.

CASE STUDY 2: Swissi HSE Management Platform

Swissi HSE Management Platform www.hseplatform.com allows companies to manage all aspects related to health, safety and

effectiveness. This IT tool, with customisable modules, integrates all prevention measures, safety regulations and relevant documents. It is a powerful database with integrated and related information from all the modules, can be used to manage one or several sites, generates reports automatically and can be hosted in the company’s own system to

CASE STUDY 3: Tailor-made proceedings

Companies are increasingly concerned by safety, health and environment. To meet its clients' needs, Swissi provides consultancy services to develop tailor-made proceedings to help companies to manage its procedures and thus increase effectiveness and reduce costs.This service is the fruits of years of experience in consulting.

STAFF SELECTION

Dr Alexis Pey – Director of Swissi Instituto Suizo de Seguridad

Dr Alexis Pey started Swissi in 2004. He has a PhD in chemical engineering and specialises in electrostatics, process safety, accident investigation and risk analysis. He has also worked at the consumer care Division of Ciba Specialty Chemicals. He is a member of the board of Bequinor and a permanent member of EFCE.

Montserrat Fernández – REACH Business Group Leader

Montserrat Fernández has worked since 2009 at Swissi and holds a degree in chemistry. She is a consultant specialising in REACH

packaging (CLP) and transport safety (ADR). She also worked at the R&D department of Clariant, where she held various positions.

Dr Otto Holzschuh – Consultant (REACH, Regulatory A#airs) and Laboratory Manager.

Dr Otto Holzschuh, working at Swissi Process Safety GmbH in Switzerland, is an experienced REACH specialist with a chemical engineering and process safety background. He has had responsibilities for safety and environment in leading chemical and pharmaceutical companies. He has experience in laboratory testing for transport

sheets. He is coordinating Swissi’s collaboration with other laboratories to offer one-stop services for REACH registration.

Dolors Vinyoles – Consultant (REACH, ORP and Environment)

Dolors Vinyoles has worked since 2008 at Swissi and holds a degree in chemistry. She is a consultant specialising in REACH regulation, environmental safety, safety management systems, and occupational risk prevention.Before joining Swissi, she worked at Clariant Spain, where she used to be ESHA (Environment, Safety, and Health Affairs) country head.

Mariàngels Custal – Consultant (Environment)

Mariàngels Custal has worked since 2010 at Swissi and is a chemical engineer. She is a consultant specialising in environmental safety, explosive atmospheres (ATEX), and transport safety (ADR). Before joining Swissi, she was responsible for the environment and the industrial wastewater plant at various Clariant factories in Spain and Belgium.

Joan Marc Juncosa – Consultant (REACH and Machine Directive)

Joan Marc Juncosa has worked since 2009 at Swissi and is a chemical

labelling and packaging (CLP), explosive atmospheres (ATEX) and machinery safety.

Berta Albaigés – Consultant (REACH and Thermal Process Safety)

Berta Albaigés has worked since 2011 at Swissi and is a chemical engineer. She is a consultant specialising in REACH and product safety and thermal process safety. Before joining Swissi, she worked at RPN, a consultancy for the pharmaceutical industry specialized in regulatory affairs.

Ester Pellicer – Consultant (REACH and Crisis Management)

Ester Pellicer has worked since 2009 at Swissi and holds a degree in communication science. She is a consultant specialising in REACH (supply chain communications), crisis management – crisis communication and emergency exercises.

Jordi Campos – Consultant (Emergency Plans and Major Accidents)

Jordi Campos has worked since 2006 at Swissi and is a chemical engineer. He specialises in emergency plans, major accidents (SEVESO) and safety management systems. He has also worked for PQAT group of IQS (Institut Químic de Sarrià).

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Website www.triskelion.nl


Head o"ce Utrechtseweg 48, PO Box 844, 3700 AV Zeist, The Netherlands

Tel +31 88 866 16 28

Fax +31 88 866 69 70


Ownership Private company, wholly-owned by TNO

Locations Zeist, The Netherlands

Founded

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 and analysis services characterised by strong communication with a personal touch that larger CROs cannot match.




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Staff, group 4,500




30%

Representation

& management10%

Information5%

Laboratory45%

IT &software

5%

Training5%

GLOBAL OFFICES

Headquarters group: TNO, Delft, The Netherlands,Headquarters TNO Triskelion: Zeist, The Netherlands

SERVICES PROVIDED

Risk assessment and chemicals management

Our focus is on REACH and its implementation. Besides registration, authorisation and building exposure scenarios, we support the evaluation of risk management options. We can audit your own implementation and communication under REACH and its eSDS’s. Additionally ,we support biocides and the safe use of nanoparticles. TNO and TNO Triskelion have together developed a range of assessment tools to help evaluate human exposure and to avoid and reduce health risks. Our expertise is available to address regulatory issues as well as to solve day-to-day chemicals management problems.

Experimental toxicology

of REACH, biocides, pesticides and nanomaterials customers. Our toxicological research centre provides new and improved methods in toxicology, especially inhalation, reproduction, immuno-toxicology and (f gh f i j k ) skin adsorption. We have been developing novel methods to reduce, f g h f h k studies such as repeat-dose (28/90d), repro screening and f g h f h k gentox in the same study. We can offer the new OECD 443 guideline for an extended one-generation reproduction toxicity (EOGRTS) study, already validated in our laboratories, as well as the OECD 488 transgenic rodent test.

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,

assessment, our tailor-made services can make a difference, for example:

mechanistic studies of toxic compounds ` a b ` b e using sophisticated

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

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

ensures you that deadlines are met and that the assignment meets your needs. Your project manager maintains contact with you during phone and/or conference calls (scheduled as and when you require), and also provides regular update reports.Quality assurance and reporting – our GLP reports are consistently subjected to the required auditing and control procedures to ensure compliance. All the documentation you receive (proposals, reports,

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

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1932Research is founded

1946 Founding of the Central Organic Chemistry Institute in Zeist

2004chemical groups including organotins

2005 TNO Business Unit Quality and 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

2010 Successful completion of 325 full and partial REACH dossiers

2011 Incorporation of TNO Triskelion as a private company

2011 ReachCentrum and TNO Triskelion join forces to offer REACH workshops and training courses

2012 Extensive application of our exposure experience to the evaluation of Risk Management Options for SVHC’s

ACCREDITATIONS

PARTNERS

TNO Quality and Safety (R&D): we work together with TNO on development of alternative toxicological methods and (bio)analytical methods.ReachCentrum: workshops and trainingWhere needed we supply additional services like ecotoxicology, physicochemical testing and special evaluations (as SEA) through our network of co-operators.

CLIENTS

Three top-10 and 12 top-50 global chemicals manufacturers are our clients.We have provided long-term chemical safety services to the following

biocides, chlorinated solvents, fuel oxygenates, organic peroxides, formaldehyde, amines, polyols and isocyanates, silicates and mineral oxides (micro and nano grades), coal chemicals, fragrances.

TESTIMONIALS

“TNO Triskelion recently performed a comprehensive risk assessment on behalf of our industry. As well as their knowledge and experience,

communicating across the interfaces within the industry.” – Phil Hope, Secretary General, Formacare."In the past three years TNO Triskelion has steered us safely through

registration of chemicals." – Harrie Camps, SABIC.

CASE STUDY 1: Successful registration within REACH, post-2010 follow-up and 2013&2018 preparations

With Phase II REACH registration rapidly approaching in mid 2013, this is another year in which to push ahead with the preparation of safety dossiers. We have combined the necessary data searches, testing where needed, chemical safety assessment, and exposure scenarios into IUCLID 5, chemical safety reports and eSDS and all under the same roof.

of nanomaterials that they will ultimately fall under REACH and ECHA has

By 1 June 2013, companies should have completed the registration of substances in the 100-1000 tonnage band. Based on the 2013 experience, TNO Triskelion can help you plan the registration, guide you through the process, and work with you to ensure timely and successful registration for 2018 as well. Grouping and read across will be needed to keep costs down and has to be prepared early.

CASE STUDY 2: ECHA test proposal evaluations including EOGRTS

REACH requires that for substance volumes of 100-1,000t and >1,000t, missing higher tier safety studies be included in the registration dossier in the form of a test proposal. ECHA is in the process of evaluating these proposals and (draft) decisions are being sent to lead registrants. Many have already been published on the ECHA website and were open for public comment for several weeks.

Our advice to clients faced with an ECHA test-proposal that diverges from their own, is to enter, as far as possible, into a dialogue with

support your case to ECHA. Should testing be needed, TNO Triskelion is specialised in higher

cover gases, volatile liquids, solids and nano-grade materials, while our reproduction toxicology skills are second to none and include the EOGRTS (OECD 443). We have validated OECD 443 in our laboratory, gaining us the necessary experience.

CASE STUDY 3: Chemicals mamagement

Our experts can support you in your day-to-day management of issues related to chemical safety. Our expertise can help you to avoid compliance issues in the future that could affect your production of chemical substances, mixtures and articles. For example, we can:

assist you with the production and implementation of extended safety

prepare an audit of REACH readiness in preparation for government

prepare answers to questions from ECHA and competent authorities/

follow-up on any ongoing work on your substances in Siefs and

help you in answering questions from your clients regarding their

create and follow-up on watch lists of your substances as they become impacted by regulatory measures in the future.

Solutions as outlined above are offered on a contract basis with a primary contact point that becomes your personal advisor.

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

that we remain vigorous and up to date.

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CONTACTS

Website www.toxminds.com


Head o"ce 116, Avenue de Broqueville, 1200 Brussels, Belgium

Tel +32 (2) 762 91 45

Fax +32 (2) 762 91 46

Contact Daniéle van Haute

Directors Dr Thomas Petry

Dr Francesca Tencalla


Locations Belgium, Germany

Founded 2006

OVERVIEW

to a broad range of industries. Human and environmental safety of industrial and consumer products is essential for business sustainability and growth. With our broad industry experience, we support our clients in bringing safe, regulatory compliant and publicly acceptable products to the market.


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Staff, group 10 - 25

Staff, chemical service provision 10 - 25



60%

Representation

& management10%

Information25%

Training5%

GLOBAL OFFICES

SERVICES PROVIDED

The (eco)toxicology and regulatory experts of ToxMinds provide high quality consulting and technical support services to a broad range of industry clients that are subject to human and environmental health legislation. All our senior consultants have long term industry experience

are centred on our three competence areas: applied human health and

and science-based advocacy.

Applied human health and environmental risk assessment

Literature review: retrieval, organisation, analysis and presentation of accurate information on the (eco)toxicological effects of chemical substances.Hazard assessment: in-depth evaluation of (eco)toxicological hazards, target organ toxicity or species and characterisation of dose-response relationships.Environmental fate: determination of the fate of substances in soil, water and air and derivation of predicted environmental concentrations

industries.Data completion: evaluation of non-testing approaches to support chemical and chemical-based product safety including grouping/read-

management of ` a b ` c d e /vivo non-clinical and clinical safety programmes.Risk assessment: comprehensive human health and environmental risk assessments.

EU regulatory strategy and compliance

Chemicals and commodities: strategic consulting, technical registration and post-submission support to ensure success under the REACH as well as compliance with the CLP Regulation.Biocides and agrochemicals: pre-registration/registration support including literature search, data gap analysis, human and environmental risk assessment as well as dossier assembly and post-submission support.Pharmaceuticals and OTC: strategic non-clinical programme planning and conduct, eCTD dossier development, client representation to authorities and post-marketing support.Plant biotechnology: development of regulatory submissions as well

queries from regulatory authorities).

Science-based advocacy

Strategy: develop and implement strategies to support products against

Authority review: support on science and regulatory matters in discussions with regulatory authorities.Communication: communicate (eco)toxicology and risk assessment

non-governmental organisations).Scientific review panels: addressing complex health or environmental issues through organisation and management of independent multidisciplinary peer review panels.


2006 Foundation of ToxMinds BVBA by Dr Thomas Petry

2009the EU institutions

CLIENTS

ToxMinds is providing its (eco)toxicology, product safety and regulatory compliance services to a wide range of multinational fortune 100 companies, SMEs, and industry associations from the chemical, metal/mining, consumer product, biotechnology and pharmaceutical sector.

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TESTIMONIALS

“We have been working with ToxMinds BVBA for many years on various complex toxicology, ecotoxicology and regulatory issues. The professionals at ToxMinds are thorough, knowledgeable and always

ecotoxicology and regulatory compliance.” – Senior manager, Global Product Regulatory Compliance, international specialty chemical company

CASE STUDY 1: Consortium management and technical support to REACH consortia

ToxMinds provides technical REACH support for a number of REACH consortia and individual chemical companies covering more than 80 chemical substances, predominantly UVCBs. Our technical work includes:

desktop search and data gap analysis QSAR modelling and analysis design of intelligent testing strategies placement and monitoring of testing programmes development of Iuclid 5 registration dossiers, chemical safety

assessments and reports (CSR) strategy advice and support during registration and evaluation phases client representation in discussions with authorities applications for authorisation, strategic and technical support during

authorisation phase.

CASE STUDY 2: Human and environmental risk assessment

ToxMinds (eco)toxicology consultants have long experience in conducting human and environmental risk assessments of commodity and specialty chemicals for our clients as part of regulatory or voluntary industry programmes or for internal safety assurance purposes. The human health risk assessments considered human exposures to chemicals at the workplace, in indoor/outdoor air or due to their release from consumer products such as cosmetics, cleaning or pest control products. The environmental assessments typically included environmental fate and ecotoxicicty evaluations of chemical releases into the environment at

from “down the drain” consumer products.

CASE STUDY 3: Science-based advocacy

ToxMinds has been supporting and advising global chemical and consumer product companies whose main product categories were subject to public discussion on potential human health effects in its

evaluation of possible response strategies. On behalf of the industry,

Commission, EU Member States as well as non-governmental organisations leading to a less emotional and a more rational debate supported by science.

STAFF SELECTION

Thomas Petry, PhD, ERT, DABT

Dr Petry is the founder and manager of ToxMinds BVBA. He is a product safety and regulatory affairs consultant with 20 years’ industry, consulting and research experience in the human safety assessment of chemical exposures occurring at the workplace, through their use or presence in consumer products, or via the environment. He is a European registered toxicologist (ERT) as well as a diplomate of the American Board of Toxicology (DABT) and earned his PhD in toxicology from the Institute of Toxicology of the Swiss Federal Institute of Technology (ETH) of Zurich.

Francesca Tencalla, PhD, ERT

Dr Tencalla is a (eco)toxicology and regulatory affairs consultant with 20 years’ of industry, consulting and research experience in the human and environmental safety assessment of chemicals, metals, agrochemicals and pharmaceuticals. She is a European registered toxicologist (ERT) and earned her PhD in (eco)toxicology from the Institute of Toxicology of the Swiss Federal Institute of Technology (ETH) of Zurich.

Nirmala Ranggasami, MSc, ERT

Ms Ranggasami is a toxicology and regulatory affairs consultant with more than ten years’ of industry and consulting experience in the human and environmental safety assessment of substances. She is a European registered toxicologist (ERT) and earned her MSc in toxicology from the University of Surrey, UK.

Ms Daniela Jeronimo Roque, MSc

Ms Daniela Jeronimo Roque has been a researcher at ToxMinds BVBA since 2011. She supports the team in conducting thorough desktop searches, (eco)toxicological hazard assessments, QSAR and exposure modelling. Daniela has a biomedical license in life science and health/biology with a specialisation in nutrition. She obtained a master’s degree in health risk sciences at the University of Clermont-Ferrand in France

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CONTACTS

Website www.tuev-sued.de/technical_installations/reach


Head o"ce TÜV SÜD Industrie Service GmbH, Westendstr 199, D-80686 Munich, Germany

Tel +49 / 89 / 5791-1004

Fax +49 / 89 / 5791-1174

Contact Dr Dieter Reiml

Ownership TÜV SÜD Holding AG

Locations TÜV SÜD Group employs more than 17,000 people in 80 countries in ca. 800 locations

Founded 1866

OVERVIEW

The principle of REACH, "No data, no market", may seem alarming. Additionally, comprehensive obligations governing the provision of information along the supply chain and to ECHA are gradually coming into effect.As a globally recognised expert in all chemical law issues, TÜV SÜD continuously pursues the reform process in the EU and supports companies throughout all steps of REACH and GHS implementation.To assist the companies affected by REACH, TÜV SÜD has established an international REACH network. Our environmental experts are tracking REACH implementation in the EU on an ongoing basis. And in addition, we also help to maintain business secrets of our customers in spite of mandatory data sharing provisions.In view of the 2018 registration deadline TÜV SÜD developed a service package custom tailored for small and medium enterprises (SME) as well as for global players.Our maxim is “REACH – Made easy with TÜV SÜD expertise.”


Turnover, group €1,700m


800


Staff, group 17,000




35%

Representation

& management

35%

Information10%

Laboratory10%

Training10%

GLOBAL OFFICES

Japan, Singapore, China, India, Taiwan, Indonesia, Thailand, Vietnam, Serbia, Russia, Ukraine, South Korea, USA

SERVICES PROVIDED

Only representative

TÜV SÜD Industrie Service acts as reliable and impartial OR to numerous manufacturers of substances established outside the community. The obligations of an OR outlined in Art. 8 of the REACH regulation comprise not only registration but also all obligations for importers under REACH. Calling in an OR has the following advantages: importers need not become active themselves, and manufacturers established outside the

individually. We experience that often manufacturers address to us when

obligations.

REACH initiative for midsized and small companies

All companies must register their chemicals by mid-2013 and by 2018 at the very latest – which is especially challenging for small and midsized businesses! TÜV SÜD aims to help these companies ensure that REACH is not a threat, but a path to safeguarding business. With the special needs of small and midsized companies in mind, TÜV SÜD has created a service package that provides these companies with assistance in all questions related to chemicals. The spirit of initiative: focus on your core competences, not on REACH.

Authorisation

The authorisation procedure aims to assure that the risks from SVHC are properly controlled and that these substances are progressively replaced by suitable alternatives. SVHC may be included in the authorisation list and become subject to authorisation. These substances cannot be placed on the market or used after a given date, unless an authorisation is

Our support extends from the management of authorisation consortia to

effective manner.

In-house training and seminars

Companies affected by REACH or CLP are seeking advice on how to deal with the challenges caused by REACH in a timely effective manner. Desired training events vary depending on participants’ existing knowledge:

workshops to create solutions under the guidance of an experienced

in-house consulting for the ad-hoc solution of characteristic problems.

Any other activities concerning REACH and CLP

REACH and CLP shift most of the responsibility for the safe handling of chemicals from the regulatory bodies to producers, importers and downstream users and retailers. The relevant requirements and

all kind of services related to REACH and CLP, from the starting point to implement REACH via testing in our own GLP accredited laboratory to long-term compliance with chemicals regulations.


1866 Established in Mannheim

1926 Introduction of the “TÜV SÜD mark / stamp” in Germany

1960 Establishing chemical services

1990 Conglomeration of TÜVs from the southern part of Germany to form TÜV SÜD and the expansion of business operations into Asia

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Best brand of technical services, testing, consulting, training,

and providers, nuclear power plants, chemical industry

2006 Expansion of services in ASEAN by acquiring Singapore-based PSB Group

2007 Establishing REACH services. Founder member of the "BUSINESSEUROPE REACH Implementation Network”.

ACCREDITATIONS

GLP

CLIENTS

sectors. We support a network of chemical plants. Company size varies from worldwide operating entities to SMEs. We support clients in all their roles under the REACH regulation.

CASE STUDY 1: Consortium management

a series of substances with registration deadlines from 2010 to 2018. The duty to act as lead registrant was shared among the individual consortium members. The main bodies of the consortium are the steering committee, the technical committee and the secretariat. TÜV SÜD rendered consortium management to all bodies. Technical REACH consultancy and

CASE STUDY 2: Support in REACH implementation

An EU manufacturer of articles and substances required support in implementing a REACH system for the entire company. The tasks focused on communication in the supply chain, registration, SVHC, training and organisational building. A team was formed for continuous

site.

CASE STUDY 3: Complete service package for lead registrants

Several clients from the chemical industry lacked capacity to prepare lead dossiers. TÜV SÜD prepared and submitted the lead dossiers on behalf of the clients. Additionally, all accompanying steps were performed as well: Sief communication, data-gap analyses, testing, expert statements, QSAR modelling, communication within consortium, preparation of safety data sheets, cost calculation of letter of access, handling of letter of access.

CASE STUDY 4: Testing strategies and testing

The lead registrant of four substances had to conduct studies in order to

the information requirements.All available information that had been gathered was assessed for

vPvB status and the derivation of a dose descriptor to be used in the chemical safety assessment (CSA). The information was evaluated for its completeness and quality (relevance, reliability and adequacy). Cost for data sharing is one of the crucial issues of negotiations in Siefs. High quality data outsell a higher price than data of low quality.Some data gaps were closed by QSAR and read-across. Other data gaps had to be closed by testing. A thorough and meaningful test strategy was set up in order to minimise cost and to comply with the registration deadlines on one hand and to comply with REACH annexes VII to X on the other hand.TÜV SÜD operates its own GLP testing laboratory capable of performing all testing required by REACH. The data gaps were closed by physico-chemical properties testing, ecotoxicological studies as well as toxicological studies.

CASE STUDY 5: SVHC

A EU-based group with legal entities in several member states was seeking support in making an inventory of SVHC of the articles put into market, as well as in implementing a system to comply with the duties to communicate information on SVHC in articles. The legal entities were predominantly in the role of importers of articles or retailers of articles. TÜV SÜD offered an integrated approach over all affected legal entities in order to avoid duplication of work. Representative articles were selected for chemical testing in case of uncertainty on the presence or concentration of SVHC. Testing was performed in TÜV SÜD’s own chemical laboratory.

implemented in the entire group. The system ensured full compliance with REACH Art. 33 to 36. Furthermore, supply contracts were amended to increase legal certainty, to avoid the risk of lawsuits and to avoid image problems.

CASE STUDY 6: Only representative

TÜV SÜD acts as OR for many non-EU manufacturers. In several

approach guarantees direct contact to the end-client and avoids language barriers where applicable. Thus, also smaller non-EU manufacturers

English and technical terms.

STAFF SELECTION

Dr Fritz Prechtl

than 30 years' professional experience. His core activities are only representative preparing registration dossiers communication up and down the supply chain communication in Siefs and with authorities complex role analyses consultancy on REACH

Dr Dieter Reiml

with more than 30 years' professional experience. His core activities are consortium management authorisation only representative preparing lead dossiers CSA / CSR consultancy on REACH and CLP

Other sta#

The majority of the Munich REACH team of TÜV SÜD has gained the

of commerce.

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CONTACTS

Website www.wilresearch.com


Head o"ce 1407 George Road, Ashland, Ohio, 44805

Tel (419) 289-8700

Fax (419) 289-3650


Ownership Privately owned

Locationsin the UK, Japan and Switzerland

OVERVIEW

support personnel with locations in the United States, Europe and Japan. The United States locations include Ashland OH, Skokie IL, Hillsborough NC and Boothwyn PA. WIL Research provides regulatory affairs support and programme management for the chemical industry, helping you to focus on the core activity of your company and advancing your compounds and products to the market. Our experts give advice on the full range of regulatory and exploratory studies you will need. Importantly, they are skilled experts and able to deliver relevant information to you with full transparency.WIL Research Europe specialises in personalised contract research and expert consultancy for the registration of pharmaceutical products, biocides and (agro)chemicals worldwide. More than 290 well-trained and dedicated specialists and modern purpose built laboratories and

Our operations have been endorsed by the GLP monitoring authorities


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No of countries represented 40-50

Staff, group 900




17%

Representation

& management3%

Laboratory80%

GLOBAL OFFICES

Headquartered in the US, our main facility is in Ashland OH, with support

SERVICES PROVIDED

Our objective is to contribute to better human health, environmental safety and industrial progress by accelerating the development process of our client’s products. We support our clients by providing quality driven contract research services. Our added value results from dedicated staff working together with our client’s project team and enhancing the

of results. Our staff create the company’s value and this is enhanced by continuous education, exciting career opportunities and personal development. By these means the WIL Research team remains dedicated and its objectives clear.

REACH compliance

REACH consultancy and Sief management and full testing portfolio

REACH safety testing

To help you comply with the regulations WIL Research has set up a ten-step action plan which will cover all aspects of the registration needs for both phase-in (EINECS materials) and the non-phase-in substances (new chemicals). The different steps are given below. For each of these steps we can provide more details on the activities within that step and the cost estimation for completing that part of the work.

Full service portfolio for Annex 7-8-9-10

Registration chemicals worldwide

WIL Research provides regulatory affairs support and programme management, helping you to focus on the core activity of your company and advancing your compounds and products to the market.

Registration of agrochemicals and biocides

EDSP – endocrine disruptor screening programme (complete set of assays) in conformity with EPA requirements.

Safety testing including (eco) toxicology and risk assessment

Toxicology and ADME, general toxicology ,genetic toxicology, ` a b ` c d e toxicology, developmental and reproduction toxicology, carcinogenicity, ADME and kinetics, safety pharmacology, special toxicity studies, environmental toxicology, formulation development, juvenile toxicity studies, lead optimisation, single rat PK

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ACCREDITATIONS

WIL Research has achieved Good Laboratory Practice (GLP) compliance status for more than 20 years, with the most recent GLP endorsement statement signed in May 2011.

WIL Research publication was referenced in the guidance document 117 for OECD 443 guideline.

WIL Research published article is referenced in the guidance document 126 for the OECD 203 guideline.

We’re proud of our longstanding accreditation through the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC).

We never get complacent about quality. Constantly striving to improve it, we regularly analyse our processes and have established quality improvement teams as part of our total quality management (TQM) policy.

CLIENTS

Non-disclosure agreements prohibit this level of information.

CASE STUDY 1: WIL Research 10 steps to REACH compliance

We understand clearly that each situation is different and we therefore advocate discussing this in a personal meeting going through the following distinct steps:

Step 10 - Safety data sheet.

CASE STUDY 2: Biocidal registration

WIL Research’s regulatory affairs department provides a complete service for the registration of biocides under the biocidal products Directive 98/8/EC.Our aim is to provide you with a high quality service which will help you in

We provide complete hazard characterisation and exposure assessments for operators, workers, bystanders and consumers as well as for the environment (groundwater, surface water, soil, air, non-target organisms). These assessments are carried out using various modelling tools (eg USES, EUSES, etc) and are based on the most up to date guidelines and emission scenario documents.WIL Research’s experienced team consists of regulatory experts in chemistry, environmental fate and behavior, residues, ecotoxicology and human toxicology. In addition to outstanding technical knowledge, we have well-established contact with EU and national authorities and a thorough understanding of the procedures involved in obtaining registrations for biocides.We assist you with dossier preparation at EU and Member state level. We compile complete dossiers (Documents I, II, III and study reports) in electronic format. Prior to dossier compilation, we assist you in identifying data gaps and project management, outsourcing and study monitoring, writing data waivers to save costs and time, and discussions with authorities.

assistance with single sections and smaller regulatory questions to the preparation of complete dossiers.

CASE STUDY 3: Complete hazard and exposure assessments

WIL Research’s regulatory affairs department provides a complete service for the registration of agrochemicals under the regulations 91/414/EC, 1107/2009.We provide complete hazard and exposure assessments for operators, workers, bystanders and consumers, as well as for the environment (groundwater, surface water, soil, air, non-target organisms). These assessments are carried out using various modelling tools and are based on the most up to date guidelines.WIL Research’s experienced team consists of regulatory experts in chemistry, environmental fate and behavior, residues, ecotoxicology and human toxicology. In addition to outstanding technical knowledge, WIL Research has well established contact with EU and national authorities and has a thorough understanding of the procedures involved in obtaining registrations for agrochemicals. We assist you with dossier preparation at EU (Annex II) and member state level (Annex III) – taking into account the national dossier requirements.Our services are custom-made to suit your needs. They include dossier compilation (electronic submissions, CADDY), technical dossier writing, data gap analysis and project management, outsourcing and study monitoring, risk and exposure assessments and post-submission

import tolerance dossiers, and setting of MRLs or help you with complete dossiers or single sections and smaller regulatory questions.

STAFF SELECTION

Wilbert Frieling, DVM – Managing Director

Wilbert Frieling graduated in veterinary science from the University of Utrecht, The Netherlands, in 1991. From 1991 until 1996 he directed a veterinary practice. He joined WIL Research as a supporting veterinarian in December 1994. In April 1996 he was appointed as section head General and Industrial Toxicology, in 1997 he was appointed as head of Toxicology and in 2004 he was appointed director of Toxicology. When WIL Research joined WIL Holding in 2005, he was appointed as managing director of WIL Research BV.

toxicologist. He is also a board member of NVDEC (Dutch society of animal ethical committees). He has presented various papers on international meetings on toxicology (mini-pig in toxicology, continuous infusion technology and preclinical safety testing strategies).

Steven D Barkyoumb, DVM, PhD – Sr Vice-President, Global Operations – Nonclinical Safety Assessment

experience in the pharmaceutical and contract research industries. He brings extensive experience in regulatory-driven toxicology, pathology and laboratory sciences. Most recently, he served as Vice President, Nonclinical Safety Assessment for Covance Laboratories and held

Services. He directed the growth of Covance’s toxicology business in North America and managed the pathology and immunology services across six sites in the United States, Europe and Asia. Clients describe Steve as a leader with high integrity, strong principles and outstanding

Prior to joining Covance, Steve served as the Executive Director for Nonclinical Drug Safety at Quintiles and the Director of Regulatory Toxicology and Safety Pharmacology for the Drug Safety Evaluation unit at Abbott Laboratories. He began his career with a series of roles with increasing responsibility with Hoechst Marion Roussel and its predecessor companies. Steve holds a Doctor of veterinary medicine degree and a PhD in veterinary pathology from Kansas State University. He is a Diplomate, American College of Veterinary Pathologists (1984 – present) and previously a Diplomate, American Board of Toxicology (1989-2004).

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A D I V I S I O N O F E AG, I N C.

E N V I R O N M E N TA L FAT E & E COTOX I CO LO G Y T E S T I N G

CONTACTS

Website www.wildlifeinternational.com and www.eaglabs.com


Head o"ce 8598 Commerce Drive, Easton Maryland 21601, USA

Tel/ Fax +1 410 822 8600/ +1 410 822 0632

Contact Annegaaike Leopold

Directors Mark Jaber, Managing Director

Jim Miraldi, Vice President Finance

Dave Palmer, Director of Business Services

Annegaaike Leopold, Director Global Business Development


Locations USA, The Netherlands

Founded 1976

OVERVIEW

Wildlife International 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 pesticides, pharmaceutical and animal health products and industrial chemicals. Wildlife leads in endocrine ecotoxicological testing and screening. Bioaccumulation testing is one of our major areas of specialisation. Our mass spectrometrist and Bruker maXis impact UHR-TOF instrument completes our environmental fate capabilities. Wildlife International is a part of the Environment Fate, Chemistry and Ecotoxicology Division of EAG, Inc together with PTRL-West and PTRL-Europe. PTRL provides specialised services in analytical chemistry and residue analysis, environmental fate and metabolism helping us to complete our service offerings.


Turnover, group US$21

Turnover, chemical service provision US$3.5m

2


Staff, group 135




5%

Laboratory90%

Training3%

Other2%

GLOBAL OFFICES

Zutphen, The Netherlands

SERVICES PROVIDED

Biodegradability testing and environmental fate

Biodegradation screening and testing (OECD 301, 310, 314, 303 etc). Environmental fate testing (OECD 307, 308, 309, 106). All these studies can be

manure degradation study is another major area of specialisation at Wildlife.

Endocrine disruptor screening and testing

testing, We have in-house histopathology services to evaluate the potential of

Sediment toxicity and terrestrial plant testing

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

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

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. The lab can run up to ten bioaccumulation studies per year.


1976

1983 Company acquired by current managing director and partner

1986 Opened laboratory designed for full service avian toxicology testing

1990 Opened 2,800m2 aquatic toxicology and chemistry laboratory

1990 Expanded avian toxicology laboratory to 3,600m2

1992 Established biodegradation department to offer ready, inherent and specialty biodegradation testing

1997The Netherlands

2000 Opened 1,300m2 environmentally controlled greenhouse facility

2006 Expanded biodegradation and e-fate department to include 300m2 of new laboratory space

2009 Completed in-house histopathology laboratory to evaluate

2010 Acquired by the Riverside Company

2011 Opened up 1,100m2 expansion designed to conduct aquatic endocrine testing.

2012 Acquired a Bruker maXis impact UHR-TOF

Dec 2012 Merged with Evans Analytical Group (EAG, Inc) adding the expertise of PTRL-West and PTRL-Europe to our range of services.

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ACCREDITATIONS

PARTNERS

Wildlife International works with many other contract laboratories and consultancies with the aim of optimally serving our clients. Within the Environment Fate, Chemistry and Ecotoxicology Division of EAG, Inc we partner with PTRL-West and PTRL-Europe.

CLIENTS

Agricultural chemicals: Dupont, Syngenta, DowAgro, BASF, Bayer, Monsanto, Makteshim-Agan, Sumitomo, Nihon Nohyaku, Valent, Gowan, Agrichem, Nufarm

Industrial chemicals: The Dow Chemical Company, Albemarle, ICL, Arkema, Bayer, Dupont, Akzo Nobel, Procter and Gamble, RIFM

Animal health: MSD (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.

if at all possible. We have enjoyed working with Wildlife International Ltd

Dow Chemical Company

doorstep of our clients.”– TNO-Triskelion.

CASE STUDY 1: Glyphosate: fish short term reproduction assay (FSTRA) with the fathead minnow (Pimephales promelas) – a paper presented at SETAC US 2012, S. Schneider et al, Wildlife International

The objective of this assay was to determine if glyphosate might impact the hypothalamus-pituitary-gonadal (HPG) endocrine axis resulting

conditions at mean measured concentrations of 0.046, 0.23, 1.2, 6.2 and 33 mg ae/L for 21 days. Endpoints that were evaluated for endocrine disruption of the reproductive system included fecundity, fertility, secondary sex characteristics (including tubercle and fatpad scores), gonadosomatic index (GSI), histopathology of gonads, as well as plasma vitellogenin. Other endpoints included survival, general observations of health, weight, and length. There were no apparent effects on survival, growth, reproduction, secondary sex characteristics, GSI, VTG or gonad histopathology in male

evaluated, glyphosate does not appear to impact the function of the hypothalamuspituitary-gonadal (HPG) endocrine axis in fathead minnows.

CASE STUDY 2: E how a new builder in automatic dishwashing detergent became ready biodegradable in the US: widespread microbial adaptation in the field – work performed at Wildlife International Ltd. Poster presented at SETAC US 2012, Itrich et al

L-GLDA (Glutamatediacetate) is a chelant that was introduced as a phosphate replacement in a North America (NA) automatic dishwashing (ADW) detergent gel in early 2010. Prior to ADW use, LGLDA failed multiple biodegradation screening tests (OECD301B) in the NA region and was not considered ready biodegradable in this geography. However, results from a more realistic continuous activated sludge treatment test (OECD 303A) predicted that a microbial population pre-exposed to L-GLDA would extensively degrade it after a lag period. In this same time frame, activated sludge inoculum from a single EU plant did degrade L-GLDA and produced a bacterium that could utilise it as a sole

nitrogen, carbon and energy source. The market introduction of this new ADW and the subsequent widespread distribution of L-GLDA in wastewater offered a unique opportunity to monitor for potential microbial

tests were conducted using inoculum collected from multiple WWTPs in two NA regions. Within several months, WWTP inoculums that had previously produced negative results, measuring 9-21% CO

2 production,

demonstrated that L-GLDA was “ready biodegradable” (65-100% CO2).

Inoculum from additional WWTPs also showed positive ready test results and a decrease in the measured lag period (< 10% CO

2) was observed as

new chemical, that consistently failed ready biodegradation tests in the US became ready biodegradable across a wide geographical region following its introduction in a commercial product. The ready test is required under most regulatory schemes for the registration of a new chemical and to demonstrate a lack of persistence. However the use of pre-exposed inoculum is strictly prohibited in some regions. This work demonstrates that when pre-exposure occurs under realistic conditions, laboratory tests can accurately predict ultimate real world behaviour indicating the importance of considering potential adaptation in regulatory assessments.

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

and amphibian endocrine disrupter studies. Expert aquatic toxicologist,

testing and endocrine test design, conduct and interpretation.

Timothy Springer, PhD – Director of Special Projects

Dr Tim Springer manages special projects and technical support. He was responsible for the development of the abbreviated ` a b ` b ebioconcentration test. Dr Springer has played a critical role in the revision of the OECD guideline 305, and in development methods to estimate BCF values using data from BMF studies.

Edward Schaefer – Director of Fate and Biodegradation

Mr Schaefer has more than 20 years of experience in the area of degradation and environmental fate testing. Responsible for study design and oversight of testing programmes. Key contributor to development of

Dr Timothy Blake – Metabolite Identification Specialist

Dr Blake is a senior level scientist who has spent more than 25 years

Dr Alex Ponizovsky – Senior Scientist of Environmental Fate

Dr. Ponizovsky holds a PhD in physical chemistry from the Institute of General and Inorganic Chemistry, Academy of Sciences, USSR, Moscow, 1981. He has 30 years of research experience and more than ten years of environmental fate testing experience, specialising in adsorption/desorption studies.

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Website www.wtconsulting.ch


Head o"ce Weierweg 7, 4410 Liestal, Switzerland

Tel +41 61 923 30 00

Fax +41 61 923 30 02

Contact Ulrich Wietschorke

Directors Ulrich Wietschorke

Dr rer nat Andreas Tschech


Locations Switzerland

Founded 2007

OVERVIEW

WTConsulting is an independent and neutral full-service provider in international regulatory affairs, environment, health and safety, offering more than 25 years of sound knowledge and experience.The regulatory disciplines covered include chemicals, food contact substances/ food packaging, drinking water contact substances, direct food additives, feed additives, medical devices, cosmetics and cosmetics raw materials, toys and pharmaceutical packaging.Geographic regions covered: Europe, North America, Japan, Korea, China and Australia.


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Information5%

Training5%

GLOBAL OFFICES

Covered by partner network.

SERVICES PROVIDED

REACH compliance

(Klimisch etc) literature search development of intelligent test strategies QSAR, read-across / bridging, waiving compilation of technical dossier and chemical safety report in

IUCLID5 technical dossier submission, updates and follow-up support on joint submissions

(physical-chemical, mutagenicity, toxicity, eco-toxicity, environmental fate) at test laboratories

CLP / GHS notification, classification and labelling

collection and assessment of data available QSAR and read-across / testing proposal

Agency)

Chemical notifications worldwide

with local independent regulatory experts to ensure appliance of the very latest expert information and direct access to regulatory agencies and test laboratories, as needed.

Food contact substances/ food packaging materials

review of existing data, gap analysis and test programme proposal compilation of safety assessments, and depending on the country

environmental impact assessments compilation and submission of registration dossiers, including follow-up analytical method development and validation migration calculation and migration studies

(migration, mutagenicity, toxicity) at test laboratories

preparation of compliance documentation according to Regulation 1935/2004

support on GMP other countries upon request.

Cosmetics and cosmetic raw materials

safety evaluation of cosmetic raw materials, and cosmetics and fragrances applying QSAR, read-across

compilation of registration dossier of cosmetic ingredients and submission

Food additives and feed additives

review of existing data, gap analysis and test programme proposal compilation and submission of registration dossiers, including follow-

up analytical method development and validation

(physical-chemical, mutagenicity, toxicity, eco-toxicity, environmental fate) at test laboratories

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Medical devices

evaluation of biocompatibility in accordance with ISO 10993-1 / USP literature search and data collection for safety assessment/ gap

analysis/ conception of test programme

(haemocompatibility, migration/ leaching, cytotoxicity, mutagenicity, toxicity, ADME studies) at test laboratories

assessments reports

Toys

evaluation of the chemical safety of toys in accordance with Directive 2009/48/EC

literature search and data collection for safety assessment/ gap analysis/ conception of test programme

(migration/ leaching, cytotoxicity, mutagenicity, toxicity, ADME studies) at test laboratories

assessments reports

consulting on safety strategies


2007 WTConsulting GmbH founded

2008 Establish CRO network

2009 Establish global network of expert regulatory consultants

ACCREDITATIONS

WTConsulting staff is member of the Swiss Society of Toxicology and the Swiss Society of Chemistry.

PARTNERS

Partner companies can be viewed on our website.

CLIENTS

WTConsulting does not release the identity of clients. WTConsulting works for international companies covering the whole supply chain including OEMs.

TESTIMONIALS

Testimonials will be provided upon individual request.

CASE STUDY 1: Overall experience

WTConsulting staff members experience is based on:

more than 3,550 compliance evaluations of plastic formulations for

more than 150 safety assessments for plastic formulations and

active involvement in regulatory working groups.

CASE STUDY 2: Time to market/cost savings

For a new chemical substance WTConsulting developed a test

schemes and for the registration as an additive for food contact plastics in Europe and in the USA. With the developed test programme the chemical

became regulated / approved for food contact / packaging applications “across the board” in Europe (EU-EFSA and German BfR) and in the USA (FDA). The toxicological test programme was optimised to the extent that also the eventual degradation products were covered, resulting in

food contact application could start 18 months early.

CASE STUDY 3: Business impact analysis and support

Industry is exposed to an increasingly growing regulatory and non-regulatory environment worldwide. At WTConsulting, we see this development as a mega-trend. We support our companies taking these developments into account and achieving sustainable global business, growth and development.WTConsulting successfully consulted and navigated a multi-national chemical

with agencies, NGOs and OEMs, demonstrating regulatory compliance, environment and consumer safety of strategically important products.

CASE STUDY 4: Development of safety strategy and synergies

For a world-leading toy manufacturer WTConsulting successfully developed a global safety strategy going beyond applicable toys regulations. The strategy addresses the rapid developments in the regulatory environment not limited to consumer safety, but also addressing the product life cycle per se. As the evaluation of the raw materials was part of the project, sensitive information was disclosed – under a secrecy agreement. The safety strategy grants compliance (beyond) toy regulations and directs permanent optimisation of raw materials in view of life cycle aspects.

STAFF SELECTION

Ulrich Wietschorke

BSc in biology founder of WTConsulting GmbH 26 years’ experience in the CRO industry as global senior regulatory

affairs professional, consultant and managing director

Dr rer nat Andreas Tschech

PhD in biology co-founder of WTConsulting GmbH 23 years’ experience in the CRO industry as global senior regulatory

affairs professional, consultant and regulatory toxicologist

Dr rer nat Birgit Seyfried

PhD in biology 22 years' experience in the CRO industry as eco-toxicologist/ study

director and department head, and six years as regulatory affairs manager

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CONTACTS

Website www.yash.com


Head o"ce 841 Avenue of the Cities, East Moline, IL 61244, USA

Tel 847-903-2564

Fax 309-755-3742

Contact Hari Vyakarnam, Vice President and Practice Director – Sustainability Solutions

Directors Paul Struck, SAP Practice Director

Yogesh Nagpal, REACH and SAP EH&S Program Manager

Ownership Privately held

Locations North America, South America, Europe, Asia, Australia

Founded 1996

OVERVIEW

YASH Technologies has been providing services and support around environmental health and safety management to global customers for years, helping them to cost-effectively meet various product, health and safety, and environmental compliance. With the strong functional, technical and business knowledge around the EHS and regulatory compliance (REACH, RoHS, GHS, etc), YASH has brought together all of its experience to bring in a holistic compliance approach which aligns to


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20%

Information5%

IT & software70%

Training3%

Other2%

GLOBAL OFFICES

Brazil: São Paulo.

Australia: Sydney, New South Wales .

SERVICES PROVIDED

SAP EHS (and sustainability) services portfolio

business assessment solution consulting and mapping SAP product (module) implementation application maintenance support roll outs and upgrades EHS data migration/ management user/ business training

MSDS and label authoring (and management)

MSDS authoring with various regions /regulatory requirements

guidelines (CLP/ OSHA /others) regular updates in SDS, labels as per the changes in the regulations,

business or customer requirement

creation of various types of labels in WWI (SAP) automatic report shipping, distribution, label determination and management (in SAP) MSDS help desk – for prompt support on MSDS requests MSDS management – complete business outsourcing related to

entire MSDS operations

REACH compliance services

REACH assessment, consulting and management IUCLID dossier creation for REACH registration robust summary preparation – per OECD/ REACH guidelines

supporting data/system preparedness towards REACH

CSA and CSR creation and validation literature search from authentic and reliable sources guidance, training and orientation towards REACH compliance process/ systems setup

Regulatory consulting and EHS support services

compliance process/system evaluation and optimisation compliance data collection and management complete business process outsourcing for EHS data/ processes for

organisation wide compliance management in-house organisational-wide training and consulting services guidance and advisory workshops IT application modernisation to meet the obligations from various

regulations such as RoHS, REACH, GHS, OSHA, TSCA, WEEE, etc other ITES (MDM) support with regards to EHS compliance

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1996 YASH Technologies is founded

2000

2008 YASH starts its REACH and RC CoE with services focused around REACH, GHS, OSHA and other regulatory compliance

2009 Gartner includes YASH in REACHing Downstream document

2010 inREACH, a proprietary solution by YASH, is launched

2011 YASH solutions around MSDS/ label management is included into the SAP PLM –LoB Solutions portfolio

2011 YASH is recognised as the development and testing partner for SAP – Chemical BP Solutions releases

2012expands global reach to Australia

2012 YASH receives the Pinnacle award from SAP

ACCREDITATIONS

chemicals industry best practices development with SAP (ChemOne India V1 603 & V1 605)

product development/ testing partner for SAP EHS solutions experienced professionals in providing solutions on regulatory

compliance for chemical, E&E, manufacturing industries dedicated and established CoE on regulatory compliance to support

EHS (and regulatory) consulting and services

CLIENTS

Sampling of customers includes: DOW Chemical, Chemtura, Nova Chemicals, Arch Chemicals, Quaker Chemicals, Red Spot, Gulbrandsen, Cheminova, Asian Paints, Dr Reddy’s.

TESTIMONIALS

“[...] If you are looking for a system integration partner for your implementation project, the SAP chemicals team highly recommends YASH Technologies based on their deep experience in the chemical industry and their proven success." – Frank Kochendoerfer, Director, SAP IBU Chemicals“[…] YASH had the deep chemical industry expertise we were looking for in a partner. We felt really comfortable with the customer-centric and

– Kevin Kolley, Corporate Director of IT, Red Spot

CASE STUDY 1: Chemtura Corporation

YASH was engaged as strategic partner for over four years to support SAP landscape globally. YASH’s compliance services include:

global support team with 24*7 availability BoM-BoS transfer property tree/ regulatory data update.

CASE STUDY 2: Red Spot Paint and Varnish

This company provides high performance coatings for plastics, with a focus in the automotive industry. They implemented YASH’s SAP Business All-in-One ChemOne solution for ERP in 30 weeks. Thisincluded:

leveraging SAP for reporting and dashboards for one version of the

plans to implement warehouse management, quality management, and mobility.

CASE STUDY 3: Dow Chemicals

Dow is a global leading manufacturer of specialty chemicals, advanced materials, agro-sciences, and plastics to customers in 160 countries. However its internal team could not keep pace with growing demand for material safety data sheet (MSDS) creation, and was only able to produce approximately 200 MSDSs a monthYASH was selected to provide MSDS “authoring” with a 100% accuracy goal and shortened cycles. YASH’s involvement led to:

STAFF SELECTION

Hari Vyakarnam – Practice Director – Sustainability

Responsible for managing YASH’s services and solutions related to environment, health and safety. Besides EHS, Hari focuses in offering regulatory compliance services for a variety of regulations such as REACH, RoHS, GHS etc. He has more than 21 years of experience in product management, account management, practice management, alliance management, business development and over six years’ experience in providing SAP EHS and regulatory solutions to global large chemical companies. Hari has 15 years of experience working with globally distributed teams and providing consolidated professional services to Fortune 500 clients. He holds a Master’s degree in business

Yogesh Nagpal – Program Manager – SAP EH&S and REACH – is the SME on EU-RoHS, REACH and SAP EHS business suite

Responsible for managing and driving various projects around EHS and regulatory compliance with many reputed accounts. He brings more than ten years of experience in EHS solution consulting and business

the product compliance like RoHS, REACH, GHS, IMDS, WEEE. He holds a Master’s degree in business management along with a PG diploma in environmental sciences.

Paul Struck – Practice Director, Process Industries

Responsible for enhancing YASH's services and solutions portfolio to directly address the business challenges of the process industry vertical. Paul has more than 20 years of information technology and business process consulting experience. Prior to joining YASH, Paul managed a variety of SAP solution-based business transformation initiatives with Fortune 500 clients including DuPont, BP, PepsiCo, and Microsoft. He has 18 years’ experience in consulting, including senior positions at Deloitte, Accenture, and Hitachi Consulting.

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Website www.ag-hera.com


Head o"ce 23 London Street, Faringdon, Oxfordshire SN7 7AG, UK

Tel/ Fax +44 (0) 1865 58 98 93/ 7805609296

Contact Albania Grosso

Ownership Sole ownership

Locations Spain, United Kingdom

Founded 2020

OVERVIEW

AG-HERA specialises in REACH, CLP, and chemical hazard, exposure and risk assessment. The company, founded by Albania Grosso after 20 years of employment in environmental

AG-HERA’s unique combination of technical and project management capabilities, plus leading edge experience of REACH and CLP registrations, provides clients with seamless solutions to any chemical risk assessment challenge. We can model worker and consumer exposure to chemicals, exposure of the general population via the environment, and the exposure of different environmental compartments. We are experienced in the use of EUSES, Chesar, ART, IUCLID and ECETOC TRA. In collaboration with our associate companies we provide the full range of technical, legal and administrative services required for effective compliance with environmental regulations such as REACH and CLP.

SERVICES PROVIDED

Consortium management, dossier preparation and data management, pre-registration/registration, risk assessment (environmental), risk assessment (human), testing strategies, corporate strategy/advice.

CLIENTS

(HOPA ) Consortium, Hydrocarbon Solvents REACH Consortium (HCSRC), CONCAWE, International Lead Association (ILA), Frits Consortium, Precious Metals Consortium, Rutgers Belgium, Penman Consulting, Regulatory Science Associates Ltd, wca environment ltd.

CONTACTS

Website www.altox.dk


Head o"ce Tonsbakken 16-18, DK-2740 Skovlunde, Denmark

Tel/ Fax +45 3834 7798/ +45 3834 7799

Contact Pernille Hjaltalin


Locations Denmark

Founded 1992

OVERVIEW

ALTox is a consultative company that provides counselling and training within: REACH and CLP requirements of chemicals and articles (C&L, SDS, ECHA

registrations and communication) biocides cosmetics and toys other registration services (eco labelling, national product registers, COLIPA etc) general safety counselling for professional and private use (on-site handling,

storage etc in relation to regulations for occupational health and environment) Scandinavian regulations (eg MAL codes and order on carcinogenic substances).

SERVICES PROVIDED

At ALTox we assist private companies (SMEs as well as large companies), authorities and

ALTox is widely recognised for the development of helpful desk tools to ease implementation of C&L and preparation of SDS. Being independent from software solutions (C&L, SDS) and

CLIENTS

Importers, downstream users and manufactures of chemicals primarily in Europe. ALTox also provides counselling to trade organisations, universities and other professionals within the chemical area.

CONTACTS

Website www.big.be


Head o"ce Technische Schoolstraat 43A, 2440 Geel, Belgium

Tel/Fax + 32 14 58 45 47 / +32 14 58 35 16

Contact Zita Snellinx

Ownership

Locations Belgium

Founded 1979

OVERVIEW

BIG is an independent information and emergency call centre for dangerous chemical substances. Information is gathered on physico-chemical and (eco)toxic properties, as well as regulations on safety, health, environmental protection and transport related to hazardous materials. Based on these data BIG delivers a large number of products and services to clients from diverse sectors, including: industry, emergency services, governmental and inspection services, healthcare and academia.

SERVICES PROVIDED

BIG offers expertise concerning information on hazardous substances. For REACH and CLP this means assisting our clients in determining what their role and obligations are, the complete registration process from A to Z (including data gap analysis, CSA/CSR/

ext-SDSs, CLP compliant labels), onsite training in REACH and/or CLP, onsite REACH audits, only representative and third party representative services. BIG also specialises in

CLIENTS

BIG is only representative for many global players, providing customised services to large international companies and SMEs. Our clients are in many sectors, such as: raw chemicals,

paints, article manufacturers.

CONTACTS

Website www.calebgroup.net


Head o"ce The Stables, Somerset House, Church Road, Tormarton,

Badminton, Gloucestershire, UK

Tel/ Fax +44 (0)1454 269330/ +44 (0)1454 216030

Contact John Yates

Ownership Private companyLocations UK, Germany, USA

Founded 1994

OVERVIEW

Caleb Management Services Ltd is a policy and regulatory consultancy that has

governments, multi-national companies and worldwide consortia to small companies with a single substance. Caleb tailors its support to take account of a client’s internal resources in order to maximise the value of our contribution. The company has a considerable track record in sustainable management recently adding a sustainable procurement support service for our clients.

SERVICES PROVIDED

consortium management REACH dossier development and registration Sief management CLP compliance management SDS authoring and management OR and TPR services sustainable procurement support

CLIENTS

Caleb supports SMEs and large corporations, European and global industry associations and task forces globally. Currently the company is OR or TPR for about 20 companies and provides consultancy support for many more. Caleb also supports more than ten REACH consortia as managers and advisors.

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Head o"ce CFCS-Consult GmbH, Essen - Tübingen, Alfredstraße 68-72, 45130 Essen, Germany

Tel/ Fax +49 201 79870 191/ +49 201 79870 386

Contact Dr Barbara Lohmann

Directors Dr Barbara Lohmann (CEO), Dr Felix Endres (CEO)


Locations Germany, Italy

Founded 2007

OVERVIEW

CFCS is a team of experienced: toxicologists, chemists, eco-toxicologists, biologists and environmental chemists. Our experts are specialised in the areas of: regulatory affairs, chemical assessments, chemical safety, risk assessment, environmental protection and occupational safety. Our main focuses are: REACH services, project and

authorisation of biocides and biocidal products, authorisation of pharmaceuticals and

for REACH, Ecetoc TRA, IUCLID 5, Chesar.

SERVICES PROVIDED

to the assessment of the biological or chemical impact of substances on humans and on the environment. We provide ample support on regulatory issues and project

even for very complex projects, we are always available as your key reference partner.

CLIENTS

Manufacturers, importers or downstream users of industrial chemicals, veterinary drugs, plant protection products or cosmetic ingredients.

CONTACTS

Website www.chemsw.com


Head o"ce

Tel/ Fax +1 707 864 0845/ +1 707 864 2815

Ownership Private

Locations USA

Founded 1991

OVERVIEW

Founded more than two decades ago, ChemSW is the leading provider of chemical and biochemical inventory management systems, MSDS systems and other chemistry laboratory software and services. ChemSW’s products streamline laboratory processes and reduce chemical purchasing and disposal costs. ChemSW supports over 15,000 customers in more than 40 countries throughout the world.

and accurate, real-time data, enabling companies to: identify and optimise critical

SERVICES PROVIDED

We offer a complete range of systems to meet the needs of diverse organisations in both regulated and non-regulated environments. We provide laboratory chemical inventory management and MSDS systems to meet the needs of the smallest desktop application to the largest multinational enterprise. ChemSW maintains a comprehensive R&D programme, coupled with rigorous usability testing and quality control processes. We support all of our customers and systems with an experienced, dedicated customer service staff.

CLIENTS

ChemSW serves major customers in the pharmaceutical, biotechnology, chemical, petrochemical, food and environmental industries as well as colleges and universities.

CONTACTS

Website www.conusbat.com

E-mail [email protected] / [email protected]

Head o"ces Germany: Kruppstr 18, D-52072 Aachen

Tel +49 241 518 5 7790 (internet)/ +49 241 81987 (Germany)Skype: steven.hanft

Fax +49 241 81928

Contact Dr Annelie Struessmann, Technical and Regulatory Director

Ownership Steven L Hanft, MA, President (private ownership)

Locations Germany

Founded

OVERVIEW

CONUSBAT specialises in EU/Global regulations for cosmetics, personal care and consumer

representative (OR), safety assessor-responsible person (RP), compliance analysis, CLP review, strategic planning, online or onsite training on global regulations, and more. While focusing internally on the EU frameworks, we cooperate worldwide with third parties (ASEAN, China, S Korea, Brazil, USA, S Africa) in compliance approaches for our key industry sectors.

SERVICES PROVIDED

preparation and analysis, safety assessment

and analysis Safety assessors-responsible person (RP) for cosmetic products in the EU:

etc Global regulatory workshops (online/onsite) for the cosmetic, personal and

Brazil, USA Global regulatory workshops (online/onsite) for the cosmetic, personal and

Korea, Brazil, USA

compliance analysis, implementation

CLIENTS

Fortune 500s, SMEs, academic or training institutes, governmental agencies in

CONTACTS

Website www.crowell.com


Head o"ce Rue Joseph Stevens 7, Brussels, B-1000, Belgium

Tel +32 2 282 4082

Fax +32 2 230 6399

Contact Laurent Ruessmann


Locations Washington DC, New York, California, Anchorage, London and Brussels

Founded 1979

OVERVIEW

internationally recognised for its representation of Fortune 500 companies in high-stakes litigation, as well as its ongoing commitment to pro bono service and diversity.

SERVICES PROVIDED

Crowell & Moring provides legal services in relation to EU chemicals legislation including REACH, CLP and WEEE.

CLIENTS

Representative clients include: AT&T, BAE Systems, BMW, Caterpillar, EI du Pont de Nemours, Eastman Kodak, Hitachi, Lockheed Martin, Siemens and United Technologies Ltd.

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Website www.dangerandsafety.it


Head o"ce Via Bugatti, 53, 56022 Castelfranco di Sotto (Pisa), Italy

Tel +390571367427

Fax +390571382829

Contact Paola Ulivi


Locations Italy

Founded 2000

OVERVIEW

With more than ten years of experience, Danger and Safety provides prompt and

general for chemicals’ regulatory affairs (Reach-CLP-Dangerous goods transport). All

SERVICES PROVIDED

CLP compliance management SDS and e-SDS authoring for substances and mixtures risk and hazard assessment for health in working place

CLIENTS

We serve a wide variety of clients, from very small to large enterprises, operating in

CONTACTS

Website www.mach-chemguide.com


Head o"ce Boernsener Str 16f, 21039 Hamburg-Boernsen, Germany

Tel/ Fax +49 40 729 10 933/ +49 40 729 10 934

Contact Dr Bettina Mach

Ownership Private

Locations Germany

Founded 2011

OVERVIEW

We guide you through REACH and CLP and the new cosmetic regulation 1223/2009.We rely on more than 20 years of experience in product safety in the chemical and cosmetic industry.

SERVICES PROVIDED

identify your obligations prepare late preregistrations prepare ECHA inquiries prepare dossiers in IUCLID 5

represent your interests in Siefs and consortia monitor toxicological studies

advice on the implementation of the new cosmetic regulation EC 1223/2009 conduct safety assessments and prepare chemical safety reports for cosmetics

according to EC 1223/2009

CLIENTS

Dr MACH Chemical Compliance and Competence focuses on SMEs in the European chemical and cosmetic industry: manufacturers, importers, distributors and downstream users of chemicals and manufacturers of cosmetic products.

CONTACTS

Website www.ecotox.com.au


Head o"ce Unit 27, 2 Chaplin Drive, Lane Cove 2066, Australia

Tel +61 2 9420 9481

Fax +61 2 9420 9484

Contact Dr Rick Krassoi


Locations Australia

Founded 2001

OVERVIEW

Ecotox Services International (ESI) is the sister company of Ecotox Services Australasia

testing services for chemicals and products for international regulatory assessment purposes in compliance with the OECD Principles of Good Laboratory Practice (GLP). These studies are used to satisfy international regulatory requirements for programmes such as the REACH programme.

SERVICES PROVIDED

Ecotox Services International offers testing services in compliance with the OECD Principles of Good Laboratory Practice (GLP). A wide range of acute and chronic ecotoxicity tests are available, run with aquatic and terrestrial organisms.

CLIENTS

requirements for chemicals registration such as industrial chemical manufacturer/importers and agrochemical companies. ESI also works with consultancies managing REACH dossiers.

CONTACTS

Website www.es4chem.eu


Head o"ce PO Box 8186, 6710 AD, Ede, The Netherlands

Tel/ Fax +31 636224088/ +31 318 846 538

Contact Dr Evelyn Tjoe Nij


Locations The Netherlands

Founded 2012

OVERVIEW

ES4chem is a dedicated service provider in the area of human exposure and risk assessment. You can expect independent and objective advice on exposure related issues of substances and mixtures in the workplace, consumer products and the environment. Many years of

hygiene and epidemiology), excellent communication skills and a problem solving attitude, make ES4chem a highly valued partner in risk assessment issues related to REACH.

SERVICES PROVIDED

(ECETOC TRA), consumers (ConsExpo) and the environment (EUSES) higher tier exposure assessment (by models such as ART and Stoffenmanager,

and statistical analysis of measurement data) update of 2010 dossiers (chapters 9 and 10)

assessment derivation of OELs, DNELs/DMELs based on human data implementation of exposure scenarios (eSDS) down the chain advice on REACH compliance for all actors in the supply chain

CLIENTS

ES4chem offers its services related to chemical safety assessment to the chemical industry and sector groups of downstream users in Europe and to other contract research organisations.

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Head o"ce Pères Blancs Street 4, 1040 Etterbeek, Brussels, Belgium

Tel/ Fax + 32 (0)2 740 43 36/ + 32 (0)2 740 43 87

Contact Charlotte Crauwels

Ownership Private

Locations Belgium, France, Finland, Germany

Founded November 2011

OVERVIEW

eSpheres, founded in 2011 as a Solvay spin-out. eSpheres is a global leader in delivering cloud health, safety, environment (HSE) and corporate sustainability solutions to organisations worldwide. Our in-depth IT solutions and HSE support services help industrial companies in improving their management of safety, industrial hygiene, and occupational health processes.

SERVICES PROVIDED

eSpheres supports responsible care all along the product’s life cycle. From industrial hygiene and accident management, to air emissions and resource consumption – we help companies automate and streamline compliance with HSE and sustainability requirements with SAP® EHSM software. We host, secure and manage your HSE data in a private cloud environment. SAP® EHSM software helps customers address sustainability initiatives to reduce business risk, protect brands, manage scare resources, and ensure compliance.

CLIENTS

We support global companies (Fortune 500s, SMEs) in a large number of industries: (petro)-chemicals, pharmaceuticals, Iron, steel and alloys production, mining and minerals and pulp and paper, but also at downstream users like polymers and polymer transformation, electronic, cosmetic, and automotive industry.

CONTACTS

Website www.eupoc.de


Head o"ce Schlossblick 14, D-87748 Fellheim, Germany

Tel/ Fax +49-8335-987951/ +49-8335-987952

Contact Dr Malte-Matthias Zimmer


Locations Germany

Founded 2012

OVERVIEW

Eupoc was established to focus mainly on consortium management and representation of interest. From the outset our business was driven by SMEs looking for partners able

gained a lot of experience in managing different interests and corporate philosophies. Combining knowledge with respect to the various visions of the future is making Eupoc’s core business such successful: creating a future in Europe’s regulated markets.

SERVICES PROVIDED

Eupoc supports clients in communication – between each other (eg along supply chains) and with customers, suppliers, associations, authorities, politicians and lawyers. This is the base

combines technological expertise with successful interdisciplinary networking. Our main focus

practical, working together directly and establishing a cooperative sense inside the consortia.

CLIENTS

Eupoc began with an impressive number of SMEs in surface technology and engineering, together with their customers. This is currently the core area of our business: our clients are concerned by legal regulations, especially REACH registration, restriction and/or

network of external experts we are able to handle European consortia.

CONTACTS

Website www.eurideastranslation.com


Head o"ce 475 Avenue Louise, 1050 Brussels, Belgium

Tel +32 (0)2 669 7701 / +32 (0)2 669 77 87

Fax +32 (0)2 627 5655

Contact Kristina Bitvai


Locations Belgium

Founded 2007

OVERVIEW

Eurideas Linguistic Services provides professional translation and interpretation services. We specialise in chemical, technical, medical translations, as well as in other

speaker chemical translators are experts on the REACH regulation and other related EU legislation. We have great experience in translating MSDSs, exposure scenarios, and other chemistry, environment and health related documents. We have developed our own unique methodology through years of translating REACH documents, and are therefore able to offer 60% discount for the repetitions.

SERVICES PROVIDED

Translation: translations are always done by a native speaker translator and proofread by a second native speaker translator. This way we ensure the highest quality of translation and that the correct terminology is used.Interpretation: we provide simultaneous, consecutive and liaison interpretation in Belgium, France, Germany, the Netherlands and the UK.Typesetting: we prepare your ready-to-print publications based on a given artwork.

CLIENTS

Glencore International Imports, Rio Tinto, ReachLaw, FEFCO, Codelco, Molymet, the International Molybdenum Association, the International Lead Association, the Nickel Institute, Aurubis AG, DonauChem, Euromines, EcoMundo, Chemtopia, and many more.

CONTACTS

Website

E-mail

Head o"ce Itainen Pitkakatu 4B, FIN-20520 Turku, Finland

Tel

Contact Dr Jan Nylund

Locations Finland

Founded 2009

OVERVIEW

FinnREACH provides chemical safety services to companies under REACH, the Biocidal Products Regulation and the Cosmetic Products Regulation. We offer top notch research and expert services to support our customers’ registration tasks. We help you with the whole process starting from data acquisition, testing strategies and

preparation, IUCLID 5, Chesar and REACH-IT expertise. We have specialised in

and packaging of chemical substances and preparations and to prepare appropriate and correct safety data sheets (SDS) and other documents required by law. Our SDS

dangerous goods safety adviser services including consultation and preparation of all reports as required by the Transport of Dangerous Goods Regulation (Safety Adviser).

SERVICES PROVIDED

REACH and biocide registration and consultancy testing strategy – planning and coordination data search and assessment human health and environment assessment cosmetics safety assessment

safety data sheet preparation and translation R&D-services – formulation and substance replacement

laboratory and testing – l m n l n o , l m n l p q o , physico-chem

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CONTACTS

Website www.fobig.com


Head o"ce Klarastraße 63, 79106 Freiburg, Germany

Tel/Fax +49 761 38608-12/ +49 761 38608-20

Contact Klaus Schneider


Locations Freiburg, Germany

Founded 1992

OVERVIEW

FoBiG is a privately owned consultant institute specialised in toxicological risk assessment with two decades of experience in exposure assessment and risk characterisation. FoBiG’s

sponsored SPORT project, the REACH baseline study and VCI projects on exposure-based waiving and the “practical guide” on exposure assessment and communication in the supply

REACH registration deadlines and supports companies with applications for authorisation.

SERVICES PROVIDED

reliability, application of read-across and category approaches and inquiry dossiers for new substances)

chemical safety reports (including hazard assessment, derivation of DNELs, DMELs and PNECs, exposure assessment and risk characterisation)

support for preparing applications for authorisations under REACH support in Sief and consortium discussions and communications downstream user inquiries and communication

Other activities relate to cosmetics ingredients, safety evaluations and regulatory support in the areas of food toxicology, environmental contaminants and occupational toxicology.

CLIENTS

FoBiG supports SMEs and large European chemical companies with their REACHobligations and works for industry associations, European institutions and governmental organisations in methodological projects and other areas of toxicological assessment.

GHS-expertCONTACTS

Website www.GHSexpert.com and www.REACHexpert.eu


Head o"ce 51 Haromszek str, 1194 Budapest, Hungary

Tel +36202205737

Contact Agnes Botos


Locations Hungary

Founded 2010

OVERVIEW

We ensure 100% compliance with REACH and CLP (GHS) regulation. Together with an

SERVICES PROVIDED

GHS support:chemical substances and mixtures with 100% legal compliance with EU and US GHSREACH support:

CLIENTS

software and REACH services.We have supported more than 70 Hungarian and foreign companies in completing the

Countries of clients: Hungary, USA, Ukraine, Uzbekistan, Germany, UKPlease visit our website and click on References.

CONTACTS

Website www.grcci.com


Head o"ce Greenwich Chemical Consulting, Inc, 3300 PGA Boulevard, Suite 635, Palm Beach Gardens, FL 33410, USA

Tel/ Fax (561) 578-8110/ (561) 578-8120

Contact Mr John V Massingale

Ownership Mr John V Massingale

Locations Palm Beach Gardens, Florida, USA

Founded 1999

OVERVIEW

Greenwich Chemical Consulting provides environmental, chemical control, and regulatory consulting assistance to a diverse array of US and international chemical companies.

SERVICES PROVIDED

Greenwich Chemical Consulting was established in 1999 and provides environmental

in the Toxic Substances Control Act (TSCA) and the international chemical control schemes of Australia, Canada, China, European Union, Japan, and South Korea.

(PMNs), polymer exemption reviews, and low volume exemptions (LVEs)), TSCA inventory and chemical identity issues, test rules and related negotiations, existing chemical regulation, reporting and recordkeeping, import and export matters, and R&D

including TSCA Section 5(e) consent order negotiations with EPA.Compliance assistance is also provided to clients in the related areas of the Osha

and labelling of chemicals (GHS).

CLIENTS

US and international industrial chemical companies.

CONTACTS

Website www.igcon.nl


Head o"ce Booglaan 4, 5348JJ Oss, The Netherlands

Tel +31 412854594/+1 9412660583

Contact Ineke Gubbels


Locations Netherlands

Founded 2011

OVERVIEW

Ineke Gubbels assists clients with services related to regulatory compliance. Extensive knowledge of 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 and the new Biocides Regulation or become a toxicologist yourself.

SERVICES PROVIDED

Strategic consultancy:consortium management.Technical consultancy:

Toxicology:to animal testing.REACH:

CLIENTS

Clients come mainly from the chemical industry, governmental organisations and others. Identity of individual clients and the nature of the work performed will only

delivered.

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CONTACTS

Website www.jongeriusconsult.com


Head o"ce Begijnenhof 26, 6584 CW Molenhoek, The Netherlands

Tel +31 615962071

Contact Onno Jongerius


Locations Netherlands

Founded 2009

OVERVIEW

Jongerius Consult BV offers strategic and practical support to the various stakeholders

chemicals legislation. We combine our extended network, thorough legislative knowledge, joy in strategic and practical consultancy, enthusiastic facilitation and training of group

SERVICES PROVIDED

Sounding board for companies and partners such as Caesar Consult, Apeiron-team and

Providing powerful support tools, eg practical (ext-)SDS assessment solution on site and REACHsuite Advantage, a web based registration and Sief management tool that will ease your lead registration and non-lead registration management towards 2013 and 2018 tremendously. Check our website for more detailed services and references!

CLIENTS

legislation with focus on the added value for the organisation. We are pleased with

compliance training programme 2011-12. We’ll continue to focus on providing added value and making REACH work for industry.

CONTACTS

Website www.jrfonline.com


Head o"ce NH-08, Near Daman Ganga River, Valvada, Valsad, Gujarat, India

Tel/ Fax (+91) 260 654 0242, 329 1873/ (+91) 22 6646 6119 (Fax)

Contact Dr Abhay Deshpande


Locations India, USA, UK

Founded 1977

OVERVIEW

JRF Global is a regulatory contract research organisation, with a multinational presence in India, the USA and the UK. JRF Global offers cost effective data generation, in compliance with good laboratory practice (GLP) services in toxicology, ecotoxicology, chemistry, environmental fate, metabolism, residues, and regulatory affairs. Studies are conducted in accordance with global as well as Japanese regulatory guidelines. The studies are well received by global regulatory authorities. JRF Global has professional experience exceeding a few thousand man-years thanks to a combined life of 80 years in three continents. This expertise gives JRF Global, a competitive edge over the competing CROs and establishes itself as a highly revered multinational brand.

SERVICES PROVIDED

Mammalian toxicology: acute toxicity, mutagenicity, developmental and reproductive toxicity, repeated dose toxicity covering immunotoxicity and neurotoxicity parameters, canine toxicity, endocrine disruptor screening tests (Tier-I), rodent ADME (oral and dermal), etc. Ecotoxicology: acute toxicity to aquatic test systems, avian, earthworms and honeybees. Environmental fate and metabolism: metabolism in soil and plant, adsorption/desorption, photolysis and hydrolysis, C/N transformation, biodegradability,

Chemistry: product characterisation, method development and validation studies, product stability and purity analysis, physico-chemical studies, residue trials offering quantitation of residues and metabolites.

CLIENTS

JRF Global boasts of a strong sponsor base exceeding 800 companies, which include leading multinationals for their pharmaceutical, biopharmaceutical, agrochemical, biocidal and chemical products.

CONTACTS

Website www.linmarkconsulting.com


Head o"ce Bernoullistrasse 20, CH-4056 Basel, Switzerland

Tel +41 79 500 9719

Contact Dr Martin G Richards, Dr Al Wiedow


Locations Switzerland, France, USA

Founded 2007

OVERVIEW

Linmark Consulting is a consulting and service company engaged in regulatory affairs, advocacy and communications for the chemical and life sciences industries. Linmark Consulting is headquartered in Basel, Switzerland, a major European industrial centre with good communications globally. Its French subsidiary, Linmark Consulting Europe SARL, offers only representative services under REACH, for importers into Europe. Linmark Consulting USA LLC specialises in US registration, advocacy using its strong links to EPA and FDA.

SERVICES PROVIDED

Particular skills are in generating new business and protecting client businesses through regulatory knowledge and practice, stakeholder analysis, problem-solving and communications with stakeholders. Offerings based on over 25 years’ senior operational experience in regulatory affairs management and product development functions in multi-national chemical, agricultural biotechnology and biopharma companies in UK, USA and Switzerland. Key European and USA strengths in consortium management and advocacy.

CLIENTS

where 2010 registration deadlines were successfully met. Consortia support is continuing to meet 2013 and 2018 deadlines. Linmark Consulting has successfully managed global and EU chemical advocacy programmes for industrial chemical and biocide clients. Operating as third party representative for non-EU clients in Europe.

CONTACTS

Website www.LKC-ltd.com


Head o"ce Postfach 167, Hauptstrasse, Fuellinsdorf, Switzerland

Tel/ Fax +41 61 906 8500 / +41 61 906 8509

Contact Dr David Kane


Locations Switzerland and UK

Founded 2001

OVERVIEW

LKC provides European registration and development services to the international chemical industry. The LKC team is multifaceted, offering technical skills, regulatory

medicines and industrial chemicals.

SERVICES PROVIDED

Services for crop protection products, biocidal products, veterinary medicines and industrial chemicals include: Regulatory sciences: data gap analysis, data evaluation, contracting and managing of higher tier studies, study monitoring of chemistry, analytical, toxicology, ecotoxicology,

Conducting risk assessments and modelling for dietary, human and environmental exposures.Dossiers: dossier preparation for active substance submissions for Annex I inclusion, product dossiers for national registrations, provisional authorisations and mutual recognition. CADDY-dossiers, IUCLID5-dossiers, re-registrations, renewals, label extensions, import tolerance settings, REACH, CLP and JMAFF dossiers.Regulatory support: pre and post submission meetings with regulatory authorities, negotiation communications, estimating data package compensation for data-sharing and product defence.

CLIENTS

in sectors that include crop protection, biocides, animal health and general chemicals.

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CONTACTS

Website www.mckennalong.com


Head o"ce 2 Avenue de Tervueren, 1040 Brussels, Belgium

Tel/ Fax +32 2 278 12 11/ +32 2 278 12 00

Contact Ursula Schliessner

Ownership Partnership

Locations USA, Brussels

OVERVIEW

Chemical regulation is one of MLA’s marquee practices. Lawyers in our Brussels

biocides, pesticides and cosmetics.MLA Brussels manages eight REACH registration consortia and two REACH authorisation consortia. We handle issuance of REACH letters of access for more than 70 substances and substance groups for numerous lead registrants (see www.mlalaw.eu). We advise on and handle ECHA Board of Appeal cases and are involved in several testing proposal and compliance check decisions.

acquisitions.

SERVICES PROVIDED

hedge funds and venture capital.

CLIENTS

Miscellaneous Chromate Substances REACH authorisation consortium (CCST)

CONTACTS

Website www.ecotoxchem.co.uk

E-mail

Head o"ce Saxon House, John Roberts Business Park, Pean Hill,Nr Canterbury, Kent, CT5 3BJ, UK

Tel/ Fax +44 (0)1227 470901/ +44 (0)1227 765117

Contact Dr Peter Fisk

Ownership Limited company

Locations UK

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

OVERVIEW

Peter Fisk Associates offers specialist services to industry and regulatory organisations in

and high-level experience to chemical consultancy, tailored to our clients’ needs. We collaborate closely with our clients to harness their insights into their own products.

SERVICES PROVIDED

PFA has the capability to undertake technical and commercial services in support of compliance with all aspects of the REACH and CLP requirements, as well as other chemical and related regulations and we have more than 15 years’ experience of chemical regulatory compliance. We have worked on technical dossiers for more than 100 substances in Phase 1 of REACH and a similar amount for Phase 2. Working with partners, we provide a comprehensive REACH service covering all areas including SEA, and other areas of chemical regulation (including biocides and plant protection products). We have also successfully provided REACH-related secretariat services, including consortium

development – all technical aspects, chemistry, toxicology, ecotoxicology, quantitative structure-activity relationships, exposure assessment and modelling, risk management measures, consortium management, supply chain analysis and authorisation support.

CLIENTS

A wide variety of industrial clients including chemical manufacturers’ consortia from several sectors, downstream users of chemicals and national competent authorities.

CONTACTS

Website www.reachdelivery.com


Head o"ce Hamilton House, 111 Marlowes, Hemel Hempstead, Hertfordshire, HP1 1BB, UK

Tel/ Fax +44 (0) 1442 450460/ +44 (0) 1442 450335

Contact Malcolm Carroll

Ownership Part of the Mpower1 Group of Companies

Locations Worldwide support

Founded 2009

OVERVIEW

The REACH Delivery service is used worldwide by manufacturers, importers, distributors and downstream users. It supports the fully audited sending, receiving and automated update of MSDS and associated documents for large and small companies alike both to their customers and internal staff. It addresses the delivery and update requirements of REACH, EPCRA, (HAZCOM) OSHA and other similar legislation in other countries. In addition, it automates,

SERVICES PROVIDED

REACH Delivery is an electronic mail service that works seamlessly with email, yet:

generates automatic updates to all previous recipients of a document, with new

provides full audit trails and compliance reports to meet multiple legislative

the service is designed to dramatically reduce the time, risk and cost of administration in maintaining compliance. A low cost multi language service accessible world-wide.

Support, demonstration, installation and trial usage are all completely free

CLIENTS

Clients are from the chemical industry, and downstream users encompassing the entire supply chain worldwide

CONTACTS

Website www.reach-gs.euE-mail [email protected] o"ce Rond Point Schuman, 6 Box 5, B-1040 Brussels, BelgiumTel/ Fax +32 (2) 234 77 78/ +32 (2) 234 79 11Contact Mr Richard L RodenOwnership Istanbul Chemicals and Chemical Products Exporters’ Association

(IKMIB) 95% and Steel Exporters’ Association (CIB) 5%. Two divisions of Istanbul Minerals and Metal Exporter’s Association, a joint venture between Turkish private industry and the Ministry of Economy.

LocationsLocations ideal for European and Turkish chemical industry and

European Chemicals Agency (ECHA) in Helsinki.Founded 2008

OVERVIEW

REACH Global Services SA (RGS) is a professional regulatory consulting company advising private and public sector clients in the chemicals and allied industries to comply with European Union and Turkish Republic chemicals legislation. RGS’s experienced staff, based in Europe and Turkey consults to a diverse array of chemical companies, international and Turkish operating across a range of industrial sectors.

SERVICES PROVIDED

REACH audit and related support services including Only Representation to non-EU manufacturers. EU Cosmetics Regulation compliance services for Turkish exporters to the EU. Turkish chemicals legislation compliance including by-law on chemicals inventory and control, seveso II, food and biocides regulatory compliance.

CLIENTS

RGS’s client portfolio range from multinational blue chip and leading Turkish chemical and allied industry companies to small and medium enterprises.

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CONTACTS

Website www.rorltd.com


Head o"ce Hippocampus House, Hulme Lane, UK

Tel +44 (0)1565 724241

Fax +44 (0)1565 723500

Contact Client Services


Locations Europe, local agents: Asia, Middle East

Founded 2006

OVERVIEW

Representatives established in Europe. UK based, assisting non-European chemical manufacturers, and EU manufacturers and importers to comply with their REACH obligations. ROR is recognised as one of the most competent specialist Only Representative companies in Europe with the ability to provide compliance services to all members of the supply chain.

SERVICES PROVIDED

Only Representative services for non-EU manufacturers to export to the EU. Third party representative services for EU manufacturers, importers and internal Only Representatives so they comply with their obligations. Lead registration representation in consortia, within the Sief or on committees. Document preparation: IUCLID technical dossier, chemical safety report (CSR), safety data sheet (SDS) authoring, provision and distribution. Additionally we can offer auditing services to ensure your company remains compliant with REACH.

CLIENTS

Countries of clients: China, India, USA, UK, Brazil, Qatar, Egypt, South Africa, South America and other regions.

CONTACTS

Website www.reachready.co.uk


Head o"ce Kings Buildings, Smith Square, London, UK

Tel/ Fax +44 (0)20 7901 1444/ +44 (0)87 1813 0304

Contact Suzan Gunnee

Ownership Chemical Industries Association

Locations London, UK

Founded 2006

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

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

Matchmaker service can match trusted suppliers of REACH and CLP services to your particular need. There is also a comprehensive training programme of public or in-house workshops to help you manage your own compliance.

CLIENTS

We have a global customer base with clients from all industries subject to the REACH and CLP Regulations. Our services are used by businesses 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.

CONTACTS

Website www.reachwise.eu


Head o"ce 22, St Albans Avenue, London W4 5JP, UK

Tel +44 (0)20 87470873

Contact Peter Douben


Locations UK, Netherlands, Germany

Founded 2007

OVERVIEW

With extensive knowledge of REACH and CLP, REACHWise provides tailor-made

Environmental Protection, Unilever, before founding REACHWise. Our focus on REACH and CLP means our efforts are targeted. We change complex situations into manageable elements and processes, and provide solutions.

SERVICES PROVIDED

Impact of REACH and CLP:you on the best way to approach your REACH and CLP “problem” and to remain compliant. Sief support: we provide the whole spectrum of Sief and consortium management.REACH registration: for individual and groups of companies, our REACH support covers data evaluation and sharing, preparation of the technical dossier, use and exposure requirements, chemical safety assessment and report, and exposure scenarios.Safety data sheets: we prepare and update SDSs (body and annex ESs) including translations.Exposure scenarios: for individual substances as well as mixtures we ensure they are

them easy to understand.Downstream user support: using specialist models we ensure that your conditions of use are compliant even when they deviate from the registrant’s information.

CLIENTS

sector, health care sector, home and personal care, lubricants manufacturers and suppliers, metals sector, minerals sector, pigments and colorants sector, speciality chemicals industry.

CONTACTS

Website www.refac.eu


Head o"ce Lyme Building, Westmere Drive, Crewe Business Park, Crewe, Cheshire, CW1 6ZD UK

Tel/ Fax +44 (0)1270 258530/ +44 (0)1270 2584444

Contact Ms Rachel Green, Dr Virginia Gretton


Locations United Kingdom

Founded 2007

OVERVIEW

ReFaC is an independent privately owned organisation which provides regulatory assistance, primarily to suppliers of industrial chemicals etc – both within Europe and from across the world – who seek to comply with REACH. Our team of regulatory professionals provide

associations and consortia. Wherever possible ReFaC aims to reduce the burden imposed by REACH and CLP and provides tailored support to clients in order to maximise the value of our contribution. ReFaC delivers REACH compliance solutions using its own staff and a select group of industry partners, including BIBRA, Harlan, Intertek and LSM Analytical Services.

SERVICES PROVIDED

ReFaC provide a complete range of services for those seeking compliance with REACH and CLP regulation. Our services include: REACH dossier development and submission,

CLIENTS

ReFaC supports individual SMEs and large organisations from across the chemical industry, both within Europe and worldwide, and assists industry associations and consortia who require management, consultancy and study services.

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Website www.rsireg.com


Head o"ce P.O. Box 1280, Peterborough, PE2 2NG, Cambridgeshire, United Kingdom

Tel/ Fax +44 (0)1223 969 972

Contact Andy Burgess


Locations China, UK, USA

Founded 2010

OVERVIEW

Regulatory Services International (RSI) is a multinational company primarily delivering Chinese chemical regulatory services and strategic business impact assessments. Our goals are to provide our clients with pragmatic business focused solutions to regulatory compliance challenges and to guide them through the continually evolving regulatory landscape. We have a highly experienced team with an in-depth practical knowledge of the services we offer delivered through locally based contacts in the EU, USA and China.

SERVICES PROVIDED

Specialist Chinese chemical regulatory support: extensive experience and

execution, registration preparation/translation, arranging in-country testing, submission/post submission support and registration agent. Hazardous chemicals support under SAWS Decree 591 and supporting legislation: compliance status determination,

Business focused solutions to regulatory compliance challenges: we work alongside our client to identify the major business impacts from regulatory compliance challenges and then

CLIENTS

We serve a wide range of clients from a broad range of industries, along with

marketing chemical substances and formulated products.

CONTACTS

Website www.steptoe.com


Head o"ce 1330 Connecticut Avenue, NW, Washington, DC 20036, USA

Tel +32 2 626 0500/ +1 202 429 3000

Fax +32 2 626 0510/ +1 202 429 3902

Contact Seth Goldberg/ Darren Abrahams/ Dr Anna Gergely

Ownership Limited liability partnership

Locations Belgium, China, UK, US

Founded 1945

OVERVIEW

but also the underlying science. Our integrated team of legal, regulatory and science professionals located in the EU, US and China, along with our network of contacts in other jurisdictions, provide the breadth of expertise and geographic reach to enable our clients to accomplish their commercial objectives. We have the experience to leverage the investments our clients have made, and knowledge of their products across a range

SERVICES PROVIDED

Our practice has a particular focus on the full breadth of legal and commercial issues arising under the regimes on biocides (antimicrobials), plant protection products (agrochemicals), food contact materials, nanotechnologies, REACH (where we act as OR and TPR) and CLP.We have a strong body of experience in the following additional areas: agricultural and industrial biotechnology, chemicals (commodity and speciality), cosmetics, electronics,

CLIENTS

Our clients are national and multinational companies, in sectors including: automotive, chemicals, food, metals, mining, plastics, textiles and waste. We work with European and international trade associations, public institutions, agencies and bodies at the regional and national levels.

CONTACTS

Website www.thewercs.com


Head o"ce The Wercs Ltd, 23 British American Blvd, Latham NY 12110, USA

Tel + 1 800 572 6501 / +1 518 229 3489

Fax +1 518 640 9299

Contact Steffan Kilmer

Ownership Private

Founded 1984

OVERVIEW

The Wercs provides software tools and services to help advance the health and safety of the environment in which people live and work. For almost 30 years The Wercs has partnered with clients to develop innovative solutions that go beyond global regulatory and sustainability compliance. Key areas of support include (M)SDS authoring software and services, management and distribution software and services, retail supplier compliance, and green chemistry and sustainability solutions. In addition, we offer GHS- and REACH-compliant solutions for all types of companies, regardless of size or location.

SERVICES PROVIDED

(M)SDS authoring software and services Retail supplier compliance Green chemistry and sustainability solutions

CLIENTS

Manufacturing including:

Retail including:Government

CONTACTS

Website www.toxfocus.com


Head o"ce 3016 Shenandoah Valley Drive, Little Rock, AR 72212, USA

Tel/ Fax +1 501 351 4389

Contact Barbara Vogt, PhD, DABT


Locations USA

Founded 2008

OVERVIEW

content for REACH, the Cosmetics Regulation, and other regulatory programmes. Principal Barbara Vogt, PhD Toxicology, DABT, has more than 15 years’ experience in corporate and clinical toxicology. The consultancy has authored numerous REACH registration dossiers,

SERVICES PROVIDED

REACH: high-quality toxicology assessments and strategic planning for compliance with data

analogues and categories, computer modelling and support (QMRF, QPRF), laboratory test

evaluation support and dossier defence. EU Cosmetic Regulation: product risk assessment

CLIENTS

Cytec Industries Inc, The Redstone Group, Unilever, 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, Gerber

LP, Gulf Bayport Chemicals LP, Shepherd Chemical Company, Connecticut Business and Industry Association, United States Department of Commerce.

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Website www.toxcel.com

E-mail [email protected] / [email protected]

Head o"ce PO Box 93, Ledbury, HR8 9JE, UK

Tel +44(0)1531 638999 (UK) / +1 703 754 0248 (USA)

Contacts Christine McAlinden (UK) / Alan Katz (USA)


Locations UK, USA

Founded 1999

OVERVIEW

coordinated regulatory resource for seamless development and execution of strategies, designed for cost-effective regulatory approvals, leading to domestic, regional, and global export market expansion.

SERVICES PROVIDED

toXcel provides a full range of services to support obtaining marketing approvals by governmental agencies, with emphasis on regulatory strategy development and all aspects of preparing applications and dossiers. toXcel advises companies about compliance with REACH, the Biocidal Products Regulation, the Cosmetics Directive, the Plant Protection Products Regulation, and other EU registration requirements. We can provide you with a full REACH registration service (including only representative function), or we can support your in-house activities as required. Our experts provide FIFRA, TSCA, and FDA services to our

and risk assessments, environmental assessment, safety and toxicological evaluations, and

fate, mammalian toxicity, metabolism/pharmacokinetics (ADME), and ecotoxicity studies.

CLIENTS

Our leading consultants focus their collective professional talents on assisting chemical manufacturers, formulators, pharmaceutical companies, personal care/consumer product

CONTACTS

Website www.toxservices.com


Head o"ce 1367 Connecticut Avenue NW, Suite 300, Washington, DC 20036, USA

Tel/ Fax 202-429-8787/ 202-429-8788

Contact Margaret H Whittaker, PhD, MPH, CBiol, FSB, ERT, DABT

Ownership Limited Liability Company

Locations USA

Founded 2003

OVERVIEW

SERVICES PROVIDED

We specialise in evaluating potential human health and ecological hazards and risks from industrial chemicals, pharmaceuticals cleaning products, cosmetics, dietary supplements, food additives, and pesticides. We provide third-party auditing services to ensure that contract laboratories and food, pharmaceutical, and dietary supplement manufacturing facilities adhere to current good manufacturing practices (cGMPs) and current good laboratory practices (cGLPs). We help clients comply with applicable international, federal, state, and local environmental health and safety regulations, and provide clients with strategic assistance in instances when products are claimed to be associated with adverse effects.Key areas of ToxServices expertise comprise: US EPA Design for the Environment

compliance and expert witness support.

CLIENTS

Located across the US, Europe,and Asia.

CONTACTS

Website www.verdantlaw.com


Head o"ce 1025 Connecticut Ave, NW, Suite 1000, Washington, DC 20036, USA

Tel/ Fax +01 202 828 1233

Contact Philip A Moffat, Esq

Ownership Private – professional limited liability company (PLLC)

Locations

Founded 2009

OVERVIEW

providing high-quality services to domestic and foreign clients on matters at the federal, state, and local levels, as well as those arising internationally. Verdant specialises in product risk management with an emphasis on sustainability, environmental, and

chemicals management, right-to-know, and nanotechnology, among others.

SERVICES PROVIDED

experts, Verdant is well-positioned to assist companies manufacturing, importing, using, or marketing chemicals and other affected products in major markets around the globe.

CLIENTS

Verdant provides services to clients in many different industries, but has particular expertise with respect to the following: coatings, consumer products, electronics, industrial chemicals, medical devices, personal care products and pharmaceuticals, among others.

CONTACTS

Website www.wca-environment.com


Head o"ce Brunel House, Volunteer Way, Faringdon, Oxon, UK SN7 7YR

Tel 01367 246026

Contact Dean Leverett


Locations England, Scotland, Italy

OVERVIEW

Wca-environment provides independent and objective advice on the sources, fate and effects of chemicals in the natural and industrial environments.Our staff of environmental scientists, ecotoxicologists, toxicologists and chemists provide quality assured advice and consultancy for clients in commercial and governmental organisations worldwide.

SERVICES PROVIDED

We help our clients meet their obligations under regulations such as REACH, CLP/GHS, the Water Framework Directive, the Priority Substances Daughter Directive, the

of human and veterinary medicines, the Biocidal Products Directive, and the Plant Protection Products Directive. We also help them identify and deal with new or emerging chemical and technological issues that might threaten their business.

CLIENTS

The Environment Agency (England and Wales), States of Jersey Environmental Protection, Environment Canada, Alberta Environment (Canada), United Kingdom

Institute, Syngenta, Defra, European Commission, ERGTC, European Copper Institute, the chemical industries.

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CONTACTS

Website www.thewercs.com


Head o"ce 23 British American Blvd, Latham, NY 12110

Tel/ Fax +1 518 640 9283/ +1 518 640 9299

Contact Bob Sheehan

Ownership Private

Locations USA, Belgium, Germany, China, Japan

Founded 2004

OVERVIEW

Since 2004, WERCS Professional Services (WPS) has been providing expert SDS and hazard label authoring and translation services to companies large and small. Today WPS has authored and translated SDS and other hazard communication documents for over 4,000 companies around the world. Our regulatory experts come from a diverse group of international companies in the chemical manufacturing, consumer product, lubricants, paints and coatings and pharmaceutical/ biotech industries, among others.Due to the increasing demands on companies, WPS has continued to invest in technology, tools, and experienced personnel to provide comprehensive, cost-effective solutions to a variety of clients. From authoring product SDS and hazard labels for small and large chemical companies, to building and maintaining a regulatory compliance reporting system for 19 of the top 25 US retailers (and growing), WPS is equipped to deploy whatever is necessary to address and satisfy each customer’s unique regulatory requirements.

SERVICES PROVIDED

CLIENTS

CONTACTS

Website www.wrcplc.co.uk


Head o"ce Frankland Road, Swindon, UK

Tel/ Fax 01793 86 5000/ 01793 86 5001

Contact Ian Johnson


Locations UK

Founded 1927

OVERVIEW

WRc’s REACH team consists of experienced mammalian and environmental toxicologists, risk assessment analysts, chemists, QSAR and exposure scenario modellers and REACH legislation experts. WRc has extensive experience of dealing with national and European regulators and industrial clients.

SERVICES PROVIDED

Arrangement of toxicological and ecotoxicological testing. Compilation and evaluation of physico-chemical, environmental, fate, toxicological

and ecotoxicological data packages.

replacement for some endpoints. Exposure modelling and derivation of exposure scenarios. Reviews of epidemiological data and health monitoring studies.

Preparation of technical dossiers in IUCLID 5, chemicals safety reports (CSRs) and safety data sheets (SDSs).

Validation of registration dossiers prior to agency submission.

CLIENTS

A wide variety of clients ranging from single industrial chemical manufacturers to multi-national consortia.

CONTACTS

Website www.wspenvironmental.com


Head o"ce 70 Chancery Lane, London, UK

Tel/ Fax 0161 886 2400/ 0161 886 2401

Contact Stuart Burrow/ Dr Stephen Bounds


Locations UK, Europe, worldwide

Founded 8 April 1997

OVERVIEW

WSP Environment & Energy provide a wide range of environmental, health and safety, and regulatory consultancy services. Our global REACH Group includes chemical industry professionals experienced in all aspects of chemical regulation and includes registration specialists, toxicologists and ecotoxicologists experienced in dealing with REACH projects for a wide range and size of clients. We are part of WSP and GENIVAR,

SERVICES PROVIDED

We offer a complete range of services to deal with all our client’s REACH requirements including: identifying a client’s REACH registration obligations and developing the

CLIENTS

SMEs through to large corporations. Our clients include manufacturers, importers and downstream users. We act as only representative for about 20 companies and provide support over and above the basic service as required. We specialise in helping companies with compliance problems.

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Further information

24-7 Response 36 UK Australia 50-100 50-100 r r r r r www.24-7response.org

3E Company 38 USA Denmark, Canada, Asia

100-500 100-500 s s t s www.3ecompany.com

3S-Safely Serving Science Greece 2-5 1 u s r s www.3s-chem.gr

Accenture Belgium 5,000 plus 5,000 plus r s u s s www.accenture.com

ACTA 40 UK USA, China 25-50 25-50 r r r s s s s www.actagroup.com

Actio Corporation USA 25-50 10-25 t www.actio.net

Aegis Regulatory Inc Canada 5-10 5-10 t www.aegisreg.com

AG-HERA 147 UK Spain 2-5 2-5 t s s www.ag-hera.com

Alberi EcoTech USA 1 1 u r r www.alberieco.com

Alchemy Compliance Ltd UK 1 1 r r u www.alchemycompliance.com

Alemare Solutions UK 2-5 1 r r r s v www.alemare.co.uk

ALTox 147 Denmark 2-5 2-5 r v u r v www.altox.dk

AMEC UK Belgium, The Netherlands, Germany, Italy, USA, Canada

5,000 plus 10-25 r s s s u www.amec.com/reach

Antea Group USA The Netherlands, France, Belgium, Colombia, Africa, Germany

5,000 plus 100-500 t s s s s s www.anteagroup.com

APC UK France, Spain, Poland10-25 10-25 t v www.apc.eu.com

Apeiron-Team NV Belgium 10-25 10-25 t s s www.apeiron-team.eu

ARCADIS 42 The Netherlands Belgium, United States, Switzerland

5,000 plus 25-50 t r s s s s www.arcadis.com

ARCHE 44 Belgium 10-25 10-25 t s s s www.arche-consulting.be

Argentum Environment Sweden UK 100-500 25-50 r s r r s www.argentumenvironment.se

ASCHEM Chemical Consulting Poland 1 1 u s r s www.aschem.waw.pl

Assent Compliance Canada USA, Germany, UK, Taiwan, India, Kenya

100-500 10-25 r r r r www.assentcompliance.com

ATOUT REACH France 2-5 2-5 u r r www.atoutreach.fr

Austen Business Solutions Ltd UK 2-5 1 u u www.austenbusinesssolutions.co.uk

Beveridge & Diamond, P.C. USA 50-100 10-25 t www.bdlaw.com

bibra toxicology advice & consulting 46 UK 10-25 10-25 t s v s v www.bibratoxadvice.co.uk

BIG vzw 147 Belgium 25-50 25-50 u s s s r s www.big.be

Bioagri 48 Brazil France, China 1,000-2,000 100-500 s s t s www.merieuxnutrisciences.com

BioQuanta France Japan, Thailand, USA 25-50 10-25 t www.bioquanta.net

Blue Frog Scientific 50 UK 5-10 5-10 t r s vBoeije Consulting Belgium 1 1 t r www.boeijeconsulting.com

Borenius & Kemppinen, Attorneys at law Ltd Finland 100-500 5-10 t www.borenius.com

Brixham Environmental Laboratory 52 UK 50-100 50-100 r s t s www.brixham-lab.com

BSL BIOSERVICE Scientific Laboratories GmbH 54 Germany Representatives in Switzerland, Japan, India, Poland, Scandinavia, Italy and other countries

100-500 50-100 s t www.bioservice.com

Buckman USA 2,000-5,000 1,000-2,000 s r s r s s s www.buckman.com

Bureau Veritas 56 France Worldwide (140 countries)

5,000 plus 100-500 s r r s s s www.bureauveritas.com

Burges Salmon LLP UK 500-1000 2-5 t www.burges-salmon.com

Caleb Management Services 147 UK Germany, USA 10-25 5-10 t r s s www.calebgroup.net

Cambridge Environmental Assessments UK 100-500 10-25 t r s www.cea-res.co.uk

Cardno ENTRIX USA South America, Canada

1,000-2,000 25-50 t www.cardnoentrix.com

CEHTRA 58 France Belgium, UK, India, Canada

25-50 25-50 t s v v s s www.cehtra.com

Centro Reach 60 Italy 5-10 2-5 t s s s s www.centroreach.it

CFCS-Consult 148 Germany Italy 2-5 5-10 t s s s s www.cfcs-consult.com

Charles River UK 5,000 plus 50-100 t www.criver.com

ChemADVISOR, Inc USA Belgium 50-100 50-100 r s u s s www.chemadvisor.com

Chemest Ltd. Finland 2-5 2-5 t s s s s sChemHaz Solutions Ireland 1 1 t s www.chemhazsolutions.com

Key: t >60% u 40-60% r 20-40% s 5-20% v <5%

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Consultancy/advisory Repre./management Information IT solutions Laboratories Training

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Supp

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Dos

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Man

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Regu

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Ecot

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Phy

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Trai

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D/C

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Lobb

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Insu

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24-7 Response

3E Company

3S-Safely Serving Science

Accenture

ACTA

Actio Corporation

Aegis Regulatory Inc

AG-HERA

Alberi EcoTech

Alchemy Compliance Ltd

Alemare Solutions

ALTox

AMEC

Antea Group

APC

Apeiron-Team NV

ARCADIS

ARCHE

Argentum Environment

ASCHEM Chemical Consulting

Assent Compliance

ATOUT REACH

Austen Business Solutions Ltd

Beveridge & Diamond, P.C.

bibra toxicology advice & consulting

BIG vzw

Bioagri

BioQuanta

Blue Frog Scientific

Boeije Consulting

Borenius & Kemppinen, Attorneys at law Ltd

Brixham Environmental Laboratory

BSL BIOSERVICE Scientific Laboratories GmbH

Buckman

Bureau Veritas

Burges Salmon LLP

Caleb Management Services

Cambridge Environmental Assessments

Cardno ENTRIX

CEHTRA

Centro Reach

CFCS-Consult

Charles River

ChemADVISOR, Inc

Chemest Ltd.

ChemHaz Solutions

Key: Icons above represents the extent to which the company provides the service as follows:

Core service Service that is occasionally provided Service provided by partners and third parties

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Further information

ChemPharmaServe Ltd UK 2-5 2-5 u u www.chempharmaserve.com

Chemphex Finland 1 1 t s www.chemphex.com

ChemRegs (UK) Ltd UK 2-5 2-5 t r www.chemregs.co.uk

ChemRisk USA 50-100 50-100 t www.chemrisk.com

Chemsafe 62 Italy Qatar 10-25 5-10 u r s s s s s www.chemsafe-consulting.com

Chemservice 64 Germany, Luxmbourg

South Korea, Turkey, France

25-50 25-50 u r s s s s www.chems ervice-group.com

ChemService Srl Controlli e Ricerche 66 Italy Agent in China 25-50 25-50 r t s www.chemservice.it

ChemSW 148 USA 25-50 u u www.chemsw.com

Chilworth – a DEKRA Company 68 UK 80+ globally 5,000 plus 100-500 r s u s s www.chilworth.co.uk

Chris Braun Consultancy The Netherlands 1 1 t s www.cbconsult.nl

CJV Consulting Ltd UK 1 1 t s r s cjvconsultingltd.wix.com/cjvconsultingltd

Clariant Italy 5,000 plus 100-500 u r r s www.clariant.com

Compliance & Risks Ireland USA, UK, Belgium 25-50 10-25 s u u www.complianceandrisks.com

Compliance Footprint AG Switzerland 5-10 5-10 u u s www.compliance-footprint.com

Compliance Services International USA UK 10-25 10-25 t s s s s s www.complianceservices.com

compliance2business Italy 1 1 r r s s r www.compliance2business.eu

Consortia Management GmbH Germany 5-10 5-10 t www.consortia-management.com

CONUSBAT 148 Germany 5-10 2-5 t r s www.conusbat.com

CRAD Ltd. Sti Turkey 10-25 10-25 r u s s www.crad.com.tr

Crowell & Moring 148 USA UK, Belgium 1,000-2,000 25-50 t www.crowell.com

CS Regulatory Ltd 70 UK 5-10 5-10 t r s s www.csregulatory.com

CTT China 100-500 100-500 r t s s www.cttlab.com

CURRENTA GmbH & Co.OHG 72 Germany 100-500 25-50 r s u s v v www.analytik.currenta.de

Danger and Safety srl 149 Italy 5-10 5-10 t s s s r www.dangerandsafety.it

DanGoods Training & Consultancy Ltd UK 1 1 u r r www.dangoods.co.uk

Datalab USA 2-5 1 t www.datalabsj.com

David Ryberg Norway 10-25 2-5 r r u 0

Defense Logistics Agency USA 1,000-2,000 10-25 r r r r www.dla.mil

Denehurst Chemical Safety Ltd USA 5-10 2-5 t www.ehscareers.com

DHI 74 Denmark 500-1,000 50-100 t v v s s v v v www.tox.dhigroup.com

DIPHEX Ltd UK 5-10 2-5 s s t www.diphex.com

Dr. Andrea Volpato Italy 1 1 t s s s www.andreavolpato.it

Dr. Knoell Consult GmbH 76 Germany UK, Switzerland, China, The Netherlands, Thailand

100-500 100-500 t r s s www.knoell.com

DR. MACH Chemical Compliance & Competence

149 Germany 1 1 u u s www.mach-chemguide.com

Dr. Philipp Langenbach GmbH Germany 1 1 u r s s www.dr-langenbach.de

EBRC Consulting 78 Germany 25-50 10-25 t s s s www.ebrc.de

ECETOC Belgium 5-10 5-10 t www.ecetoc.org

Ecolab USA 5,000 plus 50-100 v t www.ecolab.com

Ecomatters The Netherlands 5-10 2-5 t s s www.ecomatters.nl

EcoMundo France Belgium 25-50 25-50 u s u s v www.ecomundo.eu

ECOonline 80 Norway Sweden, Finland, Denmark, Switzerland

50-100 5-10 s t s s www.ecoonline.com

Ecotox Services International 149 Australia 5-10 5-10 t www.ecotox.com.au

EggCentris Belgium 5-10 5-10 s t www.EggCentris.com

EHS Strategies, Inc USA 1 1 t s www.ehsstrategies.com

elc group UK Czech Republic, India, Romania

50-100 10-25 u u s v s v www.elc-group.com

Elemica USA Germany, UK, The Netherlands, Japan, Singapore, China, South Korea

100-500 100-500 t www.elemica.com

Emveo Belgium 1 1 u r s s v www.emveo.be

Enthone B.V. The Netherlands 2,000-5,000 10-25 www.cooksonelectronics.comENVIRON 82 UK 1,000-2,000 50-100 t s s www.environcorp.com

Environmental Science Limited UK 2-5 2-5 u u s www.esldatasheets.com

EnviroPlanning AB Sweden 5-10 2-5 t 0

Key: t >60% u 40-60% r 20-40% s 5-20% v <5%

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D/C

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Lobb

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Insu

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ChemPharmaServe Ltd

Chemphex

ChemRegs (UK) Ltd

ChemRisk

Chemsafe

Chemservice

ChemService Srl Controlli e Ricerche

ChemSW

Chilworth – a DEKRA Company

Chris Braun Consultancy

CJV Consulting Ltd

Clariant

Compliance & Risks

Compliance Footprint AG

Compliance Services International

compliance2business

Consortia Management GmbH

CONUSBAT

CRAD Ltd. Sti

Crowell & Moring

CS Regulatory Ltd

CTT

CURRENTA GmbH & Co.OHG

Danger and Safety srl

DanGoods Training & Consultancy Ltd

Datalab

David Ryberg

Defense Logistics Agency

Denehurst Chemical Safety Ltd

DHI

DIPHEX Ltd

Dr. Andrea Volpato

Dr. Knoell Consult GmbH

Dr. Mach Chemical Compliance & CompetenceDr. Philipp Langenbach GmbH

EBRC Consulting

ECETOC

Ecolab

Ecomatters

EcoMundo

ECOonline

Ecotox Services International

EggCentris

EHS Strategies, Inc

elc group

Elemica

Emveo

Enthone B.V.ENVIRON

Environmental Science Limited

EnviroPlanning AB



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Info

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Trai

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Oth

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Further information

Equitox 84 France Switzerland 5-10 2-5 u r v s v www.equitox.eu

ERA Technology Ltd UK 50-100 5-10 t s v s s www.era.co.uk

ERM 86 UK 2,000-5,000 50-100 t r s www.erm.com

ES4chem 149 The Netherlands 1 1 u u www.ES4chem.eu

eSpheres 150 Belgium France, Finland, Germany

25-50 25-50 s s u r www.espheres.com

ETC Slovakia 10-25 5-10 t s s s www.ekotox.sk

Eupoc 150 Germany 1 1 r u s s s www.eupoc.de

Eurideas Linguistic Services 150 Belgium 5-10 2-5 t www.eurideastranslation.com

Euro Safety and Health UK 2-5 2-5 t s s www.eurosh.com

USA Denmark, Germany, France, China

5,000 plus 2,000-5,000 r t www.airtoxics.com

Denmark Belgium, China, France, Germany, Italy, The Netherlands, Spain, Sweden, USA

5,000 plus 100-500 s tEuromines Belgium 5-10 2-5 www.euromines.orgEversheds LLP UK

Europe, Middle East and Singapore

2,000-5,000 25-50 t www.eversheds.com

Exitss Belgium 10-25 2-5 r r s s s s s www.exitss.eu

Exponent International Limited 88 UK USA, Switzerland, China

500-1,000 25-50 t r s v v www.exponent.com

Fanwood Chemical, Inc USA Germany 2-5 2-5 t www.fanwoodchemical.com

FinnREACH 150 Finland 2-5 2-5 r s r r sFlashpoint srl Italy 10-25 5-10 t rFoBiG 151 Germany 10-25 5-10 t s s s www.fobig.com

Foresite Systems, Ltd. USA 25-50 5-10 s t www.foresitesystems.com

Gain Claude France 1 0 t 0

Gentrochema BV The Netherlands 2-5 1 u u s s www.gentrochema.nl

GHS Expert Ltd. 151 Hungary 2-5 2-5 u u s www.GHSexpert.com

Gillies Associates Ltd UK 2-5 2-5 t s www.gilliesassociates.co.uk

GlobalMSDS UK 5-10 5-10 u r r www.globalmsds.co.uk

Golder Associates Italycountries

5,000 plus 50-100 t r www.golder.com

GreenSoft Technology, Inc USA Taiwan, Japan, China, Spain

50-100 50-100 u u www.greensofttech.com

Greenwich Chemical Consulting 151 USA 1 1 t www.grcci.com

H2 Compliance Ireland USA 10-25 5-10 u u s s www.h2compliance.com

Hangzhou RUIO Technology Co. Ltd China 50-100 50-100 s t s s s s www.reach24h.com

Harlan Laboratories 90 USA France, Germany, Israel, Italy, Japan, Korea, Mexico, The Netherlands, Spain, Switzerland, UK, USA

2,000-5,000 500-1,000 r t www.harlan.com

HAZMAT Ltd Israel UK 25-50 10-25 t r s s www.hazmat.co.il

herbert smith llp UK 2,000-5,000 2-5 t www.herbertsmith.com

HFL Risk Services Ltd UK 10-25 10-25 t s sIBACON GmbH Germany 100-500 100-500 t www.ibacon.com

ICF International 92 USA Belgium, Brazil, China, Russia, India

2,000-5,000 50-100 tIGCON 151 The Netherlands 1 1 t r s s www.igcon.nl

IHS 94 USA Worldwide 5,000 plus 50-100 r u r s www.ihs.com/ehs-sustainability

International Cosmetics & Chemical Services 96 USA UK 5-10 5-10 t s s r www.Intlcosmetics.com

Intertek 98 UK 110+ Countries 5,000 plus 1,000-2,000 s u v v r www.intertek.com

IOM UK Singapore 100-500 10-25 t s s s s www.iom-world.org

IPO O/Pszczyna Poland 50-100 50-100 t www.ipo-pszczyna.pl

iPoint 100 Germany Austria, France, USA, China, UK

50-100 10-25 r s u s s www.ipoint-systems.com

Jaehak Jung South Korea China, Vietnam 50-100 2-5 r s s r s s s s www.kotiti.re.kr

Japan Chemical Safety Institute Japan 1 1 s s s s t s 0

Key: t >60% u 40-60% r 20-40% s 5-20% v <5%

A-Z

LIS

TIN

G



Organisation Gui

danc

e on

reg

ulat

ory

inte

rpre

tati

on

Pro

duct

com

plia

nce

Cor

pora

te s

trat

egy/

stra

tegi

c pl

anni

ng

Test

ing

stra

tegi

es

Supp

ly c

hain

com

mun

icat

ions

Regi

stra

tion

str

ateg

ies

Ass

essm

ent

of d

ata

qual

ity

Che

mic

al t

rans

port

/war

ehou

sing

SVH

C a

dvis

ory

serv

ices

Envi

ronm

enta

l ris

k as

sess

men

t

Repr

esen

tati

on

Man

agem

ent

(Sie

f, C

onso

rtiu

m e

tc)

Bus

ines

s pr

oces

s ou

tsou

rcin

g (B

PO

)

Regi

stra

tion

ser

vice

s

Dos

sier

pre

para

tion

GH

S no

tifi

cati

on

CLP

not

ifica

tion

Regu

lato

ry/p

olic

y tr

acki

ng

Man

aged

reg

ulat

ory

cont

ent

Che

mic

al h

azar

d da

taba

se

(Mat

eria

l) s

afet

y da

ta s

heet

s

Lega

l rep

rese

ntat

ion

Subs

tanc

e in

vent

ory

man

agem

ent

(Mat

eria

l) s

afet

y da

ta s

heet

sys

tem

s

EH&

S so

luti

ons

Regu

lato

ry in

form

atio

n m

anag

emen

t

Supp

ly c

hain

man

agem

ent

Con

sort

ia/r

egis

trat

ion

solu

tion

s

Labo

rato

ry m

anag

emen

t so

luti

ons

Ecot

oxic

olog

y

Envi

ronm

enta

l fat

e &

deg

rada

tion

Phy

sica

l & a

naly

tica

l che

mis

try

Envi

ronm

enta

l mon

itor

ing

Expo

sure

tes

ting

Hum

an h

ealt

h to

xico

logy

SVH

C t

esti

ng

Trai

ning

cou

rses

/web

inar

s

Bes

poke

/in-

hous

e tr

aini

ng

CP

D/C

ES c

erti

fied

tra

inin

g

Lobb

ying

/adv

ocac

y

Insu

ranc

e

Equitox

ERA Technology Ltd

ERM

ES4chem

eSpheres

ETC

Eupoc

Eurideas Linguistic Services

Euro Safety and Health

EurominesEversheds LLP

Exitss

Exponent International Limited

Fanwood Chemical, Inc

FinnREACH

Flashpoint srl

FoBiG

Foresite Systems, Ltd.

Gain Claude

Gentrochema BV

GHS Expert Ltd.

Gillies Associates Ltd

GlobalMSDS

Golder Associates

GreenSoft Technology, Inc

Greenwich Chemical Consulting

H2 Compliance

Hangzhou RUIO Technology Co. Ltd

Harlan Laboratories

HAZMAT Ltd

herbert smith llp

HFL Risk Services Ltd

IBACON GmbH

ICF International

IGCON

IHS

International Cosmetics & Chemical ServicesIntertek

IOM

IPO O/Pszczyna

iPoint

Jaehak Jung

Japan Chemical Safety Institute



A-Z

LIS

TIN

G



Chemical sta# C

onsu

ltan

cy/a

dvis

ory

Repr

esen

tati

on/m

anag

emen

t

Lega

l ser

vice

s

Labo

rato

ry s

ervi

ces

IT &

sof

twar

e so

luti

ons

Info

rmat

ion

serv

ices

Trai

ning

Oth

er(s

)

Further information

Jean Warshaw, Esq. USA 2-5 2-5 t 0

Jongerius Consult BV 152 The Netherlands 1 1 u s s r r www.jongeriusconsult.com

JRF Global 152 India USA, UK 100-500 100-500 s t www.jrfonline.com

JSC International 102 UK 25-50 10-25 t r s s www.jsci.co.uk

K J Bray & Associates UK 1 1 u u www.kjba.talktalk.net

K&L Gates LLP Belgium 1,000-2,000 25-50 t www.klgates.com

Kathrin Lanz Germany 10-25 10-25 s r t s www.qualisys.eu

Keller and Heckman LLP USA Belgium, China 100-500 10-25 t www.khlaw.com

KFT Chemieservice 104 Germany 10-25 10-25 u s v v v s s www.kft.de

Konica Minolta Business Expert, Inc Japan 2,000-5,000 10-25 r r t www.konicaminolta.com

LAUS Germany 10-25 10-25 s s t www.laus.de

LG CNS South Korea Japan, China, India, Brazil, Indonesia, Europe, USA, Middle East

5,000 plus 50-100 s s v v r u v v www.lgcns.com

LGC UK 1,000-2,000 50-100 t s www.lgc.co.uk

Linmark Consulting 152 Switzerland USA, France 2-5 2-5 u u s www.linmarkconsulting.com

Linnunmaa Oy Finland 10-25 5-10 t r rLKC Switzerland Ltd 152 Switzerland UK 10-25 10-25 t s s s www.LKC-ltd.com

LSR Associates UK USA, Japan 25-50 10-25 t r v v v s www.lsr-associates.com

MB Research Laboratories USA 25-50 25-50 t www.mbresearch.com

McKenna Long & Aldridge LLP 153 USA Belgium 100-500 10-25 v t v www.mckennalong.com

Mercer USAAmericas

100-500 2-5 t www.mercer.com

Miami Chemical USA 10-25 5-10 s t www.miamichemical.com

Micromeritics Analytical Services USA 10-25 1 t www.particletesting.com

MSDS Europe Hungary France, Germany, Poland, Italy, Spain

10-25 10-25 s u s v s r s www.msds-europe.com

National Chemical Emergency Centre (NCEC) 106 UK China, Czech Rep, Germany, India, Italy, Japan, Korea, Russia, USA, Malaysia

100-500 25-50 r s r s s r s v the-ncec.com

Neuralog, LP USA Canada 25-50 10-25 t www.neuralog.com

Noerr LLP Germany Slovakia, Hungary, Romania, Ukraine, Russian Federation, Czech Republic, Poland

1,000-2,000 5-10 t www.noerr.com

NovaTox Inc Canada 2-5 2-5 t www.novatox.ca

Oil Recruitment UK 10-25 1 t www.oilrecruitment.co.uk

Pace Analytical - Regulatory Services 108 USA 50-100 50-100 u v u www.paceregulatoryservices.com

Paul Illing Consultancy Services Ltd UK 1 1 t s 0

Penman Consulting Belgium UK, Netherlands 5-10 5-10 u r s s s www.penmanconsulting.com

Peter Fisk Associates 153 UK 10-25 10-25 t s s s s www.ecotoxchem.co.uk

Pinnacle Associates UK 2-5 2-5 u u www.pinnacleassoc.com

Polgar ACRO Hungary Belarus, Kazakhstan, Moldova, Russia, Ukraine

10-25 5-10 t r www.polgar-acro.eu

Pöyry Finland Oy Finland 2,000-5,000 10-25 t s s www.poyry.com

Prosacon GmbH Germany 5-10 5-10 t s s s s www.prosacon.eu

PwC The Netherlands Global presence 2,000-5,000 25-50 u u r www.pwc.nl/nl/reach

REACh ChemAdvice 110 Germany USA, India 5-10 5-10 t s r s s www.reach-chemadvice.com

REACh ChemConsult GmbH Germany UK 5-10 5-10 t s s s www.reach-chemconsult.com

REACH Delivery 153 UK USA, Japan 25-50 0 s t s www.reachdelivery.com

REACH Global Services 153 Belgium Turkey 10-25 10-25 t s www.reach-gs.eu

REACH mastery 112 Italy 5-10 5-10 t s v v v s www.reachmastery.com

REACH Monitor Spain 10-25 2-5 t s s www.reachmonitor.org

Reach Only Representative Ltd 154 UK Agents: Asia, Middle East

5-10 2-5 r r s s s s s www.rorltd.com

Reach Registration Services UK 10-25 2-5 r r s s s s s v www.reach-rs.com

Reach24H Consulting Group China Canada, Ireland 50-100 50-100 u s s s s s s www.reach24h.com/en

ReachCentrum 114 Belgium 10-25 10-25 r r s s v r www.reachcentrum.eu

Key: t >60% u 40-60% r 20-40% s 5-20% v <5%

A-Z

LIS

TIN

G



Organisation Gui

danc

e on

reg

ulat

ory

inte

rpre

tati

on

Pro

duct

com

plia

nce

Cor

pora

te s

trat

egy/

stra

tegi

c pl

anni

ng

Test

ing

stra

tegi

es

Supp

ly c

hain

com

mun

icat

ions

Regi

stra

tion

str

ateg

ies

Ass

essm

ent

of d

ata

qual

ity

Che

mic

al t

rans

port

/war

ehou

sing

SVH

C a

dvis

ory

serv

ices

Envi

ronm

enta

l ris

k as

sess

men

t

Repr

esen

tati

on

Man

agem

ent

(Sie

f, C

onso

rtiu

m e

tc)

Bus

ines

s pr

oces

s ou

tsou

rcin

g (B

PO

)

Regi

stra

tion

ser

vice

s

Dos

sier

pre

para

tion

GH

S no

tifi

cati

on

CLP

not

ifica

tion

Regu

lato

ry/p

olic

y tr

acki

ng

Man

aged

reg

ulat

ory

cont

ent

Che

mic

al h

azar

d da

taba

se

(Mat

eria

l) s

afet

y da

ta s

heet

s

Lega

l rep

rese

ntat

ion

Subs

tanc

e in

vent

ory

man

agem

ent

(Mat

eria

l) s

afet

y da

ta s

heet

sys

tem

s

EH&

S so

luti

ons

Regu

lato

ry in

form

atio

n m

anag

emen

t

Supp

ly c

hain

man

agem

ent

Con

sort

ia/r

egis

trat

ion

solu

tion

s

Labo

rato

ry m

anag

emen

t so

luti

ons

Ecot

oxic

olog

y

Envi

ronm

enta

l fat

e &

deg

rada

tion

Phy

sica

l & a

naly

tica

l che

mis

try

Envi

ronm

enta

l mon

itor

ing

Expo

sure

tes

ting

Hum

an h

ealt

h to

xico

logy

SVH

C t

esti

ng

Trai

ning

cou

rses

/web

inar

s

Bes

poke

/in-

hous

e tr

aini

ng

CP

D/C

ES c

erti

fied

tra

inin

g

Lobb

ying

/adv

ocac

y

Insu

ranc

e

Jean Warshaw, Esq.

Jongerius Consult BV

JRF Global

JSC International

K J Bray & Associates

K&L Gates LLP

Kathrin Lanz

Keller and Heckman LLP

KFT Chemieservice

Konica Minolta Business Expert, Inc

LAUS

LG CNS

LGC

Linmark Consulting

Linnunmaa Oy

LKC Switzerland Ltd

LSR Associates

MB Research Laboratories

McKenna Long & Aldridge LLP

Mercer

Miami Chemical

Micromeritics Analytical Services

MSDS Europe

National Chemical Emergency Centre (NCEC)

Neuralog, LP

Noerr LLP

NovaTox Inc

Oil Recruitment

Pace Analytical - Regulatory Services

Paul Illing Consultancy Services Ltd

Penman Consulting

Peter Fisk Associates

Pinnacle Associates

Polgar ACRO

Pöyry Finland Oy

Prosacon GmbH

PwC

REACh ChemAdvice

REACh ChemConsult GmbH

REACH Delivery

REACH Global Services

REACH mastery

REACH Monitor

Reach Only Representative Ltd

Reach Registration Services

Reach24H Consulting Group

ReachCentrum



A-Z

LIS

TIN

G



Chemical sta# C

onsu

ltan

cy/a

dvis

ory

Repr

esen

tati

on/m

anag

emen

t

Lega

l ser

vice

s

Labo

rato

ry s

ervi

ces

IT &

sof

twar

e so

luti

ons

Info

rmat

ion

serv

ices

Trai

ning

Oth

er(s

)

Further information

REACHLaw 116 Finland Belgium, India, Turkey25-50 25-50 r r r s s s sREACHReady 154 UK 5-10 2-5 u s v v v s r www.reachready.co.uk

ReachSpektrum, s.r.o. Czech Republic 2-5 2-5 u s s s s r www.reachspektrum.eu

ReachSuite Ltd UK The Netherlands, Belgium, North America

5-10 5-10 s t www.baytouch.com

REACHWise 154 UK The Netherlands, Germany

2-5 2-5 t r s www.reachwise.eu

Redeker Sellner Dahs Rechtsanwälte Germany Belgium 100-500 5-10 s t www.redeker.de

ReFaC 154 UK 2-5 2-5 r t www.refac.eu

Regulatory Services International 155 China UK 10-25 10-25 r t s s www.rsireg.com

Regulatus UK 1 1 t 0

Ricerca Biosciences, LLC USA 500-1,000 500-1,000 s s t www.ricerca.com

RimaOne Germany 25-50 25-50 t www.rimaone.com

Risk & Policy Analysts 118 UK 25-50 10-25 t s www.rpaltd.co.uk

Riskchem South Africa 2-5 1 r s t www.riskchem.co.za

Rivendell International Ireland USA, Spain and Japan

10-25 10-25 u s s r www.rivendell.ie

Roisin McEneany Ireland 1 1 u r r 0

Royal HaskoningDHV 120 The Netherlands 5,000 plus 50-100 u s s v s s s www.royalhaskoningdhv.com

SAFENANO UK Singapore 100-500 25-50 t r s www.safenano.org

Safety Data Services UK 1 1 t s 0

Safeware Quasar Ltd UK Turkey, USA, Japan, The Netherlands, Greece, Ireland

25-50 10-25 r t www.safeware.co.uk

SAP AG Germany 5,000 plus 5,000 plus u u www.sap.com

SAP Japan Co., Ltd. Japan 1,000-2,000 5-10 t www.sap.com

SATRA Technology Centre UK 0 0 v s v v t www.satra.co.uk

SCC 122 Germany Japan 50-100 25-50 t s v s www.scc-gmbh.de

Science & Environnement Switzerland France 5-10 5-10 t s s s s www.sci-env.ch

SciVera LLC USA 5-10 5-10 s t s www.scivera.com

Selcia 124 UK USA 50-100 50-100 t www.selcia.com

SGS 126 Switzerland China, France, Germany, Hong Kong, UK, USA

5,000 plus 0 s t v www.sgs.com/reach

ShawCor Canada 2,000-5,000 2-5 t www.shawcor.com

Shridhar Rajappanavar India 2,000-5,000 50-100 u u s www.cae.com

SIEF-IT Poland 5-10 5-10 u s u s www.sief-it.com

Siletz SPRL Belgium 2-5 1 t www.siletz.eu

SiteHawk USA 25-50 25-50 u u www.sitehawk.com

Sitmae Reach Services The Netherlands 2-5 2-5 r t r www.sitmaereachservices.com

Smithers Viscient USA UK 100-500 5-10 t www.smithersviscient.com

Spetsinterproject Oy Finland Russia, Ukraine 5-10 2-5 u u s www.spetsinterproject.com

Spinnaker Coating, LLC USA 2-5 2-5 v t s v s v v www.spinps.com

SSS (Europe) AB 128 Sweden India, Hong Kong 25-50 10-25 u s s s r www.reach-onlyrep.eu

Stefanie Merenyi Germany 1 1 t www.merenyi.de

Steptoe & Johnson LLP 155 USA Belgium, China, UK 1,000-2,000 25-50 s s t s s www.steptoe.com

Stewardship Solutions Ltd UK 2-5 2-5 u u r www.stewardshipsolutions.co.uk

Sumika Chemical Analysis Service Ltd (SCAS) Belgium Japan, China, Singapore

1,000-2,000 25-50 s t v v www.scas-eu.be

Surface Science Western Canada 10-25 1 u u s www.surfacesciencewestern.com

SustChem Engineering Greece 5-10 5-10 t s s s www.sustchem.gr

Swissi Instituto Suizo de Seguridad 130 Spain Switzerland, Taiwan 100-500 50-100 u r s s www.swissiesp.com

Syska Voskian Consulting Denmark USA 2-5 2-5 t r www.sysvoskconsulting.com

TEI Analytical, Inc USA 5-10 5-10 s t www.teianalytical.com

Telematic srl Italy 10-25 5-10 s t s www.epyplus.com

Tenviro Sweden The Netherlands 1 1 r r r r r www.tenviro.eu

Tetra Tech USA Canada, Japan 5,000 plus 50-100 t s s r www.tetratech.com

The REACH Centre Ltd UK Italy, Japan 10-25 5-10 s u r s s s www.thereachcentre.com

Key: t >60% u 40-60% r 20-40% s 5-20% v <5%

A-Z

LIS

TIN

G



Organisation Gui

danc

e on

reg

ulat

ory

inte

rpre

tati

on

Pro

duct

com

plia

nce

Cor

pora

te s

trat

egy/

stra

tegi

c pl

anni

ng

Test

ing

stra

tegi

es

Supp

ly c

hain

com

mun

icat

ions

Regi

stra

tion

str

ateg

ies

Ass

essm

ent

of d

ata

qual

ity

Che

mic

al t

rans

port

/war

ehou

sing

SVH

C a

dvis

ory

serv

ices

Envi

ronm

enta

l ris

k as

sess

men

t

Repr

esen

tati

on

Man

agem

ent

(Sie

f, C

onso

rtiu

m e

tc)

Bus

ines

s pr

oces

s ou

tsou

rcin

g (B

PO

)

Regi

stra

tion

ser

vice

s

Dos

sier

pre

para

tion

GH

S no

tifi

cati

on

CLP

not

ifica

tion

Regu

lato

ry/p

olic

y tr

acki

ng

Man

aged

reg

ulat

ory

cont

ent

Che

mic

al h

azar

d da

taba

se

(Mat

eria

l) s

afet

y da

ta s

heet

s

Lega

l rep

rese

ntat

ion

Subs

tanc

e in

vent

ory

man

agem

ent

(Mat

eria

l) s

afet

y da

ta s

heet

sys

tem

s

EH&

S so

luti

ons

Regu

lato

ry in

form

atio

n m

anag

emen

t

Supp

ly c

hain

man

agem

ent

Con

sort

ia/r

egis

trat

ion

solu

tion

s

Labo

rato

ry m

anag

emen

t so

luti

ons

Ecot

oxic

olog

y

Envi

ronm

enta

l fat

e &

deg

rada

tion

Phy

sica

l & a

naly

tica

l che

mis

try

Envi

ronm

enta

l mon

itor

ing

Expo

sure

tes

ting

Hum

an h

ealt

h to

xico

logy

SVH

C t

esti

ng

Trai

ning

cou

rses

/web

inar

s

Bes

poke

/in-

hous

e tr

aini

ng

CP

D/C

ES c

erti

fied

tra

inin

g

Lobb

ying

/adv

ocac

y

Insu

ranc

e

REACHLaw

REACHReady

ReachSpektrum, s.r.o.

ReachSuite Ltd

REACHWise

Redeker Sellner Dahs Rechtsanwälte

ReFaC

Regulatory Services International

Regulatus

Ricerca Biosciences, LLC

RimaOne

Risk & Policy Analysts

Riskchem

Rivendell International

Roisin McEneany

Royal HaskoningDHV

SAFENANO

Safety Data Services

Safeware Quasar Ltd

SAP AG

SAP Japan Co., Ltd.

SATRA Technology Centre

SCC

Science & Environnement

SciVera LLC

Selcia

SGS

ShawCor

Shridhar Rajappanavar

SIEF-IT

Siletz SPRL

SiteHawk

Sitmae Reach Services

Smithers Viscient

Spetsinterproject Oy

Spinnaker Coating, LLC

SSS (Europe) AB

Stefanie Merenyi

Steptoe & Johnson LLP

Stewardship Solutions Ltd

Sumika Chemical Analysis Service Ltd (SCAS)

Surface Science Western

SustChem Engineering

Swissi Instituto Suizo de Seguridad

Syska Voskian Consulting

TEI Analytical, Inc

Telematic srl

Tenviro

Tetra Tech

The REACH Centre Ltd



A-Z

LIS

TIN

G



Chemical sta# C

onsu

ltan

cy/a

dvis

ory

Repr

esen

tati

on/m

anag

emen

t

Lega

l ser

vice

s

Labo

rato

ry s

ervi

ces

IT &

sof

twar

e so

luti

ons

Info

rmat

ion

serv

ices

Trai

ning

Oth

er(s

)

Further information

The Sapphire Group USA 5-10 5-10 t s s s www.thesapphiregroup.com

The Wercs 155 USA France, Belgium, UK, Italy, Germany, Japan

50-100 50-100 u u s www.thewercs.com

TNO Triskelion 132 The Netherlands 2,000-5,000 100-500 r s u s s s www.triskelion.nl

Tox Focus, LLC 155 USA 2-5 2-5 t s s v v www.toxfocus.com

toXcel International Ltd 156 UK USA 10-25 10-25 u u s s v v www.toxcel.com

Toxikon USA Belgium 100-500 5-10 s t www.toxikon.be

ToxMinds 134 Belgium Germany 10-25 10-25 t s r s www.toxminds.com

Toxservices LLC 156 USA 25-50 10-25 t s s s www.toxservices.com

TRASYS Belgium France, Greece, Luxembourg, Spain, UK

500-1000 25-50 r t s www.trasys.be

TSGE UK Germany, Spain, Slovenia, Poland, USA, Canada

50-100 25-50 t s s www.TSGEurope.com

TUV Rheinland Hong Kong Ltd. Hong Kong 5,000 plus 100-500 u s s s s s www.chn.tuv.com

TÜV Rheinland LGA Products GmbH Germany China, India, Bangladesh, Turkey

500-1000 50-100 u u www.tuv.com

TÜV SÜD Industrie Service GmbH 136 Germany Germany, Japan, Singapore, China, India

2,000-5,000 25-50 r r s s s v www.tuev-sued.de/technical_installations/reach

TUV SUD Japan Japan 100-500 2-5 s t s v v www.tuv-sud.jp

UL UK USA, Switzerland, Bangladesh

5,000 plus 500-1000 s t s s s ul.com/consumer-products

Universit Bordeaux Segalen France 500-1,000 100-500 s s s r s s s s www.u-bordeaux2.fr

Verdant Law, PLLC 156 USA Global network of 2-5 2-5 r s t s s www.verdantlaw.com

Von Roll REACH GmbH Germany 2-5 2-5 t s s www.vonroll.com

VRS Regulatory UK 5-10 2-5 t www.vrs-regulatory.net

wca environment 156 UK Italy 25-50 25-50 t s v www.wca-environment.com

Weeset Advisors USA 1 1 t 0

Wercs Professional Services, LLC 157 USA Belgium, Germany, China, Japan

50-100 10-25 t r www.thewercs.com

WIL Research 138 USA The Netherlands 1,000-2,000 100-500 s v t www.wilresearch.com

Wildlife International, a division of EAG 140 USA The Netherlands 100-500 50-100 s t v v www.wildlifeinternational.com

Wilmer Tox Consulting Switzerland 1 1 t s www.reachwilmer.com

WRc plc 157 UK 100-500 10-25 u u s s www.wrcplc.co.uk

WSP Group 157 UK Africa, Asia, Europe, Middle East, Oceania

5,000 plus 50-100 t s s s s www.wspenvironmental.com

WTConsulting 142 Switzerland 5-10 5-10 t s s s www.wtconsulting.ch

Xiaodan Pei China USA 100-500 100-500 s s s u s s s v www. hach.com

YASH Technologies 144 USA Europe, Asia, Australia

2,000-5,000 50-100 r t s v v www.yash.com

Zanos Limited UK 2-5 1 s s t www.zanos.co.uk

Key: t >60% u 40-60% r 20-40% s 5-20% v <5%

A-Z

LIS

TIN

G



Organisation Gui

danc

e on

reg

ulat

ory

inte

rpre

tati

on

Pro

duct

com

plia

nce

Cor

pora

te s

trat

egy/

stra

tegi

c pl

anni

ng

Test

ing

stra

tegi

es

Supp

ly c

hain

com

mun

icat

ions

Regi

stra

tion

str

ateg

ies

Ass

essm

ent

of d

ata

qual

ity

Che

mic

al t

rans

port

/war

ehou

sing

SVH

C a

dvis

ory

serv

ices

Envi

ronm

enta

l ris

k as

sess

men

t

Repr

esen

tati

on

Man

agem

ent

(Sie

f, C

onso

rtiu

m e

tc)

Bus

ines

s pr

oces

s ou

tsou

rcin

g (B

PO

)

Regi

stra

tion

ser

vice

s

Dos

sier

pre

para

tion

GH

S no

tifi

cati

on

CLP

not

ifica

tion

Regu

lato

ry/p

olic

y tr

acki

ng

Man

aged

reg

ulat

ory

cont

ent

Che

mic

al h

azar

d da

taba

se

(Mat

eria

l) s

afet

y da

ta s

heet

s

Lega

l rep

rese

ntat

ion

Subs

tanc

e in

vent

ory

man

agem

ent

(Mat

eria

l) s

afet

y da

ta s

heet

sys

tem

s

EH&

S so

luti

ons

Regu

lato

ry in

form

atio

n m

anag

emen

t

Supp

ly c

hain

man

agem

ent

Con

sort

ia/r

egis

trat

ion

solu

tion

s

Labo

rato

ry m

anag

emen

t so

luti

ons

Ecot

oxic

olog

y

Envi

ronm

enta

l fat

e &

deg

rada

tion

Phy

sica

l & a

naly

tica

l che

mis

try

Envi

ronm

enta

l mon

itor

ing

Expo

sure

tes

ting

Hum

an h

ealt

h to

xico

logy

SVH

C t

esti

ng

Trai

ning

cou

rses

/web

inar

s

Bes

poke

/in-

hous

e tr

aini

ng

CP

D/C

ES c

erti

fied

tra

inin

g

Lobb

ying

/adv

ocac

y

Insu

ranc

e

The Sapphire Group

The Wercs

TNO Triskelion

Tox Focus, LLC

toXcel International Ltd

Toxikon

ToxMinds

Toxservices LLC

TRASYS

TSGE

TUV Rheinland Hong Kong Ltd.

TÜV Rheinland LGA Products GmbH

TÜV SÜD Industrie Service GmbH

TUV SUD Japan

UL

Universit Bordeaux Segalen

Verdant Law, PLLC

Von Roll REACH GmbH

VRS Regulatory

wca environment

Weeset Advisors

Wercs Professional Services, LLC

WIL Research

Wildlife International, a division of EAG

Wilmer Tox Consulting

WRc plc

WSP Group

WTConsulting

Xiaodan Pei

YASH Technologies

Zanos Limited



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