Global Service Providers Guide 2013 A guide to chemicals management and control services
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Chemical Watch | Global Service Providers Guide 2013
Foreword I’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 afford not to take a look?
Chemical Watch | Global Service Providers Guide 2013
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 different services offered 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.
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A scientific and regulatory consulting firm providing experts that assist companies making or using chemicals to market and sustain their products globally. · 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
www.actagroup.com Global Chemical Product Innovation and DevelopmentTM Beijing, China 86-10-84534538
Manchester, U.K. +44 (0) 161 212 7405
Washington, D.C. (202) 266-5020
Contents Chemical service providers editoral ..... 5 Increasing 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 .......................................36 24-7 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
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: cw.enquiries@chemicalwatch.com www.chemicalwatch.com
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 ....................... 147 AG-HERA ........................................... 147 ALTox .................................................. 147 BIG vzw .............................................. 147 Caleb Management Services ............ 147 CFCS-Consult .................................... 148
Editor Mamta Patel, mamta@chemicalwatch.com Contributing Editor Cynthia Challener, cynthia@chemicalwatch.com 3URÀOH SURGXFWLRQ Nick Hazlewood, nick@chemicalwatch.com &OLHQW 5HODWLRQVKLS 'LUHFWRU June Meagher, june@chemicalwatch.com $FFRXQW 0DQDJHUV Kerry Williamson, kerry @ chemicalwatch.com Lotte Spencer, lotte @ chemicalwatch.com Glen Marechal, glen @ chemicalwatch.com +HDG RI 0DUNHWLQJ Richard Butterworth, richard @ chemicalwatch.com 2SHUDWLRQV 'LUHFWRU Stuart Foxon, stuart@chemicalwatch.com 0DQDJLQJ 'LUHFWRU Julian Rose, julian@chemicalwatch.com
Chemical Watch | Global Service Providers Guide 2013
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
'LVWULEXWLRQ SROLF\ Copying of this document including electronic circulation is not permitted without consent of the publisher. 'LVFODLPHU 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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Introduction Effective 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 offering 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 difficult 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 drivers Not surprisingly, REACH and GHS compliance requirements helped continue to drive the workload of chemicals management and control professionals in 2012. survey confirm that The results of the 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
Chemical Watch | Global Service Providers Guide 2013
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 forwardthinking 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 productspecific 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 Schßller, director REACH & regulatory affairs for Eastman Chemical EMEA B.V., expects GHS requirements will be big in 2013.
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Chemical service providers
Chemical service providers
Figure 1 Leading regulatory drivers for survey participants REACH
89%
CLP
65%
Chemical service providers
National GHS classification, labelling and inventory notification regulations
46%
Biocides regulations
29%
US TSCA inventory reporting
28%
China new chemical notification (MEP order 7)
27%
Nanomaterials regulations
25%
China: registration of general hazardous chemicals (SAWS Order 53)
23%
Food contact material regulations
22%
China: registration of hazardous chemicals for environmental management (MEP Order 22)
21%
Other country new chemical notifications
20%
Cosmetics regulations
20%
Packaging regulations
19%
International Carriage of Dangerous Goods by Road (ADR)
16%
Korea: Notification under TCCA
15%
International Maritime Dangerous Goods (IMDG) Code
15%
Other country chemical manufacture/import inventory reporting
15%
Agrochemical regulations
13%
Japan: notification and annual reporting under CSCL
13%
Taiwan: nomination to existing chemicals inventory
11%
Taiwan: registration of designated substances under TCSCA
11%
Turkey: notification under CICR
10%
Pharmaceutical regulations
9%
Medical devices regulations
8%
Veterinary product regulations
4%
Other
4% 0%
20%
40%
60%
80%
100%
% 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
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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
Chemical Watch | Global Service Providers Guide 2013
Figure 2 Leading non-regulatory drivers for survey participants Economic growth 49% Customer pressure 42% Governmental policies/spending 37% NGO pressure 27% Non-statutory ‘voluntary’ corporate initiatives/CSR 22% Downsizing of inhouse chemical management and control teams 19% Increased commercialisation/better management of service provider business 14% Outsourcing of business support functions (by client organisations) 11% Other 3%
0%
20%
40%
60%
% of participants
Key trends and issues in chemicals management and control Requests 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,
Chemical Watch | Global Service Providers Guide 2013
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 difficult, 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 Gefahrstoffe 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 affairs: REACH, with JSC International. Beyond that, she is also concerned that substances that are not supported could be taken off the market, which would have a knock-on effect on a range of different 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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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 efficiency and discontinuation of products in the supply base.
Extended safety data sheets Extended 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
Chemical Watch | Global Service Providers Guide 2013
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 difficult 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 ‘official’ 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 timeintensive and can burden a company’s in-house product stewardship and regulatory compliance resources,” asserts Jeffrey 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 affected 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 alignment Implementation 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 differ 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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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.
Chemical Watch | Global Service Providers Guide 2013
searchable, easy-to-use database that provides quick access to official 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 inhouse 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 efforts Demand 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 sufficient because they have global activities and thus have to deal with, often new, regulations in nonEU target markets,” notes Michael Cleuvers, head of industrial chemicals – global regulatory affairs 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 countryspecific 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
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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 Steffan Kilmer, International Business Manager for The Wercs. Companies who have a desire to expand into new markets will find it increasingly difficult 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 GHSbased 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,
CHEMICAL SAFETY
--- Toxicological Testing
(Inhalation, Repro, Gentox, .….)
-- Registration
(REACH, Authorisation, Food Contact Materials, …..)
--- Analytical Chemistry
(Methods, Migration, Product Identity, …..)
& Chemicals Management (Exposure, eSDS, Audits, …..)
Extended One Generation Reproduction Toxicity Study (EOGRTS) Validated and implemented in our laboratory triskelion.nl Utrechtseweg 48 | P.O. Box 844 3700 AV Zeist | The Netherlands P +31 88 866 16 20 chemistry@tno.triskelion.nl
Product legislation Product-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,â€? 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 official guidance by the European Commission’s Scientific Committee on Consumer Safety has been slow, with the latest released just in December 2012,â€? 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,â€? 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,â€? she concludes. As an example, a significantly higher toxicity studies has been required for amount of cosmetic ingredients dossiers, according to Jean-Luc Garrigue, director scientific affairs – Europe for BIOAGRI, a MĂŠrieux NutriSciences Company. “Many companies have anticipated the animal testing and marketing bans that take effect in March 2013, and have accelerated their safety evaluation programmes for strategic ingredients,â€? 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 affairs: biocides & REACH. The legislation was published in June 2012 and takes effect 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
Chemical Watch | Global Service Providers Guide 2013
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,â€? notes LCK’s Mr Kane. CEHTRA’s Sara Kirkham, senior regulatory affairs 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 affected companies are slowly starting to move forward to ensure that they are compliant when the BPR goes into effect. 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,â€? 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 ArrĂŞtĂŠ, 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,â€? stresses Linmark Consulting’s Mr Richards. It is certainly possible that some alternative substances may require registration under the various product-specific regulations.â€?
Training needs Not 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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Chemical service providers
will be made on modernisation of the country’s ageing Toxic Substances Control Act (TSCA) legislation.
Chemical service providers
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 different 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 ( ), and Hazmat 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.
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Legal services Key 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
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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-ENFORCE-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 effect 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 effect, 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 effectively ‘free-riding’,� she adds.
Testing times The 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-off 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 toxicity 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
Chemical Watch | Global Service Providers Guide 2013
Chemical service providers notes that lab availability has been an issue, but not an insurmountable one. Smaller companies have also often found it difficult 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 effective 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 sufficient 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 effectively ensure supplier product compliance is critical to business continuity and to avoid supply chain disruptions.”
Chemical Watch | Global Service Providers Guide 2013
As a result, in 2013, 3E Company expects that the focus on data management as a critical component of effective 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 effective systems that enable business process outsourcing for regulatory departments.
Communication challenges There 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 affairs activities are a business strategy that can help differentiate suppliers from the competition. CEHTRA’s
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Chemical service providers
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 suffer 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 effects 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 compliance One 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
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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 affect 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 cliff” 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.”
Chemical Watch | Global Service Providers Guide 2013
TSCA reform and legislation The 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 Affiliates (Socma). However, adds Mike Walls, vice president of regulatory & technical affairs 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, different 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
Chemical Watch | Global Service Providers Guide 2013
the effectiveness and efficiency 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 efforts 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 difficult 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 different in the US and Europe. “Industry is entering a new era. Corporate EHS, product stewardship and legal staff need to decide whether they will proactively
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Chemical service providers
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 different 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.
Chemical service providers
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 effective 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 affairs 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 longchained chlorinated paraffins 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 effective, 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, scientificallybased 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 affairs 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
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in 2013 on its decision-making processes for SNURs, and particularly for substances that are difficult to test and multicomponent products. It is worth noting that some of the EPA proposals outlined above have yet to receive approval from the Office of Information and Regulatory Affairs (Oira) in the Office 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 affairs 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 affairs 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 activities As 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
Chemical Watch | Global Service Providers Guide 2013
Clean Water Act issues Under 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 offering 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 Act The 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.
BPA in polycarbonate used for baby bottles and beverage containers.
Can the EPA manage it all Based 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 difficult 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 exports Looking 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-effective.
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 tariffs 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.
Specific product regulations
Beyond compliance
With respect to specific product legislation on the national level, two different 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
Voluntary 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.
Chemical Watch | Global Service Providers Guide 2013
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Chemical service providers
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 difficult. 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 difficult for the EPA to find a problem and issue a citation she says.
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 O
O
O
O
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
China O
O
O
EU Commission to review endocrine disrupting chemicals (EDC) provisions of REACH on 1 June O
O
O
O
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
O
O
O
O
O
O
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;
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 O
O
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
Chemical Watch | Global Service Providers Guide 2013
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
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 O
California to adopt final Safer Consumer Products rule in the spring Requirements under Osha’s 2012 Hazard Communications Standard to implement GHS take effect, including new training duties by December 2013
List of hazardous chemicals for priority environmental management is expected to be issued before the summer
Taiwan
US O
Measures for Environmental Administration Registration of Hazardous Chemicals (MEP Order 22) come into force on 1 March
Schedule set for new chemical notifications from April to December under Chemical Substances Control Law (separate schedule for low-volume substance notifications)
South Korea O
Proposed Act on chemicals registration and evaluation, dubbed “K-REACH”, due to be adopted by the summer
Mexico O
Proposal for chemicals regulation (policy and legal options) to provide a legal framework for recently published first national chemicals inventory possible
Malaysia O
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 O
Revision expected of main chemicals management law, Decree 108/2008
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Chemical service providers
IHS believes that voluntary nonfinancial reporting is another type of industry effort 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
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 staffing 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.
Chemical service providers
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 staffers continue to work overtime due to the bleak economic outlook. There should certainly be no lay-offs.” survey support these The results of the 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 3 Staffing trends within your employer 100% 90%
Figure 4 8.7%
12.9%
100%
80% 55.9%
50.1%
37.0% 47.2%
60%
40%
50%
30% 20%
80% 70%
50%
4.0%
10.2%
90%
70% 60%
Job prospects
40% 37.0%
35.4%
10%
30%
59.0% 42.6%
20%
0% Last 12 months
Next 12 months
10% 0%
Decreasing
Static
Increasing
In your country Poor
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
Page 22
Stable
Globally Good
“To my mind,” adds Chemservice’s Mr Drohmann, “jobs are safe. Good regulatory affairs people are not generally available on the jobs market, and if they are, extraordinary salaries must be offered 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 staff. 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.”
Chemical Watch | Global Service Providers Guide 2013
Chemical service providers Chemical Watch | Global Service Providers Guide 2013
Page 23
Figure 5
Figure 7
Job security compared with 12 months ago
Career progression opportunities
100% 90%
Chemical service providers
100% 11.3%
14.4%
80%
80%
70%
70%
60%
25.3% 31.0%
60% 68.8%
50%
66.1%
40%
30%
30%
20%
20%
10%
36.7%
50%
40%
63.0% 38.0%
10%
19.9%
19.6%
In own role
Across all roles
0%
0%
Less secure
Similarly secure
In your company
More secure
Poor
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.
Job satisfaction Dissatisfied 11.2%
Satisfied 59.8% Neither satisfied or dissatisfied 29.0%
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 staff are hired at two extremes of the spectrum: basic entry-level and clerical staff to do compulsory paperwork, and higherlevel 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 staff members are minimal,” she notes.
Wider jobs market
Neither
Good
Figure 6
Page 24
6.0%
90%
Salary trends Participants 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 affairs 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 officers 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 differentiation 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.
Chemical Watch | Global Service Providers Guide 2013
Figure 8
Figure 9
Average salary by job title
Average salary by organisation type
Business management/development
Chemicals, life sciences and similar 37.2
45.4 Consumer products, cosmetics and similar
Consultant 44.6
Engineering, automotive, aerospace and similar
EHS management
44.4
47.9 Government & agencies
Other
52.7
49.6 Other
Product safety/stewardship
45.3
47.9 Other manufacturing
Regulator
46.8
53.0
Service provider, including consultants, laboratories, lawyers etc
Regulatory affairs management
46.6
46.1 Trade association or professional body Toxicologist/chemist/scientist
50.7
45.3 Average salary
0
10
20
46.2
0
10
20
30 40 Euros 000s
50
60
Those employed by consumer products firms, nonchemical 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).
30 Euros 000s
40
50
60
Figure 10 Average salary by job region Europe 53.8 North America 35.9 Rest of world
30.7 Average 46.2
0
Chemical Watch | Global Service Providers Guide 2013
10
20
30 Euros 000s
40
50
60
Page 25
Chemical service providers
47.1
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 3645 (~€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). survey respondents Over two-thirds of the (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.
Chemical service providers
Figure 12 Average pay rise Europe 2.0 2.4
Figure 11
5.9 North America 2.4 3.0 7.6 Rest of world 6.0 7.1 10.5 Average
Average salary by age
2.4 3.0
21-25
7.0
33.9 26-30
0
2
33.9 31-35
Only promotions
44.3 36-40
4
6 %
8
41-45 49.5
Excluding promotions
Including promotions
While there is a lot of work to be done in the regulatory and product safety areas, many firms are relying more on in-house staff, 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 affairs & 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 staff 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 directorlevel positions.
46-50 54.8 51-55 47.7 56-60 40.9 61-65 41.7 >65 28.8
10
20
30 Euros 000s
Page 26
40
50
12
Jobs and salaries in the UK and Europe
49.3
0
10
60
Chemical Watch | Global Service Providers Guide 2013
The US employment scene Within 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 differentiate themselves from the competition with non-salary offerings, 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
Training 9.7%
Other services 3.2% Consultancy 25.6%
Information 7.3%
IT & software 12.4%
Representation & management 6.9% Legal 6.4% Laboratory 28.5%
Chemical Watch | Global Service Providers Guide 2013
Page 27
Chemical service providers
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 staff 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 affairs 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.”
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REACH PPP Biocides Cosme"cs Food/Feed Contact OSPAR e-SDS Services EHS Services Industrial Hygiene OPEX Studies Expert Advice, Bespoke Regulatory Support QSARs & Modeling Regulatory Watchdog Study Design & Monitoring Training
Consultancy for Environmental & Human Toxicology and Risk Assessment ent Bordeaux – Lyon – Paris – No$ngham – Waterloo – Toronto – New Delhi – Trivandrum
%
&
'
(
)
*
+
,
-
+
.
*
&
Figure 14
Interestingly, compared to the fairly significant differences in the distribution of services used in 2010 and 2011, only minor differences 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 differences 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 100%
Percent of chemical management work performed by in-house teams at survey participant firms
90% 80%
100%
70%
90%
60%
80%
50%
70%
40%
60%
30%
50%
20%
40%
10%
30%
0% 2010
20% 10% 0% 2010
2011
80-100%
40-60%
60-80%
20-40%
2012 0-20%
2011
2012
Other services
Laboratory
Training
Legal
Information
Representation & management Consultancy
IT & software
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. -
%
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 Move towards general management 24%
Remained the same 45%
Move towards separate compliance divisions 31%
Chemical Watch | Global Service Providers Guide 2013
Page 29
Chemical service providers
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 â‚Ź1.3m on outsourced services, which equates to a total yearly expenditure of â‚Ź370m. 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 efforts, 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 17 Frequency of service retention by survey participants Consultancy/advisory 10%
26%
49%
Representation & management
Chemical service providers
3% 10%
30%
Legal services 3% 12%
53%
Laboratory 10%
27%
37%
IT & software solutions 9%
17%
38%
Information services 9%
16%
35%
Training 2%
21%
52%
Other services 2%
21%
0% Permanent
52%
% of participants Frequent
100%
Occasional
Customer perceptions of the service provider market Even 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.
Page 30
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 effect 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 efforts.” 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 difficult. 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 efficient and effective, 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.
Chemical Watch | Global Service Providers Guide 2013
between clients and service providers has also declined by 10%. Figure 19 Satisfaction levels in 2012 and 2011 Availability 53% 70% Personal relationship 60% 70% Experience/knowledge in all countries in which you operate 43% 50% Offering flexibility 48% 53% Adding value on top of agreed deliverables 34% 49% Technical knowledge 68% 75% Providing value for money 44% 47% Price of service 33% 41%
Figure 18 Change in overall satisfaction levels for survey respondents
Delivering on schedule 57% 63%
% of participants 100% 90%
3% 9%
80%
3%
2%
19%
25%
Meeting your brief 62% 72%
70% 60%
0%
% of participants satisfied
100%
50% 40%
88% 78%
2012
30% 20% 10% 0% 2010
2011
2011
73%
2012
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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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
Chemical Watch | Global Service Providers Guide 2013
Page 31
Chemical service providers
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, efficient communications, effective 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 20 Satisfaction levels of survey participants with prices charged for services Dissatisfied 12%
Chemical service providers
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. Staff 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%). -
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Expertise of key staff 86% Proven experience on similar projects 79%
Figure 21 Interest level of survey respondents in changing suppliers 100%
In-depth knowledge of country-specific regulations 66% Availability
90% 80%
51% 46%
39%
47%
70%
Comprehensiveness/accuracy of proposal 51%
60%
Ability to operate on a global scale
50%
46%
40% 30%
51% 48%
44%
Contract price
20%
37%
10% 0%
6%
10%
9%
2010
2011
2012
No
Possibly
Yes
Appropriate accreditation/certification 35% Recommendation from peers 28%
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 different respondents as major reasons for switching to a different 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.
Page 32
Independence of supplier organisation 21% ISO9001 or equivalent (quality management) 19% ISO14001 or equivalent (environmental management) 17% Inhouse equipment/software 13% Large size of supplier organisation 5% Proximity to your office 4%
0%
20%
40%
60%
80%
100%
% of participants
Chemical Watch | Global Service Providers Guide 2013
Fig. 23
Figure 24 Anticipated future need for in-house staff 1%
Next 12 months 8%
37%
7%
47%
Next 5 years
2%
11%
0%
Most important relationship factors for survey participants
100%
% of participants
Increase significantly
Strict adherence to project protocols
11%
28%
48%
Decrease
Increase
Static
Decrease significantly
47% Building long-term relationships with individual staff 47% Service level agreements in place 37% Suppliers keeping costs as low as possible 33% Regularly reviewing (and at times changing) suppliers
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.
27% Figure 25
Regular face-to-face meetings
Anticipated future need for external services
23% Paying more to get better value
2%
Next 12 months
13%
5%
44%
44%
5%
Use of penalty clauses 3%
0%
Next 5 years 10%
20%
30%
40%
8%
50%
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31%
8%
% of participants
Implications for the future demand for services Overall, participants in the survey were positive about the health of the services market. With respect to the need for in-house staff, 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 staff rising over the next five years to 59%.
0%
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Chemical Watch | Global Service Providers Guide 2013
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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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Page 33
Chemical service providers
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 staff 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.
Figure 26
Figure 27
Anticipated need for external sector services by survey participants in the next 12 months
Anticipated need for external sector services by survey participants in the next 5 years
Consultancy/advisory
Consultancy/advisory
Chemical service providers
36%
7%
63%
8%
56%
Legal services
Legal services
47%
5%
59%
36%
5%
49%
Laboratory
Laboratory
40%
56%
63%
5%
32%
5%
Information
Information 34%
64%
29% 2%
69%
2% Training
Training 32%
64%
29% 4%
66%
4% Other(s)
Other(s) 81%
17%
% of participants Increase
8%
36%
IT & software
IT & software
0%
56%
7%
45%
47%
Static
26%
2%
100%
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.
Page 34
9%
35%
Representation & management
Representation & management 30%
56%
7%
43%
51%
0%
2%
72%
100%
% of participants
Increase Decrease A breakdown of theStatic 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. -
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Concluding remarks It’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 staff 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.
Chemical Watch | Global Service Providers Guide 2013
Figure 28 Anticipated need for specific external sector services by survey participants over the next five years
Product compliance
2%
41%
57%
Supply chain communications
48%
46%
6%
Environmental risk assessment
47%
48%
5%
Consultancy/ advisory
Registration strategies
42%
52%
6%
Assessment of data quality
40%
55%
6%
Testing strategies
33%
61%
6%
SVHC advisory services
32%
61%
7%
Corporate strategy/strategic planning
32%
62%
6%
Chemical transport and warehousing advice
68%
21%
Dossier preparation & safety assessment, including CSA/ CSR
40%
GHS notification Representation & management
11% 49%
7%
54%
6%
44%
Registration services
56%
35%
CLP notification
9%
58%
32%
10%
Management (SIEF, Consortium etc)
25%
65%
10%
Representation (Lead, Only representative, 3rd party etc)
24%
65%
11%
Business process outsourcing (BPO)
73%
15%
(Material) safety data sheets Information
Laboratory
12%
60%
38%
2%
Chemical hazard database
56%
42%
1%
Regulatory/policy tracking
55%
44%
1%
Managed regulatory content
45%
Ecotoxicology
43%
52%
4%
Environmental fate & degradation
41%
53%
5%
Human health toxicology
39%
57%
4%
53%
2%
Physical & analytical chemistry
37%
58%
5%
Exposure testing
36%
60%
5%
Environmental monitoring
34%
61%
5%
SVHC testing
IT solutions
3%
34%
64%
64%
31%
5%
Regulatory information management
56%
42%
2%
(Material) safety data sheet systems
54%
43%
3%
Substance inventory management systems
49%
46%
4%
Supply chain management/ communications systems
46%
49%
4%
EH&S solutions Consortia/registration management solutions
CPD/CES certified training Lobbying/advocacy Other
23%
Insurance
18% 0%
Chemical Watch | Global Service Providers Guide 2013
7%
60%
7%
71%
6%
78% % of participants
Increase
7%
77%
33%
Legal representatve
4%
60%
34% 16%
10% 42%
54%
Bespoke/inhouse training
10%
70%
20%
Training courses/webinars
4%
67%
23%
Laboratory information management solutions
Training
57%
39%
Static
5% 100% Decrease
Page 35
Chemical service providers
Guidance on regulation interpretation
SERVICE AREA BREAKDOWN Other 20%
Consultancy/ advisory 20%
PROFILE: 24-7 Response
CONTACTS www.24-7response.org
info@24-7response.org
Head office
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
Â
Richard Shreeve
Ownership
OAMPS
Locations
UK based, Worldwide work
Founded
2011
Information 20%
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.
OVERVIEW Chemical emergency response, incident management, clean up and training for the chemical and fuel industries: from providing ¿UVW DLG DGYLFH WR DVVLVWLQJ WKRVH PDQDJLQJ PDMRU HPHUJHQFLHV 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: O SHUVRQDO LQMXU\ PD\ UHVXOW XQOHVV WKH FRUUHFW ¿UVW DLG LV JLYHQ O FKHPLFDO UHDFWLRQV FDQ RFFXU LI PRUH WKDQ RQH SURGXFW LV LQYROYHG O 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 FKHPLFDO LQFLGHQW DGYLVRUV ¹ DOO KLJKO\ TXDOL¿HG FKHPLVWV VSHFLDOLVLQJ LQ 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
<ÂŁ100,000
Turnover, chemical service provision
<ÂŁ100,000
1R RI RIÂżFHV No of countries represented
Representation & management 20%
Training 20%
Website
1 All
Staff, group
10-100
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10-100
Chemical emergency line â&#x20AC;&#x201C; 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 SHUVRQQHO LV KHOG RQ RXU V\VWHP VKRXOG XUJHQW QRWLÂżFDWLRQ EH UHTXLUHG Âą 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 RI WKHVH GHPDQGV DUH UHJXODWRU\ REOLJDWLRQV ZKLOVW RWKHUV UHĂ&#x20AC;HFW WKH 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 â&#x20AC;&#x201C; 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 yearsâ&#x20AC;&#x2122; experience of providing expert advice to those dealing with emergencies: O (XURSHDQ ODQJXDJHV O SULPDU\ $VLDQ ODQJXDJHV DQG $UDELF O UHJXODWRU\ REOLJDWLRQV PHW LQ &KLQD DQG HOVHZKHUH O EXLOW LQ EDFN XS DQG IDLOVDIH IXQFWLRQDOLW\ O DOO FDOOV DUH UHFRUGHG O UHDVRQDEO\ SULFHG O LQFLGHQW UHVSRQGHUV DUH DOO FKHPLVWV O 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
Page 36
Chemical Watch | Global Service Providers Guide 2013
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. 'XH WR WKH UHFHQW FKDQJH LQ OHJLVODWLRQ XQGHU WKH FODVVLÂżFDWLRQ ODEHOOLQJ DQG SDFNDJLQJ 5HJXODWLRQ &/3 DOO VXEVWDQFHV QHHGHG WR EH UHFODVVLÂżHG 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 :H FDQ KHOS \RX WR PDQDJH WKH FODVVLÂżFDWLRQ ODEHOOLQJ DQG QRWLÂżFDWLRQ 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 TXDOLÂżHG '*6$V WKDW DUH DEOH WR RIIHU DGYLFH RU DFW DV \RXU '*6$ 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 oncall OHES incident manager and arrange for them to attend the scene. Training Drawing on our incident advisorsâ&#x20AC;&#x2122; expertise, we have designed training courses that will give your staff an understanding of the risks when handling chemicals â&#x20AC;&#x201C; and mitigate the consequences should things go wrong. Chemical transport training Chemical safety training CLP (classification, labelling and packaging) training Lithium battery safety and legislation training DGSA training
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 victimâ&#x20AC;&#x2122;s eye out for 15 minutes (as per the advice given on the product label and SDS), however he was still in VLJQLÂżFDQW GLVFRPIRUW DQG WKH FDOOHU ZDV DERXW WR GULYH KLP WR WKH QHDUHVW 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. %HLQJ DEOH WR RIIHU TXLFN DQG FRUUHFW ÂżUVW DLG DGYLFH UHGXFHG WKH ULVN RI serious personal injury and the employerâ&#x20AC;&#x2122;s liability claim, which could KDYH SRWHQWLDOO\ UXQ WR D VL[ ÂżJXUH VXP STAFF SELECTION Caroline Raine â&#x20AC;&#x201C; 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 SURMHFWV &DUROLQH LV D TXDOLÂżHG GDQJHURXV JRRGV VDIHW\ DGYLVRU IRU WKH 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 5LFKDUG KDV PRUH WKDQ WHQ \HDUVÂś H[SHULHQFH LQ WKH VSHFLDOLVW ÂżHOG RI 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 yearsâ&#x20AC;&#x2122; 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 Responseâ&#x20AC;&#x2122;s consultancy and training services. Stephen Walker
PARTNERS
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.
Westfarmers, OAMPS, OHES, PTF Training, PTF Consultancy
Darryl McLeod
TESTIMONIALS
Darryl joined 24-7 Response as an incident advisor in August 2012, with several yearsâ&#x20AC;&#x2122; 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.
â&#x20AC;&#x153;We have found 24-7 has provided us with a completely professional and HIÂżFLHQW VHUYLFH LW LV YHU\ LPSRUWDQW WR NQRZ WKDW DOO FDOOV DUH GHDOW ZLWK E\ 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.â&#x20AC;? â&#x20AC;&#x201C; Ray Fowler at Goff Petroleum â&#x20AC;&#x153;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 D FUHGLEOH DQG SURIHVVLRQDO VXSSOLHU LQ WKH +6 ( ÂżHOG ´ Âą 1HLO 5\GLQJ DW FAST Exocet
Chemical Watch | Global Service Providers Guide 2013
Page 37
PROFILE: 24-7 Response
services include: 5($&+ LPSDFW DVVHVVPHQWV O 5($&+ GRVVLHU SUHSDUDWLRQ O 5($&+ 6LHI UHSUHVHQWDWLRQ O 5($&+ WKLUG SDUW\ DQG RQO\ UHSUHVHQWDWLYH VHUYLFHV O REACH exposure scenarios advice. O
GLOBAL OFFICES Carlsbad, CA, USA: 3E Company's world headquarters and the worldrenowned EH&S Mission Control call centre Copenhagen, Denmark: European headquarters and SDS authoring and related regulatory services centre-of-excellence Montreal, QC, Canada: SDS management products and services operations Bethesda, MD, USA: Ariel global regulatory data development and operations Kingsport, TN, USA: SDS authoring centre-of-excellence Canton, OH, USA: MSDgen SDS authoring platform product, operations and support centre
PROFILE: 3E Company
CONTACTS Website
www.3ecompany.com
info@3ecompany.com
Head office
3207 Grey Hawk Court, Carlsbad, CA 92010, USA
Tel/ Fax
+1 760 602 8700/ +1 760 930 6662
SERVICES PROVIDED
Directors
Robert S Christie, President and CEO Leo Oves, Vice President, Research and Development Jeffrey Starr, Vice President, Marketing Greg Merwin, Vice President, Global Sales Andrea Verspay, Vice President, European Sales Alan Goodman, Director, Asia and Latin America Sales Alex Ortiz, Vice President, Ariel US Operations Clark VanScoder, Vice President, MSDgen Operations
Regulatory data access and delivery â&#x20AC;&#x201C; decision support
Ownership
Owned by public company, Verisk Analytics
Locations
US, Canada, Europe, Asia
Founded
1988
Ariel WebInsightâ&#x201E;˘ â&#x20AC;&#x201C; a subscription-based online reference tool for researching and tracking how chemicals and substances are regulated. ArielLogicâ&#x201E;˘ for food and flavours â&#x20AC;&#x201C; a subscription-based online reference WRRO IRU UHVHDUFKLQJ DQG WUDFNLQJ UHJXODWHG Ă&#x20AC;DYRXUV DQG IRRG DGGLWLYHV Ariel Data Managerâ&#x201E;˘ (ADM) â&#x20AC;&#x201C; seamlessly integrates chemical regulatory GDWD LQWR FRUSRUDWH V\VWHPV DQG SURYLGHV HIÂżFLHQW FKDQJH PDQDJHPHQW DQG regular updates as regulations change and new ones are released. Ariel Solutions for SAPÂŽ â&#x20AC;&#x201C; 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
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 OHYHO UHJXODWRU\ GDWD DQG SURGXFW OHYHO 6'6 GDWD URXQG WKH FORFN JOREDO FRYHUDJH DQG FXVWRPHU VXSSRUW GDWD DFFXUDF\ TXDOLW\ DQG LQWHJULW\ a breadth of solutions covering upstream product stewardship and GRZQVWUHDP ZRUNSODFH VDIHW\ DQG XQSDUDOOHOHG H[SHULHQFH DQG GRPDLQ H[SHUWLVH 6HUYLFHV LQFOXGH UHIHUHQFH DQG LQWHJUDWHG UHJXODWRU\ GDWD 6'6 DXWKRULQJ V\VWHPV DQG VHUYLFHV 6'6 GLVWULEXWLRQ DQG PDQDJHPHQW WUDQVSRUWDWLRQ HPHUJHQF\ UHVSRQVH UHJXODWRU\ UHSRUWLQJ DQG KD]DUGRXV waste management.
MSDgen ÂŽ SDS Authoring Software â&#x20AC;&#x201C; an enterprise software solution suite designed for companiesâ&#x20AC;&#x2122; in-house EH&S staff SDS authoring services â&#x20AC;&#x201C; provides outsourced or co-sourced assistance with authoring SDSs via 3Eâ&#x20AC;&#x2122;s own fully-dedicated, in-house VWDII RI KLJKO\ TXDOLÂżHG PXOWL OLQJXDO DXWKRUV SDS distribution â&#x20AC;&#x201C; facilitates the dissemination of SDSs to all stakeholders Professional services
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
6
No of countries represented
-
Staff, group
-
REACH â&#x20AC;&#x201C; 3E can work collaboratively with a company to produce exposure scenarios for eSDSs GHS Âą FODVVLÂżFDWLRQ VHUYLFHV DQG FRQVXOWLQJ WR FRPSDQLHV ZKR QHHG assistance with understanding the implications of GHS has on their business TSCA â&#x20AC;&#x201C; services range from fully outsourcing TSCA compliance to SURMHFW EDVHG IXQFWLRQ VSHFLÂżF DUHDV C&L notification â&#x20AC;&#x201C; assists manufacturers and importers with CLP FODVVLÂżFDWLRQ DQG VXEVHTXHQW (&+$ QRWLÂżFDWLRQ XQGHU WKH (XURSHDQ Unionâ&#x20AC;&#x2122;s CLP Regulation European product registration â&#x20AC;&#x201C; 3E can determine which products need to be registered, perform the registration process, the maintenance of the registration and any necessary updates to SDSs and labels DGSA (dangerous goods safety adviser) â&#x20AC;&#x201C; 3E can serve as a companyâ&#x20AC;&#x2122;s DGSA
Staff, chemical service provision
-
Supply chain data and sustainability tools
VITAL STATISTICS
 2011/12
SERVICE AREA BREAKDOWN
IT & software 10%
Other 5%
Consultancy/ advisory 5%
SDS management and workplace safety
Information 80%
Page 38
Supply Chain Product Compliance Management â&#x20AC;&#x201C; products and service to facilitate compliance with regulatory and market driven requirements related to detailed information about the source and origin of products 3E Green Product Analyser â&#x20AC;&#x201C; provides powerful regulatory and toxicology analysis of products 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 FODVVLÂżFDWLRQ RI VKLSSLQJ KD]DUGRXV PDWHULDOV IRU DQ\ PRGH 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.
Chemical Watch | Global Service Providers Guide 2013
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1998
Company founded
2004
$FTXLVLWLRQ $ULHO 5HVHDUFK &RUSRUDWLRQ LQWHUQDWLRQDO H[SDQVLRQ
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 -13
Seven-time winner Environmental Business Journal Business $FKLHYHPHQW DZDUGV :LQQHU RI ¿YH RFFXSDWLRQDO KHDOWK DQG 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. ³:H DUH FRQ¿GHQW WKDW :HE,QVLJKW SURYLGHV XV ZLWK WKH FRPSUHKHQVLYH 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 turbines Challenge: 9HVWDV KDG QR ZD\ WR FRQVLVWHQWO\ DQG HI¿FLHQWO\ PDQDJH 3500 SDSs in multiple languages across its 14 business units. Solution: 3E Online-SDS Results: ³3HUKDSV RQH RI WKH PRVW VLJQL¿FDQW EHQH¿WV LV KDYLQJ LQFUHDVHG FRQ¿GHQFH WKDW 6'6 XSGDWHV DUH EHLQJ H[HFXWHG LQ DQ HI¿FLHQW 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.
Chemical Watch | Global Service Providers Guide 2013
CASE STUDY 2: Illinois Tool Works relies on MSDgen to forge accurate, compliant, multilingual SDSs Industry: GLYHUVL¿HG LQGXVWULDO PDQXIDFWXUHU RI YDOXH DGGHG FRQVXPDEOHV 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: ³:H DUH FRQ¿GHQW WKDW 06'JHQ LV SURYLGLQJ XV ZLWK WKH 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 6\UDFXVH 8QLYHUVLW\ KLV XQGHUJUDGXDWH GHJUHH LV LQ *HUPDQ DQG 5XVVLDQ languages and literatures from the University of Kansas.
Page 39
PROFILE: 3E Company
Hazardous waste management and classification services: that support customers’ hazardous waste management obligations, including proper storage and disposal.
GLOBAL OFFICES The Acta Group LLC 2200 Pennsylvania Avenue, NW Suite 100W, Washington, DC 20037-1701 Tel: +1 (202) 266-5020 The Acta Group China LLC 1009 Tongguang Tower No 12 Nongzhanguan Nanli Beijing, China 100125 TEL: 86-10-84534538
PROFILE: ACTA
CONTACTS Website
www.actagroup.com
lmacdougall@actagroup.com
Head office
23, New Mount Street, Manchester, M4 4DE, UK
Tel
+44 (0)1612127405
Contact
lbergeson@actagroup.com
Directors
Lynn L Bergeson and Lisa M Campbell
Ownership
3ULYDWH FRPSDQ\ DIÂżOLDWHG ZLWK Bergeson & Campbell PC B&C Consortia Management LLC
Locations
US, UK and China
Founded
2004
SERVICES PROVIDED General consulting services We represent and counsel individuals, business entities, trade associations, and industry associations. Our fundamental goals are to VROYH RXU FOLHQWVÂś H[LVWLQJ SUREOHPV DQG WR PLQLPLVH IXWXUH GLIÂżFXOWLHV We take a multi-disciplinary approach in assisting our clients. Attention must be paid to the interplay of all branches of government and interest JURXSV 2XU FDSDELOLWLHV ERUQH RI VLWH DQG LVVXH VSHFLÂżF H[SHULHQFH combined with our national and international view on policy and regulatory developments, position us to handle all these tasks with judgment, FUHDWLYLW\ DQG HIÂżFLHQF\
OVERVIEW The Acta Group LLC is a leading international specialist in chemical product approval, support, and regulatory defence. $FWD ZDV HVWDEOLVKHG WR FRQWURO WKH VSLUDOOLQJ FRVWV DQG LQHIÂżFLHQFLHV 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 WKH VNLOOV DQG H[SHULHQFH RI SURIHVVLRQDOV ZKR KDYH ZRUNHG LQ WKH VSHFLÂżF 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. VITAL STATISTICS
2011/12
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
3
No of countries represented
>25
Staff, group
>25
Staff, chemical service provision
>25
SERVICE AREA BREAKDOWN Training 5%
Other 5%
Representation & management 20% Information 10%
Page 40
5HJXODWRU\ FKHPLFDO SURGXFW QRWLÂżFDWLRQ UHJLVWUDWLRQ DQG WHFKQLFDO defence under the framework of global chemical programmes. Acta concentrates on obtaining, maintaining, and supporting product approvals DQG HIÂżFLHQWO\ RYHUFRPLQJ FRPPHUFLDO RU UHJXODWRU\ LPSHGLPHQWV WR WKH VXFFHVVIXO DQG SURÂżWDEOH PDUNHWLQJ RI DSSURYHG SURGXFWV 7KH 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
Consultancy/ advisory 30%
Legal 25%
IT & software 5%
Global product registration and agent services (only representative services)
Undertaking the appropriate document preparation and coordination to support a registration and post registration activities, ie chemical substance dossier preparation, exposure assessments, hazard assessments, VSHFLÂżF HIIHFW DQDO\VLV DQG DVVHVVPHQWV SHWLWLRQV UHVSRQVH WR FRPPHQW documents, inquiries, and safety data sheet (SDS) preparation. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1998
Parent company, Bergeson & Campbell PC formed in Washington DC, USA
2000
%HUJHVRQ &DPSEHOO 3& HVWDEOLVKHV FRQVXOWLQJ DIÂżOLDWH 7KH Acta Group LLC in Washington DC, USA
2004
The Acta Group LLC establishes an international consulting DIÂżOLDWH 7KH $FWD *URXS (8 /WG LQ WKH 8.
2010
%HUJHVRQ &DPSEHOO 3& HVWDEOLVKHV D FRQVXOWLQJ DIÂżOLDWH B&C Consortia Management LLC in Washington DC, USA
2011
The Acta Group LLC establishes an international consulting DIÂżOLDWH 7KH $FWD *URXS &KLQD //& Chemical Watch | Global Service Providers Guide 2013
ACCREDITATIONS
STAFF SELECTION
2FFXSDWLRQDO +HDOWK DQG 6DIHW\ $VVHVVPHQW 6HULHV ,QWHUQDWLRQDO 2UJDQLVDWLRQ IRU 6WDQGDUGLVDWLRQ ,62 ,62
Lynn L Bergeson â&#x20AC;&#x201C; Principal/Director
B&C Consortia Management LLC Bergeson & Campbell, PC CLIENTS Acta EUâ&#x20AC;&#x2122;s clients are involved in many businesses, including basic, VSHFLDOW\ DJULFXOWXUDO DQG DQWLPLFURELDO FKHPLFDOV ELRWHFKQRORJ\ QDQRWHFKQRORJ\ DQG HPHUJLQJ WUDQVIRUPDWLYH WHFKQRORJLHV PHGLFDO GHYLFHV DQG GLDJQRVWLF SURGXFWV ÂżEUHV SDLQWV DQG FRDWLQJV SODVWLF SURGXFWV DQG FKHPLFDO PDQXIDFWXULQJ IRUPXODWLRQ GLVWULEXWLRQ DQG consumer product sectors. TESTIMONIALS 2XU FOLHQW OLVW LV PDLQWDLQHG RQ D FRQÂżGHQWLDO EDVLV :H GR QRW SXEOLVK client names/testimonials. CASE STUDY 1: Successful ECHA appeal Provided strategic technical support to our European legal counsel, )LHOG )LVKHU :DWHUKRXVH LQ WKH ÂżUVW VXFFHVVIXO DSSHDO XQGHU WKH 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 ECHAâ&#x20AC;&#x2122;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. 2XU ZRUN LQ WKLV DUHD EXLOGV XSRQ RXU VLJQLÂżFDQW DQG H[WHQVLYH GDWD 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.
Chemical Watch | Global Service Providers Guide 2013
Leslie Scott MacDougall â&#x20AC;&#x201C; Director of Regulatory Affairs Ms MacDougall has more than two decades experience in various FKHPLFDO UHODWHG PDWWHUV 6KH VSHQW D VLJQLÂżFDQW SRUWLRQ RI KHU FDUHHU 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 â&#x20AC;&#x201C; Regulatory Specialist Ms Downes specialises in REACH registrations and worldwide QRWLÂżFDWLRQV 0V 'RZQHV LV H[SHULHQFHG LQ SHUIRUPLQJ 5($&+ UHODWHG 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 â&#x20AC;&#x201C; 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 DQG KXPDQ KHDOWK ULVN DVVHVVPHQW DQG SURGXFW FODVVLÂżFDWLRQ ODEHOLQJ and safety. Dr Hayley Clayton, PhD â&#x20AC;&#x201C; Regulatory Specialist Dr. Clayton has a deep understanding of risk assessment, regulatory FRPSOLDQFH DQG GDQJHURXV JRRGV VDIHW\ 6KH LV DQ ,$7$ FHUWLÂżHG 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 VXSUDPROHFXODU FKHPLVWU\ IURP WKH 8QLYHUVLW\ RI +XGGHUVÂżHOG
Page 41
PROFILE: ACTA
PARTNERS
Ms Bergeson has for over two decades assisted individual companies and a wide range of trade groups and ad hoc consortia on chemicalVSHFLÂżF OHJLVODWLYH DQG UHJXODWRU\ PDWWHUV 0V %HUJHVRQÂśV SUDFWLFH areas include Toxic Substances Control Act (TSCA), FIFRA, REACH, DQG UHODWHG LQWHUQDWLRQDO FKHPLFDO QRWLÂżFDWLRQ UHJLVWUDWLRQ DQG VWUDWHJLF product defence and product approval litigation matters.
GLOBAL OFFICES Centres of excellence for our product stewardship services are located in both Europe (Belgium and Switzerland) and the US, with partners in JURZLQJ PDUNHWV LQ WKH $VLD 3DFLÂżF DQG 6RXWK $PHULFD UHJLRQV For Europe, contact ARCADIS Belgium: Citylink, Posthofbrug 12, 2600 Antwerpen-Berchem, Belgium. Alain Vassart, +32 3 328 62 48, a.vassart@arcadisbelgium.be For the US, contact ARCADIS US: 4665 Cornell Road, Suite 350, Cincinnati, Ohio 45241, USA. Michelle Langefeld, +1 513 860 8700, michelle.langefeld@arcadis-us.com
PROFILE: ARCADIS
CONTACTS Website
www.arcadis.com/Global_Product_Stewardship.aspx
reach@arcadisbelgium.be AUSInternet@arcadis-us.com
Head office
Gustav Mahlerplein 97-103, 1082 MS Amsterdam
SERVICES PROVIDED
Â
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+
Our global product stewardship (GPS) practice focuses on: O product stewardship systems and programmes O global regulatory surveillance O due diligence reviews O sustainability support O supply chain management O registration support, permitting, and licensing O VWUDWHJLF VFLHQWLÂżF VROXWLRQV Examples of our work are provided below.
Founded
1888
REACH from A to Z
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 ZRUOG WR VROYH WKHLU PRVW GLIÂżFXOW SURGXFW VWHZDUGVKLS FKDOOHQJHV DQG bring their products to market in a compliant and safe manner. VITAL STATISTICS
2012/13
Turnover, group
â&#x201A;Ź2.4bn
Turnover, chemical service provision
â&#x201A;Ź5m 300+ covering all regions of the world
1R RI RIÂżFHV No of countries represented
40
Staff, group
21,000+
Staff, chemical service provision
49
SERVICE AREA BREAKDOWN IT & software 5% Laboratory 5% Information 5% Representation & management 20%
Page 42
Training 5%
7KH PLVVLRQ RI RXU *36 WHDP LV WR HQDEOH RXU FOLHQWV WR HIÂżFLHQWO\ manufacture and market their products, and to manage their supply chains in a safe, responsible, and globally compliant manner. Currently, a major IRFXV LV 5($&+ DQG &/3 *+6 LQ DOO LWV DVSHFWV ZH SURYLGH VFLHQWLÂżF DQG managerial support, combined with pragmatic and strategic advice, resulting LQ UHJXODWRU\ FRPSOLDQFH LQ DQ HIÂżFLHQW DQG FRVW HIIHFWLYH ZD\ $5&$',6 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 WKH JHQHUDO DQG ÂżQDQFLDO PDQDJHPHQW RI VHYHUDO FRQVRUWLD ,Q WKLV UROH ZH 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 timeconsuming 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
Consultancy/ advisory 60%
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 productâ&#x20AC;&#x2122;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.
Chemical Watch | Global Service Providers Guide 2013
CASE STUDY 3: Authorisation under REACH
1888
Parent company Heidemij formed in the Netherlands
1993
Geraghty & Miller merges with Heidemij
1998
Global company becomes ARCADIS
2002
%%/ 86 FRQVXOWLQJ ÂżUP HVW HVWDEOLVKHV D JOREDO 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
7KH ÂżUVW DXWKRULVDWLRQ GRVVLHUV KDYH EHHQ VXEPLWWHG WR (&+$ DQG PDQ\ PRUH DUH XQGHU GHYHORSPHQW $5&$',6 KDV VLJQLÂżFDQW H[SHULHQFH ZLWK 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 UHTXLUHG IRU D UHJLVWUDWLRQ GRVVLHU H[SHUWLVH LQ WKH ÂżHOG RI KXPDQ KHDOWK 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 ULVNV H[SHFWHG HIIHFWV RQ VRFLDO DQG HFRQRPLF OHYHO HWF GHÂżQLQJ WKH consequences of a refusal (non-use scenarios), and most often, additional exposure data to better characterise the remaining risks. ARCADIS VXSSRUWV RXU FOLHQWVÂś EXVLQHVV VXFFHVV E\ RIIHULQJ DOO RI WKH ÂżHOGV RI H[SHUWLVH WKDW DUH UHTXLUHG WR GHÂżQH WKH FRQVHTXHQFHV RI D UHIXVDO RI authorisation (non-use scenarios) vs the continued use of the substance.
2011-12
/
ARCADIS acquires BMG Engineering Ltd in Switzerland, a OHDGLQJ FRPSDQ\ LQ WKH ÂżHOGV RI SURGXFW VWHZDUGVKLS DQG 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 (XURSHDQ 5HJLVWHUHG 7R[LFRORJLVWV (XURSHDQ 5HJLVWHUHG &KHPLVWV 'LSORPDWV of the American Board of Toxicology (DABT). The ecotoxicology laboratory of %0* LV */3 FHUWLÂżHG DQG DOVR DFFUHGLWHG DFFRUGLQJ WR ,62 ,(& 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: O KXPDQ DQG HQYLURQPHQWDO VDIHW\ DVVHVVPHQWV O XSGDWLQJ SURGXFW PDWHULDO VDIHW\ GDWD VKHHWV O 86 76&$ LPSRUW H[SRUW UHYLHZ O VFLHQWLÂżF PDQXVFULSW SUHSDUDWLRQ O GHYHORSLQJ ZHEVLWH FRQWHQW O VXSSRUW IRU JUHHQ FHUWLÂżFDWLRQ DQG O 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. :H PRQLWRU FKDQJHV LQ VSHFLÂżF OHJLVODWLRQ RQ FKHPLFDOV DUWLFOHV PHGLFDO devices, and biological substances and partner with our clients to develop VWUDWHJLHV LQFOXGLQJ SURFHVVHV DQG WRROV WR FRQÂżUP DQG GRFXPHQW compliance. We work with our clients to integrate those strategic solutions into their business processes. Through our thorough understanding of our partnersâ&#x20AC;&#x2122; 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.
Chemical Watch | Global Service Providers Guide 2013
STAFF SELECTION Andreas Häner PhD â&#x20AC;&#x201C; 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 /WG KH KDV EHHQ D VSHFLDOLVW LQ WKH ÂżHOGV RI FKHPLFDO VDIHW\ VXFK DV product stewardship, legal compliance, REACH, GHS) and environmental risk assessment .and has supervised non-clinical GLP studies (aquatic toxicology and biodegradability) in BMGâ&#x20AC;&#x2122;s own ecotoxicology laboratory. Nele Deleebeeck PhD â&#x20AC;&#x201C; Ecotoxicologist Dr Deleebeeck holds the academic degrees of MSc in biology, MSc in environmental sciences and technologies, and a PhD in applied bioengineering sciences. She has worked for academics, industry, the Belgian government and consultancy. She has more than ten yearsâ&#x20AC;&#x2122; experience in environmental risk assessment and this for a wide variety of chemicals, with her main specialty being metals and metalloids. Kate Sellers PE â&#x20AC;&#x201C; 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 WKH 5,90 UHSRUW RQ WKH GHÂżQLWLRQ RI QDQRSDUWLFOHV GXULQJ D &KHP:DWFK 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 â&#x20AC;&#x201C; 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 SODQV H6'6 FRPSOLDQFH SURFHVV Ă&#x20AC;RZV HWF ,Q DGGLWLRQ VKH LV LQYROYHG LQ 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 â&#x20AC;&#x201C; Environmental risk assessor Ms Schraepen holds the academic degrees of MSc Eng in biochemistry and MSc in environmental sciences. She has more than 15 yearsâ&#x20AC;&#x2122; 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.
Page 43
PROFILE: ARCADIS
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
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 DQG DVVLVW \RX ZLWK WKH IXOÂżOPHQW RI \RXU REOLJDWLRQV DV SURGXFHU LPSRUWHU distributor and/or downstream user of phase 2 and 3 substances under 5($&+ :H FDQ DVVLVW LQ D OLWHUDWXUH VHDUFK DQG GDWD HYDOXDWLRQ E ,8&/,' F H[SRVXUH VFHQDULRV G &6$ &65 H UHDG DFURVV DQG GDWD ZDLYLQJ I 46$5 DQG J 5($&+ GRVVLHU VXEPLVVLRQ XSGDWLQJ DQG follow-up.
PROFILE: ARCHE
CONTACTS Website
www.arche-consulting.be
info@arche-consulting.be
Head office
Stapelplein 70, box 104, 9000 Gent, Belgium
Tel
+32 9 265 87 58
Contact
Marnix Vangheluwe
Directors
Marnix Vangheluwe
Â
Patrick Van Sprang
Ownership
Private company
Locations
Gent and Leuven, Belgium
Founded
2009
Classification of substances and complex mixtures under CLP/GHS
OVERVIEW ARCHE was founded in 2009 by key experts from EURAS who hold a XQLTXH WUDFN UHFRUG \HDUV LQ WKH ÂżHOG RI HQYLURQPHQWDO WR[LFRORJ\ 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 WRSLFV 2WKHU NH\ VHUYLFHV LQFOXGH WKH FODVVLÂżFDWLRQ RI VXEVWDQFHV DQG FRPSOH[ PL[WXUHV *+6 &/3 VHWWLQJ DQG RU HYDOXDWLRQ RI VLWH VSHFLÂżF environmental quality standards, and the assessment of pharmaceuticals in the environment, plant protection products and biocidal products. VITAL STATISTICS
2011/12
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
2
No of countries represented
1
Staff, group
14
Staff, chemical service provision
14
SERVICE AREA BREAKDOWN
In order to remain compliant with all the current legislation related to the KD]DUG FODVVLÂżFDWLRQ RI VXEVWDQFHV DQG FRPSOH[ PL[WXUHV $5&+( SURYLGHV VHUYLFHV RQ D LGHQWLÂżFDWLRQ RI REOLJDWLRQV XQGHU &/3 DQG 5($&+ E UH FODVVLÂżFDWLRQ RI VXEVWDQFHV PL[WXUHV WR PHHW WKH QHZ &/3 UHTXLUHPHQWV F XSGDWLQJ DQG DVVLJQPHQW RI FODVVLÂżFDWLRQ DFFRUGLQJ WR &/3 DQG 5($&+ UHTXLUHPHQWV LQFOXGLQJ SUHSDUDWLRQ RI &/3 QRWLÂżFDWLRQ GRVVLHU G FRPSOLDQFH FKHFN RI H 6'6 IRU FODVVLÂżHG VXEVWDQFHV ZLWK regard to format, content, and agreement with the information included LQ 5($&+ UHJLVWUDWLRQ GRVVLHUV H HYDOXDWH ZKHWKHU WKH XVHV DQG operational conditions that are described in he exposure scenarios cover WKH DFWLYLWLHV IRU D VSHFLÂżF GRZQVWUHDP XVHU Water Framework Directive (WFD) and Environmental Quality Standard (EQS) Directive The WFD and EQS Regulations directly impact the operation of industrial VLWHV RQH RI LWV JRDOV LV WR DVVHVV SURWHFW WKH FKHPLFDO VWDWXV RI ZDWHU ERGLHV HJ LPSDFW RI HIĂ&#x20AC;XHQWV $5&+( SURYLGHV WDLORU PDGH SODQV WR increase the realism of the compliance assessment: (a) translation of JHQHULF (46 E GHULYDWLRQ RI VLWH VSHFLÂżF (46 XVLQJ ELRDYDLODELOLW\ EDFNJURXQG FRUUHFWLRQV F LPSOHPHQWDWLRQ RI SUREDELOLVWLF WHFKQLTXHV FRYHULQJ WHPSRUDO YDULDWLRQV G GHYHORSPHQW DQG PDQDJHPHQW RI full-scale monitoring programmes (biological and physico-chemical FKDUDFWHULVDWLRQ H PRGHOOLQJ DQG ULVN H[SRVXUH DVVHVVPHQW RI WKH HIĂ&#x20AC;XHQW PL[LQJ ]RQH 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) HIIHFW DQG H[SRVXUH DVVHVVPHQW IRU DFWLYH VXEVWDQFHV DQG SURGXFWV E GDWD JDS LGHQWLÂżFDWLRQ DQG GHVLJQLQJ KLJKHU WLHU VWXGLHV F H[SRVXUH modelling (FOCUS suite of models, EUSES, USES, CONSEXPO, ($6( G KLJKHU WLHU H[SRVXUH VFHQDULR GHYHORSPHQW H &/3 I GRVVLHU SUHSDUDWLRQ VXEPLVVLRQ DQG IROORZ XS J FOLHQW UHSUHVHQWDWLRQ LQ PHHWLQJV ZLWK UHJXODWRU\ DXWKRULWLHV DQG K SURGXFW VWHZDUGVKLS CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Training IT & software 7% 5% Representation & management 5%
Consultancy/ advisory 83%
2009
)RXQGDWLRQ RI $5&+( VWDII ÂżYH SHRSOH
2010
([SDQVLRQ RI WKH WHDP WR SHRSOH ZLWK RIÂżFHV LQ *KHQW and Leuven
2013
Further expansion to 14 people, and further development of the services on biocides and pesticides
PARTNERS EBRC Consulting GmbH, Hannover PietConsulting
GLOBAL OFFICES PJ Van Benedenstraat 4, box 203 3000 Leuven, Belgium Tel: +32 16 28 49 00
Page 44
Chemical Watch | Global Service Providers Guide 2013
Industrial clients and consortia related to the following chemical substances: O metals including: Cu, Ni, Mo, Pb, Zn, Hg, V, Co, Fe, Se, Sr, Mg, Bi, Te, Ti O RUJDQLF FRPSRXQGV FKORULQDWHG Ă&#x20AC;DPH UHWDUGDQWV RUJDQLF DFLGV plasticisers, amines, biocides, pesticides O complex materials: Cu slags, Ti slags O other inorganic substances: Ca, B, NaOH, KOH, sulphur dioxiderelated substances (SO2, sulphites, thiosulphates, dithionites), lime, nitric acid, phosphoric acid TESTIMONIALS Âł,02$ KDV ZRUNHG IRU WKH ODVW ÂżYH \HDUV ZLWK WKH HQYLURQPHQWDO VFLHQWLVWV 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 WKHLU ÂżHOG ´ Ă 6DQGUD &DUH\ ,QWHUQDWLRQDO 0RO\EGHQXP $VVRFLDWLRQ CASE STUDY 1: REACH 2010 chemical safety reports for metals and metals compounds The people currently working at ARCHE assisted several metal consortia in their REACH dossier preparation and chemical safety report generation for their metals and metal compounds that had to be registered by 1 December 2010. Data gap analysis with regard to the WRQQDJH VSHFLÂżF 5($&+ LQIRUPDWLRQ UHTXLUHPHQWV RQ SK\VLFR FKHPLFDO 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 â&#x20AC;&#x201C; 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. 7KH 0H&ODV WRRO RIIHUV D XQLTXH ZHE HQDEOHG FODVVLÂżFDWLRQ WRRO WKDW LV DOZD\V XSGDWHG WR WKH ODWHVW FODVVLÂżFDWLRQ UXOHV 7KH WRRO FRPSULVHV VHYHUDO WLHUV DLPHG DW WKH SURJUHVVLYH UHÂżQHPHQW RI FODVVLÂżFDWLRQ WKURXJK UHFRJQLWLRQ RI VSHFLDWLRQ VSHFLÂżF PLQHUDO FRQWHQW DQG WKH DYDLODELOLW\ 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, ,&00 DQG (XURPLQHV 7KH FODVVLÂżFDWLRQ WRRO FDQ EH VLPSO\ DFFHVVHG E\ registering via www.meclas.eu
Chemical Watch | Global Service Providers Guide 2013
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 W\SLFDO GDLU\ IDUP DQG (86(6 EDVHG RQ ORFDO FRQVXPSWLRQ HVWLPDWHV extrapolated from EU/regional tonnage. For the ESD, formulae and default values were implemented into an Excel worksheet. In EUSES VFHQDULR ZDV XVHG FXUUHQWO\ WKHUH LV QR VFHQDULR DYDLODEOH IRU 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 GHJUDGDWLRQ UDWHV LQ VRLO DQG VOXUU\ $OWKRXJK D VSHFLÂżF H[SRVXUH VFHQDULR for PT3/PT4 biocides is not yet available, EUSES is preferred due to WKH PRUH UHÂżQHG IDWH FDOFXODWLRQV WKH IDFW WKDW LW WDNHV LQWR DFFRXQW D great number of characteristics of substances and that the outcomes of EUSES are far more extended than with an ESD calculation. The results of this study were published at the SETAC Special Science Symposium in October 2011. STAFF SELECTION Patrick Van Sprang â&#x2C6;&#x2019; Managing Director ARCHE Patrick Van Sprang graduated as master of science in engineering (environmental technology) at Ghent University (1988). At Ghent University (1994-2000) he was responsible for the research group aquatic ecotoxicology. He was co-founder of EURAS, a consultancy company specialising in environmental risk assessment. Patrick Van Sprang is the main author of the environmental part of several risk assessments (eg Cu, Ni, Pb) and contributed to the metal risk assessment guidance document (MERAG). Marnix Vangheluwe â&#x2C6;&#x2019; Managing Director ARCHE Marnix Vangheluwe graduated as master of science in engineering (biochemistry) at Hogeschool Gent (1989). In 1991 he obtained a master in environmental sanitation (Ghent University). At Ghent University (19922000) he was responsible for the research group sediment ecotoxicology. He was co-founder of EURAS, a company specialising in environmental risk assessment. He is the main author of the metal risk assessment JXLGDQFH GRFXPHQW 0(5$* DQG WKH RIÂżFLDO 5($&+ $SSHQGL[ 5 Frederik Verdonck â&#x2C6;&#x2019; 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 GHYHORSLQJ DQG LPSOHPHQWLQJ QHZ WRROV LQ WKH ÂżHOG RI H[SRVXUH VFHQDULR building. Hilde Dosogne â&#x2C6;&#x2019; 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.
Page 45
PROFILE: ARCHE
CLIENTS
PROFILE: bibra toxicology advice & consulting
SERVICE AREA BREAKDOWN IT & software Training 1% Information 3% 6% Representation & management 12%
CONTACTS Website
www.bibra-information.co.uk
info@bibratoxadvice.co.uk
Head office
Cantium House, Railway Approach, Wallington, Surrey, SM6 0DZ, UK
Tel/ Fax
+44 (0)20 8544 4150/ +44 (0)20 8544 4151
Contact
Peter Watts
GLOBAL OFFICES
Directors  Â
James Hopkins, Managing Director
London
Peter Watts, Director of Toxicology
SERVICES PROVIDED
Graham Hunt, Commercial Director
Dossier preparation, including CSA/CSRs (DNEL/DMEL derivation)
Ownership
Private company
Locations
United Kingdom
Founded
1961, acquired by current management 2005
Highly skilled in working directly into IUCLID preparing technical dossiers required under REACH and the Biocidal Products Directive, and in describing WR[LFRORJLFDO GDWD LQ D UREXVW EXW HIÂżFLHQW ZD\ 9HU\ H[SHULHQFHG LQ LQWHUSUHWLQJ 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 RI WKH ÂżQDO FKHPLFDO VDIHW\ UHSRUW IRU VXEPLVVLRQ :H FDQ DOVR DGYLVH RQ UHOHYDQW FODVVLÂżFDWLRQ ODEHOOLQJ :RUNLQJ ZLWK SDUWQHUV ZH FRYHU DOO DVSHFWV RI REACH. We also provide a IUCLID 5 web-hosting service to our clients.
Consultancy/ advisory 79%
OVERVIEW Bibra toxicology advice & consulting, an amalgamation of two sister companies â&#x20AC;&#x201C; Toxicology Advice & Consulting Ltd and Bibra Information Services Ltd â&#x20AC;&#x201C; 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 RXWVWDQGLQJO\ TXDOLÂżHG WR[LFRORJLVWV ZLWK WKH ÂżQHVW LQGHSHQGHQWO\ RZQHG toxicological databank in the world. This unique combination of worldclass 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 D KLJKO\ HIÂżFLHQW DQG FRVW HIIHFWLYH PDQQHU 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 RI VXEVWDQFHV IRU WKH ÂżUVW 5($&+ GHDGOLQH LQ DQG FRQWLQXH WR support companies with their REACH obligations for the 2013 and 2018 deadlines. VITAL STATISTICS
2011/12
Turnover, group
ÂŁ1.4m
Turnover, chemical service provision
ÂŁ1.4m
1R RI RIÂżFHV
1
No of countries represented
1
Staff, group
15
Staff, chemical service provision
13
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 UDQJH RI FOLHQWV 7DLORULQJ RXU RXWSXW WR VXLW WKH VSHFLÂżF UHTXLUHPHQWV RI 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 WDNLQJ ZHLJKW RI HYLGHQFH DSSURDFKHV WR ÂżOO GDWD JDSV ,I IXUWKHU WHVWLQJ is deemed necessary we advise on testing strategies to minimise both WKH XVH RI DQLPDOV RYHUDOO FRVWV WR WKH FOLHQW ZKLOH PDLQWDLQLQJ VFLHQWLÂżF 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 FKHPLFDO VSHFLÂżF ZD\ 0XFK RI WKLV VFLHQWLÂżF OLWHUDWXUH LV KHOG LQ KRXVH LQ 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 FULWLFDO LQ KHOSLQJ XV SURGXFH WKH ÂżQHVW KD]DUG DQG ULVN DVVHVVPHQW ZRUN for our clients, in the most timely and cost-effective manner. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Page 46
1960
Formation of BIBRA
1960
Establishment of Toxicology Information and Advisory Department Chemical Watch | Global Service Providers Guide 2013
Began to build the technical library
CASE STUDY 2: Urgent request for help with chemical safety report
1987
TRACE, a database designed to source data, from the tech library (databank), was developed
2000
TRACE, and associated databank, independently assessed DV WKH ÂżQHVW WR[LFRORJLFDO GDWD VRXUFH RI LWV W\SH ZRUOGZLGH
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 DGYLFH FRQVXOWLQJ IURP 6XWWRQ 6XUUH\ RIÂżFHV
2010
5HORFDWHG WR QHZ ODUJHU RIÂżFHV LQ :DOOLQJWRQ 6XUUH\
ACCREDITATIONS
We are very happy to take on smaller projects and have been working ZLWK D QXPEHU RI FOLHQWV WR KHOS RXW ZLWK VSHFLÂżF DUHDV RI WKHLU 5($&+ 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 LQYROYHG WKH SHHU UHYLHZ DQG VLJQLÂżFDQW LPSURYHPHQW RI SUHYLRXVO\ 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.
Our senior toxicologists are all Society of Biology/British Toxicology Society and EUROTOX registered toxicologists. We are a REACHReady approved supplier
CASE STUDY 3: Provision of alerting service to keep industry upto-date on emerging issues
PARTNERS
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 â&#x20AC;&#x201C; selective dissemination of information), the bibra team receives daily QRWLÂżFDWLRQ RI QHZO\ SXEOLVKHG RU SUH SXEOLVKHG SDSHUV DEVWUDFWV RU comment, and alerts the sector group members to keep them abreast RI WKH VFLHQWLÂżF OLWHUDWXUH DQG GHYHORSLQJ DUHDV RI SRVVLEOH FRQFHUQ 7KH service allows the industry to successfully foresee and manage arising issues in a co-ordinated and proactive way.
TSGE Enviresearch Ltd Linmark Consulting Gmbh wca environment Ltd ReFaC Campden BRI group Leatherhead Food International Ltd CLIENTS 0DQ\ RI RXU FOLHQWV KDYH D QHHG IRU FRQÂżGHQWLDOLW\ VR WKRVH OLVWHG EHORZ are just a small sample of the types of organisations that we work with: O Actavis Group O CSL Behring Biotherapies for Life O Environment Agency (UK) O Health Canada O International Programme on Chemical Safety O World Health Organization O Groupe Danone O ,QÂżQHXP 8. /WG O Innospec Active Chemicals O IRSST (Canada) O Johnson Matthey plc
STAFF SELECTION James Hopkins â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; Director of Toxicology
TESTIMONIALS â&#x20AC;&#x153;Reliable, responsive and adept at applying their toxicology expertise to REACH, our experience of working with bibra has been very positiveâ&#x20AC;? â&#x20AC;&#x201C; ,QÂżQHXP 8. /WG "In my opinion the toxicologists at bibra/toxicology advice & consulting are able to provide a very high-quality service by applying a combination RI PDQ\ \HDUV RI H[SHULHQFH DQG D KLJK OHYHO RI HIÂżFLHQF\ LQ UHODWLRQ WR VFLHQWLÂżF WR[LFRORJLFDO OLWHUDWXUH UHYLHZV DQG ULVN DVVHVVPHQW Âą 0DUF %DULO 3K' &RQVHLOOHU VFLHQWLÂżTXH ,5667 CASE STUDY 1: Complex REACH submission involving a large category of substances Bibra toxicology advice & consulting has been working on a number of REACH submissions that involve large categories of substances. In one case, we are supporting a consortium of companies with all the mammalian toxicology aspects of their regulatory obligations for a group of more than 70 related metal compounds. The work has involved the evaluation of a large number of proprietary studies and published literature, drafting of endpoint study records (ESRs) in IUCLID 5, assessment of Annex III compliance, complex data-gap analyses and advice on possibilities for read-across and weight-of-evidence approaches, and the development of an appropriate integrated testing strategy, to minimise the amount of animal testing required. Chemical Watch | Global Service Providers Guide 2013
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 , 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). 0
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Philip Copestake â&#x20AC;&#x201C; 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 SURIHVVLRQDOO\ TXDOLÂżHG WKH PDMRULW\ DUH 6% %76 DQG (85272; 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 5($&+ UHODWHG ZRUN GXULQJ WKH SDVW IRXU WR ÂżYH \HDUV
Page 47
PROFILE: bibra toxicology advice & consulting
1961
SERVICE AREA BREAKDOWN Other Consultancy/ advisory 5% 15% Representation & management 5%
PROFILE: Bioagri
CONTACTS Website
www.merieuxnutrisciences.com
jlgarrigue@bioagri.fr
Head office
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
GLOBAL OFFICES
Directors
M. Luis Fernando Torres Maida
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Dr Paulo Silva
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Dr Milton Vargas
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M Edivan Tonhi
Headquarters MĂŠrieux NutriSciences: Chicago, USA Headquarters Bioagri Laboratorios: Piracicaba, Brazil 6DOHV 2IÂżFHV 3LUDFLFDED %UD]LO /\RQ )UDQFH 5HVDQD ,WDO\ 6KHQJDL (China) SERVICES PROVIDED
M Celso Zaccaria Ownership
MĂŠrieux Nutrisciences
Locations
Brazil, France, China
Founded
1991
Toxicology
Bioagri is the Brazilian business unit of MĂŠrieux 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. /DERUDWRULHV DUH 2(&' */3 FHUWLÂżHG DFFUHGLWHG E\ $$$/$& International and employ the most current equipment and technologies. Bioagri, within its parent company MĂŠrieux NutriSciences, has the ambition to become the partner of choice of chemical industry leaders, towards the following unique strengths: O reactivity, very short decision-making centres (in Brazil, Europe or &KLQD LI QHFHVVDU\ O international locations throughout MĂŠrieux NutriSciences, able to IDFLOLWDWH WKH ORFDO FRRUGLQDWLRQ RI SURMHFWV RQ WKH VSRW O LQWHJULW\ VFLHQWLÂżF TXDOLW\ DQG DFFRXQWDELOLW\ SLYRWDO YDOXHV RI 0pULHX[ 1XWULVFLHQFHV IRU WKUHH JHQHUDWLRQV O KLJK Ă&#x20AC;H[LELOLW\ RI RXU SURMHFW PDQDJHPHQW GHGLFDWHG WR VWXGLHV O global network and access to key opinion leaders in China, Brazil, USA and Europe. The acquisition in 2012 by MĂŠrieux Nutrisciences of CHELAB laboratories located in Italy contributed to a global expansion of the services offered WR[LFRORJ\ DQG HIÂżFDF\ RI FRVPHWLFV DQG ELRFLGHV (including Overall, 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 VHUYLFHV ZLWKLQ XQGLVSXWHG ÂżQDQFLDO UREXVWQHVV DQG LQWHUQDWLRQDO IRRWSULQW F
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VITAL STATISTICS
2012/2013
Turnover, group
US $60m
Turnover, chemical service provision
US $38m
1R RI RIÂżFHV No of countries represented
16 3
Staff, group
950
Staff, chemical service provision
450
Page 48
studies are conducted: In Italy the following O acute skin corrosion â&#x20AC;&#x201C; human reconstructed epidermis (EST1000) O acute skin Irritation â&#x20AC;&#x201C; human reconstructed epidermis (EPISKIN) O acute eye irritation/corrosion â&#x20AC;&#x201C; human corneal epithelium (HCE) O VNLQ VHQVLWLVDWLRQ Âą GLUHFW SHSWLGH ELQGLQJ DVVD\ '3%$ 08667 &' H[SUHVVLRQ RQ 8 GHQGULWLF FHOO OLQH K&/$7 &' &' expression on THP1 dendritic cell line) O JHQHWLF WR[LFLW\ Âą $PHV WHVW PRXVH O\PSKRPD DVVD\ WN ORFXV micronucleus test O phototoxicity â&#x20AC;&#x201C; 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: O DFXWH RUDO GHUPDO RU LQKDODWLRQ WR[LFLW\ O acute dermal or eye irritation study O skin sensitisation (LLNA, M&K, BU) O repeated dose (7-d, 14-d, 28-d, 90-d) oral or dermal toxicity O kinetics and metabolism (ADME) (single or repeated dose for one radio-labelled substance) O genetic toxicity (Ames test, micronucleus test) O fertility and early embryonic development to implementation O embryo-foetal developmental toxicity O one or two-generation reproduction toxicity O reproduction and developmental toxicity screening O combined repeated dose toxicity study with the reproduction/ development toxicity screening O carcinogenicity (alone or combined with chronic toxicity). E
OVERVIEW
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Laboratory 75%
Conducts all required studies on physico-chemical properties of products according to OECD, EU and US-EPA guidelines (eg molecular LGHQWLÂżFDWLRQ YDSRXU SUHVVXUH Q 2FWDQRO SDUWLWLRQ FRHIÂżFLHQW HWF
Ecotoxicology Evaluates all classical effects of products on aquatic and soil organisms: O ready biodegradability O inherent biodegradability (aerobic) O acute immobilisation (Daphnia magna) O algea growth inhibition (Pseudokirchneriella subcapitata) O activated sludge respiration inhibition O soil microrganisms (nitrogen test) O earthworm acute or reproduction toxicity (Eisenia foetida) O Daphnia magna reproduction â&#x20AC;&#x201C; 21 days O DFXWH FKURQLF ÂżVK WR[LFLW\ Danio rerio, or truta)
Chemical Watch | Global Service Providers Guide 2013
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ÂżVK ELRFRQFHQWUDWLRQ 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
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
MĂŠrieux NutriSciences announces the acquisition of Italybased CHELAB, a market leader in chemical, microbiological and toxicology laboratory services.
Analytical chemistry 7KH ODUJHVW QXPEHU RI KLJK HQG FKHPLVWU\ HTXLSPHQW RIIHULQJ Ă&#x20AC;H[LELOLW\ and shorter detection limits: O ICP-MS (n = 2) O ICP-OES (3) O DWRPLF Ă&#x20AC;XRUHVFHQFH
O GC-MS/MS (40) O LC-MS/MS (12 ) O HPLC (80) Mass spectrometry Performs qualitative/quantitative assays of the active ingredients and LPSXULWLHV DQG PHWDEROLWH LGHQWLÂżFDWLRQ GHJUDGDWLRQ LQ ZDWHU VRLO DQG biological matrices). Radiochemistry Evaluates the behaviour and fate of pesticides in plants, animals and soils, according to OECD and US-EPA guidelines. Microbiology (YDOXDWHV EDFWHULFLGDO IXQJLFLGDO SURSHUWLHV RI ELRFLGHV FRQGXFWV WR[LFLW\ DQG HIÂżFDF\ HYDOXDWLRQ RI LQVHFWLFLGHV UHSHOOHQWV RQ LQVHFW YHFWRUV LQ association with quality control and analytical chemistry of the active ingredients in the tested formulations. Pesticide residues $QDO\VLV RI KHUELFLGH DQG SHVWLFLGH UHVLGXHV LQ VDPSOHV IURP ÂżHOG WULDOV Safety evaluation of cosmetics and detergents in humans In Italy: patch test (irritation) on volunteers, ophtalmological irritation test on volunteers Efficacy evaluation of cosmetics and detergents in humans determination of SPF, water resistance, hydratation test, In Italy: TEWL, assessment of anti-wrinkle and anti-cellulite products, etc... E
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ACCREDITATIONS GLP, OECD, AAALAC, INMETRO, ISO-17025 PARTNERS Sister companies of Bioagri within MĂŠrieux Nutrisciences: Silliker (food safety) including Chelab-Silliker ( toxicology), Biofortis (R&D in nutrition, clinical trials and sensory analysis for nutrition and cosmetics) European consulants (regulatory, toxicology), working with Bioagri under FRQÂżGHQWLDO DJUHHPHQW 7
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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 sponsorâ&#x20AC;&#x2122;s expectations in >95% as far as time schedule and VFLHQWLÂżF TXDOLW\ ZHUH FRQFHUQHG 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).
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CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1991
Bioagri foundation in Brazil by two PhD researchers from the Centre for Nuclear Energy in Agriculture (University of SĂŁo Paulo).
2000
%LRDJUL LV WKH ÂżUVW /DWLQ $PHULFD ODE WR EH DFFUHGLWHG IRU JRRG laboratory 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 FROODERUDWRUV LQFOXGLQJ VFLHQWLVWV TXDOLÂżHG LQ WR[LFRORJ\ analytical chemistry, physicochemistry, mass spectrometry and microbiology.
2010
%LRDJUL LV WKH ÂżUVW /DWLQ $PHULFD ODE WR EH DFFUHGLWHG E\ WKH Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).
2010
Bioagri is part of MĂŠrieux NutriSciences Corporation, With more than 40 years of experience and part of Institut MĂŠrieux, MĂŠrieux NutriSciences helps advance science and solutions for food safety, quality and nutrition with 4,000 professionals in FRXQWULHV 7KLV FROODERUDWLRQ LQFUHDVHV ÂżQDQFLDO UREXVWQHVV and provides Bioagriâ&#x20AC;&#x2122;s clients with the highest levels of quality, customer service and worldwide technical support.
Chemical Watch | Global Service Providers Guide 2013
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 SURIHVVLRQDOO\ WUDLQHG VFLHQWLVWV TXDOLÂżHG LQ PDPPDOLDQ WR[LFRORJ\ (including VetD, MD, PhD, EUROTOX toxicologist, expert in immunotoxicology), ecotoxicology, analytical chemistry, physicochemistry, mass spectrometry and microbiology among others. Bioagriâ&#x20AC;&#x2122;s testing services are reliable, timely, accurate and cost-effective. Tailormade custom services are provided to meet all of our clientsâ&#x20AC;&#x2122; needs.
Page 49
PROFILE: Bioagri
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GLOBAL OFFICES Edinburgh, Scotland, UK Cardiff, Wales, UK SERVICES PROVIDED Scientific consultancy
PROFILE: Blue Frog Scientific Limited
CONTACTS
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regulatory testing design and study monitoring intelligent testing strategies ecotoxicology and environmental fate environmental hazard and risk assessment toxicology human health hazard and risk assessment compilation of dossiers and expert reports
Website
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Head office
10 York Place, Edinburgh, Midlothian, EH1 3EP, UK
Tel
+44 (0) 131 523 1412
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Damien Carson
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Directors
Damien Carson
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Tom Hargreaves
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Private Limited Company
Locations
UK (Edinburgh and Cardiff)
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2006
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OVERVIEW %OXH )URJ 6FLHQWLÂżF LV DQ LQGHSHQGHQW UHJXODWRU\ FRQVXOWDQF\ SURYLGLQJ VFLHQWLÂżF DQG UHJXODWRU\ DIIDLUV VROXWLRQV WR FRPSDQLHV LQ DOO VHFWRUV RI the chemical industry. Blue Frogâ&#x20AC;&#x2122;s philosophy is achieving regulatory compliance through the application of good science, innovation and FODULW\ HQVXULQJ WKDW DOO VXEPLVVLRQV DUH SUHSDUHG HIÂżFLHQWO\ DQG WR D KLJK standard. :H RIIHU VFLHQWLÂżF DQG UHJXODWRU\ DIIDLUV VHUYLFHV ZLWK SDUWLFXODU 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, OHJDO VXSSRUW DQG ÂżQDQFLDO DFFRXQWLQJ HQVXUHV WKDW ZH FDQ DVVLVW RXU 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 QHHG OHDGHUV LQ VSHFLDOLVHG ÂżHOGV HJ UHSURGXFWLYH WR[LFRORJ\ WR DGGUHVV issues requiring an expert opinion, statement or report. VITAL STATISTICS
2011/12
Turnover, group
-
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1R RI RIÂżFHV
2
No of countries represented
1
Staff, group
6
Staff, chemical service provision
6
SERVICE AREA BREAKDOWN IT & software 10%
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) %OXH )URJ 6FLHQWLÂżF SURYLGHV D IXOO WHFKQLFDO DQG DGPLQLVWUDWLYH registration service for chemical substances under Regulation (EC) 1R 5($&+ 2XU WHDP LV KLJKO\ TXDOLÂżHG DQG H[SHULHQFHG 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: O PRQRPHUV SURFHVV FKHPLFDOV FRDWLQJV DQG FDWDO\VWV O RLOÂżHOG FKHPLFDOV DQG SHWUROHXP SURGXFWV O SKDUPDFHXWLFDO LQWHUPHGLDWHV O substances of unknown or variable composition, complex reaction SURGXFWV RU ELRORJLFDO RULJLQ 89&% O 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 %OXH )URJ 6FLHQWLÂżF KDV GHYHORSHG D PRGHO IRU PDQDJLQJ WKH ÂżQDQFLDO 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: O SURYLVLRQ RI D FRQVRUWLXP EDQN DFFRXQW O DFFRXQWV SD\DEOH DQG DFFRXQWV UHFHLYDEOH O 9$7 DQG WD[ DFFRXQWLQJ O SXUFKDVH FRQWUDFW PDQDJHPHQW O WHOHFRQIHUHQFLQJ IDFLOLWLHV O GDWD VWRUDJH DQG PDQDJHPHQW YLD WKH VHFXUH %OXH )URJ 6FLHQWLÂżF extranet. Environmental risk assessment of human medicinal products (HMPs) and veterinary medicinal products (VMPs)
Representation & management 30%
Page 50
Consultancy/ advisory 60%
%OXH )URJ 6FLHQWLÂżF KDV H[WHQVLYH H[SHULHQFH LQ DVVHVVLQJ WKH SRWHQWLDO environmental risk posed by human pharmaceuticals and veterinary medicines. Environmental risk Assessment: O authoring expert reports for inclusion in European marketing DXWKRULVDWLRQ DSSOLFDWLRQV DQG )'$ ÂżOLQJV O planning and coordinating the necessary activities required in the SUHSDUDWLRQ RI ULVN DVVHVVPHQWV IRU UHJXODWRU\ VXEPLVVLRQ O H[SHUW HYDOXDWLRQ RI ODERUDWRU\ VWXGLHV
Chemical Watch | Global Service Providers Guide 2013
Agrochemicals %OXH )URJ 6FLHQWLÂżF DQG DVVRFLDWHV RIIHU D IXOO GRVVLHU VHUYLFH IRU 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: O RYHUYLHZ RI TXDOLW\ RI H[LVWLQJ VWXGLHV DQG LGHQWLÂżFDWLRQ RI DQ\ GDWD JDSV IRU UH VXEPLVVLRQ RI GRVVLHUV DFFRUGLQJ WR (& O preparation of updating statements. Study management: O UHJXODWRU\ WHVWLQJ GHVLJQ O WHVWLQJ VWUDWHJLHV DQG VWXG\ GHVLJQ */3 *(3 O VWXG\ PRQLWRULQJ O SUHSDUDWLRQ RI VWXG\ VXPPDULHV Dossier preparation and regulatory affairs: O 2(&' DQG G55 VHFWLRQV WR SUHSDUHG WR D KLJK VWDQGDUG O communication with regulatory authorities within EU 27 to support submissions. Key sectors of experience include: ,QVHFWLFLGHV S\UHWKURLG QHRQLFRWLQRLG RUJDQRSKRVSKDWH DQG FDUEDPDWH +HUELFLGHV RUJDQRSKRVSKRUXV SKHQ\OS\UD]ROH EHQ]R\OF\FORKH[DQHGLRQH FKORURDFHWDQLOLGH )XQJLFLGHV WULD]ROH DQLOLQRS\ULPLGLQH DPLGH S\UD]ROH Other: semiochemicals and biopesticides.
CLIENTS %OXH )URJ 6FLHQWLÂżF VXSSRUWV D JOREDO FOLHQW EDVH RI FKHPLFDO pharmaceutical, veterinary, agrochemical and feed additive companies, ranging from SMEs to large multinational corporations. We take our FOLHQWVÂś FRQÂżGHQWLDOLW\ YHU\ VHULRXVO\ DQG ZLOO QRW GLVFORVH WKHLU LGHQWLW\ CASE STUDY 1: REACH advisor to a European Defence Agency 3URYLGHG ORQJ WHUP VXSSRUW WR D (XURSHDQ 'HIHQFH $JHQF\ LQ GHÂżQLQJ WKH parameters of the defence exemption, training staff on the fundamental aspects of REACH, and developing internal procedures for assessing exempt/non-exempt chemical substances and complying with REACH. CASE STUDY 2: Assessment of the environmental fate and effects of the PPARgamma receptor agonist, pioglitazone The environmental fate and effects of pioglitazone prescribed for the treatment of type 2 diabetes were evaluated in an environmental risk assessment. A predicted environmental concentration (PEC) for surface ZDWHU ZDV HVWLPDWHG DW Č?J /-1, triggering a comprehensive battery of laboratory evaluations. Pioglitazone and its major metabolites ZHUH GHWHUPLQHG QRW WR VLJQLÂżFDQWO\ DGVRUE WR VHZDJH VROLGV ZHUH 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 â&#x20AC;&#x201C; Director An expert in chemical hazard and risk assessment with more than ten yearsâ&#x20AC;&#x2122; experience across a wide range of sectors in the industrial and ÂżQH FKHPLFDO LQGXVWU\ ([SHUW LQ *RRG /DERUDWRU\ 3UDFWLFH DQG WHVWLQJ strategies. Tom Hargreaves BSc (Hons) â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; 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.
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006
Formation of Chemical Regulatory Services team within BMT Cordah Limited, part of the BMT group of companies
2007
Development of REACH technical consulting services supporting a global client base
2008
Development of human pharmaceutical and veterinary medicine consulting services supporting a global client base
2010
Management buy-out of Chemical Regulatory Services business by D Carson and T Hargreaves, forming Blue Frog 6FLHQWLÂżF /LPLWHG
2010
Development of agrochemical consulting services
2012
Sustained growth leads to major expansion of company with QHZ VWDII DQG RIÂżFHV WR VXSSRUW JURZLQJ FOLHQW EDVH
ACCREDITATIONS European Partner: Society of Environmental Toxicology and Chemistry (SETAC).
Chemical Watch | Global Service Providers Guide 2013
Page 51
PROFILE: Blue Frog Scientific Limited
protocol development and environmental testing requirements to */3 DQG IROORZLQJ LQWHUQDWLRQDO JXLGHOLQHV O preparing literature based â&#x20AC;&#x153;weight-of-evidenceâ&#x20AC;? risk assessments for VSHFLDOLVW SURGXFWV O multimedia mathematical modelling of the fate of pharmaceuticals in VRLO IUHVKZDWHU VHGLPHQW DQG PDULQH FRPSDUWPHQWV O deterministic and higher tier probabilistic assessment of effects on ELRWD DQG H[SRVXUH FRQFHQWUDWLRQV O preparation of conclusions of risk, with relevance to the â&#x20AC;&#x153;real worldâ&#x20AC;? DQG PLWLJDWLRQ VROXWLRQV O XVH RI PDPPDOLDQ $'0( GDWD WR UHÂżQH PRGHOV DQG DLG FRQFOXVLRQV regarding bioaccumulation and secondary poisoning. Key sectors of experience: +03V $,'6 FKURQLF NLGQH\ GLVHDVH DWD[LD DQ LQĂ&#x20AC;DPPDWRU\ K\SHUWHQVLRQ GLDEHWHV 903V DQWLELRWLFV SDUDVLWLFLGHV FRFFLGLRVWDWV DQWLS\UHWLFV $OO FODVVHV RI FDWWOH VZLQH VKHHS SRXOWU\ 2UDO GUHQFKHV LQMHFWDEOHV SRXU RQV LQ IHHG LQ GULQNLQJ ZDWHU Product defence, particularly for two â&#x20AC;&#x153;priority listâ&#x20AC;? substances. O
SERVICES PROVIDED
PROFILE: Brixham Environmental Laborator y
We offer laboratory based assessment of the environmental effects, ecotoxicity and environmental fate of new and existing substances. Our VHUYLFHV FDQ EH HDVLO\ FODVVLÂżHG DFFRUGLQJ WR WKH IROORZLQJ LQGXVWULDO VHFWRUV Industrial chemicals (REACH) CONTACTS Website
www.brixham-lab.com
infomaster.brixham@astrazeneca.com
Head office
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
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.
OVERVIEW
Biocidal products
%UL[KDP (QYLURQPHQWDO /DERUDWRU\ GHOLYHUV ÂżW IRU SXUSRVH HQYLURQPHQWDO 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 FRQÂżGHQWLDOLW\ The laboratory has good laboratory practice (GLP) accreditation, and is licensed to work with radio-labelled materials.
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.
VITAL STATISTICS
2011/12
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
1
No of countries represented
1
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 and WHVWLQJ RI HIÂżFDF\ already included a great deal of safety, metabolism and pharmacokinetics. Brixham Environmental Laboratory has experience of interpreting these data and using them to design an intelligent environmental testing strategy. E
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SERVICE AREA BREAKDOWN
Representation & management 5% Information 5%
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Solution driven, we work at the forefront of environmental research often acting as a central hub on cross disciplinary collaborations with a range of research institutes, funding bodies, industrial and academic partners, ensuring realism and a pragmatic application of science. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1948
Established as a marine research station for ICI Paints
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
ÂŁ12m laboratory refurbishment and expansion to include state of the art facilities Chemical Watch | Global Service Providers Guide 2013
1948 -2012
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 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 'XH WR FOLHQW FRQÂżGHQWLDOLW\ LQGLYLGXDOV FDQQRW EH QDPHG EXW ZH ZRUN 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) DQG WKH &HÂżF ORQJ UDQJH UHVHDUFK SURJUDPPH SURMHFW WHDPV OHDG E\ Dr Jason Snape established the proof of concept studies for a new generation of biodegradation test that have been recently included ZLWKLQ WKH WHFKQLFDO JXLGDQFH IRU 5($&+ 7KHVH LQFOXGH WKH PRGLÂżHG biodegradation tests for poorly water soluble chemicals and the enhanced biodegradation studies for persistence assessments. Dr Jason Snape LV FXUUHQWO\ D FR FRQWUDFWRU RQ (&2 D &HÂżF /5, SURMHFW YDOLGDWLQJ 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: BELâ&#x20AC;&#x2122;s intelligent approach marks an important milestone for 3Rs in fish full lifecycle testing $ UHTXHVW ZDV PDGH E\ D UHJXODWRU WR SURYLGH ÂżVK IXOO OLIHF\FOH ))/& 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 rangeÂżQGLQJ VWXG\ ,W UHTXLUHG OHVV WKDQ KDOI WKH QXPEHU RI ÂżVK DQG FRPSOHWHG 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 DOVR UHSUHVHQWV D VLJQLÂżFDQW PLOHVWRQH IRU LQFRUSRUDWLQJ LQWHOOLJHQW WHVWLQJ ZLWKLQ FKURQLF ÂżVK WHVWLQJ DQG ZLOO SRWHQWLDOO\ OHDG WR VLJQLÂżFDQW UHGXFWLRQV of animal usage in the future. Chemical Watch | Global Service Providers Guide 2013
STAFF SELECTION Dr Grace Panter â&#x2C6;&#x2019; Ecotoxicologist Grace Panter is an ecotoxicologist with more than 12 years' laboratory H[SHULHQFH LQ DTXDWLF HFRWR[LFRORJ\ DQG ÂżVK UHSURGXFWLYH KHDOWK 6KH KDV H[WHQVLYH H[SHULHQFH RI VHYHUDO DUHDV RI ÂżVK WHVWLQJ HVSHFLDOO\ 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 FKHPLFDOV FRPPLWWHH DQG WKH 2(&' ÂżVK GUDIWLQJ WHVW JXLGHOLQH JURXS 6KH KDV SXEOLVKHG H[WHQVLYHO\ RQ WKH LVVXH RI HQGRFULQH GLVUXSWLRQ LQ ÂżVK both as papers and technical reports. Dr Jason Snape â&#x2C6;&#x2019; Environmental Foresight Business Manager Jason is an environmental microbiologist and biochemist with 18 years' ODERUDWRU\ DQG ÂżHOG H[SHULHQFH LQ WKH ELRGHJUDGDWLRQ DQG SHUVLVWHQFH RI chemical products in the environment. He uses this extensive empirical experience at the interface between science and science-based policy and the development of pragmatic environmental regulations for exposure and persistence assessment. Jason is actively involved in chairing/cochairing committees, task forces and working groups. His expertise has also produced many published papers. Dr Paul McCormack â&#x20AC;&#x201C; LC/MS and MSn Specialist, Chemistry Paul has over 12 yearsâ&#x20AC;&#x2122; experience in liquid chromatography and multi-stage mass spectrometry (LC/MSn). His experience includes the GHWHFWLRQ VHSDUDWLRQ FKDUDFWHULVDWLRQ DQG LGHQWLÂżFDWLRQ RI LURQ FRPSOH[HV LQ VHDZDWHU DQG RLOÂżHOG FKHPLFDOV LQ FUXGH RLO DQG SURGXFHG ZDWHUV +H 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 PHWKRGRORJ\ IRU WKH LGHQWLÂżFDWLRQ RI WUDQVIRUPDWLRQ 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 â&#x2C6;&#x2019; Senior SHE Specialist, Environmental Fate Gary is a specialist in studying the environmental fate of biologically active chemicals. Garyâ&#x20AC;&#x2122;s research interests include the biodegradability RI YRODWLOH SRRUO\ ZDWHU VROXEOH VXEVWDQFHV WKH SDUWLWLRQLQJ RI SKDUPDFHXWLFDOV LQ ELRVROLGV VRLO DQG VHGLPHQW DQG WKH DQDHURELF degradation of pharmaceuticals. Gary chaired the organising committee IRU WKH (FHWRF ZRUNVKRS 6LJQLÂżFDQFH RI ERXQG UHVLGXHV LQ HQYLURQPHQWDO 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 â&#x2C6;&#x2019; 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. ([SHULHQFH RI WHVWLQJ ZLWK YDULRXV VSHFLHV LQFOXGLQJ ÂżVK LQYHUWHEUDWHV algae, macrophytes and mesocosm studies and analysing the results JHQHUDWHG IURP VXFK WHVWV 6SHFLÂżF H[SHUWLVH LQ WKH ELRDFFXPXODWLRQ RI chemicals in the environment. Active contributor to international working groups such as OECD and ILSI HESI bioaccumulation groups. Other staff BEL currently employs 83 people, from all over the world with a wide UDQJH RI SURIHVVLRQDO TXDOLÂżFDWLRQV 7KHVH LQFOXGH LQWHUQDWLRQDOO\ acclaimed scientists with doctorates and established publication records as well as individuals with professional business and management TXDOLÂżFDWLRQV 2XU VSHFLDOLVHG VFLHQWLVWV FRYHU D ZLGH UDQJH RI GLVFLSOLQHV including ecotoxicology, analytical chemistry, environmental fate and environmental risk assessment, etc.
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PROFILE: Brixham Environmental Laborator y
2011
PROFILE: BSL BIOSERVICE Scientific Laboratories GmbH
GLOBAL OFFICES Our facilities are located in Planegg/Munich, Germany. In addition, we have representatives in Switzerland, Japan, India, Poland, Scandinavia, Italy and other countries. SERVICES PROVIDED CONTACTS
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.
Website
www.bioservice.com
info@bioservice.com
Head office
Behringstr 6/8, 82152 Planegg / Munich, Germany
Tel
+49-89-899 650-0
Fax
+49-89-899 650-11
Contact
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Directors
Dr Wolfram Riedel, CEO
Locations
Germany
Founded
1984
Toxicology for chemicals, PPPâ&#x20AC;&#x2122;s and biocides We cover all common toxiclogy services relevant for chemicals, plant protection products (PPPâ&#x20AC;&#x2122;s) and biocides. This includes the classical studies from acute to repeated dose and DART studies. In addition, testing strategies with BSL puts a high emphasis on alternative UHJDUG WR WKH 5 VWUDWHJ\ IRU UHÂżQHPHQW UHSODFHPHQW DQG UHGXFWLRQ RI assays for all animal studies. We have established a big range of endpoints where this is possible yet. Our services include: O irritation/corrosion ( / ) O sensitisation O dermal absorption ( / ) O genetic toxicity ( / ) O acute toxicity O repeated dose toxicity O reproductive and developmental toxicity (DART) O toxikokinetics O carcinogenicity O neurotoxicity O endocrine disruptor testing E
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%6/ %,26(59,&( 6FLHQWLÂżF /DERUDWRULHV *PE+ LV DQ LQWHUQDWLRQDOO\ DFWLYH &52 ZLWK WKH IRFXV RQ VDIHW\ DQG HIÂżFDF\ WULDOV IRU LQGXVWULDO chemicals, agrochemicals, biocides, cosmetics, medical device, food and pharmaceuticals. The interdisciplinary and internationally accepted DSSURDFK RI WKH LQVWLWXWH ZLWK LWV YDULRXV DFFUHGLWDWLRQV FHUWLÂżFDWLRQV and numerous successful audits (GLP, DIN EN ISO 17025, GMP, FDA) guarantees high-quality biological trials. The laboratories have in the PHDQWLPH EHHQ FHUWLÂżHG IRU WKH HLJKWK WLPH LQ DFFRUGDQFH ZLWK */3 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 FXVWRPHUÂ?V LQGLYLGXDO QHHGV E\ D KLJK OHYHO RI Ă&#x20AC;H[LELOLW\ %6/ %,26(59,&( LV UHQRZQHG IRU LWV FRPPXQLFDWLRQ VFLHQWLÂżF LQSXW DQG high quality standards. %6/ %,26(59,&( LV D SDUWQHU RI WKH (XURÂżQV *URXS ZKLFK LV D JOREDO leader in the pharmaceutical, food and environmental testing market and offers also a comprehensive portfolio for the chemical and agrochemical SURGXFW VHFWRUV 7KH (XURÂżQV *URXS ZLWK DQ DQQXDO UHYHQXH RI 86 EQ has over 13,000 employees in more than 170 laboratories across 33 countries. VITAL STATISTICS
2011/12
Turnover, group
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1
No of countries represented
6-10
Staff, group
170+
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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 RIIHUHG LQ FRRSHUDWLRQ ZLWK WKH (XURÂżQV *URXS DQG RWKHU H[SHULHQFHG 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 O O O O O O
mutagenicity, clastogenicity, carcinogenicity skin and eye irritation/ corrosion â&#x20AC;&#x201C; several models dermal absorption photo-induced toxicity reproductive toxicity (embryonic stem cell test) sensitisation â&#x20AC;&#x201C; several models under development
Laboratory 90%
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Chemical Watch | Global Service Providers Guide 2013
STAFF SELECTION
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 H[SHULHQFHG UHJXODWRU\ GLYLVLRQ ZLWKLQ WKH (XURÂżQV *URXS DQG RWKHU partners that support us in covering the regulatory issues of chemicals, agrochemicals and biocides.
Dr Wolfram Riedel, CEO Dr Wolfram Riedel has worked as CEO of BSL BIOSERVICE since 1994. He holds a masterâ&#x20AC;&#x2122;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 Pharmacology/ Toxicology LV ZRUNLQJ WRGD\ DV 6FLHQWLÂżF 'LUHFWRU 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 Pharmacology and Toxicology, Study working at BSL as Head of and was writing biological evaluation reports. Dr Albrecht Director has a PhD in veterinary medicine and is a member in various expert groups. E
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1984
Foundation under the name Dr MĂźller Lierheim AG
1992
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1995
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2006
BSL BIOSERVICE becomes a partner laboratory of the (XURÂżQV JURXS
2007
Expansion into an additional building and establishment of a facility with a laboratory brand new state-of-the-art area of 3000 m2 E
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ACCREDITATIONS Good Laboratory Practice (GLP) DIN EN ISO IEC 17025 Good Manufacturing Practice (GMP) FDA approved Radioactive handling permission CLIENTS Chemical industry Agrochemical/ biocides industry Pharmaceutical/ biotech industry Food industry Cosmetic industry
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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 $V 5($&+ 0DQDJHU DW %6/ %,26(59,&( 'U ,ULV 3ÂżVWHUHU LV GHGLFDWHG to support our clients with all enquiries and questions about REACH and project manages large projects. This may include projects from data gap DQDO\VLV YLD ODERUDWRU\ WHVWLQJ WR WKH ÂżQDO GRVVLHU SUHSDUDWLRQ 'U 3ÂżVWHUHU holds a masterâ&#x20AC;&#x2122;s degree and PhD in biology and has supported our clients at BSL since 2009. Other staff 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 OHYHO RI Ă&#x20AC;H[LELOLW\
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PROFILE: BSL BIOSERVICE Scientific Laboratories GmbH
Consulting, testing strategies and individual study designs
GLOBAL OFFICES *OREDO JHRJUDSKLFDO FRYHUDJH RIÂżFHV ODEV LQ FRXQWULHV across: O $PHULFDV O (XURSH O 0LGGOH (DVW ,QGLD 5XVVLD DQG $IULFD O $VLD 3DFLÂżF
PROFILE: Bureau Veritas
CONTACTS Website
www.bureauveritas.com
SERVICES PROVIDED
hse@bureauveritas.com
Head office
67/71 Boulevard du Château, 92578 Neuilly/ Seine, France
The below are only a selection of Bureau Veritas services, focusing on chemical risks
Tel/ Fax
+33 1 5524 7000/ +33 1 5524 7001
Contact
Marie-Laure HĂŠraud, Chemical SGP Mgr
Directors
Didier Michaud-Daniel, CEO
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Ownership
Listed private company (Paris Stock Market)
Locations
Global geographical coverage (140 countries)
Founded
1828
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 â&#x20AC;&#x201C; REACH/CLP context
OVERVIEW %XUHDX 9HULWDV LV D ZRUOG OHDGHU LQ FRQIRUPLW\ DVVHVVPHQW DQG FHUWLÂżFDWLRQ 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: O PDULQH VKLSV DQG HTXLSPHQW FODVVLÂżFDWLRQ O LQGXVWU\ FRQIRUPLW\ DVVHVVPHQW RI LQGXVWULDO DVVHWV O LQ VHUYLFH LQVSHFWLRQ DQG YHULÂżFDWLRQ RI IDFLOLWLHV O FRQVWUXFWLRQ YHULÂżFDWLRQ LQ EXLOGLQJV LQIUDVWUXFWXUHV O FHUWLÂżFDWLRQ RI 4+6( PDQDJHPHQW V\VWHPV DQG VSHFLÂżF VFKHPHV O FRPPRGLWLHV LQVSHFWLRQ DQG WHVWLQJ RI UDZ PDWHULDOV O FRQVXPHU SURGXFWV DQG JRRGV WHVWLQJ DQG FHUWLÂżFDWLRQ O government services and international trade services. VITAL STATISTICS
2011/12
Turnover, group
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Dangerous goods safety advisory (DGSA) %XUHDX 9HULWDV RIIHUV GHGLFDWHG VHUYLFHV IRU VSHFLÂżF WUDQVSRUWDWLRQ LVVXHV such as chemical risk assessment and DGSA assistance, drawing-up of transport documents and packing, packaging, labelling consultancy according to eg ADR, RID, IMDG, IATAâ&#x20AC;Ś frameworks. Also a complete set of qualifying training courses is provided (eg for drivers... warehouse workers, etc). Indeed â&#x20AC;&#x153;DGdoc.netâ&#x20AC;? business software is delivered onpurpose by Bureau Veritas. CORPORATE DEVELOPMENTS & ACHIEVEMENTS Operations in marine Operations in industry
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1988
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2007
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2008
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2010
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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.
Consultancy/ advisory 10%
IT & software 10% Representation & management 30% Laboratory 20% Information 15%
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Chemical Watch | Global Service Providers Guide 2013
CASE STUDY 3
Selected credentials: JURXS FHUWLÂżHG DJDLQVW ,62 IRU DOO DFWLYLWLHV DQG DOPRVW DOO ORFDWLRQV O DFFUHGLWDWLRQV IRU FHUWLÂżFDWLRQ LQVSHFWLRQ WHVWLQJ DQG WUDLQLQJ services by many organisations (UKAS and IRCA in the United Kingdom, ANAB in the United States, JASANZ in Australia and New =HDODQG ,10(752 LQ %UD]LO HWF
)RU WKH EHQHÂżW RI D FKHPLFDO SURGXFWV SURFHVVLQJ FRPSDQ\ WKDW ZLVKHG to sell chemicals/chemical products at the European marketplace level, Bureau Veritas has acted as an independent third party handling FRQÂżGHQWLDO LQIRUPDWLRQ IURP VXE VXSSOLHUV On this basis, Bureau Veritas has taken care of client labelling, FODVVLÂżFDWLRQ QRWLÂżFDWLRQ WR DXWKRULWLHV LVVXHV DQG PDQDJHG WKHLU VDIHW\ 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.
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PARTNERS To offer further REACH services, Bureau Veritas has developed partnership with other service providers. CLIENTS 400,000 clients in various markets (aeronautics â&#x20AC;&#x201C; agriculture â&#x20AC;&#x201C; automotive â&#x20AC;&#x201C; construction and real estate â&#x20AC;&#x201C; consumer products â&#x20AC;&#x201C; food â&#x20AC;&#x201C; governments and public organisations â&#x20AC;&#x201C; industrial equipment â&#x20AC;&#x201C; international trade â&#x20AC;&#x201C; IT, telecoms and electronics â&#x20AC;&#x201C; maritime industry â&#x20AC;&#x201C; mines and minerals â&#x20AC;&#x201C; oil and gas â&#x20AC;&#x201C; power and utilities â&#x20AC;&#x201C; process Industries â&#x20AC;&#x201C; chemical industries and chemistries â&#x20AC;&#x201C; retail â&#x20AC;&#x201C; services â&#x20AC;&#x201C; transport and infrastructures) CASE STUDY 1 'XULQJ WKH ÂżUVW 5($&+ UHJLVWUDWLRQ SHULRG %XUHDX 9HULWDV JDLQHG H[SHULHQFH ZLWK WKH UHJLVWUDWLRQ RI QRW RQO\ XVXDO VXEVWDQFHV EXW DOVR YHU\ VSHFLÂżF 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: O FKHPLFDO FODVVLÂżFDWLRQ O FKHPLFDO ULVN DVVHVVPHQW O FKHPLFDO H[SRVXUH DVVHVVPHQW DQG FRQWURO O design and delivery of technical training including for chemical KD]DUGV DQG FRQWURO O statutory safety compliance assessments and audits.
STAFF SELECTION Dr Gautier Vincent â&#x20AC;&#x201C; Senior Toxicologist, Practice Leader Gautier is a pharmacist and a civil engineer. He has 12 yearsâ&#x20AC;&#x2122; 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 â&#x20AC;&#x201C; Chemical Practice Leader Simon holds a masters degree in environmental science, backed up by 30 yearsâ&#x20AC;&#x2122; experience delivering health, safety and environmental VFLHQWLÂżF VXSSRUW WR FOLHQWV VSDQQLQJ D ZLGH UDQJH RI LQGXVWULDO DQG 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 â&#x20AC;&#x201C; 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 Veritasâ&#x20AC;&#x2122;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 â&#x20AC;&#x153;DGdoc.netâ&#x20AC;?, that can ensure legal performance when delivering documentation for transport. Cathy Alvarez â&#x20AC;&#x201C; Senior Ecotoxicologist Cathy is an ecotoxicologist who has seven yearsâ&#x20AC;&#x2122; 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 â&#x20AC;&#x201C; 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, HVSHFLDOO\ WKURXJK D FRVW EHQHÂżW DSSURDFK 6KH KDV SUHYLRXVO\ ZRUNHG RQ environmental questions for international institutions (World Bank, UNEP, WTO, etc) and on economic and social issues on the West Bank. Joseph J Fater, CIH â&#x20AC;&#x201C; Industrial Hygiene Practice Leader Joe has more than 35 yearsâ&#x20AC;&#x2122; 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.
Chemical Watch | Global Service Providers Guide 2013
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PROFILE: Bureau Veritas
ACCREDITATIONS
GLOBAL OFFICES CEHTRA Lyon â&#x20AC;&#x201C; 80, rue Condorcet, 38090 Vaulx Milieu, France CEHTRA Paris â&#x20AC;&#x201C; 25, rue des Bas, 92600 Asnières sur Seine, France CEHTRA Europe â&#x20AC;&#x201C; 134, rue Saint Germain, 1410 Waterloo, Belgium CEHTRA UK â&#x20AC;&#x201C; 6th Floor City Gate East, Toll House Hill, Nottingham, NG1 5FS, UK &(+75$ ,QGLD Âą 7& )RUHVW 2IÂżFH /DQH % 9D]KXWKDFDXG Trivandrum, 695014, Kerala, India CEHTRA India â&#x20AC;&#x201C; Cabin No: 245, Level 2, Elegance Building, Mathura Road, Jasola, New Delhi, 25, India CEHTRA North America â&#x20AC;&#x201C; 24 Ivy Lea Crescent, Toronto, ON M8Y 2B6, Canada
PROFILE: CEHTRA
CONTACTS Website
www.cehtra.com
cehtra@cehtra.fr
Head office
43-45, rue Laroque, 33560 Sainte-Eulalie, France
Tel
+33 557775610
Fax
+33 557775620
Contact
Paul Thomas
Directors
Pierre-GĂŠrard Pontal, President
Â
Peter Jenkinson, CEO
SERVICES PROVIDED Regulatory dossier services
Jason Nugent, Director CEHTRA North America
CEHTRA provides clients with bespoke services for the production of regulatory dossiers worldwide or together with our partners, be that LQ WKH ÂżHOG RI JHQHUDO FKHPLFDOV FRVPHWLFV ELRFLGHV SHVWLFLGHV RU 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 DGGLQJ D PRGXOH WR DOORZ VSHHG\ IRUPDWWLQJ RI ÂżQDO GRVVLHUV
Ownership
Private company
Industrial hygiene and worker exposure studies
Locations
Bordeaux FR, Lyon FR, Paris FR, Brussels BE, Nottingham UK, Delhi IN, Trivandrum IN, Toronto CA
Founded
2001
Nathalie Ledirac, R&D Director Michel Guilhem, Director, Business Development Â
Philippe Adrian, Director CEHTRA Europe
Â
Paul Thomas, Director CEHTRA Lyon Peter Jenkinson, Director CEHTRA UK
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 VXSSRUW LQ LQGXVWULDO K\JLHQH DGDSWHG WR \RXU VSHFLÂżF QHHGV
OVERVIEW
Consortium and Sief management
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
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
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 WLPH PDLQWDLQLQJ VWULFW FRQÂżGHQWLDOLW\ IRU WKRVH DUHDV WKDW PDWWHU IRU 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.
8
Expert services
No of countries represented
5
Our experts have been successful in proposing and supporting complex LVVXHV IRU &05 FODVVLÂżFDWLRQV PRGLI\LQJ DFFHSWDEOH H[SRVXUH OLPLWV DQG 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.
VITAL STATISTICS
2011/12
Staff, group
50
Staff, chemical service provision
45
SERVICE AREA BREAKDOWN
REACH OR Services
IT & Legal Training software 2% 6% 2%
CEHTRA provides a REACH only representative (OR) service via its subsidiary company LTS REACH-OR SAS.
Information 5%
Authorisation services &(+75$ KDV WHDPHG XS ZLWK RWKHU UHFRJQLVHG H[SHUWV LQ WKH ÂżHOG RI authorisation and created a joint venture, ChemAdvocacy, to provide a full service including socio-economic analysis.
Representation & management 10%
Consultancy/ advisory 75%
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CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2001
Company established
2004
2SHQLQJ RI 8. RIÂżFH
2008
2SHQLQJ RI %UXVVHOV RIÂżFH
2008
2SHQLQJ RI /\RQ RIÂżFH
2009
Start of the Indian Joint venture
Chemical Watch | Global Service Providers Guide 2013
2011
2SHQLQJ RI 1RUWK $PHULFD RIÂżFHV
Philippe Adrian PhD â&#x2C6;&#x2019; General Manager of Brussels Office
2012
Opening of ChemAdvocacy
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.
1XPEHU RI (XURSHDQ UHJLVWHUHG WR[LFRORJLVWV (57 DQG RWKHU FHUWLÂżFDWHV 11 ERTs O one IOB/UKEMS GT O two Chartered chemists (MRSC) O RQH &,+ &HUWLÂżHG ,QGXVWULDO +\JLHQLVW
O
PARTNERS LTS REACH OR, ChemService GmbH, ECOonline, NCEC, ERM CLIENTS &KHPLFDO FRPSDQLHV Ă&#x20AC;DYRXUV DQG IUDJUDQFHV SHWURFKHPLFDOV FRVPHWLF companies, plant protection industry, biocides, veterinary products, pharmaceuticals. TESTIMONIALS â&#x20AC;&#x153;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 VXEVWDQFHV WXUQHG RXW WR EH ÂľGLIÂżFXOW WR WHVWÂś GXH WR WKHLU SK\VLFR FKHPLFDO properties. We have decided to use them again and are once more FRQÂżGHQW RI VXFFHVV IRU RXU GRVVLHUV ´ Âą VLJQHG '57 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 DXWKRULVDWLRQ GRVVLHU IRU D ZRRG SURWHFWLRQ SURGXFW 37 FODVVLÂżHG &05 3%7 :H DUH GHYHORSLQJ D PHWKRGRORJ\ WKH ÂżUVW RI LWV NLQG IRU ELRFLGH products, inspired by the available guidance (REACH, etc), and we have presented our proposal to the French Competent Authorities, with H[SHFWHG ÂżQDOLVDWLRQ RI SUHSDUDWLRQ IRU VXEPLVVLRQ LQ HDUO\ 6XPPHU CASE STUDY 2: In silico predictions a priority
Nathalie Ledirac PhD, ERT â&#x20AC;&#x201C; R&D Director Nathalie has a PhD in cellular and molecular aspect of biology and 13 yearsâ&#x20AC;&#x2122; 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 E\ LQFUHDVLQJ WKH VFLHQWLÂżF SDUWLFLSDWLRQ RI &(+75$ H[SHUWV LQ UHVHDUFK projects (research programmes, publications, model development for pesticides, accreditation, etc). Pierre-GĂŠrard Pontal MD, ERTâ&#x2C6;&#x2019; President of CEHTRA Pierre-GĂŠrard 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 â&#x20AC;&#x201C; Director, Business development Michel has three masterâ&#x20AC;&#x2122;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 â&#x20AC;&#x201C; Industrial Hygienist
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.
Charles has a PhD in Geochemistry and over 12 years' experience as DQ LQGXVWULDO K\JLHQLVW DQG ZDV RQH RI WKH ÂżUVW LQ )UDQFH WR REWDLQ WKH SUHVWLJLRXV &,+ FHUWLÂżFDWLRQ VWLOO RQO\ RQH RI WHQ LQ )UDQFH +H MRLQHG 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.
STAFF SELECTION
Jason Nugent MSc â&#x20AC;&#x201C; Director of CEHTRA NA
Peter Jenkinson â&#x2C6;&#x2019; PhD, GT â&#x20AC;&#x201C; CEO and Director of UK Office
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.
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 0DUFK KH MRLQHG &(+75$ WR RSHQ WKH 8. RIÂżFH DQG KDV SURYLGHG expert toxicology advice, particularly for study monitoring and data interpretation. Paul Thomas PhD, ERT â&#x2C6;&#x2019; Director and Manager of Lyon Office 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.
Chemical Watch | Global Service Providers Guide 2013
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PROFILE: CEHTRA
ACCREDITATIONS
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.
PROFILE: Centro Reach
CONTACTS
REACH services
Website
www.centroreach.it
inforeach@centroreach.it
Head office
Centro Reach Srl, Via Giovanni da Procida, 11, 20149 Milan, Italy
Tel/ Fax
+39 02 8724 5901/ +39 02 3456 5631
Contact
Ralf Knauf
Directors
Bruno Brianzoli
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 ÂżHOG LV RQH RI WKH NH\ DFWLYLWLHV RI &HQWUR 5HDFK 7KH FRPSDQ\ V ZLGH H[SHUW QHWZRUN LV DEOH WR IXOÂżO DOO RXU FXVWRPHUVÂś VXSSRUW QHHGV
Â
Sergio Treichler
CLP and SDS management
Ownership
Private Company
Locations
Milan
Founded
2007
&RQVXOWDQF\ DQG VXEPLVVLRQ RI &/3 QRWLÂżFDWLRQV XQGHU WKH &/3 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
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 WR SURYLGH SURIHVVLRQDO FRQVXOWDQF\ VXSSRUW WR FKHPLFDO LQGXVWU\ ÂżUPV 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. :H KDYH H[SHUWLVH LQ &/3 QRWLÂżFDWLRQV VXSSRUW IRU VDIHW\ GDWD VKHHWV training courses, in-company consultancy, legal assistance for chemical regulations, regulatory services for non-EU countries thanks to our LQWHUQDWLRQDO QHWZRUN DQG 5 ' LQ WKH ÂżHOG RI 170 PHWKRGV 46$5 SURMHFWV VITAL STATISTICS
Centro Reach and its network is able to support companies in the ÂżHOG RI ELRFLGHV DQG IRRG FRQWDFW PDWHULDO UHTXLUHPHQWV DOVR RXWVLGH Europe. Our consultants have proven experience in submitting chemical QRWLÂżFDWLRQV LQ NH\ DUHDV OLNH 1RUWK DQG 6RXWK $PHULFD &KLQD -DSDQ Korea, India and Australia as well as countries like Turkey, Switzerland DQG RWKHUV 76&$ QRWLÂżFDWLRQV LQ WKH 86 DUH VXSSRUWHG E\ RXU QHWZRUN 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 RIIHUHG WKURXJK &RQÂżQGXVWULD V\VWHP DQG GHGLFDWHG VHUYLFH DFWLYLWLHV CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007
Founded by Federchimica (Association of Italian Chemical Industry) and Assolombarda â&#x20AC;&#x201C; the largest regional enterprise organisation in Italy.
2008
A further ten industrial associations belonging to the &RQÂżQGXVWULD V\VWHP EHFRPH VWDNHKROGHUV &HQWUR 5HDFK Partnership with Reach Centrum in Brussels begins
2009
3XEOLFDWLRQ RI ,QYHQWRU\ RQ FHUWLÂżHG ,WDOLDQ ODERUDWRULHV IRU REACH registration studies. Set-up of expert network and cooperation agreements Involvement in more than 15 national and EU consortia Intensive training activities involving almost 500 professionals, both in-house and in-company courses
2010
Individual registrations for 95 companies successfully submitted. Management and involvement in 20 consortia IRU UHJLVWUDWLRQ ,QWHQVLYH WUDLQLQJ VSHFLÂżFDOO\ RQ &/3 UHJXODWLRQ DQG QRWLÂżFDWLRQ SURFHVV VDIHW\ GDWD VKHHWV DQG labelling. Service for SDS management launched. CLP QRWLÂżFDWLRQV RI PRUH WKDQ VXEVWDQFHV
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 VXEVWDQFH QRWLÂżFDWLRQV RI ,WDOLDQ FRPSDQLHV LQ 7XUNH\
2012
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ca â&#x201A;Ź1m
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ca â&#x201A;Ź0.7m
1R RI RIÂżFHV
1
No of countries represented
All of the EU
Staff, group
6
Staff, chemical service provision
3 (plus wide expert network)
SERVICE AREA BREAKDOWN Training 15% Legal 5% Information 5% Representation & management 15%
Page 60
Consultancy/ advisory 60%
Chemical Watch | Global Service Providers Guide 2013
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 RQ FHUWLÂżHG ,WDOLDQ ODERUDWRULHV IRU 5($&+ UHJLVWUDWLRQ studies.
STAFF SELECTION Bruno Brianzoli â&#x20AC;&#x201C; 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.
ACCREDITATIONS
Sergio Treichler â&#x20AC;&#x201C; General Director
&HUWLÂżHG ,62
$W SUHVHQW 6HUJLR LV WKH FHQWUDO WHFKQLFDO Âą VFLHQWLÂżF GLUHFWRU RI )HGHUFKLPLFD +H SUHYLRXVO\ ZRUNHG LQ WKH LQGXVWULDO DQG ÂżQDQFLDO ÂżHOGV for the World Bank in Uganda, Ethiopia and Paraguay. Sergio has been D PHPEHU RI LPSRUWDQW JURXSV LQ &HÂżF VXFK DV WKH 3URGXFW 6WHZDUGVKLS 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.
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 â&#x20AC;&#x153;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 UHVXOWV RI VHYHUDO (8 SURMHFWV LQFOXGLQJ VSHFLÂżF GLVVHPLQDWLRQ DQG exploitation measures for the different stakeholders â&#x20AC;&#x201C; including regulators, LQGXVWU\ FLWL]HQV LQWHUQDWLRQDO ERGLHV VFLHQWLÂżF DQG RWKHU DVVRFLDWLRQV 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
Ralf Knauf â&#x20AC;&#x201C; Business Development Manager ,Q DIWHU ÂżQLVKLQJ KLV SURIHVVLRQDO HGXFDWLRQ LQ HFRQRP\ DQG LQGXVWU\ DW WKH KHDG RIÂżFH RI %D\HU $* *HUPDQ\ 5DOI PRYHG WR %D\HU ,WDOLD V 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 VDIHW\ ZLWKLQ WHFKQLFDO DQG VFLHQWLÂżF GHSDUWPHQW IRFXVLQJ RQ 5($&+ DQG related regulations. Since 2009 he has been heavily involved in Centro Reach, coordinating training and consortia activities. Stefano Arpisella â&#x20AC;&#x201C; Technical Manager Graduated in chemistry and pharmaceutical technologies. After his activity in R&S at UniversitĂ di Ferrara, he worked in the Federchimica technical DQG VFLHQWLÂżF GHSDUWPHQW IRU FKHPLFDOV DQG SURGXFW VDIHW\ +H KDV KXJH practical experience in REACH thanks to more than 300 in-company activities and visits.
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 QHFHVVDU\ HQGSRLQWV ZLWK VSHFLÂżF GDWD RI WKH VXEVWDQFH LQ QDQRVL]H showing that REACH regulation can handle nanomaterials, and that WKHUH LV QR VFLHQWLÂżF HYLGHQFH IRU DVVXPLQJ WKDW VXEVWDQFHV LQ QDQRVL]H 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.
Chemical Watch | Global Service Providers Guide 2013
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PROFILE: Centro Reach
2012
SERVICES PROVIDED World regulatory affairs 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 VSHFL¿F DUHDV RI 5($&+ VXFK DV GDWD HYDOXDWLRQ DQG VWXG\ PRQLWRULQJ &KHPVDIH KDV VLJQL¿FDQW H[SHULHQFH LQ SURJUDPPH DQG SURMHFW management and Sief and consortia management.
PROFILE: Chemsafe
CONTACTS Website
www.chemsafe-consulting.com
chemsafe@chemsafe-consulting.com
Head office
Chemsafe Srl, Via Ribes, 5, 10010 Colleretto Giacosa (TO), Italy
Tel
+39 0125 538888
Fax
+39 0125 538475
Contact
José V Cantavella Cabedo
Directors
Dr Antonio Conto, European Registered Toxicologist (ERT), Managing Director
Ownership
Private company
Locations
Italy, Qatar
Founded
2001
REACH and CLP/GHS Chemsafe provides its clients with strategic, legal and technical support in order to comply with REACH and CLP/ GHS. Our technical support includes, for example, preparation of full registration dossiers (as lead or joint submissions), data gap analysis, review and analysis of physicochemical, 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.
OVERVIEW &KHPVDIH¶V YLVLRQ LV WR RIIHU UHJXODWRU\ DQG WHFKQLFDO VFLHQWL¿F VROXWLRQV DQG VHUYLFHV LQ WKH ¿HOG RI FKHPLFDO VDIHW\ ZLWK D ³NH\ SRLQW´ DSSURDFK and customer care attitude.
Sief and consortia management
Turnover, group
€1.7m
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.
Turnover, chemical service provision
€1.7m
Only representative (OR) and third party representative (TPR)
VITAL STATISTICS
2011/12
1R RI RI¿FHV
2
No of countries represented
2
Staff, group
12
Staff, chemical service provision
10
SERVICE AREA BREAKDOWN Legal 10%
Training 5%
IT & software 5% Laboratory 5% Information 10% Representation & management 20%
GLOBAL OFFICES Chemsafe Srl, Colleretto Giacosa (To), Italy Chemsafe International, Doha, Qatar
Consultancy/ advisory 45%
Since 2008 Chemsafe has been acting as only representative for non (XURSHDQ PDQXIDFWXUHUV DQG IXO¿OOLQJ WKH SUH UHJLVWUDWLRQ DQG UHJLVWUDWLRQ 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 PHPEHUV RI \RXU VXSSO\ FKDLQ \RX ZLOO KDYH D KLJK OHYHO RI FRQ¿GHQWLDOLW\ E\ VHSDUDWLQJ WKH FRPSDQ\ QDPH IURP SURSULHWDU\ SURGXFW FRQVWLWXHQWV \RX ZLOO PDLQWDLQ VXSSO\ FKDLQ SULYDF\ EHWZHHQ EX\HUV DQG VHOOHUV 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. &KHPVDIH LV DFWLQJ DV 25 IRU GLIIHUHQW ¿HOGV RI H[SHUWLVH DQG IRU GLIIHUHQW 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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Chemical Watch | Global Service Providers Guide 2013
Cosmetics O O O
O O
STAFF SELECTION
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. 3,) SURGXFW LQIRUPDWLRQ ÂżOH RU 365 SURGXFW VDIHW\ UHSRUW administrative activity, including robust study summaries and substance information sheet (SIS) with ingredient evaluation.
Dr Antonio Conto â&#x20AC;&#x201C; Managing Director Biology degree, European Registered Toxicologist (ERT). Founder of Chemsafe ! \HDUV RI H[SHULHQFH LQ WKH FKHPLFDO DQG WR[LFRORJLFDO ÂżHOG Lara De Luca â&#x20AC;&#x201C; Head of Technical Department Industrial chemist, with more than 11 years of experience. Risk assessment, exposure scenarios, CSR/CSA.
Petrochemicals
Dr JosĂŠ V Cantavella Cabedo â&#x20AC;&#x201C; Head of Legal Department
We advise our clients on legal aspects of chemical trade around the world and related chemical control regulations.
Attorney, JD in environmental law, with more than 17 years of experience Environmental and chemical law Francesca Fasano â&#x20AC;&#x201C; Head of Biocides Department Industrial chemist, with more than 10 years of experience. Biocides, agrochemicals and ecotoxicology.
2001
Start-up in Italy as â&#x20AC;&#x153;a one manâ&#x20AC;? company
2004
Staff increase up to four people
2007
REACH services offered
2009
Biocides and agrochemicals group creation
Biologist, with more than 11 years of experience. Technical dossier preparation, study monitoring, IUCLID.
2010
Technical consortia advisers for three international consortia. Staff increase up to ten people
Loredana Savin â&#x20AC;&#x201C; Head of CLP/GHS group
2011
Petrochemicals derivatives, wastes, cosmetics and pharmaceuticals consortia management. Staff increase to 12 people.
2012
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PROFILE: Chemsafe
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Elena Meriano â&#x20AC;&#x201C; Head of REACH Registration group
Biologist, with more than 11 years of experience &ODVVLÂżFDWLRQ ODEHOOLQJ *+6
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 O
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.
Chemical Watch | Global Service Providers Guide 2013
Page 63
GLOBAL OFFICES Chemservice SA, Grevenmacher, Luxembourg Chemservice GmbH, Worms, Germany Chemservice Asia Co Ltd, Seoul, Korea Chemservice Ltd Sti, Bodrum/Mugla, Turkey Chemservice EHNS GmbH, Worms, Germany Consortia Management GmbH, Worms, Germany ChemCehtra SAS, Bordeaux, France ChemAdvocacy SA, Grevenmacher, Luxembourg
PROFILE: Chemservice
CONTACTS Website
www.chemservice-group.com
info@chemservice-group.com
Head offices
Chemservice GmbH / Chemservice S.A.
Â
Von-Steuben-Str 13 / 5, an de Laengten
Â
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 GĂźnter Spang
Directors
Dr Dieter Drohmann, Managing Director Karl-Heinz Reis, Director Global Regulatory Affairs Dr Gßnter Spang, Director Toxicology and Risk Assessment Thomas Schäfer, Director Data and System Services
Ownership
Privately owned group of companies
Locations
Germany, Luxembourg, Korea, Turkey, France
Founded
2007
SERVICES PROVIDED Global regulatory affairs consulting Chemservice provides a broad range of services designed to assist clients in preparing for and in complying with international and national chemical control legislation. The application range for chemistry is extensive. Therefore, chemical control legislation is comprehensive in order to assure product safety, producer liability and consumer and environmental protection to regulate the PDUNHWLQJ RI FKHPLFDO VXEVWDQFHV %HVLGH LQYHQWRU\ QRWLÂżFDWLRQV ZH FRQGXFW 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 DQG ,8&/,' DVVLVWDQFH &/3 QRWLÂżFDWLRQ VDIHW\ GDWD VKHHW DQG ODEHO FUHDWLRQ Through our new legal entity, ChemAdvocacy, we provide REACH authorisation services (including SEA), advocacy and product stewardship consulting.
OVERVIEW
Consortia, Sief and letter of access management
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 ERGLHV DQG JRYHUQPHQWV ZLOO EH EHQHÂżFLDO LQ VROYLQJ UHJXODWRU\ LVVXHV Different in-house disciplines (chemists, chemical engineers, toxicologists, env scientists, agronomists, biologists, veterinarian, regulatory specialists etc) enables broad issue addressing.
Independent secretariat, trustee and accounting services to REACH consortia and Siefs in order to enable the chemical industry and its YDOXH FKDLQ WR IXOÂżO WKHLU UHJLVWUDWLRQ REOLJDWLRQV DFFRUGLQJ WR WKH 5($&+ 5HJXODWLRQ 7KH DXWRPDWHG RQOLQH OHWWHU RI DFFHVV WRRO SURYLGHV DQ HIÂżFLHQW /R$ PDQDJHPHQW IRU 6LHIV PHPEHUV WR DFTXLUH DFFHVV ULJKWV IRU D VSHFLÂżF 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 â&#x20AC;&#x201C; including trustee account management.
VITAL STATISTICS
2011/12
Turnover, group
c â&#x201A;Ź3m
Turnover, chemical service provision
c â&#x201A;Ź3m
1R RI RIÂżFHV
7
No of countries represented
5
Staff, group
30
Staff, chemical service provision
28
SERVICE AREA BREAKDOWN Other Training 5% 5% IT & software 10%
Information 15%
Consultancy/ advisory 45%
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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007
Start-up in Luxembourg
2008
2SHQLQJ RI &KHPVHUYLFH RIÂżFH LQ *HUPDQ\
2009
Launch of Consortia Management GmbH as full service provider for consortia and Sief management
2010
2SHQLQJ RI &KHPVHUYLFH RIÂżFHV LQ .RUHD DQG 7XUNH\
2011
Launch of Chemservice EHNS
2011
/DXQFK RI -9 &KHP&HKWUD ZLWK RIÂżFH LQ )UDQFH
2012
/DXQFK RI &KHP$GYRFDF\ 6$ ZLWK RIÂżFH LQ /X[HPERXUJ
Representation & management 20%
Page 64
Chemical Watch | Global Service Providers Guide 2013
ACCREDITATIONS
STAFF SELECTION
We are a member of ORO, the Only Representatives Organisation in Brussels and comply with the quality standards of ORO. Dr Drohmann is chairing ORO as president.
Dr Dieter Drohmann â&#x20AC;&#x201C; Managing Director
PARTNERS
O
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
O
PhD in environmental sciences founder of the Chemservice Group >20 years of experience in the chemical industry as regulatory affairs manager
Dr Neslihan Altinbas â&#x20AC;&#x201C; Managing Director of Chemservice Ltd Sti, Turkey O O
PhD in chemistry >10 < 15 years of experience in GLP and GMP quality assurance LQ WKH ÂżHOG RI SKDUPDFRORJ\ DQG SODQW SURWHFWLRQ SURGXFWV DQG nanoparticles
Dr GĂźnter Spang â&#x20AC;&#x201C; Director Toxicology and Risk Assessment O O
PhD in agronomy >15 < 20 years of experience in regulatory affairs consulting, including risk assessments and dossier preparation
Natalia Jansen-Bouriatchenko â&#x20AC;&#x201C; Regulatory Affairs Advisor (Ukrainian)
:H KDYH VLJQLÂżFDQW H[SHULHQFH LQ JOREDO LQYHQWRU\ UHJLVWUDWLRQV DQG FRQGXFWHG DURXQG QRWLÂżFDWLRQV WR WKH 7XUNLVK LQYHQWRU\ DQG nominations to the inventory in Taiwan. For one client we supplied a global inventory strategy for a new polymer, and for multiple clients we FRQGXFWHG QRWLÂżFDWLRQV WR FKHPLFDO LQYHQWRULHV OLNH $XVWUDOLD $,&6 Canada (DSL), China (IECSC), Korea (ECL), New Zealand (NZIOC), Philippines (PICCS) and USA (TSCA).
Karl-Heinz Reis â&#x20AC;&#x201C; Director Global Regulatory Affairs
CASE STUDY 2: REACH-Code-Model
Thomas Schaefer â&#x20AC;&#x201C; Director Data and System Services
REACH does not distinguish between direct and indirect imports into the EU. Therefore, non-EU business followed by export to EU is more complicated â&#x20AC;&#x201C; in particular if several non-EU steps along the supply chain are involved and substances have been formulated into SUHSDUDWLRQV ZLWK FRQÂżGHQWLDO FRPSRVLWLRQ ,Q D PXOWL OHYHO QRQ (8 VXSSO\ chain the manufacturer of a substance usually does not know through ZKLFK FKDQQHOV LQ ZKLFK SURGXFWV DQG ÂżQDOO\ KRZ PXFK YROXPH RI KLV 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(8 PDQXIDFWXUHU UHSUHVHQWHG E\ WKH 25 QRU WKH LPSRUWHU FDQ IXOÂżO 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.
O O
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master in biochemistry >15 < 20 years of experience in analytical and ecological chemistry, ecotoxicology and toxicology master in biology ! \HDUV RI H[SHULHQFH LQ WKH ÂżHOG RI ULVN DVVHVVPHQWV 3%7 assessments and CRO study director IT specialist and SDS expert >20 years of experience in IT and data systems
Yong Jiang â&#x20AC;&#x201C; Regulatory Affairs Advisor (Chinese) O O
master in chemistry eight years of experience as chemical specialist, consultant and compliance manager
Ah-Reum Seo â&#x20AC;&#x201C; Regulatory Affairs Advisor (Korean) O O
chemist eight years of experience in R&D and regulatory affairs
CASE STUDY 3: REACH dossier work Chemservice has experience with around 200 Tier 1 and 2 REACH GRVVLHUV LQFOXGLQJ PHPEHU DQG OHDG GRVVLHUV 0RUHRYHU D VLJQLÂżFDQW 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 FOLHQWV LQ PRUH WKDQ &/3 QRWLÂżFDWLRQV
Chemical Watch | Global Service Providers Guide 2013
Page 65
PROFILE: Chemservice
Our partner companies can be viewed on our website.
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PROFILE: ChemService Srl Controlli e Ricerche
GLOBAL OFFICES ChemService Srl Controlli e Ricerche â&#x20AC;&#x201C; Via Fratelli Beltrami 15 20026 Novate Milanese (MI), Italy ChemService agent in China: Ms Ina Cui IGW First Chemical Co Ltd â&#x20AC;&#x201C; Suite 352, 3rd Floor, OG Plaza, Building C, No 327 Tian Yao Qiao Road, Xuhui District, Shanghai, 200030, PR China.
CONTACTS
SERVICES PROVIDED
Website
www.chemservice.it
c.marchiori@chemservice.it
Head office
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
Ownership
Private company
Short and long term ecotoxicological tests on aquatic (alga, daphnia, ÂżVK DFWLYDWHG VOXGJH DQG WHUUHVWULDO RUJDQLVPV HDUWKZRUPV 7HVWV RQ soil microorganisms (OECD 216, 217), aquatic plants (OECD 221 on lemna sp). Biodegradability testing (OECD 301). Tests on terrestrial plants 2(&' QRQ WDUJHW DUWKURSRGV DQG KLJKHU WLHU WHVWV RQ ÂżVK (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).
$IÂżOLDWHG ZLWK ),1$*52 63$
REACH and CLP
Locations
Novate Milanese (MI), Italy
Founded
1992
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 , in silico (OECD Toolbox, CAESAR, ToxTree, Lazar, strategies (3, 6XLWH HWF DQG UHDG DFURVV FDWHJRU\ DSSURDFK ,8&/,' ÂżOH preparation and submission to ECHA. Contacts with ECHA during pre/ post (follow-up) dossiers submission.
Ecotoxicology and biodegradability testing. Analytical methods development and validation, physico-chemistry testing
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 customerâ&#x20AC;&#x2122;s competitiveness DQG ORQJ WHUP SURÂżWDELOLW\ ZLWK KLJK TXDOLW\ DQG UHOLDEOH WHVWLQJ DQG UHJXODWRU\ VHUYLFHV $ ORQJ ODVWLQJ H[SHULHQFH LQ WKH ÂżHOGV RI DQDO\WLFDO 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 WR WKH (IVD VFLHQWLÂżF XQLWV RQ WR[LFRORJ\ DQG HFRWR[LFRORJ\ DQG E\ (8 in 2008 (EuropeAid/123060/D/SUP/RO) for building an ecotoxicological laboratory in Romania. VITAL STATISTICS
2011/12
Turnover, group
â&#x201A;Ź5m
Turnover, chemical service provision
â&#x201A;Ź5m
E
F
G
E
H
I
J
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 PRGHOOLQJ HJ )2&86 PRGHO IRU 333 6FLHQWLÂżF PRQLWRULQJ RI HIÂżFDF\ trials and preparation of biological assessment dossiers-BAD-for PPP. 6FLHQWLÂżF PRQLWRULQJ RI VXE FRQWUDFWHG VWXGLHV WR[LFRORJLFDO VWXGLHV 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.
1R RI RIÂżFHV
2
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
No of countries represented
2
1992
ChemService Srl incorporated as international contract research organisation in Milan, Italy.
1992
Achievement of ISO/IEC 17025 accreditation
Staff, group
50
Staff, chemical service provision
45
SERVICE AREA BREAKDOWN Training 5% Consultancy/ advisory 35%
Laboratory 60%
Page 66
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.
2012
,PSOHPHQWDWLRQ RI KLJKHU WLHU WHVWV RQ ÂżVK ÂżVK OLIH F\FOH test), tests on non-target terrestrial plants and non-target arthropods.
Chemical Watch | Global Service Providers Guide 2013
CASE STUDY 3: Assistance to the Efsa scientific units on toxicology and ecotoxicology
Good Laboratory Practice (GLP) and ISO/IEC 17025:2005 PARTNERS IGW First Chemical Co Ltd , Shanghai â&#x20AC;&#x201C; PRC acts as agent of &KHP6HUYLFH 6UO &RQWUROOL H 5LFHUFKH LQ &KLQDÂśV WHUULWRULHV 7KH VSHFLÂżF 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 â&#x20AC;&#x153;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 productsâ&#x20AC;? â&#x20AC;&#x201C; 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 WLPH QHYHUWKHOHVV WKH KLJK YROXPH XVHG LQ WKH ÂżHOG DQG WKH GLIÂżFXOW\ LQ distinguishing the natural background level in the environment, gave rise WR WKH UHTXHVW IRU QRQ VWDQGDUG VWXGLHV VXFK DV ÂżHOG RSHUDWRU H[SRVXUH study and tests on sediment â&#x20AC;&#x201C; dwelling organisms with radiolabelled PDWHULDO 6XOSKXU LV D SURGXFW EURDGO\ XVHG LQ (XURSH DV D FRQVHTXHQFH 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 SHULRG ZDV MXVW H[SLUHG 7LPLQJ ZDV FUXFLDO LQ RUGHU WR EH WKH ÂżUVW RI the newcomers and gain immediate market shares. In a three months timeframe, ChemService performed a preliminary screening of the GLIIHUHQW TXDOLWLHV RI 3HQGLPHWKDOLQ PDQXIDFWXUHG E\ )LQFKLPLFD LGHQWLÂżHG the level of quality needed in order to match the technical product UHJLVWHUHG SHUIRUPHG D ÂżYH EDWFK DQDO\VLV RQ 3HQGLPHWKDOLQ RI VDLG quality and submitted the relevant chemical equivalence dossier to CRD ) were using the fast track option. Non testing data (QSAR and included in the dossier in order to support the toxicological equivalence of Finchimicaâ&#x20AC;&#x2122;s towards registered source. The dossier was accepted E\ &5' LQ 'HFHPEHU DQG )LQFKLPLFD EHFDPH WKH ÂżUVW DSSURYHG source of Technical Pendimethalin in Europe after the originator. E
F
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Chemical Watch | Global Service Providers Guide 2013
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Since May 2009 ChemService Srl Controlli e Ricerche has been part RI D SDQHO RI H[SHUWV VHOHFWHG E\ (IVD IRU DVVLVWLQJ LWV VFLHQWLÂżF XQLWV RQ toxicology and ecotoxicology (Multiple Framework Service Contract CT/ EFSA/AMU/2009/07, budget available â&#x201A;Ź1m) and has been awarded two VSHFLÂżF FRQWUDFWV IRU WKH GDWD HQWU\ RI SHVWLFLGH HFRWR[LFRORJ\ HQGSRLQWV in a IUCLID 5 database. In October 2012 ChemService Srl Controlli e 5LFHUFKH ZDV DZDUGHG D VSHFLÂżF FRQWUDFW IRU WKH FROOHFWLRQ RI VFLHQWLÂżF information within the public domain on the toxicity of chromium and nickel in experimental animals and humans (NP.EFSA.CONTAM.2012.01, budget â&#x201A;Ź60,000). STAFF SELECTION Giacomo Ravetta â&#x20AC;&#x201C; Managing Director Masters degree in industrial chemistry, 20+ yearsâ&#x20AC;&#x2122; 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 customersâ&#x20AC;&#x2122; 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 â&#x20AC;&#x201C; Head of Regulatory Services Masters degree in biology and PhD in environmental sciences, ten yearsâ&#x20AC;&#x2122; H[SHULHQFH LQ UHJXODWRU\ ÂżHOG HFRWR[LFRORJ\ DQG HQYLURQPHQWDO ULVN assessment. Head of the Dossier department she coordinates a team of VL[ UHJXODWRU\ H[SHUWV SOXV D VHQLRU VFLHQWLÂżF FRQVXOWDQW ZLWK H[SHUWLVH 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 â&#x20AC;&#x201C; 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 (FRWR[LFRORJLFDO 7HVWLQJ XQLW VKH FRRUGLQDWHV D WHDP RI ÂżYH HFRWR[ H[SHUWV VXSSRUWHG E\ D VHQLRU VFLHQWLÂżF FRQVXOWDQW 6LQFH VKH KDV been involved, as an ecotoxicology expert, in EU and Efsa projects. Stefano Garofani â&#x20AC;&#x201C; Head of Analytical Studies Unit Masters degree in chemistry, 20+ yearsâ&#x20AC;&#x2122; experience in development and validation of analytical methods, GLP physico-chemical studies, residue DQG ÂżYH EDWFK DQDO\VLV +LV KLJKO\ VNLOOHG JURXS RI FKHPLVWV FRQGXFWHG more than 3,000 GLP analytical studies from 2005-2011 (600+ in 2012). Dr Carlotta Casalegno â&#x20AC;&#x201C; 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 (ECEAEBUAV) 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.
Page 67
PROFILE: ChemService Srl Controlli e Ricerche
ACCREDITATIONS
GLOBAL OFFICES
PROFILE: Chilworth â&#x20AC;&#x201C; a DEKRA Company
DEKRA Industrial GmbH Handwerkstr. 15 D-70565 Stuttgart Germany CONTACTS
SERVICES PROVIDED
Website
www.chilworth.co.uk
O O
process safety consultancy GXVW ÂżUH DQG H[SORVLRQ SURWHFWLRQ chemical reaction hazards material testing laboratory testing regulatory testing process safety training
info@chilworth.co.uk
Head office
Beta House, Southampton Science Park, Southampton, SO16 7NS, UK
O
Tel
+44 (0)23 8076 0722
O
Fax
+44 (0)23 8076 7866
O
Contact
Dr David Firth, Mr Daniel Baker, Mr Mike Weaver
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Directors
DEKRA Explosion & Process Safety Business Line
1986
Foundation of Chilworth Technology Ltd
Ownership
Wholly owned subsidiary of DEKRA SE
1991
Chilworth Technology Inc established in USA
Locations
UK, USA, India, Germany, France, Spain, Benelux, Scandinavia, Eastern Europe, Japan, Brazil, Northern and Southern Africa, Israel, Japan and China
1995
Received Good Laboratory Practice accreditation
2001
IChemE safety and environmental awards winner
2003
&KLOZRUWK JRHV JOREDO FDSDELOLWLHV HVWDEOLVKHG LQ )UDQFH Italy and India
OVERVIEW
2008
Chilworth acquires Spanish facility
Chilworth â&#x20AC;&#x201C; a DEKRA company is the UKâ&#x20AC;&#x2122;s leading provider of expert NQRZOHGJH DQG TXDOLW\ WHVW GDWD LQ WKH ÂżHOG RI SURFHVV VDIHW\ :LWK DQ international consulting base, we employ doctorate engineering and VFLHQWLÂżF VWDII DORQJ ZLWK FRQVXOWDQW HQJLQHHUV VFLHQWLVWV DQG WHFKQLFLDQV 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 FRYHU SURÂżOLQJ RI SRZGHUV ÂżOPV DQG OLTXLGV IRU ERWK SURGXFWLRQ KDQGOLQJ problems and electrostatic ignition hazards. '(.5$ IXOÂżOV WKH RQO\ UHSUHVHQWDWLYH SRVLWLRQ IRU VHYHUDO FRPSDQLHV EDVHG 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!
2009
Acquisition of JCI, the UKâ&#x20AC;&#x2122;s electrostatic measurement experts
2011
Wholly acquired by DEKRA, Europeâ&#x20AC;&#x2122;s leading safety provider
Founded
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1925 (DEKRA)
VITAL STATISTICS
2011/12
Turnover, group
â&#x201A;Ź1.8bn
Turnover, chemical service provision
â&#x201A;Ź495m
1R RI RIÂżFHV
30+
No of countries represented
80+
Staff, group
25,000
Staff, chemical service provision
500+
SERVICE AREA BREAKDOWN Other 10% Training 5%
Laboratory 50%
Page 68
Consultancy/ advisory 30%
Representation & management 5%
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ACCREDITATIONS *RRG /DERUDWRU\ 3UDFWLFH 8. ,62 86
CLIENTS Chilworth â&#x20AC;&#x201C; a DEKRA company provides consultancy and testing services WR D EURDG UDQJH RI FXVWRPHUV ZKR IRU UHDVRQV RI FRQÂżGHQWLDOLW\ FDQQRW 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 â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; a DEKRA company has carried out a range of physicochemical 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.
Chemical Watch | Global Service Providers Guide 2013
STAFF SELECTION Dr Stephen Rowe â&#x20AC;&#x201C; Managing Director
PROFILE: Chilworth â&#x20AC;&#x201C; a DEKRA Company
Managing director â&#x20AC;&#x201C; with more than 20 yearsâ&#x20AC;&#x2122; experience in process safety â&#x20AC;&#x201C; Steve has particular expertise in chemical reaction hazards testing, exothermic reaction hazards consulting and dust, gas and vapour Ă&#x20AC;DPPDELOLW\ WHVWLQJ DQG FRQVXOWLQJ SURJUDPPHV Dr David Firth â&#x20AC;&#x201C; Business Development and Marketing Manager Business development and marketing manager â&#x20AC;&#x201C; covering all areas of process safety â&#x20AC;&#x201C; David has many years of experience working with customers in a variety of industries including chemicals, pharmaceuticals, agrochemicals, paint, polymers, adhesives, electronics, fuel additives, V\QWKHWLF ÂżEUHV DQG PDQ\ RWKHUV Mr Michael Weaver â&#x20AC;&#x201C; Principal Specialist Process Safety Principal specialist process safety â&#x20AC;&#x201C; bringing more than two decades of testing and consultancy experience to the team â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; Safety Testing Specialist Safety testing specialist â&#x20AC;&#x201C; responsible for the management of our laboratories â&#x20AC;&#x201C; Daniel has more than a decade of experience in testing and project management and brings a wealth of knowledge on regulatory WHVW UHTXLUHPHQWV $V D TXDOLÂżHG '*6$ KH SURYLGHV JXLGDQFH RQ WKH LPSOLFDWLRQ RI UHVXOWV RQ FODVVLÂżFDWLRQ RI SURGXFWV Dr Andrew Starkie â&#x20AC;&#x201C; Principal Process Safety Specialist Principal process safety specialist â&#x20AC;&#x201C; managing our GLP programme and with over a quarter of a century of experience in the sphere of process safety testing and consultancy â&#x20AC;&#x201C; Andy has particular expertise in the handling and testing of hazardous and sensitive materials and chemical reaction hazards. Mr Jochen Dettke â&#x20AC;&#x201C; Head of REACH RegistrationTeam in Germany An expert at DEKRA Industrial GmbH â&#x20AC;&#x201C; based in Stuttgart â&#x20AC;&#x201C; Jochen heads up the REACH registration team in Germany, providing consultancy and testing advice from portfolio optimisation, through data acquisition and into dossier preparation.
Chemical Watch | Global Service Providers Guide 2013
Page 69
SERVICES PROVIDED Registration of chemicals in the EU
Website
www.csregulatory.com
helpline@csregulatory.com
Head office
The Old Courthouse, St. Peters Churchyard, Derby, UK
Tel
+44 (0)1332 380692
Fax
+44 (0)1332 380692
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. 6HUYLFHV LQFOXGH DVVLVWDQFH ZLWK ODWH SUH UHJLVWUDWLRQ HVWDEOLVKLQJ 5($&+ ,7 DFFRXQWV SUHSDUDWLRQ RI UHJLVWUDWLRQ GRVVLHU LQ ,8&/,' IRUPDW SUHSDUDWLRQ RI FKHPLFDO VDIHW\ UHSRUWV LQFOXGLQJ H[SRVXUH scenarios and risk characterisation), production of CLP compliant MSDS (including extended format), submission to and liaison with ECHA.
Contact
Mr Steven Green
Worldwide notification of chemicals
Directors
Mr Steven Green
Â
Mr Craig Deegan
Ownership
Private company
Locations
+HDG RIÂżFH RQO\
Founded
2007
PROFILE: CS Regulator y Ltd
CONTACTS
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 SURIHVVLRQDO H[SHULHQFH ZLWKLQ WKH LQGXVWULDO HQYLURQPHQW ZH KDYH 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 DQG &/3 SXUSRVHV ZRUOGZLGH QRWLÂżFDWLRQ RI FKHPLFDOV UHSUHVHQWDWLRQ of clients within Europe, production of associated chemical safety documents, liaison with authorities and product defence, advice on testing strategies and project management of data packages, acquisition of existing data and product stewardship. VITAL STATISTICS
2011/12
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
1
No of countries represented
1
Staff, group
7
Staff, chemical service provision
7
SERVICE AREA BREAKDOWN
Information 10%
Training 5%
Representation & management 20% Consultancy/ advisory 65%
6WDII DW &6 5HJXODWRU\ DUH H[SHUWV LQ WKH QRWLÂżFDWLRQ RI FKHPLFDOV LQ FRPSOLDQFH ZLWK DOO QRWLÂżFDWLRQ VFKHPHV DURXQG WKH ZRUOG KDYLQJ ZRUNHG ZLWK HYHU\ QDWLRQDO UHJLVWUDWLRQ VFKHPH DQG EHQHÂżWLQJ IURP D JOREDO network of independent regulatory experts to ensure that we are in possession of the very latest expert information. &6 5HJXODWRU\ LV H[SHULHQFHG LQ SUHSDULQJ QRWLÂżFDWLRQ GRVVLHUV LQ WKH DSSURSULDWH IRUPDW WR DFKLHYH QRWLÂżFDWLRQ VXEPLWWLQJ WKH QRWLÂżFDWLRQ DQG 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 HIÂżFLHQWO\ PDQDJH WKH VXSSO\ FKDLQ LQWHUDFWLRQV DV QHHGHG $V WKH representative, CS Regulatory can work in the Sief and consortium on behalf of our client, representing their best interests, minimising our FOLHQWÂśV ZRUNORDG DQG PDLQWDLQLQJ DQG UHWDLQLQJ RXU FOLHQWÂśV FRQÂżGHQWLDO 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 QHHGV :H RIIHU SURGXFW HYDOXDWLRQ DQG GDWD JDS DQDO\VLV OLWHUDWXUH DQG LQYHQWRU\ VHDUFKLQJ DSSOLFDWLRQ RI 46$5 DQG in silico modelling to FKHPLFDOV UHDG DFURVV DQG JURXSLQJ RI FKHPLFDOV SURYLVLRQ RI H[SHUW reports for data-waiving and IUPAC name derivation. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007
CS Regulatory established as an LLP
2007
Established a global network of expert regulatory consultants
2008
Incorporated as a private limited company
2009
Established the preferred partner agreement with LAB Research Inc
2009
First achieved the ISO 9001:2008 accreditation for all services, including registration
ACCREDITATIONS ISO 9001:2008
GLOBAL OFFICES Not applicable. CS Regulatory has a global network of independent expert consultants for global regulatory compliance.
Page 70
PARTNERS CiTox LAB preferred partner
Chemical Watch | Global Service Providers Guide 2013
CLIENTS
Craig Deegan â&#x2C6;&#x2019; Director
'XH WR VWULFW WHUPV RI FRQÂżGHQWLDOLW\ DQG WKH QDWXUH RXU EXVLQHVV &6 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.
0U 'HHJDQ KDV EHHQ ZRUNLQJ LQ WKH ÂżHOG RI LQWHUQDWLRQDO UHJXODWRU\ affairs and health, safety and environmental consultancy for 18 years, incorporating development of testing strategies based on risk hierarchy, HYDOXDWLRQ DQG LQWHUSUHWDWLRQ RI FOLHQW VSHFLÂżF UHTXLUHPHQWV WR HQVXUH 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.
6SHFLÂżF UHIHUHQFHV FDQ EH SURYLGHG WR SRWHQWLDO FOLHQWV XSRQ UHTXHVW 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 VFLHQWLÂżF SULQFLSOHV DQG WKH SUDJPDWLF XVH RI SXEOLF GRPDLQ UHDG DFURVV and QSAR assessment to reduce the need for animal testing and DFKLHYLQJ VLJQLÂżFDQW FRVW UHGXFWLRQ RI UHJXODWRU\ FRPSOLDQFH 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.
Tracey Thomas â&#x20AC;&#x201C; Regulatory Specialist 0V 7KRPDV KDV EHHQ ZRUNLQJ LQ WKH ÂżHOG RI KHDOWK DQG PHGLFDO consultancy for 15 years. Her work within CS Regulatory incorporates FROOHFWLQJ DQG FROODWLQJ D ZLGH UDQJH RI LQIRUPDWLRQ IRU QRWLÂżFDWLRQ 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 â&#x20AC;&#x201C; Regulatory Affairs Officer 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 Regulatoryâ&#x20AC;&#x2122;s clients with regulatory compliance GRFXPHQWDWLRQ VSHFLÂżFDOO\ IRU 5($&+
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 GHWHUPLQLQJ RXU FOLHQWVÂś UHJLVWUDWLRQ DQG QRWLÂżFDWLRQ REOLJDWLRQV %\ PHDQV 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 UHOHYDQW QRWLÂżFDWLRQ UHTXLUHPHQWV ZDV DOVR FRQGXFWHG 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 â&#x2C6;&#x2019; 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 UHJXODWRU\ DVVHVVPHQW DQG FOHDUO\ GHÂżQHG EXVLQHVV SULQFLSOHV ZKLFK LV essential to compliance with REACH.
Chemical Watch | Global Service Providers Guide 2013
Page 71
PROFILE: CS Regulator y Ltd
TESTIMONIALS
GLOBAL OFFICES CHEMPARK Leverkusen, Germany CHEMPARK Dormagen, Germany CHEMPARK Uerdingen, Germany SERVICES PROVIDED
PROFILE: CURRENTA
CONTACTS Website
www.analytik.currenta.de
analytik@currenta.de
Head office
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). VITAL STATISTICS
2011/12
Turnover, group
-
Turnover, chemical service provision
-
1R RI RI¿FHV
3
No of countries represented
1
Staff, group
3.300
Staff, chemical service provision
All services of the REACH regulation in the broadest sense, including: O strategic REACH consulting O impact analysis O LGHQWL¿FDWLRQ RI GDWD UHTXLUHPHQWV O literature searches O LGHQWL¿FDWLRQ RI GDWD JDSV O recommendation of an intelligent test strategy (category approach, waiving, read-across, QSAR calculations) O planning and performance of studies (physico-chemical and HFRWR[LFRORJLFDO SDUDPHWHUV HQYLURQPHQWDO IDWH DQG EHKDYLRXU toxicological endpoints*) O preparation of technical dossiers and chemical safety reports O performance of exposure estimates and risk assessments O PBT and vPvB assessments O consulting on SVHC issues O submission of registration dossiers and communication with ECHA/ national authorities O active product defence, including the evaluation and authorisation process O representation in Siefs/ consortia O consortium management WR[LFRORJLFDO HQGSRLQWV LQ FRRSHUDWLRQ ZLWK TXDOL¿HG SDUWQHUV CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1971
%D\HU $* &HQWUDO 5HVHDUFK =HQWUDOH )RUVFKXQJ
2002
%D\HU $* 6WDQGRUWGLHQVWH &HQWUDO $QDO\WLFV
2003
%D\HU ,QGXVWU\ 6HUYLFHV $QDO\WLFV
2008
CURRENTA, Analytics CURRENTA, and its precursor organisations have been dealing with all kinds of product safety issues for more than \HDUV (QFRPSDVVLQJ IRU LQVWDQFH WKH ¿HOGV RI *HUPDQ 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.
450
SERVICE AREA BREAKDOWN Training Other 2% 3%
Consultancy/ advisory 35% Laboratory 45%
Information 5%
Page 72
Representation & management 10%
Chemical Watch | Global Service Providers Guide 2013
ACCREDITATIONS GLP, GMP, DIN EN ISO 17025, active member in international working groups e.g. CEFIC, VCI, DIN PARTNERS 'U .12(// &RQVXOW *PE+ FRRSHUDWLRQ ZLWK ODERUDWRULHV DQG H[SHUW teams within the Bayer AG enterprise in single cases CLIENTS 9DOLG FRQ¿GHQWLDOLW\ DJUHHPHQWV ZLWK FXVWRPHUV GLYHUVLW\ RI customers reaches from industrial sectors (chemistry, agrochemicals, pharmaceuticals, cosmetics, plastics) to various company sizes (big international companies and SMEs) and consortia management
PROFILE: CURRENTA
CASE STUDY 1: CURRENTA successfully accomplished the REACH registration process of more than 170 HPV substances to the satisfaction of its customers since 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
Chemical Watch | Global Service Providers Guide 2013
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SERVICES PROVIDED REACH registration services DHI offers manufacturers and importers of substances following technical expert services: O guidance and strategic counselling on chemicals legislation and 5($&+ WDVNV O preparation of registration dossiers based on development of individual testing strategies and integrated use of non-test methods 46$5 UHDG DFURVV ZDLYLQJ O 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.
PROFILE: DHI
CONTACTS Website
www.dhigroup.com www.tox.dhigroup.com
jet@dhigroup.com
Head office
Agern AllÊ 5, DK-2970 Hørsholm, Denmark
Tel
+ 45 4516 9200
Fax
Regulatory services and IT based support tools
+ 45 4516 9292
Contact
Jens Tørsløv, Head of Projects.
Directors
$VJHU .HM &KLHI ([HFXWLYH 2IÂżFHU
Â
3HWHU 5DVPXVVHQ &KLHI )LQDQFLDO 2IÂżFHU
Ownership
1RW IRU SURÂżW RUJDQLVDWLRQ
Locations
ZRUOGZLGH RIÂżFHV DQG RSHUDWLRQV
Founded
1964
'+, IDFLOLWDWHV FRPSDQ\ VSHFLÂżF *+6 VWUDWHJLHV IRU JOREDO FRPSDQLHV DV ZHOO DV FODVVLÂżFDWLRQ DQG ODEHOOLQJ RI FKHPLFDO VXEVWDQFHV DQG PL[WXUHV 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 OLVWV RQ FODVVLÂżFDWLRQ VXEVWDQFH QDPHV H[SRVXUH OLPLWV &$6 QXPEHUV phrase modules with 4,500+ phrases in more than 40 languages and WUDQVODWLRQ RI FRPSDQ\ VSHFLÂżF SKUDVHV
OVERVIEW
Environmental laboratory
DHI is a global and independent consulting and research organisation DGYDQFLQJ WHFKQRORJLFDO GHYHORSPHQW ZLWKLQ WKH ÂżHOGV RI ZDWHU 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.
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).
VITAL STATISTICS
DHI offers regulatory assistance for both industry and authorities: O GDWD VHDUFK DQG LQIRUPDWLRQ UHWULHYDO O GDWD JDS DQDO\VHV O WR[LFRORJLFDO VHUYLFHV DQG WHVWLQJ O HFRWR[LFRORJLFDO WHVWV O preparation of dossiers on biocidal active substances and biocidal SURGXFWV O preparation of dossiers on active substances and plant protection SURGXFWV O IRUPXODWLRQ RI FODLPV QRWLÂżFDWLRQV DQG H[SHUW UHSRUWV DQG ZDLYHUV
2011/12
Turnover, group
â&#x201A;Ź116m
Turnover, chemical service provision
â&#x201A;Ź8.9m
1R RI RIÂżFHV
27
No of countries represented
40
Staff, group
981
Staff, chemical service provision
62
SERVICE AREA BREAKDOWN
Pharmaceuticals and medical devices
Training Other Legal 3% 2% 2% IT & software 12% Laboratory 7% Information 1% Representation & management 1%
Consultancy/ advisory 72%
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.
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Biocides and pesticides
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 DQG GRFXPHQWDWLRQ GDWD VFUHHQLQJ OLWHUDWXUH VHDUFKHV FRPSDUDWLYH 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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1964
Danish Hydraulic Institute (DHI) founded
1973
Approved as Authorised Technological Service Institute by the Danish Minister for Science, Innovation and Higher Education
Chemical Watch | Global Service Providers Guide 2013
1982
VKI laboratory accredited by DANAK, the Danish Accreditation and Metrology Fund
STAFF SELECTION
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
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.
2005
Merge with Danish Toxicology Centre (DTC)
2007
Establishment of the Environment and Toxicology unit
Ecotoxicology tests: LQ DFFRUGDQFH ZLWK ,62 O DFFUHGLWHG E\ '$1$. WKH 'DQLVK $FFUHGLWDWLRQ DQG 0HWURORJ\ )XQG O in compliance with the OECD and principles of good laboratory practice (GLP). O
PARTNERS Software: O ECOonline, Safeware Quasar Ltd, The Wercs, InterSolia AB O 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 6SHFLÂżF UHIHUHQFHV FDQ EH SURYLGHG WR SRWHQWLDO FOLHQWV XSRQ UHTXHVW CASE STUDY 1: The chemical management system ChemManagerÂŽ '+, HYDOXDWHV WKH UDZ PDWHULDOV XVHG E\ 5DGLRPHWHU DQG LGHQWLÂżHV DQ\ GHÂżFLHQFLHV '+, DOVR SUHSDUHV DQG PDLQWDLQV GRFXPHQWDWLRQ IRU 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 â&#x20AC;&#x201C; regardless of the 20 languages in use. The DHI databases and phrase libraries and web-based chemical management system, ChemManagerÂŽ, help ensure the quality. The use of ChemManagerÂŽ enables Radiometer to screen their products for problematic substances (for example SVHCs) and to take proactive action concerning the use of chemicals.
Lars S Rasmussen, MSc, Chemical Engineering â&#x20AC;&#x201C; Business Area Manager IT and Hazard Communication Expert knowledge of European chemical legislation, in particular FODVVLÂżFDWLRQ ODEHOOLQJ DQG SDFNDJLQJ RI FKHPLFDOV DV ZHOO DV 06'6 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 â&#x20AC;&#x201C; 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 LQFOXGLQJ ,8&/,' QRWLÂżFDWLRQ RI QHZ FKHPLFDO VXEVWDQFHV DVVHVVPHQW and control of risks from existing substances, mathematical modelling, ie QSAR and read-across in risk assessment. Poul Bo Larsen, MSc â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; 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 DVVHVVPHQW DQG FODVVLÂżFDWLRQ RI FKHPLFDOV DQG SURGXFWV GHYHORSPHQW RI environmental quality standards.
CASE STUDY 2: A science and technology based AoA to nickel Since 2011 DHI has provided services on analysis of alternatives (AoA) WR WKH 1LFNHO ,QVWLWXWH 1LFNHO DQG QLFNHO FRPSRXQGV DUH QRW LGHQWLÂżHG DV 69+& XQGHU 5($&+ EXW D QXPEHU RI VDOWV DUH FODVVLÂżHG DV &DUF $ 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.
Chemical Watch | Global Service Providers Guide 2013
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PROFILE: DHI
ACCREDITATIONS
Jens Tørsløv, PhD, Ecotoxicology â&#x20AC;&#x201C; Head of Projects
GLOBAL OFFICES Dr. Knoell Consult GmbH, Mannheim, Germany Dr. Knoell Consult GmbH, Leverkusen, Germany Dr. Knoell Consult GmbH, Wageningen, The Netherlands Dr. Knoell Consult Ltd, Cardiff, United Kingdom Dr. Knoell Consult Shanghai Ltd, Pudong, Shanghai, China Dr. Knoell Consult Schweiz GmbH, Basel, Switzerland Dr. Knoell Consult Thai Co Ltd, Chiang Mai, Thailand FORIM GmbH, Mannheim, Germany Cyton Biosciences Ltd, Bristol, United Kingdom Knoell Academy GmbH, Mannheim, Germany
PROFILE: Dr. Knoell Consult GmbH
CONTACTS Website
www.knoell.com
info@knoell.com
Head office
DynamostraĂ&#x;e 19, 68165 Mannheim, Germany
Tel
+49 (0)621718858-0
SERVICES PROVIDED
Fax
+49 (0)621718858-100
Registration of industrial and specialty chemicals
Contact
Dr Michael Cleuvers
Directors
Dr Hans-Emil Knoell, Managing Director
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. 'RVVLHU SUHSDUDWLRQ HJ ,8&/,' ÂżOHV IRU 5($&+ WR[LFRORJLFDO DQG ecotoxicological hazard and risk assessment, exposure modelling, extended safety data sheets. Post submission support, communication with authorities, OR- and TPRservices, full consortia management.
Dr Runar Eberhardt, Managing Director Ownership
Private company, majority-owned by Dr Knoell
Locations
Germany, UK, Switzerland, China, Netherlands, Thailand
Founded
1996
Registration of agrochemicals and biocides
OVERVIEW Provider of full-services in the areas of global regulatory affairs, product safety and consulting for agrochemicals, biocides, industrial/specialty chemicals, human and veterinary pharmaceuticals, medical devices and cosmetics. Chemical business is a global business, and all around the world new chemical legislation is appearing! Working with Dr. Knoell Consult means that you can be sure to be in compliance with the latest developments, not only in Europe (EU and non-EU), but also in the, USA, &DQDGD 6RXWK $PHULFD DQG WKH HQWLUH $VLD 3DFLÂżF UHJLRQ &KLQD -DSDQ Korea, Australia and others). With a global network of cooperation partners we match our services to support your business needs. VITAL STATISTICS
2012/13
Turnover, group
approx.> â&#x201A;Ź30m
Turnover, chemical service provision
approx.> â&#x201A;Ź26m
1R RI RIÂżFHV
10
No of countries represented
5
Staff, group
305
Staff, chemical service provision
260
SERVICE AREA BREAKDOWN Training 5% Information 8%
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) DQG SRVW DXWKRULVDWLRQ VDIHW\ VWXGLHV 3$66 FODVVLÂżFDWLRQ RI PHGLFDO 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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Representation & management 25% Consultancy/ advisory 63%
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Strategic advice and consulting, literature research, data evaluation, data gap analysis, completeness check, study management and monitoring. 'RVVLHU SUHSDUDWLRQ ELRORJLFDO HIÂżFDF\ UHVLGXHV DQG PHWDEROLVP dietary safety, toxicology, human exposure, exposure modelling, PECreports, environmental risk assessment, ecotoxicology, CADDY-dossiers. Regulatory affairs, communication with authorities, post-submission report, full service provider.
1996
Foundation, Mannheim, Germany
2002
2IÂżFH LQ /HYHUNXVHQ *HUPDQ\
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 FRYHULQJ DOO RXU ÂżHOGV RI H[SHUWLVH
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) Chemical Watch | Global Service Providers Guide 2013
2010
2SHQLQJ RI D QHZ RIÂżFH LQ :DJHQLQJHQ 1/
STAFF SELECTION
2010
Acquisition of Cyton Biosciences Ltd, Bristol, UK
Toxicology
2010
Extension of regulatory affair services to Japan and Asia/ 3DFLÂżF UHJLRQ
> 30 toxicologists
2010
Set up of Dr. Knoell Consult Shanghai Ltd in China
12 specialists
2010
Successful preparation of more than 400 REACH dossiers and more than 100 chemical safety reports
Ecotoxicology
2010
Knoell has been appointed as institution for the training of experts in toxicology
Dietary safety
2012
Set up of Dr. Knoell Consult Thai Co Ltd, in Thailand
>15 specialists
2013
Knoell Iberia in Madrid in the course of incorporation
Product safety specialists (C&L, MSDS preparation)
4XDOLÂżHG &HÂżF Âą SDUWQHU
> 30 ecotoxicologists
> 30 specialists Global regulatory affairs chemicals > 10 specialists
PARTNERS
Consortium management, OR, TPR
SCAS Japan, SCAS Europe, BSL Bioservice, Ibacon, Currenta, Ceres International, ,Tier3 solutions
> 10 t consortium managers
CLIENTS
> 12 specialists
Our clients are mainly the big international companies, but also SMEs.
Environmental fate and risk assessment
TESTIMONIALS
> 40 specialists
The Spanish Ministry of Environment informed us that "our dossier for a wood-preservative was the best organised and well-done dossier in comparison with the rest of dossiers received from other companies" Additional testimonials can be provided on request. CASE STUDY 1: REACH: consortium management and dossier preparation 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 VFLHQWLÂżF MXVWLÂżFDWLRQV QHZ WHVWLQJ ZDV UHGXFHG WR D PLQLPXP 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 â&#x20AC;&#x153;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.â&#x20AC;?
Chemical Watch | Global Service Providers Guide 2013
PROFILE: Dr. Knoell Consult GmbH
ACCREDITATIONS
Regulatory affairs agrochemicals/biocides
Residues and metabolism
Efficacy, biological dossiers > 12 specialists Human pharmaceutical experts Ten Vet pharmaceutical experts 20 Selected staff Dr Michael Cleuvers â&#x20AC;&#x201C; Head of Industrial Chemicals and Biocides, Global Regulatory Affairs Torsten Hauck â&#x20AC;&#x201C; Head of Agrochemicals, Global Regulatory Affairs, Human and Environmental Safety, Environmental Risk Assessment Dr Volker Mostert â&#x20AC;&#x201C; Managing Director Knoell Academy GmbH Dr Marika Suhm-Tintelnot â&#x20AC;&#x201C; Head of Industrial Chemicals and Biocides, Human and Environmental Safety Dr Elisabeth Wekel â&#x20AC;&#x201C; Head of Industrial Chemicals and Biocides â&#x20AC;&#x201C; Product Safety Dr Iain A MacKinnon â&#x20AC;&#x201C; Managing Director, Dr. Knoell Consult Ltd Dr Jan Tuinstra â&#x20AC;&#x201C; Senior Expert REACH, Wageningen office Stefanie Schickâ&#x20AC;&#x201C; Managing Director,Dr. Knoell Consult Schweiz GmbH Dr Sylvana P MĂźller Managing Director FORIM GmbH
Page 77
SERVICES PROVIDED Industrial Chemicals â&#x20AC;&#x201C; REACH (%5& RIIHUV FRPSUHKHQVLYH VFLHQWLÂżF UHJXODWRU\ DQG DGPLQLVWUDWLYH support on industrial chemicals, including: O data gathering, literature searches and evaluation O data-gap analysis, closing of data-gaps and study monitoring O chemical safety assessment (CSA) and report (CSR) O PBT and vPvB assessment O technical dossier (IUCLID 5) O LGHQWLÂżFDWLRQ RI NQRZQ XVHV O development of exposure scenarios for HH and ENV O risk characterisation O FODVVLÂżFDWLRQ DQG ODEHOOLQJ O safety data sheets O consortium and Sief management
PROFILE: EBRC Consulting
CONTACTS Website
www.ebrc.de
info@ebrc.de
Head office
Raffaelstr 4, 30177 Hannover, Germany
Tel
+49 511 898389 0
Fax
+49 511 898389 10
Contact
Torsten Grewe
Directors
Dr RĂźdiger Battersby
Ownership
Privately owned
Locations
Germany
Founded
1993
Agrochemicals
Staff, group
50
Active substance approval and national product registration. (8 QRWLÂżFDWLRQ RI DFWLYH VXEVWDQFHV UHJXODWHG XQGHU UHJXODWLRQ (& 1R 1107/2009: O support of existing substances in the context of the EU review programme O support of new active substances O 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: O aII dossiers (dRRs) for registration and re-registration of plant protection products, label extensions and formulation changes O 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. O previous experience (among others) includes herbicides, fungicides, insecticides, rodenticides and nematicides.
Staff, chemical service provision
30
Biocides
OVERVIEW EBRC is a privately-owned consulting organisation based in Hannover, Germany, providing consulting services with a focus on chemical, biocidal DQG DJURFKHPLFDO LQGXVWULHV 6SHFLDOLVHG VFLHQWLÂżF H[SHULHQFH LV DYDLODEOH in all key disciplines relevant for product safety with respect to human health and environment. Task force management and coordination of industry consortia is another important aspect of our work. VITAL STATISTICS
2011/12
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
1
No of countries represented
1
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. O active substances (Annex I inclusion both of existing and new a.s.) O biocidal products (registration/authorisation in EU member states) O task force/consortia management O HYDOXDWLRQ RI VXEVWDQFHV Âą DV VSHFLÂżHG IRU LQGXVWULDO FKHPLFDOV DQG agrochemicals above
SERVICE AREA BREAKDOWN Training IT & 5% software 5% Representation & management 15%
Special services Consultancy/ advisory 75%
GLOBAL OFFICES EBRC Consulting GmbH Raffaelstr 4 30177 Hannover Germany
Page 78
(%5& KDV LQ KRXVH H[SHULHQFHG VFLHQWLÂżF VXSSRUW IRU D ZLGH UDQJH RI statistical services: O statistical (re-)evaluation of data O implementation of EU-models and/or scenarios (eg as given in OECD emission scenario documents) O ready-to-use spreadsheet solutions for various applications (eg VXEVWDQFH VSHFLÂżFDWLRQ
O probabilistic exposure assessments O derivation of species sensitivity distributions O 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: O importing and (re-)structuring of data O online generation status update reports O provision of web-interfaces for data-entry and analysis
Chemical Watch | Global Service Providers Guide 2013
STAFF SELECTION
1993
)RXQGDWLRQ RI (%5& LQLWLDO VWDIÂżQJ VL[ SHRSOH
RĂźdiger Battersby â&#x20AC;&#x201C; Director
2013
Continual growth, leading to a current staff count of 50
Dr RĂźdiger 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 EBRCâ&#x20AC;&#x2122;s agrochemical, biocidal and industrial chemical risk assessments. His professional expertise encompasses involvement in the German governmentâ&#x20AC;&#x2122;s review programme (BUA) on existing chemicals, representation of industry consortia in RA conducted under the ESR programme (793/93) and at EU-TCNES level, as well as the conduct of several dozen occupational exposure surveys in various sectors of the chemical industry. Among other professional activities, he is an appointed member of the German Expert Gremium for Chemicals Safety of the German Chemical Society.
PARTNERS ARCHE, Belgium CLIENTS A wide range of companies producing agrochemicals, biocides and industrial chemicals and/or formulated products. CASE STUDY 1: MEASE On behalf of EUROMETAUX, EBRC developed a tool for the estimation and assessment of occupational exposure (MEASE) which combines approaches from the EASE expert system, from the TRA tool and from the health risk assessment guidance for metals (HERAG). It represents a ZLGHO\ XVHG ÂżUVW WLHU VFUHHQLQJ WRRO IRU RFFXSDWLRQDO LQKDODWLRQ DQG GHUPDO exposure to metals and inorganic substances.
Arne Burzlaff â&#x20AC;&#x201C; Senior Registration Manager Industrial Chemicals
With its extensive background in metals risk assessments, EBRC was contracted from 2005-2007 by the European Metals Industry to compile a guidance document for the human health risk assessment of metals and inorganic metal compounds. The HERAG documents provide guidance WR WKH ZRUOGZLGH UHJXODWRU\ DQG VFLHQWLÂżF FRPPXQLW\ RQ VHYHUDO DVSHFWV of risk assessment methodology for metals where classic tools developed for organics are not applicable.
Dr Arne Burzlaff graduated as a chemist (2000) and obtained a PhD in technical chemistry/biotechnology (2005). He worked for the German Federal Institute for occupational safety and health, Division for Chemicals and Biocides Regulation (2005-2007) on dossier evaluation for biocides, collaboration in EU working groups and scoping issues on borderline cases among legal frameworks. Since 2007 he has been working at EBRC as senior scientist/toxicologist. In this position he has been compiling REACH registration dossiers, with a focus on human health hazard assessment and risk characterisation, and initiation and monitoring of experimental studies on industrial chemicals.
CASE STUDY 3: RiCoG
Andreas BĂźsing â&#x20AC;&#x201C; Senior Registration Manager Agrochemicals
The rigorous containment guide (RiCoG provides guidance to registrants of isolated intermediates on how rigorous containment (RiCo) of their intermediates can be assessed and documented according to the stipulations of regulation (EC) 1907/2006 (REACH). In an integrated assessment of SCC for an entire process (adopted from an approach published by Hirst et al. (2002)), RiCoG can be used to prioritise individual process steps requiring higher tier assessments, and provides an easy and structured way to assess and to document RiCo for the remaining process steps. Experts from various metals' industries have contributed with their practical experience to the development of RiCoG.
Andreas BĂźsing graduated as a biochemist at the University of Hannover $IWHU \HDUV RI H[SHULHQFHV LQ ELRFKHPLFDO DQDO\WLFV ZLWK VSHFLÂżF 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.
CASE STUDY 4: Development of standard handling frequencies of rodenticide baits
Dr Silke Burger graduated as a biologist (2000) and obtained a PhD in molecular biology/toxicology (2004). Since 2006 she has been working at EBRC as registration manager for biocides. In this position she has been compiling dossiers in support of 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.
CASE STUDY 2: HERAG (Health Risk Assessment Guidance)
'XH WR WKH QRQ H[LVWHQFH RI UREXVW ÂżJXUHV GHVFULELQJ WKH KDQGOLQJ 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 KDQGOLQJ ÂżJXUHV ZKLFK DUH WKH FXUUHQW VWDQGDUG IRU RSHUDWRU H[SRVXUH assessment and have been a key prerequisite for including anticoagulant rodenticide active substances in Annex I of Directive 98/8/EC.
Chemical Watch | Global Service Providers Guide 2013
Silke Burger â&#x20AC;&#x201C; Senior Registration Manager Biocides
Daniel Vetter â&#x20AC;&#x201C; 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 RFFXSDWLRQDO H[SRVXUH SURYLGLQJ ÂżUVW WLHU HVWLPDWHV RI LQKDODWLRQ DQG dermal exposure to metals. As part of his current work, he incorporates probabilistic techniques into the HEC (human equivalent concentrations) approach.
Page 79
PROFILE: EBRC Consulting
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
SERVICE AREA BREAKDOWN
Training 10%
Consultancy/ advisory 10% Information 10%
PROFILE: ECOonline
CONTACTS Website
www.ecoonline.com
lgp@ecoonline.com
Head office
Trudvangveien 77, N-3117 Toensberg, Norway
Tel/ Fax
+47 33 01 68 00/ +47 33 01 68 01
Contact
Mr Luis G Paulsen
Directors
Mr Ă&#x2DC;yvind Thorsen, CEO
Â
Mr Kjell Hamnes, CTO
Â
Ms Martina Jonsson, VP Product Management
Â
Mr Luis G Paulsen, VP International Sales
Ownership
Privately held, employees
Locations
Norway, Sweden, Finland, Denmark, Switzerland
SERVICES PROVIDED
Founded
2000
Supply chain communication
IT & software 70%
GLOBAL OFFICES Norway Sweden Finland Denmark Switzerland
SDS/eSDS authoring
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 VROXWLRQ IRU VXSSO\ FKDLQV DQG LQGXVWU\ ERGLHV VHHNLQJ HIÂżFLHQW PHDQV RI 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. $ WHDP RI HPSOR\HHV DQG D QHWZRUN RI KLJKO\ TXDOLÂżHG FRQVXOWLQJ partners, are ready to give a demonstration of the applications and EHQHÂżWV Please contact Mr Luis Paulsen for more information. VITAL STATISTICS Turnover, group
2011/12 -
1R RI RIÂżFHV
6
No of countries represented
8
Staff, chemical service provision
Page 80
SDS/eSDS database SDS substance/chemical inventory management Workplace risk assessment Employee exposure tracking and storing Up and downstream reporting CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2000
Founded by Mr Kjell Hamnes, long time industry professional ZLWK D YLVLRQ WR FUHDWH WKH ¿UVW DQG PRVW ZLGHO\ XVHG RQOLQH platform for SDS communication. HQ in Tønsberg, Norway
2001
/DXQFKHG WKH ÂżUVW LQWHJUDWHG RQOLQH VHUYLFH IRU 6'6 communication
2007
2SHQHG RIÂżFH LQ *RWKHQEXUJ 6ZHGHQ
2011
2SHQHG RIÂżFH LQ +HOVLQNL )LQODQG
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 ZHOFRPH DOO WR H[SORUH KRZ WKH VHUYLFH FDQ EHQHÂżW \RX DQG meet your requirements.
â&#x201A;Ź7m
Turnover, chemical service provision
Staff, group
SDS/eSDS distribution
65 -
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 QRWLÂżFDWLRQ DQG RFFXSDWLRQDO KHDOWK Please contact Mr Luis G Paulsen if you would like to learn more about opportunities for working together with ECOonline.
Chemical Watch | Global Service Providers Guide 2013
CLIENTS
STAFF SELECTION
Small and large, public and private, multinationals and locals, our clients represent most segments and industries. A total of more than 3,500 enterprises connect to the services.
Mr Kjell Hamnes â&#x20AC;&#x201C; Norway, International
Please contact us for testimonials. Weâ&#x20AC;&#x2122;ll be happy to provide you with referrals that are relevant to your needs and your industry! CASE STUDY 1: Automotive industry O O O
O
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 O
O
O
O
O
O
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 companyâ&#x20AC;&#x2122;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 WKLV LPSURYHV FRPPXQLFDWLRQ VLPSOLÂżHV ZRUN SURFHVVHV LQFUHDVHV speed, and reduces time spent on relevant tasks no installations are required, no local IT maintenance costs involved
Ms Martina Jonsson â&#x20AC;&#x201C; Sweden, International 0DUWLQD LV LQWHUQDWLRQDO SURGXFW PDQDJHU DW (&2RQOLQH DQG D NH\ ÂżJXUH in Sweden on the issue of REACH and SDS management. Mrs Christy Whiddon â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; International and Partner relations Luis is responsible for international operations and partner relations. Mr Ă&#x2DC;yvind Thorsen â&#x20AC;&#x201C; CEO Ă&#x2DC;yvind has extensive background from the software and computer industry.
CASE STUDY 3: Universities, hospitals, municipalities, public institutions O
O O
O
O O
O
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 WKH VXSSOLHUV EHQHÂżW IURP HDV\ DXWKRULQJ DQG GLVWULEXWLRQ RI 6'6V and the service to customers is greatly improved FRPPXQLFDWLRQ XSVWUHDP WR WKH VXSSOLHU LV VLPSOLÂżHG LQ WKH SODWIRUP 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 O
O O O
an automated service enabling direct communication between materials supplier, construction company and building project SDSs are automatically transferred to the inventory for the project saves time and workload for all parties ensures all correct documentation is in place, including technical information and workplace safety
Chemical Watch | Global Service Providers Guide 2013
Page 81
PROFILE: ECOonline
TESTIMONIALS
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.
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
PROFILE: ENVIRON
CONTACTS
Risk management, strategic support and regulatory compliance (REACH, CLP, biocides, PPP, cosmetics, food contact materials)
Website
www.environcorp.com
sbullock@environcorp.com
Head office
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
Â
Jose Fernandez (F), President Europe
Â
Sue Bullock (UK), Aidan Turnbull (UK)
Â
Henk Verhaar (NL), Martina Vosteen (DL)
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 clientsâ&#x20AC;&#x2122; technical, regulatory and commercial interests through sound science DQG VWUDWHJ\ FOLHQWV UHJXODUO\ HQWUXVW RXU PXOWL GLVFLSOLQDU\ WHDP ZLWK WKHLU PRVW UHFDOFLWUDQW DQG FULWLFDO SUREOHPV :H SURYLGH VWUDWHJLF VFLHQWLÂżF DQG 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.
Joseph Rodricks (US) Ownership
Private limited company
Locations
2YHU RIÂżFHV ZRUOGZLGH
Founded
1982
Global chemical notifications and regulatory compliance support
OVERVIEW An international health, environmental, safety and sustainability consultancy, ENVIRON works with clients to resolve their most demanding environmental and human health issues. Our global product safety and regulatory compliance team helps companies gain regulatory approval for products to comply with chemical regulations around the world. Beyond this, we assist industry leaders and innovators alike to 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 LQ SURGXFW VDIHW\ &OLHQWV DURXQG WKH ZRUOG EHQHÂżW IURP RXU XQLTXH DELOLW\ to bring clarity to issues at the intersection of science, business and policy. We provide a single point of support for chemical regulation and risk management. VITAL STATISTICS
2011/12
Turnover, group (2011)
â&#x201A;Ź223m
Turnover, chemical service provision
-
1R RI RIÂżFHV
89
No of countries represented
19
Staff, group
1,400
Staff, chemical service provision
50
SERVICE AREA BREAKDOWN Representation & management 10%
Laboratory 5%
ENVIRON evaluates obligations and provides support for regulatory DSSURYDOV UHTXLUHG WR PDUNHW SURGXFWV DFURVV $VLD 3DFLÂżF $PHULFD Europe and Africa. We assess new market opportunities, substance QRWLÂżFDWLRQ DQG UHJXODWRU\ REOLJDWLRQV FODVVLÂżFDWLRQ DQG ODEHOOLQJ *+6 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: O toxicology (and toxicokinetic modelling) O epidemiology O exposure modelling, measurement and reconstruction O risk assessment and mitigation O ecotoxicology O environmental fate O regulatory affairs O chemistry O occupational health O supply chain issues O product vigilance O advocacy This means we are ideally placed to advise clients on problems â&#x20AC;&#x201C; 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.
Consultancy/ advisory 85%
Page 82
Chemical Watch | Global Service Providers Guide 2013
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
CASE STUDY 4: Exposure data drives regulatory scrutiny
1982
Founded in Washington, DC, USA
1996
Acquired UK consultancy EAG
2000
2SHQHG RIÂżFHV LQ ,WDO\ )UDQFH *HUPDQ\ DQG )LQODQG
2001
2SHQHG RIÂżFHV LQ $XVWUDOLD &KLQD 0DOD\VLD DQG 6LQJDSRUH
2003
Merged with AEI to bring full range of services in occupational health, environmental health and injury and disability research
'HWHFWDEOH OHYHOV RI SHUĂ&#x20AC;XRURRFWDQRDWH 3)2 KDYH EHHQ PHDVXUHG LQ 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.
2008
Acquired Gustitus Group.
2009
Acquired ArquipĂŠlago in Brazil
2010
Chemical Industry Association (CIA) REACH service provider of the year
2012
2SHQHG ÂżUVW $IULFDQ RIÂżFH LQ -RKDQQHVEXUJ
Clients in the following industries: industrial and specialty chemicals, petrochemicals, agrochemicals, food and food packaging, cosmetics, medical devices, electronics, manufacturing TESTIMONIALS â&#x20AC;&#x153;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)â&#x20AC;? â&#x20AC;&#x201C; Dr Hans Certa, manager global product safety, SASOL. â&#x20AC;&#x153;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 WR EH HIÂżFLHQW FRVW HIIHFWLYH DQG GHOLYHUV UHVXOWV DV H[SHFWHG´ Âą -DPHV ( Mumby PhD, global director product stewardship and regulatory affairs, Elementis Specialties Inc. Âł7KLV LV MXVW SHUIHFW , ZLOO QHYHU DJDLQ EH LQĂ&#x20AC;XHQFHG E\ VLWH DUJXPHQWV LQ RWKHU FRXQWULHV WKDW ZH VKRXOG KLUH ORFDO ÂżUPV WR SHUIRUP ULVN DVVHVVPHQWV ,I WKH\ KDG DJUHHG WR XVH (19,521 LQ WKH ÂżUVW SODFH 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 requestedâ&#x20AC;? â&#x20AC;&#x201C; 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 DQG &65V IRU D JURXS RI KLJK SURÂżOH KD]DUGRXV RUJDQLF VXEVWDQFHV 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 PRGHOOHG GDWD IRU FDUHIXOO\ GHÂżQHG H[SRVXUH VFHQDULRV LQ RUGHU WR EH accessible and useful to registrants and their customers alike. CASE STUDY 2: Support for SVHC and Annex XIV REACH :H SURYLGHG VWUDWHJLF DQG VFLHQWLÂżF VXSSRUW WR KHOS LQGXVWU\ GHYHORS 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 â&#x20AC;&#x201C; new consumer product ENVIRON evaluated regulatory obligations in more than 50 countries, FRQVLGHULQJ FKHPLFDO QRWLÂżFDWLRQ SDFNDJLQJ DQG ODEHOOLQJ UHTXLUHPHQWV for a company wishing to market a product globally. The review allowed LGHQWLÂżFDWLRQ RI NH\ PDUNHW RSSRUWXQLWLHV :H WKHQ SUHSDUHG QRWLÂżFDWLRQV IRU SULRULW\ FRXQWULHV LQFOXGLQJ LGHQWLÂżFDWLRQ DQG PDQDJHPHQW RI ORFDO UHSUHVHQWDWLYH WR ÂżOH GRFXPHQWV DV QHHGHG
Chemical Watch | Global Service Providers Guide 2013
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 FRPPXQLFDWLRQV DV ZHOO DV VXSSRUWLQJ SURGXFW UHJXODWRU\ QRWLÂżFDWLRQV CASE STUDY 6: Review proposed carcinogenicity classification 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 â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; Principal, chemist and ecotoxicologist Over 20 years' experience in modelling the fate of chemicals in the environment and assessing and predicting their ecotoxicity, Henkâ&#x20AC;&#x2122;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 â&#x20AC;&#x201C; 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 SURGXFW DQG HQYLURQPHQWDO OLDELOLW\ ÂżQDQFLDO ORVVHV SDUWLFXODUO\ IRU WKH chemical, pharmaceutical, medical devices and food industries. She has DFWHG DV WHFKQLFDO VFLHQWLÂżF H[SHUW LQ VHYHUDO SURGXFW OLDELOLW\ FDVHV DQG advises the industry in relation to REACH and other product regulatory relations (cosmetics, pesticides, etc). Dr Joe Rodricks â&#x20AC;&#x201C; Principal, toxicologist $Q LQWHUQDWLRQDOO\ UHFRJQLVHG H[SHUW LQ WKH ÂżHOG RI WR[LFRORJ\ DQG 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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PROFILE: ENVIRON
CLIENTS
CASE STUDY 5: Regulatory action related to product contamination
SERVICES PROVIDED Regulatory compliance O
CONTACTS
O
PROFILE: EQUITOX
O
Website
www.equitox.eu and www.sci-env.ch
contact@equitox.eu
Head office
63 rue AndrĂŠ 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
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Dr Erwan Saouter, Director S&E
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EquiTox and S&E are associated since 01.2012
Ownership
Private company
Locations
Lyon, France Geneva, Switzerland
Founded
2011 (EquiTox), 2007 (S&E)
O O
REACH: data collection, data gap analysis and testing. REACH registration dossiers (IUCLID) and submission to ECHA via REACHIT, chemical safety reports (CSR), exposure scenario and scaling, etc biocides and cosmetics FODVVLÂżFDWLRQ DQG ODEHOOLQJ QRWLÂżFDWLRQ & / FODVVLÂżFDWLRQ RI substance and mixtures according to CLP, GHS UN, DSD, DPD registration dossiers (China, US...) ecolabels.
Regulatory information O O O O O
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 JOREDO SURGXFW VWUDWHJ\ *36 VXPPDU\ DQG HFR WR[LFRORJLFDO SURÂżOH
Product advocacy and project management O O O
product defence strategy animation and technical representation in consortia communication strategy
Impact assessment and eco-design O
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 RI ÂżYH KLJKO\ TXDOLÂżHG H[SHUWV HDFK ZLWK WHQ WR \HDUV RI H[SHULHQFH 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. VITAL STATISTICS
2011/12
Turnover, group
â&#x201A;Ź950,000
Turnover, chemical service provision
â&#x201A;Ź750,000
1R RI RIÂżFHV
2
No of countries represented
2
Staff, group
6
Staff, chemical service provision
5
O
O O
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
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007
Science & Environnement founded
2011
EquiTox founded S&E approved as REACH Ready supplier
2012
Association between EquiTox and S&E
ACCREDITATIONS O O O
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, Lâ&#x20AC;&#x2122;OrĂŠal, Procter & Gamble, Roquette, Laboratoires Expanscience, UIC Rhone-Alpesâ&#x20AC;Ś
SERVICE AREA BREAKDOWN Training 10% Information 3%
Representation & management 30%
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Consultancy/ advisory 57%
Chemical Watch | Global Service Providers Guide 2013
STAFF SELECTION
(TXL7R[ ZDV DVNHG WR GHWHUPLQH WKH RFWDQRO ZDWHU FRHIÂżFLHQW IRU PXOWL FRQVWLWXHQW VXEVWDQFHV 7KH PRVW HIÂżFLHQW ZD\ WR REWDLQ WKH ORJ.RZ ZDV to use QSAR models. In order to provide reliable and robust predictions the project was divided in four steps: O 46$5 PRGHOV VHOHFWLRQ O 46$5 YDOLGDWLRQ O GUDIWLQJ RI 4635 DQG ,8&/,' HQWULHV O training of the customerâ&#x20AC;&#x2122;s technical team. 7KH ÂżUVW NH\ SRLQW ZDV WR ÂżQG UHOHYDQW 46$5 PRGHOV DOORZLQJ REWDLQLQJ UHOHYDQW SUHGLFWLRQV FRQVLGHULQJ WKH VWUXFWXUDO VSHFLÂżFLWLHV RI WKH 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.
Dr Christine Reteuna â&#x20AC;&#x201C; Regulatory Ecotoxicologist â&#x20AC;&#x201C; EquiTox
CASE STUDY 2: Extended SDS â&#x20AC;&#x201C; 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: O the training of key people (HSE, product-stewardship, plant managementâ&#x20AC;Ś) on the different drawbacks related to this new set of information (regulatory, administrative, relationship with customers, WHFKQLFDO VNLOOVÂŤ O the internal IT solutions for tracking a raw material on a manufacturing VLWH IURP WKH SXUFKDVH VHUYLFH WR WKH SODQW IDFLOLWLHV O the description of the occupational tasks, starting from HSE language to REACH understandable vocabulary, and the comparison with the H[SRVXUH VFHQDULRV UHTXLUHPHQWV O 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 â&#x20AC;&#x153;Annex IX and X testing proposalsâ&#x20AC;?. The registrants now face ECHAâ&#x20AC;&#x2122;s draft decision requesting them to perform animal testing that will cost several â&#x201A;Ź100k, and they are disconcerted. A lack of continuity in service provider FDSDFLWLHV FDQ SXW D UHJLVWUDQW LQ GLIÂżFXOWLHV IRU LWV EXVLQHVV VXVWDLQDELOLW\ 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 GRVVLHU WR GHÂżQH DOO WKH DYDLODEOH RSWLRQV DQG WKH UHODWHG OHJDO DQG business risks, and to submit comments to ECHA. Once the consensus was reached between the customer, ECHA and the member state FRPSHWHQW DXWKRULWLHV WKH GHFLVLRQ ZDV ÂżQDOLVHG DQG D SDQHO RI &52V has been contacted for budgeting the studies.
Chemical Watch | Global Service Providers Guide 2013
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 VFLHQWLÂżF (&(72& DQG SURIHVVLRQDO RUJDQLVDWLRQV 8,& $63$ &HÂżFÂŤ &KULVWLQH GHYHORSHG VSHFLÂżF VNLOOV LQ WKH DVVHVVPHQW RI HQYLURQPHQWDO LPSDFW RI FKHPLFDO SURGXFWV HJ SRO\PHUV VXUIDFWDQWV FRVPHWLFV covering data collection, study monitoring, the establishment of HFRWR[LFRORJLFDO SURÂżOHV SURGXFW FODVVLÂżFDWLRQ DQG ULVN DVVHVVPHQW 6KH took part in the production of several regulatory dossiers and their support against competent authorities. Dr Erwan Saouter â&#x20AC;&#x201C; 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, ,QVWLWXW 1DWLRQDO GH OD 5HFKHUFKH 6FLHQWLÂżTXH 4XHEHF (UZDQ KDV GHYHORSHG H[SHUWLVH LQ WKH ÂżHOGV RI HQYLURQPHQWDO VFLHQFH DQG ULVN DVVHVVPHQW VFLHQWLÂżF FRPPXQLFDWLRQ VXVWDLQDEOH GHYHORSPHQW DQG VWDNHKROGHU GLDORJXH VFLHQWLÂżF SXEOLF UHODWLRQV FRPPXQLFDWLRQ ZLWK media and governments. StĂŠphanie Moulin â&#x20AC;&#x201C; Regulatory Toxicologist â&#x20AC;&#x201C; EquiTox StĂŠphanie spent ten years working in the chemical industry for Rhodia, as regulatory toxicologist. She also worked for the CNRS (French national VFLHQWLÂżF UHVHDUFK FHQWHU LQ WKH FKHPLFDO ULVN SUHYHQWLRQ XQLW DQG KDV teaching experience. 6WpSKDQLHÂśV PDLQ ÂżHOGV RI DFWLYLWLHV DUH WKH GHYHORSPHQW RI WHVWLQJ methods, the cost optimisation strategies and the use of based on analogy and weight of evidence approaches, the selection DQG TXDOLÂżFDWLRQ RI &52V WKH UHJLVWUDWLRQ VWUDWHJLHV LQ (XURSH DQG LQ other zones, and chemical product defence. In addition, StĂŠphanie is specialised in human health risk assessment, with a focus on the safety assessment of cosmetic products. E
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Dr Marie-Laure Teisseire â&#x20AC;&#x201C; Regulatory ecotoxicologist â&#x20AC;&#x201C; EquiTox 0DULH /DXUH VWDUWHG KHU FDUHHU LQ UHVHDUFK UHVHDUFK LQ WKH ÂżHOG RI JURXQG and surface water pollution, and teaching (six years at the University of Reims) and continued as a regulatory ecotoxicologist for a Chemical Company (Rhodia). 7KH PDLQ SURMHFWV PDQDJHG E\ 0DULH /DXUH VXFK DV QRWLÂżFDWLRQ RI QHZ substances in EU or China or compilation of REACH dossiers, allowed her to improved her expertise in environmental exposure assessment WR HQYLURQPHQWDO ULVN FKDUDFWHULVDWLRQ DQG WKH GHÂżQLWLRQ RI ULVN UHGXFWLRQ VWUDWHJLHV 6HYHUDO RWKHU ÂżHOGV RI H[SHUWLVH DUH HQYLURQPHQWDO DQG physico-chemical hazard assessment of chemical products, study monitoring and hazard communication (SDS, C&L). Dr Benoit Fraysse â&#x20AC;&#x201C; Regulatory (Eco)toxicologist â&#x20AC;&#x201C; 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 KDV SDUWLFXODUO\ GHYHORSHG KLV H[SHUWLVH LQ WKH ÂżHOGV RI GHYHORSPHQWDO 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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PROFILE: EQUITOX
CASE STUDY 1: Use of QSAR for multi-constituent substances
O O O O O
chemical safety assessments &/3 QRWLÂżFDWLRQV Sief management REACH compliance assessments support advocacy
Toxicology, ecotoxicology and risk assessment
PROFILE: ERM
CONTACTS
Study placement/ protocol review and development, development of UREXVW VWXG\ VXPPDULHV UHYLHZ RI GDWD IRU FODVVLÂżFDWLRQ SXUSRVHV EHS risk assessments
Website
www.erm.com
rudolf.wilden@erm.com
Head office
Frankfurt: SiemensstraĂ&#x;e 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)
Classification, labelling and packaging (CLP/GHS) &ODVVLÂżFDWLRQ VXSSRUW VDIHW\ GDWD VKHHW 6'6 DQG ODEHO DXWKRULQJ SDS and label review and improvement Emerging chemical control laws around the world 1HZ FKHPLFDO QRWLÂżFDWLRQ WUDFNLQJ RI HPHUJLQJ OHJLVODWLRQ EDQV UHVWULFWLRQV Downstream product legislation, eg food/food contact, biocides O O
Ownership
Private Limited Company
O
Locations
140
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Founded
1971
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IRRG FRQWDFW QRWLÂżFDWLRQV FRPSOLDQFH ZLWK FRXQWU\ VSHFLÂżF OHJLVODWLRQ FIFRA / BPD/BPR support national registrations local/ regional registration labelling and claims support
Lifecycle assessment and sustainability
OVERVIEW Environmental Resources Management (ERM) is one of the worldâ&#x20AC;&#x2122;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 SRVLWLRQHG DV D VWUDWHJLF JURZWK LQLWLDWLYH ZLWKLQ WKH ÂżUP (50 RIIHUV integrated product service across all divisions within the company.
O O O O O O O
VITAL STATISTICS
2012
Turnover, group
$572m
Turnover, chemical service provision
$10m
1R RI RIÂżFHV
O
carbon footprinting and emission inventories lifecycle management (LCM) also to ISO14040 LQSXW RXWSXW DV ZHOO DV HFR HIÂżFLHQF\ DQDO\VLV supply chain management and carbon reduction advice design for environment (DfE) environmental product declarations (EPDs) lifecycle analysis (LCA) sustainable business strategy
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2010
Preparation of more than 100 REACH registration dossiers DQG FRPSLODWLRQ RI WKH ÂżUVW VRFLR HFRQRPLF DQDO\VLV 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
140
No of countries represented
39
Staff, group
> 4,500
Staff, chemical service provision
>50
SERVICE AREA BREAKDOWN Training 10%
ACCREDITATIONS
Representation & management 20%
ISO 9001 & ISO 14001 PARTNERS Consultancy/ advisory 70%
GLOBAL OFFICES
3DUWQHU RI &HÂżF ReachCentrum CLIENTS ,Q WKH SDVW ÂżYH \HDUV ZH KDYH ZRUNHG IRU PRUH WKDQ RI WKH *OREDO Fortune 100 and more than 50% of the Global Fortune 500 companies.
We support our clients in all countries globally. SERVICES PROVIDED Registration, evaluation and authorisation of chemicals (REACH) O O O O
socio-economic analyses preparation of application for authorisation REACH training/ REACH impact assessments preparation of lead and member registration dossiers
Page 86
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 FROODERUDWLRQ %RWK RQ SUDFWLFDO FRPPXQLFDWLYH DQG WHFKQLFDO VFLHQWLÂżF 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." â&#x20AC;&#x201C; Frits Wielaard, REACH programme manager, Merck Sharp & Dohme
Chemical Watch | Global Service Providers Guide 2013
CASE STUDY 1: Supporting the REACH team of Momentive Performance Materials (MPM) MPM required support for its REACH team using ERMâ&#x20AC;&#x2122;s REACH expertise, including toxicologists, ecotoxicologists and chemists. The ERM REACH SURMHFW WHDP ZDV IXOO\ LQWHJUDWHG LQWR WKH 030 WHDP DQG HDUO\ LGHQWLÂżFDWLRQ and discussions of issues encountered provided timely resolution of such. Benefits and value: O WLPHO\ DQG VXFFHVVIXO VXEPLVVLRQ RI DOO UHJLVWUDWLRQ GRVVLHUV LQ O comprehensive documentation of approaches and work products to HQDEOH 030 WR GHPRQVWUDWH FRPSOLDQFH WR WKH (&+$ &$V O alignment of global teams with same company culture ensures highly HIÂżFLHQW FRRSHUDWLRQ O cooperation of the team with a view beyond registration (eg on health DQG VDIHW\ PDQDJHPHQW KHOSHG VROYLQJ XSFRPLQJ LVVXHV O OHVVRQV OHDUQHG GXULQJ WKH ÂżUVW UHJLVWUDWLRQ SKDVH ZLOO LQIRUP DQG streamline future REACH management. CASE STUDY 2: Supporting a multinational pharmaceutical companyâ&#x20AC;&#x2122;s new chemical registration in China An ERM client needed to register a new chemical product with high toxicity HJ ÂżVK /& K Č?J / LQ &KLQD 'XH WR LWV KLJK WR[LFLW\ WKH UHJLVWUDWLRQ 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: O VXFFHVVIXOO\ UHJLVWHUHG WKH QHZ FKHPLFDO SURGXFW ZLWK RQH VXEPLVVLRQ O to facilitate the approval, full and comprehensive analysis, which was QRW IRUPDOO\ UHTXHVWHG ZDV SURYLGHG LQ DGGLWLRQ WR 0(3 O utilise the laboratory data, analysis results and ERMâ&#x20AC;&#x2122;s expertise and experience to forego several expensive and time-consuming laboratory tests, saving time and cost for the client.
Dominique Gangneux â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; Technical Director PhD in microbial biochemistry, coordinating ERMâ&#x20AC;&#x2122;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 â&#x20AC;&#x201C; Senior Ecotoxicologist PhD in biological sciences with 20 years of experience in risk assessment, ecological research, environmental science with consulting ÂżUPV DFDGHPLF LQVWLWXWLRQV DQG JRYHUQPHQW Dr Randy Shuler â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; Principal Partner +DV \HDUV RI H[SHULHQFH LQ WKH ÂżHOG RI (+6 FRPSOLDQFH DQG 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 â&#x20AC;&#x201C; Principal Partner +DV \HDUVÂś FRQVXOWLQJ H[SHULHQFH LQ WKH ÂżHOGV RI (+6 FRPSOLDQFH REACH and risk assessment. Donna Morrall â&#x20AC;&#x201C; 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 yearsâ&#x20AC;&#x2122; 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.
STAFF SELECTION
Carolyn Hammer â&#x20AC;&#x201C; Senior Ecotoxicologist
ERMâ&#x20AC;&#x2122;s Global Product Stewardship TEAM (GPS)
%HIRUH MRLQLQJ (50 &DURO\Q ZRUNHG IRU WKH 86 (3$ LQ WKH ÂżHOGV RI ecological risk assessment of pesticides and the development of new Federal rules and regulations related to waste, chemicals and pesticides.
(50 KDV PRUH WKDQ SURIHVVLRQDOV ZLWK H[WHQVLYH VSHFLÂżF *36 H[SHULHQFH ORFDWHG DW YDULRXV RIÂżFHV ZRUOGZLGH 7KHVH FRQVXOWDQWV DUH able to utilise the full resources of ERM globally to provide full back-up for all GPS-related services.
Dianne Green â&#x20AC;&#x201C; Senior Project Manager
PhD in environmental sciences with more than 12 yearsâ&#x20AC;&#x2122; consulting H[SHULHQFH LQ WKH ÂżHOGV RI (+6 SURGXFW FRPSOLDQFH VXEVWDQFH UHJLVWUDWLRQ QRWLÂżFDWLRQ VFKHPHV DQG ULVN DVVHVVPHQW
0RUH WKDQ \HDUV RI H[SHULHQFH LQ WKH ÂżHOG RI JOREDO SURGXFW VWHZDUGVKLS DQG UHJXODWRU\ DIIDLUV GLYHUVH H[SHULHQFH LQ 86 DQG LQWHUQDWLRQDO SURGXFW 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.
Dr Salvatore Giolando â&#x20AC;&#x201C; Head of Global Product Stewardship Team
Tze Shin Goh â&#x20AC;&#x201C; Principal Consultant
Dr Rudolf Wilden â&#x20AC;&#x201C; Product Sustainability Lead Central Europe
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
Chemical Watch | Global Service Providers Guide 2013
0RUH WKDQ \HDUV RI H[SHULHQFH ZRUNLQJ LQ VXEVWDQFH QRWLÂżFDWLRQ (+6 compliance, management systems and performance improvement and assurance projects in various European and Asian countries.
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PROFILE: ERM
â&#x20AC;&#x153;ERM have provided support and advice for us throughout the pre-registration and registration phase of REACH and have always been totally professional, Ă&#x20AC;H[LEOH DQG TXLFN WR UHVSRQG WR RXU QHHGV 7KH\ SURYLGH DQ H[FHOOHQW VHUYLFH and we look forward to continuing our partnership with them in the years to come.â&#x20AC;? â&#x20AC;&#x201C; Steve Williams, Regulatory Manager Europe, Knauf Insulation â&#x20AC;&#x153;ERM has been Momentiveâ&#x20AC;&#x2122;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.â&#x20AC;? â&#x20AC;&#x201C; Ralf Maecker, Momentive Performance Materials
SERVICES PROVIDED General REACH services ([SRQHQW V FRQVXOWDQWV KDYH VLJQLÂżFDQW H[SHULHQFH LQ WKH SURYLVLRQ RI D 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 SKDVHV ([SRQHQW KDV VLJQLÂżFDQW H[SHULHQFH LQ SURJUDPPH DQG SURMHFW management and Sief and consortia management and we can also act as your only representative registrant or third party representative.
CONTACTS Website
www.exponent.com
jreddy@uk.exponent.com
PROFILE: Exponent
Head office The Lenz, Hornbeam Business Park, Harrogate, North Yorkshire, HG2 8RE, UK Tel
+44 (0)1332 868000
Fax
+44 (0)1332 868099
Contact
Julian Reddy
Ownership
Wholly owned subsidiary of Exponent Inc.
Locations
'HUE\ 8. %DVHO 6ZLW]HUODQG
Founded
2002
Preparation of REACH registration dossiers and chemical safety reports
OVERVIEW Exponent Inc is one of the world's largest regulatory, engineering and VFLHQWLÂżF FRQVXOWDQFLHV SURYLGLQJ LQQRYDWLYH VROXWLRQV WR FRPSOH[ WHFKQLFDO problems. Exponent International Limited is a wholly owned subsidiary of Exponent Inc and is the European arm of the Chemical Regulation and )RRG 6DIHW\ SUDFWLFH ZLWK RIÂżFHV LQ +DUURJDWH DQG 'HUE\ LQ WKH 8. DQG Basel in Switzerland. Exponent combines unparallelled technical expertise with the ability to focus this knowledge to meet our clientsâ&#x20AC;&#x2122; needs within short timeframes. Our ability to create multidisciplinary teams of scientists, regulatory consultants and project managers means that we can either SHUIRUP LQ GHSWK VFLHQWLÂżF UHVHDUFK DQG DQDO\VLV RU YHU\ UDSLG UHVSRQVH evaluations to provide our clients with the critical information that they need to make day-to-day strategic decisions. VITAL STATISTICS
2011/12
Turnover, group
Est US$10m
Turnover, chemical service provision
Est US$3m
1R RI RIÂżFHV
3
No. of countries represented
35
Staff, group
50
Staff, chemical service provision
30
SERVICE AREA BREAKDOWN Training Other 2% 3% Information 5%
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 LGHQWLÂżFDWLRQ XVH RI LQWHOOLJHQW VWUDWHJLHV WR DGGUHVV GDWD JDSV DQG VWXG\ 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. 2QFH WKH DVVHVVPHQWV KDYH EHHQ FRPSOHWHG ZH FDQ SURGXFH WKH ÂżQDO exposure scenarios and extended safety data sheets. Global chemical notifications Our consultants have considerable experience in compiling and VXEPLWWLQJ FKHPLFDO QRWLÂżFDWLRQV ZRUOGZLGH XWLOLVLQJ RXU WHDP RI specialists we are capable of preparing and submitting chemical QRWLÂżFDWLRQV WR DOO FRXQWULHV WKDW RSHUDWH D UHOHYDQW VFKHPH :H FDQ prepare and submit dossiers for Australian, Canadian, New Zealand and 6ZLVV UHJLVWUDWLRQV DQG FDQ DFW DV VROH UHSUHVHQWDWLYH QRWLÂżHU XWLOLVLQJ RXU 6ZLVV RIÂżFH :H KDYH D QHWZRUN RI ORFDO DJHQWV WR KHOS ZLWK WKH preparation and submission of regulatory documentation in China, Japan, Korea, the Philippines, Taiwan and Turkey and can utilise the experience RI RXU 86 FROOHDJXHV IRU 76&$ QRWLÂżFDWLRQV Other regulatory regimes ([SRQHQW V FRQVXOWDQWV KDYH VLJQLÂżFDQW H[SHULHQFH LQ DVVLVWLQJ 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 UHJXODWRU\ VWUDWHJ\ DQG FDQ SUHSDUH WKH SURGXFW LQIRUPDWLRQ ÂżOHV DQG cosmetic product safety reports. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Representation & management 25% Consultancy/ advisory 65%
GLOBAL OFFICES *OREDO KHDG RIÂżFH ([SRQHQW ,QF &RPPRQZHDOWK 'ULYH 0HQOR Park, CA 94025, USA 2WKHU 8. RIÂżFH 3ULGH 3RLQW 'ULYH 3ULGH 3DUN 'HUE\ '( %; United Kingdom 6ZLW]HUODQG RIÂżFH $HVFKHQYRUVWDGW %DVHO 6ZLW]HUODQG
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1967
Parent company Exponent Inc formed
2001
Novigen Sciences formed
2002
Novigen acquired by Exponent. Exponent International Limited established in the UK
2006
Exponent REACH team formed
2008
'HUE\ 8. RIÂżFH RSHQHG
2010
%DVHO 6ZLW]HUODQG RIÂżFH RSHQHG
ACCREDITATIONS ISO 9001 accreditation
Chemical Watch | Global Service Providers Guide 2013
CASE STUDY 3: REACH support for the 2013 deadline
:H KDYH QR IRUPDO SDUWQHUV EXW XVH DQ LQIRUPDO QHWZRUN RI OHJDO ÂżUPV CROs and in-country agents to provide the best service to our clients for 5($&+ DQG JOREDO FKHPLFDO QRWLÂżFDWLRQV
([SRQHQW SURYLGHV IXOO DVVLVWDQFH IRU D ÂżQH FKHPLFDO PDQXIDFWXUHU LQ 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 LGHQWLW\ SURÂżOHV DQG ZH DUH FXUUHQWO\ LQ WKH SURFHVV RI ÂżQLVKLQJ WKH 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 DQG SURYLGH RXU FOLHQW ZLWK FRQÂżGHQFH WKDW WKH\ ZLOO PHHW WKHLU 5($&+ obligations ahead of the 2013 deadline.
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 LQGXVWULHV FRPSDQLHV UDQJLQJ IURP 60(V ZRUNLQJ LQ RQH LQGXVWU\ WR JOREDO companies conducting business in all areas of the chemical industry. TESTIMONIALS "Exponent International has consistently provided high-quality REACH DQG ELRFLGHV VHUYLFHV DQG VXSSRUW WR RXU FRPSDQ\ IRU RYHU ÂżYH \HDUV 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 ZKHQ ZH QHHG KHOS LQ WKHVH DUHDV Ă 5HJXODWRU\ $IIDLUV 0DQDJHU JOREDO 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 WDVNV WKDW KDYH EHHQ XQGHUWDNHQ LQ VXSSRUW RI WKLV SURMHFW DUH LGHQWLÂżFDWLRQ 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 UHJLPHV IRU RYHU ÂżYH \HDUV 7DNLQJ D KROLVWLF DSSURDFK ZH SURYLGH JOREDO 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 GRFXPHQWDWLRQ IRU ZRUOGZLGH FKHPLFDO QRWLÂżFDWLRQV SUHSDULQJ DQG UHYLHZLQJ (XURSHDQ VDIHW\ GDWD VKHHWV DQG GHWHUPLQLQJ WKH FODVVLÂżFDWLRQ and labelling of the substances for GHS inside and outside of the EU. We DOVR DFW DV D VROH UHSUHVHQWDWLYH IRU WKHLU 6ZLVV QRWLÂżFDWLRQV )ROORZLQJ the sale of part of this companyâ&#x20AC;&#x2122;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.
Chemical Watch | Global Service Providers Guide 2013
STAFF SELECTION Dr Caroline Harris â&#x20AC;&#x201C; 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 UKâ&#x20AC;&#x2122;s Advisory Committee on Pesticides since 2009. Julian Reddy â&#x20AC;&#x201C; 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 FKHPLFDO QRWLÂżFDWLRQ VFKHPHV 0U 5HGG\ PDQDJHV ([SRQHQWÂśV 'HUE\ RIÂżFH ZKLFK VSHFLDOLVHV LQ 5($&+ DQG WKH JOREDO QRWLÂżFDWLRQ RI LQGXVWULDO chemicals. He is responsible for the management of individual projects as well as overall programme management for clients and consortia. John Hislop â&#x20AC;&#x201C; REACH Regulatory Specialist Mr Hislop specialises in REACH and particularly the registration requirements for phase-in substances. He has almost 20 years of H[SHULHQFH ZRUNLQJ RQ JOREDO QRWLÂżFDWLRQV RI QHZ FKHPLFDO VXEVWDQFHV Mr Hislop has considerable experience in the preparation of regulatory documentation, development of testing programmes for regulatory purposes specialising in the use of an â&#x20AC;&#x153;intelligent approachâ&#x20AC;? to safety testing and is a leading advocate of the principle of the read-across approach. Dr Alec Willis â&#x20AC;&#x201C; REACH Regulatory Specialist Dr Willis leads Exponentâ&#x20AC;&#x2122;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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PROFILE: Exponent
PARTNERS
VITAL STATISTICS
PROFILE: Harlan Laboratories
www.harlan.com/crs
crs.uk@harlan.com
Head office
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
Â
Manuela Leone
Ownership
Private company
Locations
:RUOGZLGH RIÂżFHV DQG RSHUDWLRQV
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 DQG VWXG\ GLUHFWRUV FRPELQH UHJXODWRU\ DQG VFLHQWLÂżF DFXLW\ ZLWK WKH 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, itâ&#x20AC;&#x2122;s UHDOO\ DOO DERXW VFLHQWLÂżF H[FHOOHQFH 7RGD\ UHVHDUFK LV LQFUHDVLQJO\ EHLQJ RXWVRXUFHG DQG UHVHDUFKHUV QHHG WR KDYH FRQÂżGHQFH LQ WKHLU VXSSOLHU partners. Stability, reliability, consistency, and quality are all essential. Thatâ&#x20AC;&#x2122;s what Harlan Laboratories offers with our passion for science and decades of proven expertise in both research models and services, and contract research services. Products and services Harlan is made up of two major business units offering local expertise, presence, service, and state-of-the-art facilities in all of the countries it serves. Contract Research Services provides non-clinical and pre-clinical laboratory research services supported by state-of-the-art facilities worldwide. Our core capabilities are in: O URGHQW DQG QRQ URGHQW WR[LFRORJ\ O JHQHWLF WR[LFRORJ\ O HFRWR[LFRORJ\ O LQKDODWLRQ WR[LFRORJ\ O UHSURGXFWLRQ WR[LFRORJ\ O UHJXODWRU\ DIIDLUV FRQVXOWLQJ DQG SURJUDPPH PDQDJHPHQW O DQDO\WLFDO FKHPLVWU\ O HQYLURQPHQWDO IDWH DQG PRGHOOLQJ O DOWHUQDWLYH WHVWLQJ O SDWKRORJ\ VHUYLFHV O GUXJ PHWDEROLVP DQG SKDUPDFRNLQHWLFV O discovery services. G
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Turnover, chemical service provision
-
1R RI RIÂżFHV
12
Staff, group
Website
F
Turnover, group
No of countries represented
CONTACTS
E
2012
2,800
Staff, chemical service provision
800
SERVICE AREA BREAKDOWN Consultancy/ advisory 30%
Laboratory 70%
GLOBAL OFFICES France, Germany, Israel, Italy, Japan, Korea, Mexico, Netherlands, Spain, Switzerland, UK, US SERVICES PROVIDED REACH testing +DUODQ /DERUDWRULHV FDQ RIIHU DOO VWDQGDUG DQG KLJKHU WLHU VWXGLHV LQ WKH ÂżHOGV 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 SK\VLFR FKHPLFDO WHVWV HQYLURQPHQWDO IDWH ODE DQG ÂżHOG DQLPDO $'0( 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
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Chemical Watch | Global Service Providers Guide 2013
STAFF SELECTION
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 LQFOXGH DFFHVV WR LQ VLOLFR DQDO\VLV WR DVVLVW LQ KD]DUG LGHQWLÂżFDWLRQ DQG risk assessment.
John Handley, BSc MSc CBiol FSB â&#x20AC;&#x201C; Global Vice President Operations
1931
Foundation
2004
Acquisition RCC Ltd
John Handley is global vice president Operations at Harlan Laboratories Ltd and has some 26 yearsâ&#x20AC;&#x2122; 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.
2005
Acquisition Cidasal SA
Ciriaco Maraschiello
2007
Acquisition SafePharm Laboratories
2007
Acquisition IMTC (surgical models)
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 $JUR ,QGXVWU\ 5HVHDUFK SURJUDP FRQVLVWLQJ RI LQYHVWLJDWLQJ D VSHFLÂżF 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 &KHPLVWU\ GHSDUWPHQW LQ WKH ÂżUVW \HDUV RI KLV SURIHVVLRQDO FDUHHU DQG ZDV 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.
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 clientsâ&#x20AC;&#x2122; products. Our turnkey service, from the initiation of a project to SUHSDUDWLRQ RI WKH ÂżQDO GRVVLHU HQVXUHV UHJXODWRU\ FRPSOLDQFH :LWK 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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
ACCREDITATIONS Contract Research Services (CRS): AALAC O ISO/IEC 17025 O EN 45011 O GLP O GMP O GEP O
CLIENTS Chemicals industry Agrochemicals industry Pharmaceuticals industry
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 and ex vivo tests into regulatory toxicology by the integration of tiered testing strategies. E
Chemical Watch | Global Service Providers Guide 2013
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PROFILE: Harlan Laboratories
Genetic toxicology
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 VXEVWDQFH ZKHWKHU WKH EHQHÂżWV RI FRQWLQXHG XVH RXWZHLJK ULVNV WR human health and the environment. Based on our 40 years of experience FRQGXFWLQJ 6($V RQ D ZLGH UDQJH RI LVVXHV ZH KDYH LGHQWLÂżHG ERWK 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.
PROFILE: ICF International
CONTACTS Website
ZZZ LFÂż FRP
UHDFK#LFÂż FRP
Head office
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
Â
John Wasson, President and COO
Â
Isabel Reiff, Executive Vice President
Ownership
Public company (NASDAQ:ICFI)
Locations
UK, Belgium, Russian Federation, China, India, Brazil, Canada, USA
Founded
1969
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 UHTXLUHPHQWV DV HIÂżFLHQWO\ DFFXUDWHO\ DQG TXLFNO\ DV SRVVLEOH ,&) DOVR SURYLGHV VHFXUH WKLUG SDUW\ PDQDJHPHQW RI FRQÂżGHQWLDO EXVLQHVV information to assist with communication up and down the value chain. Science support
OVERVIEW ICF International partners with commercial and government clients to deliver professional services and technology solutions in the energy and climate FKDQJH HQYLURQPHQW DQG LQIUDVWUXFWXUH KHDOWK KXPDQ VHUYLFHV DQG VRFLDO SURJUDPPHV DQG KRPHODQG VHFXULW\ DQG GHIHQFH PDUNHWV 7KH ÂżUP FRPELQHV 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. VITAL STATISTICS
2011/12
Turnover, group
2011 US$841m
Turnover, chemical service provision
-
1R RI RIÂżFHV
50
No of countries represented
8
Staff, group
4,500
Staff, chemical service provision
90
SERVICE AREA BREAKDOWN
ICF International has more than 30 years of experience and more than VFLHQWLÂżF VWDII IRFXVHG RQ WR[LFRORJ\ FKHPLVWU\ HQYLURQPHQWDO IDWH exposure assessment, risk characterisation, and risk management. Our experts have applied this knowledge and experience in preparing FKHPLFDO GRVVLHUV DQG VDIHW\ UHSRUWV WKDW PHHW WKH VSHFLÂżF UHTXLUHPHQWV of REACH. Examples of support we can provide include assisting with FODVVLÂżFDWLRQ DQG ODEHOOLQJ SUHSDULQJ GRVVLHUV LQFOXGLQJ FKHPLFDO VDIHW\ 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 FDQ ÂżOO GDWD JDSV WR PHHW H[WHQVLYH 5($&+ UHTXLUHPHQWV DQG SURYLGH indicative costs. REACH-CAT reports will help you to make sound business decisions about which substances to register and your registration strategy. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Consultancy/ advisory 100%
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 Americaâ&#x20AC;&#x2122;s Best small 100 companies
2011
Environmental Finance Market Survey â&#x20AC;&#x201C; Best advisory/ consultancy North American markets (All)
2011
Environmental Finance Market Survey â&#x20AC;&#x201C; Best advisory/ consultancy EU emissions trading
2012
Environmental Finance Market Survey â&#x20AC;&#x201C; Best advisory/ consultancy North American markets (all)
2012
Environmental Finance Market Survey â&#x20AC;&#x201C; Best advisory/ consultancy EU emissions trading
GLOBAL OFFICES %UXVVHOV %HOJLXP /RQGRQ 8QLWHG .LQJGRP 0RVFRZ 5XVVLDQ )HGHUDWLRQ 5LR GH -DQHLUR %UD]LO 2WWDZD DQG 7RURQWR &DQDGD %HLMLQJ &KLQD 1HZ 'HOKL ,QGLD )DLUID[ 9LUJLQLD 86$
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Chemical Watch | Global Service Providers Guide 2013
ACCREDITATIONS
STAFF SELECTION
CMMI Level 3 designation/ Project Management Institute global executive council/ Project Management Institute registered education provider
Robert Hegner, PhD â&#x20AC;&#x201C; Senior Vice President
Penman Consulting BVBA: ICFâ&#x20AC;&#x2122;s partnership with Penman Consulting enables us to provide an even more complete range of REACH services to our clients. CLIENTS O O
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a major American chemical industry trade association VHYHUDO SHWURFKHPLFDO DQG UHÂżQLQJ LQGXVWU\ 5($&+ FRQVRUWLD (subcontractor to Penman Consulting) major trade associations in the metals and chemical industries WZR PDMRU LQWHUQDWLRQDO FKHPLFDO FRPSDQLHV DQG PDQ\ PRUH
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. ICFâ&#x20AC;&#x2122;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. ICFâ&#x20AC;&#x2122;s technical responsibilities included data collection, literature review, data preparation and entry into IUCLID, mapping of lifecycle stages for industrial chemicals, LGHQWLÂżFDWLRQ RI H[SRVXUH VFHQDULRV H[SRVXUH PRGHOOLQJ XVLQJ (&(72& TRA and other tools, risk characterisation, and preparation of various other GRFXPHQWDWLRQ QHHGHG IRU UHJLVWUDWLRQ :H DUH FXUUHQWO\ XSGDWLQJ ,8&/,' ÂżOHV WR incorporate changes introduced in the latest major version of IUCLID.
Stephanie Barrett â&#x20AC;&#x201C; Senior Manager 0V %DUUHWW EDVHG LQ ,&) V %UXVVHOV %HOJLXP RIÂżFH KDV PRUH WKDQ \HDUV 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 LQFOXGHV 5($&+ FRQVRUWLXP SURMHFW RIÂżFHU SRVLWLRQV DQG 6LHI PDQDJHPHQW DQG 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 â&#x20AC;&#x201C; Manager 'U 'HGHULFN KDV PRUH WKDQ ÂżYH \HDUV RI H[SHULHQFH LQ H[SRVXUH DQDO\VLV 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 â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; Senior Technical Specialist Dr Louise Assem has more than six yearsâ&#x20AC;&#x2122; of experience in chemical toxicological hazard, exposure and risk assessment for human health. 6KH KDV D 3K' LQ PROHFXODU WR[LFRORJ\ DQG VSHFLÂżF H[SHUWLVH LQ 5($&+ 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 MXULVGLFWLRQV ZRUOGZLGH LQ UHODWLRQ WR FODVVLÂżFDWLRQ DQG ODEHOOLQJ RI VXEVWDQFHV 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
CASE STUDY 3: Classification and labelling ,&) ,QWHUQDWLRQDO KDV PDGH FODVVLÂżFDWLRQ DQG ODEHOOLQJ & / UHFRPPHQGDWLRQV for hundreds of industrial chemicals for several European-based chemical consortia and international chemical companies. ICFâ&#x20AC;&#x2122;s experience using readacross strategies and weight-of-evidence arguments has provided our clients with recommendations in accordance with CLP and GHS regulations. ICFâ&#x20AC;&#x2122;s FODVVLÂżFDWLRQ DQG ODEHOOLQJ UHFRPPHQGDWLRQV KDYH EHHQ XVHG WR SRSXODWH VDIHW\ 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 webbased, searchable database to facilitate access to this information. Chemical Watch | Global Service Providers Guide 2013
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Dr Hecht has more than 13 years of experience in economic and policy analysis, research, and education. One particular area of Dr. Hechtâ&#x20AC;&#x2122;s expertise is in the application of survey-based stated preference methods to estimate the monetary value of â&#x20AC;&#x153;non-marketâ&#x20AC;? 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 WKH YDOXH RI D UHODWHG QRQ PDUNHW JRRG RU VHUYLFH DQG EHQHÂżW WUDQVIHU 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 coauthored several publications that have appeared in peer-reviewed journals. Page 93
PROFILE: ICF International
PARTNERS
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.
GLOBAL OFFICES Willoughby Road, Bracknell, West Berkshire RG12 8FB, UK 78 Shenton Way, Singapore 4777 Levy Street, St. Laurent, Quebec, Canada H4R 2P9 Oranjesingel 34, 6511 NV Nijmegen, The Netherlands 9 Monroe Parkway, Suite 150, Lake Oswego, Oregon 97035, USA
PROFILE: IHS
CONTACTS Website
www.ihs.com/ehs-sustainability
SERVICES PROVIDED
ehs-sustainability@ihs.com
IHS Product Stewardship Solutionâ&#x201E;˘
Head office
15 Inverness Way East, Englewood, Colorado 80112, USA
Tel
+1 503 303 6544
Contact
Trish Jones
Directors
Jerre Stead, Chairman and CEO
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6FRWW .H\ 3UHVLGHQW DQG &KLHI 2SHUDWLQJ 2IÂżFHU
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Arshad Matin, Executive Vice President
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Scott Lockhart, Vice President, EHS and Sustainability
Ownership
Publicly Traded Company (NYSE: IHS)
Locations
Worldwide
Founded
1959
OVERVIEW Information management solutions for EHS and sustainability IHS is a global information company with leading experts in the pivotal areas shaping todayâ&#x20AC;&#x2122;s business landscape, including chemicals, energy, economics, geopolitical risk, sustainability and supply chain management. IHS is also the leading provider of information management solutions â&#x20AC;&#x201C; combining software, content and insight â&#x20AC;&#x201C; for environmental, health, safety and sustainability. In todayâ&#x20AC;&#x2122;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. VITAL STATISTICS
2011/12
Turnover, group
US $1.53bn
Turnover, chemical service provision
n/a
1R RI RIÂżFHV
193
No of countries represented
31
Staff, group
More than 6,000
Staff, chemical service provision
150
SERVICE AREA BREAKDOWN Training 5%
Consultancy/ advisory 20%
IT & software 40%
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 LQYHVWRUV DQG FXVWRPHUV IRU WUDQVSDUHQF\ LQWR D KRVW RI QRQ ÂżQDQFLDO UHSRUWLQJ issues, including product stewardship, environment, health and safety, risk management, natural resources, social responsibility and governance. An enterprise sustainability management (ESM) information strategy HQDEOHV RUJDQLVDWLRQV WR PDQDJH ULVN GULYH ZRUNĂ&#x20AC;RZ HIÂżFLHQF\ DQG optimise resources â&#x20AC;&#x201C; uncovering opportunities for innovation and growth. ESM establishes a structure for managing sustainability performance by collecting, aggregating and reporting information from the bottom up â&#x20AC;&#x201C; from the laboratory to the executive suite â&#x20AC;&#x201C; as part of your big data and analytics strategy. Industry and domain expertise
Information 35%
Page 94
The IHS Product Stewardship Solutionâ&#x201E;˘ 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 Authoringâ&#x201E;˘, IHS Comply PlusÂŽ and IHS DolphinRTKâ&#x201E;˘, this comprehensive solution combines software, content and industry expertise, enabling organisations to HIÂżFLHQWO\ PRQLWRU DQG PDQDJH SURGXFW FRPSOLDQFH ZLWK ULJRURXV regulatory mandates at every stage of the product lifecycle, from product design through manufacturing. IHS supports your companyâ&#x20AC;&#x2122;s compliance programme with these powerful information management capabilities: O SDS Authoring â&#x20AC;&#x201C; 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 \RXU SURGXFWV DQG FRQWLQXHG DFFHVV WR JOREDO PDUNHWV O Documentation and Labels â&#x20AC;&#x201C; Simplify the process of producing labels and regulatory documents while reducing your companyâ&#x20AC;&#x2122;s FRPSOLDQFH UHODWHG ULVNV DFURVV WKH HQWHUSULVH O Product Compliance Analysis â&#x20AC;&#x201C; Minimise risks to your companyâ&#x20AC;&#x2122;s go-to-market strategy by aligning regulatory compliance analysis with your product lifecycle management plan. IHS helps you keep your SURGXFWV FRPSOLDQW O Chemical Management â&#x20AC;&#x201C; In order to identify opportunities to reduce costs and optimise operational processes while maintaining FRPSOLDQFH ZLWK UHJLRQDO DQG QDWLRQDO UHJXODWLRQV O Supply Chain Communications â&#x20AC;&#x201C; Improve communication between your internal stakeholders and suppliers, so you can PDLQWDLQ \RXU DFFHVV WR NH\ PDUNHWV O Quality Risk Management Âą /HYHUDJH LPSURYHG ULVN LGHQWLÂżFDWLRQ DQG DQDO\VLV VR \RX FDQ DFFXUDWHO\ XQGHUVWDQG \RXU RUJDQLVDWLRQÂśV ULVN SURÂżOH IHS enables your business to make your product stewardship programme SDUW RI D XQLÂżHG LQIRUPDWLRQ PDQDJHPHQW VWUDWHJ\ IRU HQWHUSULVH sustainability management, and supported by a single world-class provider.
IHS domain and technology experts possess a wealth of domain knowledge and have proven experience at global implementations that ensure alignment with our clientsâ&#x20AC;&#x2122; business requirements. IHS regulatory
Chemical Watch | Global Service Providers Guide 2013
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Result: WKH VLQJOH LQVWDQFH RI D XQLÂżHG GDWDEDVH HOLPLQDWHG WKH QHHG for repetitive support roles and reduced structural costs at multiple sites. Dow was able to save $2m in redundant legacy systems and improve its FRPSOLDQFH UHSRUWLQJ HIÂżFLHQF\
1959
IHS founded
STAFF SELECTION
2005
IHS becomes a publicly-traded company
Jeff Ladner, Senior Director, EHS and Sustainability Solutions
2007
IHS launches EHS & Sustainability Business
IHS acquires Syntex Systems
-HII /DGQHU RYHUVHHV WKH GHYHORSPHQW RI XQLÂżHG LQIRUPDWLRQ PDQDJHPHQW solutions that enable global organisations to proactively address EHS and VXVWDLQDELOLW\ EXVLQHVV FKDOOHQJHV DV ZHOO DV ERRVW RSHUDWLRQDO DQG ÂżQDQFLDO performance. Under Ladnerâ&#x20AC;&#x2122;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 HQWHUSULVH LQIRUPDWLRQ PDQDJHPHQW V\VWHPV WKDW HIÂżFLHQWO\ PDQDJH environmental, energy and carbon management, risk management, product stewardship and corporate responsibility programmes.
IHS acquires Atrion International
Francis Trudeau, Solutions Manager
IHS acquires Chemical and Energy Products
Francis Trudeau has worked for nearly 15 years in product compliance and FKHPLFDO PDQDJHPHQW 7UXGHDX KDV VLJQLÂżFDQW H[SHULHQFH LQ VROXWLRQV 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.
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 6RIWZDUH E\ LQGHSHQGHQW DQDO\VW ÂżUP
2011
IHS named Enterprise Sustainability Management Solution /HDGHU E\ OHDGLQJ UHVHDUFK ÂżUP 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 and support its globalisation efforts. This software and regulatory content suite of products provides seamless raw materials management, auto creation and authoring of SDS in nearly 50 languages. Results: the IHS solution greatly improved Americhemâ&#x20AC;&#x2122;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 Solutionâ&#x201E;˘.
Chemical Watch | Global Service Providers Guide 2013
Mary Rudolph, Senior Manager â&#x20AC;&#x201C; Global Content Mary Rudolph has more than 25 years of international environmental, health and safety experience, including technical and business implementations of authoring services. She offers IHS customers an indepth and often sought after understanding of the needs of global EHS departments. She has also managed the development of EHS-related databases, including RTECSÂŽ, 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 Commissionâ&#x20AC;&#x2122;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 yearsâ&#x20AC;&#x2122; 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 yearsâ&#x20AC;&#x2122; 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.
Page 95
PROFILE: IHS
experts continuously monitor and track legislation changes in order to FRQVWDQWO\ UHÂżQH RXU VROXWLRQV ZKLFK VXSSRUW LQGXVWU\ EHVW SUDFWLFHV WKDW enable organisations to contain costs while reducing business risks.
PROFILE: International Cosmetics & 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: O SURGXFW LQIRUPDWLRQ ÂżOH 3,) IRU HDFK SURGXFW O VDIHW\ DVVHVVPHQW O DGGUHVV RQ DOO SURGXFW ODEHOOLQJ O DFFHVV IRU WKH FRPSHWHQW DXWKRULWLHV FRXQWULHV IRU 3,)V O 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 PDQXIDFWXUHU DQG RXU FRPSDQ\ WR SURYLGH FRQÂżGHQWLDOLW\ :LWK WKH agreement in place we only share information with an EU authority WKURXJK DFFHVV DW RXU 8. RIÂżFH
CONTACTS Website
www.intlcosmetics.com
info@intlcosmetics.com
Head office
947 Manhattan Beach Boulevard, Suite A, Manhattan Beach, CA 90266, USA
Tel
+1 310 545 3223
Fax
+1 310 546 6204
Contact
Georgia@intlcosmetics.com
Directors
Janet Winter Blaschke
Â
Georgia Boehm
Ownership
Private company
Locations
USA, UK
Founded
1997
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. &/3 QRWLÂżFDWLRQ VHUYLFHV DUH DOVR DYDLODEOH LQ DGGLWLRQ WR VDIHW\ GDWD sheets to meet the requirements of REACH and CLP.
OVERVIEW International Cosmetics and Regulatory Specialists LLC, a US organisation and International Cosmetics and Chemical Services Ltd, a UK entity are sister companies comprised of experienced 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 DERXW \RXU VSHFLÂżF QHHGV VITAL STATISTICS
2011/12
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
2
No of countries represented
28
Staff, group
6
Staff, chemical service provision
3
SERVICE AREA BREAKDOWN
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 LV JLYHQ WR WDLORULQJ WKHVH VNLOOV WR ÂżW WKH FOLHQW QHHGV IRU HQWLUH SURMHFWV multiple countries, or for an individual project for one country. We provide GMP training and audits to the newly-required ISO 22716 CORPORATE DEVELOPMENTS & ACHIEVEMENTS REACH
Training 20%
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
$PRQJ WKH ÂżUVW RQO\ UHSUHVHQWDWLYHV WR VXFFHVVIXOO\ FRPSOHWH D FRVPHWLF LQJUHGLHQW IXOO UHJLVWUDWLRQ LQ SULRU WR WKH ÂżUVW 2010 deadline. This resulted due to a company who missed WKH SUH UHJLVWUDWLRQ SKDVH ZKLOH LPSRUWLQJ ÂżQLVKHG SURGXFW using the ingredient at 1 ton or more the previous three years.
GLOBAL OFFICES
2010
USA: International Cosmetics and Regulatory Specialists LLC UK: International Cosmetics and Chemical Services Ltd
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 ZLWK &/3 QRWLÂżFDWLRQV
Information 10%
Consultancy/ advisory 60%
Representation & management 10%
ISO 2006
Page 96
Designated expert in the Cosmetic ISO workgroup for TC217, Cosmetic GMP, Sunscreens and Microbiology in Paris. Chemical Watch | Global Service Providers Guide 2013
Designated expert in Cosmetic GMP and Sunscreen workgroup in Den Haag, The Netherlands.
2008
Designated expert Cosmetic GMP and Microbiology workgroup in Paris.
2009
Designated expert Cosmetic GMP and Microbiology workgroup in Baltimore, MD, 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 *03V )'$ F*03V DV ZHOO DV FRXQWU\ VSHFLÂżF UHJXODWLRQV depending on the market and or country needs.
ACCREDITATIONS O O O O O
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Personal Care Products Council (Formerly CTFA) Society of Cosmetic Chemists (SCC) Regulatory Affairs Professionals (RAPS) American Society for Quality (ASQ). 9ULMH 8QLYHUVLW\ RI %UXVVHOV 98% TXDOLÂżHG VDIHW\ DVVHVVRU WUDLQLQJ DQG FHUWLÂżFDWH IURP WKH GHSDUWPHQW RI 3KDUPDFRORJ\ DQG 7R[LFRORJ\ Chartered biologist, Society of Biology, UK
PARTNERS Manhattan Repro (graphic design for labelling)
Georgia Boehm, AA Business Management, Glendale College O
O
O
Deborah Rediet, BA French and International Relations, California State University Long Beach O
O O
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regulatory manager - seven yearsâ&#x20AC;&#x2122; experience in regulatory affairs in Canada, the US, Europe and Asia expert in labelling compliance and PIF requirements FHUWLÂżFDWHG IURP &DOLIRUQLD 6WDWH 8QLYHUVLW\ 6DQ 'LHJR &686' LQ regulatory affairs, College of Science Ă&#x20AC;XHQW LQ )UHQFK ,WDOLDQ DQG 6SDQLVK
Harmony Gates, MS Chemical Engineering O
chemical engineer - 12 yearsâ&#x20AC;&#x2122; experience in regulatory affairs in the 86 &DQDGD DQG WKH (8 VSHFLDOLVLQJ LQ HQYLURQPHQWDO UHJXODWRU\ issues
Robert Blaschke, BA, French, Loyola Marymount University O
O O
regulatory affairs specialist.- four yearsâ&#x20AC;&#x2122; 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 O
CLIENTS
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
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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 O O
O
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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: UHJXODWRU\ DFFHSWDQFH RI FRVPHWLF LQJUHGLHQWV LQ LQGLYLGXDO FRXQWULHV 5 ' DQG PDQXIDFWXULQJ IRU WKH JOREDO PDUNHW PLFURELRORJ\ DQG quality control of cosmetic products. SDVW FKDLUPDQ 6RFLHW\ RI &RVPHWLF &KHPLVWV PHPEHU ERDUG RI GLUHFWRUV 6RFLHW\ RI &RVPHWLF &KHPLVWV UHJXODWRU\ DIIDLUV FKDLUPDQ contributing author to SCC publications chartered biologist, Society of Biology, United Kingdom SRVW JUDGXDWH FHUWLÂżFDWH LQ 5($&+ PDQDJHPHQW 8QLYHUVLW\ RI +XOO 8.
Chemical Watch | Global Service Providers Guide 2013
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PROFILE: International Cosmetics & Chemical Services Ltd
2006
SERVICES PROVIDED Advisory â&#x20AC;&#x201C; services to help you advance your business Auditing â&#x20AC;&#x201C; services to help you control operations Certification â&#x20AC;&#x201C; services to help you reach new markets Outsourcing â&#x20AC;&#x201C; services to help you focus on core activities Quality assurance â&#x20AC;&#x201C; services to help you meet expectations
PROFILE: Intertek
CONTACTS Website
www.intertek.com/green/chemicals/
Training â&#x20AC;&#x201C; services to help you improve your performance
regulatoryaffairs@intertek.com
Testing â&#x20AC;&#x201C; services to help you improve your performance
Head office
25 Savile Row, London W1S 2ES, UK
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Tel
+44 0161 245 8071
2004
ASG in Manchester, UK was acquired from Zeneca and Avecia.
Contact
Jeremy Ramsden
2007
MSG in Wilton, UK was acquired from ICI.
Directors
Sir David Reid, Chairman
2010
Intertek acquires CIBA Expert Services and Cantox Health Sciences International.
2011
Intertek acquires Moody International.
:ROIKDUW +DXVHU &KLHI ([HFXWLYH 2IÂżFHU Â
/OR\G 3LWFKIRUG &KLHI )LQDQFLDO 2IÂżFHU
Ownership
Public
2011
Intertek acquires Analytical Sciences Americas (ASA).
Locations
Intertek is the industry leader with more than 33,000 people in 1,000 locations in over 100 countries.
2011
Intertek continued to expand and develop services in the 25plus industries it operates in.
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.
2011
Intertek is a partner to some of the worldâ&#x20AC;&#x2122;s most loved brands and their suppliers and this work continued in 2011.
2011
Demand for Intertekâ&#x20AC;&#x2122;s work was fuelled by its clientsâ&#x20AC;&#x2122; desire for greater quality, safety and sustainability in their products, WKHLU GULYH IRU VXSSO\ FKDLQ DQG FRVW HIÂżFLHQF\ DQG WKHLU expansion into new markets and product innovations.
2011
Intertekâ&#x20AC;&#x2122;s underlying business grew at a rate of 8% during the year â&#x20AC;&#x201C; a strong performance given the pressure of global economic uncertainty on many 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 SURGXFWLRQ SURFHVVHV RU WR HQKDQFH WKHLU HIÂżFLHQFLHV VITAL STATISTICS
O
O
2011/12
Turnover, group
O
ÂŁ1,374.2m
Turnover, chemical service provision
1,000+
No of countries represented
100+
Staff, group
30,000+
Staff, chemical service provision
2,000+
SERVICE AREA BREAKDOWN
Other 29%
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.
ÂŁ151.5m
1R RI RIÂżFHV
Consultancy/ advisory 10% Information 3%
Training 3% Laboratory 55%
GLOBAL OFFICES USA: 801 Travis, Suite 1500, Houston, TX 77002, USA, +1-877- 274-0181 Germany: Stangenstr 1, 70771 Leinfelden-Echterdingen, Germany, +49 711 27311 152 China: 4/F, Block B, JinLing Business Square, No. 801, Yi Shan Road, &DRKHMLQJ 'HYHORSPHQW =RQH 6KDQJKDL &KLQD 2IÂżFH 6127 6132 Page 98
2012
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 WR RXU FXVWRPHUV DQG ZKLOH WKH FRPSDQ\ KROGV PHPEHUVKLS WR WKHVH RUJDQLVDWLRQV LQGLYLGXDOO\ ,QWHUWHN KDV HPSOR\HHV WKDW UHSUHVHQW WKH company on different boards. Examples of these would be: O Dr Naeem Mady â&#x20AC;&#x201C; industry segment council board member and a national board council member at the the Plastics Industry Trade $VVRFLDWLRQ 63, O Dr David Bechtel Âą GLSORPDW RI WKH $PHULFDQ %RDUG RI 7R[LFRORJ\ O Dr Paul Lambert â&#x20AC;&#x201C; committee member of the European Structural ,QWHJULW\ 6RFLHW\ (6,6 7& O Dr Ian Fletcher Âą PHPEHU RI WKH (365& ÂľFROOHJHÂś IRU SHHU UHYLHZ O Dr Jeff Franks Âą 5R\DO 6RFLHW\ RI &KHPLVWU\ 0HPEHUVKLS $IIDLUV %RDUG O Dr Neil Everall â&#x20AC;&#x201C; European editor of Applied Spectroscopy journal. CLIENTS Our clients include: Behr, Bosch, BP, ChevronTexaco, Citgo, ConocoPhillips, Haier, Lubrizol, Petrobas, Siemens
Chemical Watch | Global Service Providers Guide 2013
"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." â&#x20AC;&#x201C; Citgo â&#x20AC;&#x153;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!â&#x20AC;? â&#x20AC;&#x201C; Braskem SA â&#x20AC;&#x153;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 SURYLGHG D VHULHV RI &/3 VXEPLVVLRQV ZKLFK IDOO XQGHU WKH QHZ FODVVLÂżFDWLRQ 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.â&#x20AC;? â&#x20AC;&#x201C; NOVA Chemicals Corporation CASE STUDY 1: Incorrect definition of substance can lead to unnecessary registration 2QH RI WKH ÂżUVW PDMRU KXUGOHV WR FURVV LQ WKH SUHSDUDWLRQ RI WKH WHFKQLFDO dossier for REACH is to ensure the registrant is certain that the substance is ZHOO GHÂżQHG 7KH EHWWHU WKH NQRZOHGJH RQ WKH VXEVWDQFH GHÂżQLWLRQ WKH HDVLHU it is to decide on a registration strategy. In one case our client was uncertain DERXW WKH KDQGOLQJ DQG LQWHUSUHWDWLRQ RI WKH SURGXFW E\ SURFHVV GHÂżQLWLRQ VR our expert spent several hours discussing the problem. As the descriptions became quite complicated this led to the point that our expert was invited WR WKH SODQW DQG YLVLW RQVLWH WR EHWWHU GHÂżQH WKH FDVH $IWHU D IHZ KRXUV RI 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 WKLV ZDV D PLQRU LQYHVWPHQW FRPSDUHG WR D IXOO UHJLVWUDWLRQ GRVVLHU WKH FOLHQW easily saved â&#x201A;Ź 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 IRU KXPDQ KHDOWK DQG WKH HQYLURQPHQW 9DULRXV Ă&#x20AC;DYRXUV DQG IUDJUDQFHV 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: Intertekâ&#x20AC;&#x2122;s global network of experts helps clients achieve cost-effective registrations worldwide As most companies focus more and more on core competencies such as R&D, marketing and production, it is our role as true service provider to help our clients with exactly those support services no longer considered core.
Chemical Watch | Global Service Providers Guide 2013
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 DQG $VLD 3DFLÂżF 5LP 'XH WR RXU LQ GHSWK XQGHUVWDQGLQJ RI WKH UHJXODWRU\ requirements locally we helped a multinational chemical company save â&#x201A;Ź80k by coordinating the testing requirements for China, Japan and Europe. STAFF SELECTION Dr Andrew Swift â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; Vice President, Global Health, Environmental and Regulatory Services Dr Ruud Overbeek manages Intertekâ&#x20AC;&#x2122;s Health and Environmental (H&E) business which includes restricted substances, REACH, and climate changerelated services. Ruud and his global team deliver solution-led services to KHOS FRPSDQLHV IXOÂżO WKH UHTXLUHPHQWV RI HYHU FKDQJLQJ JOREDO OHJLVODWLRQ He is a regular author in respected industry and environmental publications, holds advisory roles on environmental business impact within the US health and beauty industryâ&#x20AC;&#x2122;s governing association and has a doctorate in chemistry. Dr Marc Thouin â&#x20AC;&#x201C; 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 NĂśrlem, Esq â&#x20AC;&#x201C; Chief Counsel Torben NĂśrlem, Intertekâ&#x20AC;&#x2122;s senior legal counselor, has a LLM in Law from the legal faculty at Copenhagen University and 15 yearsâ&#x20AC;&#x2122; 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 â&#x20AC;&#x201C; Senior Expert Consultant Michael Leise is one of Intertekâ&#x20AC;&#x2122;s regulatory affairs senior expert FRQVXOWDQW ZKRVH UHVSRQVLELOLWLHV LQFOXGH FRQVXOWLQJ RQ QRWLÂżFDWLRQ strategies for chemicals worldwide, test-programme development, FKHPLFDO ULVN DVVHVVPHQW QHJRWLDWLRQV ZLWK DXWKRULWLHV DQG VFLHQWLÂżF bodies. He studied at Heidelberg, researched in Boston at MIT and aquired environmental expertise at TĂ&#x153;V Rheinland before he joined Ciba Specialty Chemicals in Lampertheim as head of product safety in 1995. Dr Manuela Corazzaâ&#x20AC;&#x201C; Global Regulatory Operations Manager Manuela Corazza is Intertekâ&#x20AC;&#x2122;s country manager for Italyâ&#x20AC;&#x2122;s Regulatory Services, Global Operations support manager, and a senior regulatory projects manager. Karen Levins â&#x20AC;&#x201C; SVP, Global BD & Marketing, Intertek Cantox Health Sciences Karen Levins serves as Interteksâ&#x20AC;&#x2122;s senior vice president, Global Business Development Cantox and vice president Chemicals Group Cantox. As a regulatory toxicologist with more than 19 yearsâ&#x20AC;&#x2122; 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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PROFILE: Intertek
TESTIMONIALS
SERVICES PROVIDED Software solutions Environmental product compliance and sustainability: ELV, IMDS, RoHS, 5($&+ &/3 /&$ 'I( 555 FRQĂ&#x20AC;LFW PLQHUDOV *+* VXVWDLQDEOH RSHQ innovation, SDS, dangerous goods management.
PROFILE: iPoint
CONTACTS
Consulting Sustainability strategies, business and process analysis, impact analysis, EH&S consulting, sustainable products and brands, sustainable supply chain, sustainable manufacturing
Website
www.ipoint-systems.com
info@ipoint-systems.de
Head office
Ludwig-Erhard-StraĂ&#x;e 52-56, 72760 Reutlingen, Germany
Tel
+49 7121 144 89 60
Fax
+49 7121 144 89 89
Contact
Christoph Junk
Directors
JĂśrg Walden, CEO
Â
Hans-Gerhard Lang, Director Sales
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Â
Christoph Junk, Director Marketing
2001
iPoint-systems gmbh founded in Reutlingen/Germany
Ownership
Private (Germany: GmbH, US: Inc, GB: LLC)
2002
6DOHV RIÂżFH LQ *UHDW %ULWDLQ RSHQHG
Locations
Germany, Austria, Great Britain, France, China, USA
2007
2IÂżFH LQ 1RUWK $PHULFD RSHQHG
Founded
2001
2008
6DOHV RIÂżFH LQ &KLQD RSHQHG
2010
Acquisition of KERP GmbH in Austria
2012
O
Training 7UDLQLQJ HYHQWV LQ WKH ÂżHOG RI HQYLURQPHQWDO SURGXFW FRPSOLDQFH DQG sustainability Data care services Sustainability services for handling data from companiesâ&#x20AC;&#x2122; supply chain
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. (QVXUH FRPSOLDQFH ZLWK UHTXLUHPHQWV VXFK DV FRQĂ&#x20AC;LFW PLQHUDOV (/9 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.
O
2012
2011/12
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
7
No of countries represented
6
O
O
20
O
Staff, chemical service provision
O
O
SERVICE AREA BREAKDOWN Training 10%
AIAG, TetraTech,
CLIENTS O
Staff, group
/DXQFK RI L3RLQW &RQĂ&#x20AC;LFW 0LQHUDOV 3ODWIRUP L3&03 L3&03 is an on-demand software solution which enables companies WR IXOÂżO WKH HQRUPRXV FKDOOHQJH RI FROOHFWLQJ PDQDJLQJ DJJUHJDWLQJ DQG UHSRUWLQJ FRQĂ&#x20AC;LFW PLQHUDOV LQIRUPDWLRQ DQG meet the requirements of their customers and the regulatory authorities.
PARTNERS O
VITAL STATISTICS
Gartner recognises iPoint-systems as Cool Vendor Quality seal â&#x20AC;&#x153;Top 100â&#x20AC;?: iPoint-systems is Innovator of the Year 2012
OEM: Daimler, Jaguar/Landrover, Nissan, Renault, Honda, Hyundai/ KIA, GM Supplier: Automotive Lightning, Johnson Controls, Mahle, Valeo, Magna, Lear Electronics: Bosch, ZUMTOBEL, Electrolux 3KDUPD 5RFKH VDQRÂż $YHQWLV Manufacturing: Rexroth, Voith Other Industries: Tesa, Lavazza, HP, MTU, Sika
Consultancy/ advisory 20% Representation & management 5%
IT & software 55%
Information 10%
GLOBAL OFFICES Reutlingen (Headquarters), Dortmund, Vienna, Manchester, Paris, 6RXWKÂżHOG 6KDQJKDL
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Chemical Watch | Global Service Providers Guide 2013
TESTIMONIALS
STAFF SELECTION
Gartner recognises iPoint-systems as Cool Vendor 2012: Why cool? O â&#x20AC;&#x153;Holistic solutions covering a sustainable supply chain management remain absent from the marketplace. O In existence since 2001, iPointâ&#x20AC;&#x2122;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. O Central to their solution suite is their Compliance and Sustainability Hub which acts as an integration platform for critical compliance, materials and sustainability dataâ&#x20AC;? O http://www.ipoint-systems.com/en/newsroom/news/news-details/ artikel/weltweit-fuehrendes-analystenhaus-waehlt-ipoint-systemszum-cool-vendor/ Quality seal â&#x20AC;&#x153;Top 100â&#x20AC;?: iPoint is one of the three main award winners O â&#x20AC;&#x153;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. O 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 companyâ&#x20AC;&#x2122;s management level excels in its extraordinarily strong commitment in innovation management.â&#x20AC;? O http://www.ipoint-systems.com/en/newsroom/news/news-details/ artikel/ipoint-systems-ist-innovator-des-jahres-2012/
Management consulting Chemical and material experts Software engineering Support and services
PROFILE: iPoint
Sales and marketing
CASE STUDY 1: Automotive Lighting O
O
O
iPoint-systems optimises global ELV processes at Automotive Lighting with Compliance Agentâ&#x20AC;&#x2122;s IMDS Solutions. FORVLQJ WKH Ă&#x20AC;RRGJDWHV RQ GDWD $/ KDV WR FUHDWH DERXW LQ KRXVH material datasheets (MDB) for annual average of 75 new products â&#x20AC;&#x201C; about two per day. This means that on top of our own MDB, we receive about 20 times as many again from suppliers â&#x20AC;&#x201C; which PDNHV IRU D Ă&#x20AC;RRG RI GDWD )LQGLQJ WKH OLJKW DW WKH HQG RI WKH WXQQHO 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: O 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 O 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. O http://www.ipoint-systems.com/en/newsroom/brochures/#c1369 CASE STUDY 3: iPoint-systems equip Turkish household goods sector leader with new software solution O
O
O
In the EU, housewares producers are faced with innumerable regulations. In particular, surface properties and pure substances of imported products are closely monitored. ,Q RUGHU WR PDLQWDLQ SURÂżWDELOLW\ DQG HQVXUH D FRPSOHWH RYHUYLHZ RI WKH FRXQWU\ VSHFLÂżF VWDQGDUGV WKH 7XUNLVK OHDGHU LQ WKH KRXVHKROG goods sector has chosen the iPoint Supplier Entry Portal (SEP) and the Compliance Agent (module SAM-M). www.ipoint-systems.com/en/newsroom/news/
Chemical Watch | Global Service Providers Guide 2013
Page 101
SERVICES PROVIDED REACH services -6& FRQVXOWDQWV KDYH VLJQLÂżFDQW H[SHULHQFH LQ DOO DVSHFWV RI 5($&+ We have prepared a large number of registration dossiers and chemical VDIHW\ UHSRUWV &65ÂśV DQG KDYH SURYLGHG H[SHUW DGYLFH RQ VSHFLÂżF DUHDV 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.
PROFILE: JSC International
CONTACTS Website
www.jsci.co.uk
enquiries@jsci.co.uk
Head office
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
-6& H[SHUWV DUH DEOH WR DVVLVW ZLWK FODVVLÂżFDWLRQ ODEHOOLQJ DQG VDIHW\ data sheet creation including the extended safety data sheet containing exposure scenarios.
Directors
Lucy Croucher, Managing Director
DGSA
Â
Denis Kaye, Finance Director
Ownership
Private company
Locations
UK
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.
Founded
1992
CLP/GHS
Biocidal products
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 FRQWDFWV ZLWK UHJXODWRU\ RIÂżFLDOV DQG VFLHQWLÂżF H[SHUWV WKURXJKRXW WKH ZRUOG VITAL STATISTICS
2011/2012
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
1
No of countries represented
30+
Staff, group
26
Staff, chemical service provision
23
SERVICE AREA BREAKDOWN Other Training 5% 5% Representation & management 20% Consultancy/ advisory 70%
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 PDQXIDFWXUHUV DQG IRUPXODWRUV LQ DUHDV VXFK DV VFRSH LVVXHV HIÂżFDF\ 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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1992
(8 RIÂżFHV RI -6& IRUPHG Âą 86 RZQHUV
1996
2IÂżFHV UHORFDWHG WR +DUURJDWH
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
GLOBAL OFFICES JSC International Limited, Simpson House, Windsor Court, Clarence Drive, Harrogate, North Yorkshire, HG1 2PE, United Kingdom
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Chemical Watch | Global Service Providers Guide 2013
ACCREDITATIONS
STAFF SELECTION
$OO WHFKQLFDO VWDII DUH TXDOLÂżHG WR GHJUHH OHYHO RU KLJKHU 06F DQG or PhD). Our senior toxicologists are Society of Biology / British Toxicology Society and EUROTOX registered and our DGSA has current FHUWLÂżFDWLRQ :H HPSOR\ D QXPEHU RI FKDUWHUHG ELRORJLVWV &%LRO LQFOXGLQJ two fellows of the Society of Biology (FSB).
Lucy Croucher â&#x20AC;&#x201C; Managing Director
Network of locally recognised contacts across the globe. CLIENTS Our clients range from large international companies to SMEs located worldwide. TESTIMONIALS :H DUH XQDEOH WR LGHQWLI\ RXU FOLHQWV GXH WR FOLHQW FRQÂżGHQWLDOLW\ 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 WKH LGHQWLÂżFDWLRQ RI GDWD JDSV DQG ZKHUH QHFHVVDU\ SODFLQJ DQG 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 -6& VXFFHVVIXOO\ VXEPLWWHG RQH RI WKH YHU\ ÂżUVW 5($&+ GRVVLHUV IRU a new non-phase in substance. This substance dossier has now been upgraded through the tonnage bands.
Dr Samantha Wright â&#x20AC;&#x201C; Regulatory Affairs: 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 DQG GHWHUPLQLQJ FODVVLÂżFDWLRQ DQG ODEHOOLQJ 6DPDQWKD KDV EHHQ LQYROYHG with strategy planning for business compliance and delivering training for REACH and CLP. Samanthaâ&#x20AC;&#x2122;s background in regulatory affairs was gained through working with clients in the cosmetic, pharmaceutical and industrial sectors. Dr Richard Elsmore â&#x20AC;&#x201C; Regulatory Affairs: Biocides and REACH Richard Elsmore has held a number of senior roles with speciality chemical manufacturers and formulators and has experience of working ZLWK D ZLGH UDQJH RI SURGXFW FKHPLVWULHV KH KDV D SUDFWLFDO EDFNJURXQG of operating within the global chemical market and with FMCGâ&#x20AC;&#x2122;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 (8 OHJLVODWLRQ DQG LQ WKH DUHD RI HIÂżFDF\ WHVWLQJ DQG FODLP VXSSRUW +H 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 â&#x20AC;&#x201C; Regulatory Affairs: 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 â&#x20AC;&#x201C; Director of Regulatory Affairs Peter has many yearsâ&#x20AC;&#x2122; 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.
Chemical Watch | Global Service Providers Guide 2013
Page 103
PROFILE: JSC International
PARTNERS
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.
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 customerâ&#x20AC;&#x2122;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.
PROFILE: KFT Chemieservice
CONTACTS Website
www.kft.de, www.kft-academy.com and www.KFTebook24.com
mail@kft.de
Head office
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
Generating of working instructions pursuant to §14 of the Ordinance on Hazardous Substances (Gefahrstoffverordnung â&#x20AC;&#x201C; GefStoffV) and the technical standards for hazardous substances (TRGS) 555.
Ownership
Private company
Labels
Locations
Griesheim (near Darmstadt), Germany
Founded
1995
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
Working instructions
OVERVIEW
Research
KFT Chemieservicesâ&#x20AC;&#x2122; business is its competence in regulatory and product safety affairs. We ensure our customersâ&#x20AC;&#x2122; 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.
Customised substance data research, marketability check, limitations for chemicals prohibition ordinance and substances of very high concern (SVHC), special packaging and labelling requirements.
VITAL STATISTICS
Product registration
2011/12
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.
Turnover, group
-
REACH
Turnover, chemical service provision
-
1R RI RIÂżFHV
1
No of countries represented
1
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: O RQO\ UHSUHVHQWDWLYH VHUYLFHV SXUVXDQW WR DUWLFOH 5($&+ O WKLUG SDUW\ UHSUHVHQWDWLYH VHUYLFHV SXUVXDQW WR DUWLFOH 5($&+ O UHSUHVHQWDWLYH VHUYLFHV DV OHDG UHJLVWUDQW O UHJLVWUDWLRQV DFFRUGLQJ DUWLFOH DQG RI 5($&+ O preparations of IUCLID dossiers and CSR (chemical safety reports). Our REACH and management services cover: O impact analysis, strategic and operative REACH consulting, portfolio as well as supply chain communication consultation. Our Sief management provides: O SURMHFW PDQDJHPHQW ÂżQDQFLDO SURFHVVLQJ DQG VHWWOHPHQW WUXVWHH services, conducting studies and organisation of data sharing , communication with customers, authorities and competitors.
Staff, group
12
Staff, chemical service provision
8
SERVICE AREA BREAKDOWN Legal IT & software 2% 2% Laboratory 3% Information 14% Representation & management 16%
Training 8% Consultancy/ advisory 55%
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 www.KFT-Ac@demy.com In-house training and customised coaching are available on demand at sales@kft.de. Monthly webinars can be accessed free of charge. The launch of ebooks on legal aspects around Compliance has started 2013.
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CASE STUDY 3: REACH lead registrant support
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, ÂżUVW ELRFLGH VXEVWDQFH UHJLVWHUHG
2010
Launch of KFT-ChemDoc24.de
2011
)LUVW VXEVWDQFHV LQ DUWLFOHV QRWLÂżHG
2012
Introduction of SDS Control & Care
2013
Launch of KFT-Ebook 24 with legal information worldwide
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. .)7 &KHPLHVHUYLFH YHULÂżHV WKH UHTXLUHPHQWV ,I WKHUH LV QR OHDG 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 RWKHU 6LHI SDUWLFLSDQWV ÂżQG WKH H[LVWLQJ GDWD DQG GDWD JDSV XQGHUWDNH negotiations with data keepers and contract testing labs to close the GDWD JDSV :H FUHDWH WKH ,8&/,' ÂżOH DQG WKH &65 DQG WDNH FDUH RI 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.
ACCREDITATIONS VCH (association of chemical suppliers) subsidiary of FECC (European Association of Chemical Distributors) Member of ENES (European Network on Exposure Scenarios)
STAFF SELECTION Dr Karl-Franz Torges â&#x20AC;&#x201C; Managing Partner
Chemical manufacturers, distributors, importers of consumer goods, biocide substances, pharmaceutical raw materials, hygiene products for veterinary applications, household cleaner formulations and other products.
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 5($&+ SURFHVVHV 0HPEHU RI &HÂżF DQG 9&, ZRUNLQJ JURXSV &RQVXOWLQJ for the development of IUCLID 5.0. Consulting and training projects and workshops for hazardous materials management, registrations, and chemical compliance.
CASE STUDY 1: Marketability study
Angelika Torges â&#x20AC;&#x201C; Member of the board
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 SURYLGHUV DUH DVNHG WR VXEPLW D FRQÂżUPDWLRQ IURP .)7 &KHPLHVHUYLFH GmbH that all documents and labels conform to legal regulations. KFT Chemieservice checks the requirements and legal conformity with regard to: O FKHPLFDO OHJLVODWLRQ O 2UGLQDQFH RQ 'HWHUJHQWV O FRVPHWLFV UHJXODWLRQV O ELRFLGH UHJXODWLRQV O HQYLURQPHQWDO UHJXODWLRQV O FRPPRGLWLHV UHJXODWLRQV O WUDQVSRUW ODZ KD]DUGRXV PDWHULDOV HWF O and ultimately issues approval for marketing.
Board member and heading the division hazardous materials, marketability study and MSDS. Experience and responsibilities in these VHJPHQWV VLQFH &HUWLÂżHG GDQJHURXV JRRGV RIÂżFHU IRU VHYHUDO companies. Expertise in toxicology, ecotoxocology, chemical compliance LH IRU ZDVKLQJ DQG FOHDQLQJ DJHQWV DQG KDV H[SHUW FHUWLÂżFDWH IRU Â&#x2020; RI Restriction Ordinance on Chemicals.
PARTNERS Tradas Translations and Consulting Services (Flexible customised solutions for linguistic and technical needs) /DXV *PE+ */3 FHUWLÂżHG WHVWLQJ ODERUDWRU\
CLIENTS
Other staff Majority of staff are PhD chemists, biologists and experts in food technology with years of experience for material registrations and MSDS. In-house training is a strong focus and sustainable external training is obligatory.
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.
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PROFILE: KFT Chemieservice
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
SERVICES PROVIDED Software
Website
http://the-ncec.com/
ChemdataÂŽ â&#x20AC;&#x201C; clear and concise chemical hazard information on more WKDQ VXEVWDQFHV DW \RXU ÂżQJHUWLSV Pocket ChemdataÂŽ â&#x20AC;&#x201C; ChemdataÂŽ for pocket PCs and smartphones running Windows Mobile and Android operating systems ChemeDoxÂŽ â&#x20AC;&#x201C; online, simple-to-use, chemical safety document management system
ncec@ricardo-aea.com
Emergency Response
Head office
Ricardo-AEA, The Gemini Building, Fermi Avenue, Harwell, Didcot, UK, OX11 0QR
Tel
+44 (0)870 190 1900
Fax
+44 (0)870 190 6318
Contact
ncec@ricardo-aea.com
Directors
Daniel Haggarty
Ownership
Part of Ricardo-AEA
Carechem 24 â&#x20AC;&#x201C; for MSDS, labels and packaging â&#x20AC;&#x201C; legal compliance and the gold standard of responsible care Carechem Marine â&#x20AC;&#x201C; for transport by sea â&#x20AC;&#x201C; guarding your cargo... and your reputation CERS â&#x20AC;&#x201C; for keeping your business running â&#x20AC;&#x201C; protect your employees and reduce the risk of business downtime Chemsafe â&#x20AC;&#x201C; 24-hour support for the UK's emergency services Haulsafe 24 â&#x20AC;&#x201C; for UK road transport â&#x20AC;&#x201C; guaranteed specialist advice to keep your wagons on the road
Locations
UK
SDS Services
Founded
1973
NCEC's SDS authoring services and SDS management software SDS authoring â&#x20AC;&#x201C; keeping your safety data sheets legal and compliant with REACH and GHS ChemeDoxÂŽ â&#x20AC;&#x201C; online, simple-to-use, chemical safety document management system
PROFILE: NCEC
CONTACTS
OVERVIEW The National Chemical Emergency Centre (NCEC) offers a 24-hour emergency response service that provides fast, trusted and up-to-theminute advice to emergency services dealing with chemical incidents. NCEC also offers a number of other commercial emergency response services. Since 1973, NCECâ&#x20AC;&#x2122;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 RIIHUV D QXPEHU RI VHUYLFHV LQFOXGLQJ WUDLQLQJ 5($&+ FRQVXOWDQF\ DQG SDS authoring. VITAL STATISTICS
2011/12
Turnover, group
ÂŁ307.7 million
Turnover, chemical service provision
ÂŁ4.0 million
1R RI RIÂżFHV
Training Chemical training to help you comply with legislation and to help you and your staff deal with chemical emergencies Bespoke training courses â&#x20AC;&#x201C; including Hazmat 1st Response and Chemical Spill Response Open training courses â&#x20AC;&#x201C; including chemical hazard awareness and making COSHH assessments Consultancy &ODVVLÂżFDWLRQ ODEHOOLQJ LQIRUPDWLRQ DQG DGYLFH RQ FKHPLFDO VDIHW\ legislation as well as chemical risk management REACH services â&#x20AC;&#x201C; help with your responsibilities under REACH and GHS REACH Glossary â&#x20AC;&#x201C; a list of REACH-related terms and abbreviations CORPORATE DEVELOPMENTS & ACHIEVEMENTS 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 â&#x20AC;&#x201C; providing chemical emergency response VHUYLFHV WR 8. ÂżUH SROLFH DQG DPEXODQFH IRU \HDUV through the Chemsafe scheme on behalf of UK government
2012
Chemdata â&#x20AC;&#x201C; 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.
21
No of countries represented
11
Staff, group
2,300
Staff, chemical service provision
27
SERVICE AREA BREAKDOWN Training 10%
Consultancy/ advisory 20% Representation & management 10%
IT & software 10% Laboratory 10%
Information 20%
GLOBAL OFFICES
ACCREDITATIONS Quality Assurance As part of Ricardo-AEA, the NCEC is recognised via Lloyd's Register Quality $VVXUDQFH /54$ ZKLFK KDV LVVXHG WKH FHUWLÂżFDWH RI DSSURYDO WR 5LFDUGR AEA for the environmental and quality management system standards below: O BS EN ISO 9001: 2008 O ISO 14001: 2004 O 7KH 7LFN,7 *XLGH ,VVXH 2YHUDOO EXVLQHVV FHUWLÂżFDWH FHUWLÂżFDWH expiry: 30 November 2014
UK, China, Czech Rep, Germany, India, Italy, Japan, Korea, Russia, USA, Malaysia
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Chemical Watch | Global Service Providers Guide 2013
NCEC is part of Ricardo-AEA, and also part of: REACH Consultant Network O GCC Network Supported by the Department for Transport (DfT) and the Chemical Industries Association (CIA) O
CLIENTS O O O O O O O O O O O O O O O
BASF CPS Colour Group Air Products Flint Hills Chemtura Albemarle Henkel Ltd BP Chemicals Nova Chemicals Yara UK Ltd Wincanton Monsanto BWA Water Additives Leighsâ&#x20AC;&#x2122; Paints DKSH
TESTIMONIALS Chemsafe â&#x20AC;&#x153;All requests for information and advice were handled quickly and information explained concisely.â&#x20AC;? â&#x20AC;&#x201C; group manager David Somerville, Fife Fire and Rescue Service Emergency Response â&#x20AC;&#x153;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 DQG ZDUHKRXVLQJ RSHUDWLRQV ZKHWKHU WKH\ XVH URDG UDLO DLU RU VHD WUDIÂżF :LWK 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 â&#x20AC;&#x201C; the UKâ&#x20AC;&#x2122;s only specialist palletnetwork for the carriage of palletised dangerous goods.â&#x20AC;? â&#x20AC;&#x201C; Ali Karim, managing director, Hazchem Network Ltd 7UDLQLQJ DQG FRPSOLDQFH Âł7KLV LV WKH ÂżUVW WLPH ZH KDYH XVHG WKH 1&(& IRU HPHUJHQF\ UHVSRQVH WUDLQLQJ DQG ZH IRXQG LW UHDOO\ EHQHÂżFLDO WR 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.â&#x20AC;? â&#x20AC;&#x201C; Sue Clegg, UOP Ltd CASE STUDY 1: Polyurethane foam manufacturing fire incident, July 2012 1&(& UHFHQWO\ UHFHLYHG D FDOO IURP D ÂżUH DQG UHVFXH VHUYLFH VWDWLRQ PDQDJHU ZKR ZDV GHDOLQJ ZLWK D PDMRU ÂżUH DW D IDFWRU\ ZKHUH 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 â&#x20AC;&#x201C; 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 Ă&#x20AC;DPPDEOH WR[LF LUULWDQW VNLQ VHQVLWLVLQJ DQG KD]DUGRXV WR WKH HQYLURQPHQW 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 SURYLGH WKH PRVW XS WR GDWH VDIHW\ GDWD VKHHWV WR WKH ÂżUH DQG UHVFXH VHUYLFH Expertise: NCECâ&#x20AC;&#x2122;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 DQG UHOHDVHG VPRNH DQG IXPHV 7KH ÂżUH DQG UHVFXH VHUYLFH ZDV LQ DWWHQGDQFH DQG KDG HYDFXDWHG WKH EXLOGLQJ $ ÂżUHÂżJKWHU FRQWDFWHG 1&(& 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 GHOD\HG RQVHW DQG FDXVHV Ă&#x20AC;X OLNH V\PSWRPV 7KH HPHUJHQF\ UHVSRQGHU recommended suitable PPE including breathing apparatus, in accordance with the emergency action code (4W) for lithium batteries. Furthermore, WKH HPHUJHQF\ UHVSRQGHU DGYLVHG WKH ÂżUHÂżJKWHU WKDW GU\ DJHQWV VXFK DV VDQG VKRXOG EH XVHG WR VPRWKHU WKH EDWWHU\ ÂżUH DQG WKDW WKH DUHD VKRXOG EH 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 1&(& UHFHQWO\ UHFHLYHG D FDOO IURP D ÂżUH VWDWLRQ PDQDJHU ZKR ZDV GHDOLQJ ZLWK D EDUQ ÂżUH ODWH LQ WKH HYHQLQJ 7KH EDUQ ZDV FRQVWUXFWHG RI asbestos and contained two tonnes of ammonium nitrate fertiliser. The station manager was concerned about the environmental impact of the ÂżUH ZDWHU GXH WR WKH DPPRQLXP QLWUDWH IHUWLOLVHU 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 GHFRPSRVHV FDXVLQJ ÂżVK DQG RWKHU DTXDWLF RUJDQLVPV WR GLH :KHQ DVNHG LI DPPRQLXP QLWUDWH ZDV WR[LF LQ ÂżUH WKH HPHUJHQF\ UHVSRQGHU H[SODLQHG WKDW nitrogen oxides would be produced, which pose a risk of pulmonary oedema, DQG WKDW ÂżUHÂżJKWHUV VKRXOG EH PRQLWRUHG IRU KRXUV DIWHU H[SRVXUH 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 â&#x20AC;&#x201C; Chemdata/Hazmat Event Bethan Davies â&#x20AC;&#x201C; Chemsafe Mike Kent â&#x20AC;&#x201C; SDS Authoring Rob Whiting â&#x20AC;&#x201C; REACH Consultancy Paul Rast-Lindsell â&#x20AC;&#x201C; Training Matt Hawes â&#x20AC;&#x201C; Scalecards Richard Davey â&#x20AC;&#x201C; ChemeDox
Chemical Watch | Global Service Providers Guide 2013
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PROFILE: NCEC
PARTNERS
SERVICES PROVIDED
PROFILE: Pace Analytical â&#x20AC;&#x201C; Regulator y Services
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 SHU FXVWRPHU VSHFLÂżFDWLRQV 7KH 5'0 WHDP RSHUDWHV XQGHU DQ ,62 9001:2008 quality system ensuring consistent deliverables. Clients are always provided with metrics so they can rest assured expectations are met.
CONTACTS Website
www.pacelabs.com/regulatory
Lisa.Rettinger@pacelabs.com
Head office
1800 Elm St SE, Minneapolis, MN 55414, USA
Tel
612-751-6986
Fax
612-656-1181
Contact
Lisa Rettinger
Directors
Todd Mitchell, General Manager
Â
Angela Wutz, Regulatory Operations Manager
Â
Lisa Rettinger, New Business Development
Ownership
Private Company, division of: Pace Analytical Services, Inc.
Locations
USA
Founded
1998
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 clientâ&#x20AC;&#x2122;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
OVERVIEW The Product Regulatory Services division of Pace Analytical offers the following primary services: O VXSSO\ FKDLQ GDWD FROOHFWLRQ O KD]DUG FRPPXQLFDWLRQ O product stewardship. 2XU Ă&#x20AC;H[LEOH FXVWRP VROXWLRQV DUH EDVHG DURXQG WKH IROORZLQJ PRGHOV O SURFHVV LQ VRXUFLQJ DW \RXU ORFDWLRQ O SURFHVV RXW VRXUFLQJ DW RXU ORFDWLRQ O VWDII DXJPHQWDWLRQ O consulting/project-based expertise requests.
Our product stewardship services are extensive and include: â&#x20AC;˘ Regulatory compliance Âą DFWLYLWLHV LQFOXGH YHULÂżFDWLRQV RI VWDWXV 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. â&#x20AC;˘ Product assessments â&#x20AC;&#x201C; 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: FKHPLFDO DQG UDZ PDWHULDO HQYLURQPHQWDO KD]DUG DVVHVVPHQWV SURGXFW HQYLURQPHQWDO KD]DUG DVVHVVPHQWV SURGXFW ULVN DQG OLIH F\FOH DVVHVVPHQWV H[SRVXUH VFHQDULRV robust summaries. â&#x20AC;˘ Green label claims support â&#x20AC;&#x201C; involves guidance through the requirements involved to obtain desired green product labels. _
_
VITAL STATISTICS
2011/12
_
_
Turnover, group
-
Turnover, chemical service provision
-
_
1R RI RIÂżFHV
1
No of countries represented
1
Staff, group
85
Staff, chemical service provision
85
SERVICE AREA BREAKDOWN Laboratory 1% Consultancy/ advisory 55% Information 44%
Process in-sourcing/outsourcing, staff augmentation or consulting 3DFH RIIHUV Ă&#x20AC;H[LEOH FXVWRP VROXWLRQV EDVHG RQ WKH QHHGV RI RXU FOLHQWV Our extensive in-house regulatory training system is the driver behind Paceâ&#x20AC;&#x2122;s ability to offer such unique solutions, including: â&#x20AC;˘ Business process outsourcing â&#x20AC;&#x201C; Pace can offer dedicated resources and manage the process at your location (in-sourcing) or at our location (outsourcing). â&#x20AC;˘ Staff augmentation â&#x20AC;&#x201C; Pace employees of all levels are deployed to our client locations and they have the support of our Minneapolis staff and training systems. â&#x20AC;˘ Consulting services â&#x20AC;&#x201C; experts are available for project-based ZRUN WKDW LV DSSURSULDWH WR GR IURP RXU FRUSRUDWH RIÂżFH ACCREDITATIONS ISO 9001:2008 AIHA/SCHC Registered SDS authors CLIENTS 2XU OLVW RI FOLHQWV LV FRQÂżGHQWLDO KRZHYHU WKH\ UDQJH IURP VWDUW XSV LQ need of complete regulatory guidance to Fortune 50 companies looking for effective strategies to manage their workload.
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Chemical Watch | Global Service Providers Guide 2013
John Hutchinson, PhD â&#x20AC;&#x201C; Toxicologist
2XU FOLHQW UHWDLQHG 3DFH LQ RUGHU WR RIĂ&#x20AC;RDG D URXWLQH GDWD PDQDJHPHQW 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 HVVHQWLDO WKDW WKH SURFHVV EH HIÂżFLHQW SUHFLVH DQG SURYLGH KLJK TXDOLW\ GDWD 3DFH ZRUNHG FORVHO\ ZLWK WKH FOLHQW WR GHÂżQH D FXVWRPLVHG 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 RQJRLQJ FRQVLVWHQW SURJUDPPH WKDW SURYLGHV WKH FXVWRPHU ZLWK HIÂżFLHQW 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.
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 Wisconsin0DGLVRQ +LV JUDGXDWH UHVHDUFK IRFXVHG RQ SURWHLQ PRGLÂżFDWLRQ DQG 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.
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 Paceâ&#x20AC;&#x2122;s Sr regulatory specialists to meet customer VSHFLÂżF UHJXODWRU\ LQTXLULHV 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, VLWH SHUPLWWLQJ '27 SHUPLWWLQJ '+6 VXSSRUW HWF &RQÂżGHQW LQ 3DFHÂśV KDQGOLQJ RI WKHLU UHJXODWRU\ UHTXLUHPHQWV WKH FOLHQW LV DEOH WR IRFXV on core business activities such as product development, sales and marketing.
Steve Ernst â&#x20AC;&#x201C; Sr Regulatory Specialist Steve Ernst has more than 20 yearsâ&#x20AC;&#x2122; 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 â&#x20AC;&#x201C; 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 childrenâ&#x20AC;&#x2122;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 Paceâ&#x20AC;&#x2122;s comprehensive internal regulatory training system.
STAFF SELECTION Todd Mitchell â&#x20AC;&#x201C; General Manager Todd Mitchell has more than 25 yearsâ&#x20AC;&#x2122; 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 LQFOXGLQJ ÂżHOG VDPSOLQJ FRQWUDFW ODERUDWRU\ DQG UHJXODWRU\ FRQVXOWLQJ services. At Pace Analytical, Todd is responsible for the professional service business which provides creative in-sourcing and outsourcing VROXWLRQV WR VFLHQWLÂżF EDVHG FRPSDQLHV Angela Wutz â&#x20AC;&#x201C; Regulatory Operations Manager Angela Wutz has more than 10 years of direct industry experience in the FKHPLFDO UHJXODWRU\ ÂżHOG 6KH KDV DXWKRUHG WKRXVDQGV RI 0 6'6V DQG 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.
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PROFILE: Pace Analytical â&#x20AC;&#x201C; Regulator y Services
CASE STUDY 1: Fortune 50 conglomerate chemical manufacturer
SERVICES PROVIDED REACH services O
PROFILE: REACh ChemAdvice GmbH
CONTACTS Website
www.reach-chemadvice.com
info@reach-chemadvice.com
Head office
Am Marktplatz 5, D-65779 Kelkheim / Taunus, Germany
Tel/ Fax
+49 6195 96 199 0/ +49 6195 96 199 33
Contact
Dr Rudolf Staab
Directors
Dr Rudolf Staab, Managing Partner
Ownership
Privately owned company
Locations
Germany, USA, India, Portugal, Sweden
Founded
2007
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OVERVIEW
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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. VITAL STATISTICS
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2011/12
Turnover, group
c â&#x201A;Ź1.5m
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c â&#x201A;Ź1.5m
1R RI RIÂżFHV
5
No of countries represented
5
Staff, group
10
Staff, chemical service provision
10
SERVICE AREA BREAKDOWN
Training 10%
Other 5%
Representation & management 5%
GLOBAL OFFICES REACh ChemAdvice GmbH, Germany 5HJLRQDO RIÂżFHV 86$ ,QGLD 6ZHGHQ 3RUWXJDO
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CLP services As your CLP-consultant REACH ChemAdvice we provide: LGHQWLÂżFDWLRQ RI REOLJDWLRQV XQGHU WKH &/3 5HJXODWLRQ O LPSOHPHQWDWLRQ RI VWUDWHJ\ IRU &/3 FRPSOLDQFH O &/3 ZRUNVKRSV O &/3 GXH GLOLJHQFH O FXVWRPLVHG WUDLQLQJ DGDSWHG WR \RXU FRPSDQ\ÂśV QHHGV O SURMHFW PDQDJHPHQW O FODVVLÂżFDWLRQ DQG UHFODVVLÂżFDWLRQ RI VXEVWDQFHV DQG PL[WXUHV LQ DFFRUGDQFH ZLWK WKH &/3 5HJXODWLRQ O VDIHW\ GDWD VKHHWV 6'6 DXWKRULQJ DQG UHYLHZ O &/3 QRWLÂżFDWLRQV GRVVLHUV &/3 JURXS QRWLÂżFDWLRQV GRVVLHUV O outsourcing of CLP services. O
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Page 110
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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: LGHQWLÂżFDWLRQ RI REOLJDWLRQV XQGHU WKH 5($&+ 5HJXODWLRQ LPSOHPHQWDWLRQ RI VWUDWHJ\ IRU 5($&+ FRPSOLDQFH RQO\ UHSUHVHQWDWLYH $UW RI WKH 5($&+ 5HJXODWLRQ WKLUG SDUW\ UHSUHVHQWDWLYH $UW RI WKH 5($&+ 5HJXODWLRQ ODWH SUH UHJLVWUDWLRQ 6LHI FRPPXQLFDWLRQ PDQDJHPHQW LPSRUW FHUWLÂżFDWHV IRU 5($&+ FRPSOLDQFH creation and submission of IUCLID 5 dossiers (registration, inquiry, 3325' QRWLÂżFDWLRQ DXWKRULVDWLRQ VXEVWDQFH LQ DUWLFOHV QRWLÂż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ÂżFDWLRQ SUHSDUDWLRQ IRU LQVSHFWLRQV IURP WKH DXWKRULWLHV creation and review of REACH-compliant SDS/ e-SDS (safety data VKHHWV LQ DOO (8 PHPEHU VWDWHV ODQJXDJHV analysis of exposure scenarios and implementation of risk PDQDJHPHQW PHDVXUHV &/3 QRWLÂżFDWLRQV &/3 JURXS QRWLÂżFDWLRQV outsourcing of REACH services.
Consultancy/ advisory 60%
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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007
Start up in Frankfurt am Main, Germany
2007
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2008
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2009
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Start cosmetics consultancy
2011
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Chemical Watch | Global Service Providers Guide 2013
Expansion into the Iberian peninsula (Portugal and Spain)
2012
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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 3HUVRQ $VVRFLDWLRQ VXSSRUWV WKH FRVPHWLF LQGXVWU\ LQ DOO 5($&+ GLIÂżFXOWLHV 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 IURP 60( WR PXOWLQDWLRQDO ÂżUPV :H DOVR UHSUHVHQW (XURSHDQ FOLHQWV DV third party representatives and offer consultancy work under REACH.
Mr Fazendeiro is an expert in FODVVLÂżFDWLRQ DQG ODEHOOLQJ RI FKHPLFDOV safety data sheets (authoring, management and distribution). He worked DV D UHJXODWRU\ RIÂżFHU DW ,1)272; LQ 3RUWXJDO ZKHUH KH GHDOW ZLWK administrative issues related to REACH, assessment of test data reliability under the biocidal products Directive and gave support to business development activities. +H LV D OLFHQWLDWH LQ LQGXVWULDO FKHPLVWU\ ÂżYH \HDUV GHJUHH 8QLYHUVLW\ of Beira Interior, Portugal), and has practical education and training on REACH, CLP/GHS, IUCLID 5, REACH-IT and SDS Silvia Teige â&#x20AC;&#x201C; Finance and Administration Ms Teigeâ&#x20AC;&#x2122;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 WR KHDG RI EXVLQHVV XQLW DGGLWLYHV +RHFKVW $* DQG &ODULDQW IXOÂżOOLQJ WKH same role to the head of division chemicals, Hoechst AG. Prof Dr Dieter Mayer â&#x20AC;&#x201C; Toxicologist Professor Mayer has extensive research experience having worked at the Institutes of Human Genetics, University of Heidelberg, and Environmental +HDOWK 8QLYHUVLW\ RI &DOLIRUQLD 'DYLV +H ZDV VFLHQWLÂżF GLUHFWRU DW WKH Centre International de Toxicologie, Evreux, France, and professor at Frankfurtâ&#x20AC;&#x2122;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.
CASE STUDY 2: Consortia management
Dr Sebastian Hoffmann â&#x20AC;&#x201C; Scientific Consultant
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.
Dr Hoffman has extensive experience as a REACH consultant (TĂ&#x153;V 5KHLQODQG %LR7HFK *PE+ DV ZHOO DV SURMHFW PDQDJHPHQW DQG VFLHQWLÂżF consulting and hazard and risk assessment. He is an expert on human toxicological methods, having worked as a health hazards and VFLHQWLÂżF RIÂżFHU DW WKH (XURSHDQ &RPPLVVLRQÂśV -RLQW 5HVHDUFK &HQWUH LQ test methods Italy). His speciality is assessment (validation) of DQG PDQDJHPHQW RI VFLHQWLÂżF SURMHFWV +H LV TXDOLÂżHG WR DVVHVV GDWD reliability and relevance, and has 25 peer reviewed publications to his name.
CASE STUDY 3: Cosmetics industry
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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 â&#x20AC;&#x201C; 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 GHYHORSPHQW DQG LPSOHPHQWDWLRQ EXVLQHVV UH HQJLQHHULQJ HIÂżFLHQF\ 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 â&#x20AC;&#x201C; SaarbrĂźcken, Germany, and a PhD in inorganic chemistry (Dr rer nat â&#x20AC;&#x201C; SaarbrĂźcken, Germany). Carlos Fazendeiro â&#x20AC;&#x201C; Regulatory Affairs Consultant (Head Office and Portugal) Mr Fazendeiro has worked in regulatory compliance (CTR Lda, Portugal, and has considerable experience of purchasing and sales of chemical raw PDWHULDOV IRU FRDWLQJV FODVVLÂżFDWLRQ ODEHOOLQJ DQG SDFNDJLQJ RI FKHPLFDOV 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.
Chemical Watch | Global Service Providers Guide 2013
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Jim DeLisi â&#x20AC;&#x201C; Regional Head, North America Jim DeLisi is a president of Fanwood Chemical, Inc, where he looks after the sale of organic intermediates in North America, South America and Europe, as well as tariff and trade affairs, monitoring of imports and exports and REACH. He has been chairman of SOCMAâ&#x20AC;&#x2122;s International Trade Committee, and chairman of the Industry Trade Advisory Committee on Chemicals, Pharmaceuticals, Health/Science Products and Services. He has a BA in business administration (Rutgers College, USA), and an MBA in chemical marketing (Fairleigh Dickinson, USA). Barbara Fertl â&#x20AC;&#x201C; Regional Head, Sweden Barbara Fertl has extensive experience having worked at: the Institute IRU 3K\VLFDO %LRFKHPLVWU\ 0XQLFK 0XQLFK 0XQLFLSDO +RVSLWDO *URXS /LQGH $* 0XQLFK '46 'HXWVFKH *HVHOOVFKDIW ]XU =HUWLÂż]LHUXQJ YRQ 0DQDJHPHQWV\VWHPHQ )UDQNIXUW 6DVRO +DPEXUJ 6KH KDV EHHQ a chemical consultant for KemikalierĂĽdgivare in Sweden and has experience of safety data sheets, registrations, national and international regulations on chemicals Ms Fertl has an MSc in biology (Diplom-Biologin, Ludwig-Maximilians8QLYHUVLW\ 0XQLFK *HUPDQ\ DQG LV D FHUWLÂżHG DXGLWRU IRU TXDOLW\ management systems
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PROFILE: REACh ChemAdvice GmbH
2012
SERVICES PROVIDED General consulting services O Supply chain communication Importers and manufacturers, downstream users and manufacturers/ importers of article, are all responsible for the effective communication Ă&#x20AC;RZ RI LQIRUPDWLRQ :H SURYLGH DOO WKH QHFHVVDU\ VXSSRUW E\ GLVWULEXWLQJ standard templates or customised forms to properly manage the FRPPXQLFDWLRQ Ă&#x20AC;RZ EHWZHHQ FXVWRPHUV DQG VXSSOLHUV O Strategic implementation of European regulations Participation to consortia, co-registrants agreements, data sharing, deadline and tonnages for registration are decisions that are managed LQ RUGHU WR ÂżQG WKH PRVW FRVW HIIHFWLYH VROXWLRQ DQG WKH PRVW FRQYHQLHQW choice on the market. O 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. O Implementation of IT systems to manage chemicals Companies will internally develop new management systems to integrate existing tools to monitor the presence of chemical substances, including deadlines, total amounts, risk management measures etc.
PROFILE: REACH master y
CONTACTS Web site
www.reachmastery.com
info@reachmastery.com
Head office
Via Giovio 16, 22100 Como, Italy
Tel
+39 031 269513
Fax
+39 031 2756370
Contact
monicalocatelli@reachmastery.com
Directors
Monica Locatelli
Ownership
Private company
Locations
Italy
Founded
2008
OVERVIEW REACH mastery is a provider of a wide range of services in the area of chemical regulatory affairs. The staff are a highly motivated team, VNLOOHG LQ GLIIHUHQW VFLHQWLÂżF DUHDV FKHPLVWU\ ELRORJ\ KXPDQ KHDOWK and environmental toxicology. Our commitment is to assist customers along the supply chain with our industrial experience and to help them LQ WKH FRVW HIÂżFLHQW LPSOHPHQWDWLRQ RI WKH (XURSHDQ UHJXODWLRQV 2XU mission is to look for innovative solutions and develop strategies using, and in silico when applicable, alternatives to animal testing like methods, through the high quality of our services and the expert support. `
VITAL STATISTICS
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2011/12
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
1
No of countries represented
1
Staff, group
7
Staff, chemical service provision
7
SERVICE AREA BREAKDOWN Training Legal 1% Other 2% 5% Information 2% Representation & management 15%
Consultancy/ advisory 75%
REACH services Consortia management A lot of experience has been gained on consortia rules and management. We will provide also legal advice, agreement documents, meeting location, cost calculation, managing of LoAs. O Data gap analysis and data collection *DWKHULQJ H[LVWLQJ LQIRUPDWLRQ LV WKH ÂżUVW VWHS LQ WKH SUHSDUDWLRQ RI DQ\ 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 DGHTXDF\ WR ÂżOO WKH UHTXLUHPHQWV O Testing strategy development, strategies development, QSAR modelling $Q LQWHJUDWHG WHVWLQJ VWUDWHJ\ LV WKH ÂżUVW VWHS IRU FRVW UHGXFWLRQ DQG building rationale for waiving. International well known partners are helping us in focusing on the right choice. O 0DQDJLQJ RI DQDO\WLFDO LGHQWLÂżFDWLRQ DQG LQTXLU\ GRVVLHUV Our big expertise in analytics and experience in enquiries let us face without problems one of the most critical aspect of REACH regulation. O Tests monitoring In case new tests are required, REACH mastery will take care of selecting the most appropriate lab, will review the protocol and check the results. O Dossier preparation (IUCLID compilation) Dedicated expert persons are managing IUCLID compilation. O Human health and environmental risk assessment The focused experience and the support of high experienced toxicologists let us make of the risk assessment the core part of the developing registration dossier. O CSA-CSR REACH mastery is part of the consultation group of Chesar in ECHA. We followed the development of the tool since the beginning and we are DPRQJ WKH ÂżUVW H[SHUWV LQ (XURSH WR XVH LW O
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CLP/GHS services O O O
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FEED and FOOD registration O O O O
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dossier preparation risk assessment test monitoring assistance to customer for Efsa calls for data Chemical Watch | Global Service Providers Guide 2013
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full dossier preparation for active substances and placing a biocidal product in the market testing strategy development study monitoring risk assessment ÂżQDOLVDWLRQ DQG GLVFXVVLRQ ZLWK QDWLRQDO DQG (8 DXWKRULWLHV post-submission support
PPP services O
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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 ÂżQDOLVDWLRQ DQG GLVFXVVLRQ ZLWK QDWLRQDO DQG (8 DXWKRULWLHV post-submission support
EU cosmetic directive O O O O O O O O
regulatory compliance support SURGXFW QRWLÂżFDWLRQV DVVLVWDQFH LQ *03 FHUWLÂżFDWLRQ FRVPHWLFV LQJUHGLHQW SURÂżOHV SURGXFW LQIRUPDWLRQ ÂżOHV clinical studies: design and monitoring cosmetic product safety reports product labelling review and support
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 LPSURYHG WKH UHG SKRVSKRUXV WR[LFRORJLFDO DQG HFRWR[LFRORJLFDO SURÂżOH 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 DQ HIIHFWLYH FRPPXQLFDWLRQ Ă&#x20AC;RZ ZLWK ()6$ 3URWRFROV IRU QHZ VWXGLHV were all agreed together and in some cases we managed to change the study into . request for `
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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 â&#x20AC;&#x201C; 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.
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Dr ssa Costanza Rovida â&#x20AC;&#x201C; REACH Regulatory Specialist
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
*UDGXDWHG LQ FKHPLVWU\ DIWHU \HDUVÂś H[SHULHQFH LQ WKH ÂżHOG RI DQDO\WLFDO 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.
PARTNERS RTC, QSAR group of Bicocca University, Vitroscreen,CAAT Europe as preferred cooperations. CLIENTS :H DUH ZRUNLQJ IRU DERXW FXVWRPHUV DURXQG (XURSH WKH\ DUH manufacturers, distributors, downstream users, from SMEs to international FKHPLFDO FRPSDQLHV GLVWULEXWHG LQ PDQ\ LQGXVWULDO ÂżHOGV IHUWLOLVHUV OHDWKHU 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. ,Q PRUH WKDQ VXEVWDQFH KDYH EHHQ QRWLÂżHG RQ EHKDOI RI RXU customers, after extensive bibliographic research, read-across approach and computational predictions
Chemical Watch | Global Service Providers Guide 2013
Dr Leon Van der Wal â&#x20AC;&#x201C; Eco toxicologist Obtained a PhD in environmental toxicology and chemistry in 2003, and has more than ten yearsâ&#x20AC;&#x2122; 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 â&#x20AC;&#x201C; 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 LPPXQH DQG KDHPDWRSRLHWLF V\VWHPV :KLOH ZRUNLQJ IRU ÂżYH \HDUV DW WKH laboratory of European Centre for The Validation of Alternative Method of the European Commission he was actively involved in the validation of CFU-GM as alternative to animal testing to evaluate immunotoxicity. He is now responsible for the evaluation of toxicological outcomes of testing in compliance with REACH Regulation
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PROFILE: REACH master y
BPD services
SERVICES PROVIDED REACH business solutions
PROFILE: ReachCentrum
CONTACTS Website
www.reachcentrum.eu
info@reachcentrum.eu
Head office
Avenue E van Nieuwenhuyse 6, B-1160 Brussels, Belgium
Tel/ Fax
+32 26767400/ +32 2 6767499
Contact
Francesca Furlan
Directors
Leo Appelman, Managing Director
Ownership
Private company
Locations
Brussels, Belgium
Founded
2006
OVERVIEW 5HDFK&HQWUXP ZDV FUHDWHG LQ -XQH E\ &HÂżF WKH (XURSHDQ 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 nonEuropean companies working on their own or in close collaboration with other companies. VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
1
No of countries represented
-
Staff, group
14
Staff, chemical service provision
14
SERVICE AREA BREAKDOWN Training 20%
Information 2%
Admin, financial, data management, audit and legal support Financial issues for a project are handled in-house. Support is backedXS E\ RXU RZQ ÂżQDQFLDO GHSDUWPHQW DQG Ă&#x20AC;H[LEOH GDWD PDQDJHPHQW 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 coregistrants 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 coregistrants 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
Consultancy/ advisory 30%
Legal 13% IT & software 5%
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. ReachCentrumâ&#x20AC;&#x2DC;s approach is to listen to and carefully analyse each FXVWRPHUVÂś QHHGV DQG WKHQ WR ÂżQG WKH EHVW VROXWLRQ DGDSWHG WR WKHLU UHTXLUHPHQWV DQG ÂżQH WXQH WKH VXSSRUW QHHGHG WKURXJKRXW WKH registration, evaluation and authorisation phases of REACH. 5HDFK&HQWUXPÂśV RYHUDOO VHUYLFHV DUH VHWWOHG DURXQG VL[ FRUH ÂżHOGV RI H[SHUWLVH O project management support O strategic guidance and support O ÂżQDQFLDO DQG GDWD PDQDJHPHQW VXSSRUW O Sief support and supply chain communication O OHJDO VXSSRUW DQG DXGLW PDQDJHPHQW VXSSRUW O preparation of application for authorisation, including the SEA. Moreover, ReachCentrum has set up a series of transversal services beyond REACH regulation: O DataCentrum (data brokerage) O trustee service for indirect reports O CLP for mixtures O biocides support O nanomaterial support
Representation & management 30%
ReachCentrum organises a series of courses covering all aspects of the REACH legislation by offering practical guidance â&#x20AC;&#x201C; what to do, when and how. ReachCentrum applies blended learning to its courses to offer Ă&#x20AC;H[LELOLW\ DQG FRQYHQLHQFH WR WKH SDUWLFLSDQWV Âą FODVVURRP ZHE EDVHG 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.
GLOBAL OFFICES (8 $VLD 3DFLÂżF 86
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Chemical Watch | Global Service Providers Guide 2013
2006
)RXQGHG E\ &HÂżF WKH (XURSHDQ &KHPLFDO ,QGXVWU\ &RXQFLO
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 O O O O
LPI accredited as authorised training assessment centre LPI accredited as authorised training organisation /3, FHUWLÂżHG RQOLQH OHDUQLQJ IDFLOLWDWRU FHUWLÂżHG OHDG DXGLWRU IRU HQYLURQPHQWDO PDQDJHPHQW V\VWHPV
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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 â&#x20AC;&#x153;The conference REACH registration 2013 â&#x20AC;&#x201C; where should you be now â&#x20AC;&#x201C; 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 registrationâ&#x20AC;? â&#x20AC;&#x201C; Norbert Petereit, Sasol. Âł0\ WUDLQHU LV YHU\ IRUWKFRPLQJ ZLWK KLV H[SODQDWLRQV DQG , ÂżQG SDUWLFXODUO\ instructive when he makes examples of the possible mistakes that one can make while working on IUCLIDâ&#x20AC;? â&#x20AC;&#x201C; 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" â&#x20AC;&#x201C; 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 LV VXSSRUWLQJ LW ZLWK JHQHUDO FRQVXOWDQF\ SURMHFW PDQDJHPHQW ÂżQDQFHV communication, as well as all related legal matters, and acts as trustee for the EXVLQHVV FRQÂżGHQWLDO DQG FRPSHWLWLRQ ODZ VHQVLWLYH LQIRUPDWLRQ
Chemical Watch | Global Service Providers Guide 2013
CASE STUDY 2: Virtual learning for IT tools related to REACH 'XULQJ 5HDFK&HQWUXP KDV EHHQ WKH ÂżUVW FRPSDQ\ WR RIIHU YLUWXDO learning for IT tools related to REACH to the chemical industry. These virtual courses are real-time training conducted by our experts through DQ RQOLQH HQYLURQPHQW SURYLGLQJ DQ LGHDO FRPELQDWLRQ RI Ă&#x20AC;H[LELOLW\ DQG knowledge transfer, in a convenient manner anywhere with an internet connection. The virtual training has allowed many more people to attend FRXUVHV DV WKH\ FDQ VWD\ LQ WKHLU FRXQWULHV DQG OHDUQ IURP WKHLU RIÂżFH RU 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. 2QH SLHFH RI VLJQLÂżFDQW IHHGEDFN IURP WKH SDUWLFLSDQWV KDV EHHQ WKDW WKH\ 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 â&#x20AC;&#x201C; 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 SURGXFWV DQG QRWLÂżFDWLRQV IRU QHZ FKHPLFDO VXEVWDQFHV Mark Meesters â&#x20AC;&#x201C; 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 D YDULHW\ RI DXGLHQFHV DQG LV LQYROYHG LQ DGYLVLQJ FRPSDQLHV LQ WKLV ÂżHOG Vincenzo Girardi â&#x20AC;&#x201C; Head of REACH Training and Workshops Vincenzo has more than 20 yearsâ&#x20AC;&#x2122; experience as a professional trainer, with experience in the various industry sectors and since 2007 in REACH. $V D WUDLQHU DQG FHUWLÂżHG RQOLQH OHDUQLQJ IDFLOLWDWRU KH KDV DGYLVHG RQ 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 â&#x20AC;&#x201C; 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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PROFILE: ReachCentrum
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
GLOBAL OFFICES Helsinki, Brussels, New Delhi and Istanbul SERVICES PROVIDED REACH and global compliance services
PROFILE: REACHLaw
CONTACTS
We support companies as their service provider or as their only UHSUHVHQWDWLYH LQ IXOÂżOOLQJ WKH 5($&+ UHTXLUHPHQWV :H PDQDJH 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. :H DOVR SHUIRUP WKH UHTXLUHG QRWLÂżFDWLRQV DQG UHJLVWUDWLRQV DV ZHOO DV the authoring of compliant SDSs and labels according to the market requirements in question.
Website
ZZZ UHDFKODZ Âż
VDOHV#UHDFKODZ Âż
Head office
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
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Mr Lasse Musakka, CEO-Partner
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Mr Frederik Johanson, Head of Environmental ServicesPartner
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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
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 FRYHUV WKH LVVXHV IURP GHÂżQLQJ WKH RYHUDOO VWUDWHJ\ DQG VFRSH RI 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).
Ownership
Private company
www.compliantsuppliers.com
Locations
Finland, Belgium, India, Turkey
Founded
2006
www.compliantsuppliers.com connects buyers and suppliers of compliant FKHPLFDOV 7KH VHUYLFH SURYLGHV VXSSOLHUV ZLWK D ZD\ WR EHQHÂżW IURP 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 DQG FKHPLFDOV YHULÂżHG DV FRPSOLDQW 5($&+/DZ /WG YHULÂżHV WKH compliance by validating chemicals per regulation per region and takes care of all the required documentation.
OVERVIEW 5($&+/DZ SURYLGHV ÂżUVW FODVV VROXWLRQV LQ JOREDO UHJXODWRU\ FRPSOLDQFH 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. VITAL STATISTICS
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 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 DQG 1HZ 'HOKL RIÂżFHV RSHQHG 5($&+/DZ GHOLYHUHG PRUH 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+
2011
,VWDQEXO RIÂżFH RSHQHG 5($&+/DZ VXSSRUWHG ODUJH FRPSDQLHV to ensure compliance with global chemical regulations.
2012
20+ REACH lead registrant cases. First authorisation cases. 6HYHUDO JOREDO QRWLÂżFDWLRQV ZHUH GRQH 5($&+/DZ EHFDPH shareholder in eSpheres Ltd. REACHlaw established a business partnership with BioSafe â&#x20AC;&#x201C; 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
2011/12
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
4
No of countries represented
40+
Staff, group
30+
Staff, chemical service provision
25+
SERVICE AREA BREAKDOWN Training 5% Legal 20%
Consultancy/ advisory 30%
IT & software 10% Laboratory 5% Information 5%
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Representation & management 25%
Chemical Watch | Global Service Providers Guide 2013
ACCREDITATIONS
STAFF SELECTION
,QWHUQDWLRQDOLVDWLRQ DZDUG IURP WKH SUHVLGHQW RI )LQODQG LQ $$$ ÂżQDQFLDO rating in 2010. Innovative â&#x20AC;&#x201C; 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.
Mr Riku Rinta-Jouppi, MA (Law), MSc â&#x20AC;&#x201C; Head of Global Compliance â&#x20AC;&#x201C; Partner
Selected partners: Chemtopia, ChemRisk, Chemitox, Dynamic Orbits, Mourao Henrique Consultores Associados, AIDA, Chamber of Chemical and Petrochemical Industry of Argentina â&#x20AC;&#x201C; CIQyP, CICM, eSpheres, BioSafe â&#x20AC;&#x201C; 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 â&#x20AC;&#x153;REACHLaw has provided excellent legal services to our REACH working group. Their business approach and expertise in global compliance KDYH EHHQ RI JUHDW KHOS WR RXU RUJDQLVDWLRQ :H DUH YHU\ VDWLVÂżHG ZLWK REACHLaw serviceâ&#x20AC;? â&#x20AC;&#x201C; Petrochina. â&#x20AC;&#x153;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 serviceâ&#x20AC;? â&#x20AC;&#x201C; Dr Thomas Slotte, OMG Kokkola Chemicals Ltd. â&#x20AC;&#x153;REACHLaw assisted us in registering our substances as regular registrant and as lead registrant in 2010. We are very pleased with REACHLawâ&#x20AC;&#x2122;s servicesâ&#x20AC;? â&#x20AC;&#x201C; Mr Ludo Schyvinck, Minerals Technologies Europe NV. CASE STUDY 1: REACH â&#x20AC;&#x201C; authorisation
Mr Tim Becker, MA (Law) â&#x20AC;&#x201C; EU Compliance Officer 0U %HFNHU LV D *HUPDQ TXDOLÂżHG ODZ\HU +H KDV EHHQ DFWLQJ DV OHJDO 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 nonEU countries and the determination of exemptions from the REACH registration and authorisation requirements. Dr Ying Zhu, PhD (Biochemistry), MSc in Economics, COOPartner 'U =KX KDV ERWK D VFLHQWLÂżF DQG HFRQRPLF HGXFDWLRQ EDFNJURXQG 6KH has also worked in various management positions in industry for more than ten years. Her unique educational background and work experience DUH TXDOLÂżFDWLRQV WKDW HQDEOH KHU WR DFW DV D OHDGLQJ H[SHUW LQ WKH DUHD RI 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) â&#x20AC;&#x201C; Project Director and Specialist in Risk Assessment
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 â&#x20AC;&#x201C; 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 VSHFWUXP UHTXLUHG LQ WKHVH FDVHV IURP DQDO\VLV RI DOWHUQDWLYHV WR &65 update to socio-economic analysis and project management
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 VHYHUDO \HDUVÂś H[SHULHQFH LQ WKHVH ÂżHOGV
CASE STUDY 2: Lead registrant registration
Ms Sini Suomela, MSc (Organic Chemistry) â&#x20AC;&#x201C; Technical Project Manager
REACHLaw will be lead registrant for numerous substances in 2013 on behalf of our customers. Compared to 2010 the substances are much PRUH FRPSOLFDWHG GXH WR WKHLU VSHFLÂżF QDWXUH $V DQ H[DPSOH LQ RQH case REACHLaw acts as lead registrant for eight substances with similar chemical characteristics such as high reactivity when in contact with water or moisture. Thus there is a need to concentrate on more than 20 degradation products for these substances. Proving that substances that will be registered in 2013 are more demanding and require more expertise WKDQ LQ 5($&+/DZ KDV SURYLGHG WKH FRQVRUWLXP ÂżQDQFLDO DQG SURMHFW management as well as the technical work required for the registration.
Chemical Watch | Global Service Providers Guide 2013
Mrs Mia BlĂĽfield, MSc (Toxicology) â&#x20AC;&#x201C; 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 H[SHULHQFH RI ZRUNLQJ LQ WKH ÂżHOG RI UHJXODWRU\ WR[LFRORJ\
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 DQG &/3 QRWLÂżFDWLRQV
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PROFILE: REACHLaw
PARTNERS
Graduate of Cambridge university. He is widely recognised as one of the leading European legal experts in chemicals regulations. In addition WR KLV OHJDO TXDOLÂżFDWLRQV KH KROGV D PDVWHUV GHJUHH LQ ELR LQIRUPDWLRQ technology. Mr Rinta-Jouppi is responsible for REACHLaw global compliance services.
SERVICE AREA BREAKDOWN Training 5%
PROFILE: Risk & Policy Analysts (RPA)
CONTACTS Website
www.rpaltd.co.uk
post@rpaltd.co.uk
Head office
1 Beccles Road, Loddon, Norfolk, NR14 6LT, UK
Tel
+44 1508 528465
Fax
+44 1508 520758
GLOBAL OFFICES
Contact
Panos Zarogiannis
UK
Directors
Pete Floyd
Meg Postle
Ownership
Private
Locations
UK
Founded
1990
Consultancy/ advisory 95%
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.
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 ULVN PDQDJHPHQW DQG LWV UHSXWDWLRQ IRU H[FHOOHQFH LQ WKLV ¿HOG 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 UHVXOWHG LQ GHWDLOHG VWXGLHV RQ RYHU KLJK SUR¿OH FKHPLFDOV %XLOGLQJ RQ RXU 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. VITAL STATISTICS
£1.4m
Turnover, chemical service provision
£0.8m
No of countries represented
1 Focus on EU-27, EEA and Candidate Countries
Staff, group
27
Staff, chemical service provision
15
Page 118
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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1992
53$ GHYHORSV D ULVN EHQH¿W DQDO\VLV PHWKRGRORJ\ IRU chemical 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 WR DVVHVV WKH SRWHQWLDO FRVWV DQG EHQH¿WV RI WKH WKHQ (8 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 WKH ¿UVW \HDUV RI 5($&+ LPSOHPHQWDWLRQ
2011/12
Turnover, group 1R RI RI¿FHV
REACH – restrictions
Chemical Watch | Global Service Providers Guide 2013
STAFF SELECTION
RPA works with FoBiG, DHI, TNO, RIVM, ARCHE, Hydrotox, Royal Haskoning, Denehurst, ReachCentrum and EPPA amongst others.
Meg Postle â&#x20AC;&#x201C; Director
CLIENTS O
O
O O
O
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 socioeconomic 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 usersâ&#x20AC;&#x2122; 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. 7KH REMHFWLYH RI WKH VWXG\ ZDV WR SURYLGH VFLHQWLÂżF HFRQRPLF DQG 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 GRVVLHU IRU WKH LGHQWLÂżFDWLRQ RI WKH VXEVWDQFH DV D 69+& The emphasis of the analysis was on uses other than those in which WKH VXEVWDQFH LV XVHG DV DQ LQWHUPHGLDWH DV GHÂżQHG XQGHU WKH 5($&+ 5HJXODWLRQ DV ZHOO DV RQ WKRVH XVHV SRWHQWLDOO\ UHVXOWLQJ LQ VLJQLÂżFDQW 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.
Chemical Watch | Global Service Providers Guide 2013
Meg is an environmental economist and policy analyst with more than 20 yearsâ&#x20AC;&#x2122; experience of consultancy. She has led RPAâ&#x20AC;&#x2122;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 â&#x20AC;&#x201C; Director Risk assessment expert with more than 25 yearsâ&#x20AC;&#x2122; consultancy experience. He has led studies ranging from hazard and risk assessments relating WR WKH PDQXIDFWXUH VWRUDJH WUDQVSRUW XVH DQG GLVSRVDO RI Ă&#x20AC;DPPDEOH 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 RPAâ&#x20AC;&#x2122;s framework contract with ECHA. Phil Holmes â&#x20AC;&#x201C; Technical Director, Chemical Science Phil Holmes is a technical director at RPA with more than 35 yearsâ&#x20AC;&#x2122; 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 â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; 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. +H KDV FROODWHG DQG DQDO\VHG LQIRUPDWLRQ RQ WKH KD]DUG SURÂżOH DQG physicochemical properties of various chemicals to inform REACH authorisation studies.
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PROFILE: Risk & Policy Analysts (RPA)
PARTNERS
GLOBAL OFFICES HaskoningDHV Nederland BV: Barbarossastraat 35, 6522DK Nijmegen, Netherlands Haskoning UK Ltd: Rightwell House, Bretton, Peterborough, PE3 8DW, UK Haskoning Belgium SA: SchaliĂŤnhoevedreef 20D, B-2800 Mechelen, Belgium
PROFILE: Royal HaskoningDHV
CONTACTS Website
www.royalhaskoningdhv.com
secretariat.pci@rhdhv.com
Head office
HaskoningDHV Nederland BV, Laan 1914 nr. 35, 3818 EX Amersfoort
Tel
+31 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
Ownership
Private company
Locations
100 Locations worldwide. Key locations Europe: Nijmegen, Amersfoort (Nl), Peterborough (UK), Mechelen (Be)
Founded
SERVICES PROVIDED REACH
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.
1881
OVERVIEW 7KH ÂżUP ZDV IRXQGHG LQ LQ WKH 1HWKHUODQGV 2XU HPSOR\HHV combine a wide range of knowledge and experience. Rooted in a technical background, our consulting services focus on the broad ÂżHOG RI WKH LQWHUDFWLRQ EHWZHHQ SHRSOH DQG WKHLU HQYLURQPHQW :H are committed to working enthusiastically with our clients to achieve sustainable solutions in an increasingly complex society. The expertise and experience of our professionals in a variety of disciplines allows us to consider all technical, logistical, legal, organisational, social, environmental and economic aspects of the projects of our clients, in order to subsequently develop sustainable and practical solutions. We have been working with the industry on chemicals management for several decades and contributed to the implementation of many legislative programmes. In 2012 Royal Haskoning and DHV merged to the current organisation. VITAL STATISTICS
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 FKHFNV *+6 &/3 LPSOHPHQWDWLRQ &/3 QRWLÂżFDWLRQ UH FODVVLÂżFDWLRQ RI 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.
â&#x201A;Ź312M and â&#x201A;Ź434M
Turnover, chemical service provision
-
1R RI RIÂżFHV
100
No of countries represented
35
Staff, group
7,900
Staff, chemical service provision
80
SERVICE AREA BREAKDOWN
IT & software 5% Laboratory 2% Information 15% Representation & management 15%
Storage of chemicals and (external) safety Royal HaskoningDHV can assist you with assessing, designing and permitting of storage facilities for hazardous chemicals, modelling of external safety (SEVESO) and assessing aspects such as explosion safety (ATEX). Other services Royal HaskoningDHV provides a wide range of services that provide solutions for multidisciplinary challenges to industry, such as engineering/ design of installations and buildings, responsible care and environmental impact assessments. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Training Legal 8% 5%
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GHS/CLP
2011/2012
Turnover, group (2011)
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.
Consultancy/ advisory 50%
1881
Founding fathers Johan van Hasselt and Jacobus de Koning start their business in Nijmegen.
1917
Founding fathers Dwars, Hederik en Verheij start their business in 's Gravenhage.
1981
Haskoning is granted the designation 'koninklijk' (Royal) at its 100th birthday.
1991
EaSI is developed by Royal Haskoning: a database with hazard information from legislation all over the world
Chemical Watch | Global Service Providers Guide 2013
1994
5R\DO +DVNRQLQJ GHYHORSHG 5RVHWWD RQH RI WKH ÂżUVW programs able to produce multilingual safety data sheets.
STAFF SELECTION
2005
RIP 3.10 on characterisation and checking of substance identity is prepared by Royal Haskoning.
2007
Royal Haskoning joins the organisation of ChemCon Conferences
2012
Merge between Royal Haskoning and DHV
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.
ACCREDITATIONS
Dr Ingrid Sterenborg â&#x20AC;&#x201C; Senior Expert Toxicology
ISO 9001 ISO 14001 OHSAS 18001
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.
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, Ă&#x20AC;DYRXUV DQG IUDJUDQFHV SODVWLFV SHWURFKHPLFDOV SDLQWV DQG FRDWLQJV 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 GRVVLHUV IRU WKHVH VSHFLÂżF VXEVWDQFHV DOO SDUWLHV FRPPLWWHG WR WKH RSWLPDO 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 DQG 5+ SURYLGHG JXLGDQFH RQ LQ KRXVH WHVWLQJ WR HIÂżFLHQWO\ JHQHUDWH 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 UHPDLQ Ă&#x20AC;H[LEOH ZLWKLQ LWV FXUUHQW RSHUDWLRQDO HQYLURQPHQW 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.
Chemical Watch | Global Service Providers Guide 2013
Conny Hoekzema Msc â&#x20AC;&#x201C; GHS/CLP and SDS Expert &RQQ\ +RHN]HPD KDV VL[ \HDUVÂś H[SHULHQFH LQ WKH ÂżHOG RI FKHPLFDOV management. She has extensive knowledge and experience in safety GDWD VKHHWV DQG FODVVLÂżFDWLRQ DQG ODEHOOLQJ )XUWKHUPRUH VKH LV 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 GDWD VKHHWV DQG FODVVLÂżFDWLRQ DQG ODEHOOLQJ IRU D YDULHW\ RI DXGLHQFHV Tjeerd Bokhout, MSc MBA â&#x20AC;&#x201C; 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 worldâ&#x20AC;&#x2122;s leading conference on chemical control legislation and trade aspects. ir. Leo van der Biessen Msc â&#x20AC;&#x201C; Senior Expert Occupational Exposure Leo van der Biessen has more than 20 yearsâ&#x20AC;&#x2122; 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 â&#x20AC;&#x201C; Project Manager Christiaan van Daalen is trained as an environmental scientist, specialising in both regulatory toxicology and business communication with a focus on REACH. He has been involved in the production of several large dossiers under REACH and advises on various REACH implementation processes. Besides the preparation of technical dossiers Christiaan acts as project manager in many REACH registration projects for individual companies and consortia and he is teamleader of the advisory group in Nijmegen.
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PROFILE: Royal HaskoningDHV
ir. Froukje Balk Msc â&#x20AC;&#x201C; Senior Expert Ecotoxicology
SERVICES PROVIDED Registration of chemicals â&#x20AC;&#x201C; REACH 6&& KDV SUHSDUHG KXQGUHGV RI FKHPLFDO QRWLÂżFDWLRQV IRU QHZ FKHPLFDO substances (including high volume products of more than 1,000 t/a) and VXFFHVVIXOO\ ÂżOHG RYHU OHDG GRVVLHUV IRU WKH GHDGOLQH XQGHU 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 &HÂżF RU +HUD 6&& FDQ SURYLGH \RX ZLWK O RQO\ UHSUHVHQWDWLYH VXSSRUW O VXSSRUW LQ WKH SUH ODWH SUH UHJLVWUDWLRQ SURFHVV O support in prioritisation/advice on required action in your company for WKH XSFRPLQJ GHDGOLQHV O OLWHUDWXUH UH VHDUFK DQG HYDOXDWLRQ O GDWD UHYLHZ DQG LGHQWLÂżFDWLRQ RI GDWD JDSV O establishment of study requirements as well as organising and PRQLWRULQJ RI WKRVH VWXGLHV O analysis of potential analogous/family approaches and development RI WHVW VWUDWHJLHV O VXSSRUW ZLWK XVHV XVH FDWHJRULHV 352&V VS (5&V O exposure modelling (eg EUSES, Risk of Derm, CONSEXPO, EASY75$ $57 O KXPDQ DQG HQYLURQPHQWDO ULVN DVVHVVPHQWV O SUHSDUDWLRQ RI WKH FKHPLFDO VDIHW\ UHSRUW O VXEPLVVLRQ GHIHQFH RI WKH GRVVLHU DW DXWKRULW\ OHYHO O 6LHI DQG FRQVRUWLD VXSSRUW PDQDJHPHQW LQFOXGLQJ WUXVW DFFRXQW O C&L support (CLH dossier according to Annex XV, eSDS including $QQH[ O 6FLHQWLÂżF UHJXODWRU\ VXSSRUW DW (8 H[SHUW PHHWLQJV DQG O QSAR tools.
PROFILE: SCC
CONTACTS Website
www.scc-gmbh.de
scc@scc-gmbh.de
Head office
Am Grenzgraben 11, 55545 Bad Kreuznach, Germany
Tel
+49 671 298 46-0
Fax
+49 671 298 46-100
Contact
Dr Werner Koehl (Chemicals, REACH, Consumer Products)
Directors
Dr Friedbert Pistel, Owner and President Dr Albrecht Heidemann (Agrochemicals and Biopesticides)
Â
Dr Monika Hofer (Regulatory Science)
Â
Dr Hans-Josef Leusch (Biocides)
Â
Dr Werner Koehl (Chemicals, REACH, Consumer Products) Ruud Huibers MSc (Feed and Food Additives and Veterinary Medicine)
Ownership
Private company
Locations
Germany and Japan
Founded
1989
OVERVIEW
Registration of consumer products
6&& Âą 6FLHQWLÂżF &RQVXOWLQJ &RPSDQ\ Âą ZDV IRXQGHG LQ E\ 'U 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
-
6&& KDV WKH H[SHULHQFH WR GHDO ZLWK DOO UHOHYDQW VFLHQWLÂżF DQG UHJXODWRU\ 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.
Turnover, chemical service provision
-
Registration of agrochemicals and biopesticides
1R RI RIÂżFHV
2
No of countries represented
2
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 ODWHVW VFLHQWLÂżF UHVHDUFK GDWD )RU WKLV UHDVRQ WKH DJURFKHPLFDOV DQG biopesticides department is at the forefront in strategic planning and defence, negotiations with authorities, or task force support.
VITAL STATISTICS
2011/12
Staff, group
100
Staff, chemical service provision
45
SERVICE AREA BREAKDOWN
Information 10%
Registration of biocides IT & software 2%
Representation & management 18% Consultancy/ advisory 70%
GLOBAL OFFICES Bad Kreuznach in Germany (HQ) and Tokyo in Japan
Page 122
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 ÂżOHG 2XU H[SHUWLVH DQG FRQQHFWLRQV ZLWK JRYHUQPHQWV DQG LQGXVWULHV HQDEOH XV WR SXW WRJHWKHU WKH RSWLPDO SRUWIROLR RI VFLHQWLÂżF GDWD DQG H[SHUW statements for your products. These portfolios will be as concentrated as possible and as extensive as necessary.
Chemical Watch | Global Service Providers Guide 2013
Regulatory science
STAFF SELECTION
7KH VFLHQWLÂżF VSHFLDOLVWV LQ WKH 6&& UHJXODWRU\ VFLHQFH GHSDUWPHQW DUH the backbone of the company and the key to its success. SCC unites experts from all regulatory relevant disciplines, such as chemists, physicists, food chemists, biologists, geo-ecologists, toxicologists, ecotoxicologists, environmental fate specialists, agronomists etc. This access to a wide spectrum of expertise ensures that clients of SCC can take DGYDQWDJH RI D KLJKO\ HIÂżFLHQW VHUYLFH
Dr Werner Koehl â&#x20AC;&#x201C; Head of the Chemicals, REACH, Consumer Products Department
SCC offers a complete GLP-compliant archiving concept for all regulatory QHHGV WR WKH EHQHÂżW RI DOO RXU FOLHQWV VLQFH 6&& FDQ DFW DV \RXU European or worldwide central archive for GLP-compliant storage.
Isabel Kirbach
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Dr Charlotte Krone
1989
SCC GmbH founded
1989
Establishment of Agrochemical and Biopesticides department
1989
Establishment of Regulatory Science department
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 /LDLVRQ 2IÂżFH LQ 7RN\R -DSDQ
1996
Establishment of Chemical and Consumer Products department
2000
Establishment of Biocides department
2004
*/3 DUFKLYH FHUWLÂżFDWLRQ
2007
(VWDEOLVKPHQW RI /LDLVRQ 2IÂżFH LQ 7RN\R -DSDQ
Dr Heidemann has a PhD in biology. He has been with SCC since 1994 and is head of the Agrochemicals and Biopecticides department.
2007
Establishment of Feed and Food Additives and Veterinary Medicine department
Dr Monika Hofer
Mrs Kirbach has a masterâ&#x20AC;&#x2122;s degree in chemical engineering. She has been with SCC since 2004 and her focus is on Sief and IUCLID 5.
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
ACCREDITATIONS
Dr Hofer has a PhD in chemistry. She has been with SCC since 1998 and is head of the Regulatory Science department.
GLP archive (since 2004)
Dr Hans-Josef Leusch â&#x20AC;&#x201C; Head of Biocides Department
PARTNERS
Dr Leusch has a PhD in agronomy. He has been with SCC since 2000 and is head of the Biocides department.
7KURXJK RXU +4 DQG RXU OLDLVRQ RIÂżFH LQ -DSDQ ZH KDYH D JOREDO QHWZRUN 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
Ruud Huibers MSc â&#x20AC;&#x201C; Head of Feed and Food Additives, Veterinary Medicine Department Mr Huibers has a masterâ&#x20AC;&#x2122;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 â&#x20AC;&#x201C; GLP Archive Dr Brielbeck has a PhD in chemistry. He has been with SCC since 2001 DQG LV UHVSRQVLEOH IRU RXU */3 FHUWLÂżHG DUFKLYH
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 OHYHO RI FRQÂżGHQWLDOLW\ 7KHUHIRUH ZH DUH XQDEOH WR IRFXV RQ LQGLYLGXDO 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.
Chemical Watch | Global Service Providers Guide 2013
Page 123
PROFILE: SCC
GLP archive
'U .RHKO KDV D 3K' LQ IRRG FKHPLVWU\ DQG LV D FHUWLÂżHG H[SHUW IRU toxicology. He has been with SCC since 2001 and is head of the Chemicals, REACH, Consumer Products department. He previously ZRUNHG IRU WKH VFLHQWLÂżF FRPPLWWHH RQ IRRG VDIHW\ DQG D ODUJH FKHPLFDO multinational, and has gained many years of experience in the registration processes of the chemical world.
SERVICES PROVIDED 14C custom radiolabelling
PROFILE: Selcia
CONTACTS
Our services include: O 14C radiosynthesis including de novo development of synthetic URXWHV O V\QWKHVLV RI & UDGLRODEHOOHG $3, WR *03 O UDSLG UH SXULÂżFDWLRQ VHUYLFH O VWRFN PDQDJHPHQW RI UDGLRODEHOOHG FRPSRXQGV O FHUWLÂżFDWH RI DQDO\VLV DQG DQDO\WLFDO SURÂżOH O */3 DQDO\VLV O 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 GRFXPHQWDWLRQ $ FHUWLÂżFDWH RI DQDO\VLV VSHFLI\LQJ FKHPLFDO DV ZHOO as radiochemical purity by NMR, MS and HPLC accompanies each compound.
Website
www.selcia.com
contact@selcia.com
Head office
)\ÂżHOG %XVLQHVV DQG 5HVHDUFK 3DUN 2QJDU (VVH[ &0 0GS, UK
Tel
+44 1277 367000
Fax
+44 1277 367099
Contact
David Carver
Directors
Simon Saxby, CEO
Â
Dr Hans Fliri, Chairman
Ownership
Private
Locations
UK, USA
Founded
GMP radiolabelled API
2001
6HOFLD LV FHUWLÂżHG E\ WKH 8. 0HGLFLQHV DQG +HDOWKFDUH SURGXFWV Regulatory Agency (MHRA) for the preparation and C-14 labelling of active pharmaceutical ingredients (API) for clinical trials. :KHWKHU \RX UHTXLUH D V\QWKHVLV RU UH SXULÂżFDWLRQ XQGHU *03 ZH perform both in compliance with EMEA and the recent FDA Phase I GMP guidance (IQCH Q7A Section 19: Single batches for investigational GUXJV :H DUH FHUWLÂżHG E\ WKH 8. V 0+5$ IRU SUHSDUDWLRQ DQG & labelling of APIs for clinical trials.
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 PLFURWUDFHU VWXGLHV UHVHDUFK DQG UHJXODWRU\ VWXGLHV RI FRVPHWLF SURGXFWV and environmental fate studies of pharmaceutical, agricultural and industrial chemicals. Selciaâ&#x20AC;&#x2122;s analytical laboratory is a member of the UK GLP compliance monitoring programme and specialises in GLP NMR. VITAL STATISTICS
2011/12
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
2
No of countries represented
Global
Staff, group
75
Staff, chemical service provision
75
SERVICE AREA BREAKDOWN
Laboratory 100%
GLP analytical services and metabolite synthesis :H SHUIRUP VWUXFWXUDO HOXFLGDWLRQ DQG LPSXULW\ SURÂżOLQJ WRJHWKHU ZLWK 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: O GLP analysis including mass spectrometry and infrared VSHFWURVFRS\ O */3 105 VHUYLFH O FXVWRP V\QWKHVLV RI PHWDEROLWHV LPSXULWLHV DQG UHIHUHQFH VWDQGDUGV O custom synthesis of compounds labelled with stable isotopes such as FDUERQ QLWURJHQ GHXWHULXP O DOO FXVWRP SUHSDUHG SURGXFWV DUH DYDLODEOH ZLWK D */3 FHUWLÂżFDWH RI DQDO\VLV O non-routine analytical studies including structural elucidation and LPSXULW\ SURÂżOLQJ DW PLFURJUDP OHYHOV XVLQJ FDSLOODU\ 105 Selcia can act as study director or principle investigator to support your GLP regulatory study Drug discovery
GLOBAL OFFICES UK, USA
Page 124
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 WHFKQRORJLHV PHGLFLQDO FKHPLVWU\ RQ FRPSOH[ QDWXUDO SURGXFWV (2) capillary electrophoresis-based fragment and natural product VFUHHQLQJ SURWHLQ SURWHLQ LQWHUDFWLRQ WDUJHWV LQ SDUWLFXODU SHSWLG\O prolyl isomerases (including cyclophilins, FKBPs, Pin1, together called PPIases).
Chemical Watch | Global Service Providers Guide 2013
Simon Saxby â&#x20AC;&#x201C; Chief Executive Officer
2012
Selcia celebrates 20 years of radiolabelling at Ongar
2010
Selciaâ&#x20AC;&#x2122;s radiochemistry facility is granted a Good 0DQXIDFWXULQJ 3UDFWLFH *03 FHUWLÂżFDWH IRU WKH SUHSDUDWLRQ of C-14 labelled active pharmaceutical ingredients (APIs) following a successful inspection by the UKâ&#x20AC;&#x2122;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.
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 yearsâ&#x20AC;&#x2122; experience as a board director and has led successful M&A activities for two companies. Mr Saxby has a VFLHQWLÂżF EDFNJURXQG LQ LPPXQRORJ\ DQG GXULQJ KLV \HDUV LQ WKH OLIH sciences industry he has been a founder and fundraiser for companies LQ WKH 8. 0DOD\VLD DQG WKH 86$ ZKHUH KH VSHQW ÂżYH \HDUV OHDGLQJ WKH development of a CMO business for Unisyn Technologies. Prior to that KH ZDV D VFLHQWLÂżF IRXQGHU RI 0XUH[ 'LDJQRVWLFV D IRXQGHU GLUHFWRU RI 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 Directorsâ&#x20AC;&#x2122; Policy Voice forum, advising the IoD, legislators and government, on business issues.
2001
Aventisâ&#x20AC;&#x2122;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 UDGLRFKHPLFDOV IDFLOLW\ DW ZKDW LV QRZ WKH )\ÂżHOG 5HVHDUFK and Business Park, Ongar.
ACCREDITATIONS Selcia has been a full member of the GLP Compliance Monitoring Programme in the UK since 2006. 6HOFLD KROGV D *RRG 0DQXIDFWXULQJ 3UDFWLFH *03 FHUWLÂżFDWH IRU WKH preparation and C-14 labelling of active pharmaceuticalingredients (APIs) for clinical trials from the UKâ&#x20AC;&#x2122;s Medicines and Healthcare products Regulatory Agency (MHRA). Selcia is an approved service provider under the French CrĂŠdit ImpĂ´t Recherche (CIR) scheme for the years 2012 to 2014.
Dave Roberts â&#x20AC;&#x201C; 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 Kingâ&#x20AC;&#x2122;s College London. He is a co-inventor of the animal health insecticide Fipronil and WKH PDL]H KHUELFLGH ,VR[DĂ&#x20AC;XWROH Clive Cornell â&#x20AC;&#x201C; Chief Operating Officer
TESTIMONIALS
Clive heads up Selciaâ&#x20AC;&#x2122;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 RI WKH 6&, )LQH &KHPLFDOV *URXS DQG WKH FR DXWKRU RI RYHU VFLHQWLÂżF DUWLFOHV DQG SDWHQWV &OLYH FRPSOHWHG KLV ÂżUVW GHJUHH DW WKH 8QLYHUVLW\ RI 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.
References can be provided on request.
Dr Gill Little â&#x20AC;&#x201C; Director, Radiochemistry and Analytics
STAFF SELECTION
Gill has headed up Selciaâ&#x20AC;&#x2122;s 30-strong radiolabelling group and overseen the groupâ&#x20AC;&#x2122;s associated project portfolios since 2006. She was a cofounder 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 VFLHQWLÂżF SDSHUV DQG SDWHQWV DQG LV D FR LQYHQWRU RI WKH PDL]H KHUELFLGH ,VR[DĂ&#x20AC;XWROH
CLIENTS &OLHQW FRQÂżGHQWLDOLW\ LV JXDUDQWHHG :H ZRUN ZLWK D ODUJH SRUWIROLR RI FOLHQWV RI DOO VL]HV RQ ÂżYH FRQWLQHQWV PDQXIDFWXUHV RI SKDUPDFHXWLFDOV agrochemicals, biocides, veterinary medicines, chemicals as well as life science research and development organisations and contract laboratories.
Dr Hans Fliri â&#x20AC;&#x201C; 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 yearsâ&#x20AC;&#x2122; 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 RhonePoulenc Rorer and later Aventis in Paris (1994-2000). He held research and management positions at Sandoz (now Novartis) in Basel between 1977 DQG +DQV KDV DOVR VHUYHG RQ VFLHQWLÂżF DGYLVRU\ ERDUGV IRU FRPSDQLHV in Europe and the US. He holds a PhD in chemistry from the University of ,QQVEUXFN DQG LV WKH DXWKRU RI DSSUR[LPDWHO\ VFLHQWLÂżF DUWLFOHV DQG SDWHQWV
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PROFILE: Selcia
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
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.
PROFILE: SGS
CONTACTS
Consultancy/ impact analysis
Website
www.sgs.com/reach
reach@sgs.com
Head office
1, Place des Alpes, PO Box 2152, Geneva, 1211, Switzerland
Tel
+41 22 739 91 11
Fax
+41 22 739 98 86
Contact
Emilie.Viengchaleune@sgs.com
Directors
&KULV .LUN &KLHI ([HFXWLYH 2IÂżFHU
Â
Malcolm Reid, Consumer Testing Services EVP
Ownership
Private company
Locations
Brazil, China, Finland, France, Germany, Hong-Kong, Spain, UK, US, etc
Founded
1878
Our teams assess companiesâ&#x20AC;&#x2122; role and current compliance status to GHÂżQH D VSHFLÂżF 5($&+ VWUDWHJ\ Analysis Laboratory testing: SGS can develop testing strategy and generate required testing data according to the REACH requirements. Testing services are available through our laboratory networks in Europe, Asia and the Americas. Our labs can perform testing according to and in compliance with Good Laboratory Practices (GLP) as required by the regulation for toxicological and eco-toxicological studies. Analysis of restricted substances and SVHC: SGS is a pioneer for consumer products testing. We can meet all requests of product chemical analysis enforced by regulations. Data collection and volume tracking
OVERVIEW 6*6 LV WKH ZRUOGÂśV OHDGLQJ LQVSHFWLRQ YHULÂżFDWLRQ WHVWLQJ DQG FHUWLÂżFDWLRQ company. SGS is recognised as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of RYHU RIÂżFHV DQG ODERUDWRULHV DURXQG WKH ZRUOG Since 2006, SGS has offered a comprehensive suite of services to help customers comply with their obligations under REACH, from initial 5($&+ UHJLVWUDWLRQ WR FRQVXOWLQJ WHVWLQJ DXGLWLQJ DQG YHULÂżFDWLRQ services to support ongoing compliance. VITAL STATISTICS
2011/12
Turnover, group
5,578m CHF
Turnover, chemical service provision
-
1R RI RIÂżFHV
1,500
No of countries represented
+100
Staff, group
75,000
Staff, chemical service provision
-
SERVICE AREA BREAKDOWN
SGS has an extensive network in EU and non-EU countries assisting EU importers and retailers to collect substance data for registration as well as 69+& QRWLÂżFDWLRQ ,Q FDVHV ZKHUH WKH LPSRUWHUV DQG UHWDLOHUV GR QRW KDYH 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, ecotoxicologist, 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 )XUWKHU WR WKH DFKLHYHPHQWV RI LWV *OREDO 5($&+ WHDP IRU WKH ÂżUVW 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 WKH ORFDWLRQ RI LPSRUW ZH FDQ SUHSDUH 6'6 LQ DOO (XURSHDQ ODQJXDJHV DQG VLPSOLÂżHG &KLQHVH Risk assessment and strategy consultation for SVHC notification
Consultancy/ advisory 10%
Laboratory 89%
6*6 RIIHUV YDULRXV VROXWLRQV WR LGHQWLI\ DQG VXSSRUW 69+& QRWLÂżFDWLRQ 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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1878
GLOBAL OFFICES
1900s
Expanded beyond agriculture in early and mid 20th century to: PLQHUDOV O RLO JDV DQG FKHPLFDOV O FRQVXPHU JRRGV O industrial sector. O
Brazil, China, Finland, France, Germany, Hong-Kong, Spain, UK, US, etc
1915
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GoldstĂźck-Heinz & Co was founded in 1878 in Rouen as a grain inspection company
Headquarter in Geneva
Chemical Watch | Global Service Providers Guide 2013
The company adopted the name SociĂŠtĂŠ GĂŠnĂŠrale de Surveillance
1980s
Expanded our activities to: O DXWRPRWLYH O HQYLURQPHQWDO O FHUWLÂżFDWLRQ O JRYHUQPHQWDO O 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 â&#x20AC;&#x153;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 VWUDWHJ\ VXSSRUWHG XV UHJDUGLQJ WKH QHFHVVDU\ WHVWLQJ KDQGOHG FRQÂżGHQWLDO 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.â&#x20AC;? â&#x20AC;&#x201C; 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 WKH FOLHQWV UHJLVWUDWLRQ DQG QRWLÂżFDWLRQ REOLJDWLRQV WR EH HYDOXDWHG 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 WHVWLQJ WKDW VHOHFWLYHO\ LGHQWLÂżHG 69+&CV PRVW OLNHO\ WR EH SUHVHQW DQG QRW unnecessarily testing SVHCs that had a low likelihood of being present. 7KH FOLHQWV E\ XVLQJ 6*6CV VHUYLFHV ZHUH DEOH WR UHGXFH WKH OHYHO RI manpower that they were committing to REACH management whilst maintaining a high level of regulatory compliance.
CASE STUDY 3: Faced with the question of whether a read-across from the results gained from WR[LFLW\ VWXGLHV FRQGXFWHG ZLWK D VSHFLÂżF DONDOL PHWDO VDOW FRXOG DQG KDG WR EH 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 WKH LVVXH ZLWK D FRQVXOWDQF\ UHSRUW RQO\ DQG QR IXUWKHU WHVWLQJ RU FODVVLÂżFDWLRQ of the substance was needed. The SGS consultancy report was used by our FOLHQW IRU WKHLU RIÂżFLDO FRPPXQLFDWLRQ ZLWK WKH SHUWLQHQW DXWKRULW\ STAFF SELECTION CĂŠline Goulois Ms Goulois is a regulatory (eco)toxicologist, specialist in REACH regulation. She is in charge of SGS clientsâ&#x20AC;&#x2122; 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, ,8&/,'V GRVVLHUV HFR WR[LFRORJLFDO SURÂżOH +39 GRVVLHUV FXVWRPHU LQTXLULHV FODVVLÂżFDWLRQ (8 DQG *+6 DQG 5($&+ UHJLVWUDWLRQ ULVN assessment, technical support). Anne Kleinkauf $IWHU UHFHLYLQJ KHU 3K' GHJUHH LQ WKH ÂżHOG RI ELRPDUNHUV IRU HQGRFULQH 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 7RQ\ 6PLWK LV D &KDUWHUHG &KHPLVW ZLWK RYHU WZHQW\ ÂżYH \HDUVÂś H[SHULHQFH LQ WKH HQYLURQPHQWDO DQG UHJXODWRU\ ÂżHOGV 7HQ \HDUV ZDV VSHQW ZRUNLQJ 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.
CASE STUDY 2:
Jerome Vandenbroucke
Asked by a major player in the cycle industry to verify that their Indian VXSSOLHU ZDV VXIÂżFLHQWO\ HQVXULQJ WKDW QR 69+& OLVW FDQGLGDWHV ZHUH contained in the products exported to Germany, SGS staff from Germany and India carried out a training and site audit at the Indian supplierâ&#x20AC;&#x2122;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 customerâ&#x20AC;&#x2122;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.
Jerome is a chemical engineer specialised in formulation. He worked two years on chemical legislations applied to mixture: REACH, biocide, FODVVLÂżFDWLRQ DQG ODEHOOLQJ RI KD]DUGRXV VXEVWDQFHV DQG PL[WXUHV DQG IRUPXODWLRQ UHSHOOHQWV ÂżUHOLJKWHUV 89 DQG 38 UHVLQV
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PROFILE: SGS
1919
PROFILE: Sustainability Support Services (Europe) AB
SERVICE AREA BREAKDOWN Training 20%
Legal 10%
CONTACTS Website
www.reach-onlyrep.eu
sk@reach-onlyrep.eu
Head office
Markaskälsvägen 6, Lund â&#x20AC;&#x201C; 22647, Sweden
Tel
+46 46 2850418
Contact
Shisher Kumra
GLOBAL OFFICES
Directors
Shisher Kumra and Mukta Kumra
Sweden, India, Hong Kong
Ownership
Private Limited Company
Locations
SERVICES PROVIDED
Sweden, India, Hong Kong
Founded
Late pre-registration (LPR)
2008
IT & software 10% Representation & management 10%
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: O China Chamber of Commerce of Metals Minerals and Chemicals &&&0& DQG O 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 SUHSDUDWLRQ RI &KLQHVH FRPSOLDQW 6'6 DV ZHOO DV QRWLÂżFDWLRQ RI QHZ 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 VXEVWDQFHV E\ WKH ÂżUVW 5($&+ UHJLVWUDWLRQ GHDGOLQH RI 1RYHPEHU 2010 â&#x20AC;&#x201C; including being the lead registrant. SSS is now working as lead registrant on over 100 substances for 2013. SSS also: O RUJDQLVHG /35 IRU RYHU VXEVWDQFHV O &/3 QRWLÂżFDWLRQ RI DSSUR[LPDWHO\ VXEVWDQFHV DQG O developed MSDS for 2,000 substances (including 500 MSDS translation in various European languages). VITAL STATISTICS
2011/12
Turnover, group
â&#x201A;Ź2.5m
Turnover, chemical service provision
â&#x201A;Ź2.0m
1R RI RIÂżFHV No of countries represented
3 20
Staff, group
30
Staff, chemical service provision
25
Page 128
Consultancy/ advisory 50%
SSS offers LPR services to help non-European companies, either new PDQXIDFWXUHUV RU ÂżUVW WLPH H[SRUWHUV RI VXEVWDQFHV WR ODWH SUH UHJLVWHU 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 666 SURYLGHV WKH &/3 QRWLÂżFDWLRQ VHUYLFHV WR QRQ (XURSHDQ FRPSDQLHV in the capacity of an importer for which the company has to furnish the identity of the substance like the CAS Number, EC Number. 666 KDV WR GDWH VXFFHVVIXOO\ FRPSOHWHG RYHU &/3 QRWLÂżFDWLRQV 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 FULWHULD RI FODVVLÂżFDWLRQ DV GDQJHURXV Extended SDS (e-SDS): 666 DOVR SURYLGHV H 6'6 IRU WKH FODVVLÂżHG 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 &RPSDQLHV H[SRUWLQJ DUWLFOHV WR (XURSHDQ FRXQWULHV QHHG WR FRQÂżUP WKH presence or absence of substances of very high concern (SVHC) and the REACH compliance obligations. SSS offers a very economical and WHFKQLFDOO\ VRXQG VROXWLRQ WR WKHVH FRPSDQLHV IRU IXOÂżOOLQJ WKHLU 5($&+ REOLJDWLRQV DQG FHUWLÂżFDWLRQ UHTXLUHPHQW RI WKHLU (XURSHDQ EX\HUV 7KLV solution is in line with the guidance provided by ECHA. So far, SSS has provided around 75 companies exporting articles to Europe with the most FRVW HIIHFWLYH 5($&+ 69+& FRPSOLDQFH FHUWLÂżFDWLRQ
Chemical Watch | Global Service Providers Guide 2013
O O O O O
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)
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2008
Established and registered as a private limited company
2008
Successfully pre-registered over 7,000 substances within REACH
2009
Professionals trained in IUCLID from REACH Centrum
2009
Trained over 100 industry professionals in use of IUCLID
2010
35 REACH registrations successfully completed
2010
Delivered 1,500 REACH and CLP compliant SDS
2011
Acquired capacity in Chesar and QSAR
2011
Mandated as lead registrant for 50 substances
2012
Mandated as lead registrant for over 60 additional substances
PARTNERS O O O
O O
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
CASE STUDY 2: Successful REACH registration for CMR category 2 substance Problem: ZLWK RQO\ D FRXSOH RI PRQWKV UHPDLQLQJ WR WKH ÂżUVW 5($&+ registration deadline of 30th November 2010, a company sought assistance for successful registration within the deadline. Solution: SSS took up the challenge and adopted a multi-pronged strategy to successfully meet the deadline. It also made diligent use of computational models for generating certain end points in a cost effective way. SSS coordinated well with various agencies involved in completion of the IUCLID dossier. Due to SSSâ&#x20AC;&#x2122;s diligence at each stage of the UHJLVWUDWLRQ SURFHVV WKH GRVVLHU ZDV DFFHSWHG E\ (&+$ DW WKH YHU\ ÂżUVW 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 GRFXPHQWDWLRQV DQG UHFRUGV WKDW WKH (XURSHDQ RIÂżFH RI WKH QRQ (8 company should have in place before the audit, including compliance with WKH &/3 QRWLÂżFDWLRQ DV ZHOO DV SURYLVLRQ RI VDIHW\ GDWD VKHHWV 6'6 DQG translated safety data sheet (wherever applicable). Accordingly company YHULÂżHG LWV FRPSOLDQFH VWDWXV SULRU WR WKH $XGLW STAFF SELECTION Mr Shisher Kumra â&#x20AC;&#x201C; Executive Director Area of expertise includes specialisation in regulatory affairs, legal expertise, chemical assessment, toxicology.
CLIENTS
Dr Rashmi Naidu
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.
Area of expertise includes REACH data inventory, REACH registration process, environmental toxicology, bio-assay and other regulatory affairs.
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.
Mr Shrirang Bhoot Area of expertise includes specialisation in the softwareâ&#x20AC;&#x2122;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.
CASE STUDY 1: Technical support to a multinational company
Dr Shruti Ralegaonkar
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 UHDVRQ IRU WKH UHJLVWUDWLRQ GRVVLHU IDLOXUH 6XLWDEOH PRGLÂżFDWLRQV ZHUH 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.
Area of expertise includes REACH and articles, SVHC assessment and 5($&+ FRPSOLDQFH YHULÂżFDWLRQ
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PROFILE: Sustainability Support Services (Europe) AB
SSS also provides compliance assistance for the following:
PROFILE: Swissi Instituto Suizo de Seguridad
GLOBAL OFFICES Swissi Instituto Suizo de Seguridad: C Lope de Vega, 22-24. 08005 Barcelona, Spain Swissi AG: Richtistrasse 15, 8304 Wallisellen, Switzerland Swissi Process Safety GmbH: Schwarzwaldallee, 215 WRO-1055.5.24, 4002 Basel, Switzerland Swissi Process Safety GmbH: An der Leiten 12, 82069 Hohenschäftlarn/ MĂźnchen, Germany Swissi France SARL: 10, Place Charles Beraudier. Immeuble Lâ&#x20AC;&#x2122;Orient. 69428 Lyon CĂŠdex 03, France 7DLZDQ 6DOHV 2IÂżFH ) 1R -LDQ 6LQJ 5G 6DQ0LQ 'LVW .DRKVLXQJ 807, Taiwan, ROC
CONTACTS Website
www.swissiesp.com
info@swissiesp.com
Head office
C Lope de Vega, 22-24, 08005 Barcelona, Spain
Tel
+34 933 036 612
Fax
+34 933 036 612
Contact
Montserrat FernĂĄndez (REACH Business Group Leader) 0U .LPP\ :X 6DOHV RIÂżFH LQ 7DLZDQ
SERVICES PROVIDED
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 â&#x20AC;&#x201C; Swissi in Spain, 2004
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. 2011/12
Turnover, group
â&#x201A;Ź17m
Turnover, chemical service provision
â&#x201A;Ź9m
1R RI RIÂżFHV
10
No of countries represented
Global
Staff, group
143
Staff, chemical service provision
55
SERVICE AREA BREAKDOWN
Training 11% Consultancy/ advisory 55%
Page 130
6ZLVVL FDQ RIIHU PRUH WKDQ GLIIHUHQW WHVWV LQ WKH ÂżHOGV RI WKHUPDO SURFHVV VDIHW\ ÂżUH DQG H[SORVLRQ SURWHFWLRQ HOHFWURVWDWLFV 5($&+ DQG GHS and highly active and highly toxic materials. We also offer tests IRU FODVVLÂżFDWLRQ DFFRUGLQJ WR WKH 2UDQJH %RRN 81 5HFRPPHQGDWLRQV on Transportation of Dangerous Goods) ie GHS (globally harmonised V\VWHP :H DUH FHUWLÂżHG LQ DFFRUGDQFH ZLWK ,62 ,(& DQG RXU WHVW laboratories are accredited under ISO/IEC 17025. Process safety and loss prevention :H FRQGXFW DXGLWV DQG DQDO\VH ULVN LQ RXU ÂżHOGV RI H[SHUWLVH SURFHVV 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
Other 11%
Laboratory 23%
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
OVERVIEW
VITAL STATISTICS
REACH and product safety
We are accredited to prepare emergency plans and also help companies to implement them with training and emergency exercises aimed at both the companiesâ&#x20AC;&#x2122; management and staff. As part of the global services we give to our clients, we develop crisis management and communication manuals to minimise negative publicity. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1945
Company founded in Switzerland
2004
Company established in Barcelona, Spain
2008
REACH department is set up
2008
Sales company in Taiwan
2011
Delegation in Madrid, Spain
2012
Delegation in Murcia, Spain
2012
SVTI Group acquires Swissi AG
Chemical Watch | Global Service Providers Guide 2013
6ZLVVL LV FHUWLÂżHG LQ DFFRUGDQFH ZLWK ,62 ,(& DQG LWV WHVW 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 LPSRUW RQO\ UHSUHVHQWDWLYH FHUWLÂżFDWHV WRQQDJH FHUWLÂżFDWHV 6'6 HWF 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 SURGXFW VDIHW\ VHPLQDUV DQG WUDLQ WKHP GHSHQGLQJ RQ WKHLU VSHFLÂżF 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 HQYLURQPHQW ZLWK D VLQJOH WRRO DQG WKXV LPSURYH HIÂżFLHQF\ DQG 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 companyâ&#x20AC;&#x2122;s own system to JXDUDQWHH FRQÂżGHQWLDOLW\ DQG GDWD VDIHW\ 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 â&#x20AC;&#x201C; 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.
Dr Otto Holzschuh â&#x20AC;&#x201C; Consultant (REACH, Regulatory Affairs) 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 FODVVLÂżFDWLRQV DQG 5($&+ UHJLVWUDWLRQ DV ZHOO DV LQ SUHSDULQJ VDIHW\ GDWD sheets. He is coordinating Swissiâ&#x20AC;&#x2122;s collaboration with other laboratories to offer one-stop services for REACH registration. Dolors Vinyoles â&#x20AC;&#x201C; 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. MariĂ ngels Custal â&#x20AC;&#x201C; Consultant (Environment) MariĂ ngels 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 â&#x20AC;&#x201C; Consultant (REACH and Machine Directive) Joan Marc Juncosa has worked since 2009 at Swissi and is a chemical HQJLQHHU +H LV D FRQVXOWDQW VSHFLDOLVLQJ LQ 5($&+ FODVVLÂżFDWLRQ labelling and packaging (CLP), explosive atmospheres (ATEX) and machinery safety. Berta AlbaigĂŠs â&#x20AC;&#x201C; Consultant (REACH and Thermal Process Safety) Berta AlbaigĂŠs 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 â&#x20AC;&#x201C; 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 â&#x20AC;&#x201C; crisis communication and emergency exercises. Jordi Campos â&#x20AC;&#x201C; 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 QuĂmic de SarriĂ ).
Montserrat FernĂĄndez â&#x20AC;&#x201C; REACH Business Group Leader Montserrat FernĂĄndez has worked since 2009 at Swissi and holds a degree in chemistry. She is a consultant specialising in REACH UHJXODWLRQ VDIHW\ GDWD VKHHWV 6'6 FODVVLÂżFDWLRQ ODEHOLQJ DQG packaging (CLP) and transport safety (ADR). She also worked at the R&D department of Clariant, where she held various positions.
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PROFILE: Swissi Instituto Suizo de Seguridad
ACCREDITATIONS
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 eSDSâ&#x20AC;&#x2122;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.
PROFILE: TNO Triskelion
CONTACTS Website
www.triskelion.nl
chemistry@tno.triskelion.nl
Head office
Utrechtseweg 48, PO Box 844, 3700 AV Zeist, The Netherlands
Tel
+31 88 866 16 28
Fax
+31 88 866 69 70
Contact
chemistry@tno.triskelion.nl
Ownership
Private company, wholly-owned by TNO
Experimental toxicology :H RIIHU KLJK TXDOLW\ WR[LFRORJ\ VWXGLHV VSHFLÂżFDOO\ WDLORUHG WR WKH QHHGV of REACH, biocides, pesticides and nanomaterials customers. Our toxicological research centre provides new and improved methods in toxicology, especially inhalation, reproduction, immuno-toxicology and ( ) skin adsorption. We have been developing novel methods to reduce, UHÂżQH DQG UHSODFH DQLPDO WHVWLQJ IRU QHDUO\ WZR GHFDGHV DQG DUH SURXG RI RXU SHUIRUPDQFH UHFRUG LQ WKLV ÂżHOG HVSHFLDOO\ UHVRXUFH VDYLQJ FRPELQHG studies such as repeat-dose (28/90d), repro screening and 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. f
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Zeist, The Netherlands
Founded
712 712 7ULVNHOLRQ
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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. VITAL STATISTICS
1R RI RIÂżFHV No of countries represented Staff, group
IT & Training software 5% 5%
Laboratory 45%
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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 6DIHW\ $XWKRULW\ (IVD DQG IRU IRRG FRQWDFW QRWLÂżFDWLRQV )&1 WR WKH 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.
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GLOBAL OFFICES Headquarters group: TNO, Delft, The Netherlands, Headquarters TNO Triskelion: Zeist, The Netherlands 6DOHV 2IÂżFH 6KLQ <RNRKDPD -DSDQ
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TNO Triskelionâ&#x20AC;&#x2122;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, Ă&#x20AC;XRURFDUERQV IRUPDOGHK\GH ELRFLGHV SHVWLFLGHV IUDJUDQFH PDWHULDOV WR QDPH EXW D IHZ $W WKH LQWHUIDFH RI WKH ÂżHOGV RI WR[LFRORJ\ DQG ULVN assessment, our tailor-made services can make a difference, for example: O WHVW VXEVWDQFH LGHQWLÂżFDWLRQ DQG FKDUDFWHULVDWLRQ O mechanistic studies of toxic compounds using sophisticated DQDO\WLFDO WHFKQLTXHV O human and environmental exposure studies in various settings (industrial, agricultural).
2011/12
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Project management â&#x20AC;&#x201C; your assignment with TNO Triskelion is always led by one of our experienced project managers, your primary contact SHUVRQ ZKR PDQDJHV \RXU SURMHFW LQWHUDFWV ZLWK WKH VFLHQWLÂżF WHDP DQG 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 â&#x20AC;&#x201C; our GLP reports are consistently subjected to the required auditing and control procedures to ensure compliance. All the documentation you receive (proposals, reports, DQDO\WLFDO UHVXOWV ,8&/,' ÂżOHV FKHPLFDO VDIHW\ UHSRUWV H6'6V LV reviewed by a senior staff member before being sent out to you. Relationship management â&#x20AC;&#x201C; 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 FRQWDFWV ZLWKLQ 712 7ULVNHOLRQ ZKR ZLOO KHOS \RX ÂżQG WKH ULJKW VROXWLRQ
Chemical Watch | Global Service Providers Guide 2013
1932
712 7KH 1HWKHUODQGV 2UJDQLVDWLRQ IRU $SSOLHG 6FLHQWLÂżF Research is founded
1946
Founding of the Central Organic Chemistry Institute in Zeist
2004
&RPSOHWLRQ RI ÂżYH \HDU +39 SURJUDPPHV RQ YDULRXV chemical 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 SVHCâ&#x20AC;&#x2122;s
ACCREDITATIONS ,Q FRPSOLDQFH ZLWK */3 WR[LFRORJ\ DQG DQDO\WLFDO FKHPLVWU\ ,62 FHUWLÂżHG 6RPH DQDO\WLFDO VHUYLFHV XQGHU ,62 PARTNERS TNO Quality and Safety (R&D): we work together with TNO on development of alternative toxicological methods and (bio)analytical methods. ReachCentrum: workshops and training Where needed we supply additional services like ecotoxicology, physicochemical testing and special evaluations (as SEA) through our network of co-operators. CLIENTS Three top-10 and 12 top-50 global chemicals manufacturers are our clients. We have provided long-term chemical safety services to the following FKHPLFDO VHFWRUV Ă&#x20AC;XRURFKHPLFDOV K\GURFDUERQ GLVWLOODWHV RUJDQRWLQV biocides, chlorinated solvents, fuel oxygenates, organic peroxides, formaldehyde, amines, polyols and isocyanates, silicates and mineral oxides (micro and nano grades), coal chemicals, fragrances. TESTIMONIALS â&#x20AC;&#x153;TNO Triskelion recently performed a comprehensive risk assessment on behalf of our industry. As well as their knowledge and experience, DQG WKHLU VFLHQWLÂżF LQWHJULW\ ZH KDYH EHHQ LPSUHVVHG E\ WKHLU VNLOO LQ communicating across the interfaces within the industry.â&#x20AC;? â&#x20AC;&#x201C; Phil Hope, Secretary General, Formacare. "In the past three years TNO Triskelion has steered us safely through WKH GLIÂżFXOWLHV DQG XQFHUWDLQWLHV RI 5($&+ UHJLVWUDWLRQ ,W LV D WKRURXJK VFLHQWLÂżFDOO\ UHOLDEOH DQG SUR DFWLYH SDUWQHU IRU WKH ULVN DVVHVVPHQW DQG registration of chemicals." â&#x20AC;&#x201C; 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. ,W KDV DOVR QRZ EHFRPH FOHDU ZLWK WKH SXEOLFDWLRQ RI D GHÂżQLWLRQ E\ WKH (& of nanomaterials that they will ultimately fall under REACH and ECHA has SXEOLVKHG LWV ÂżUVW DGYLFH RQ KRZ WKDW SURFHVV PD\ WDNH VKDSH RQ LWV ZHEVLWH 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. O 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 (&+$ :H FDQ KHOS GHYHORS DQG VXSSRUW WKH VFLHQWLÂżF DUJXPHQWV WR support your case to ECHA. O Should testing be needed, TNO Triskelion is specialised in higher WLHU WHVWLQJ ZLWK GLIÂżFXOW WHVW PDWHULDOV 2XU LQKDODWLRQ WR[LFRORJ\ VNLOOV 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: O assist you with the production and implementation of extended safety GDWD VKHHWV H6'6 O prepare an audit of REACH readiness in preparation for government LQVSHFWLRQV O HYDOXDWH FXUUHQW H[SRVXUH RI ZRUNHUV DW \RXU SURGXFWLRQ VLWHV O prepare answers to questions from ECHA and competent authorities/ UDSSRUWHXUV UHJDUGLQJ FRPSOLDQFH RI \RXU GRVVLHUV O follow-up on any ongoing work on your substances in Siefs and FRQVRUWLD O help you in answering questions from your clients regarding their 5($&+ REOLJDWLRQV IRU WKH VXEVWDQFHV \RX VXSSO\ WR WKHP O 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 \RXU VXEVWDQFHV DV ZHOO $ VWHDG\ LQĂ&#x20AC;RZ RI \RXQJ DFDGHPLFV HQVXUHV that we remain vigorous and up to date.
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PROFILE: TNO Triskelion
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
SERVICES PROVIDED
Website
www.toxminds.com
info@toxminds.com
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 DQG WKHUHIRUH XQGHUVWDQG WKH VSHFLÂżF QHHGV RI LQGXVWU\ 2XU VHUYLFHV are centred on our three competence areas: applied human health and HQYLURQPHQWDO ULVN DVVHVVPHQW (8 UHJXODWRU\ VWUDWHJ\ DQG FRPSOLDQFH and science-based advocacy.
Head office
116, Avenue de Broqueville, 1200 Brussels, Belgium
Applied human health and environmental risk assessment
Tel
+32 (2) 762 91 45
Fax
+32 (2) 762 91 46
Contact
DaniĂŠle van Haute
Directors
Dr Thomas Petry
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Dr Francesca Tencalla
Ownership
Private company
Locations
Belgium, Germany
Founded
2006
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 3(&V DFFRUGLQJ WR WKH PHWKRGRORJLHV VSHFLÂżF IRU WKH GLIIHUHQW W\SHV RI industries. Data completion: evaluation of non-testing approaches to support chemical and chemical-based product safety including grouping/readDFURVV DSSURDFKHV DQDORJXH LGHQWLÂżFDWLRQV DV ZHOO DV WKH XVH RI 46$5 PHWKRGRORJLHV LGHQWLÂżFDWLRQ RI LQWHOOLJHQW WHVWLQJ VWUDWHJLHV GHVLJQ DQG /vivo non-clinical and clinical safety programmes. management of Risk assessment: comprehensive human health and environmental risk assessments.
PROFILE: ToxMinds
CONTACTS
OVERVIEW 7R[0LQGV %9%$ LV D SURGXFW VDIHW\ DQG UHJXODWRU\ DIIDLUV ÂżUP ORFDWHG LQ %UXVVHOV %HOJLXP :H SURYLGH VFLHQWLÂżF UHJXODWRU\ DQG VWUDWHJLF VXSSRUW 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. VITAL STATISTICS
2011/12
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
2
No of countries represented
4
Staff, group
10 - 25
Staff, chemical service provision
10 - 25
SERVICE AREA BREAKDOWN Training 5% Information 25%
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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 DV VFLHQWLÂżF SRVW VXEPLVVLRQ VXSSRUW HJ GHYHORSPHQW RI UHVSRQVHV WR queries from regulatory authorities). Science-based advocacy
Consultancy/ advisory 60%
Representation & management 10%
GLOBAL OFFICES +HDG RIÂżFH $YHQXH GH %URTXHYLOOH %UXVVHOV %HOJLXP
Strategy: develop and implement strategies to support products against VFLHQWLÂżFDOO\ XQMXVWLÂżHG KHDOWK RU HQYLURQPHQW UHODWHG DOOHJDWLRQV Authority review: support on science and regulatory matters in discussions with regulatory authorities. Communication: communicate (eco)toxicology and risk assessment ÂżQGLQJV WR GLYHUVH DXGLHQFHV HJ DFDGHPLD DXWKRULWLHV FRQVXPHU DQG non-governmental organisations). Scientific review panels: addressing complex health or environmental issues through organisation and management of independent multidisciplinary peer review panels. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006
Foundation of ToxMinds BVBA by Dr Thomas Petry
2009
2SHQLQJ RI 7R[0LQGV RIÂżFH LQ %UXVVHOV LQ WKH GLUHFW YLFLQLW\ RI the 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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Chemical Watch | Global Service Providers Guide 2013
TESTIMONIALS
STAFF SELECTION
â&#x20AC;&#x153;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 PHHW WKH GHPDQGV DQG GLIÂżFXOW WLPHOLQHV UHTXLUHG E\ RXU FRPSDQ\ :H FRQWLQXH WR UHO\ RQ 7R[0LQGV DV H[SHUWV LQ WKH ÂżHOGV RI WR[LFRORJ\ ecotoxicology and regulatory compliance.â&#x20AC;? â&#x20AC;&#x201C; Senior manager, Global Product Regulatory Compliance, international specialty chemical company
Thomas Petry, PhD, ERT, DABT
Francesca Tencalla, PhD, ERT
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: O desktop search and data gap analysis O QSAR modelling and analysis O design of intelligent testing strategies O placement and monitoring of testing programmes O development of Iuclid 5 registration dossiers, chemical safety assessments and reports (CSR) O strategy advice and support during registration and evaluation phases O client representation in discussions with authorities O applications for authorisation, strategic and technical support during authorisation phase.
Dr Tencalla is a (eco)toxicology and regulatory affairs consultant with 20 yearsâ&#x20AC;&#x2122; 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.
CASE STUDY 2: Human and environmental risk assessment
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 masterâ&#x20AC;&#x2122;s degree in health risk sciences at the University of Clermont-Ferrand in France
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 PDQXIDFWXULQJ RU XVDJH VLWHV ÂżHOG XVHV LQ WKH FDVH RI DJURFKHPLFDOV RU from â&#x20AC;&#x153;down the drainâ&#x20AC;? consumer products.
Nirmala Ranggasami, MSc, ERT Ms Ranggasami is a toxicology and regulatory affairs consultant with more than ten yearsâ&#x20AC;&#x2122; 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
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 VFLHQWLÂżF H[WHUQDO UHODWLRQ SURJUDPPHV 2XU ZRUN LQYROYHG WKH DQDO\VLV RI WKH VFLHQWLÂżF EDVLV RI WKH FODLPV RQ SRWHQWLDO KHDOWK LPSDFWV DQG WKH evaluation of possible response strategies. On behalf of the industry, 7R[0LQGV SUHVHQWHG LWV VFLHQWLÂżF YLHZV LQ GLVFXVVLRQV ZLWK WKH (XURSHDQ Commission, EU Member States as well as non-governmental organisations leading to a less emotional and a more rational debate supported by science.
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PROFILE: ToxMinds
CASE STUDY 1: Consortium management and technical support to REACH consortia
Dr Petry is the founder and manager of ToxMinds BVBA. He is a product safety and regulatory affairs consultant with 20 yearsâ&#x20AC;&#x2122; 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.
GLOBAL OFFICES Japan, Singapore, China, India, Taiwan, Indonesia, Thailand, Vietnam, Serbia, Russia, Ukraine, South Korea, USA SERVICES PROVIDED Only representative
PROFILE: TĂ&#x153;V SĂ&#x153;D Industrie Service
CONTACTS Website
www.tuev-sued.de/technical_installations/reach
REACH@tuev-sued.de
Head office
TĂ&#x153;V SĂ&#x153;D Industrie Service GmbH, Westendstr 199, D-80686 Munich, Germany
Tel
+49 / 89 / 5791-1004
Fax
+49 / 89 / 5791-1174
Contact
Dr Dieter Reiml
TĂ&#x153;V SĂ&#x153;D 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 (8 FDQ EXQGOH QRWLÂżFDWLRQV DQG GR QRW KDYH WR DGGUHVV HDFK LPSRUWHU individually. We experience that often manufacturers address to us when WKHLU SUHYLRXV 25 IDLOHG WR DFW WR WKHLU VDWLVIDFWLRQ RU GLG QRW IXOÂżO LWV obligations.
Ownership
TĂ&#x153;V SĂ&#x153;D Holding AG
REACH initiative for midsized and small companies
Locations
TĂ&#x153;V SĂ&#x153;D Group employs more than 17,000 people in 80 countries in ca. 800 locations
Founded
1866
All companies must register their chemicals by mid-2013 and by 2018 at the very latest â&#x20AC;&#x201C; which is especially challenging for small and midsized businesses! TĂ&#x153;V SĂ&#x153;D 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, TĂ&#x153;V SĂ&#x153;D 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.
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, TĂ&#x153;V SĂ&#x153;D 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, TĂ&#x153;V SĂ&#x153;D 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 TĂ&#x153;V SĂ&#x153;D developed a service package custom tailored for small and medium enterprises (SME) as well as for global players. Our maxim is â&#x20AC;&#x153;REACH â&#x20AC;&#x201C; Made easy with TĂ&#x153;V SĂ&#x153;D expertise.â&#x20AC;? VITAL STATISTICS
2011/12
Turnover, group
â&#x201A;Ź1,700m
Turnover, chemical service provision
-
1R RI RIÂżFHV
800
No of countries represented
80
Staff, group
17,000
Staff, chemical service provision
40
SERVICE AREA BREAKDOWN Training 10% Laboratory 10% Information 10%
Representation & management 35%
Page 136
Consultancy/ advisory 35%
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 JUDQWHG IRU WKHLU VSHFLÂżF XVH RU WKH XVH LV H[HPSWHG IURP DXWKRULVDWLRQ Our support extends from the management of authorisation consortia to VXSSRUWLQJ LQGLYLGXDO FRPSDQLHV LQ IXOÂżOOLQJ WKHLU GXWLHV LQ D FRVWO\ DQG 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 participantsâ&#x20AC;&#x2122; existing knowledge: O LQWURGXFWRU\ WUDLQLQJ FRXUVHV WR JDLQ DQ RYHUYLHZ RI 5($&+ DQG &/3 O VHPLQDUV RQ VHOHFWHG WRSLFV RI 5($&+ O workshops to create solutions under the guidance of an experienced H[SHUW O 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 FRQVHTXHQFHV KRZHYHU DUH QRW FOHDU DW ÂżUVW VLJKW &RQVHTXHQWO\ ZH RIIHU all kind of services related to REACH and CLP, from the starting point to implement REACH via testing in our own GLP accredited laboratory to long-term compliance with chemicals regulations. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1866
Established in Mannheim
1926
Introduction of the â&#x20AC;&#x153;TĂ&#x153;V SĂ&#x153;D mark / stampâ&#x20AC;? in Germany
1960
Establishing chemical services
1990
Conglomeration of TĂ&#x153;Vs from the southern part of Germany to form TĂ&#x153;V SĂ&#x153;D and the expansion of business operations into Asia
Chemical Watch | Global Service Providers Guide 2013
2006
Expansion of services in ASEAN by acquiring Singaporebased PSB Group
2007
Establishing REACH services. Founder member of the "BUSINESSEUROPE REACH Implementation Networkâ&#x20AC;?.
ACCREDITATIONS GLP CLIENTS 'XH WR FOLHQW FRQÂżGHQWLDOLW\ LQGLYLGXDOV FDQQRW EH QDPHG 2XU FOLHQWV IURP PRUH WKDQ FRXQWULHV DUH DFWLYH LQ DOO ÂżHOGV RI LQGXVWU\ DQG SURIHVVLRQDO 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 $ FRQVRUWLXP ZLWK UHSUHVHQWDWLYHV IURP ÂżYH FRXQWULHV WRRN RYHU WR UHJLVWHU 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. TĂ&#x153;V SĂ&#x153;D rendered consortium management to all bodies. Technical REACH consultancy and ÂżQDQFLDO FRQVXOWDQF\ ZDV SDUW RI WKH VHUYLFHV WR EH GHOLYHUHG
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. TĂ&#x153;V SĂ&#x153;D 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 TĂ&#x153;V SĂ&#x153;Dâ&#x20AC;&#x2122;s own chemical laboratory. $V D UHVXOW RI WKH LQYHVWLJDWLRQ DQG FRQVXOWLQJ D XQLÂżHG V\VWHP ZDV implemented in the entire group. The system ensured full compliance with REACH Art. 33 to 36. Furthermore, supply contracts were amended to increase legal certainty, to avoid the risk of lawsuits and to avoid image problems. CASE STUDY 6: Only representative TĂ&#x153;V SĂ&#x153;D acts as OR for many non-EU manufacturers. In several FRXQWULHV WKLV LV SHUIRUPHG E\ LQYROYLQJ ORFDO 7h9 6h' RIÂżFHV 7KLV approach guarantees direct contact to the end-client and avoids language barriers where applicable. Thus, also smaller non-EU manufacturers FDQ EHQHÂżW IURP 25 VHUYLFHV ZKLFK DUH QRW VXIÂżFLHQWO\ FRQYHUVDQW ZLWK English and technical terms. STAFF SELECTION Dr Fritz Prechtl
An EU manufacturer of articles and substances required support in implementing a REACH system for the entire company. The tasks focused on communication in the supply chain, registration, SVHC, training and organisational building. A team was formed for continuous DVVLVWDQFH WKH FRUH WHDP ZDV IXOO\ LQWHJUDWHG LQ WKH FOLHQWÂśV DFWLYLWLHV RQ site.
)ULW] 3UHFKWO LV D FKHPLVW DQG FHUWLÂżHG 5($&+ PXOWLSOLFDWRU ZLWK PRUH than 30 years' professional experience. His core activities are O only representative O preparing registration dossiers O communication up and down the supply chain O communication in Siefs and with authorities O complex role analyses O consultancy on REACH
CASE STUDY 3: Complete service package for lead registrants
Dr Dieter Reiml
Several clients from the chemical industry lacked capacity to prepare lead dossiers. TĂ&#x153;V SĂ&#x153;D 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.
'LHWHU 5HLPO LV D PROHFXODU ELRORJLVW DQG FHUWLÂżHG 5($&+ PXOWLSOLFDWRU with more than 30 years' professional experience. His core activities are O consortium management O authorisation O only representative O preparing lead dossiers O CSA / CSR O consultancy on REACH and CLP
CASE STUDY 2: Support in REACH implementation
CASE STUDY 4: Testing strategies and testing The lead registrant of four substances had to conduct studies in order to IXOÂżO WKH LQIRUPDWLRQ UHTXLUHPHQWV XQGHU 5($&+ 7ZR RI WKH VXEVWDQFHV ZHUH FODVVLÂżHG DV KD]DUGRXV DFFRUGLQJ WR &/3 WKH FODVVLÂżFDWLRQ RI WKH RWKHUV ZDV QRW \HW FODULÂżHG 7h9 6h' SHUIRUPHG DOO VWHSV WR FRPSO\ ZLWK the information requirements. All available information that had been gathered was assessed for LWV DGHTXDF\ IRU FODVVLÂżFDWLRQ DQG ODEHOOLQJ GHWHUPLQDWLRQ RI 3%7 RU 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. TĂ&#x153;V SĂ&#x153;D 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. Chemical Watch | Global Service Providers Guide 2013
Other staff The majority of the Munich REACH team of TĂ&#x153;V SĂ&#x153;D has gained the TXDOLÂżFDWLRQ Âł&HUWLÂżHG 5($&+ PXOWLSOLFDWRU´ IURP WKH $XVWULDQ &KDPEHU of commerce.
Page 137
PROFILE: TĂ&#x153;V SĂ&#x153;D Industrie Service
Best brand of technical services, testing, consulting, training, FHUWLÂżFDWLRQ LQ DOO LQGXVWULHV ZRUOGZLGH Âą HQHUJ\ SURGXFHUV and providers, nuclear power plants, chemical industry
GLOBAL OFFICES Headquartered in the US, our main facility is in Ashland OH, with support RIÂżFHV LQ +LOOVERURXJK 1& 6NRNLH ,/ DQG %RRWKZ\Q 3$ ,Q (XURSH RXU PDLQ IDFLOLW\ LV LQ ÂľV +HUWRJHQERVFK 1/ ZLWK VXSSRUW RIÂżFHV LQ 6ZLW]HUODQG DQG 8. $GGLWLRQDO VXSSRUW RIÂżFHV LQ 7RN\R -DSDQ
PROFILE: WIL Research
CONTACTS
SERVICES PROVIDED
Website
www.wilresearch.com
info@wilresearch.com
Head office
1407 George Road, Ashland, Ohio, 44805
Tel
(419) 289-8700
Fax
(419) 289-3650
Contact
info@wilresearch.com
Ownership
Privately owned
Locations
0DLQ RIÂżFHV 86$ DQG 7KH 1HWKHUODQGV 6XSSRUW RIÂżFHV in the UK, Japan and Switzerland
OVERVIEW :,/ 5HVHDUFK FRQVLVWV RI RYHU GHGLFDWHG VFLHQWLÂżF WHFKQLFDO DQG 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 RIÂżFHV DUH DYDLODEOH WR SHUIRUP \RXU UHJXODWRU\ HFR WR[LFRORJ\ VWXGLHV Our operations have been endorsed by the GLP monitoring authorities 2(&' (3$ )'$ -0$)) FHUWLÂżFDWLRQ VITAL STATISTICS
Our objective is to contribute to better human health, environmental safety and industrial progress by accelerating the development process of our clientâ&#x20AC;&#x2122;s products. We support our clients by providing quality driven contract research services. Our added value results from dedicated staff working together with our clientâ&#x20AC;&#x2122;s project team and enhancing the SURFHVVHV WKURXJK FOHDU FRPPXQLFDWLRQ DQG VFLHQWLÂżF LQWHUSUHWDWLRQ of results. Our staff create the companyâ&#x20AC;&#x2122;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 tenstep action plan which will cover all aspects of the registration needs for both phase-in (EINECS materials) and the non-phase-in substances (new chemicals). The different steps are given below. For each of these steps we can provide more details on the activities within that step and the cost estimation for completing that part of the work. Full service portfolio for Annex 7-8-9-10 Registration chemicals worldwide WIL Research provides regulatory affairs support and programme management, helping you to focus on the core activity of your company and advancing your compounds and products to the market. Registration of agrochemicals and biocides EDSP â&#x20AC;&#x201C; endocrine disruptor screening programme (complete set of assays) in conformity with EPA requirements.
2011/12
Safety testing including (eco) toxicology and risk assessment
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
8
Toxicology and ADME, general toxicology ,genetic toxicology, 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
No of countries represented
40-50
Staff, group
`
a
b
`
c
d
e
900
Staff, chemical service provision
-
SERVICE AREA BREAKDOWN Consultancy/ advisory 17% Representation & management 3%
Laboratory 80%
Page 138
Chemical Watch | Global Service Providers Guide 2013
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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. Weâ&#x20AC;&#x2122;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: O 6WHS ,QYHQWRU\ O 6WHS Âą ODWH 3UH UHJLVWUDWLRQ RU LQTXLU\ 6WHS 5HÂżQHPHQW RI LQYHQWRU\ O 6WHS 'DWD HYDOXDWLRQ O 6WHS 'HWHUPLQDWLRQ RI GDWD JDSV O 6WHS &RPSOHWLRQ GDWD UHTXLUHPHQWV $QQH[ 9,, 9,,, O 6WHS &KHPLFDO VDIHW\ DVVHVVPHQW UHSRUW &6$ &65 O 6WHS 3UHSDUH D WHVW SURSRVDO ! W \ O 6WHS 'RVVLHU SUHSDUDWLRQ ÂżQDOLVDWLRQ DQG VXEPLVVLRQ O Step 10 - Safety data sheet. CASE STUDY 2: Biocidal registration WIL Researchâ&#x20AC;&#x2122;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 DFKLHYLQJ SURGXFW UHJLVWUDWLRQV LQ D IDVW DQG HIÂżFLHQW ZD\ 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 Researchâ&#x20AC;&#x2122;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. 2XU VHUYLFHV DUH FXVWRP PDGH WR ÂżW \RXU QHHGV DQG UDQJH IURP assistance with single sections and smaller regulatory questions to the preparation of complete dossiers.
Chemical Watch | Global Service Providers Guide 2013
CASE STUDY 3: Complete hazard and exposure assessments WIL Researchâ&#x20AC;&#x2122;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 Researchâ&#x20AC;&#x2122;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) â&#x20AC;&#x201C; 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 VXSSRUW :H IXUWKHU DVVLVW \RX ZLWK FODVVLÂżFDWLRQ DQG ODEHOOLQJ LVVXHV 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 â&#x20AC;&#x201C; 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. 6LQFH KH KDV EHHQ UHJLVWHUHG DV D (XURWR[ ERDUG FHUWLÂżHG 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 â&#x20AC;&#x201C; Sr Vice-President, Global Operations â&#x20AC;&#x201C; Nonclinical Safety Assessment 6WHYH KDV RYHU WZHQW\ ÂżYH \HDUV RI QRQ FOLQLFDO VDIHW\ DVVHVVPHQW 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 WKH UROH RI *OREDO &KLHI 6FLHQWLÂżF 2IÂżFHU 3DWKRORJ\ DQG ,PPXQRORJ\ Services. He directed the growth of Covanceâ&#x20AC;&#x2122;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 RSHUDWLRQDO VNLOOV ZLWK D VKDUS IRFXV RQ VFLHQWLÂżF H[FHOOHQFH DQG TXDOLW\ 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 â&#x20AC;&#x201C; present) and previously a Diplomate, American Board of Toxicology (1989-2004).
Page 139
PROFILE: WIL Research
ACCREDITATIONS
GLOBAL OFFICES (XURSHDQ 2IÂżFH RI :LOGOLIH ,QWHUQDWLRQDO :DWHUVWUDDW +0 Zutphen, The Netherlands -DSDQHVH $JHQW /6* &RUSRUDWLRQ 6 6 %XLOGOLQJ 6KLQ 2JDZDPDFKL 6KLQMXNX NX 7RN\R -DSDQ
A D I V I S I O N O F E AG, I N C . E N V I R O N M E N TA L FAT E & E COTOX I CO LO G Y T E S T I N G
SERVICES PROVIDED
PROFILE: Wildlife International
CONTACTS Website
www.wildlifeinternational.com and www.eaglabs.com
aleopold@wildlifeinternational.com
Head office
8598 Commerce Drive, Easton Maryland 21601, USA
Tel/ Fax
+1 410 822 8600/ +1 410 822 0632
Contact
Annegaaike Leopold
Directors
Mark Jaber, Managing Director
Â
Jim Miraldi, Vice President Finance
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Dave Palmer, Director of Business Services
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Annegaaike Leopold, Director Global Business Development
Ownership
Private company
Locations
USA, The Netherlands
Founded
1976
Biodegradability testing and environmental fate Biodegradation screening and testing (OECD 301, 310, 314, 303 etc). Environmental fate testing (OECD 307, 308, 309, 106). All these studies can be SHUIRUPHG LQFOXGLQJ PHWDEROLWH LGHQWLÂżFDWLRQ 6SHFLÂżF H[SHUWLVH LQ WKH FRQWH[W RI 5($&+ LV LQ WKH ÂżHOG RI ELRGHJUDGDELOLW\ VFUHHQLQJ DQG VLPXODWLRQ WHVWLQJ 7KH manure degradation study is another major area of specialisation at Wildlife. Endocrine disruptor screening and testing )XUWKHU VSHFLÂżF H[SHUWLVH OLHV LQ WKH ÂżHOG RI HQGRFULQH GLVUXSWLRQ VFUHHQLQJ DQG testing, We have in-house histopathology services to evaluate the potential of FKHPLFDOV WR HIIHFW HQGRFULQH VHQVLWLYH WLVVXHV LQ ÂżVK DPSKLELDQV DQG IURJV 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.
OVERVIEW
Ecotoxicology testing
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.
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 FRQWURO FKDPEHUV ZLWK EXLOW LQ UHFRQÂżJXUDEOH GLOXWHU V\VWHPV FDSDEOH RI 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.
VITAL STATISTICS Turnover, group Turnover, chemical service provision
1976
(VWDEOLVKHG DV DQ DYLDQ WR[LFRORJ\ IDFLOLW\ ZLWK D VWDII RI ÂżYH
1983
Company acquired by current managing director and partner
1986
Opened laboratory designed for full service avian toxicology testing
2012/13
1990
Opened 2,800m2 aquatic toxicology and chemistry laboratory
US$21
1990
Expanded avian toxicology laboratory to 3,600m2
US$3.5m
1992
Established biodegradation department to offer ready, inherent and specialty biodegradation testing
1997
2SHQHG WKH (XURSHDQ RIÂżFH RI :LOGOLIH ,QWHUQDWLRQDO /WG LQ The Netherlands
2000
Opened 1,300m2 environmentally controlled greenhouse facility
2006
Expanded biodegradation and e-fate department to include 300m2 of new laboratory space
2009
Completed in-house histopathology laboratory to evaluate HQGRFULQH HIIHFWV LQ ÂżVK DPSKLELDQV DQG ELUGV
2010
Acquired by the Riverside Company
2011
Opened up 1,100m2 expansion designed to conduct aquatic endocrine testing.
2012
Acquired a Bruker maXis impact UHR-TOF
Dec 2012
Merged with Evans Analytical Group (EAG, Inc) adding the expertise of PTRL-West and PTRL-Europe to our range of services.
1R RI RIÂżFHV
2
No of countries represented
3
Staff, group
135
Staff, chemical service provision SERVICE AREA BREAKDOWN Other Consultancy/ Training 2% advisory 3% 5%
Laboratory 90%
Page 140
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
80
Chemical Watch | Global Service Providers Guide 2013
*RRG ODERUDWRU\ SUDFWLFH */3 Ă PXOWLSOH LQVSHFWLRQV E\ (3$ ZLWK QR ÂżQGLQJV 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 O
O
O O
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 3KDUPDFHXWLFDO 3Âż]HU 6DQRÂż $YHQWLV (OL /LOO\ 0HUFN &R 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. :LOGOLIH LV DOVR Ă&#x20AC;H[LEOH DQG ZLOO DWWHPSW WR PHHW WLPHOLQHV RQ NH\ SURMHFWV if at all possible. We have enjoyed working with Wildlife International Ltd SHUVRQQHO IRU RYHU \HDUV DQG ZLOO FRQWLQXH WR GR VR LQ WKH IXWXUH Ă 7KH Dow Chemical Company Âł7KH (XURSHDQ 2IÂżFH RI :LOGOLIH ,QWHUQDWLRQDO EULQJV WKH ODERUDWRU\ WR WKH doorstep of our clients.â&#x20AC;?â&#x20AC;&#x201C; TNO-Triskelion. CASE STUDY 1: Glyphosate: fish short term reproduction assay (FSTRA) with the fathead minnow (Pimephales promelas) â&#x20AC;&#x201C; a paper presented at SETAC US 2012, S. Schneider et al, Wildlife International
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 DGDSWDWLRQ LQ WKH ÂżHOG $IWHU ODXQFK RI WKH $': D VHULHV RI 2(&' % 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% CO2 production, demonstrated that L-GLDA was â&#x20AC;&#x153;ready biodegradableâ&#x20AC;? (65-100% CO2). Inoculum from additional WWTPs also showed positive ready test results and a decrease in the measured lag period (< 10% CO2) was observed as GLVWULEXWLRQ RI WKH $': JUHZ LQGLFDWLQJ DQ LQFUHDVH LQ WKH ÂżHOG SRSXODWLRQ RI FRPSHWHQW GHJUDGHUV 7KLV LV WKH ÂżUVW V\VWHPDWLF VWXG\ VKRZLQJ KRZ D 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 â&#x20AC;&#x201C; Director of Aquatic and Non-Target Plant Testing Director of aquatic toxicology since 1995. Responsible for all aspects of WKH :LOGOLIH ,QWHUQDWLRQDO /WG DTXDWLF WR[LFRORJ\ SURJUDPPH LQFOXGLQJ ÂżVK and amphibian endocrine disrupter studies. Expert aquatic toxicologist, ZLWK VSHFLÂżF H[SHUWLVH LQ ELRDFFXPXODWLRQ WHVWLQJ VHGLPHQW WR[LFRORJ\ testing and endocrine test design, conduct and interpretation. Timothy Springer, PhD â&#x20AC;&#x201C; Director of Special Projects Dr Tim Springer manages special projects and technical support. He ÂżVK was responsible for the development of the abbreviated bioconcentration test. Dr Springer has played a critical role in the revision of the OECD guideline 305, and in development methods to estimate BCF values using data from BMF studies. `
The objective of this assay was to determine if glyphosate might impact the hypothalamus-pituitary-gonadal (HPG) endocrine axis resulting LQ WKH GLVUXSWLRQ RI UHSURGXFWLRQ LQ ÂżVK %UHHGLQJ JURXSV RI IDWKHDG PLQQRZV 3LPHSKDOHV SURPHODV ZHUH H[SRVHG WR JO\SKRVDWH XQGHU Ă&#x20AC;RZ WKURXJK 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 RU IHPDOH ÂżVK H[SRVHG WR JO\SKRVDWH IRU GD\V %DVHG RQ WKH HQGSRLQWV 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 â&#x20AC;&#x201C; 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
Chemical Watch | Global Service Providers Guide 2013
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Edward Schaefer â&#x20AC;&#x201C; 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 (3$ 2(&' WHVW JXLGHOLQHV Âą VSHFLÂżFDOO\ 2(&' JXLGHOLQH Dr Timothy Blake â&#x20AC;&#x201C; Metabolite Identification Specialist  Dr Blake is a senior level scientist who has spent more than 25 years SHUIRUPLQJ GHÂżQLWLYH VWUXFWXUH ,' DQDO\VLV 'U %ODNH FRPSOHWHV RXU DELOLW\ WR FRQGXFW PHWDEROLWH LGHQWLÂżFDWLRQ ZRUN XVLQJ RXU 8+5 72) LQVWUXPHQW Dr Alex Ponizovsky â&#x20AC;&#x201C; 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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PROFILE: Wildlife International
ACCREDITATIONS
SERVICES PROVIDED REACH compliance O
O
CONTACTS
O
PROFILE: WTConsulting
O
Website
www.wtconsulting.ch
info@wtconsulting.ch
Head office
Weierweg 7, 4410 Liestal, Switzerland
Tel
+41 61 923 30 00
Fax
+41 61 923 30 02
Contact
Ulrich Wietschorke
Directors
Ulrich Wietschorke
Â
Dr rer nat Andreas Tschech
Ownership
Private company
O
Locations
Switzerland
O
Founded
2007
O
O O O
O
GDWD JDS DQDO\VLV LQFOXGLQJ VFLHQWLÂżF DQG PRQHWDU\ HYDOXDWLRQ RI GDWD (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 SURMHFW PDQDJHPHQW LQLWLDWLRQ DQG VFLHQWLÂżF PRQLWRULQJ RI VWXGLHV (physical-chemical, mutagenicity, toxicity, eco-toxicity, environmental fate) at test laboratories QHJRWLDWLRQV ZLWK UHJXODWRU\ DJHQFLHV DQG VFLHQWLÂżF ERGLHV
CLP / GHS notification, classification and labelling O
O
collection and assessment of data available QSAR and read-across / testing proposal FODVVLÂżFDWLRQ DFFRUGLQJ WR &/3 DQG '6' ((&
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OVERVIEW
Chemical notifications worldwide
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.
:7& VWDII DUH IDPLOLDU ZLWK WKH UHTXLUHPHQWV IRU WKH QRWLÂżFDWLRQ RI QHZ FKHPLFDOV WR DOO QRWLÂżFDWLRQ VFKHPHV DURXQG WKH ZRUOG :H FRRSHUDWH 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.
VITAL STATISTICS
2011/12
Turnover, group
-
Turnover, chemical service provision
-
1R RI RIÂżFHV
1
No of countries represented
1
Staff, group
7
Staff, chemical service provision
7
Food contact substances/ food packaging materials O O
O O O O
O O
O O
SERVICE AREA BREAKDOWN
O
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 SURMHFW PDQDJHPHQW LQLWLDWLRQ DQG VFLHQWLÂżF PRQLWRULQJ RI VWXGLHV (migration, mutagenicity, toxicity) at test laboratories FRPSOLDQFH FHUWLÂżFDWLRQ RI SODVWLF IRUPXODWLRQV VXSSO\ FKDLQ VXSSRUW
preparation of compliance documentation according to Regulation 1935/2004 QHJRWLDWLRQV ZLWK UHJXODWRU\ DJHQFLHV DQG VFLHQWLÂżF ERGLHV support on GMP other countries upon request.
Cosmetics and cosmetic raw materials Training Information 5% 5%
O
Representation & management 10%
O
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 Consultancy/ advisory 80%
O O
O O
GLOBAL OFFICES Covered by partner network. O
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review of existing data, gap analysis and test programme proposal compilation and submission of registration dossiers, including followup analytical method development and validation SURMHFW PDQDJHPHQW LQLWLDWLRQ DQG VFLHQWLÂżF PRQLWRULQJ RI VWXGLHV (physical-chemical, mutagenicity, toxicity, eco-toxicity, environmental fate) at test laboratories QHJRWLDWLRQV ZLWK UHJXODWRU\ DJHQFLHV DQG VFLHQWLÂżF ERGLHV
Chemical Watch | Global Service Providers Guide 2013
O O
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evaluation of biocompatibility in accordance with ISO 10993-1 / USP literature search and data collection for safety assessment/ gap analysis/ conception of test programme SURMHFW PDQDJHPHQW LQLWLDWLRQ DQG VFLHQWLÂżF PRQLWRULQJ RI VWXGLHV (haemocompatibility, migration/ leaching, cytotoxicity, mutagenicity, toxicity, ADME studies) at test laboratories assessments reports FRPSOLDQFH FHUWLÂżFDWLRQ
Toys O
O
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 SURMHFW PDQDJHPHQW LQLWLDWLRQ DQG VFLHQWLÂżF PRQLWRULQJ RI VWXGLHV (migration/ leaching, cytotoxicity, mutagenicity, toxicity, ADME studies) at test laboratories assessments reports FRPSOLDQFH FHUWLÂżFDWLRQ FRPSLODWLRQ RI WHFKQLFDO LQIRUPDWLRQ ÂżOHV DFFRUGLQJ WR (8 7R\V 'LUHFWLYH consulting on safety strategies
CASE STUDY 2: Time to market/cost savings For a new chemical substance WTConsulting developed a test SURJUDPPH IRU WKH JOREDO QRWLÂżFDWLRQ XQGHU FKHPLFDO UHJXODWLRQV 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 VXEVWDQFH REWDLQHG JOREDO QRWLÂżFDWLRQ XQGHU FKHPLFDO VFKHPHV DQG LW became regulated / approved for food contact / packaging applications â&#x20AC;&#x153;across the boardâ&#x20AC;? 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 VLJQLÂżFDQW FRVW DQG WLPH VDYLQJV IRU WKH FOLHQW 0DUNHW LPSOHPHQWDWLRQ IRU food contact application could start 18 months early. CASE STUDY 3: Business impact analysis and support
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Industry is exposed to an increasingly growing regulatory and nonregulatory 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 FRPSDQ\ WKURXJK VFLHQWLÂżF UHJXODWRU\ DQG QRQ UHJXODWRU\ QHJRWLDWLRQV with agencies, NGOs and OEMs, demonstrating regulatory compliance, environment and consumer safety of strategically important products.
2007
WTConsulting GmbH founded
CASE STUDY 4: Development of safety strategy and synergies
2008
Establish CRO network
2009
Establish global network of expert regulatory consultants
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 â&#x20AC;&#x201C; 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.
O
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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 ,Q OLQH ZLWK RXU FRQÂżGHQWLDOLW\ WHUPV DQG WKH QDWXUH RI RXU EXVLQHVV 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: O PRUH WKDQ FKHPLFDO QRWLÂżFDWLRQV LQFOXGLQJ WHVWLQJ DQG ULVN DVVHVVPHQW O PRUH WKDQ IRRG FRQWDFW VXEVWDQFH QRWLÂżFDWLRQV DQG UHJLVWUDWLRQ GRVVLHUV O more than 3,550 compliance evaluations of plastic formulations for IRRG FRQWDFW XVH O more than 150 safety assessments for plastic formulations and LQGLYLGXDO LQJUHGLHQWV LQFOXGLQJ GHJUDGDWLRQ SURGXFWV IRU XVH LQ WR\V O RYHU VDIHW\ DVVHVVPHQWV RI FRVPHWLF LQJUHGLHQWV O RYHU HYDOXDWLRQV RI ELR FRPSDWLELOLW\ RI PHGLFDO GHYLFHV O active involvement in regulatory working groups.
Chemical Watch | Global Service Providers Guide 2013
STAFF SELECTION Ulrich Wietschorke O O O
BSc in biology founder of WTConsulting GmbH 26 yearsâ&#x20AC;&#x2122; experience in the CRO industry as global senior regulatory affairs professional, consultant and managing director
Dr rer nat Andreas Tschech O O O
PhD in biology co-founder of WTConsulting GmbH 23 yearsâ&#x20AC;&#x2122; experience in the CRO industry as global senior regulatory affairs professional, consultant and regulatory toxicologist
Dr rer nat Birgit Seyfried O O
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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PROFILE: WTConsulting
Medical devices
GLOBAL OFFICES 86 (DVW 0ROLQH ,/ WZR ORFDWLRQV :REXUQ 0$ 'HV 0RLQHV ,$ 6W /RXLV 02 6DQ $QWRQLR 7; 1HZDUN &$ 3ULQFHWRQ 1- Brazil: SĂŁo Paulo. (XURSH :DOOGRUI *HUPDQ\ /RQGRQ 8. 6ROQD 6ZHGHQ ,QGLD ,QGRUH 03 +\GHUDEDG 0DGKDSXU WZR ORFDWLRQV 3XQH 0+ WZR ORFDWLRQV %DQJDORUH .$ 0XPEDL 0+ *XUJDRQ 1&5 Australia: Sydney, New South Wales .
PROFILE: YASH Technologies
CONTACTS Website
www.yash.com
info@yash.com
Head office
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 â&#x20AC;&#x201C; Sustainability Solutions
O
Directors
Paul Struck, SAP Practice Director
O
Â
Yogesh Nagpal, REACH and SAP EH&S Program Manager
Ownership
Privately held
Locations
North America, South America, Europe, Asia, Australia
Founded
1996
SERVICES PROVIDED SAP EHS (and sustainability) services portfolio O O O
O
O
MSDS and label authoring (and management) O O
O
OVERVIEW
O
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 DGGUHVV LQGXVWU\ VSHFLÂżF FRPSOLDQFH QHHGV VITAL STATISTICS
2011/12
O O O O O
O O O
-
Turnover, chemical service provision
-
O
21
O
No of countries represented
7
Staff, group
2,500 total globally
Staff, chemical service provision
100
SERVICE AREA BREAKDOWN Other Training 2% 3%
O
O O O O
O O
O O
Information 5% IT & software 70%
Page 144
REACH assessment, consulting and management IUCLID dossier creation for REACH registration robust summary preparation â&#x20AC;&#x201C; per OECD/ REACH guidelines VXEVWDQFH DQG XVH VSHFLÂżF GDWD FROOHFWLRQ supporting data/system preparedness towards REACH VXEVWDQFH VSHFLÂżF H[SRVXUH VFHQDULR H 6'6 JHQHUDWLRQ 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 O
Consultancy/ advisory 20%
MSDS authoring with various regions /regulatory requirements 06'6 FRQYHUVLRQ IURP RWKHU IRUPDWV WR FRXQWU\ VSHFLÂżF *+6 guidelines (CLP/ OSHA /others) regular updates in SDS, labels as per the changes in the regulations, business or customer requirement FODVVLÂżFDWLRQ DQG ODEHOOLQJ RI VXEVWDQFHV SURGXFWV creation of various types of labels in WWI (SAP) automatic report shipping, distribution, label determination and management (in SAP) MSDS help desk â&#x20AC;&#x201C; for prompt support on MSDS requests MSDS management â&#x20AC;&#x201C; complete business outsourcing related to entire MSDS operations
REACH compliance services
Turnover, group 1R RI RIÂżFHV
business assessment solution consulting and mapping SAP product (module) implementation application maintenance support roll outs and upgrades EHS data migration/ management user/ business training
O
O
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
Chemical Watch | Global Service Providers Guide 2013
CASE STUDY 3: Dow Chemicals
1996
YASH Technologies is founded
2000
<$6+ HVWDEOLVKHV LWV ÂżUVW RIIVKRUH GHYHORSPHQW FHQWUH LQ ,QGLD
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 â&#x20AC;&#x201C;LoB Solutions portfolio
2011
YASH is recognised as the development and testing partner for SAP â&#x20AC;&#x201C; Chemical BP Solutions releases
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 month YASH was selected to provide MSDS â&#x20AC;&#x153;authoringâ&#x20AC;? with a 100% accuracy goal and shortened cycles. YASHâ&#x20AC;&#x2122;s involvement led to: O UHÂżQHG SURFHVV GRFXPHQWV DQG WUDLQLQJ O H[WUDFWHG GDWD UHOHYDQW WR VWDQGDUGV DQG UHJXODWLRQV O DQ DYHUDJH PRQWKO\ 06'6 RXWSXW IURP <$6+ ZDV 06'6V O 'RZ UHDOLVLQJ VLJQLÂżFDQW FRVW VDYLQJV
2012
<$6+ RSHQV RIÂżFHV LQ *HUPDQ\ DQG 6ZHGHQ LQ (XURSH DQG expands global reach to Australia
2012
YASH receives the Pinnacle award from SAP
ACCREDITATIONS O
O O
O
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 Reddyâ&#x20AC;&#x2122;s. TESTIMONIALS â&#x20AC;&#x153;[...] 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." â&#x20AC;&#x201C; Frank Kochendoerfer, Director, SAP IBU Chemicals â&#x20AC;&#x153;[â&#x20AC;Ś] YASH had the deep chemical industry expertise we were looking for in a partner. We felt really comfortable with the customer-centric and Ă&#x20AC;H[LEOH GHOLYHU\ RSWLRQV WKDW D PLGVL]H FRPSDQ\ OLNH <$6+ FRXOG SURYLGH ´ â&#x20AC;&#x201C; 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. YASHâ&#x20AC;&#x2122;s compliance services include: O 06'6 GLVWULEXWLRQ PDQDJHPHQW O GDWD PLJUDWLRQ FOHDQ XS O ::, ODEHOV FUHDWLRQ O global support team with 24*7 availability O BoM-BoS transfer O property tree/ regulatory data update.
STAFF SELECTION Hari Vyakarnam â&#x20AC;&#x201C; Practice Director â&#x20AC;&#x201C; Sustainability Responsible for managing YASHâ&#x20AC;&#x2122;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 yearsâ&#x20AC;&#x2122; 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 Masterâ&#x20AC;&#x2122;s degree in business DQG V\VWHPV PDQDJHPHQW DQG LV D FHUWLÂżHG TXDOLW\ DQDO\VW Yogesh Nagpal â&#x20AC;&#x201C; Program Manager â&#x20AC;&#x201C; SAP EH&S and REACH â&#x20AC;&#x201C; 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 DVVHVVPHQW IURP YDULHG LQGXVWU\ VHJPHQWV VSHFLÂżFDOO\ IRFXVHG DURXQG the product compliance like RoHS, REACH, GHS, IMDS, WEEE. He holds a Masterâ&#x20AC;&#x2122;s degree in business management along with a PG diploma in environmental sciences. Paul Struck â&#x20AC;&#x201C; 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 yearsâ&#x20AC;&#x2122; experience in consulting, including senior positions at Deloitte, Accenture, and Hitachi Consulting.
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 YASHâ&#x20AC;&#x2122;s SAP Business All-in-One ChemOne solution for ERP in 30 weeks. This included: O H[WHQVLYH FRPSOH[ UHFLSH PDQDJHPHQW O leveraging SAP for reporting and dashboards for one version of the WUXWK O plans to implement warehouse management, quality management, and mobility.
Chemical Watch | Global Service Providers Guide 2013
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PROFILE: YASH Technologies
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
CONTACTS www.ag-hera.com albania.grosso@ag-hera.com 23 London Street, Faringdon, Oxfordshire SN7 7AG, UK +44 (0) 1865 58 98 93/ 7805609296 Albania Grosso Sole ownership Spain, United Kingdom 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 FRQVXOWDQF\ ÂżUPV DQG JRYHUQPHQW DJHQFLHV LQ WKH 86 DQG WKH 8. KDV H[WHQVLYH WHFKQLFDO DQG SURMHFW PDQDJHPHQW H[SHULHQFH LQ WKH ÂżHOG RI HQYLURQPHQWDO OHJLVODWLRQ DQG FRPSOLDQFH AG-HERAâ&#x20AC;&#x2122;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 /RZHU 2OHÂżQV DQG $URPDWLFV /2$ &RQVRUWLXP +LJKHU 2OHÂżQV DQG 3RO\ $OSKD 2OHÂżQV (HOPA ) Consortium, Hydrocarbon Solvents REACH Consortium (HCSRC), CONCAWE, International Lead Association (ILA), Frits Consortium, Precious Metals Consortium, Rutgers Belgium, Penman Consulting, Regulatory Science Associates Ltd, wca environment ltd.
Website E-mail Head office Tel/Fax Contact Ownership Locations Founded
www.big.be info@big.be Technische Schoolstraat 43A, 2440 Geel, Belgium + 32 14 58 45 47 / +32 14 58 35 16 Zita Snellinx 1RQ SURÂżW RUJDQLVDWLRQ Belgium 1979
OVERVIEW BIG is an independent information and emergency call centre for dangerous chemical substances. Information is gathered on physico-chemical and (eco)toxic properties, as well as regulations on safety, health, environmental protection and transport related to hazardous materials. Based on these data BIG delivers a large number of products and services to clients from diverse sectors, including: industry, emergency services, governmental and inspection services, healthcare and academia. SERVICES PROVIDED BIG offers expertise concerning information on hazardous substances. For REACH and CLP this means assisting our clients in determining what their role and obligations are, the complete registration process from A to Z (including data gap analysis, CSA/CSR/ (6 QRWLÂżFDWLRQV DQG DXWKRULVDWLRQV FRPPXQLFDWLRQ XS DQG GRZQVWUHDP FRPSLODWLRQ RI ext-SDSs, CLP compliant labels), onsite training in REACH and/or CLP, onsite REACH audits, only representative and third party representative services. BIG also specialises in GRZQVWUHDP XVHU UHSRUWV DQG '8 &6$ &65 (6 IRU QRQ LGHQWLÂżHG XVHV 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, ÂżQH FKHPLFDOV SRO\PHUV DGKHVLYHV SODVWLFV KHDOWKFDUH SKDUPDFHXWLFDOV FRDWLQJV DQG paints, article manufacturers.
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CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
CONTACTS
www.altox.dk altox@altox.dk Tonsbakken 16-18, DK-2740 Skovlunde, Denmark +45 3834 7798/ +45 3834 7799 Pernille Hjaltalin Private limited company Denmark 1992
OVERVIEW ALTox is a consultative company that provides counselling and training within: O REACH and CLP requirements of chemicals and articles (C&L, SDS, ECHA registrations and communication) O biocides O cosmetics and toys O other registration services (eco labelling, national product registers, COLIPA etc) O general safety counselling for professional and private use (on-site handling, storage etc in relation to regulations for occupational health and environment) O 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 WUDGH RUJDQLVDWLRQV DQG ZRUN LQ FROODERUDWLRQ ZLWK WKH FOLHQW WR ÂżQG WKH PRVW DSSURSULDWH UHVXOW :H DLP DW ÂżQGLQJ SUDFWLFDO VROXWLRQV EDVHG RQ VFLHQFH DQG UHJXODWRU\ UHTXLUHPHQWV 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 WHVW ODERUDWRULHV &52 DOORZV IRU D PRUH Ă&#x20AC;H[LEOH DSSURDFK WRZDUGV UHJXODWRU\ FKDQJHV 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.
Chemical Watch | Global Service Providers Guide 2013
Website E-mail Head office
www.calebgroup.net john@calebgroup.net The Stables, Somerset House, Church Road, Tormarton, Badminton, Gloucestershire, UK +44 (0)1454 269330/ +44 (0)1454 216030 John Yates
Tel/ Fax Contact Ownership
Private company
Locations Founded
1994
UK, Germany, USA
OVERVIEW Caleb Management Services Ltd is a policy and regulatory consultancy that has EHHQ DFWLYH LQ WKH ÂżHOG RI FKHPLFDO UHJXODWLRQ VLQFH &DOHEÂśV FOLHQWV UDQJH IURP governments, multi-national companies and worldwide consortia to small companies with a single substance. Caleb tailors its support to take account of a clientâ&#x20AC;&#x2122;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 O O REACH dossier development and registration O Sief management O CLP compliance management O SDS authoring and management O OR and TPR services O 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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CONTACTS
CONTACTS
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Website E-mail Head office Tel/ Fax Contact Directors Ownership Locations Founded
www.cfcs-consult.com info@cfcs-consult.com CFCS-Consult GmbH, Essen - TĂźbingen, AlfredstraĂ&#x;e 68-72, 45130 Essen, Germany +49 201 79870 191/ +49 201 79870 386 Dr Barbara Lohmann Dr Barbara Lohmann (CEO), Dr Felix Endres (CEO) Private company Germany, Italy 2007
OVERVIEW CFCS is a team of experienced: toxicologists, chemists, 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 ÂżQDQFH PDQDJHPHQW ULVN DQDO\VLV FODVVLÂżFDWLRQ DQG ODEHOOLQJ DFFRUGLQJ WR *+6 &/3 authorisation of biocides and biocidal products, authorisation of pharmaceuticals and YHWHULQDU\ GUXJV DVVLVWDQFH ZLWK WKH FHUWLÂżFDWLRQ SURFHVV IRU WKH HFRODEHO ZRUNVKRSV for REACH, Ecetoc TRA, IUCLID 5, Chesar. SERVICES PROVIDED &)&6 LV D TXDOLÂżHG SDUWQHU RIIHULQJ VHUYLFHV LQ YDULRXV OLIH VFLHQFH GLVFLSOLQHV GHGLFDWHG 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 PDQDJHPHQW WR RXU FOLHQWV $PRQJ RXU VHUYLFHV RXU FOLHQWV FDQ EHQHÂżW IURP RXU QHWZRUN RI ZHOO UHQRZQHG DQG FHUWLÂżHG VFLHQWLÂżF SDUWQHUV DQG LQVWLWXWLRQV &RQVHTXHQWO\ DQG even for very complex projects, we are always available as your key reference partner. CLIENTS Manufacturers, importers or downstream users of industrial chemicals, veterinary drugs, plant protection products or cosmetic ingredients.
CONTACTS Website E-mail Head office Tel/ Fax Ownership Locations Founded
www.chemsw.com info@chemsw.com 0DQJHOV %OYG )DLUÂżHOG &$ 86$ +1 707 864 0845/ +1 707 864 2815 Private USA 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. ChemSWâ&#x20AC;&#x2122;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. 2XU ODERUDWRU\ FKHPLFDO LQYHQWRU\ V\VWHPV HQVXUH XVHU DGRSWLRQ SURFHVV HIÂżFLHQFLHV and accurate, real-time data, enabling companies to: identify and optimise critical LQYHQWRU\ V\VWHP FRPSRQHQWV RSWLPLVH FKHPLFDO VDIHW\ DQG LQYHQWRU\ GDWD VWUHDPOLQH ORW WUDFNLQJ DQG TXDOLÂżFDWLRQ IRU SURFHVV HIÂżFLHQFLHV DGGUHVV UHJXODWRU\ UHTXLUHPHQWV DXWRPDWH 7LHU ,, )LUH &RGH *+6 UHSRUWLQJ DXWRPDWH DXGLW WUDLOV 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.
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Website E-mail
www.conusbat.com steven.hanft@conusbat.com / annelie.struessmann@conusbat.com
Head offices Tel
Germany: Kruppstr 18, D-52072 Aachen +49 241 518 5 7790 (internet)/ +49 241 81987 (Germany) Skype: steven.hanft +49 241 81928 Dr Annelie Struessmann, Technical and Regulatory Director Steven L Hanft, MA, President (private ownership) Germany $DFKHQ *HUPDQ\
Fax Contact Ownership Locations Founded
OVERVIEW CONUSBAT specialises in EU/Global regulations for cosmetics, personal care and consumer KHDOWKFDUH SURGXFWV DQG ÂżQH FKHPLFDOV 2XU IXOO VHUYLFH VSHFWUXP LQFOXGHV 5($&+ RQO\ 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 (8 FRVPHWLF UHJXODWLRQV VWUDWHJLF FRQVXOWLQJ GRVVLHU ÂżOLQJ O preparation and analysis, safety assessment O 5($&+ RQO\ UHSUHVHQWDWLYH 25 VWUDWHJLF FRQVXOWLQJ GRVVLHU ÂżOLQJ SUHSDUDWLRQ and analysis O Safety assessors-responsible person (RP) for cosmetic products in the EU: VWUDWHJLF FRQVXOWLQJ 3,)V GRVVLHU SUHSDUDWLRQ QRWLÂżFDWLRQ WR WKH &313 WR[LFRORJ\ etc O Global regulatory workshops (online/onsite) for the cosmetic, personal and FRQVXPHU KHDOWK FDUH SURGXFWV ÂżQH FKHPLFDOV (8 $6($1 &KLQD 6 .RUHD Brazil, USA O Global regulatory workshops (online/onsite) for the cosmetic, personal and FRQVXPHU KHDOWK FDUH SURGXFWV ÂżQH FKHPLFDO VHFWRUV (8 $6($1 &KLQD 6 Korea, Brazil, USA O &/3 FODVVLÂżFDWLRQ ODEHOOLQJ DQG QRWLÂżFDWLRQV O ,QWHUQDWLRQDO UHJXODWLRQV IRU FRVPHWLFV IRRG ÂżQH FKHPLFDOV VWUDWHJLF FRQVXOWLQJ compliance analysis, implementation O 3URGXFW FHUWLÂżFDWHV VWUDWHJLF FRQVXOWLQJ DQG DSSOLFDWLRQ SURFHVVLQJ CLIENTS Fortune 500s, SMEs, academic or training institutes, governmental agencies in FRVPHWLFV SHUVRQDO DQG FRQVXPHU KHDOWK FDUH ÂżQH FKHPLFDOV KRXVHKROG SURGXFWV
CONTACTS Website E-mail Head office Tel Fax Contact Ownership Locations Founded
www.crowell.com brussels@crowell.com Rue Joseph Stevens 7, Brussels, B-1000, Belgium +32 2 282 4082 +32 2 230 6399 Laurent Ruessmann Private company Washington DC, New York, California, Anchorage, London and Brussels 1979
OVERVIEW &URZHOO 0RULQJ LV DQ LQWHUQDWLRQDO ODZ ÂżUP ZLWK QHDUO\ ODZ\HUV UHSUHVHQWLQJ FOLHQWV LQ OLWLJDWLRQ DQG DUELWUDWLRQ UHJXODWRU\ DQG WUDQVDFWLRQDO PDWWHUV 7KH ÂżUP LV internationally recognised for its representation of Fortune 500 companies in highstakes 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.
Chemical Watch | Global Service Providers Guide 2013
Website E-mail Head office Tel Fax Contact Ownership Locations Founded
CONTACTS www.dangerandsafety.it info@dangerandsafety.it Via Bugatti, 53, 56022 Castelfranco di Sotto (Pisa), Italy +390571367427 +390571382829 Paola Ulivi Private company Italy 2000
OVERVIEW With more than ten years of experience, Danger and Safety provides prompt and SURIHVVLRQDO VHUYLFHV ZLWKLQ WKH ÂżHOGV RI ULVN DVVHVVPHQW HQYLURQPHQW KHDOWK DQG LQ general for chemicalsâ&#x20AC;&#x2122; regulatory affairs (Reach-CLP-Dangerous goods transport). All WKH VWDII DUH KLJKO\ TXDOLÂżHG FKHPLVWV DQG ELRORJLVWV SERVICES PROVIDED O IXOO UHJXODWRU\ VXSSRUW IRU 5($&+ UHJXODWLRQ 6LHI DQG FRQVRUWLXP PDQDJHPHQW GRVVLHU GHYHORSPHQW DQG VXEPLVVLRQ &6$ DQG &65
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Website E-mail Head office Tel Fax Contact Ownership Locations Founded
www.ecotox.com.au info@ecotox.com.au Unit 27, 2 Chaplin Drive, Lane Cove 2066, Australia +61 2 9420 9481 +61 2 9420 9484 Dr Rick Krassoi Private limited company Australia 2001
OVERVIEW Ecotox Services International (ESI) is the sister company of Ecotox Services Australasia (6$ IRUPHG LQ (6, ZDV FUHDWHG VSHFLÂżFDOO\ WR SURYLGH FRQWUDFW HFRWR[LFLW\ 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 We serve a wide variety of clients, from very small to large enterprises, operating in PDQ\ ÂżHOGV DV LQGXVWULDO FKHPLFDOV IUDJUDQFH VHFWRU SLJPHQWV DQG G\HV
CLIENTS (FRWR[ 6HUYLFHV ,QWHUQDWLRQDO ZRUNV ZLWK FRPSDQLHV WKDW QHHG WR IXOÂżO LQWHUQDWLRQDO requirements for chemicals registration such as industrial chemical manufacturer/ importers and agrochemical companies. ESI also works with consultancies managing REACH dossiers.
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Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.mach-chemguide.com info@mach-chemguide.com Boernsener Str 16f, 21039 Hamburg-Boernsen, Germany +49 40 729 10 933/ +49 40 729 10 934 Dr Bettina Mach Private Germany 2011
OVERVIEW We guide you through REACH and CLP and the 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 O O prepare late preregistrations O prepare ECHA inquiries O prepare dossiers in IUCLID 5 O SUHSDUH DOO NLQGV RI QRWLÂżFDWLRQV O represent your interests in Siefs and consortia O monitor toxicological studies O DGYLVH RQ FODVVLÂżFDWLRQ DQG ODEHOOLQJ DQG SUHSDUH & / QRWLÂżFDWLRQ O advice on the implementation of the new cosmetic regulation EC 1223/2009 O 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.
Chemical Watch | Global Service Providers Guide 2013
Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.es4chem.eu info@es4chem.nl PO Box 8186, 6710 AD, Ede, The Netherlands +31 636224088/ +31 318 846 538 Dr Evelyn Tjoe Nij Private company The Netherlands 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 H[SHULHQFH LQ D VFLHQWLÂżF HQYLURQPHQW D VWURQJ FRPELQDWLRQ RI H[SHUWLVH RFFXSDWLRQDO 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 O FKHPLFDO VDIHW\ DVVHVVPHQW LQFOXGLQJ ÂżUVW WLHU H[SRVXUH DVVHVVPHQW IRU ZRUNHUV (ECETOC TRA), consumers (ConsExpo) and the environment (EUSES) O higher tier exposure assessment (by models such as ART and Stoffenmanager, and statistical analysis of measurement data) O update of 2010 dossiers (chapters 9 and 10) O SUHSDUDWLRQ RI H[SRVXUH DVVHVVPHQW ÂżHOG VWXGLHV IRU FRPSOLDQFH DQG ULVN assessment O derivation of OELs, DNELs/DMELs based on human data O implementation of exposure scenarios (eSDS) down the chain O 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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Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.espheres.com charlotte.crauwels@espheres.com Pères Blancs Street 4, 1040 Etterbeek, Brussels, Belgium + 32 (0)2 740 43 36/ + 32 (0)2 740 43 87 Charlotte Crauwels Private Belgium, France, Finland, Germany 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 productâ&#x20AC;&#x2122;s life cycle. From industrial hygiene and accident management, to air emissions and resource consumption â&#x20AC;&#x201C; we help companies automate and streamline compliance with HSE and sustainability requirements with SAPÂŽ EHSM software. We host, secure and manage your HSE data in a private cloud environment. SAPÂŽ 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 E-mail Head office Tel/ Fax Contact Ownership Locations Founded
Website E-mail Head office Tel Fax Contact Ownership Locations Founded
www.eurideastranslation.com translation@eurideastranslation.com 475 Avenue Louise, 1050 Brussels, Belgium +32 (0)2 669 7701 / +32 (0)2 669 77 87 +32 (0)2 627 5655 Kristina Bitvai Private company Belgium 2007
OVERVIEW Eurideas Linguistic Services provides professional translation and interpretation services. We specialise in chemical, technical, medical translations, as well as in other ÂżHOGV VXFK DV (8 OHJLVODWLRQ ODZ HQYLURQPHQW KHDOWK DQG PDQ\ PRUH 2XU QDWLYH 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 :H KDYH ZRUNHG RQ 5($&+ UHODWHG SURMHFWV IRU &HÂżF 5($&+ &HQWUXP ,623$ (X3& 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 www.eupoc.de eupoc@eupoc.de Schlossblick 14, D-87748 Fellheim, Germany +49-8335-987951/ +49-8335-987952 Dr Malte-Matthias Zimmer Private company Germany 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 WR XQGHUVWDQG WKHLU VSHFLÂżF QHHGV 7RJHWKHU ZLWK WKH 60(VÂś FXVWRPHUV (XSRF KDV 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 Eupocâ&#x20AC;&#x2122;s core business such successful: creating a future in Europeâ&#x20AC;&#x2122;s regulated markets. SERVICES PROVIDED Eupoc supports clients in communication â&#x20AC;&#x201C; between each other (eg along supply chains) and with customers, suppliers, associations, authorities, politicians and lawyers. This is the base IRU VXFFHVVIXOO\ SXWWLQJ VSHFLÂżF WHFKQRORJLFDO NQRZOHGJH LQWR UHJXODWLYH SURFHVVHV (XSRF combines technological expertise with successful interdisciplinary networking. Our main focus LV 5($&+ ZKHUH (XSRF ZDV WKH OHDGLQJ PDQDJHU RI RQH RI WKH ÂżUVW DXWKRULVDWLRQ FRQVRUWLD 2XU GDLO\ FRPPXQLFDWLRQ LV IDVW WUDQVSDUHQW DQG FRQÂżGHQWLDO :H DOZD\V ZRUN WRZDUGV EHLQJ 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 DXWKRULVDWLRQ :H DUH GHYHORSLQJ DQG ZLOO H[SDQG RXU DFWLYLWLHV LQ WKLV ÂżHOG 7RJHWKHU ZLWK RXU network of external experts we are able to handle European consortia.
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ZZZ ÂżQQUHDFK FRP LQIR#ÂżQQUHDFK FRP Itainen Pitkakatu 4B, FIN-20520 Turku, Finland )D[
Dr Jan Nylund Finland 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 customersâ&#x20AC;&#x2122; registration tasks. We help you with the whole process starting from data acquisition, testing strategies and GDWD HYDOXDWLRQ WR SUHSDUDWLRQ RI WKH ÂżQDO UHJLVWUDWLRQ GRFXPHQWDWLRQ :H SURYLGH */3 FHUWLÂżHG ODERUDWRU\ VHUYLFHV GDWD DQG H[SRVXUH DVVHVVPHQWV GRVVLHU DQG GRFXPHQW preparation, IUCLID 5, Chesar and REACH-IT expertise. We have specialised in VHUYLFHV WR DVVLVW FXVWRPHUV FRPSO\ ZLWK WKH &/3 5HJXODWLRQ RQ FODVVLÂżFDWLRQ ODEHOOLQJ 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 VHUYLFH DOVR LQFOXGHV 6'6 WUDQVODWLRQV WR DOO (8 DQG RWKHU ODQJXDJHV :H RIIHU TXDOLÂżHG 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 O O testing strategy â&#x20AC;&#x201C; planning and coordination O data search and assessment O human health and environment assessment O cosmetics safety assessment O &/3 Âą FODVVLÂżFDWLRQ DQG ODEHOOLQJ O safety data sheet preparation and translation O R&D-services â&#x20AC;&#x201C; formulation and substance replacement O TXDOLÂżHG GDQJHURXV JRRGV VDIHW\ DGYLVHU O laboratory and testing â&#x20AC;&#x201C; , , physico-chem l
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CONTACTS www.fobig.com klaus.schneider@fobig.de KlarastraĂ&#x;e 63, 79106 Freiburg, Germany +49 761 38608-12/ +49 761 38608-20 Klaus Schneider Private company Freiburg, Germany 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. FoBiGâ&#x20AC;&#x2122;s 5($&+ H[SHULHQFH GDWHV EDFN WR ZLWK SDUWLFLSDWLRQ LQ 5,3 SURMHFWV WKH &HÂżF sponsored SPORT project, the REACH baseline study and VCI projects on exposure-based waiving and the â&#x20AC;&#x153;practical guideâ&#x20AC;? on exposure assessment and communication in the supply FKDLQ )R%L* VXFFHVVIXOO\ SUHSDUHG QXPHURXV UHJLVWUDWLRQ GRVVLHUV IRU WKH ÂżUVW DQG VHFRQG REACH registration deadlines and supports companies with applications for authorisation. SERVICES PROVIDED )R%L* SURYLGHV IXOO VFDOH VFLHQWLÂżF VXSSRUW WR PHHW LQGXVWU\ÂśV 5($&+ REOLJDWLRQV O ,8&/,' ÂżOHV LQFOXGLQJ OLWHUDWXUH VHDUFKHV GDWD JDS DQDO\VLV HYDOXDWLRQ RI reliability, application of read-across and category approaches and inquiry dossiers for new substances) O FODVVLÂżFDWLRQ DQG ODEHOOLQJ DFFRUGLQJ WR &/3 5HJXODWLRQ O chemical safety reports (including hazard assessment, derivation of DNELs, DMELs and PNECs, exposure assessment and risk characterisation) O support for preparing applications for authorisations under REACH O support in Sief and consortium discussions and communications O downstream user inquiries and communication Other activities relate to cosmetics ingredients, safety evaluations and regulatory support in the areas of food toxicology, environmental contaminants and occupational toxicology. CLIENTS FoBiG supports SMEs and large European chemical companies with their REACH obligations and works for industry associations, European institutions and governmental organisations in methodological projects and other areas of toxicological assessment.
GHS-expert CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded
www.GHSexpert.com and www.REACHexpert.eu agnes.botos@GHSexpert.com 51 Haromszek str, 1194 Budapest, Hungary +36202205737 Agnes Botos Private company Hungary 2010
OVERVIEW We ensure 100% compliance with REACH and CLP (GHS) regulation. Together with an ,7 ÂżUP Âą ,46 FR Âą ZH SUHSDUHG D *+6 H[SHUW VRIWZDUH DLPLQJ WR KHOS SHUIRUP &/3 FODVVLÂżFDWLRQ RI VXEVWDQFHV DQG PL[WXUHV 7KLV *+6 VRIWZDUH LV D SODWIRUP IUHH ZHE DSSOLFDWLRQ ZKLFK ZDONV RXU FOLHQWV WKURXJK WKH RSWLPDO SDWK RI WKH FODVVLÂżFDWLRQ LQ RUGHU WR PDNH WKLV FRPSOH[ SURFHVV WKH PRVW HIÂżFLHQW SRVVLEOH SERVICES PROVIDED GHS support: SURIHVVLRQDO &/3 *+6 VRIWZDUH IRU FODVVLÂżFDWLRQ DQG ODEHOOLQJ RI chemical substances and mixtures with 100% legal compliance with EU and US GHS REACH support: OHDG UHJLVWUDWLRQ GRVVLHU SUHSDUDWLRQ PHPEHU UHJLVWUDWLRQ GRVVLHU SUHSDUDWLRQ RQO\ UHSUHVHQWDWLYH VHUYLFHV IRU QRQ (8 FRPSDQLHV 5($&+ DQG &/3 DXGLW WUDLQLQJ ,8&/,' &KHVDU 5($&+ *+6 &/3 CLIENTS *+6 H[SHUW /WG KDV D ZLGH UDQJH RI VDWLVÂżHG JOREDO FXVWRPHUV IRU ERWK *+6 H[SHUW software and REACH services. We have supported more than 70 Hungarian and foreign companies in completing the 5($&+ UHJLVWUDWLRQ DQG &/3 FODVVLÂżFDWLRQ LQ D WLPHO\ PDQQHU Countries of clients: Hungary, USA, Ukraine, Uzbekistan, Germany, UK Please visit our website and click on References.
Chemical Watch | Global Service Providers Guide 2013
CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.grcci.com john@grcci.com Greenwich Chemical Consulting, Inc, 3300 PGA Boulevard, Suite 635, Palm Beach Gardens, FL 33410, USA (561) 578-8110/ (561) 578-8120 Mr John V Massingale Mr John V Massingale Palm Beach Gardens, Florida, USA 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 FRQVXOWLQJ DVVLVWDQFH WR 86 DQG LQWHUQDWLRQDO FKHPLFDO FRPSDQLHV 7KH ÂżUP VSHFLDOLVHV in the Toxic Substances Control Act (TSCA) and the international chemical control schemes of Australia, Canada, China, European Union, Japan, and South Korea. 7KH ÂżUP VXSSRUWV FOLHQWV RQ 76&$ QHZ FKHPLFDO QRWLÂżFDWLRQV SUHPDQXIDFWXUH QRWLFHV (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 H[HPSWLRQ PDWWHUV *UHHQZLFK &KHPLFDO &RQVXOWLQJ DOVR KDV VLJQLÂżFDQW H[SHULHQFH DVVLVWLQJ FOLHQWV ZLWK 76&$ QHZ FKHPLFDO QRWLÂżFDWLRQV 301V RQ QDQRVFDOH PDWHULDOV including TSCA Section 5(e) consent order negotiations with EPA. Compliance assistance is also provided to clients in the related areas of the Osha +D]DUG &RPPXQLFDWLRQ 6WDQGDUG DQG WKH JOREDOO\ KDUPRQLVHG V\VWHP RI FODVVLÂżFDWLRQ and labelling of chemicals (GHS). CLIENTS US and international industrial chemical companies.
CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded
www.igcon.nl ineke.gubbels@igcon.nl Booglaan 4, 5348JJ Oss, The Netherlands +31 412854594/+1 9412660583 Ineke Gubbels Private company Netherlands 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: UHJXODWRU\ LPSDFW RQ EXVLQHVV FDVH LQGHSHQGHQW WUXVWHH consortium management. Technical consultancy: WHVWLQJ VWUDWHJLHV LQWHUSUHWDWLRQ RI WHVW UHVXOWV DOWHUQDWLYHV WR WHVWLQJ ULVN DVVHVVPHQW Toxicology: WR[LFRORJLFDO UHYLHZ PRQLWRULQJ VHUYLFHV GRVVLHU SUHSDUDWLRQ DOWHUQDWLYHV to animal testing. REACH: 6LHI DQG FRQVRUWLXP PDQDJHPHQW LQWHUSUHWDWLRQ DQG VWUDWHJLF DGYLFH UREXVW VWXG\ VXPPDULHV &65 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 EH GLVFORVHG DIWHU IRUPDO DSSURYDO E\ WKH FOLHQW &RQÂżGHQWLDOLW\ LV NH\ WR WKH VHUYLFHV delivered.
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Website E-mail Head office Tel Contact Ownership Locations Founded
CONTACTS www.jongeriusconsult.com info@jongeriusconsult.com Begijnenhof 26, 6584 CW Molenhoek, The Netherlands +31 615962071 Onno Jongerius Private company Netherlands 2009
Website E-mail Head office Tel Contact Ownership Locations Founded
www.linmarkconsulting.com martin.richards@linmarkconsulting.com Bernoullistrasse 20, CH-4056 Basel, Switzerland +41 79 500 9719 Dr Martin G Richards, Dr Al Wiedow Private company Switzerland, France, USA 2007
OVERVIEW Jongerius Consult BV offers strategic and practical support to the various stakeholders ZRUNLQJ WRZDUGV D VXFFHVVIXO DQG HI¿FLHQW LPSOHPHQWDWLRQ RI 5($&+ &/3 DQG UHODWHG (8 chemicals legislation. We combine our extended network, thorough legislative knowledge, joy in strategic and practical consultancy, enthusiastic facilitation and training of group SURFHVVHV DI¿QLW\ IRU ,7 DQG FUHDWLYH LQQRYDWLYH DQG SURFHVV RULHQWHG WKLQNLQJ ³RXW RI WKH ER[´ XS WR ZRUNLQJ VROXWLRQV JRRG UHVXOWV DQG VDWLV¿HG SDUWQHUV DQG FXVWRPHUV
OVERVIEW Linmark Consulting is a consulting and service company engaged in regulatory affairs, advocacy and communications for the chemical and life sciences industries. Linmark Consulting is headquartered in Basel, Switzerland, a major European industrial centre with good communications globally. Its French subsidiary, Linmark Consulting Europe SARL, offers only representative services under REACH, for importers into Europe. Linmark Consulting USA LLC specialises in US registration, advocacy using its strong links to EPA and FDA.
SERVICES PROVIDED Sounding board for companies and partners such as Caesar Consult, Apeiron-team and %D\WRXFK 2UJDQLVLQJ HIÂżFLHQW 5($&+ FRPSOLDQFH VWUDWHJLHV DQG SUDFWLFDO VROXWLRQV LQ FRPSDQLHV 3URYLGLQJ VSHFLÂżF WUDLQLQJ DQG ZRUNVKRSV JHQHULF DQG LQ FRPSDQ\ 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!
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 yearsâ&#x20AC;&#x2122; senior operational experience in regulatory affairs management and product development functions in multinational chemical, agricultural biotechnology and biopharma companies in UK, USA and Switzerland. Key European and USA strengths in consortium management and advocacy.
CLIENTS 2XU FOLHQWV DUH WKRVH FRPSDQLHV WKDW ZDQW WR GHDO HIÂżFLHQWO\ ZLWK 5($&+ DQG UHODWHG legislation with focus on the added value for the organisation. We are pleased with RXU VDWLVÂżHG SDUWQHUV FXVWRPHUV DQG PDQ\ VDWLVÂżHG SDUWLFLSDQWV RQ RXU 5($&+ compliance training programme 2011-12. Weâ&#x20AC;&#x2122;ll continue to focus on providing added value and making REACH work for industry.
CLIENTS &OLHQW FRQÂżGHQWLDOLW\ LV JXDUDQWHHG 5HFHQW FRQWUDFWV LQFOXGH ZRUNLQJ DV QRQ H[FOXVLYH VXE FRQWUDFWRU WR &HÂżFÂśV 5HDFK&HQWUXP LQ WKH PDQDJHPHQW RI VL[ 5($&+ FRQVRUWLD 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
CONTACTS
Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.jrfonline.com jrf@jrfonline.com NH-08, Near Daman Ganga River, Valvada, Valsad, Gujarat, India (+91) 260 654 0242, 329 1873/ (+91) 22 6646 6119 (Fax) Dr Abhay Deshpande Private company India, USA, UK 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, FRYHULQJ LGHQWLÂżFDWLRQ TXDQWLWDWLRQ RI GHJUDGDWHV Chemistry: product characterisation, method development and validation studies, product stability and purity analysis, physicochemical 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.
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www.LKC-ltd.com LKC@lkc-ltd.com Postfach 167, Hauptstrasse, Fuellinsdorf, Switzerland +41 61 906 8500 / +41 61 906 8509 Dr David Kane Private company Switzerland and UK 2001
OVERVIEW LKC provides European registration and development services to the international chemical industry. The LKC team is multifaceted, offering technical skills, regulatory H[SHULHQFH SURMHFW PDQDJHPHQW SURÂżFLHQF\ DQG VWUDWHJ\ SODQQLQJ H[SHUWLVH &KHPLFDO PDQXIDFWXULQJ FOLHQWV FDQ EHQHÂżW IURP D IXOO UDQJH RI UHJXODWRU\ VHUYLFHV WR DFKLHYH WKH VXFFHVVIXO UHJLVWUDWLRQ RI SURGXFWV LQ WKH ÂżHOGV RI FURS SURWHFWLRQ ELRFLGHV YHWHULQDU\ 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, HQYLURQPHQWDO IDWH DQG HIÂżFDF\ VWXGLHV 3(& UHSRUWV */3 PXOWL VLWH UHVLGXH VWXGLHV 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 /.&ÂśV FOLHQWV DUH VSHFLDOW\ FKHPLFDO PDQXIDFWXUHUV ZKR EHQHÂżW IURP WHFKQLFDO VXSSRUW in sectors that include crop protection, biocides, animal health and general chemicals.
Chemical Watch | Global Service Providers Guide 2013
CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership Locations
www.mckennalong.com uschliessner@mckennalong.com 2 Avenue de Tervueren, 1040 Brussels, Belgium +32 2 278 12 11/ +32 2 278 12 00 Ursula Schliessner Partnership USA, Brussels
OVERVIEW Chemical regulation is one of MLAâ&#x20AC;&#x2122;s marquee practices. Lawyers in our Brussels RIÂżFH FRXQVHO DQG OLWLJDWH RQ DOO DVSHFWV RI (8 FKHPLFDO UHJXODWLRQ LQFOXGLQJ 5($&+ 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. 0/$ KDV VLJQLÂżFDQW H[SHULHQFH ZLWK 5($&+ UHODWHG LVVXHV FRQFHUQLQJ PHUJHUV DQG acquisitions. SERVICES PROVIDED $QWL WUXVW DQG XQIDLU FRPSHWLWLRQ FKHPLFDOV SHVWLFLGHV DQG SURGXFW UHJXODWLRQ FRUSRUDWH HQHUJ\ HQYLURQPHQW HQHUJ\ DQG SURGXFW UHJXODWLRQ (8 FRPSHWLWLRQ (8 HQYLURQPHQWDO (8 IRRG ÂżQDQFLQJ DQG OHQGLQJ JRYHUQPHQW FRQWUDFWV JUHHQ FKHPLVWU\ KD]DUGRXV ZDVWH PDQDJHPHQW OLWLJDWLRQ PHUJHUV DQG DFTXLVLWLRQV SULYDWH HTXLW\ hedge funds and venture capital. CLIENTS &KURPLXP 7ULR[LGH 5($&+ DXWKRULVDWLRQ FRQVRUWLXP &7$& (WK\O %HQ]HQH 5($&+ FRQVRUWLXP *OXFRQLF DFLG DQG LWV GHULYDWLYHV 5($&+ FRQVRUWLXP ,URQ 2[LGHV 5($&+ FRQVRUWLXP 0DOWLWRO 6RUELWRO 5($&+ UHJLVWUDWLRQ JURXS 6W\UHQH 5($&+ FRQVRUWLXP 7&33 5($&+ FRQVRUWLXP 835 9(5 5($&+ FRQVRUWLXP +6$ 5($&+ FRQVRUWLXP Miscellaneous Chromate Substances REACH authorisation consortium (CCST)
Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.reachdelivery.com info@reachdelivery.com Hamilton House, 111 Marlowes, Hemel Hempstead, Hertfordshire, HP1 1BB, UK +44 (0) 1442 450460/ +44 (0) 1442 450335 Malcolm Carroll Part of the Mpower1 Group of Companies Worldwide support 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, VLPSOLÂżHV DQG PDQDJHV GLVWULEXWLRQ DXGLW DUFKLYH XSGDWH DQG RWKHU FRPSOLDQFH IXQFWLRQV SERVICES PROVIDED REACH Delivery is an electronic mail service that works seamlessly with email, yet: O JXDUDQWHHV GHOLYHU\ DQG UHFHLSW RI GRFXPHQWV DQG PHVVDJHV O PRQLWRUV DQG UHSRUWV RQ GHOLYHU\ DFFHSWDQFH VWDWXV O generates automatic updates to all previous recipients of a document, with new DQG ODWHVW YHUVLRQV O provides full audit trails and compliance reports to meet multiple legislative UHTXLUHPHQWV O ZRUNV ZKHQHYHU FRQÂżUPHG GHOLYHU\ DQG DXGLW LV UHTXLUHG Âą H[WHUQDOO\ WR RWKHU FRPSDQLHV DQG LQWHUQDOO\ WR \RXU RZQ VWDII O LQFOXGHV LQWHJUDO GDWD UHSRVLWRU\ DUFKLYLQJ DQG GRFXPHQW PDQDJHPHQW O VLPSOH WR XVH DSS LQVWDOOHG RQ \RXU 3& FDQ LQWHJUDWH ZLWK H[LVWLQJ DSSOLFDWLRQV O 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 E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.ecotoxchem.co.uk SHWHU ÂżVN#HFRWR[FKHP FR XN Saxon House, John Roberts Business Park, Pean Hill, Nr Canterbury, Kent, CT5 3BJ, UK +44 (0)1227 470901/ +44 (0)1227 765117 Dr Peter Fisk Limited company UK Originally founded in 1995. Founded as a limited company in 2006.
OVERVIEW Peter Fisk Associates offers specialist services to industry and regulatory organisations in WKH ÂżHOGV RI HQYLURQPHQWDO FKHPLVWU\ WR[LFRORJ\ DQG ULVN DVVHVVPHQW :H EULQJ H[SHUWLVH and high-level experience to chemical consultancy, tailored to our clientsâ&#x20AC;&#x2122; 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 yearsâ&#x20AC;&#x2122; 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 PDQDJHPHQW DQG 6LHI FRPPXQLFDWLRQV 6SHFLÂżF VHUYLFHV LQFOXGH 5($&+ GRVVLHU development â&#x20AC;&#x201C; 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 manufacturersâ&#x20AC;&#x2122; consortia from several sectors, downstream users of chemicals and national competent authorities.
Chemical Watch | Global Service Providers Guide 2013
CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership
Locations
Founded
www.reach-gs.eu info@reach-gs.eu Rond Point Schuman, 6 Box 5, B-1040 Brussels, Belgium +32 (2) 234 77 78/ +32 (2) 234 79 11 Mr Richard L Roden Istanbul Chemicals and Chemical Products Exportersâ&#x20AC;&#x2122; Association (IKMIB) 95% and Steel Exportersâ&#x20AC;&#x2122; Association (CIB) 5%. Two divisions of Istanbul Minerals and Metal Exporterâ&#x20AC;&#x2122;s Association, a joint venture between Turkish private industry and the Ministry of Economy. +HDGTXDUWHUV %UXVVHOV %HOJLXP 2IÂżFHV ,VWDQEXO 7XUNH\ Locations ideal for European and Turkish chemical industry and SUR[LPLW\ WR WKH (8 &RPPLVVLRQ DQG &HÂżF LQ %UXVVHOV DQG WKH European Chemicals Agency (ECHA) in Helsinki. 2008
OVERVIEW REACH Global Services SA (RGS) is a professional regulatory consulting company advising private and public sector clients in the chemicals and allied industries to comply with European Union and Turkish Republic chemicals legislation. RGSâ&#x20AC;&#x2122;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 RGSâ&#x20AC;&#x2122;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 E-mail Head office Tel Fax Contact Ownership Locations Founded
www.rorltd.com info@rorltd.com Hippocampus House, Hulme Lane, UK +44 (0)1565 724241 +44 (0)1565 723500 Client Services Private limited company Europe, local agents: Asia, Middle East 2006
OVERVIEW 5HDFK 2QO\ 5HSUHVHQWDWLYH /WG 525 ZDV RQH RI WKH ÂżUVW FRPPHUFLDO 2QO\ 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.
Website E-mail Head office Tel Contact Ownership Locations Founded
www.reachwise.eu info@reachwise.eu 22, St Albans Avenue, London W4 5JP, UK +44 (0)20 87470873 Peter Douben Private company UK, Netherlands, Germany 2007
OVERVIEW With extensive knowledge of REACH and CLP, REACHWise provides tailor-made VHUYLFHV RYHUVHHQ E\ 3HWHU 'RXEHQ IRUPHUO\ 'LUHFWRU 5($&+ &HÂżF DQG KHDG 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: LQ ÂżQGLQJ FRPSUHKHQVLYH VROXWLRQV IRU FRPSDQLHV ZH DGYLVH you on the best way to approach your REACH and CLP â&#x20AC;&#x153;problemâ&#x20AC;? 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 FRPSUHKHQVLYH DQG FRPPXQLFDEOH \RX GLVFKDUJH \RXU REOLJDWLRQV DQG \RXU FXVWRPHUV ÂżQG 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 registrantâ&#x20AC;&#x2122;s information. CLIENTS 6DWLVÂżHG FXVWRPHUV IURP WKH FHUDPLFV LQGXVWU\ IHUWLOLVHUV DQG UHODWHG LQGXVWULHV IUDJUDQFH sector, health care sector, home and personal care, lubricants manufacturers and suppliers, metals sector, minerals sector, pigments and colorants sector, speciality chemicals industry.
CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.reachready.co.uk enquiries@reachready.co.uk Kings Buildings, Smith Square, London, UK +44 (0)20 7901 1444/ +44 (0)87 1813 0304 Suzan Gunnee Chemical Industries Association London, UK 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 GHYHORSPHQW DW HYHU\ VWDJH :H RIIHU D Ă&#x20AC;H[LEOH YDOXH IRU PRQH\ VHUYLFH IRU DOO \RXU 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 KHOS LQ WDVNV VXFK DV FODVVLÂżFDWLRQ ,8&/,' VXEPLVVLRQV RU 6LHI VXSSRUW 2XU IUHH 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 inhouse 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.
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CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.refac.eu technical.manager@refac.eu Lyme Building, Westmere Drive, Crewe Business Park, Crewe, Cheshire, CW1 6ZD UK +44 (0)1270 258530/ +44 (0)1270 2584444 Ms Rachel Green, Dr Virginia Gretton Private Limited Company United Kingdom 2007
OVERVIEW ReFaC is an independent privately owned organisation which provides regulatory assistance, primarily to suppliers of industrial chemicals etc â&#x20AC;&#x201C; both within Europe and from across the world â&#x20AC;&#x201C; who seek to comply with REACH. Our team of regulatory professionals provide HIÂżFLHQW DQG H[SHUW VHUYLFHV WR 60( FRPSDQLHV PXOWL QDWLRQDO RUJDQLVDWLRQV LQGXVWU\ 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, LQFOXGLQJ GDWD JDS DQDO\VLV KD]DUG DQG H[SRVXUH VFHQDULR GHYHORSPHQW DQG &65 DXWKRUVKLS FRQVRUWLXP DQG 6LHI PDQDJHPHQW FRQVXOWDQF\ DQG VWXG\ VHUYLFHV 3325' QRWLÂżFDWLRQ 25 DQG 735 VHUYLFHV 6'6 DQG H6'6 DXWKRUVKLS &/3 FRPSOLDQFH PDQDJHPHQW 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.
Chemical Watch | Global Service Providers Guide 2013
CONTACTS
Tel/ Fax Contact Ownership Locations Founded
www.rsireg.com info@rsireg.com P.O. Box 1280, Peterborough, PE2 2NG, Cambridgeshire, United Kingdom +44 (0)1223 969 972 Andy Burgess Private limited company China, UK, USA 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 H[SHUWLVH ZLWK DOO DVSHFWV RI WKH 1HZ &KHPLFDO 1RWLÂżFDWLRQ 6FKHPH LQ &KLQD 0(3 2UGHU 1R &RPSOLDQFH VWDWXV GHWHUPLQDWLRQ QRWLÂżFDWLRQ VWUDWHJ\ GHYHORSPHQW DQG 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, QRWLÂżFDWLRQ OLFHQVLQJ VWUDWHJ\ GHYHORSPHQW DQG H[HFXWLRQ Business focused solutions to regulatory compliance challenges: we work alongside our client to identify the major business impacts from regulatory compliance challenges and then FRQGXFW DQDO\VLV RI SURGXFW SRUWIROLRV WR VSHFLÂżFDOO\ LGHQWLI\ DQG DGGUHVV WKHVH LPSDFWV CLIENTS We serve a wide range of clients from a broad range of industries, along with FRQVXOWDQWV &52V DQG ODZ ÂżUPV LQYROYHG ZLWK PDQXIDFWXULQJ GHYHORSLQJ DQG marketing chemical substances and formulated products.
CONTACTS Website E-mail Head office Tel Fax Contact Ownership Founded
www.thewercs.com steffank@thewercs.com The Wercs Ltd, 23 British American Blvd, Latham NY 12110, USA + 1 800 572 6501 / +1 518 229 3489 +1 518 640 9299 Steffan Kilmer Private 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 GHSand REACH-compliant solutions for all types of companies, regardless of size or location. SERVICES PROVIDED (M)SDS authoring software and services O O Retail supplier compliance O Green chemistry and sustainability solutions CLIENTS Manufacturing including: DGKHVLYHV DQG VHDODQWV DJUR FKHPLFDO DXWRPRWLYH FKHPLFDO FRQVXPHU SURGXFWV GLVWULEXWRUV Ă&#x20AC;DYRXUV DQG IUDJUDQFHV SDLQWV DQG UHVLQV FRDWLQJV LQNV DQG FRORXUV SHWUROHXP SKDUPDFHXWLFDO KHDOWKFDUH DQG OLIH VFLHQFHV SODVWLFV SRO\PHUV VSHFLDOW\ FKHPLFDOV W\UH DQG UXEEHU HWF Retail including: ELJ ER[ DXWR SDUWV JURFHUV KRPH LPSURYHPHQW SKDUPDF\ ZDUHKRXVH FOXE VSHFLDOW\ UHWDLOHUV HWF Government
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www.steptoe.com information@steptoe.com 1330 Connecticut Avenue, NW, Washington, DC 20036, USA +32 2 626 0500/ +1 202 429 3000 +32 2 626 0510/ +1 202 429 3902 Seth Goldberg/ Darren Abrahams/ Dr Anna Gergely Limited liability partnership Belgium, China, UK, US 1945
OVERVIEW 7R RSHUDWH LQ WKHVH IDVW HYROYLQJ UHJXODWRU\ ÂżHOGV UHTXLUHV QRW RQO\ PDVWHU\ RI WKH ODZ 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 RI UHJXODWRU\ ÂżHOGV DQG MXULVGLFWLRQV 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, IHHG DQG VHHGV Ă&#x20AC;DYRXUV DQG IUDJUDQFHV IXQFWLRQDO IRRGV PHGLFDO GHYLFHV DQG ZDVWH 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.
Chemical Watch | Global Service Providers Guide 2013
Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.toxfocus.com barbara.vogt@toxfocus.com 3016 Shenandoah Valley Drive, Little Rock, AR 72212, USA +1 501 351 4389 Barbara Vogt, PhD, DABT Private company USA 2008
OVERVIEW 7R[ )RFXV //& LV D VSHFLDOW\ FRQVXOWLQJ SUDFWLFH SURYLGLQJ WKH WR[LFRORJLF DQG VFLHQWLÂżF content for REACH, the Cosmetics Regulation, and other regulatory programmes. Principal Barbara Vogt, PhD Toxicology, DABT, has more than 15 yearsâ&#x20AC;&#x2122; experience in corporate and clinical toxicology. The consultancy has authored numerous REACH registration dossiers, FODVVLÂżFDWLRQ DQG ODEHOOLQJ KDUPRQLVDWLRQ GRVVLHUV ZHLJKW RI HYLGHQFH SRVLWLRQV DQG 5($&+ HYDOXDWLRQ UHVSRQVHV WR (&+$ PHPEHU VWDWHV 7R[ )RFXV //& LV D TXDOLÂżHG ULVN DVVHVVRU IRU FRVPHWLFV VXSSRUWLQJ SUHPDUNHW QRWLÂżFDWLRQ IRU WKH (8 &RVPHWLFV 5HJXODWLRQ SERVICES PROVIDED REACH: high-quality toxicology assessments and strategic planning for compliance with data UHTXLUHPHQWV LQFOXGLQJ GDWD JDS ÂżOOLQJ DGDSWDWLRQV WR GDWD UHTXLUHPHQWV LGHQWLÂżFDWLRQ RI analogues and categories, computer modelling and support (QMRF, QPRF), laboratory test PRQLWRULQJ UREXVW VWXG\ DXWKRULQJ FRQVWUXFWLRQ RI ,8&/,' ÂżOHV ZLWK FRPSOHWHQHVV UHSRUWV FKHPLFDO VDIHW\ UHSRUWV ULVN DVVHVVPHQWV FODVVLÂżFDWLRQ ODEHOOLQJ DQG SDFNDJLQJ &/3 DQG evaluation support and dossier defence. EU Cosmetic Regulation: product risk assessment FHUWLÂżFDWHV DQG FRVPHWLF SURGXFW VDIHW\ UHSRUWV DV SDUW RI WKH SURGXFW LQIRUPDWLRQ ÂżOH 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 6FLHQWLÂżF ,QWHUQDWLRQDO $: &KHVWHUWRQ &RPSDQ\ &DOXPHW 6SHFLDOW\ 3URGXFWV 3DUWQHUV LP, Gulf Bayport Chemicals LP, Shepherd Chemical Company, Connecticut Business and Industry Association, United States Department of Commerce.
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www.toxcel.com Christine.McAlinden@toxcel.co.uk / info@toxcel.com PO Box 93, Ledbury, HR8 9JE, UK +44(0)1531 638999 (UK) / +1 703 754 0248 (USA) Christine McAlinden (UK) / Alan Katz (USA) Limited company UK, USA 1999
OVERVIEW WR;FHOÂśV (XURSHDQ DQG 1RUWK $PHULFDQ RIÂżFHV ZRUN FORVHO\ WRJHWKHU WR SURYLGH D coordinated regulatory resource for seamless development and execution of strategies, designed for cost-effective regulatory approvals, leading to domestic, regional, and global export market expansion. SERVICES PROVIDED toXcel provides a full range of services to support obtaining marketing approvals by governmental agencies, with emphasis on regulatory strategy development and all aspects of preparing applications and dossiers. toXcel advises companies about compliance with REACH, the Biocidal Products Regulation, the Cosmetics Directive, the Plant Protection Products Regulation, and other EU registration requirements. We can provide you with a full REACH registration service (including only representative function), or we can support your in-house activities as required. Our experts provide FIFRA, TSCA, and FDA services to our JOREDO FOLHQWHOH LQ RXU 86 RIÂżFH WR;FHO KDV JOREDO H[SHULHQFH LQ WKH SHUIRUPDQFH RI H[SRVXUH and risk assessments, environmental assessment, safety and toxicological evaluations, and WKH GHVLJQ DQG PDQDJHPHQW RI */3 DQDO\WLFDO FKHPLVWU\ UHVLGXH HIÂżFDF\ HQYLURQPHQWDO fate, mammalian toxicity, metabolism/pharmacokinetics (ADME), and ecotoxicity studies. CLIENTS Our leading consultants focus their collective professional talents on assisting chemical manufacturers, formulators, pharmaceutical companies, personal care/consumer product PDQXIDFWXUHUV DQG VXSSOLHUV WUDGH DVVRFLDWLRQV ODZ ÂżUPV DQG WKH IRRG LQGXVWU\
www.verdantlaw.com inquiry@verdantlaw.com 1025 Connecticut Ave, NW, Suite 1000, Washington, DC 20036, USA +01 202 828 1233 Philip A Moffat, Esq Private â&#x20AC;&#x201C; professional limited liability company (PLLC) 86$ ZLWK DQ LQWHUQDWLRQDO QHWZRUN RI DIÂżOLDWHG SURYLGHUV 2009
OVERVIEW 9HUGDQW /DZ 3//& LV D ERXWLTXH HQYLURQPHQWDO ODZ ÂżUP ORFDWHG LQ :DVKLQJWRQ '& $OWKRXJK ORFDWHG LQ WKH 8QLWHG 6WDWHV FDSLWDO WKH ÂżUP KDV D JOREDO SHUVSHFWLYH 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 UHODWHG FKDOOHQJHV 7KH ÂżUPÂśV SULQFLSDO SUDFWLFH DUHDV LQFOXGH JUHHQ FKHPLVWU\ DQG chemicals management, right-to-know, and nanotechnology, among others. SERVICES PROVIDED 7KURXJK D FRPELQDWLRQ RI LQ KRXVH H[SHUWLVH DQG D QHWZRUN RI MXULVGLFWLRQ VSHFLÂżF experts, Verdant is well-positioned to assist companies manufacturing, importing, using, or marketing chemicals and other affected products in major markets around the globe. 9HUGDQWÂśV VHUYLFHV LQFOXGH QHZ SURGXFW FKHPLFDO UHJLVWUDWLRQV FRPSOLDQFH DGYLFH DXGLWLQJ DQG HQIRUFHPHQW GHIHQFH GDWD ULJKWV QHJRWLDWLRQ SURGXFW GHIHQFH SURWHFWLRQ RI FRQÂżGHQWLDO LQIRUPDWLRQ WUDQVDFWLRQDO GXH GLOLJHQFH DQG FRQVRUWLXP PDQDJHPHQW 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.
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Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.toxservices.com info@toxservices.com 1367 Connecticut Avenue NW, Suite 300, Washington, DC 20036, USA 202-429-8787/ 202-429-8788 Margaret H Whittaker, PhD, MPH, CBiol, FSB, ERT, DABT Limited Liability Company USA 2003
OVERVIEW 7R[6HUYLFHV LV D VFLHQWLÂżF FRQVXOWLQJ ÂżUP WKDW H[FHOV DW SURYLGLQJ WR[LFRORJ\ UHJXODWRU\ WKLUG SDUW\ DXGLWLQJ DQG ULVN DVVHVVPHQW FRQVXOWLQJ VHUYLFHV WR FRUSRUDWLRQV FHUWLÂżFDWLRQ DQG WHVWLQJ ODERUDWRULHV JRYHUQPHQW DJHQFLHV DQG ODZ ÂżUPV 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 'I( HYDOXDWLRQV &OHDQ*UHGLHQWVÂ&#x160; HYDOXDWLRQV *UHHQ6FUHHQÂ&#x152; HYDOXDWLRQV &UDGOH WR &UDGOHÂ&#x160; DVVHVVPHQWV SURGXFW VDIHW\ DQG UHJXODWRU\ HYDOXDWLRQV VWXG\ GHVLJQ FRRUGLQDWLRQ DQG GDWD DQDO\VLV WKLUG SDUW\ *03 */3 DQG *&3 DXGLWV UHJXODWRU\ compliance and expert witness support.
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www.wca-environment.com solutions@wca-environment.com Brunel House, Volunteer Way, Faringdon, Oxon, UK SN7 7YR 01367 246026 Dean Leverett Limited company 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 /DQGÂżOO 'LUHFWLYH (0($ DQG JLYH 9,&+ JXLGDQFH RQ HQYLURQPHQWDO ULVN DVVHVVPHQW 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 :DWHU ,QGXVWU\ 5HVHDUFK &HÂżF (XURSHDQ (QYLURQPHQW $JHQF\ (&0$ 1LFNHO Institute, Syngenta, Defra, European Commission, ERGTC, European Copper Institute, the chemical industries.
CLIENTS Located across the US, Europe,and Asia.
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Chemical Watch | Global Service Providers Guide 2013
CONTACTS
Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.thewercs.com Roberts@thewercs.com 23 British American Blvd, Latham, NY 12110 +1 518 640 9283/ +1 518 640 9299 Bob Sheehan Private USA, Belgium, Germany, China, Japan 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 customerâ&#x20AC;&#x2122;s unique regulatory requirements. SERVICES PROVIDED :36 SURYLGHV 6'6 KD]DUG ODEHO DXWKRULQJ WR DQ\ UHJLRQ RI WKH ZRUOG 6'6 KD]DUG ODEHO WUDQVODWLRQ Âą FXUUHQWO\ VXSSRUW ODQJXDJHV 06'6 WR 6'6 FRQYHUVLRQ VHUYLFHV Âą FRQYHUW H[LVWLQJ SURGXFW 06'6 WR *+6 FRPSOLDQW 6'6 H 6'6 DXWKRULQJ WUDQVODWLRQ VHUYLFHV UHJXODWRU\ FRQVXOWLQJ VHUYLFHV VXVWDLQDELOLW\ VFRULQJ CLIENTS :36 FOLHQWV FRPH IURP LQGXVWLHV LQFOXGLQJ DGKHVLYHV DJURFKHPLFDO FKHPLFDO FRQVXPHU SURGXFWV Ă&#x20AC;DYRXU IUDJUDQFH LQNV SDLQWV FRDWLQJV SKDUPDFHXWLFDO ELRWHFK UHWDLO VSHFLDOW\ FKHPLFDO
Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.wspenvironmental.com Stuart.burrow@wspgroup.com 70 Chancery Lane, London, UK 0161 886 2400/ 0161 886 2401 Stuart Burrow/ Dr Stephen Bounds Private company UK, Europe, worldwide 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, D OHDGLQJ JOREDO GHVLJQ DQG HQJLQHHULQJ ÂżUP ZLWK DERXW VWDII DURXQG WKH ZRUOG SERVICES PROVIDED We offer a complete range of services to deal with all our clientâ&#x20AC;&#x2122;s REACH requirements including: identifying a clientâ&#x20AC;&#x2122;s REACH registration obligations and developing the UHJLVWUDWLRQ VWUDWHJ\ 6LHI DQG FRQVRUWLXP PDQDJHPHQW DOO DVSHFWV RI VXEVWDQFH UHJLVWUDWLRQ GRVVLHU SUHSDUDWLRQ DQG VXEPLVVLRQ MRLQW UHJLVWUDWLRQ VXEPLVVLRQ VRFLR HFRQRPLF DQDO\VLV DXWKRULVDWLRQ RI D VXEVWDQFH FODVVLÂżFDWLRQ ODEHOOLQJ DQG SDFNDJLQJ &/3 PDQDJHPHQW DQG FRPSOLDQFH RQO\ UHSUHVHQWDWLYH DQG WKLUG SDUW\ UHSUHVHQWDWLYH VHUYLFHV VDIHW\ GDWD VKHHW SUHSDUDWLRQ DQG PDQDJHPHQW 5($&+ FRPSOLDQFH FKHFNV CLIENTS :63 DVVLVWV D ODUJH JURXS RI FRPSDQLHV WR IXOÂżO WKHLU 5($&+ REOLJDWLRQV UDQJLQJ IURP 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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www.wrcplc.co.uk solutions@wrcplc.co.uk Frankland Road, Swindon, UK 01793 86 5000/ 01793 86 5001 Ian Johnson Private company UK 1927
OVERVIEW WRcâ&#x20AC;&#x2122;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 ,GHQWLÂżFDWLRQ RI UHJLVWUDWLRQ UHTXLUHPHQWV O O Arrangement of toxicological and ecotoxicological testing. O Compilation and evaluation of physico-chemical, environmental, fate, toxicological and ecotoxicological data packages. O 6XEVWDQFH JURXSLQJ 46$5 DQG UHDG DFURVV IRU GDWD JDS ÂżOOLQJ DQG WHVW replacement for some endpoints. O Exposure modelling and derivation of exposure scenarios. O Reviews of epidemiological data and health monitoring studies. O +D]DUG FODVVLÂżFDWLRQ DQG ODEHOOLQJ &/3 O Preparation of technical dossiers in IUCLID 5, chemicals safety reports (CSRs) and safety data sheets (SDSs). O Validation of registration dossiers prior to agency submission. CLIENTS A wide variety of clients ranging from single industrial chemical manufacturers to multinational consortia.
Chemical Watch | Global Service Providers Guide 2013
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Chemical Watch | Global Service Providers Guide 2013
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Chemical Watch | Global Service Providers Guide 2013
Page 163
A-Z LISTING
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Chemical Watch | Global Service Providers Guide 2013
Page 165
A-Z LISTING
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Riskchem
South Africa
2-5
1
Rivendell International
Ireland
10-25
10-25
1
1
f Risk & Policy Analysts
118
Roisin McEneany
USA, Spain and Japan
Ireland The Netherlands
RI¿FHV ZRUOGZLGH 5,000 plus
50-100
SAFENANO
UK
Singapore
25-50
Safety Data Services
UK
Safeware Quasar Ltd
UK
SAP AG
Germany
SAP Japan Co., Ltd.
Japan
1,000-2,000
5-10
SATRA Technology Centre
UK
0
0
f Royal HaskoningDHV
120
f SCC
122
Science & Environnement SciVera LLC
100-500 1
1
Turkey, USA, Japan, 25-50 The Netherlands, Greece, Ireland 5,000 plus
50-100
25-50
Switzerland
France
5-10
5-10
5-10
5-10
50-100
50-100
124
UK
USA
f SGS
126
Switzerland
5,000 plus China, France, Germany, Hong Kong, UK, USA 2,000-5,000
Canada
Shridhar Rajappanavar
India
2,000-5,000
50-100
SIEF-IT
Poland
5-10
5-10
Siletz SPRL
Belgium
2-5
1
USA
25-50
25-50
Sitmae Reach Services
The Netherlands
2-5
2-5
Smithers Viscient
USA
UK
100-500
5-10
Spetsinterproject Oy
Finland
Russia, Ukraine
5-10
2-5
Spinnaker Coating, LLC
USA
2-5
2-5
25-50
10-25
1
1
128
Stefanie Merenyi
Sweden
India, Hong Kong
Germany
f Steptoe & Johnson LLP
155
USA
Belgium, China, UK 1,000-2,000
UK
Sumika Chemical Analysis Service Ltd (SCAS)
Belgium
Surface Science Western
Canada
10-25
1
SustChem Engineering
Greece
5-10
5-10
f Swissi Instituto Suizo de Seguridad
130
2-5
2-5
1,000-2,000
25-50
Spain
Switzerland, Taiwan 100-500
50-100
Syska Voskian Consulting
Denmark
USA
2-5
TEI Analytical, Inc
USA
5-10
5-10
Telematic srl
Italy
10-25
5-10
Tenviro
Sweden
The Netherlands
1
1
Tetra Tech
USA
Canada, Japan
5,000 plus
50-100
The REACH Centre Ltd
UK
Italy, Japan
10-25
5-10
2-5
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www.shawcor.com
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Japan, China, Singapore
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f Selcia
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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
ShawCor
SGS
Selcia
Risk & Policy Analysts
Lobbying/advocacy Insurance
Training courses/webinars Bespoke/in-house training CPD/CES certified training
Human health toxicology SVHC testing
RimaOne
Shridhar Rajappanavar
SIEF-IT Siletz SPRL SiteHawk
Smithers Viscient
Spetsinterproject Oy
Spinnaker Coating, LLC
SSS (Europe) AB
Stefanie Merenyi
Steptoe & Johnson LLP
Stewardship Solutions Ltd
Swissi Instituto Suizo de Seguridad
Syska Voskian Consulting
TEI Analytical, Inc
Telematic srl
Tenviro
Tetra Tech
The REACH Centre Ltd
SustChem Engineering
Sumika Chemical Analysis Service Ltd (SCAS) Surface Science Western
Sitmae Reach Services
Key: Icons above represents the extent to which the company provides the service as follows: Core service Service that is occasionally provided Service provided by partners and third parties
Chemical Watch | Global Service Providers Guide 2013
Page 167
A-Z LISTING
Consortia/registration solutions Laboratory management solutions
Supply chain management
Regulatory information management
Ricerca Biosciences, LLC
EH&S solutions
Substance inventory management (Material) safety data sheet systems
Legal representation
Regulatus
Chemical hazard database (Material) safety data sheets
Regulatory Services International
Regulatory/policy tracking Managed regulatory content
GHS notification CLP notification
ReFaC
Dossier preparation
Redeker Sellner Dahs Rechtsanwälte
Registration services
Business process outsourcing (BPO)
REACHWise
Representation Management (Sief, Consortium etc)
SVHC advisory services Environmental risk assessment
ReachSuite Ltd
Chemical transport/warehousing
ReachSpektrum, s.r.o.
Assessment of data quality
Registration strategies
Supply chain communications
Testing strategies
REACHReady
Corporate strategy/strategic planning
Organisation
REACHLaw
Training
Exposure testing
Laboratories
Environmental monitoring
IT solutions
Physical & analytical chemistry
Information
Ecotoxicology Environmental fate & degradation
Repre./management
Guidance on regulatory interpretation Product compliance
Consultancy/advisory
Page Headquarters
A-Z LISTING
The Sapphire Group
Other locations
USA
f The Wercs
155
USA
f TNO Triskelion
132
The Netherlands
f Tox Focus, LLC
155
USA
f toXcel International Ltd
156
UK
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France, Belgium, UK, 50-100 Italy, Germany, Japan -DSDQ VDOHV RI¿FH 2,000-5,000
USA
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100-500
5-10
Germany
10-25
10-25
25-50
10-25
USA
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Belgium
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UK
TUV Rheinland Hong Kong Ltd.
Hong Kong
TÜV Rheinland LGA Products GmbH
Germany Germany
TUV SUD Japan
Japan
UL
UK
France, Greece, 500-1000 Luxembourg, Spain, UK 50-100 Germany, Spain, Slovenia, Poland, USA, Canada 5,000 plus
USA
25-50
USA, Switzerland, Bangladesh
5,000 plus
500-1000
500-1,000
100-500
2-5
2-5
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Germany
2-5
2-5
UK
5-10
2-5
25-50
25-50
1
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50-100
10-25
1,000-2,000
100-500
100-500
50-100
1
1
156
Weeset Advisors
UK
Italy
USA
f Wercs Professional Services, LLC
157
USA
f WIL Research
138
USA
Belgium, Germany, China, Japan The Netherlands
f Wildlife International, a division of EAG
140
USA
The Netherlands
Wilmer Tox Consulting
Switzerland
f WRc plc
157
UK
f WSP Group
157
UK
f WTConsulting
142
Xiaodan Pei f YASH Technologies
144
Zanos Limited
100-500
50-100
Switzerland China
USA
100-500
100-500
USA
Europe, Asia, Australia
2,000-5,000
50-100
2-5
1
5-10
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s
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s
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v
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s
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u
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s
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www.toxminds.com s
s
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t
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s
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www.tuev-sued.de/technical_ installations/reach www.tuv-sud.jp ul.com/consumer-products www.u-bordeaux2.fr www.verdantlaw.com www.vonroll.com www.vrs-regulatory.net
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www.wilresearch.com
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t
50-100
10-25
156
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5-10
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134
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5-10
2-5
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136
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2-5
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f TÜV SÜD Industrie Service GmbH
Global staff
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Organisation
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Page 168
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Chemical Watch | Global Service Providers Guide 2013
Information
IT solutions
Laboratories
Training
Lobbying/advocacy Insurance
Training courses/webinars Bespoke/in-house training CPD/CES certified training
Human health toxicology SVHC testing
Exposure testing
Environmental monitoring
Physical & analytical chemistry
Ecotoxicology Environmental fate & degradation
Consortia/registration solutions Laboratory management solutions
Supply chain management
Regulatory information management
EH&S solutions
Substance inventory management (Material) safety data sheet systems
Legal representation
Chemical hazard database (Material) safety data sheets
Toxservices LLC
Regulatory/policy tracking Managed regulatory content
ToxMinds
GHS notification CLP notification
Dossier preparation
Registration services
Toxikon
Business process outsourcing (BPO)
toXcel International Ltd
Representation Management (Sief, Consortium etc)
SVHC advisory services Environmental risk assessment
Chemical transport/warehousing
Tox Focus, LLC
Assessment of data quality
TNO Triskelion
Registration strategies
Supply chain communications
Testing strategies
The Wercs
Corporate strategy/strategic planning
Organisation
The Sapphire Group
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
Weeset Advisors
WIL Research
Wildlife International, a division of EAG
Wercs Professional Services, LLC
WRc plc
WSP Group
WTConsulting
Xiaodan Pei
Zanos Limited
Wilmer Tox Consulting
YASH Technologies
VRS Regulatory wca environment
Key: Icons above represents the extent to which the company provides the service as follows: Core service Service that is occasionally provided Service provided by partners and third parties
Chemical Watch | Global Service Providers Guide 2013
Page 169
A-Z LISTING
Repre./management
Guidance on regulatory interpretation Product compliance
Consultancy/advisory
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COMPLIANT SUPPLIERS