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Global Service Providers Guide
2014
A guide to global chemicals management and control services
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Foreword Welcome to the fourth annual Chemical Watch service providers guide and directory. Now an eagerly awaited fixture in the chemicals compliance world, this year’s directory once again brings you a comprehensive view of the companies that are offering services from legal to laboratory; IT to strategic management; and Brussels to Beijing to Buenos Aires. At the same time, we continue to dig deeper and scan broader to bring you a bird’s eye view of this evolving sector, one where salaries are good, jobs secure and which promises continued growth for those companies that are closely attuned to company needs and the global regulatory agenda. In the complementary market analysis in this year’s guide, written once again by experienced chemicals market researcher Cynthia Challener, we look more closely at the drivers and market for services in the biocides sector and
Chemical Watch | Global Service Providers Guide 2014
also ask experts how the service provider market in Asia is shaping up? We bring you survey findings from over 1,100 respondents from across the world. At the same time, we provide updated findings on our annual indicators including overall regulatory and nonregulatory drivers of chemicals management activity and the factors that influence companies’ choice of service providers. Of course, we also provide our second annual salary survey, comparing earnings for different posts and in different job markets, with commentary from recruitment experts. Definitely something to share around the water cooler! We hope you find these insights useful for you as an individual and for your company’s prospects. Mamta Patel Editorial Director
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ASIA EUROPE THE AMERICAS
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A scientific and regulatory consulting firm providing strategic, comprehensive support for global chemical registration, regulation, and sustained compliance. • Global Chemical Notification (North and South America, Europe, Asia, Australasia) • Biocides, Pesticides, Antimicrobials, Nanomaterials • Hazard Communication, GHS Classification and Labelling, SDS • Global Agent and Representative Services • Testing Strategy and Co-ordination • Toxicology & Ecotoxicology • Transport of Dangerous Goods • Dossier Preparation and Expert Review • Data Compensation
www.actagroup.com Beijing, China (86-10) 8453-4538
Manchester, U.K. +44 (0) 330 223 0610
Washington, D.C. +1 (202) 266-5020
Contents Chemical service providers editorial..... 5 Chemical inventory, GHS and sectorspecific regulations impacting all chemical users........................................ 5 Increasingly complex regulatory landscape............................................. 14 Key country regulatory highlights in 2014...................................................... 19 New European Biocidal Product Regulation: complexity driving demand for external expertise............. 21 Positive Outlook for Chemicals Management and Control Jobs Market................................................... 23 Outlook for chemicals management and control service providers............... 31
Profiles........................................42 24-7 Response...................................... 42 3E Company......................................... 44 ACTA..................................................... 46 Apeiron-Team NV.................................. 48 ARCADIS............................................... 50 ARCHE.................................................. 52 bibra toxicology advice & consulting... 54 Blue Frog Scientific Limited.................. 56 BSL BIOSERVICE Scientific Laboratories GmbH.............................. 58 CEHTRA................................................ 60 Centro Reach........................................ 62 Charles River......................................... 64 Chemsafe.............................................. 66 Chemservice......................................... 68 Chilworth – a DEKRA Company........... 70 CIS Center............................................. 72 CS Regulatory Ltd................................. 74 DHI........................................................ 76 Dr. Knoell Consult GmbH...................... 78 EBRC Consulting.................................. 80 EcoOnline.............................................. 82 eftec...................................................... 84 ENVIRON.............................................. 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 US office: +1 (202) 803 5869
Equitox.................................................. 88 ERM....................................................... 90 Exponent............................................... 92 FoBiG.................................................... 94 Harlan Laboratories.............................. 96 IHS......................................................... 98 International Cosmetics & Chemical Services Ltd........................ 100 Intertek................................................ 102 iPoint.................................................... 104 KFT Chemieservice............................ 106 Mérieux Nutrisciences........................ 108 Modern Testing Services (Global)...... 110 National Chemical Emergency Centre (NCEC).................................... 112 Pace Analytical Professional Services.............................................. 114 REACh ChemAdvice GmbH............... 116 REACH mastery.................................. 118 ReachCentrum.................................... 120 REACHLaw.......................................... 122 Risk & Policy Analysts Ltd (RPA)........ 124 Royal HaskoningDHV.......................... 126 SCC..................................................... 128 SSS (Europe) AB................................. 130 Swissi Process Safety......................... 132 TNO Triskelion..................................... 134 ToxMinds BVBA................................... 136 TÜV SÜD Industrie Service GmbH..... 138 WIL Research...................................... 140
Niche Profiles.............................. 143 AG-HERA............................................ 143 Baytouch Ltd....................................... 143 Bootman Chemical Safety.................. 143 Caleb Management Services Ltd....... 143 CFCS................................................... 144 Chymeia ApS...................................... 144 CONUSBAT......................................... 144 Danger and Safety srl......................... 144 Distefano Law Office........................... 145 Editor Mamta Patel, mamta@chemicalwatch.com Contributing Editor Cynthia Challener, cynthia@chemicalwatch.com Profile production Nick Hazlewood, nick@chemicalwatch.com Account Managers Kerry Williamson, kerry@chemicalwatch.com Lotte Spencer, lotte@chemicalwatch.com Glen Marechal, glen@chemicalwatch.com Gavin Bennett, gavin@chemicalwatch.com Head of Marketing Richard Butterworth, richard@chemicalwatch.com Commercial Director Stuart Foxon, stuart@chemicalwatch.com Managing Director Julian Rose, julian@chemicalwatch.com
Chemical Watch | Global Service Providers Guide 2014
DR MACH Chemical Compliance & Competence....................................... 145 eSpheres............................................. 145 Eupoc.................................................. 145 Eurideas Linguistic Services.............. 146 Food and Environment Research Agency (Fera)..................................... 146 Fraunhofer ITEM.................................. 146 IGCON................................................ 146 Infotox.................................................. 147 Jongerius Consult BV......................... 147 KREATiS.............................................. 147 Linmark Consulting............................. 147 LKC Switzerland Ltd............................ 148 McKenna Long & Aldridge LLP.......... 148 Peter Fisk Associates.......................... 148 Randis ChemWise (Shanghai) Co., Ltd................................................ 148 REACH ChemConsult......................... 149 REACH Delivery.................................. 149 REACH Global Services..................... 149 Reach Only Representative Ltd.......... 149 REACHReady...................................... 150 REACHWise........................................ 150 The Redstone Group.......................... 150 ReFaC................................................. 150 Safeware Quasar Ltd.......................... 151 SIAM S.L.............................................. 151 Spring Trading Company, LLC............ 151 The Wercs........................................... 151 Tox Focus, LLC.................................... 152 toXcel.................................................. 152 Toxicon................................................ 152 ToxServices......................................... 152 Verdant Law, PLLC.............................. 153 wca environment................................. 153 Wercs Professional Services.............. 153 WRc plc............................................... 153 WSP UK Ltd........................................ 154
A-Z Listing.................................. 156 Distribution policy Copying of this document including electronic circulation is not permitted without consent of the publisher. Disclaimer While Chemical Watch takes every effort to ensure the accuracy of this guide, we cannot take responsibility for any adverse consequences arising from actions taken in response to our content and we recommend that readers take appropriate professional advice. Designed and typeset by Ministry of Design, Bath, UK www.ministryofdesign.co.uk Printed by Pureprint Group Limited. Printed on 9 Lives 80 recycled stock. Front cover images © shutterstock.com First published 2014 Copyright and Database Rights © 2014 CW Research Ltd. All rights reserved
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Introduction The number of governmental regulations pertaining to the management of chemicals continues to increase around the world as existing legislation is updated and new regulations are adopted that are designed to minimise the risks to human health and the environment. In addition to companies that manufacture, store, and/or transport chemicals affected by these regulations, users of chemicals must meet requirements for proper management of these materials, and labelling and packaging of any products containing them. While large, international chemical producers and distributors and some downstream users often have much of the needed expertise in areas such as regulatory, administrative, project and information management, legal, chemistry, toxicology, laboratory testing and software systems, most SMEs and many downstream users lack the resources and skill sets required to ensure full compliance with the current complex web of global regulations. To fill
the gap, organisations seek the assistance of firms offering a range of capabilities, including consultancy/advisory, management/administrative, legal, training, laboratory and technical, information/data management and software/ IT services. As a result, the chemicals management and control service providers market continues to experience healthy growth, and the market for regulatory-related positions remains strong. These trends are reflected in the results of the fourth annual Chemical Watch survey of the regulated community, including service providers and those involved in chemical regulatory compliance, whether using outside support or not. A discussion of these results and the major trends occurring in chemicals management and control are presented below. This year we also provide special sections on compliance with Asian and biocide regulations, a summary of the current job market, highlights of regulations by country, and a discussion of user perceptions of the chemicals management and control service provision market.
OVERVIEW
Chemical inventory, GHS and sector-specific regulations impacting all chemical users Regardless of whether companies manufacture chemicals, convert them to new substances, formulate them into mixtures or use them to make products for professional or consumer use, the vast array of chemicals management and control regulations now apply to them. These include REACH, the Toxic Substances Control Act (TSCA) and similar chemical “inventory� and chemical notification regulations in many countries, individual country GHS requirements, and sector specific regulations related to biocides, agrochemicals and cosmetics. The increasing number of requirements around the world has become burdensome for chemical manufacturers and distributors, even though they have experience and expertise with compliance. For downstream users producing final products, compliance with these regulations is often new and therefore not only burdensome, but challenging. Small and medium-sized businesses with very limited resources continue to struggle to meet the requirements.
Increasing complexity reflected in drivers for service demand Consistent with previous years, compliance with REACH remained the top regulatory driver for the need for
Chemical Watch | Global Service Providers Guide 2014
chemicals management and control expertise, according to the Chemical Watch survey (Figure 1). However, REACH could be slightly losing its influence relative to other regulatory drivers. Compared to 89% of respondents in 2012, only 77% of respondents to the current survey cited any aspects of REACH to be a key driver of demand for services. In addition, EU CLP (classification, labelling and packaging of substances and mixtures) compliance is no longer as important; just 49% of respondents in 2013, compared to 66% in 2012, indicated that CLP was a leading regulatory driver. It should be noted, however, in this current survey, respondents were given the opportunity to indicate if certain components of the REACH Regulation were of particular importance. REACH substances of very high concern (SVHCs), registration and evaluation and dossier update activities were each important to nearly half of respondents (47%, 45% and 42%, respectively). Furthermore, compliance with the UN Globally Harmonized System (GHS) of classification and labelling compliance in countries other than Europe was a leading driver for 30% of respondents, and compliance with the US Hazard Communication (HazCom) 2012 GHS standard was important to 28% of participants.
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Chemical service providers
Chemicals Management and Control
The experience of AkzoNobel, a global coatings and speciality chemicals manufacturer, underscores the level of regulatory complexity that companies participating in markets around the world are facing today. In 2013, some of the regulatory activities pursed by the company included the submission of 181 applications for registration of substances in time for the second REACH deadline;
preparing materials required for compliance with GHS/ CLP initiatives; monitoring of ongoing discussions on the reform of TSCA in the US; following developments and amendments in procedures under the Chinese substance regulations; preparing for K-REACH in South Korea, which comes into force in January 2015; and complying with various import/export control regulations.
Chemical service providers
Figure 1 Leading regulatory drivers for survey participants REACH (any)
77%
EU CLP regulation
49%
US (any)
47%
EU REACH SVHC obligations
47%
EU REACH 2018 registration
45%
EU REACH evaluation related activities/dossier updates
42%
China regulations National GHS classification, labelling and inventory notification regulations US HazCom 2012 (GHS) Standard
41% 30% 28%
Biocidal product regulations
26%
South Korea regulations
25%
Nanomaterials risk assessment
21%
US: California Safer Consumer Products Regulation
20%
Food contact material regulations
19%
US EPA Work Plan on Chemicals
19%
Cosmetics regulations
17%
Japan regulations
17%
Packaging regulations
17%
Canada Chemicals Management Program
16%
Conflict minerals legislation
15%
Taiwan regulations
14%
Canada pending GHS in workplace legislation
11%
International Maritime Dangerous Goods (IMDG) Code
11%
International Carriage of Dangerous Goods by Road (ADR)
11%
Brazil regulations
11%
Russia regulations
10%
Turkey regulations
10%
Agrochemical regulations
10%
Malaysia regulations
9%
US CDR
9%
Medical devices regulations
8%
Pharmaceutical regulations
7%
Mexico regulations
6%
Argentina regulations
4%
Israel regulations
3%
Veterinary product regulations
3% 0%
20%
40%
60%
80%
100%
% of participants
Chemical Watch | Global Service Providers Guide 2014
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GET EXPERTS ON YOUR SIDE “You can do your business, we remove the regulatory roadblocks.”
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Figure 2 Leading non-regulatory drivers for survey participants Economic growth 44% Customer pressure
Importance of REACH
42% Governmental policies/spending 31% Redistribution of regulatory compliance responsibilities within organisations 30% NGO pressure 24% Downsizing of in-house chemical management and control teams 20% Non-statutory voluntary corporate initiatives/CSR 19% Outsourcing of business support functions (by client organisations) 11% Increased commercialisation/better management of service provider business 10% Other 2% 0%
20% 40% % of participants
Chemical Watch | Global Service Providers Guide 2014
Respondents to the Chemical Watch survey also noted several additional non-regulatory factors that will be driving the need for increased chemicals management and control activity. Several participants believe that large retailers are having an impact through the selection of certain suppliers. Green chemistry initiatives at local, regional and national levels, and growing interest in renewable raw materials, are also seen as impacting the chemical supply chain. One leading manufacturer of biobased speciality chemicals is hopeful that countries with chemical registration or inventory processes will consider reviewing their approaches to ensure that their processes do not have the unintended consequence of providing incumbent technologies with advantages (due to grandfathered positions) or restricting the ability of companies to bring newer, more attractive and beneficial chemicals to market efficiently. Another key concern for this biobased products manufacturer is the impact of challenging economic times on global regulatory agencies, which are being required to do more with fewer resources. “To avoid ‘gridlock’ or extremely extended timeframes securing registrations or listings on the appropriate inventories, new approaches must be developed – without compromising the ultimate objectives of ensuring that better, safer, more environmentally beneficial and sustainable products are available and used,” a company executive says. He adds that there are long-term fundamental issues that governments must address that could significantly restrict resources needed to manage registrations and listings, but hopefully some (eg sequestered reduced working days for US government employees that extend timeframes) will be more temporary.
60%
While demand for REACH registration services tended to decline after the 31 May 2013 deadline for medium-volume substances, requests for assistance with dossier updates prompted by an increase in ECHA evaluation activities kept many service providers busy throughout the year. There is an expectation that registration activity will pick up again in 2014 as many companies begin work to meet the 2018 deadline for small volume products, and that the continuing need to update dossiers will generate further business. Fortunately, according to Marc Thouin with the health, environment and regulatory services business of Intertek Chemicals and Pharmaceuticals, the registration process for medium-volume substances proceeded more smoothly than that for large-volume substances due to the increased knowledge of the regulated community and greater access to data. “The experience that was gained with the 2010 deadline and intervening years proved invaluable, in particular allowing a greater degree of confidence in the prediction of overall potential costs and timescales, which in turn helped our clients with expectations and budgets,” says Philip Copestake, principal toxicologist at Bibra Toxicology Advice & Consulting. “We are also seeing many clients already preparing for the 2018 registration deadline because there is now a realisation that certain actions need to be taken well in advance in order to guarantee successful and timely registration,” says Rudolf Staab, managing partner of REACh ChemAdvice. Companies that have embraced the legislative compliance issues and are thinking wellahead will have good advantage over those that hold off, says Mr Copestake, because there will inevitably be many
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Chemical service providers
Country-specific regulations were also top drivers for demand for chemicals management and control expertise, particularly in the US and China (47% and 41% of survey participants, respectively). Biocidal products, nanomaterials, food contact materials, cosmetics, and packaging regulations were also a concern for approximately 17 to 26% of survey respondents. With respect to non-regulatory drivers, which also have a significant effect on demand for chemicals management and control capabilities, economic growth and customer pressure continued to be the top two factors, according to over 40% of the Chemical Watch survey participants (Figure 2). Interestingly though, given the improved economic prospects in many countries, economic growth was cited by fewer of the latest group of survey respondents than for last year’s group (down 5% from 2012). In addition, while governmental policies and spending did remain the third most important non-regulatory driver, it was also less important in 2013 than 2012 (31% vs. 37%, respectively). Notably, the redistribution of regulatory compliance responsibilities within companies, a new category in the 2013 survey, was thought by survey respondents to be nearly as important as governmental activities (30%). NGO pressure (24%), downsizing of in-house teams (20%) and voluntary corporate programmes (19%) were other cited nonregulatory drivers.
Chemical service providers
challenges thrown up by the REACH registration process. “Working with several companies within a consortium, or even an integral team of staff within a single company, often means that timeframes and plans are protracted,” he says. Some, such as Monica Locatelli, managing director of REACH mastery, are worried about the 2018 deadline because the number of substances is exponentially higher and the analytical steps are longer. “We are pushing all of our customers to begin tackling this issue immediately in 2014, and expect there will be significant logistic and administrative issues in 2014 and 2015,” she says. “We have been approached by several clients who realise that it is never too early to prepare for REACH 2018 because they have a high number of chemicals to register, while at the same time there is a lack of available data,” says Michael Cleuvers, managing director for industrial chemicals and biocides at Dr Knoell Consult. “Furthermore, companies are well aware that they have indeed managed the registration part of REACH in 2013, but evaluation is ongoing and also authorisation has started for the first set of substances”. WIL Research, meanwhile, experienced greater demand in 2013 for testing following the release of ECHA draft decisions on testing proposals for 2010 substances, particularly from SMEs, who are struggling to deal with the requirements from both financial and knowledge perspectives, according to the company’s head of regulatory affairs Marie-Elene Boivin. In 2013, in response to the same trigger, Equitox worked on sub-chronic and reprotoxicity studies, and Benoit Fraysse, an ecotoxicologist with the company, expects more such jobs in 2014. Similarly, 80% of all test data requirements for KFT Chemieservice were initiated by ECHA dossier evaluations, which managing partner Karl-Franz Torges thinks will increase in 2014. Meanwhile, for TÜV SÜD Industrie Service, most testing was for the determination of ecotoxicity, granulometry, selfignition and density, according to Dieter Reiml, a certified REACH multiplicator with the company. (A certified REACH multiplicator has successfully passed exams that are part of a training programme for high quality REACH experts offered by the Austrian Chamber of Commerce). “Lead registrants were very active in updating their dossiers, and ECHA was extremely active and successful in checking the compliance of the dossiers and submitting deficiency reports,” says Dr Torges. ReachCentrum expects that the community rolling action plan (CoRAP) process and decisions on testing proposals will have an important impact as well. “We believe 2014 will bring further consolidation of, and improvements in, industry knowledge of ECHA-related dossier and substance evaluation procedures, especially due to experience gained, for example, through voluntary dossier updates and understanding what information is relevant,” says says Mark Meesters, head of manager support services . SMEs had significant difficulty preparing registration dossiers for the 2013 deadline because they had less knowledge of the requirements and less data was available,and so had to use read-across approaches, says Dr Dieter Drohmann, managing director of Chemservice. Many SMEs sought help and support with the submission of dossiers as co-registrants, says REACHCentrum’s Mr Meesters. The main focus for other firms, such as DHI, has been SVHCs and substances on Annex XIV, including how to prepare for possible authorisation requirements and documentation of the impact for advocacy purposes, according to head of projects Jens Tørsløv. AkzoNobel
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expects some key policy decisions under REACH to be made in 2014, including an explanation of how the European Commission intends to assess substances of equivalent concern to those classified as SVHCs. Meanwhile, clients of REACHLaw that are dealing with prioritised candidate list substances are shifting their emphasis to authorisation efforts. “Here,” says Tim Becker, chief EU compliance officer, “it has become more and more clear that downstream users are in a key position to provide/ prepare data on alternatives and socio-economic analysis.” In fact, ReachCentrum has observed a shift of involvement from manufacturers to downstream users, as seen, for example, with the formation of the task force of producers and downstream users of the blowing agent ADCA to respond to REACH regulatory challenges, says Cornelia Tietz, project manager in charge of authorisation. She also notes that ReachCentrum has or is supporting several other downstream user applications for authorisations, such as those for hexabromocyclododecane (HBCDD) , sodium dichromate, and trichloroethylene, whereas only one manufacturing group has been managed by the company. Dr Drohmann of Chemservice expects the demand for training related to authorisation and restriction will increase in 2014 as ECHA moves forward with this phase of REACH implementation, while Dr Staab of REACh ChemAdvice expects that demand for training on the use of Iuclid 5, the general registration process and the obligations of downstream user obligations will continue to be high. Extended safety data sheets (eSDSs) were also an issue for several service providers. In addition to registration activities, Equitox helped downstream users deal with the eSDS documents they received from raw material suppliers. “We expect further activity in this area in 2014,” says Mr Fraysse. Dr Staab also anticipates work in 2014 related to eSDSs, the implementation of risk management measures and compliance with exposure scenarios by downstream users. Similarly, ReachCentrum’s Mr Meesters expects a greater number of downstream users in the chemical industry and parallel sectors, such as plastics and cosmetics, to attend training sessions on the use of eSDSs. KFT Chemieservice’s Dr Torges also says that questions regarding exposure scenarios for mixtures and how to handle exposure scenario information for substances in a mixture SDS will be critical in 2014. “Unfortunately, there are no general answers to this challenge, and I do not see a common solution being developed by the exchange network for exposure scenarios (Enes) in 2014. Rather, I expect there will be numerous solutions that will not end in harmonisation.” With respect to legal services, in 2013, clients of REACHLaw required assistance with REACH status analyses (eg exemptions from authorisations based on intermediate use arguments) and the preparation of agreements (eg consortium agreements for joint authorisations), says Mr Becker. Acting for consortia, ReachCentrum has seen an increasing need for competition law compliance, which is expected to continue in 2014, says Mr Meesters. He also expects that ECHA’s final decision on REACH Annex IX, which is scheduled for 2014, will be significant. Mr Becker is also interested in how the ECHA Board of Appeal and European Court of Justice will rule on complaints by various companies against ECHA’s SME verification process and administrative charges. The general challenge for many companies is that the workload, including REACH-related activities, is increasing while budgets are frozen or reduced, and clients are expected to do more with less, according to Luis Paulsen of consultancy EcoOnline. He adds that much of the
Chemical Watch | Global Service Providers Guide 2014
Impact of CLP and other GHS regulations around the world The amount of work generated by CLP and other GHS programmes that have been adopted or are being established in various countries differed widely among service providers and companies using and selling chemicals in 2013. GHS/CLP is a prime growth area for The Acta Group (Acta), says president Lynn L Bergeson, who is also a managing partner of Bergeson & Campbell, a Washington DC law firm. “We are seeing a significant increase in demand for technical services in GHS-related areas clients in the US, Asia, and South and Central America and expect that to continue through to 2016 because GHS implementation requires a disciplined and time-intensive review of all product labelling and related chemical classification services,” she says. Caroline Raine, a principal consultant with 24-7 Response, dealt with issues such as relabelling, conflicts in classifications, and the development of new SDSs, while Chemservice received a lot of SDS and labelling work for clients complying with GHS requirements in South Korea, says Dr Drohmann. REACh ChemAdvice also experienced strong demand for CLP notifications of imported substances, and anticipates more requests in 2014 for the classification and labelling of mixtures given the 1 June 2015 deadline, says Dr Staab. For other firms, such as Equitox, DHI and KFT Chemieservice, GHS business was more routine, both for CLP in Europe and GHS regulations in non-EU countries. KFT’s Dr Torges, in fact, had difficulty convincing clients to change from dangerous preparations Directive (DPD) to CLP classifications because many were reluctant to make such a significant investment and deal with the impact the changeover would have on all processes related to marketing and logistics. Daniel Haggarty, development manager with the UK National Chemical Emergency Centre (NCEC), has had the same experience. “We have trained all of our response team in the GHS/CLP and the changes to the classification and labelling information on the SDS, but are still seeing DPD rather than CLP classification and labelling information.” Reach mastery’s Dr Locatelli has also found that in general it is difficult to obtain compliant documentation. “We believe most of the problems are due to the fact that only representatives are not fulfilling the requirements of the role,” she says. Most CLP activity is expected to take place in the second half of 2014. Both KFT Chemieservice’s Dr Torges and Equitox’s Mr Fraysse are anticipating high resource demand by the end of the year. Specifically, KFT is receiving requests related to the support of external raw data management. REACh ChemAdvice’s Dr Staab expects to receive requests for tests related to the determination of physico-chemical
Chemical Watch | Global Service Providers Guide 2014
properties for use in the classification of mixtures, as well as toxicological and ecotoxicological tests for components of mixture that have not yet been registered. GHS development in some Asian and emerging countries must also be closely followed as countries communicate decisions on how to interpret GHS in their respective jurisdiction, according to Intertek’s Mr Thouin. Training for CLP has been and will continue to be focused on how to best classify mixtures, says Mr Meesters of ReachCentrum.
The country factor Many of the developments with respect to country specific regulations occurred in Asia and are discussed below in the special section on the Asian chemicals management and control market. Countries to note in Asia that are making changes to chemicals management and control regulations include South Korea, China, the Philippines, Malaysia, Taiwan, Thailand and Vietnam. However, there are some changes that occurred in European countries and in the US in 2013 and some that may take place in 2014 that could serve as drivers for demand for chemicals management and control expertise. The implementation of the Swiss GHS in 2013 is significant for KFT Chemieservice’s Dr Torges in terms of the simplification it provides. However, he is still frustrated by the need to submit SDSs to local European authorities in different European countries. Article 45 of the CLP Regulation requires the establishment of poison centres in each country, rather than an overall centre for the EU, and each has a different IT platform and provides information only in the local language. It is also becoming increasingly difficult to use European approvals for other country registrations outside the EU, and often the timing and additional costs are not compatible with the needs of customers, according to Dr Locatelli of REACH mastery. For Dr Tørsløv of DHI, one of the main issues is compliance with guidance for the workplace in various European countries and how these obligations relate to REACH requirements. In the US, meanwhile, a sea change with respect to the possibility of achieving reform of TSCA took place in 2013 with the introduction of the Chemical Safety Improvement Act (CSIA, S 1009) by Senator David Vitter (R-LA) and the late Frank Lautenberg (D-NJ) on 22 May 2013. This latest bill, which has bipartisan support in the Senate and interest from both parties in the House of Representatives, as well as chemical industry approval, is a significantly shortened version of the Safe Chemicals Act, an earlier bill introduced by Senator Lautenberg that was poorly received by the sector. The chemical industry has supported the modernisation of TSCA, but has so far viewed most legislative efforts as too costly, stifling innovation, and reducing the competitiveness of US companies. The CSIA is under review by the Senate Environment and Public Works (EPW) Committee, which is chaired by Senator Barbara Boxer (D-CA), and the industry is hopeful that there will be movement by the EPW in the first half of 2014. Senator Boxer’s concerns with CSIA’s pre-emption provisions, however, do not bode well for the current version of the bill, says Acta’s Ms Bergeson. In the House, Congressman John Shimkus (R-IL) is working on a bill expected to be similar to the CSIA and to appear by the end of the second quarter. While there are areas of disagreement – notably whether the federal law should pre-empt individual state regulations such as California’s Safer Consumer Products Regulation – both Socma and the ACC are optimistic that a bill to modernise TSCA will reach
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Chemical service providers
work is attributed to internal and external documentation requirements from stakeholders such as employees and departments, members of a supply chain (customers and supplier), various certification requirements, NGOs and so on. REACH is also having an impact on supplier selection, says AkzoNobel. As a producer of both substances and mixtures, the company depends on its suppliers to fulfil requirements under chemical control laws. It therefore considers the ability of suppliers to support its compliance efforts when choosing which organisation to including in its supply chain. Such behaviour, says Bibra’s Mr Copestake, is indicative of the fact that REACH is increasingly becoming just another part of the day-to-day workload of company chemical stewardship.
Sector regulations: cosmetics draw attention With respect to regulations targeting specific types of products or sectors of the market other than general chemicals, demand for expertise in chemicals management and control has largely been driven by the EU biocidal products Regulation, which is covered in a special section below, and the EU cosmetics Regulation ((EC) 1223/2009), with some need for assistance with food contact regulations in both Europe and the US. WIL Research’s Mrs Boivin expects to see increasing demand for support in the agrochemicals sector in 2014-2016, while DHI is active in the pharmaceutical industry, and REACHLaw also provides support for coatings and metal products, in addition to speciality and petrochemicals and biocides. NCEC is also working increasingly with coatings and minerals producers. Many agree that implementation of the cosmetics Regulation is progressing fairly smoothly. KFT’s Dr Torges says the launch of the CPNP (cosmetic products notification portal) was a great success, and that it is now simple and transparent to submit notifications of new and existing cosmetic products. The demand for services related to cosmetics products varied significantly, however. Equitox, for example, found that its French SME clients were not ready to pay for the level of expertise needed to meet the requirements of the Regulation. Equitox’s Mr Fraysse does, however, expect an increase in activity in this area in 2014 as companies realise they must comply but cannot do so without assistance. Chemservice, DHI and Bibra, on the other hand, experienced strong demand for their services from the cosmetics industry. Mr Copestake attributes Bibra’s growth in cosmetics-related business to the Regulation’s focus on human health. “We expect that the increased robustness of the new legislation and the drafting of associated cosmetic product safety reports (CPSRs) will encourage a more thorough approach to risk assessment than was taken under the old Directive,” he says. “As a result, we predict a greater degree of outsourcing of safety assessments to independent experts by companies without resident
Chemical Watch | Global Service Providers Guide 2014
toxicologists or other suitably qualified individuals. Safety assessments are also likely to involve greater time and monetary investments, which will hit small cosmetics manufacturers/importers the hardest.” Chemservice and DHI also experienced demand in 2013 for services related to food contact regulations. A range of very specific product regulations have been important for clients of Acta, according to Ms Bergeson. “We have seen a significant uptick in demand from companies that are involved in the production of heavily challenged substances including BPA, phthalates, flame retardants and metals, and we expect this demand to remain constant if not increase in 2014,” she says. For Equitox and many respondents of the Chemical Watch survey, endocrine disruptors and nanomaterials are two subjects that demand close monitoring. “There is much discussion occurring amongst academics, regulators and industry, with little agreement as of yet,” Mr Fraysse notes. Toy safety regulations, the EU restriction of hazardous substances (RoHS) Directive (2011/65/EU), conflict minerals in the US and EU, pharmaceutical industry regulations, and labelling requirements for cold chain products are additional sector-related issues that survey participants consider important.
Communicating through the supply chain One of the goals of many chemicals management and control regulations, and of REACH and GHS in particular, is to increase the communication of information on chemical hazards throughout the supply chain. There is disagreement regarding whether or not any progress has been made, although even those that believe there has been some improvement acknowledge that there is still a long way to go. Italian consultancy Chemsafe has not seen any big improvements in supply chain communication with respect to regulatory compliance issues, and project manager Dr José Cantavella Cabedo doesn’t expect things to change in 2014. Mrs Boivin of WIL Research Europe adds that communication down and up the supply chain is still quite challenging, and working with comprehensive eSDSs is a huge issue for most companies. The positive changes in supply chain communication that Mr Thouin of Intertek Chemicals and Pharmaceuticals and Dr Staab of REACh ChemAdvice have observed are attributed by both to pressure coming from the inspection authorities, which has raised awareness and motivated companies to be more proactive, while more inspections at the downstream user level are still needed to drive communication, according to Chemservice’s Dr Drohmann. REACH mastery’s Dr Locatelli sees communication improving between non-European suppliers and European importers, who increasingly need to receive detailed information on the supplied substances and mixtures. “Downstream users are also recognising that they must be involved in scenario building in order to receive compliant chemical safety reports (CSRs) from lead registrants,” she says. As both a manufacturer and downstream user, AkzoNobel has found that communication of substance hazard data in the supply chain has improved as required under REACH, but in many cases the eSDSs it receives from raw material suppliers are complex and difficult to interpret. The company would welcome a simplification of eSDSs, and as a supplier itself, is also looking for ways to simplify its communication with downstream users.
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Barack Obama’s desk for signing before the end of the year. Others, however, are less certain. Several respondents to the Chemical Watch survey also noted that compliance with Turkey’s registration and CLP requirements (notifications and eSDS issues) is challenging, while others are expecting upcoming regulations on substances in Latin America to impact their businesses. In general, says Ms Bergeson, it is important to note that country-specific and region-specific regulations have had a profound impact on service providers and immeasurably complicated the workloads of their clients. “Smart companies that market chemicals/ chemical products globally are strategically aligning their regulatory, testing, and compliance needs to maximise their investments and carefully reviewing their global product registrations and data needs to ensure their investments are leveraged in the most cost-effective manner possible. To do so, carefully-trained experts must review markets and chemicals globally; country-specific reviews are necessarily missing the mark if companies market in multiple geographic regions,” she says. With more countries expected to issue country/region specific regulations that will require expert analysis and management, The Acta Group predicts increased demand for chemicals management and control services in 2014.
Chemical service providers
According to Jouni Honkavaara, a partner and the CFO of REACHLaw, as REACH registration deadlines have shifted to smaller tonnages, the focus within the supply chain has shifted as well. “The old logic of the biggest manufacturers and suppliers carrying the biggest responsibility has changed. Suddenly, downstream users further down the supply chain that are using SVHCs have their own vital interests to protect, and usually are at a worse starting point with regard to resources and knowledge,” he says. “The important vertical communication in the supply chain is still in need of development, though, and it will likely be augmented with horizontal communication between downstream users looking for new forms of co-operation with respect to authorisations.” Dr Reiml of TÜV SÜD agrees that communication in the supply chain has become more professional and targeted as a result of recent experiences. Connie Prostko-Bell, director of supply chain compliance solutions with 3E Company, believes that supply chain communication will continue to be a significant issue in 2014, and that data will play a critical role. “The goal of supply chain communication is to achieve transparency. The product of transparency is data. Data are critical to an effective supply chain compliance and risk mitigation program, but data are not the endgame. Data must be made meaningful with analytics and intellect,” she says. For real supply chain communication to be achieved, however, full electronic dataflow with electronic exposure scenarios is needed, says DHI’s Dr Tørsløv. “With increasing workloads and strained budgets, it is difficult to solve the challenges of eSDSs without turning to IT systems,” says EcoOnline’s Mr Paulsen. He adds that there are, fortunately, lots of opportunities to simplify the documentation process and actually do more with less. The building and construction and automotive industries have demonstrated that it is possible to simplify data capture and exchange, aggregate and bundle data sets, and improve documentation throughout the supply chain,
he says, while for chemicals management and control, it should be possible to make eSDSs available not only as pdf files, but as metadata, which would then provide huge opportunities for data management and exchange.” More specifically, Mr Paulsen expects to see a move from client/server or on-premise software to clouded services and wireless/mobility. Greater access to the internet from different types of terminals and devices, combined with greater and more widely available bandwidth, is driving the development of applications for chemicals management and control, from managing chemical inventory to accessing workplace protection information, that work on smartphones and tablets. Internet distribution is also enabling the connection of different data sources and the bundling of relevant sets of data so that distribution and management of the data becomes easier, as has been demonstrated in the construction and automotive industries, he says. 3E Company’s Ms Prostko-Bell agrees that technological advances can streamline supply chain compliance initiatives. “Effective corporate supply chain compliance programmes can help manufacturers, retailers, and users of raw materials and finished goods understand both existing and emerging obligations, supply chain risks, and market barriers and opportunities. Utilising a robust platform and reliable data can help companies meet their regulatory obligations, but also enrich their businesses through improved market access and enhanced competitive agility,” she says. SDSCom XML and EsCOM XML are two key initiatives targeting the development of standards for XMLcommunication for the SDS main body and exposure scenarios, respectively. “Significant effort is being made by international IT suppliers to develop the basis for these standards. Once they are ready and in use, these protocols should contribute to easier vertical and horizontal exchange and management of data,” Mr Paulson states.
Special Asia Section
Increasingly complex regulatory landscape The regulation of chemicals in Asian countries is in flux, and will be so for some time. Many countries with established regulations are modernising their chemical inventories and reporting requirements, while others are implementing completely new systems. Others have or are in the process of implementing classification, labelling and packaging regulations that are aligned with GHS. International companies looking to sell products in these countries face the challenges of learning about and understanding the new regulations, determining what data are required for their products, preparing the relevant dossiers for submission, and then tracking and reporting production and use information as needed. While these tasks must be accomplished for any national chemical regulation, it is particularly difficult in Asian countries because communications occurs in the local language of each nation. It is not surprising, therefore, that service providers and international companies that participate in the Asian market have found that having a local presence makes a big difference. Most service providers serving the Asian market are active in China, which is also not surprising given Page 14
the size and growth rate of the Chinese economy. The Chinese government is working to improve its regulatory systems across many industry sectors, and the general management and control of chemicals is no exception. “China updated its chemicals regulatory regime all through 2013, with expanding lists of regulated chemicals and uses,” says Mr Rinta-Jouppi, a partner and head of global compliance with REACHLaw. Active monitoring of regulatory changes in China is therefore clearly important. Many service providers support international companies selling products in Japan, which has an established regulatory system. Numerous companies have also recently begun to focus on South Korea, given that K-REACH will go into effect on 1 January 2015. In fact, it is anticipated by several firms that a significant portion of their business in Asia in 2014 will be related to K-REACH. Other Asian countries for which chemicals management and control service providers are asked to give regulatory compliance assistance include the Philippines, Malaysia, Myanmar and Thailand. Unlike in Europe and the US, most of the newer regulations in Asian countries are focused on the Chemical Watch | Global Service Providers Guide 2014
Services for the Chemical Industries
Agrochemicals
REACH out for the market. Biocides
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EBRC Consulting GmbH RaffaelstraĂ&#x;e 4 D-30177 Hannover Germany Phone: +49 (0) 511 - 89 83 89 - 0 Fax: +49 (0) 511 - 89 83 89 - 10 E-mail: mail@ebrc.de ebrc.de
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management and control of general chemicals, and there is little change in sector specific regulations at this time, according to Jun Ho Lee, senior researcher at the Risk Assessment Centre of the Korea Testing and Research Institute (KTR). That is not to say there is not ongoing activity relating to sectoral legislation; for instance, Beijing OCI reports work with clients in the cosmetics industry on cosmetic raw materials and imported special purpose cosmetics and clients dealing with food contact materials, food additives, and novel foods, as well as general chemical regulations, according to Frankey Liu, media supervisor for the company. Dr Knoell Consult Thai also sees agrochemicals becoming important in several Asian countries. AkzoNobel is largely involved in general chemical regulations, but does expect that activity in food contact and biocides regulations will increase. With respect to the regulation of cosmetic ingredients, there is some concern about requirements for Chinese approval, says a leading biobased speciality products producer. According to a company representative, there are some regulations in China that may require animal testing, which is in conflict with the limitations that the personal care industry has placed on such tests and creates a dilemma for companies looking to sell cosmetic ingredients in the country. Further complicating the situation for this manufacturer is the fact that it can be challenging to find service providers in Asia that are qualified and capable in terms of competency, understanding, and have the capability to conduct tests , and the capacity to do so, in a reasonable timeframe, given the generally limited options and long lead times required. For the next two years, however, the focus of attention for many will not be cosmetics, but K-REACH implementation, says KTR’s Mr Lee. He also says, though, that Taiwan is preparing to introduce improved regulations for the management of chemical substances and activities in the country should be monitored. Gunnar Kahl, managing director of Dr Knoell Consult Thai, is planning to invest more time in Myanmar, Vietnam and Indonesia, with a focus on general chemicals and agrochemicals. “We also expect that the Hazardous Substance Act in Thailand will be updated and will influence registration procedures for general chemicals and agrochemicals. In addition, Malaysia just issued its new GHS guidance and inventory submission requirements, and the implementation of a risk assessment for agrochemicals is be expected in the future. We are also waiting for the new fertiliser registration law in Vietnam, and we anticipate that Myanmar will be an interesting market for all types of chemicals,” Dr Kahl says. KTR’s Mr Lee has also observed a shift in chemical product export/import regulations away from a focus on chemical properties in isolation and toward a consideration of the impact of exposure to the chemicals as well as their hazardous properties. “We are seeing regulations that require the assessment of both the hazards and uses of chemicals and then establish controls based on the potential effects of the chemicals on the users,” he says. NCEC’s clients are often challenged by import laws in Asian countries, says Mr Haggarty. “In China, for example, it is critically important that companies that import into, or manufacture in, China include an approved domestic 24-hour chemical emergency response number on the import/manufacturing licence application or it will likely be refused,” he says. NCEC, for example, can provide domestic numbers in China through its agreement with the National Registration Centre of Chemicals (NRCC) in China,” he says.
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Co-operation with global service providers is the most common approach to providing domestic emergency response numbers and details, although some firms have established relationships with domestic partners in each country. Acta, for example, is working closely with the authorities in China and emergency response number service providers to obtain additional guidance for industry by resolving and clarifying conflicting information, identifying and securing answers for the remaining unknowns and ensuring that entities providing such services do so in a manner that diminishes rather than increases a company’s potential liability, according to Leslie MacDougall, director of regulatory affairs with Acta. As the above issue with emergency numbers illustrates, working with Asian authorities does in fact remain challenging from the perspectives of both language and culture, although there have been some improvements. “We have found that working with a network of local experts is the best approach,” says Intertek’s Mr Thouin. Knoell Consult’s Dr Kahl has also found that personal relationships are very important; emails generally receive delayed responses or are not answered at all, so phone calls to personally known representatives in each country is most efficient. “For countries where we do not have local employees, we have found that the use of local contractors or co-operation partners is an effective workaround for obtaining reliable information in a short time,” he says. As a chemical manufacturer, AkzoNobel has experienced improved interactions with Asian authorities. Although the situation is challenging, it is improving as authorities gain more experience in consulting with industry to ensure that their regulations are fit for purpose and are practical, says the company. There is also general agreement in particular that interactions are improving in South Korea. “As regulations are becoming more user oriented, the opinions of chemical substance users are becoming more important. The recommendations of a public consortium consisting of representatives from government, industry, academia, NGOs and SMEs, which was formed in order to make K-REACH as realistic and sensible as possible, were presented on 27 December 2013 and will be implemented in decrees as part of K-REACH,” says Mr Lee. REACHLaw’s Mr Rinta-Jouppi adds that the increasing use of IT systems for the submittal of regulatory information and for the authorities to manage this information is also slowly improving the situation. Web-based search systems are also making it easier to access national chemical inventories, although some countries have more advanced software than others. In cases where online databases are not available or are incomplete, Dr Knoell Consult Thai makes direct contact with the responsible authorities in order to determine whether or not a substance is listed, often with the support of its subsidiaries or local co-operation partners. However, the use of an online tracking system is necessary to ensure that the latest information is being used, says Mr RintaJouppi of REACHLaw. Translation of regulatory documents is yet another challenge for international companies working in Asian countries. Asian authorities typically do not produce regulatory documents in foreign languages, and thus companies must produce their own translations of the documents. However, many Asian languages are nuanced in the spoken and written form, and while it is crucial to ensure accurate translation, it is challenging to do so. Translators are
Chemical Watch | Global Service Providers Guide 2014
Chemical service providers
needed that both know the language and are knowledgeable of the regulations,says Acta’s Ms MacDougall. “It is not easy to produce a translation that is 100% identical with the original document,” agrees KTR’s Mr Lee. “It is therefore wise to use translated documents only as references, and to submit enquiries to the appropriate authorities if there are any questions about the meaning of the regulations,” he says. NCEC’s Mr Haggarty adds that access to a local partner network can be invaluable. “Through our network, we are able to obtain direct translations of regulatory texts, but more importantly, an interpretation of the regulations and often direct experience in how to meet the requirements.” Once the requirements are understood, many service providers and their clients attempt to streamline Asian country registration efforts by using data that was previously generated for REACH. Such an approach can be effective in some cases. “Most authorities will accept a sound scientific justification, but a simple reference is not sufficient; the scientific arguments must be outlined and related to the specific country regulation,” says WIL Research’s Mrs Boivin. However, it should be noted, says Dr Knoell Consult’s Dr Kahl, that unlike ECHA, some competent authorities in Asia are hesitant to accept a read-across approach or deviations from standard requirements, even though they are scientifically well justified. In addition, it is important to know that data that was prepared by a REACH substance information exchange forum (Sief) cannot be freely used for registrations in other countries, but must be purchased, which can for some companies be uneconomical, says KTR’s Mr Lee. Furthermore, many Asian countries (China in particular) do not accept European test data and require that animal and ecotoxicity testing be conducted domestically
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following specified procedures, according to Dr Locatelli of REACH mastery. “Our toxicologists have found numerous inaccuracies in the Asian protocols and procedures, and the need for these duplicate tests is in our opinion a real loss of time and money,” she says. The issues associated with the sharing of data for compliance with different national regulations are not limited only to Asian countries, according to Acta’s Ms MacDougall. “It would be helpful as global regulatory programmes become more aligned, for mechanisms within the regulatory framework to allow for letters of access to be submitted with a robust study summary in lieu of a full study report, or that the data owner be able to submit the full study report to the authority without sharing with the registrant. It is also important to recognise that authorities must ensure that the full study reports made available to them are not published so as to not impact the value of the data. Unless an authority has appropriate mechanisms to ensure that full study reports are maintained in a controlled environment and kept for internal use only, industry will continue to be reticent in sharing full study reports with the authority,” she says. There are also issues for Asian suppliers selling products into the European market. One of the biggest relates to SVHCs as defined by REACH. “Distance is one of the biggest factors here. Suppliers in Asia lack any sense of urgency and don’t recognise the need to be concerned about SVHCs,” says Intertek’s Mr Thouin. Acta’s Ms MacDougall does not find the specific supplier location an issue, but does say that understanding the complexity of the supply chain prior to a substance, particularly an SVHC, entering the EU, is important for determining additional management and reporting requirements. “Confidentiality
Chemical Watch | Global Service Providers Guide 2014
ability of the international regulated community to work with Asian regulatory authorities appears to be improving to some degree in most countries. However, it remains quite challenging for international manufacturers, importers and users of chemicals to stay up to date with changes to regulatory requirements and ensure that they are in compliance. Based on the experience of service providers working in this region, to ensure success, it is imperative to work closely with local experts in each country of interest.
Key country regulatory highlights in 2014 Europe OO
OO
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The first decisions on substances evaluated under the Community Rolling Action Plan are expected early April. By the end of the year, ECHA hopes to have reached agreement on all substances evaluated under the 2012 Corap. In March, the list of 2014 Corap substances will be published. February saw the REACH authorisation applications deadlines for hexabromocyclododecane (HBCDD), and related compounds, 2,4-dinitrotoluene (2,4-DNT) and tris(2-chloroethyl)phosphate (TCEP). In February ECHA published its fifth list of substances prioritised for authorisation, including N,Ndimethylformamide (DMF), diazene-1,2-dicarboxamide (C,C’-azodi(formamide)) (ADCA), two types of aluminosilicate refractory ceramic fibres, and an octylphenol ethoxylate. Proposals for substances to be added to the REACH candidate list will be consulted on in June and December In February ECHA published its annual evaluation report. In June ECHA will publish a report on the status of implementation and use of non-animal test methods and testing strategies used to generate information for REACH. In July, ECHA should publish its sixth list of substances recommended for prioritisation for authorisation under REACH. Throughout the year, new processes will start relating to the biocidal products Regulation, already six consultations have begun on candidates for substitution. The prior informed consent Regulation, which applies the Rotterdam Convention on the shipment of hazardous substances in the EU, came into operation on 1 March. On that date, ECHA assumed new responsibilities. An EDC roadmap covering an overarching strategy and criteria for identifying substances with adverse endocrine properties are expected later in the year. European Commission is working on proposals to amend the REACH Annexes on standard information requirements to better account for nanomaterials. The proposals are expected to be discussed by the EU REACH Committee after the summer. The Commission is also working on an impact assessment of an EU inventory of nanomaterials, which is expected to be completed by the end of the year.
Chemical Watch | Global Service Providers Guide 2014
OO
OO
Meanwhile, France published its nano inventory for the first time in January. Denmark and Belgium are moving ahead with national plans too. As anticipated by its Recommendation of 2011, the EU executive is also reviewing the definition of nanomaterials.
US OO
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EPA to revisit by mid-2014 confidential business information claims made under TSCA. The agency is planning to establish regulations that would require CBI claims made under TSCA to be reasserted and resubstantiated periodically. EPA to initiate a review of critical factors that have an impact on the effectiveness of its risk assessment methods for work plan chemicals. US House of Representatives to introduce TSCA reform bill in spring. California to kickstart regulatory process for its Safer Consumer Products Regulations with the publication of a draft priority products list by April. 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. Companies will be working to update chemical classifications and safety data sheets to meet next year’s deadline for compliance with Osha new GHS hazard communication standard.
Canada OO
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Canadian government to introduce amendments to the hazardous products Act and other regulations to align country’s workplace hazard communications rules with the GHS. Canadian regulators along with their US counterparts to use nanomaterial classification scheme developed by the Regulatory Co-operation Council in regulatory decision making.
China OO
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The revised Catalogue of Hazardous Chemicals may be published this year, triggering requirements under several new or recently amended laws for those substances included. A draft was issued in September 2013. Two new and 26 revised mandatory national standards on classification and labelling that align the
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of supply chains is a significant issue, and we have found that working with independent third parties under the terms of a non-disclosure agreement (NDA) is beneficial,” she adds. KTR’s Mr Lee also notes that it can be very difficult to get SVHC information for components manufactured in Asia, particularly from smaller suppliers that do not themselves export to Europe. In some cases, although official declarations are provided for products, analytical testing of batches has shown that SVHCs are present. Clearly, chemicals management control regulations in Asian countries are improving, and at the same time the
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Malaysia OO
Taiwan OO
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Provisions for the registration of designated priority substances, included in the amended Toxic Chemical Substances Control Act (TCSCA) adopted at the end of 2013 will come into force in December. Companies get a second chance to submit chemicals for supplemental inclusion in the existing substances inventory. Substances not on the inventory will qualify as new substances, and must be registered 90 days before they are placed on the market.
Japan OO
The Ministry for Health, Labour and Welfare (MHLW) wants to increase the number of substances subject to mandatory GHS labelling and risk control measures six-fold to 640 by amending the Industrial Safety and Health Law. Proposed draft amendments to the law may be submitted in the coming months.
South Korea OO
Government decrees implementing the Act on the Registration and Evaluation of Chemicals (K-REACH) are due to be adopted in September and come into force on 1 January 2015, the same date as K-REACH enters in force.
The extension of the requirement under the Occupational Health and Safety Act (Osha) to submit hazard and risk assessments for new chemicals also apply to existing chemicals from 31 March.
Under the Regulations on classification, labelling and safety data sheets for the use of hazardous chemicals in the workplace and industry (CLASS), adopted last October, companies must submit a list, or inventory, to the labour ministry’s Department of Occupational Safety and Health of all the hazardous chemicals they handle in annual quantities of at least one tonne by 31 March 2015, and each year thereafter. The regulations also require formulators, manufacturers and importers to classify hazardous substances and mixtures, and compile safety data sheets, in accordance with a list of classified chemicals set out in an industry code of practice. However the code has yet to be published. The Regulations are mandatory for substances one year after they enter into force, and for mixtures after three years.
Turkey OO
The classification and labelling regulation (SEA) adopted in December aims to align the country’s regime with the EU CLP Regulation. It requires chemical manufacturers and importers to notify substances present on the market before 1 June 2015, either on their own or in a mixture, to the Turkish C&L inventory between 1 June 2014 and 1 June 2015. Substances must be classified and labelled according to the SEA’s criteria regulation from 1 June 2015, and mixtures from 1 June 2016 but, as under CLP, a two-year transition period for products placed on the market before these dates, will apply to prevent products having to be re-labelled.
New European biocidal product Regulation: complexity driving demand for external expertise Biocides (non agricultural pesticides) – known as antimicrobials in the US – prevent the contamination of numerous types of products from microbial growth. They help maintain the sterility of surgical instruments and medical devices and help prevent the spread of infectious diseases in hospitals and other health facilities. They also play a critical role in maintaining the purity of potable water supplies and ensuring that the production equipment and facilities used to produce foods and pharmaceuticals remain free of harmful micro-organisms. They are included in most water-based products, such as cosmetics and paints, to prevent contamination and act as both disinfectants and preservatives in antimicrobial soaps, wipes and cleaners/detergents. As in many industries, consumers are becoming more educated about health and safety issues and are demanding more sustainable products that pose reduced risks for both themselves and the environment. Because biocides are designed to control microbial growth, it is challenging to develop products that are highly effective only when and where they are needed. For example, as the durability of paints and coatings increases and lifecycles are extended from just a few years to as many as ten or more, it is necessary to incorporate biocides in the paint film such that they will not be leached over time and cause harm to the environment surrounding the coated surface. Chemical Watch | Global Service Providers Guide 2014
The demand for “greener” biocide solutions is increasing and will remain a major driver in the paint and coatings and other markets for the foreseeable future, says David Tierney, head of global sales for Lonza Industrial Solutions. For example, in the architectural coatings market, “green” labels and certifications will become increasingly important for consumers, including do-it-yourselfers and contractors, he says. Most biocide manufacturers are responding by developing new controlled release technologies, which can decrease leaching of the active material and extend the duration of protection, as well as potentially enable the use of less active substance, which in turn can reduce the environmental impact and lower the cost in use. On the other hand, the development of entirely new biocidal actives based on new chemistries has been extremely limited over the past several years due to the very high cost of registering new biocides with the relevant regulatory agencies around the world, which can range from $6-10m, says Mr Tierney. Most new products, therefore, consist of blends of different actives approved for that application. More recently, companies have also begun evaluating biocidal actives approved for one set of applications to determine if they are effective in other end uses. One of the regulations contributing to the high cost of registering a new biocidal active has been the EU biocidal Page 21
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requirements with the fourth revised edition of the UN Globally Harmonized System (GHS) come into force on 1 November 2014. Changes to Guidelines for the registration and evaluation of new cosmetics ingredients take effect on 1 April 2014. The system will move closer to the system for new chemical substance notifications.
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Chemical Watch | Global Service Providers Guide 2014
complex articles under the BPR, is an unnecessary challenge and could have been avoided or at least helped by more clarification and guidelines in the legal text, say an executive of a leading speciality chemicals producer. There are also questions about borderline cases where it is not clear whether the BPR, or another law applies, says TÜV SÜD’s Dr Reiml. Meanwhile, the need for national authorisations for products under revision has been an issue for clients of Reach mastery, and Chemsafe’s Dr Cabedo finds getting the required letters of access to data and conducting risk assessments can present obstacles. There is also some concern that implementation of the BPR in Europe will affect the availability of some products. Mr Fraysse of Equitox is concerned that SMEs won’t be able to afford the higher cost of letters of access to data and will find it very difficult to comply with testing requirements, and thus won’t be able to remain competitive with larger companies. “However, while the market is dominated by large manufacturers, it is the smaller companies that actually do a lot of the selling,” says Dr Cabedo. Dr Staab of REACh ChemAdvice also expects that the BPR will make it harder for companies that import raw materials from outside of the EU to find suppliers. Of course, all of this work must be carried out in conjunction with compliance efforts related to REACH and CLP in Europe and all of the other national and productspecific regulations. As a result, one of the greatest challenges, according to ReachCentrum, is for companies to be compliant in a cost-efficient and timely manner while fully respecting competition law and given that every change in a product formulation affects their compliance efforts. More companies are responding by putting more effort into developing the right product definitions for their biocides and taking a global regulatory approach to product stewardship, using, where possible, the data from one regulatory source, such as the BPR or REACH, and trying to maximise the use of this data in as many places as possible, says WIL Research’s Mrs Boivin. One leading speciality chemical manufacturer, for example, is finding that the biggest challenge in complying with the BPR is avoiding labelling requirements under CLP. Looking at this issue from a wider perspective, REACH mastery’s Dr Locatelli wonders how the BPR will affect the development of new biocides and how the market will be able to respond if/when biological adaptation occurs and current actives are no longer effective. “It seems that in some cases the need for new biocidal actives may develop more rapidly than implementation of the regulation. In the end, therefore, a lot of money will be spent on products that may very well be off the market in as little as 20 years,” she says.
Careers and salary survey
Positive outlook for chemicals management and control jobs market With national substance notification and hazard communication regulations being implemented around the world and work beginning on the final and likely most onerous REACH deadline in 2018, plus several sector specific regulations requiring special expertise, it is not surprising that demand for people with skills and experience dealing with chemicals management and control issues remains fairly healthy.
Chemical Watch | Global Service Providers Guide 2014
In fact, 2013 was the best year in terms of sales for European firm Nonstop Recruitment, according to Abid Kanji, country manager and specialist recruiter for toxicology, ecotoxicology, and regulatory affairs. The assessment of John Sherratt, business manager with placement firm VRS Regulatory, is that in the UK and Europe, overall demand for regulatory personnel continues to outstrip supply. “The upcoming deadlines for REACH and CLP and the BPR, plus
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Chemical service providers
products Directive ((Directive 98/8/EC). This was replaced in May 2012 by the biocidal products Regulation (BPR, Regulation (EU) 528/2012), which came into force on 1 September 2013, with certain provisions being phased in over time. The intent of the BPR is to improve the European single market for products containing biocidal active substances and reduce the risks to human health and the environment posed by these products. As with the BPD, under the BPR, active biocidal substances must be approved for use in a particular application and biocidal products containing those actives must be authorised. While the BPR seeks to create a more efficient approvals process for the EU, it also introduces new provisions regarding treated articles, nanomaterials and food contact materials. As a result, the BPR has led to an increase in demand for chemicals management and control services, particularly for companies that have had a previous focus on biocides and the BPD. “We experienced a significant increase in enquiries concerning biocidal products, with many coming from smaller, niche, companies who are particularly challenged by the requirements of the new BPR,” says Bibra’s Mr Copestake. Like REACH, the BPR is a complex piece of legislation, he says, and many companies lack the resources or expertise in-house to manage the legislation. As a result, he anticipates the heightened demand to continue in 2014. “The fear is that many smaller companies will just not see the costs involved in complying with the regulation as being commercially viable.” KFT Chemieservice’s Dr Torges adds that there is much uncertainty surrounding the BPR and information is missing, and many companies are not well informed or do not believe the extent of the requirements under the new Regulation. Smaller clients in particular seem to remain unaware of the BPR, or are not informed about the additional requirements related to treated articles. Most service providers have been busy training and educating people about the various aspects of the BPR. “There has been limited awareness, and we have worked to educate our clients, making a particular effort to ensure that each audience receives the appropriate information,” says Mrs Boivin of WIL Research Europe. One group that has needed particular attention is EU companies importing and non-EU companies exporting treated articles into the EU, says REACh ChemAdvice’s Dr Staab. Treated articles are a challenge for many companies, says Chemservice’s Dr Drohman, because the definition of a treated article is not completely clear and gaining access to needed data to make a determination can be difficult. The communication around treated articles, particularly
Chemical service providers
the overall growth in the chemicals sectors, are having a very positive impact on the job market for chemicals management and control personnel,” he says. In 2013, environmental fate specialists and ecotoxicologists were once again in greatest demand, as was the case in 2012, some of which Mr Kanji attributes to demand for external testing and some to the movement of individuals. The situation was not so bright, however, for people with REACH experience who were looking to change positions following the May 2013 deadline. That should change in 2014, though, as Mr Kanji agrees that more REACH and CLP activity will lead to the creation of new positions in these areas. There should also be steady demand for toxicologists and agrochemical compliance specialists, but he does not expect to see an increase in demand for regulatory personnel in the cosmetics sector. In addition, he notes that much of the job growth will take place in the UK and Belgium, with little happening in Germany due to the slowdown of the economy there. In the US, the chemical sector is beginning to recover after several very quiet years, and many companies are switching from a focus on cost control to one of investment, and as a result there is a pent up demand for all types of employees, according to Patrick Ropella, chairman and CEO of executive search and consulting firm Ropella. “We expect that growth will take off in the coming years, and companies will be in need of people with expertise in all areas of business operations, from business development to regulatory to logistics,” he says. Specific industry sectors that are seeing higher than average growth in the US include oil and gas, largely due to hydraulic fracturing, biobased chemicals production and agrochemicals, particularly those that are more active and can help increase yields in harsher climates. The chemical industry and many allied sectors have a challenging time ahead, though, according to Mr Ropella. A large portion of the current workforce, he says, is from the baby boomer generation, and many of these people will be retiring within a few years of one another and taking much of the industry’s knowledge with them. At the same time, fewer young people are choosing to enter the fields of importance to the chemical and manufacturing sectors, so there will be a smaller pool of new recruits to fill those positions. For the present, however, Mr Ropella does not see the impending shortage affecting salaries, which are rising only slowly, except in cases where people with a particular skill set are in high demand, such as in the textile industry, which is bringing manufacturing back to the US in order to leverage new technologies developed in North America that innovators are unwilling to take to Asia due to concerns over threats to IP protection. “With respect to regulatory personnel, demand is currently tracking with the growth of the economy, and we except that trend to continue,” he adds. In the lubricants industry, the number of companies seeking to fill chemicals management and control positions has increased in recent years, says Natalie Tidbury, senior recruitment consultant for lubricants and additives with Oil Recruitment. Most of the positions, she says, are for toxicologists, and companies can have trouble filling them because the salaries are not what skilled candidates are looking for. She does see some companies responding by looking for people with REACH and related experience, even for general positions.
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Staffing and job satisfaction trends For the second year in a row, Chemical Watch asked survey respondents working within industry and as service providers to share information about their salaries and career prospects. Below we summarise the results from the latest survey, and where it makes sense, compare them with those obtained for the 2012 survey. First, we wanted to know if the size of regulatory teams changed last year, and what is expected for the next 12 months. The numbers were very similar in both cases, with close to 55% of respondents indicating that no change occurred and no change is expected (Figure 3). It should be noted, though, that fewer survey respondents expect staffing levels to decrease over the next 12 months than actually did in the previous 12 months, which is in agreement with the predictions for growth in demand for regulatory experts to meet the requirements of REACH, CLP and other laws. DHI, according to Dr Tørsløv, intends to increase its staff in 2014, and is just one of many service providers that plan to do so. Separately, it is interesting to note the experience of the Shepherd Color Company, a manufacturer of pigments. In 2013, in response to the high level of customer inquiries that the company was receiving about regulatory issues, Shepherd created a full-time position with the responsibility of managing these information requests, says marketing manager Mark Ryan. Figure 3 Staffing trends 100% 90%
7.8%
12.2%
80% 70% 60%
57.4%
53.9%
50% 40% 30% 20%
33.9%
34.8%
Last 12 months
Next 12 months
10% 0%
Decreasing
Static
Increasing
There are some companies facing budget issues, however, according to NCEC’s Mr Haggarty. “An annual survey of our customer base revealed some uncertainty about future prospects, with more than half of respondents facing noteworthy budget constraints and one in seven either going through or expecting an imminent reorganisation of their department,” he says. Importantly, though, despite this uncertainty, his customers remain upbeat about the areas in which they work, with nearly three quarters continuing to feel positive about the impact of chemical regulations.
Chemical Watch | Global Service Providers Guide 2014
Figure 4 Job prospects 100%
4.7%
10.1%
90% 80%
38.1%
70%
48.9%
60% 50% 40% 30%
57.2% 40.9%
20% 10% 0%
In your country Poor
Stable
Globally Good
With respect to career progression, survey respondents also saw greater opportunities across the wider jobs market than they did within their own companies, with 63% seeing good prospects in the overall market and just 35% feeling positive about their chances of moving to a better position if they stay with their current employer (Figure 5). Notably, nearly a quarter of survey participants feel that their
opportunities for advancement are actually poor if they don’t move elsewhere. “In 2014 and coming years,” says Dr Staab of REACh ChemAdvice GmbH, there will be an increasing demand for professionals in regulatory areas related to REACH and CLP. Their jobs will be secure and there will be opportunities for career development.” This sentiment is reflected in the results of the Chemical Watch survey (Figure 4, Job Prospects and Figure 5, Career progression opportunities). Nearly 41% of respondents believe that job prospects are good within their country, while only 10% see them as being poor (Figure 4). The numbers are even more positive when survey participants consider global opportunities; 57% see global job prospects as being good, while just 4.7% gave a negative view. Notably, these results are similar to those obtained in 2012 (43%/10% and 59%/4% of survey respondents thought their job prospects were good/bad in their country and globally, respectively). The outlook of Acta’s Ms Bergeson supports these results. “Chemical management professionals are very much in demand if they are good, creative, and efficient,” she says. “The demand is great for chemical product stewards that are proficient technically and versed in global chemical product regulation, particularly in the EU, Asia, and South American geographic areas. This need will not decline in 2014, and professionals that keep abreast of developments, both regulatory and science policy related, will experience job security and job satisfaction given the tremendous interest these regulatory programmes are inviting.”
Chemical service providers
survey participants felt as secure in their jobs in 2013 as they did the previous year (Figure 6).
Figure 5 Career progression opportunities
Figure 6
100%
6.5%
90%
24.7%
80%
30.3%
70%
60%
63.2%
30%
50%
66.9%
67.6%
22.4%
20.3%
In own role
Across all roles
40%
35.2%
10%
12.1%
70%
40%
20%
10.7%
80%
40.1%
50%
30% In your country Poor
Stable
Globally Good
WIL Research’s Mrs Boivin also expects that people working in chemical management should have job security for the upcoming years. “With the increasing complexity in the field of regulatory compliance (not just in chemicals, but also in agrochemicals, biocides, etc.), companies adhere to their specialists in this field, and job changes at the level of senior regulatory affairs managers are limited. The Chemical Watch survey results support this belief. Both when considering their own roles and all roles, 67% of Page 26
100% 90%
60%
0%
Job security compared with 12 months ago
20% 10% 0%
Less secure
Similarly secure
More secure
With respect to job satisfaction, 60% of survey respondents said they were satisfied with their work, with 27% taking a neutral position and just slightly under 13% indicating that they were unhappy with their positions (Figure 7). These numbers should not be surprising, Chemical Watch | Global Service Providers Guide 2014
Figure 8 Average salary by job title Business management/development 44.9 Consultant 44.9 EHS management
Figure 7
44.1
Job satisfaction
Other Dissatisfied 12.6%
45.2 Product safety/stewardship
Satisfied 59.9% Neither satisfied or dissatisfied 27.5%
Regulator 38.7 Regulatory affairs management 46.0 Toxicologist/chemist/scientist 38.7 Average salary
Salary trends The results of the Chemical Watch salary survey include the responses of people in a wide range of positions. We are grateful that they were willing to share this information, which has again enabled us to provide useful data on salaries, pay rises, and bonus levels in the global chemicals management and control community. Of the survey participants, 32% were specialists/ technicians, 29% were project/team managers, 24% were senior managers, and 11% were directors/associate partners. Juniors/trainees government officers each accounted for 4% of the respondents. The average salary is broken out by job title in Figure 8. The range of average salaries was surprisingly small, covering €38,700 to €46,000, with regulators and scientists earning the least, and regulatory affairs managers and consultants earning the most (Figure 8). There is, however, more variation in average salaries when considering the type of organisation (Figure 9). Survey respondents working in “other manufacturing” earned the highest average salary (€45,800), followed closely by participants with positions in the chemical and allied industries (€45,600) and with service providers (€44,000). People working for consumer product companies and trade associations earned the lowest average salaries (€38,600 and €39,800, respectively), other than those who placed themselves in the “other” category (€38,500). There was not much difference in average salaries when considering company size, although they did trend higher in larger companies. Participants at companies with over 250 employees earned an average of €44,700, while those at medium-sized organisations with 50-250 employees earned an average of €42,700, and those at firms with less than 50 employees earned an average of €41,600.
Chemical Watch | Global Service Providers Guide 2014
43.9 0
10
20 30 Euros 000s
40
50
Figure 9 Average salary by organisation type Chemicals, life sciences and similar 45.6 Consumer products, cosmetics and similar 38.6 Engineering, automotive, aerospace and similar 39.7 Government & agencies 43.5 Other manufacturing 38.5 Other 45.8 Service provider, including consultants, laboratories, lawyers etc 44.0 Trade association or professional body 39.8 0
10
20 30 Euros 000s
40
50
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Chemical service providers
according to Bibra’s Mr Copestake. “The demand in recent years for good quality but pragmatic advice has meant that our own company has been able to incrementally expand, but the challenge has been to successfully manage and train staff to a level that satisfies and builds on the integrity and reputation of the consultancy. However, working with a diverse range of clients, operating in various sectors, and dealing with the many faceted challenges of chemical control legislation and risk assessment, there is no concern about loss of significant job satisfaction,” he says.
Chemical service providers
Interestingly, company location has a significant impact on earning potential based on the results of the Chemical Watch survey (Figure 10). Those respondents lucky enough to work in Europe received the highest average salaries by far, earning an average of €51,300. Professionals in North America, meanwhile, earned on average only slightly better than two thirds as much as their European counterparts (€34,500), which was barely above the average annual salary of €33,000 in the rest of the world, not including Europe, and way below the overall average.
Figure 11 Average salary by age 21-25 31.3 26-30 34.9 31-35 45.6
Figure 10
36-40
Average salary by job region
48.7
Europe
41-45 51.3
45.6 46-50
North America
47.3
34.6 51-55
Rest of world
46.5
33.0
56-60 43.8
Average 43.9
61-65 32.1
0
10
20
30
40
50
60
>65 25.2
Euros 000s Salaries also varied somewhat with the age of the respondents, which isn’t surprising (Figure 11). However, it is interesting that survey participants aged between 31 and 60 all earned within a narrow range (€45,600 to €48,700), with those 36-40 years old earning the most. The oldest survey respondents earned the least, which is not unusual, considering that many people in that age bracket are semiretired. Survey respondents just entering the workforce earned an average salary of €31,300. Unfortunately but perhaps unsurprisingly, the average salary earned by women was slightly less than that earned by men (€42,300 vs. €45,200, respectively). For survey respondents who did not receive a promotion in 2013, the average pay rise was 2.2% and ranged from 1.6% in Europe to 2.1% in North America and 5.1% in the rest of the world, reflecting the stronger economies and lack of skilled regulatory personnel in these areas (Figure 12). In addition, just over two thirds of Chemical Watch survey respondents earned an average bonus of 10.8% in 2013. Participants in Europe and North America earned bonuses close to the average (~10%), while those located in other parts of the world received much higher average bonuses of ~16%.
0
10
20
30 Euros 000s
40
50
60
Figure 12 Average pay rise Europe 1.6 2.1 6.0 North America 2.1 2.8 6.9 Rest of world 5.1 6.8 10.4 Average 2.2 2.9 7.3 0
2
4
6
8
10
12
% Only promotions
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Including promotions
Excluding promotions
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Chemical service providers Chemical Watch | Global Service Providers Guide 2014
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Chemical Watch | Global Service Providers Guide 2014
SERVICE PROVIDERS
Outlook for chemicals management and control service providers
100% 90%
35%
80%
Training Other 8.0% services 0.8% Information
36%
70%
53%
49%
25%
31%
8% 4% 7% 2013
60% 27%
25%
30%
13%
15%
20%
10%
12%
15%
12%
8% 6% 8%
2010
2011
2012
50% 40%
0%
Services retained by participants
3.0%
Percent of chemical management work performed by in-house teams
10%
Figure 13
IT & software 6.4%
Figure 14
80-100%
60-80%
20-40%
0-20%
40-60%
Figure 15 Consultancy 27.1%
Representation & management 2.5% Legal 4.5% Laboratory 47.7% It should also be noted that, according to Chemical Watch survey respondents, on average, 73% of chemical management work in 2013 was performed by in-house teams, a proportion almost the same as in 2012 (72%) (Figure 14). The continued higher rate of in-house spending most likely continues to reflect the fact that recovery from the recent recession is occurring at a very slow pace. The trend toward establishing separate compliance divisions that was observed in 2012 also continued in 2013, which can be attributed to the ever-increasing complexity of global regulatory requirements related to chemicals management and control. Slightly over one and a half as many survey respondents reported that their companies were separating compliance responsibilities compared to those that were integrating compliance activities with overall management responsibilities (Figure 15).
Chemical Watch | Global Service Providers Guide 2014
Integration changes at survey respondents over the last 5 years Move towards general management 19%
Remained the same 50%
Move towards separate compliance divisions 30%
The large demand for laboratory services seen in Figure 13, however, reflects a fairly significant change in the distribution of spending on services by Chemical Watch survey participants, which was not the case from 2011 to 2012 (Figure 16). The increased demand for testing services in 2013 came at the expense of representation and management, IT/software, legal, information and other services.
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Chemical service providers
In 2013, the main drivers for services related to chemicals management and control were connected with registrations for the second REACH deadline, for which less data was already available, and dossier updates in response to ECHA evaluations of 2010 REACH registrations, which required the generation of missing data. Some companies were also working on 2018 REACH registrations, while many were gathering information for the numerous other regulations that now require much more extensive chemical property data. It is thus not surprising that laboratory testing was by far the largest type of outsourced service in 2013, with nearly 48% of the respondents to the Chemical Watch survey using external testing labs (Figure 13). Consultancy services were also used extensively, with 27% of survey respondents hiring this type of service provider. Training and IT/software assistance were also needed, but to a much lesser degree (8% and 6.5%, respectively), and information, representation, and legal services were used by less than 5% of survey respondents.
Figure 16
Figure 17
Changes in the proportion of spending on provider service types 100% 90%
Chemical service providers
80% 70%
9% 7% 4% 13%
60%
16%
50%
4%
40%
18%
30% 20% 10% 0%
30%
2010
0% 7% 8% 13%
33%
1% 8% 3% 6%
3% 10% 7%
Frequency of service retention by survey participants
Consultancy/advisory 11%
28%
Representation & management 4% 12%
12% 48%
29%
51%
33%
Legal services 5%
15%
57%
Laboratory 8%
6% 7%
4% 2%
24%
26%
27%
8%
2011
30%
40%
IT & software solutions 13%
18%
41%
Information services 2012
2013
Other services
Laboratory
Training
Legal
Information
Representation & management Consultancy
IT & software
8%
Regardless of the type of chemicals management and control service, the majority of Chemical Watch survey respondents seek outside assistance on an occasional basis (33-57%), rather than on a frequent (9-30%) or permanent (4-13%) basis (Figure 17). Consultancy, laboratory and information services are the most likely to be used on a frequent or permanent basis by survey participants.
Are service providers meeting customer needs? As chemicals management and control regulation has become more prominent around the world, the demand for support from external service providers has grown globally. Despite the continued preference to use in-house regulatory personnel at larger companies, SMEs by definition will need to rely on service providers. Even large companies will look to external assistance for certain compliance requirements given the specialised nature of the skills required, such as paint and speciality chemical manufacturer AkzoNobel, which uses contract research organisations to conduct studies that it does not have the capability to do in order to obtain data required for dossiers needed for substance registrations or to conduct testing in certain countries (particularly China) that require the use of domestic laboratories. However, while the outsourcing of chemicals management and control activities will continue, clients are becoming more sophisticated and better able to determine if they are receiving good value from their service providers, and those that are not satisfied will look elsewhere.
12%
24%
41%
Training 4%
24%
54%
Other services 5% 9%
39%
0%
100%
% of participants
Permanent
Frequent
Occasional
In fact, service providers should take note that the number of Chemical Watch survey respondents that have been satisfied with their service providers has been steadily declining over the past four years from 88% in 2010 to just 71% in 2013 (Figure 18). Fortunately for providers, the number of actually dissatisfied survey participants has remained quite low at 2-3%. However, the fact that the number of survey respondents that consider themselves to be neither satisfied or dissatisfied has tripled from 9% to 27% over that period should be a warning to service providers that they have some real work to do. Figure 18 Change in overall satisfaction levels for survey respondents 100% 90%
3% 9%
80%
3%
2%
2%
19%
25%
27%
78%
73%
71%
2011
2012
2013
70% 60% 50% 40%
88%
30% 20% 10% 0%
2010
% of participants Dissatisfied
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Neither
Satisfied
Chemical Watch | Global Service Providers Guide 2014
Figure 19
Figure 20 Satisfaction levels of survey participants with prices charged for services Dissatisfied 13%
Satisfied 31%
Chemical service providers
When comparing the satisfaction levels of Chemical Watch survey participants in 2013 and 2012 for specific performance criteria, most declined, but the greatest change was only four percentage points (Figure 19). Survey respondents were happier with provider availability in 2013, but less satisfied with the experience/knowledge of the service providers they used, as well as their flexibility, price, and ability to not only provide value for money, but add value beyond the agreed deliverables. Looking more closely into the question of pricing, the trend to lower satisfaction levels observed for the last two years continued, according to the Chemical Watch survey results (Figure 20). Only 31% of survey respondents in 2013 were satisfied with the price they paid for external chemicals management and control services, which is down from 33% in 2012 and 41% in 2011.
Neither 57%
Satisfaction levels in 2013 and 2012 Availability
57% 53%
Personal relationship
Figure 21 Interest level of survey respondents in changing suppliers
61% 60%
100%
Experience/knowledge in all countries in which you operate 39% 43% Offering flexibility
45% 48% Adding value on top of agreed deliverables 31% 34% Technical knowledge Providing value for money
Meeting your brief
0%
46%
39%
47%
44%
44%
48%
60% 50% 40% 68% 68%
30%
48%
51%
20% 41% 44%
10% 0%
56% 57% 64% 62%
% of participants satisfied 2012
80% 70%
Price of service
31% 33% Delivering on schedule
90%
100%
2013
Service providers may take heart, however, that the percentage of survey participants that do not have any interest in changing their current service providers remained at a level similar to that in 2012 (44% vs. 47%, respectively) (Figure 21). But they cannot afford to be complacent as more than half of respondents (55% in 2013) did indicate that they intend to or may change their suppliers.
Chemical Watch | Global Service Providers Guide 2014
6%
10%
9%
7%
2010
2011
2012
2013
No
Possibly
Yes
Survey respondents noted several factors driving them to look for alternative service providers. In many cases, companies are expanding into new geographic markets/countries or new business areas, and their current providers do not have the expertise to assist with regulatory compliance in those areas. Others were clearly unhappy with the quality and/or timeliness of the services they were receiving, while others did not feel they were getting good value for their money. Still others were looking for a service provider with a more global reach and more depth of capabilities (one-stop-shop idea). Selection of external service providers is a major decision for companies that manufacture, store, transport or use chemicals but do not have the internal resources to ensure compliance with chemicals management and control regulations. A poor choice can lead to a range of consequences, from small fines for late notifications to missed market opportunities that can never be recovered. For respondents of the Chemical Watch survey of chemicals management and control professionals, the expertise of the staff, the level of in-depth knowledge
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Chemical service providers
of country specific regulations, and proven experience on similar projects were the top three factors driving the choice of external service providers (Figure 22), with expertise being the topmost important criteria for 86% of survey participants. 54% of respondents indicated that proposal quality and provider availability are important, and around 45% said that the ability to operate on a global scale and having appropriate certifications are characteristics of good service providers. Many companies looking to use external service providers have established an extensive selection and audit procedures in place to ensure that they choose firms that provide quality results. Clients with such systems in place tend to be satisfied with the performance of their service providers. Figure 22
Once a service provider has been selected, in order to achieve the maximum performance possible, it is critical that a strong relationship between the client and the provider be developed and maintained. Different companies and service providers approach relationship building in different ways. However, of the Chemical Watch survey participants, over half (53%) indicated that building long-term relationships with individuals at their service providers was the most important factor for ensuring success (Figure 23). Following project protocols and the use of carefully crafted service level agreements were important for 44% and 42% of respondents, respectively. Interestingly, the use of penalty clauses was found to be effective for only 5% of survey participants. Figure 23
Most important choice factors for survey participants
Most important relationship factors for survey participants
Expertise of key staff
Building long-term relationships with individual staff 86%
In-depth knowledge of country specific regulations
53% Strict adherence to project protocols
75%
44%
Proven experience on similar projects
Service level agreements in place 74%
42%
Comprehensiveness/accuracy of proposal
Suppliers keeping costs as low as possible
54%
29%
Availability
Regularly reviewing (and at times changing) suppliers
51%
25%
Ability to operate on a global scale
Regular face-to-face meetings
45%
21%
Appropriate accreditation/certification
Paying more to get better value
44%
13%
Contract price
Use of penalty clauses
39%
5%
Recommendation from peers 32%
0%
ISO9001 or equivalent (quality management)
20% In-house equipment/software 16% ISO14001 or equivalent (environmental management) 16% Proximity to your office 6% Large size of supplier organisation 4% 40%
60%
% of participants
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30%
40%
50%
60%
Translating trends into expectations for service demand
Independence of supplier organisation
20%
20%
% of participants
21%
0%
10%
80%
100%
Clearly there is expectation for an increase in demand for chemicals management and control services as additional REACH and CLP deadlines approach, ECHA moves forward with the evaluation of 2010 proposals and inspection activities, GHS and new or expanded/updated chemical control regulations are adopted and implemented in countries around the world, and additional regulations targeting specific products/sectors are introduced. This growth in the complexity of global chemicals management and control regulations is expected to translate into greater demand for both internal and external services. In fact, according to the results of the fourth annual Chemical Watch survey, a similar number of respondents (46%) expect to see no change in the need for in-house staff as do expect to see use of in-house personnel increase to some degree (48%) (Figure 24). Requirements for more in-house staff may be increasing in the longer
Chemical Watch | Global Service Providers Guide 2014
Chemical service providers Chemical Watch | Global Service Providers Guide 2014
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Chemical service providers Page 36
Chemical Watch | Global Service Providers Guide 2014
term, however, with 68% expecting to need more in-house staff, and just 27% expecting no change. In both cases, less than 10% of participants expect demand for in-house staff to decrease. Notably, the longer-term outlook is more positive in terms of in-house staff requirements than that indicated by respondents in 2012 (59% expected to need more in-house personnel).
Figure 26 Anticipated need for external sector services by survey participants in the next 12 months Consultancy/advisory 49%
71%
Legal services
Next 12 months
33%
39%
46%
5% 1%
48%
14%
51%
0%
27%
7% 1% 100%
% of participants
Increase significantly
Increase
5%
47%
IT & software 55%
2%
43%
Information 2%
34%
Training
Decrease significantly
60%
37%
3%
Other(s) 12%
3%
84%
0%
100%
% of participants Increase
Static
Decrease
Figure 27 Anticipated need for external sector services by survey participants in the next 5 years
Figure 25 Anticipated future need for external services
Consultancy/advisory
Next 12 months
58% 45%
44%
6% 1%
34%
34% 53%
0%
30%
100%
% of participants
Increase significantly
Increase
7% 1%
Static
Decrease significantly
Survey participants that will be using external services over the next 12 months will be looking for more help in several areas. Most in demand will be training and information, with 60% and 64% expecting to require additional assistance in these areas (Figure 25). Just over half of survey respondents also expect to need more IT and software (55%), consultancy/advisory (49%) and laboratory (48%) services. The trends appear to continue over the next five years with the demand for information increasing the most (71%), followed by the need for training (66%), IT and software (62%), and laboratory and consultancy/advisory support (59% and 58% respectively, Figure 26). The demand for additional external legal and representation and management services will also increase significantly over the longer term. Chemical Watch | Global Service Providers Guide 2014
8%
Representation & management
Next 5 years
Decrease
3%
64%
Static
Survey respondents also expect the demand for external services to increase (Figure 25). Over the next 12 months, 50% of participants expect to use a greater level of external services, while 44% do not anticipate making any changes. Those numbers increase and decrease, respectively, to 62% and 30% when survey respondents consider the next five years. Once again, less than 10% of survey participants anticipate a decrease in demand for external services in both the short and long term.
9%
65%
Laboratory
Next 5 years
5%
6%
59%
7%
Legal services 43%
54%
3%
Laboratory 59%
34%
7%
IT & software 62%
35%
3%
Information 71%
27%
2%
Training 66%
30%
5%
Other(s) 19% 0%
79% % of participants
Increase
Static
2% 100%
Decrease
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Chemical service providers
23%
Anticipated future need for in-house staff
Decrease
7%
Representation & management
Figure 24
9%
44%
Chemical service providers
Looking in greater detail at the expectations of respondents to the latest Chemical Watch survey, interesting patterns can be detected (Figure 27). With respect to information services, survey participants indicated a similar level of need for assistance with information for chemical safety data sheets, the tracking of regulatory developments and access to chemical hazard databases and organised regulatory information. Dr Torges of KFT Chemieservice, for example, expects growth in demand for external specialists in the areas of risk management and exposure scenario generation, because major companies are willing to outsource these types of services in order to avoid the need to hire more internal long-term resources. For training assistance, courses and webinars are preferred (56%) by far over in-house/customised training services (32%) and even fewer survey participants expect to need training for certifications. Within the IT and software services category, survey respondents indicated that the greatest need will be for general regulatory management systems (62%), followed by SDS, substance inventory and supply chain management systems (55%, 47% and 45%, respectively). With respect to external laboratory support, 30%-50% of survey respondents expect to need a greater level of all of the types of testing services included in the survey. Many companies will be looking to leverage test studies across multiple regulations. When AkzoNobel commissions studies to support the registration of its products under REACH, for example, the company makes sure that the generated data is compatible with the requirements of the regulations in as many other countries as possible. In the consultancy/advisory services category, survey participants expect they will need more assistance with the interpretation of regulations (62%) and product compliance (60%), although 30% or more of respondents do anticipate the need for increased help with other services in this category. Notably, the areas where survey participants expected to see the greatest increase in the use of external service providers were IT solutions for regulatory information management (62%), consultancy/advisory support with respect to the interpretation of regulations (62%) and product compliance (60%), as well as information services related to safety data sheets and the tracking of regulations and policies. The experience of The Acta Group reflects well the trends outlined here. According to Acta’s Ms Bergeson, in 2013, the need of companies to meet REACH requirements led to a steady increase in demand for services in a number of areas, and she expects similar growth in 2014 because the firm has increased the number of chemical substances for which it serves as lead registrant. In addition, the number of chemical companies for which
Page 38
The Acta Group serves as the primary REACH service provider has increased, resulting in work related to CLP, import export, GHS, and other chemical service areas. “We anticipate double digit growth in 2014, and have recently added to our staff to accommodate the increase in demand,” she says.
Concluding remarks Given the expectations of both service providers and chemical manufacturers described in this analysis, it is clear that the need for experienced chemicals management and control personnel will remain strong in 2014 and for several years to come. Furthermore, as regulations in emerging markets catch up to those in more mature regions and updated sector focused regulations and those focused on small volume chemicals come into force in more developed countries, people and service providers with specialised skills will be in even greater demand. Large companies that tend to manage their chemical compliance efforts in-house may prefer to outsource some of the coming work because of the specialised nature of the issues. Mr Ryan of Shepherd Color Company sums it up well: “It is very difficult to be a chemical supplier on a global scale. No longer is it sufficient to have high quality products at a reasonable price. Today, in order to be competitive, companies need to have good analytical capabilities and good regulatory affairs people in order to ensure that they are in compliance with all of the various notification/registration, packaging and labelling and regulations for every country they wish to serve.” The continued growth in the chemicals management and control market is not, however, guaranteed to be enjoyed by all service providers. Purchasers of chemicals management and control services are more educated today about compliance with complex global chemicals management and control regulations. They have two REACH deadlines under their belts and now know what to expect from a high quality service provider, and they are willing to switch if they are not satisfied with the results. In addition, with many new regulations being introduced in Asia and others eventually expected in South America, providers that can offer quality assistance to clients needing to comply with various types of chemicals management and control regulations in countries around the world will attract more business.
Chemical Watch | Global Service Providers Guide 2014
Figure 28
Guidance on regulation interpretation
62%
35%
4%
Product compliance
60%
37%
3%
Consultancy/ advisory
Registration strategies
46%
45%
9%
Supply chain communications
46%
49%
5%
Environmental risk assessment
44%
51%
6%
55%
5%
Assessment of data quality
40%
Testing strategies
39%
53%
8%
Corporate strategy/strategic planning
37%
56%
7%
SVHC advisory services Chemical transport and warehousing advice
45%
7%
52%
41%
7%
CLP notification
31%
59%
10%
GHS notification
31%
61%
7%
Representation (lead, only representative, 3rd party etc)
26%
67%
7%
Management (Sief, consortium etc)
26%
66%
8%
Business process outsourcing (BPO)
Information
69%
19%
Laboratory
12%
(Material) safety data sheets
59%
39%
2%
Regulatory/policy tracking
59%
41%
1%
Chemical hazard database
44%
54%
1%
Managed regulatory content
47%
52%
1%
Exposure testing
49%
50%
1%
SVHC testing
44%
54%
2%
56%
1%
Human health toxicology
43%
Environmental fate & degradation
42%
50%
8%
Ecotoxicology
41%
52%
7%
Physical & analytical chemistry Environmental monitoring
55%
38%
7%
59%
31%
Regulatory information management
10% 36%
62%
(Material) safety data sheet systems IT solutions
13%
48%
Registration services
8%
67%
20%
Dossier preparation & safety assessment, including CSA/ CSR
Representation & management
60%
32%
2%
42%
55%
3%
Substance inventory management systems
47%
50%
3%
Supply chain management/ communications systems
45%
52%
3%
EH&S solutions Consortia/registration management solutions Laboratory information management solutions Bespoke/inhouse training
Legal representatve
4%
62%
32%
7%
73%
24%
0% Increase
11% 59%
37%
Insurance 17%
Chemical Watch | Global Service Providers Guide 2014
8% 41%
56%
CPD/CES certified training 16% Other
7%
73%
19%
Lobbying/advocacy
3%
69%
24%
Training courses/webinars Training
59%
38%
4%
71%
5%
79%
% of participants Static
4%
100% Decrease
Page 39
Chemical service providers
Anticipated need for specific external sector services by survey participants over the next five years
Chemical service providers
Look at Nature: excellence is built on rules.
REACH
AGROCHEMICALS
SDS
COSMETICS CLP
EXTRA-EU
FEED
FOOD
BIOCIDES
REACH mastery s.r.l. via Giovio 16, 22100 Como, Italy Tel +39.031.269513 info@reachmastery.com www.reachmastery.com
Chemical Watch | Global Service Providers Guide 2014
Page 41
SERVICE AREA BREAKDOWN Other 20%
Consultancy/ advisory 20%
PROFILE: 24-7 Response
CONTACTS Website
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
Richard Shreeve
Ownership
OHES Environmental Ltd
Locations
UK based, Worldwide work
Founded
2011
Training 20%
Information 20%
SERVICES PROVIDED Chemical and hazmat emergency line
OVERVIEW Chemical emergency response, incident management, clean up and training for the chemical and fuel industries: from providing first aid advice to assisting those managing major emergencies, 24-7 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: OO personal injury may result unless the correct first aid is given; OO chemical reactions can occur if more than one product is involved; OO 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 chemical incident advisors – all highly qualified chemists specialising in 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
2012/13
Turnover, group
<£4m
Turnover, chemical service provision
<£1m
No of offices No of countries represented
5 All
Staff, group
10-100
Staff, chemical service provision
10-100
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Representation & management 20%
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 proactive 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 (specialist telephone advice). Chemical emergency line – 24 hours a day, 7 days a week All calls to the Chemical and Hazmat Emergency Line are recorded and detailed reports are sent to the client. Contact information for key personnel is held on our system should urgent notification be required – 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 of these demands are regulatory obligations, while others reflect the expectations of industry and those transporting or using the products. For example, all REACH compliant safety data sheets must display an emergency number and, as GHS is rolled out to other regions, this requirement will no doubt increase – as will the need for advice to be provided in local languages. 24-7 Response has developed a robust process that enables advice to those dealing with incidents involving hazardous goods to be given in the language of the caller. The multilingual emergency line number(s) can be displayed on safety data sheets, product labels and transport documentation. Using a unique system devised by 24-7 Response, expert advice is easily accessible and delivered, if necessary via translators, by one of their team of incident advisors. They are all chemists and have, between them, nearly 20 years’ experience of providing expert advice to those dealing with emergencies. The service provides; OO 24 European languages; OO primary Asian languages and Arabic; OO regulatory obligations met in China and elsewhere; OO built in back-up and failsafe functionality; OO all calls are recorded; OO reasonably priced; OO incident advisors are all chemists and dangerous goods safety advisors; and OO mobile phones not relied on for providing advice.
Chemical Watch | Global Service Providers Guide 2014
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 services include: OO REACH impact assessments; OO REACH dossier preparation; OO REACH Sief representation; OO REACH third party and only representative services; and OO REACH exposure scenarios advice. Safety data sheets and supply labels including translations Safety data sheets (SDS) must be supplied with substances and mixtures that are hazardous to heath. However, anyone being supplied a chemical can demand an SDS even if it is not hazardous if the mixture contains hazardous components above certain thresholds. In addition, the SDS must be provided in the language of the member state it is supplied in. 24-7 Response offers a cost effective SDS translation service. Due to the recent change in legislation under the classification, labelling and packaging Regulation (CLP) all substances needed to be reclassified 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 also offer a checking service. CLP and CLP notifications We can help you to manage the classification, labelling and notification 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 qualified DGSAs that are able to offer advice or act as your DGSA. Through our sister company, PTF Training, we also run regular 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 mobilise an on-call incident manager and arrange for them to attend the scene and if required arrange clean up. Training Drawing on our incident advisors’ expertise, we have designed training courses that will give your staff an understanding of the risks when handling chemicals – and mitigate the consequences should things go wrong. Chemical transport training Chemical safety training CLP (classification, labelling and packaging) training Lithium battery safety and legislation training DGSA training
service has been excellent and we would strongly recommend 24-7 to anyone within the industry.” Ray Fowler at Goff Petroleum “Our dealings with 24-7 Response have been of a high standard. It is reassuring to both ourselves and our customers to have the back-up of a credible and professional supplier in the HS&E field.” Neil Ryding at FAST Exocet. CASE STUDY: First aid A catering assistant got a splash of caustic automatic dishwashing detergent in the eye. His colleague called the emergency number and said that he had rinsed the victim’s eye out for 15 minutes (as per the advice given on the product label and SDS), however he was still in significant discomfort and the caller was about to drive him to the nearest 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. Being able to offer quick and correct first aid advice reduced the risk of serious personal injury and the employer’s liability claim, which could have potentially run to a six figure sum. STAFF SELECTION Caroline Raine – Principal Consultant of 24-7 Response Caroline assists those managing major emergencies, to help minimise the impact of a chemical incident. Caroline is a chemical legislation expert, with experience of interpreting and implementing EU legislation relating to hazardous chemical substances. This experience has been developed while working directly in the chemical industry and on consultancy projects. Caroline is a qualified dangerous goods safety advisor, for the 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 Richard has more than twelve years’ experience in the specialist field of chemical and hazardous goods emergency response. Richard and Caroline Raine set up 24-7 Response in the spring of 2011, giving OAMPS a complementary service to the established emergency response and incident remediation capability within the group. Kate Coughlan Holding a BSc (Hons) in pharmaceutical and forensic analysis, Kate has several years’ experience in chemical emergency response and hazardous goods legislation. Kate joined 24-7 Response in the spring of 2011, where she is responsible for operations for the 24-7 Response Emergency number service. Kate is also heavily involved in delivering 24-7 Response’s consultancy and training services. Stephen Walker Stephen is an incident advisor and regulatory consultant. Stephen 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.
PARTNERS
Brendan Buckley
Westfamers, OAMPS, OHES, PTF Training, PTF Consultancy
Brendan joined the 24-7 Response team in December 2013. Holding a BSc (Hons) in environmental science and a NEBOSH health and safety certificate, he has several years’ experience in environmental management systems, consultancy and EHS legislation. Brendan works in the area of incident response and has an interest in chemical hazard awareness and safety data sheets. His personal interests outside of work include music and travelling, but mainly football, and has a tough time supporting the soon to be great again Leeds United.
TESTIMONIALS “We have found 24-7 has provided us with a completely professional and efficient service, it is very important to know that all calls are dealt with by 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
Chemical Watch | Global Service Providers Guide 2014
Page 43
PROFILE: 24-7 Response
REACH consultancy compliance help and advice
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
Directors
Uday Virkud, President, CEO Leo Oves, Vice President, Research and Development Craig Whitney, Vice President, Marketing Greg Merwin, Vice President, Global Sales Andrea Verspay, Vice President, European Sales Alex Ortiz, Vice President, Ariel US Operations Clark VanScoder, Vice President, MSDgen Operations Betty Hicks, Vice President, Global Authoring & TSCA/ Regulatory Services
Ownership
Owned by public company, Verisk Analytics
Locations
US, Canada, Europe, Asia
Founded
1988
OVERVIEW 3E Company is a global provider of EH&S and supply chain compliance information services. By combining our extensive data assets with rigorous industry-leading analytics and deep domain expertise, we provide unique insights that enable our customers to improve compliance through the entire lifecycle of a chemical product. As an industry leader with more than 5,000 customers in 35 countries, we support companies in almost every industry. Leveraging our expertise in the obtainment, management and distribution of compliance information, we provide solutions that reduce risk, achieve regulatory compliance and improve disclosure management in relation to supply chain activities. VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
6
No of countries represented
-
Staff, group
-
Staff, chemical service provision
-
SERVICES PROVIDED Product safety and stewardship tools and decision support Ariel WebInsight™ – a subscription-based online reference tool for researching and tracking how chemicals and substances are regulated. ArielLogic™ for food and flavours – a subscription-based online reference tool for researching and tracking regulated flavours and food additives. Ariel Data Manager® (ADM) – seamlessly integrates chemical regulatory data into corporate systems and provides efficient change management and regular updates as regulations change and new ones are released. Ariel Solutions for SAP® – integrated chemical, regulatory, toxicity and eco-toxicity data, vendor SDS data, expert rules, multilingual phrases, document and label templates, and data loading tools for managing EH&S compliance activities in SAP EHS management and SAP Material Master. SDS authoring MSDgen ® SDS Authoring Software – an enterprise software solution suite designed for companies’ in-house EH&S staff. SDS Authoring Services – provides outsourced or co-sourced assistance with authoring SDSs via 3E’s own fully-dedicated, in-house staff of highly qualified, multi-lingual authors. SDS Distribution – facilitates the dissemination of SDSs to all stakeholders. SDS management and workplace safety SDS Management – a variety of products and services for the management of vendor supplier SDSs. Transportation – 24-7-365 global hotline access for guidance and classification of shipping hazardous materials for any mode. Emergency Response – 24-7-365 emergency response to spills, ingestions or exposures, or for dispatching emergency responders to an incident. Regulatory Reporting – outsourced services for researching, identifying analysing, tracking, completing and submitting required disclosures, permits and reports. Hazardous Waste Management and Classification Services – supports customers’ hazardous waste management obligations, including proper storage and disposal. Supply chain data and sustainability tools
SERVICE AREA BREAKDOWN
3ESC: Supply Chain Compliance Solutions – products and services to facilitate compliance with regulatory and market driven requirements for detailed information about the source and origin of products. Service areas include conflict minerals, RoHS, REACH, California Prop 65 and more.
Consultancy/ Other advisory 5% 5% IT & software 10%
Professional services
Information 80%
Page 44
REACH – 3E can work collaboratively with a company to produce exposure scenarios for eSDSs. GHS – classification services and consulting to companies who need assistance with understanding the implications that GHS has on their business. TSCA – services range from fully outsourcing TSCA compliance to project-based, function-specific areas. C&L Notification – assists manufacturers and importers with CLP classification and subsequent ECHA notification under the European Union’s CLP Regulation.
Chemical Watch | Global Service Providers Guide 2014
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1998
Company founded.
2004
Acquisition: Ariel Research Corporation; international expansion.
2007
Acquisitions: HSE Systems and MSDS Solutions.
2008
REACH and GHS initiatives.
2009
AMR Research (now Gartner) publishes report, “3E moves its way to outsourced MSDS management leadership”.
2010
Acquired by Verisk Analytics.
2013
Launched 3ESC Supply Chain platform and services.
2002 -14
Eight-time winner Environmental Business Journal Business Achievement awards. Winner of six Occupational Health and Safety product of the year awards. Nine-time winner Commitment to Worker Safety awards from Compliance magazine.
CASE STUDY 1: Akrochem Corporation selects MSDgen authoring software to replace commercial SDS system and enable rapid development of accurate and compliant hazard communication documentation Industry: Chemicals Challenge: Previous SDS system slow and cumbersome. Did not have robust features needed to produce accurate and compliant documents and labels quickly and efficiently. Solution: MSDgen Results: “We now have consistent information on labels and SDSs. In one division, we generate between 10 to 30 samples or products on a weekly basis, all of which require accurate hazard communication documentation – we simply could not keep up with demand without a reliable platform. Using MSDgen enables us to generate SDS and labels in an extremely timely manner.” CASE STUDY 2: Perstorp relies on Ariel Data to bolster global regulatory compliance management
Enablon, Ithos, Bureau Veritas, SAP, Japan Chemical Daily, DGM Services, ChemSW, SciQuest, Kelaroo, Waste Management, RegScan
Industry: Specialty Chemicals Challenge: Perstorp’s internal team was using a home-grown system to research and track regulatory changes that became too difficult to maintain and keep up-to-date. Solutions: Ariel WebInsight Results: “Ariel WebInsight has changed the way our team works by making us more efficient. When I conduct a search in WebInsight, I instantly find out whether a chemical or substance is regulated under any relevant directives or whether it is included on any national lists and then I can take this information into account for our safety data sheets.”
CLIENTS
STAFF SELECTION
ACCREDITATIONS CHMM, CSP, DGSA, CPEA, CSBA, REA, IATA, more. PARTNERS
BJs Wholesale Club, Veolia Water Solutions and Technologies, Louisville Gas and Electric Company and Kentucky Utilities Company, Illinois Tool Works, the Linde Group, 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 , Southwest Airlines, Eastman Chemical, DTE Energy, Costco Wholesale Corporation, Temple-Inland, Exelon Corporation, Western Medical Center – A Tenet Hospital, Cleco, Menasha Corporation TESTIMONIALS ”Since deploying MSDgen, we have greatly improved the quality of the data found on our SDSs. We are also quite pleased with MSDgen’s full labelling capabilities, which allow us to author labels and manage associated labeling data from the same centralised system as the SDSs. We now have a single solution for generating all of our regulatory compliance documents. MSDgen’s proven capability as a reliable and robust multi-lingual authoring platform gives us the flexibility to quickly and efficiently meet the regulatory demands we face from new markets and emerging global regulatory requirements.” – Veolia Water Solutions and Technologies “We partner with 3E because of the depth and breadth of their global chemical and regulatory content coverage. We strongly feel that 3E Company has the experience, contacts and language skills needed to stay current with global regulations. We know that the information they are providing us is always accurate and reliable.” – Brenntag
Chemical Watch | Global Service Providers Guide 2014
Kirsten Wallerstedt, Sr Regulatory Analyst In her role at 3E Company, Kirsten Wallerstedt produces regulatory research, analysis, and customer support for the company’s Supply Chain Compliance solutions. Prior to joining 3E, Ms Wallerstedt spent five years working for a California Senator. She earned her Master’s in international business relations from the Fletcher School of Law and Diplomacy at Tufts University. At the University of California, Berkeley, she received a BS in business administration and a BA in political science. James Lee, Regulatory Analyst James Lee, Esq is responsible for research and analysis of various statutes and regulations of the US and Canada, which pertain to regulation of chemical substances. His major areas of regulatory research include legal topics in chemical classification, environmental compliance, hazard communication, safety data sheet requirements, chemical products, food additives, food contacts and pharmaceuticals. Mr Lee also monitors and updates database content for 3E Ariel products and provides regulatory and legal information support to clients. He earned his Bachelor of Science degree in chemistry from Emory University, and completed his graduate studies in chemistry at Georgia State University before earning a Juris Doctorate from University of Missouri-Kansas City Law School. Nhat Nguyen, Regulatory Analyst, Asia-Pacific Nhat Nguyen is a US licensed attorney with over five years of regulatory experience. At 3E, Mr Nguyen is responsible for providing timely and accurate regulatory content for 3E’s WebInsight and ArielLogic products, covering chemical and food safety regulations in Southeast Asia/ Pacific region. Mr Nguyen also provide consulting services to companies conducting business in the region. Prior to 3E, Mr Nguyen worked as an attorney and consultant, advising multi-national corporations on a variety of issues involving EU, US and Southeast Asian laws..
Page 45
PROFILE: 3E Company
European Product Registration – 3E can determine which products need to be registered, perform the registration process, the maintenance of the registration and any necessary updates to SDSs and labels. DGSA (dangerous goods safety adviser) – 3E can serve as a company’s DGSA.
GLOBAL OFFICES The Acta Group EU, Ltd, Brook House Suite 2B, 64-72 Spring Gardens,Manchester M2 2BQ, UK. The Acta Group, LLC, 2200 Pennsylvania Avenue, NW, Suite 100W, Washington, DC 20037-1701, US Tel: +1 (202) 266-5020. The Acta Group China, LLC, 1009 Tongguang Tower, No 12 Nongzhanguan Nanli, Beijing, China 100125, TEL: +86 108 453 4538. The Acta Group China, LLC, has affiliates in Shanghai, Nanjing, and Xi’an.
PROFILE: ACTA
CONTACTS Website
www.actagroup.com
lmacdougall@actagroup.com
Head Office
The Acta Group EU, Ltd, Brook House Suite 2B, 64-72 Spring Gardens, Manchester M2 2BQ, UK
SERVICES PROVIDED
Tel
+44 (0) 330 223 0610
Contact
lmacdougall@actagroup.com
Directors
Lynn L Bergeson and Lisa M Campbell
Ownership
Private company, affiliated with: Bergeson & Campbell, PC B&C® Consortia Management, LLC
Locations
US, UK, and China
We represent and counsel individuals, business entities, trade associations, and industry associations. Our fundamental goals are to solve our clients’ existing problems and to minimise future difficulties. We take a multidisciplinary approach in assisting our clients. Attention must be paid to the interplay of all branches of government and interest groups. Our capabilities, borne of site and issue-specific experience, combined with our national and international view on policy and regulatory developments, position us to handle all these tasks with judgment, creativity, and efficiency.
Founded
2004
General consulting services
Global product registration and agent services (only representative services)
OVERVIEW The Acta Group (Acta) is a leading international specialist in chemical product approval, support and regulatory defence, providing a fullrange of support for the process of developing, commercialising, and sustaining industrial and specialty chemicals, biocides, cosmetics, metals, food contact chemicals, products of biotechnology, nanotechnology and medical devices. Acta professionals are scientists and business and regulatory consultants. This combination and our wealth of experience in and out of laboratories, global chemical companies and government agencies makes Acta an exceptional resource for companies in the chemical space. Acta maintains offices in the US, Europe, and China, and offers expertise with regulatory programmes and chemical product approvals in North America, the European Union (EU), South and Central America, Asia, and the Pacific Rim. VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No. of offices
3
No. of countries represented
>25
Staff, group
>25
Staff, chemical service provision
>25
SERVICE AREA BREAKDOWN Other Training 5% 5%
Consultancy/ advisory 30%
Legal 25%
IT & software 5% Information 10%
Page 46
Representation & management 20%
Regulatory chemical product notification, registration, and technical defence under the framework of global chemical programmes, including REACH, biocidal products Regulation (BPR), globally harmonised system of classification and labelling of chemicals (GHS), Toxic Substances Control Act (TSCA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Korean REACH (K-REACH), the Canadian Environmental Protection Act (Cepa), China Order No 7, and California Safer Consumer Products Regulations. Acta concentrates on obtaining, maintaining, and supporting product approvals and efficiently overcoming commercial or regulatory impediments to the successful and profitable marketing of approved products. Jurisdictions we are active in are: North and South America, EU, Switzerland, Turkey, Australia and New Zealand, Malaysia, China, Japan, South Korea, Taiwan, Philippines, Singapore, and Indonesia. 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 REACH legislation, many clients continue to evaluate and pursue competition-related issues. We are actively engaged in data compensation and competition-related disputes. Technical document preparation activities Undertaking the appropriate document preparation and coordination to support registration and post-registration activities (ie, chemical substance dossier preparation, exposure assessments, hazard assessments, specific effect analysis and assessments, petitions, response to comment documents, inquiries, and safety data sheet (SDS) preparation). Dangerous goods transport, DGSA services The Acta team of professionals has decades of experience in the manufacture, handling, and transport of chemicals. We provide dangerous goods safety advisor services under contract, as well as training in dangerous goods transportation and hazardous goods handling. GHS, classification, labelling and packaging (CLP) services Acta offers comprehensive global services, including substance classification, SDS preparation/review, label formulation, hazard communication (HazCom) services, and GHS programme development and training courses.
Chemical Watch | Global Service Providers Guide 2014
1998
Parent company, Bergeson & Campbell, PC, formed in Washington, DC, US.
2000
Bergeson & Campbell, PC establishes consulting affiliate, The Acta Group, LLC, in Washington, DC, US.
2004
The Acta Group, LLC establishes an international consulting affiliate, The Acta Group EU, Ltd, in the UK.
2010
Bergeson & Campbell, PC establishes a consulting affiliate, B&C® Consortia Management, LLC, in Washington DC, US.
2011
The Acta Group, LLC establishes an international consulting affiliate, The Acta Group China, LLC.
ACCREDITATIONS Occupational Health and Safety Assessment Series 18001; International Organisation for Standardisation (ISO) 9001; ISO 14000
STAFF SELECTION Lynn L Bergeson – President Ms Bergeson has for over two decades assisted individual companies and a wide range of trade groups and ad hoc consortia on chemicalspecific legislative and regulatory matters. Ms Bergeson’s practice areas include TSCA, FIFRA, REACH, and related international chemical notification, registration, and strategic product defence and product approval litigation matters. Leslie Scott MacDougall – Director of Regulatory Affairs Ms MacDougall has more than two decades of experience in chemical control and regulation. She spent a significant portion of her career as a programme manager for the EPA. As the managing director of Acta, Ms MacDougall’s focus is on global product registration support activities. She is a key technical advisor to legal staff in support of international litigation matters (ie, appeals, data compensation issues) and international chemical legislation developments.
PARTNERS
Ruth C Downes-Norriss – Regulatory Specialist
B&C® Consortia Management, LLC Bergeson & Campbell, PC
Ms Downes-Norriss specialises in REACH registrations and worldwide notifications. Ms Downes-Norriss is experienced in performing REACHrelated submissions as well as document preparation to support international registration activities. Ms Downes-Norriss has strong links with national competent authorities and communicates with competent authorities frequently. She participates in substance information exchange fora (Sief) and consortia supporting registration activities.
CLIENTS Acta EU’s clients are involved in many businesses, including basic, specialty, agricultural, and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; medical devices and diagnostic products; fibres; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution and consumer product sectors. TESTIMONIALS Our client list is maintained on a confidential basis. We do not publish client names/testimonials. CASE STUDY 1: successful European Chemicals Agency (ECHA) appeal
Andrew R Bourne – Regulatory Specialist Mr Bourne is distinguished by his experience in both testing and consultation environments, as well as his practical expertise in both environmental modelling and monitoring. He focuses on regulatory compliance for industrial chemicals, biocidal products/substances and fertilisers. Mr Bourne's services also include guidance in environmental and human health risk assessment, and product classification, labelling, and safety. Karin F Baron, MSPH – Regulatory Consultant
Provided strategic technical support to our European legal counsel, Field Fisher Waterhouse, in the first successful appeal under the REACH legislation. It is important to note that at the time of the appeal, the technical completeness check (TCC) tool was not available. ECHA rejected the dossier based on the premise of incompleteness. A successful appeal was performed without the need to petition ECHA further. The substance was granted registration, a registration number assigned and appeal fees returned.
Ms Baron specialises in the areas of hazard and risk assessment and communication, industrial hygiene and environmental health and safety (EHS) programmes, GHS compliance, and dangerous goods safety, for which she is certified under the International Air Transport Association (IATA), the International Maritime Dangerous Goods Code (IMDG), the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR), and the US Department of Transportation.
CASE STUDY 2: data compensation issue
An esteemed toxicologist with an impressive track record of success directing global product stewardship for Fortune 500-listed chemical companies before joining Acta, Dr Vergnes has particular expertise in toxicological testing within the regulatory framework of REACH and TSCA, including study design, laboratory practices, and data requirements for new chemical introductions.
Prepared strategic counselling and documentation to support and submit data compensation dispute/appeal under the REACH legislation. Reviewed and issued response to ECHA’s position on the data-sharing dispute. Initiated documentation to support a petition for competition law infringement in association with conduct under the framework of REACH. Our work in this area builds upon our significant and extensive data compensation work in the US under FIFRA. In other roles, we perform analysis of data valuation in association with the data rights to be granted. CASE STUDY 3: import tolerance Provided strategic regulatory counselling on the development of import tolerances/exemption from tolerances for raw and/or processed agricultural goods exported from Europe into the US that have been treated with pesticides that are not registered in the US under FIFRA, and can be expected to have residues. Worked extensively with the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA) staff to bring cases to successful resolution. In addition, worked extensively with enforcement personnel in cases where commodities have been inadvertently imported bearing residues of unregistered pesticides and resolved matters successfully. Chemical Watch | Global Service Providers Guide 2014
Jane S Vergnes, PhD – Senior Toxicologist
Gyöngyi (Pearl) Németh, MSc – Regulatory Specialist Ms Németh has extensive international experience in REACH, CLP, SDS, and product stewardship support, including document preparation for International Uniform Chemical Information Database (IUCLID 5) dossiers, chemical safety reports (CSR) ,and SDSs. She has experience in scientific matters with a background in toxicology.
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PROFILE: ACTA
CORPORATE DEVELOPMENTS AND ACHIEVEMENTS
we support companies in responding to decisions in a scientifically valid way and provide guidance throughout the evaluation process. Related to eSDS compliance we provide training, company specific eSDS support and DU-CSR generation. In function of CLP, we determine the classification of substances and mixtures, perform C&L notifications and generate Annex XV dossiers. We also represent our clients in consortia on technical/scientific topics.
PROFILE: Apeiron-Team NV
CONTACTS Website
www.apeiron-team.eu
Industrial services
info@apeiron-team.eu
Head office
Berten Pilstraat 4, 2640 Mortsel, Belgium
Tel
+32 3 808 20 67
Contact
Elke Van Asbroeck
Directors
Elke Van Asbroeck and Hiram Moerman
Ownership
Private company
Locations
Mortsel (Antwerp), Belgium
Founded
2009
Apeiron-Team provides tailor made advice for a cost efficient implementation of regulations, taking into account the global business strategy and required flexibility of our clients. We provide assistance in the development of chemicals management systems and product stewardship programmes. In a nutshell, Apeiron provides support with the writing of position papers, tracking of SVHCs (substances of very high concern), communication with authorities on scientific/regulatory issues (a.o. SVHC status of substances) and with different audit programmes such as a compliance, system, supply chain and project audit. Furthermore, we provide support in the set up of monitoring programmes and other occupational hygiene programmes as well as engineering support for the implementation and documentation of strictly controlled conditions for intermediates.
OVERVIEW Our mission is to support industry with cost efficient implementation of complex chemical related regulations. We provide a high level of expertise in chemicals management in the entire supply chain for all relevant regulations as well as for internal responsible care objectives. We are a highly motivated team of doctors in toxicology and chemistry and engineers with industrial experience. As a company of ten people and a limited number of sub-contractors with niche knowledge, we provide specific expertise, while being able to act flexibly and client focused. VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
1
Staff, group
10
Staff, chemical service provision
10
SERVICE AREA BREAKDOWN
Training 15%
Apeiron-Team organises workshops on various aspects of the REACH and biocides implementation process. Highlighted course this year is an in-house workshop on REACH (pre)-authorisation, but other courses on eSDS compliance, REACH, biocides, Iuclid, PNECs and DNELs,… are all given on a regular basis. In project management, Apeiron-Team’s strength is its pro-active approach with a specific focus on in-time and in-budget delivery of results supported by state of the art IT tools. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2009
Apeiron-Team NV was founded
2010
Development of a client portfolio of SMEs and multinationals in chemical and polymer industry. Successful REACH registration of >100 substances. Consortium management for a specialised chemical. REACH training for Belgian federation of chemical industry.
2011
Extension client portfolio in food and pharma industry. Expansion of services and experience in REACH-like legislations, global SDS requirements and chemicals management. Product portfolio inclusion of extended safety data sheet related products: generation of user friendly eSDS Annexes, organisation of eSDS compliance workshops, development of eSDS compliance check tool and development of company specific DU-CSRs.
2012
Expansion of our services with the “E” of evaluation and “A” of authorisation within REACH. Scientific advocacy for several projects (related to restrictions, SVHC status, authorisation and evaluation). China REACH Notifications: submission and post-submission follow-up with authorities (in collaboration with Chinese experts). Preparation of lead and member REACH registrations dossiers for the 2013 deadline.
2013
Successful submission 2013 dossiers: > 10 Lead and > 50 member dossiers. Generation of authorisation dossiers on HBCDD and TCE. Organisation of workshops on the (pre-) authorisation process. Addition of biocides- and cosmetics-related services to our portfolio. Move to a new location in Mortsel (Antwerp).
Other 5%
Information 10% Representation & management 10%
Project management and training
Consultancy/ advisory 60%
SERVICES PROVIDED Regulatory services Apeiron-Team provides support in REACH (including requirements for nanomaterials), REACH-like legislations, CLP, food contact, biocides Regulation, cosmetics Regulation and RoHS. Our services range from referral to information sources to assistance in interpretation of legal texts. Scientific services Generation of REACH registration and authorisation dossiers, from chemical substance identification and product definition over study monitoring, hazard and risk assessment to analysis of alternatives and socio-economic analysis. For REACH substance and dossier evaluation
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ACCREDITATIONS OO OO OO
European Registered Toxicologists (ERT) Environmental advisor (Milieu Coordinator) Strategic advisor SME
Chemical Watch | Global Service Providers Guide 2014
OO
Burgess Regulatory Services Ltd , Caleb , eftec, Jongerius Consult
CLIENTS Our references are situated in several industries and cover the entire supply chain from manufacturing to recycling: petrochemical industry, fine chemicals, toll manufacturing, food industry, polymer industry, refinery, tyre industry, pharma industry. TESTIMONIALS “Apeiron-Team are professional and experienced, driven and engaged. With their expertise they translate the tangle of the REACH legislation into practical, concrete guidelines and actions” – BP Chembel "Apeiron-Team is a no-nonsense company delivering their services on time, in full and in budget" – Monument Chemical “For us, Apeiron-team distinguish themselves from other excellent consultants because they are able to think further in the benefit of the company together with us. We consider them more as one of us” – Christeyns "We have found Apeiron to be very much engaged and passionate in providing support in our application for authorisation. They cover the full scope of activities, from hands-on work on hazard and risk assessment, analysis of alternatives and socio economic analysis to full project management. Apeiron kicked off the project with a two day workshop for our stakeholders, which was much appreciated by all and in particular by top management." – Parker Hannifin CASE STUDY 1: development of downstream user chemical safety report model for ca. 500 chemicals A formulator dealing with ca. 500 incoming chemicals found that performing an eSDS compliance check and the associated communication was too cumbersome to allow for an efficient follow-up of the safe use of their chemicals. Apeiron-Team developed a user-friendly DU-CSR model tailored to their specific process. The model does an automatic safe use check of each incoming chemical based on limited input by the user. In case safe use cannot be demonstrated, operational conditions and risk management measures can be adapted in the model to determine which changes in use are required for a specific chemical. The model ultimately created a huge efficiency gain compared to the work required for a traditional eSDS compliance check. Moreover, new incoming chemicals are easily added to the model and the formulator is no longer dependent on his supplier for eSDS or any updates thereof. CASE STUDY 2: REACH registration and evaluation for a multiconstituent To support the registration of a high volume rubber chemical, we built the complete REACH registration dossier in the context of a consortium. The multi-constituent substance was analysed for all relevant physicochemical and toxicological aspects related to both human health and the environment. Exposure was assessed for all stages of the lifecycle including the waste stage. Scaling equations were generated allowing the downstream users to evaluate their compliance. Within the consortium we developed the cost-sharing model and performed the cost evaluation of the studies based on their scientific validity. The multi-constituent was selected for further substance evaluation by the MSCAs based on its potential PBT properties. During this evaluation process we assisted the lead registrant in determining the most suitable test strategy and were involved in discussion/communication with the relevant authorities. CASE STUDY 3: from strategic support to the generation of an authorisation application The REACH restriction and authorisation process is complex and business critical. For one of our clients, different approaches to deal with this process were developed for a particular substance taking into account the client’s role in the supply chain. The strategic plans
Chemical Watch | Global Service Providers Guide 2014
were aligned with process development and R&D planning to ensure efficient and effective use of available resources and to secure business continuity. Based on the evaluation of these strategic proposals, the client concluded that there was a clear need to apply for authorisation. Apeiron-Team is now in the process of generating the authorisation dossier for this client’s use of that substance. A company specific exposure scenario is being prepared, allowing clear demonstration of safe use. In addition, an analysis of the possible alternatives for the chemical is being done as well as a socio-economic analysis based on the identified non-use scenario. CASE STUDY 4: strategic support aligning REACH registrations with business objectives While REACH registration is to a large extent a scientific exercise involving a lot of communication throughout the supply chain, REACH is also very much a business driven effort. Apeiron-Team has supported several multinationals in the develoment of their REACH registration strategy taking into account their specific markets and import/export strategies. In addition, where warranted, position papers have been written in order to defend the exemption status for specific substances under REACH. By doing so, a cost effective registration strategy was developed avoiding unnecessary registration costs while securing optimal business continuity and flexibility. STAFF SELECTION Elke Van Asbroeck – ir (Bio-)chemical engineer OO OO OO OO OO
Polymer chemistry/ waste Cost-efficient regulation implementation, import/export strategy Authorisation process and related strategies Auditing/GPS Supply chain communication (eg SVHC)
Hiram Moerman – ir Chemical engineer OO OO OO OO OO
Specialised in process chemistry Product stewardship/GPS Authorisation process Auditing Consortium/ project management
Dr An Jamers – PhD Ecotoxicology OO OO OO OO OO
Registration and notification dossiers Sief/consortium representation PBT assessments Product stewardship/GPS Downstream user chemical safety report reports
Dr Katrien Monsieurs – PhD Organic Chemistry OO OO OO OO OO
Specialised in organic synthesis Substance identification Human toxicology, classification and labelling Read-across PBT assessments
Dr Tine Vandenbrouck – PhD Ecotoxicology OO OO OO OO OO
Specialised in mixture effects Registration and authorisation dossiers Hazard, exposure & PBT assessments eSDS generation/scaling tools ERT certified toxicologist
Dr Claudia Schmitt - PhD Ecotoxicology OO OO OO OO
Specialised in sediment effect assessment Authorisation dossiers and impact assessment Sief/consortium representation C&L of multi-constituents and UVCBs
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PROFILE: Apeiron-Team NV
PARTNERS
GLOBAL OFFICES Centres of Excellence for our Product Stewardship Services are located in both Europe (Belgium, Switzerland and UK) and the US, with staff at over 300 ARCADIS global offices providing our clients a local presence in growing markets such as Asia-Pacific and South America. For Europe, contact ARCADIS Belgium: Citylink, Posthofbrug 12, 2600 Antwerpen-Berchem, Belgium. Contact: Alain Vassart, +32 3 328 62 48, a.vassart@arcadisbelgium.be; and: BMG Engineering Ltd, Ifangstrasse 11, CH-8952 Schlieren, Switzerland. Contact: Andreas Häner, +41 44 732 92 52, andreas.haener@bmgeng.ch, or ARCADIS EC Harris, 2 Craven Court, Newmarket, England CN8 7FA: Katy Baker, +44 1638 674767, katy.baker@arcadis-uk.com For the US, contact: ARCADIS US: Two Executive Drive, Suite 303, Chelmsford, Massachusetts, MA 01824, USA. Contact: Kate Sellers, +1 978 322 4514, kate.sellers@arcadis-us.com
PROFILE: ARCADIS
CONTACTS Website
www.arcadis.com/Global_Product_Stewardship.aspx www.bmgeng.ch
a.vassart@arcadisbelgium.be AUSInternet@arcadis-us.com bmg@bmgeng.ch
Head office
Gustav Mahlerplein 97-103, 1082 MS Amsterdam
PO Box 7895, 1008 AB Amsterdam, the Netherlands
Tel/ Fax
+32 3 360 83 00/ +32 3 360 83 01 (ARCADIS-BE) +1 513 985 8020 / +1 513 860 8701 (ARCADIS-US) +41 44 732 92 92/ +41 44 730 66 22 (BMG, Switzerland)
Contact
Alain Vassart (Europe), Kate Sellers (US), Andreas Häner (BMG, Switzerland)
Directors
Kristof Peperstraete, European Sector Leader, Wouter Gevaerts, Executive Director Environment (Belgium) and Gary Bacon, Operations Leader (US), Fritz Krieg, CEO (BMG, Switzerland)
Ownership
Public company
Locations
300+
Founded
1888
OVERVIEW
SERVICES PROVIDED The mission of our global product stewardship (GPS) practice is to enable our clients to efficiently manufacture and market their products in a safe, responsible, and globally compliant manner. Our GPS practice focuses on: OO product stewardship systems, programmes and audit services; OO global regulatory surveillance; OO sustainability support; OO supply chain management; OO registration, permitting and licensing support; OO exposure assessments (field studies), aquatic and terrestrial modelling, risk assessment, and registration support for the agrochemical industry; and OO strategic scientific solutions, including laboratory services. REACH full spectrum implementation
ARCADIS is an international company providing consultancy, design, engineering and management services in infrastructure, water, environment and buildings. We enhance mobility, sustainability and quality of life by creating balance in the built and natural environments. ARCADIS develops, designs, implements, maintains and operates projects for companies and governments. With more than 22,000 employees and €3.3bn in revenues, the company has an extensive international network supported by strong local market positions.
Turnover, chemical service provision
€5m
ARCADIS supports multinational companies in the chemical and pharmaceutical sector with the development and implementation of their REACH compliance programme, organises compliance audits and provides on-site employee training. 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 the general and financial management of several consortia. In this role, we act as trustee and guarantee fair, transparent and non-discriminatory cost sharing between members and the Sief.
No of offices
300+
Global agrochemical registration support
VITAL STATISTICS
2013/2014
Turnover, group
€2.5bn
No of countries represented
38
Staff, group
22,000+
Staff, chemical service provision
47
SERVICE AREA BREAKDOWN IT & software 4% Laboratory 10% Information 4% Representation & management 18%
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Training 4%
Consultancy/ advisory 60%
ARCADIS provides sustainable, effective solutions to help our clients develop, register, manufacture, and ultimately market crop protection products within increasingly complex regulations that require the development and submittal of robust data to support registration eligibility decisions. We provide turnkey compliance support for compliance with individual regulations, in specific countries or entire regions, depending upon our clients’ level of need. Support is initiated by carefully reviewing the individual product for compliance with the applicable regulations in the country or countries of interest, followed by a thorough exploration of applicable exemptions, identification of data gaps or additional studies required, and then completion of licensing or permitting documentation. Where possible we maximise the use of existing data to minimise the costs by making use of exemptions, read-across strategies, and quantitative structure activity relationships (Qsar). Our highly experienced staff tailors and designs laboratory studies, develops and manages study progress and develops final study reports. Many of these studies (environmental fate, biodegradation and aquatic toxicology) are conducted at our own OECD GLP certified laboratory located in Zurich, Switzerland, following GLP standards and/ or ISO/IEC 17025 to meet client needs. Our international team consists of staff located across North America and throughout Europe. Strong relationships have been forged with multinational clients, international regulators, grower associations, and landowners across the international agricultural community. Chemical Watch | Global Service Providers Guide 2014
ARCADIS has helped our clients manage supply chains for products as diverse as household consumer products, automotive components, pulp and paper, polymer, metals and their alloys, pesticides, and food storage containers. We work with our clients to create a structured means of identifying, informing, managing and exchanging necessary information throughout a product’s global supply chain. This process can be used effectively to manage regulatory compliance, perform third-party compliance audits, and meet extended producer responsibilities. Our global footprint allows us to help our clients to work through language and cultural barriers to gather and manage information from their suppliers. Simply put, we help our clients to maintain resilient supply chains that support their business. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1888
Parent company Heidemij formed in the Netherlands.
1998
Global company becomes ARCADIS.
2002
BBL (est 1984) establishes a global product stewardship (GPS) Centre of Excellence in Cincinnati, OH, US.
2005
ARCADIS merges with BBL.
2006
ARCADIS Belgium becomes a GPS Centre of Excellence.
2010
ARCADIS manages several REACH consortia and supports clients in ~100 REACH registration dossiers.
2011
ARCADIS is engaged by multinational companies, consortia and competent authorities as a key service provider for developing and implementing their REACH compliance strategy related to registration, downstream user (DU) obligations and/or authorisation.
2012
ARCADIS acquires BMG Engineering Ltd in Switzerland, a leader in product stewardship, ecotoxicology (including GLP compliant laboratories) and REACH.
2013
ARCADIS performs global product stewardship audits to assist clients in assessing compliance to global product regulations and to help clients identify data gaps and implement programmes to meet obligations. In 2012-2013, ARCADIS prepared a large number of REACH registration dossiers and all of them were submitted on time to ECHA.
ACCREDITATIONS European registered toxicologists (EuroTox); European registered chemists; Diplomat of the American Board of Toxicology (DABT). The ecotoxicology laboratory of BMG is GLP-certified and also accredited according to ISO/IEC 17025. CASE STUDY 1: product stewardship services for a multinational producer of personal care products For over ten years ARCADIS has helped this Fortune 100 company bring products to market safely and in compliance with global regulations. Key activities include: OO human and environmental safety assessments in support of the company’s commitments to its customers; OO updating product (material) safety data sheets to comply with the globally harmonized system of classification and labelling; OO global product registrations, including REACH; OO brokering the sale of technical data to recognise the value of historical testing resulting in a revenue stream; OO US TSCA import/export reviews, keeping the supply chain moving smoothly; and OO developing website content to convey stewardship messages that have become an important positive aspect of the company brand; OO support for green certifications
Chemical Watch | Global Service Providers Guide 2014
CASE STUDY 2: product stewardship auditing and programmatic support A multinational company engaged ARCADIS to provide their environmental health and safety teams with global regulatory compliance support. The work began with a compliance audit of representative products to identify compliance gaps and patterns of noncompliance that indicated the need to strengthen internal stewardship processes. ARCADIS identified and interpreted new and emerging regulations as they applied to the client’s products: chemicals, articles, medical devices, and biological substances. We then partnered with our client to develop strategies (including processes and tools) to confirm and document compliance. We then worked with our client to integrate those strategic solutions into their business processes. Through our thorough understanding of our partner’s existing processes and evaluation of potential compliance gaps, ARCADIS tailored new product introduction processes so our client can produce globally compliant products, resulting in a dramatic decrease in product holds at customs. CASE STUDY 3: authorisation under REACH While the first authorisation dossiers are being assessed by ECHA , ARCADIS has gained significant experience with the preparation of this type of dossiers for the consortia we have managed. Successful dossiers combine several ingredients: an extensive network of contacts with downstream users, industrial knowledge of processes (beyond what is required for a registration dossier), expertise in the field of human health 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 risks, expected effects on social and economic level, etc. defining the consequences of a refusal (non-use scenarios), and most often, additional exposure data to better characterise the remaining risks. ARCADIS supports our clients‘ business success by offering all of the fields of expertise that are required to define the consequences of a refusal of authorisation (non-use scenarios) vs the continued use of the substance. STAFF SELECTION Within the ARCADIS Group we have a very broad range of expertise within our staff. Just to mention a few names: OO Andreas Häner (microbiology / ecotoxicologist); OO Nele Deleebeeck (ecotoxicologist); OO Kate Sellers (environmental engineer); OO Maaike Billau (biologist); OO Nathalie Schraepen (environmental risk assessor); and OO Matilde Ibanez (toxicologist). Xianglu Han PhD –Human Health Toxicologist Dr Han has over ten years of experience in toxicology, public health, risk assessment, and regulatory compliance. His main areas of focus are nanotoxicology, computational toxicology (Monte Carlo simulations, doseresponse modelling), epidemiological studies on air pollution, children’s nutrition, and toxicological studies on chemical mixtures (dioxins/PCBs, pesticides, endocrine disruptors). With extensive experience in both research and statistical data analysis, he has also served as an expert reviewer for a series of high-profile journals such as Toxicology, Food and Chemical Toxicology, Toxicological Sciences, Nanotoxicology, Environment International, and Journal Of Exposure Science And Environmental Epidemiology. Andy Newcombe CChem MRSC – Environmental Scientist Mr Newcombe has more than 23 years of international experience in the field of agrochemicals in the environment. With extensive expertise in design and management of fate and transport studies including groundwater monitoring studies, as well as field-scale leaching and runoff studies. He has represented industry on environmental fate issues as an expert witness and has provided project direction, technical report preparation, analytical data evaluation, cost control, and subcontractor management.
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PROFILE: ARCADIS
Supply chain management and product stewardship programmes
SERVICES PROVIDED REACH The REACH Regulation is the biggest piece of chemical legislation ever. ARCHE is well placed to help you set up a REACH implementation plan and assist you with the fulfilment of your obligations as producer, importer, distributor and/or downstream user of phase 2 and 3 substances under REACH. We can assist in (a) literature search and data evaluation; (b) Iuclid; (c) exposure scenarios; (d) CSA/CSR; (e) read-across and data waiving; (f) Qsar; (g) REACH dossier submission, updating and follow-up and h) reach compliance.
PROFILE: ARCHE
CONTACTS Website
www.arche-consulting.be
info@arche-consulting.be
Head office
Stapelplein 70, box 104, 9000 Gent, Belgium
Tel
+32 9 265 87 58
Contact
Marnix Vangheluwe
Directors
Marnix Vangheluwe
Â
Patrick Van Sprang
Ownership
Private company
Locations
Gent and Leuven, Belgium
Founded
2009
REACH enforcement services: CLP-compliance and uses evaluation ARCHE developed a one-to-one assistance programme called RESCUE to help downstream users to ensure REACH/CLP compliance for their substances and mixtures, as these elements will be the primary focus of enforcement authorities across the EU as embedded in the REACHEN-FORCE programmes. Through benchmarking the onsite operational conditions (OC) and risk management measures (RMMs) with those that are reported in the ES, a complete compliance check for each hazardous substance is undertaken. When on-site conditions of use are not in agreement with those that have been outlined in the ES, several options are explored in consultation with the DU. The deliverable of the RESCUEprogramme is a fully documented evaluation that demonstrates REACH and CLP compliance for each evaluated substance.
OVERVIEW ARCHE has an unique track record in the field of environmental toxicology, exposure modelling and the preparation of risk assessment dossiers in general. One of the key areas of expertise is the preparation of REACHrelated risk assessments and full dossiers for inorganic substances such as metals, alloys, slags, etc and, as such, the ARCHE experts have been involved in the preparation of many guidance documents (eg ECHA) on these topics. Other key services include the classification of substances and complex mixtures (GHS/CLP), setting and/or evaluation of (site-specific) environmental quality standards, and the assessment (environment and human health) of pharmaceuticals, plant protection products and biocidal products. VITAL STATISTICS
Cradle to Cradle certificationÂŽ
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
2
No of countries represented
1
Staff, group
15
Staff, chemical service provision
15
SERVICE AREA BREAKDOWN Training 10%
Representation & management 10% Consultancy/ advisory 75%
PJ Van Benedenstraat 4, box 203 3000 Leuven, Belgium Tel: +32 16 28 49 00
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Biocides and plant protection products (PPPs) ARCHE has extensive expertise and a proven track record in delivering solutions to environmental problems at all stages in the registration/ review of biocides and PPPs. Offered services include: (a) effect and exposure assessment for active substances and products; (b) data gap identification and designing higher-tier studies; (c) exposure modelling (FOCUS suite of models, Euses, Consexpo, EASE); (d) higher-tier exposure scenario development; (e) CLP; (f) dossier preparation, submission and follow-up; (g) client representation in meetings with regulatory authorities; (h) product stewardship; and (i) training Iuclid for biocides. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
IT & software 5%
GLOBAL OFFICES
As an authorised Cradle to Cradle material assessor, ARCHE assesses healthy and sustainable products under the Cradle to Cradle CertifiedCM Products Programme. The Cradle to Cradle product standard addresses five quality categories relating to human and environmental health: (a) material health, (b) material reutilisation, (c) renewable energy and carbon management, (d) water stewardship, and (e) social fairness. The ultimate goal of the Cradle to Cradle CertifiedCM Products Programme is to encourage continuous improvement, innovation, and formulation of products that benefit humans and the environment.
2009
Foundation of ARCHE (staff: five people).
2010
Expansion of the team to 12 people, with offices in Ghent and Leuven.
20132014
Further expansion to 15 people, and further development of the services on biocides and plant protection products.
PARTNERS EBRC Consulting GmbH, Hannover PietConsulting ReachCentrum ECTX-Consulting
Chemical Watch | Global Service Providers Guide 2014
CLIENTS
STAFF SELECTION
Industrial clients and consortia related to the following chemical substances: OO metals including: Cu, Ni, Mo, Pb, Zn, Hg, V, Co, Fe, Se, Sb, Sr, Mg, Bi, Te, Ti, etc; OO organic compounds: chlorinated flame retardants, organic acids, plasticisers, amines, biocides, plant protection products; OO complex materials: Cu slags, Ti slags; and OO other inorganic substances: Ca, B, NaOH, KOH, sulphur dioxiderelated substances (SO2, sulphites, thiosulphates, dithionites), lime, nitric acid, phosphoric acid.
Patrick Van Sprang − Managing Director ARCHE
TESTIMONIALS
Marnix Vangheluwe graduated as master of science in engineering (biochemistry) at Hogeschool Gent (1989). In 1991 he obtained a master in environmental sanitation (Ghent University). At Ghent University (19922000) he was responsible for the research group sediment ecotoxicology. He was co-founder of EURAS, a company specialising in environmental risk assessment. He is the main author of the metal risk assessment guidance document (Merag) and the official REACH Appendix R.7.13-2.
CASE STUDY 1: providing expert opinion on REACH Compliance Check Following a decision on a compliance check of a registration pursuant to article 41(3) of regulation (EC) N° 1907/2006 people at ARCHE were asked to provide expert support to the registrant in order to compare the release estimates and overall risk paradigms used in the CSA/CSR with the general guidance as provided by ECHA. Attention was also given to providing a proper justification of the risk management measures (RMM) and operation conditions (OC) used in the generic exposure scenarios. CASE STUDY 2: compliance with the new MARPOL Annex V and IMSBC requirements Marine shipping regulations MARPOL 73/78 (Annex V) and the IMSBC Code are aimed to ensure that risks towards men and environment as a result of the transport and use of hazardous substances overseas are reduced to an absolute minimum. Recently, criteria have been included in these legislations for the classification of hazardous substances based on the GHS classifications schemes. ARCHE has been asked to draft guidance documents on this topic for both complex organic as inorganic substances.
Marnix Vangheluwe − Managing Director ARCHE
Frederik Verdonck − Senior Science Project Manager Dr Frederik Verdonck obtained his PhD degree in bio-engineering on probabilistic risk assessment at Ghent University (Belgium). At ARCHE his main expertise area comprises the implementation and application of statistical and modelling approaches in exposure, effects and risk/safety assessment. Currently, Dr Frederik Verdonck is the leading expert in developing and implementing new tools in the field of exposure scenario building. Hilde Dosogne − Senior Science Project Manager Hilde Dosogne graduated as bio-engineer (1992) and obtained a PhD in veterinary sciences at Ghent University (1998). From 2001 until 2004 she worked as R&D and regulatory affairs consultant for Pharmavize. From 2004 until 2011 she worked as regulatory affairs manager (Europe, Middle East, Africa) for DeLaval. Her responsibilities at ARCHE include European biocidal product dossier preparation, submission and follow-up, both on national level and according to the mutual recognition procedure.
CASE STUDY 3: human health risk assessment of PT8 biocidal products (wood preservatives) Human health risks were calculated for three different PT8 biocidal products, each containing three active substances. The risks were calculated according to the new guideline for risk assessment of biocidal products (Dec. 2013), where the hazard quotient (HQ) = internal exposure/ acceptable exposure level (AEL) was calculated for each substance. In order to address toxicity of the mixture, the hazard index (HI = Σ HQ of each active substance) was also calculated. Results of the assessment were used to support strategic decisions on products to be maintained on the market.
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PROFILE: ARCHE
“IMOA has worked for the last five years with the environmental scientists working at ARCHE, and they have proved for IMOA/MoCon to be a very wise investment. We can therefore highly recommend ARCHE with regard to their technical expertise and knowledge on environmental issues (aquatic and terrestrial), organisation of research projects, and data interpretation. ARCHE worked with numerous metal consortia for REACH, and is widely recognised by the metals industry as the experts in their field.” − Sandra Carey, International Molybdenum Association
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).
GLOBAL OFFICES
PROFILE: bibra toxicology advice & consulting
London SERVICES PROVIDED Dossier preparation, including CSA/CSRs (DNEL/DMEL derivation) Highly skilled in working directly into Iuclid preparing technical dossiers required under REACH and the biocidal products Directive, and in describing toxicological data in a robust but efficient way. Very experienced in interpreting/evaluating toxicity studies and working with appropriate assessment factors to derive risk-based levels of tolerable exposure. Accurate input of information into Iuclid facilitates the overall chemical safety assessment and production of the final chemical safety report for submission. We can also advise on relevant classification/labelling. Working with partners, we cover all aspects of REACH. We also provide a Iuclid 5 web-hosting service to our clients.
CONTACTS Website
www.bibratoxadvice.co.uk
info@bibratoxadvice.co.uk
Head office
Cantium House, Railway Approach, Wallington, Surrey, SM6 0DZ, UK
Tel
+44 (0)20 8619 0770
Contact
Peter Watts
Directors
James Hopkins, Managing Director
Ownership
Private company
Locations
United Kingdom
Founded
1961, acquired by current management 2005
Human health hazard and risk assessment
Peter Watts, Director of Toxicology Graham Hunt, Commercial Director
OVERVIEW Bibra toxicology advice & consulting Ltd is one of the most experienced and successful chemical hazard and risk assessment organisations in Europe. We combine the skills and expertise of a large team of highly experienced and outstandingly qualified toxicologists with the finest, independently owned toxicological databank in the world. This unique combination of world-class expertise and consulting skills with an outstanding information system means we can provide superior quality solutions to virtually all the problems faced, both by toxicologists and related company managers, in a highly-efficient and cost-effective manner. Bibra toxicology advice & consulting has been working successfully with government departments and industry for many years across a broad range of sectors, for example industrial chemicals, agrochemicals, biocides, cosmetics, pharmaceuticals, medical devices and food/drink. We have built an enviable reputation for our ability to handle large, as well as small projects, and to deliver high quality consulting and information services to tight deadlines. We are a leading supplier of REACH compliance services, assisting chemical manufacturers, importers and downstream users with all their REACH regulatory responsibilities. VITAL STATISTICS
2012/13
Turnover, group
£2m
Turnover, chemical service provision
£2m
No of offices
1
No of countries represented
1
Staff, group
22
Staff, chemical service provision
19
SERVICE AREA BREAKDOWN IT & software Information 1% 4% Representation & management 10%
Consultancy/ advisory 85%
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The bibra toxicology advice & consulting team of toxicologists has worked together over many years, providing robust human health hazard and risk assessments for a diverse range of clients. Tailoring our output to suit the specific requirements of the client, we have worked with companies from the industrial chemicals, agrochemicals, biocides, food and food contact, consumer products, pharmaceutical and medical device sectors, as well as a number of international governments and respected NGOs. Our skill sets are very well matched to current requirements for toxicological hazard and risk assessment under REACH and other regulatory chemical control activities. Data searching, gap analysis and development of testing strategies We perform data searches as required under REACH. Retrieved information can be quickly assessed for relevance and reliability to satisfy tonnage-relevant data requirements. Additional testing can be minimised by expertly exploring opportunities for data waiving, read-across, and use of Qsar to create weight-of-evidence approaches to fill data gaps. If further testing is necessary we can advise on testing strategies to minimise both the use of animals/overall costs to the client, while maintaining scientific integrity. We assess the impact of the results of new tests conducted and provide ongoing expert guidance on what is really needed. Extensive in-house toxicological database and databank For more than 55 years, bibra toxicology advice & consulting has been scrutinising emerging toxicological literature, expert reviews or pronouncements, and indexing them systematically (by endpoint and chemical). Much of this scientific literature is held in-house in our technical library and quickly accessed using its associated database, TRACE. This unrivalled resource (listed as a valuable data source in ECHA guidance) allows instant access to relevant documents and is critical in helping us produce the finest hazard and risk assessment work for our clients, in the most timely and cost-effective manner. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1961
Formation of BIBRA
1961
Establishment of Toxicology Information and Advisory Department
1961
Began to build the technical library
1987
TRACE, a database designed to source data, from the tech library (databank), was developed
2000
TRACE, and associated databank, independently assessed as the finest toxicological data source of its type, worldwide
2003/5
Toxicology Advice & Consulting Ltd and Bibra Information Services Ltd established as vehicles to facilitate management buyout of Information and Advisory Department, including TRACE and its associated databank
Chemical Watch | Global Service Providers Guide 2014
The new combined entity began to trade as bibra toxicology advice & consulting from Sutton, Surrey offices
2010
Relocated to new, larger offices in Wallington, Surrey
ACCREDITATIONS Our senior toxicologists are all Society of Biology/British Toxicology Society and European Registered Toxicologists. We are a REACHReady approved supplier PARTNERS Enviresearch Ltd Linmark Consulting Gmbh wca environment Ltd ReFaC Campden BRI group CLIENTS Many of our clients have a need for confidentiality so those listed below are just a small sample of the types of organisations that we work with: OO Actavis Group OO CSL Behring Biotherapies for Life OO Environment Agency (UK) OO Health Canada OO World Health Organization OO Groupe Danone OO Infineum UK Ltd OO Innospec Active Chemicals OO Johnson Matthey plc TESTIMONIALS “Reliable, responsive and adept at applying their toxicology expertise to REACH, our experience of working with bibra toxicology advice & consulting has been very positive” Infineum UK Ltd "The toxicologists at bibra toxicology advice & consulting provide a very high-quality service by applying a combination of many years of experience and a high level of efficiency, in relation to scientific toxicological literature reviews and risk assessment" Marc Baril PhD, Conseiller scientifique, IRSST “INEOS involved bibra toxicology advice & consulting from conception to completion of a REACH dossier (with a short deadline and little data). We have been very impressed with their efficiency, professional manners, knowledge of the subject and their ongoing suggestions to help us to find solutions to meet our deadline. The dossier was ready on-time and of an impeccable quality" Fabienne Hubert, INEOS Oligomers CASE STUDY 1: Complex REACH submission involving a large category of substances Bibra toxicology advice & consulting has been working on a number of REACH submissions that involve large categories of substances. In one case, we are supporting a consortium of companies with all the mammalian toxicology aspects of their regulatory obligations for a group of more than 70 related metal compounds. The work has involved the evaluation of a large number of proprietary studies and published literature, drafting of endpoint study records (ESRs) in Iuclid 5, assessment of Annex III compliance, complex data-gap analyses and advice on possibilities for read-across and weight-of-evidence approaches, and the development of an appropriate integrated testing strategy, to minimise the amount of animal testing required.
CASE STUDY 2: Urgent request for help with chemical safety report We are very happy to take on smaller projects and have been working with a number of clients to help out with specific areas of their REACH registration dossiers. In one case we were asked at short notice to help improve an existing Iuclid 5 dossier on a petrochemical additive manufactured in the EU at greater than 1000 tpa. This urgent request involved the peer-review (and significant improvement) of previously drafted ESRs and associated endpoint summaries, and the compilation of a chemical safety report (CSR), which included calculation of DNELs and PNECs, a PBT/vPvB and exposure assessment, risk characterisation step, and documentation of the necessary risk management measures and operational conditions (RMMs/OCs). The size and capabilities of our team meant that, despite the late notice and tight deadline, we could incorporate this project into our work schedule and the client was able to successfully submit their registration dossier in time. CASE STUDY 3: Provision of alerting service to keep industry up-to-date on emerging issues Bibra toxicology advice & consulting was asked by an industry sector group to provide an ongoing service to track the emerging toxicological literature on a range of chemicals of particular interest to their members. Using a range of carefully tailored search and alerting strategies (SDI – selective dissemination of information), the bibra toxicology advice & consulting team receives daily notification of newly published or prepublished papers, abstracts or comment, and alerts the sector group members to keep them abreast of the scientific literature and developing areas of possible concern. The service allows the industry to successfully foresee and manage arising issues in a co-ordinated and proactive way. STAFF SELECTION James Hopkins – Managing Director James 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' guidance, reporting record results in 2012/13. James has wide experience in reviewing/ evaluating toxicological data for a range of chemicals in a cross-section of industries and has also compiled numerous critical reviews of chemicals and several strategy documents for national governments. Peter Watts – Director of Toxicology Peter is our Director of Toxicology and is a bibra veteran of 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 REACH Guidance on Information Requirements, has authored WHO-IPCS CICADS and Environment Agency CLEA reports, acted as a temporary adviser to the WHO, and provides peer-review services for OECD SIAMs (now CoCams). Philip Copestake – Senior Toxicologist Philip has more than 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 toxicology advice & consulting team of toxicologists to support a number of client companies and consortia with their registration submissions. The rest of the team We have another 16 highly-competent toxicologists, all of whom are professionally qualified (the majority are SB/BTS and European Registered Toxicologists) and, barring our graduate trainees, range in practical experience from 11 to 36 years. All are extremely skilled in chemical hazard and risk assessment and have been heavily involved in REACH-related work during the past five to six years.
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PROFILE: bibra toxicology advice & consulting
2005
SERVICES PROVIDED Scientific consultancy OO OO OO OO
PROFILE: Blue Frog Scientific Limited
CONTACTS
OO
regulatory testing design and study monitoring intelligent testing strategies ecotoxicology and environmental fate environmental hazard and risk assessment toxicology human health hazard and risk assessment compilation of dossiers and expert reports
Website
www.bluefrogscientific.com
info@bluefrogscientific.com
OO
Head office
10 York Place, Edinburgh, Midlothian, EH1 3EP, UK
Regulatory affairs
Tel
+44 (0) 131 523 1412
OO
Contact
Damien Carson
Directors
Damien Carson
Â
Tom Hargreaves
Ownership
Private limited company
Locations
UK (Edinburgh and Cardiff)
Founded
2006
OO
OO OO OO OO
Chemicals (REACH)
OVERVIEW Blue Frog Scientific is an independent regulatory consultancy, providing scientific and regulatory affairs solutions to companies in all sectors of the chemical industry. Blue Frogâ&#x20AC;&#x2122;s philosophy is achieving regulatory compliance through the application of good science, innovation and clarity; ensuring that all submissions are prepared efficiently and to a high standard. We offer scientific and regulatory affairs services with particular experience in chemicals, human pharmaceuticals, veterinary medicines, agrochemicals and feed additives. Based in the UK, our core team of consultants coordinate operations and our comprehensive network of associates (including contract laboratories, legal support and financial accounting) ensures that we can assist our clients in all areas of regulatory compliance. We have particular in-house strengths in chemistry, toxicology, ecotoxicology, environmental fate, and regulatory affairs. We utilise our network of associates when we need leaders in specialised fields (eg reproductive toxicology) to address issues requiring an expert opinion, statement or report. VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
2
No of countries represented
2
Staff, group
10
Staff, chemical service provision
10
SERVICE AREA BREAKDOWN
Blue Frog Scientific provides a full technical and administrative registration service for chemical substances under Regulation (EC) No 1907/2006 (REACH). Our team is highly qualified and experienced in preparing registration dossiers, chemical safety assessments, coordinating with Siefs and consortia, and liaising with regulatory authorities during and post dossier submission. Key sectors of experience include: OO monomers, process chemicals, coatings and catalysts; OO oilfield chemicals and petroleum products; OO fragrances; OO pharmaceutical intermediates; OO substances of unknown or variable composition, complex reaction products or biological origin (UVCB); OO transported isolated intermediates (Article 18). We also provide supply only representative services in accordance with Article 8 of REACH for non-EU companies that manufacture or formulate chemical substances and mixtures. Consortium/Sief management Blue Frog Scientific has developed a model for managing the financial and administrative challenges of consortia and task forces. We are currently managing consortia and Siefs under REACH as well as other groups of companies collectively working on research and development projects. Our services include: OO provision of a consortium bank account; OO accounts payable and accounts receivable; OO VAT and tax accounting; OO purchase contract management; OO teleconferencing facilities; OO data storage and management via the secure Blue Frog Scientific extranet. Environmental risk assessment of human medicinal products (HMPs) and veterinary medicinal products (VMPs)
IT & software 10%
Representation & management 30%
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
Consultancy/ advisory 60%
Blue Frog Scientific has extensive experience in assessing the potential environmental risk posed by human pharmaceuticals and veterinary medicines. Environmental risk assessment: OO authoring expert reports for inclusion in European marketing authorisation applications and FDA filings; OO planning and coordinating the necessary activities required in the preparation of risk assessments for regulatory submission; OO expert evaluation of laboratory studies; OO protocol development and environmental testing requirements to GLP, and following international guidelines;
GLOBAL OFFICES Edinburgh, Scotland, UK Cardiff, Wales, UK
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Agrochemicals Blue Frog Scientific and associates offer a full dossier service for registering plant protection products throughout Europe. Our range of services provides cost effective solutions to support placing your products on the European market. Data gap analysis: OO overview of quality of existing studies and identification of any data gaps for re-submission of dossiers according to EC 1107/2009; OO preparation of updating statements. Study management: OO regulatory testing design; OO testing strategies and study design (GLP/GEP); OO study monitoring; OO preparation of study summaries. Dossier preparation and regulatory affairs: OO OECD and dRR sections 1 to 7 prepared to a high standard; OO communication with regulatory authorities within EU 27 to support submissions. Key sectors of experience include: OO insecticides: pyrethroid, neonicotinoid, organophosphate and carbamate; OO herbicides: organophosphorus, phenylpyrazole; OO benzoylcyclohexanedione, chloroacetanilide; OO fungicides: triazole, anilinopyrimidine, amide, pyrazole; OO other: semiochemicals and biopesticides.
CLIENTS Blue Frog Scientific supports a global client base of chemical, pharmaceutical, veterinary, agrochemical and feed additive companies, ranging from SMEs to large multinational corporations. We take our clients’ confidentiality very seriously and will not disclose their identity. CASE STUDY 1: REACH advisor to a European Defence Agency Provided long-term support to a European Defence Agency in defining the parameters of the defence exemption, training staff on the fundamental aspects of REACH, and developing internal procedures for assessing exempt/non-exempt chemical substances and complying with REACH. CASE STUDY 2: assessment of the environmental fate and effects of the PPARgamma receptor agonist, pioglitazone The environmental fate and effects of pioglitazone prescribed for the treatment of type 2 diabetes were evaluated in an environmental risk assessment. A predicted environmental concentration (PEC) for surface water was estimated at 0.023μg L-1, triggering a comprehensive battery of laboratory evaluations. Pioglitazone and its major metabolites were determined not to significantly adsorb to sewage solids, were not persistent in the aquatic environment, did not bioaccumulate and were non-toxic to aquatic organisms. Pioglitazone does not pose an unacceptable risk to groundwater supplies, with concentrations not anticipated to be a risk to aquatic organisms or human drinking water supplies. Pioglitazone does not pose a risk of secondary poisoning. STAFF SELECTION Damien Carson BSc PhD – Director An expert in chemical hazard and risk assessment with more than ten years’ experience across a wide range of sectors in the industrial and fine chemical industry. Expert in good laboratory practice (GLP) and testing strategies. Tom Hargreaves BSc (Hons) – Director An expert in environmental hazard and risk assessment, with more than 15 years experience in veterinary medicinal products, human pharmaceuticals, agrochemicals and chemicals. Expert in good laboratory practice (GLP) and testing strategies. Nigel Halsall BSc PhD – Associate Director An expert in environmental hazard and risk assessment with more than 25 years experience in the agrochemical industry. Expert in good laboratory practice (GLP) and testing strategies.
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006
Formation of chemical regulatory services team within BMT Cordah Limited, part of the BMT group of companies.
2007
Development of REACH technical consulting services supporting a global client base.
2008
Development of human pharmaceutical and veterinary medicine consulting services supporting a global client base.
2010
Management buy-out of Chemical Regulatory Services business by D Carson and T Hargreaves, forming Blue Frog Scientific Limited.
2010
Development of agrochemical consulting services.
2012
Sustained growth leads to major expansion of company with new staff and offices to support growing client base.
ACCREDITATIONS European Partner: Society of Environmental Toxicology and Chemistry (Setac).
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PROFILE: Blue Frog Scientific Limited
preparing literature based weight-of-evidence risk assessments for specialist products; OO multimedia mathematical modelling of the fate of pharmaceuticals in soil, freshwater, sediment and marine compartments; OO deterministic and higher tier probabilistic assessment of effects on biota and exposure concentrations; OO preparation of conclusions of risk, with relevance to the “real world” and mitigation solutions; OO use of mammalian ADME data to refine models and aid conclusions regarding bioaccumulation and secondary poisoning. Key sectors of experience: OO HMPs: AIDS, chronic kidney disease, ataxia, an.-inflammatory, hypertension, diabetes; OO VMPs: antibiotics, parasiticides, coccidiostats, antipyretics; OO all classes of cattle, swine, sheep, poultry; OO oral drenches, injectables, pour-ons, in feed, in drinking water; OO product defence, particularly for two “priority list” substances. OO
PROFILE: BSL BIOSERVICE Scientific Laboratories GmbH
GLOBAL OFFICES Our facilities are located in Planegg/Munich, Germany. In addition, we have representatives in Switzerland, Japan, India, Poland, Scandinavia, Italy and other countries. SERVICES PROVIDED For the chemical, agrochemical and biocides industry BSL BIOSERVICE offers a broad scope of biological safety studies, which meets the international regulatory requirements and includes the following services.
CONTACTS 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
Dr Iris Pfisterer
Directors
Dr Wolfram Riedel, CEO
Locations
Germany
Founded
1984
Toxicology for chemicals, PPPs and biocides
OVERVIEW BSL BIOSERVICE Scientific Laboratories GmbH is an internationally active CRO with a focus on safety and efficacy trials for industrial chemicals, agrochemicals, biocides, cosmetics, medical device, food and pharmaceuticals. The interdisciplinary and internationally accepted approach of the institute with its various accreditations, certifications and numerous successful audits (GLP, DIN EN ISO 17025, GMP, FDA) guarantees high-quality biological trials. The laboratories have in the meantime been certified for the eighth time in accordance with GLP, most recently in 2012, and all tests are performed in accordance with the internationally valid guidelines (OECD, ISO, ICH, EU, EPA, MHW, FDA). With more than 25 years of experience our team of scientists offers a broad spectrum of biological test systems and is dedicated to meeting the customer´s individual needs with a high level of flexibility. BSL BIOSERVICE is renowned for its communication, scientific input and high quality standards. BSL BIOSERVICE is the preferred toxicology partner of the Eurofins Group, which is a global leader in the pharmaceutical, food and environmental testing market and also offers a comprehensive portfolio for the chemical and agrochemical product sectors. The Eurofins Group, with annual revenues of more than US$1bn, has over 15,000 employees in more than 190 laboratories across 37 countries. VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
6-10
Staff, group
200+
Staff, chemical service provision
-
SERVICE AREA BREAKDOWN Consultancy/ advisory 20%
We cover all common toxicology services relevant for chemicals, plant protection products (PPP’s) and biocides. This includes the classical in vivo studies from acute to repeated dose and DART studies. In addition, BSL puts a high emphasis on alternative in vitro testing strategies with regard to the 3R strategy for refinement, replacement and reduction of animal studies. We have established a big range of in vitro assays for all endpoints where this is possible yet. Our services include: OO irritation/corrosion (in vitro/in vivo); OO sensitisation; OO dermal absorption (in vitro/in vivo); OO genetic toxicity (in vitro/in vivo); OO acute toxicity; OO repeated dose toxicity; OO developmental and reproductive toxicity (DART); OO toxikokinetics; OO carcinogenicity; OO neurotoxicity; and OO endocrine disruptor testing. Ecotoxicology and physico-chemical properties Physico-chemical and ecotoxicology services including aquatic and terrestric studies as well as studies on biodegradation and environmental fate and behaviour are also part of our portfolio. These services are offered in co-operation with the Eurofins Group and other experienced partners and are project managed by BSL BIOSERVICE. REACH services With regard to REACH we can offer the full portfolio of studies, required for the different tonnage levels according to Annex VII-X of the REACH directive. Due to the large variety of chemicals tested for the REACH deadlines in 2010 and 2013 we are well prepared to effectively support you also for the upcoming deadlines. Furthermore, as ECHA will continue with the evaluation of the registered substances and testing proposals, we are happy to perform those higher tier studies for you and support you in updating your dossier. Studies like 90-day toxicity (OECD 408) and reproductive and developmental toxicity (OECD 414) are performed at BSL on a routine basis. With regard to the latest discussions we have also established the EOGRTS (OECD 443) as an alternative to the two-generation study (OECD 416). Endocrine disruptor testing In response to the EPA announcement of the Endocrine Disruptor Screening Programme for Biocides, we have established endocrine disruptor testing services and can offer the full Tier 1 testing battery.
In vitro safety testing OO OO OO
Laboratory 80%
OO OO OO
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mutagenicity, clastogenicity, carcinogenicity skin and eye irritation/ corrosion – several models dermal absorption photo-induced toxicity reproductive toxicity (embryonic stem cell test) sensitisation – several models under development
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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 experienced regulatory division within the Eurofins Group and other partners that support us in covering the regulatory issues of chemicals, agrochemicals and biocides.
Dr Wolfram Riedel, CEO
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1984
Foundation under the name Dr Müller Lierheim AG.
1992
GLP certification.
1995
Within a management-buyout the company was renamed to BSL BIOSERVICE Scienitific Laboratories GmbH.
1995
Accreditation according to DIN EN ISO 45001/DIN EN ISO 17025 as first laboratory in Europe.
2006
BSL BIOSERVICE becomes a partner laboratory of the Eurofins group.
2007
Acquisition of an additional building and establishment of a brand new state-of-the-art in vivo facility with a laboratory area of 3,000m2.
2009
BSL BIOSERVICE takes a leading role within the Eurofins REACH Task Force as toxicology partner.
2013
Expansion into an additional building to increase the in vitro laboratory space for bioassay, viral clearance and biosafety testing.
ACCREDITATIONS Good Laboratory Practice (GLP) DIN EN ISO IEC 17025 Good Manufacturing Practice (GMP) FDA approved Radioactive handling permission CLIENTS Chemical industry Agrochemical industry Biocides industry Pharmaceutical/ biotech industry Food industry Cosmetic industry
Chemical Watch | Global Service Providers Guide 2014
Dr Wolfram Riedel has worked as CEO of BSL BIOSERVICE since 1994. He holds a master’s degree in biology and performed his PhD thesis at the German Cancer Research Centre, Heidelberg, Germany. He has extensive experience in toxicology and regulatory services and is a member in various expert groups. Dr Marc Kunze, CSO Dr Kunze studied pharmacy and toxicology and holds a PhD in medicinal chemistry and a master in toxicology. After several years at the university giving lectures on pharmacology and toxicology, he moved to the pharmaceutical industry. He specialises in non-clinical and clinical toxicology within drug development and risk assessment of chemicals. As CSO at BSL BIOSERVICE, Dr Kunze acts as an internal and external consultant for all areas of toxicology. In addition he is responsible for preparation of study designs and project management of regulatory toxicological studies. Dr Achim Albrecht, Scientific Director With more than 20 years of experience in contract research, Dr Albrecht is working today as Scientific Director in vivo Pharmacology/ Toxicology at BSL BIOSERVICE. His experience includes biological safety testing, safety pharmacology, safety toxicology and elaboration of expert reports and statements for drugs and chemicals From 1995-2010 he has been working at BSL as Head of in vivo Pharmacology and Toxicology, Study Director in vivo and was writing biological evaluation reports. Dr Albrecht has a PhD in veterinary medicine and is a member in various expert groups. Dr Iris Pfisterer, REACH Manager As REACH Manager at BSL BIOSERVICE, Dr Iris Pfisterer is dedicated to support our clients with all enquiries and questions about REACH and project manages large projects. This may include projects from data gap analysis via laboratory testing to the final dossier preparation. Dr Pfisterer holds a master’s degree and PhD in biology and has supported our clients at BSL since 2009. Other staff In total more than 200 people work for BSL BIOSERVICE. Our highly educated and experienced staff 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 level of flexibility.
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PROFILE: BSL BIOSERVICE Scientific Laboratories GmbH
Consulting, testing strategies and individual study designs
GLOBAL OFFICES
Website
www.cehtra.com
cehtra@cehtra.fr
Head office
43, rue Laroque, 33560 Sainte-Eulalie, France
Tel
+33 557775610
CEHTRA Lyon – 80, rue Condorcet, 38090 Vaulx Milieu, France CEHTRA Paris – Avenue Laurent Cély, 92600 Asnières sur Seine, France CEHTRA Europe – 134, rue Saint Germain, 1410 Waterloo, Belgium CEHTRA UK – 6th Floor City Gate East, Toll House Hill, Nottingham, NG1 5FS, UK CEHTRA India – TC15/1764, Forest Office Lane (B51), Vazhuthacaud, Trivandrum, 695014, Kerala, India CEHTRA India –245, Level 2, Elegance Building, Mathura Road, Jasola, New Delhi, 25, India CEHTRA North America – 24 Ivy Lea Crescent, Toronto, ON M8Y 2B6, Canada
Fax
+33 557775620 Paul Thomas
SERVICES PROVIDED
Contact Directors
Philippe Adrian, President CEHTRA SAS and KREATiS, Manager CEHTRA Europe
Peter Jenkinson, CEO CEHTRA SAS, Manager CEHTRA UK
PROFILE: CEHTRA
CONTACTS
Regulatory dossier services
Jason Nugent, Manager CEHTRA North America
CEHTRA provides clients with bespoke services for the production of regulatory dossiers worldwide or together with our partners, be that in the field of general chemicals, cosmetics, biocides, pesticides or pharmaceuticals. We have all the competencies in-house to do all or any part of a project. We have contributed to, or realised over 1,000 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 adding a module to allow speedy formatting of final dossiers).
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
With more than 12 years of culture and experience in different industrial sectors, from pesticides to general chemicals, and a complete understanding of the tools used in risk-data interpretation, including generation of exposure limits, CEHTRA is able to bring you answers and support in industrial hygiene adapted to your specific needs.
Nathalie Ledirac, R&D Director Laurence Gasnot, Manager CEHTRA Paris Paul Thomas, Manager CEHTRA Lyon, CEO KREATiS
OVERVIEW CEHTRA offers scientific and innovative solutions ensuring regulatory compliance of chemicals to international obligations: from portfolio strategy to the notification of chemicals, from human exposure to site audits. CEHTRA provides high quality regulatory services, to companies committed to the safety of their products, at optimal cost.
Consortium and Sief management
Turnover, chemical service provision
-
We offer a complete service that can either be used as a stand-alone or may be combined with the technical services provided by CEHTRA. We make sure that the milestones and deadlines of your project are met while ensuring the spirit of fairness and transparency, at the same time maintaining strict confidentiality for those areas that matter for your business. We can help you with the preparation of consortium agreements, maintaining contact lists, archiving, billing and all the aspects required for effectively running consortia and Siefs.
No of offices
8
Expert services
No of countries represented
5
Our experts have been successful in proposing and supporting complex issues for CMR classifications, modifying acceptable exposure limits and other critical substance-related end-points at member state or EU level. We have also successfully used our knowledge in clinical toxicology and epidemiology to support several of our clients in court cases.
VITAL STATISTICS
2012/13
Turnover, group
€5m
Staff, group
65
Staff, chemical service provision
57
SERVICE AREA BREAKDOWN
REACH OR Services CEHTRA provides a REACH only representative (OR) service.
IT & Legal Training 6% software 2% 2% Information 5% Representation & management 10%
Authorisation services
Consultancy/ advisory 75%
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CEHTRA is one of three companies in a joint venture, ChemAdvocacy, providing a full service in the field of authorisation including socioeconomic analysis and the company has already provided SEAs for specific biocidal substances. Modelling services In January 2014 CEHTRA opened a subsidiary company, KREATiS SAS, which specialises in in silico predictions (High-Accuracy Qsars), which can be used to replace laboratory studies in many regulatory dossiers such as REACH (more info on www.kreatis.eu).
Chemical Watch | Global Service Providers Guide 2014
2001
Company established.
2004
Opening of UK office.
2008
Opening of Brussels office.
2008
Opening of Lyon office.
2009
Start of the Indian Joint venture.
2011
Opening of North America offices.
2012
Opening of ChemAdvocacy.
2014
Opening of KREATiS.
ACCREDITATIONS Number of European registered toxicologists (ERT) and other certificates: OO 11 ERTs; OO one IOB/UKEMS GT; OO two chartered chemists (MRSC); and OO one CIH (Certified Industrial Hygienist). PARTNERS KREATiS, LTS REACH OR, ChemService GmbH, ECOonline, Microeconomix CLIENTS Chemical companies, flavours and fragrances, petrochemicals, cosmetic companies, plant protection industry, biocides, veterinary products, pharmaceuticals. TESTIMONIALS “CEHTRA helped us to submit ten 2010 REACH dossiers as lead registrant. We greatly appreciated their expertise in toxicology and ecotoxicology in particular in cases where the protocols of standard studies needed to be adapted to the test substances. In fact many of our substances turned out to be ‘difficult to test’ due to their physico-chemical properties. We have decided to use them again and are once more confident of success for our 2013 dossiers.” – signed DRT CASE STUDY 1: SEA dossier for biocide The biocides products Regulation requires a socio-economic analysis of substances which may be subject to substitution (CMR, PBT endocrine disruptors, etc). ChemAdvocacy has been awarded a study on a national authorisation dossier for a wood protection product (PT8), classified CMR, PBT. We are developing a methodology, the first of its kind for biocide products, inspired by the available guidance (REACH, etc), and we have presented our proposal to the French Competent Authorities, with expected finalisation of preparation for submission in early Summer 2013. CASE STUDY 2: in silico predictions a priority
In silico methodologies to replace experimental studies are becoming a hot topic, especially with the 2018 REACH deadline approaching. CEHTRA has heavily invested in an in silico toolbox we call i-SAFERAT on the basis of high quality predictions based on best quality experimental data where necessary coupled with a read-across and weight-of-evidence approach. Our aim is to cut the cost of REACH substance submissions for lower tonnage substances without compromising data quality.
STAFF SELECTION Peter Jenkinson − PhD, GT – CEO CEHTRA SAS and Manager of UK Office Peter Jenkinson has a PhD in reproductive toxicology and over 30 years' experience in the CRO industry specialising in genetic toxicology. Latterly he was the director of the Chemical Business Unit at Harlan Laboratories with a primary role of developing the REACH services of the company. In March 2010 he joined CEHTRA to open the UK office and has provided expert toxicology advice, particularly for study monitoring and data interpretation. Paul Thomas PhD, ERT − Marketing Director CEHTRA , Manager of Lyon Office and CEO KREATiS Paul Thomas has a PhD in aquatic ecotoxicology and 17 years' experience with industrial chemicals, agrochemicals and biocides gained at CIT, ATOFINA and AkzoNobel. He joined CEHTRA in 2008 as director of CEHTRA Lyon specialising in REACH-related services and is manager of the CEHTRA ecotoxicology team. Paul has contributed strongly to numerous successful registrations including several fragrance molecules. Philippe Adrian PhD – President CEHTRA SAS and KREATiS and Manager of Brussels Office Philippe Adrian has a PhD in soil science and over 20 years' experience with agrochemicals and biocides. Prior to his current position he worked as research scientist in Germany. Later he worked at CNRS in France and then Rhone-Poulenc Agrochimie and FMC. In 2001 he created CEHTRA with Pierre-Gerard Pontal and manages the environmental fate team. He has developed modelling expertise for pesticides according to current models, as well as biocides using relevant TGDs. Nathalie Ledirac PhD, ERT – R&D Director Nathalie has a PhD in cellular and molecular aspect of biology and 13 years’ experience with agrochemicals. She worked as a research scientist at INRA in France on pesticide toxicity and has also participated in private research on drugs for pharmaceutical industries (HMR, Galderma). She joined CEHTRA in 2006 as a regulatory toxicologist and provides expert toxicology advice in study monitoring and data interpretation. She develops close partnerships with private and academic research by increasing the scientific participation of CEHTRA experts in research projects (research programmes, publications, model development for pesticides, accreditation, etc). Laurence Gasnot PhD – Manager of Paris Office Laurence has a PhD in material sciences. She worked more than 17 years in the industry where she has gained profound experience in polymer science as well as in food contact regulations and health products. She joined CEHTRA in 2008 developing the food and food contact market and proposing a pragmatic approach for cosmetic packaging assessment to our customers. For the last few years she has worked on several successful European authorisation dossiers on food contact, drinking water and food additives. Charles Alarcon PhD, CIH – Industrial Hygienist Charles has a PhD in Geochemistry and over 12 years' experience as an industrial hygienist, and was one of the first in France to obtain the prestigious CIH certification (still one of only ten in France). He joined CEHTRA in 2009 developing exposure scenario in REACH dossiers and e-SDS. Through audits and other site studies, and using currents models in risk assessment, he has gained a large experience in many industrial sector activities and acquired a unique understanding of health and safety industrial culture. Jason Nugent MSc – Manager of CEHTRA NA Jason is a highly experienced chemical registration specialist who has worked within the North American chemical industry for more than 15 years. Over the course of his career, Jason has managed and participated in the preparation of more than 400 chemical registrations in Canada, USA, the European Union, China, Australia, and Japan. In recent years he has been heavily involved in assisting North American companies to prepare for and comply with REACH.
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PROFILE: CEHTRA
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
SERVICES PROVIDED REACH consultancy Centro Reach provides in-company support on the REACH Regulation, including impact assessment and liabilities, product portfolio analysis and subsequent REACH compliance actions, supply chain communication assessment up and down, helpdesk consultancy.
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
Sergio Treichler
Ownership
Private company
Locations
Milan
Founded
2007
Centro Reach offers skills in management of registration dossier preparation for individual lead registrants, and/or among consortia, and for joint submission applicants. We provide assistance and information for registration requirements, Iuclid 5 compilation and registration submission, letter of access management, Sief management and late pre-registrations. Consortium management in technical, administration, legal and coordination field is one of the key activities of Centro Reach. The company's wide expert network is able to fulfil all our customers’ support needs. CLP and SDS management Consultancy and submission of CLP notifications under the CLP Regulation, safety data sheet assistance and management for EU territory as well as extra-EU areas are also basic activities of Centro Reach.
OVERVIEW Centro Reach was founded on 20 February 2007 on the initiative of Federchimica and Assolombarda. Federchimica, the Italian Chemical Industry Association, controls 53.3 % of the capital stock, the remaining part is held by ten other industrial associations. The company mission is to provide professional consultancy support to chemical industry firms and downstream users, helping them meet the REACH, CLP and other regulations concerned with the management of chemicals and safety in the workplace. Centro Reach assists chemical manufacturers and importers in the dossier preparation for substance registration either on an individual basis or in consortia and has participated or is participating in almost 20 consortia working on registrations for 2010 and 2013. We have expertise in: CLP notifications, support for safety data sheets, training courses, in-company consultancy, legal assistance for chemical regulations, regulatory services for non-EU countries thanks to our international network, and R&D in the field of NTM methods (Qsar projects). VITAL STATISTICS
Other chemical regulatory needs Centro Reach and its network is able to support companies in the field of biocides and food contact material requirements, also outside Europe. Our consultants have proven experience in submitting chemical notifications in key-areas like North and South America, China, Japan, Korea, India and Australia as well as countries like Turkey, Switzerland and others. TSCA notifications in the US are supported by our network and safety data sheet management is also among the services we offer. Training courses Since the very beginning training on REACH and CLP regulation has been a core activity of Centro Reach. Between 2007-2013 more than 3,300 participants have attended our training sessions which are also offered through Confindustria system and dedicated service activities. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007
Founded by Federchimica (Association of Italian Chemical Industry) and Assolombarda – the largest regional enterprise organisation in Italy.
2008
A further ten industrial associations belonging to the Confindustria system become stakeholders Centro Reach. Partnership with Reach Centrum in Brussels begins
2009
Publication of Inventory on certified Italian laboratories for REACH registration studies. Set-up of expert network and co-operation agreements Involvement in more than 15 national and EU consortia Intensive training activities involving almost 500 professionals, both in-house and in-company courses
2010
Individual registrations for 95 companies successfully submitted. Management and involvement in 20 consortia for 2010 registration. Intensive training specifically on CLP regulation and notification process, safety data sheets and labelling. Service for SDS management launched. CLP notifications of more than 550 substances.
2011
Centro Reach served around 310 customers, in large part not Federchimica members about 40% of them being downstream users. More than 50 training course sessions and two national workshops with over 150 participants. Centro Reach supports Italian University Master Reach activities. Co-operation with Reach Global Services (RGS) for substance notifications of Italian companies in Turkey
2013/14
Turnover, group
ca €1m
Turnover, chemical service provision
ca €0.7m
No of offices
1
No of countries represented
All of the EU
Staff, group
6
Staff, chemical service provision
3 (plus wide expert network)
SERVICE AREA BREAKDOWN Training 15% Legal 5% Information 5% Representation & management 15%
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Consultancy/ advisory 60%
Chemical Watch | Global Service Providers Guide 2014
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 on certified Italian laboratories for REACH registration studies. During the first half of 2013, Centro Reach focused its activities on the May 2013 Reach registration deadline. Around 450 customers and managers took advantage of our services during 2013, a significant share from nonassociated companies. Around 35 training course sessions, both in-house and at company sites, were delivered. Centro Reach is actively involved in two EU financed LIFE + projects which started during 2013.
ACCREDITATIONS Certified ISO 9001 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, VERSALIS, others as well as non-Italian customers CASE STUDY 1: EU Project ORCHESTRA Centro Reach is working in partnership with the M Negri Institute and other Italian and European subjects in the European Union's Seventh Framework Programme “Organising dissemination on results of projects on chemical evaluation, spreading techniques for risk assessment (ORCHESTRA)". Non testing methods (NTM) such as in-silico methods will be very important to 2018 registrations, which will see mostly SMEs involved in the registration of more than 20,000 substances. ORCHESTRA addresses the strategic questions concerned with a broad, systematic dissemination and exploitation of the research results of several EU projects, including specific dissemination and exploitation measures for the different stakeholders – including regulators, industry, citizens, international bodies, scientific and other associations. 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
STAFF SELECTION Bruno Brianzoli – Coordinator In 1964, after graduating in chemical engineering at Politecnico di Milano, Bruno joined the multinational group Solvay, where he worked until January 2007. As managing director of the Solvay Group from 1997 to 1999 he was in charge of managing the business of the Solvay Sodi Company (the production of sodium carbonate) in Bulgaria. From 2000 2007 he was general manager of the Solvay. Sergio Treichler – General Director At present Sergio is the central technical – scientific director of Federchimica. He previously worked in the industrial and financial fields for the World Bank in Uganda, Ethiopia and Paraguay. Sergio has been a member of important groups in Cefic such as the Product Stewardship Programme Council and HSE, Logistics and Energy Programme Council. He is a member of the board of directors of Certiquality Srl and an advisor of ICS-UNIDO. Ralf Knauf – Business Development Manager In 1980 after finishing his professional education in economy and industry at the head office of Bayer AG, Germany, Ralf moved to Bayer Italia's AgChem division, where for more than 25 years he was responsible for international business and regulatory coordination in several different Italian AgChem companies. In 2007 he joined Federchimica's product safety within technical and scientific department, focusing on REACH and related regulations. Since 2009 he has been heavily involved in Centro Reach, coordinating training, R & D projects and consortia activities. Stefano Arpisella – Technical Manager Graduated in chemistry and pharmaceutical technologies. After his activity in R&S at Università di Ferrara, he worked in the Federchimica technical and scientific department for chemicals and product safety. He has huge practical experience in REACH thanks to more than 400 in-company activities and visits.
CASE STUDY 2: Titaniumdioxide ( TiO2 ) study in nanosize under REACH Centro Reach in co-operation with ARPA E Romagna has simulated a Iuclid 5 dossier for a volume up to ten tons/year covering the necessary endpoints with specific data of the substance in nanosize, showing that REACH regulation can handle nanomaterials, and that there is no scientific evidence for assuming that substances in nanosize 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.
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PROFILE: Centro Reach
2012
SERVICE AREA BREAKDOWN
Laboratory 100%
PROFILE: Charles River
CONTACTS Website
www.criver.com
askcharlesriver@crl.com
Head office
251 Ballardvale Street, Wilmington, MA, US
Tel
+44 1875 614545/ 1- (877) CRIVER-1 (US)
Fax
+44 1875 614555
Contact
Karen McCusker
Directors
James Foster
251 Ballardvale Street Wilmington, MA United States
Ownership
Public limited company Global locations and offices
SERVICES PROVIDED
Locations Founded
1947
GLOBAL OFFICES
Services to meet REACH requirements
OVERVIEW Charles River is the market-leading provider of contract testing services to the pharmaceutical, chemical and agrochemical industry and has been providing high-quality research models and laboratory animal support expertise since 1947. Our unique safety assessment portfolio spans the entire research and development process, allowing for flexible, customised approaches to support both single-study and broad-based programmes. With facilities in Europe, North America and Asia, we are well-positioned to help optimise the discovery and development of our clientsâ&#x20AC;&#x2122; drugs, chemicals, agrochemicals, medical devices and therapies. Our customer base includes major pharmaceutical and biotechnology companies, as well as leading companies in the chemical and agrochemical sectors, academic institutions and government research centres. Always leading with science, our exceptional team of toxicologists, pathologists, veterinary surgeons, regulatory specialists and support personnel designs and conducts safety studies ranging from acute to chronic toxicity and carcinogenicity studies. Charles River is also at the forefront of the industry in the fields of developmental and reproductive toxicology, inhalation toxicology and other specialty toxicological assessments. We offer an expanding portfolio of in vitro methods to replace traditional in vivo studies where possible. All of our studies are conducted to GLP and are supported by the highest quality analytical services, including bioanalysis, central laboratories, immunology, drug metabolism and pharmacokinetics and formulation development. VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices No of countries represented Staff, group Staff, chemical service provision
17 7,000 -
Charles River has supported the chemical industry for over 40 years. Drawing on this extensive experience, we offer a full range of studies to meet the requirements of REACH. Physico-chemical testing Our service includes all the characterisation and physico-chemical studies necessary to support worldwide registrations for both active ingredients and formulated products. We offer a full range of testing services that meet REACH requirements, either as packages or stand-alone studies conducted to the appropriate guidelines. Tests available include: OO physical state; OO melting point/freezing point; OO boiling point; OO relative density; OO surface tension; OO vapor pressure; OO water solubility; OO organic solvent solubility; OO octanol/water partition coefficient; OO dissociation constant; OO flammability; OO pH; OO viscosity; OO oxidizing or reducing properties; OO hydrolysis as a function of pH; and OO spectra (UV, UV/VB, IR, NMR, MS) Acute toxicology A full spectrum of regulatory-compliant studies is offered to evaluate oral, dermal and inhalation toxicity, dermal and ocular irritation and skin sensitisation. In vitro models are available to assess dermal irritation or corrosivity and ocular irritation. Repeat, reproductive and chronic toxicology We routinely perform repeat dose studies from short term to chronic, including carcinogenicity. Reproductive toxicology screening to OECD 421 and 422 is available, as well as developmental toxicology in rats and rabbits and multigenerational studies in rats. Genetic toxicology Studies typically follow a tiered approach beginning with an in vitro Ames test and progressing to short-term in vitro assays, including the mouse lymphoma and chromosomal aberrations assays, and in vivo assays such as the rodent micronucleus test. In addition to standard study designs, we are also able to offer customised protocols for the rapid screening of candidate molecules for toxicity profiles.
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Chemical Watch | Global Service Providers Guide 2014
Ecotoxicology
STAFF SELECTION
Charles Riverâ&#x20AC;&#x2122;s custom-designed ecotoxicology building provides flexible, modern facilities for the conduct of aquatic and terrestrial ecotoxicity investigations. Each laboratory has independent environmental control to accommodate a wide variety of test organisms. Additionally, standalone maintenance cabinets are used to house a range of species, while separate environmentally controlled laboratories are used for biodegradation studies. Our team of expert scientists is experienced in handling difficult test items (eg, volatile, unstable, complex and poorly soluble mixtures), and have the facilities and equipment to deal with complex test situations. We have a proven ability in the conduct of studies in accordance with the OECD guidance document on Aquatic toxicity testing of difficult substances and mixtures. Most ecotoxicology tests can be conducted with a radiolabelled test item if necessary.
Director, Laboratory Sciences
Charles River has over 25 yearsâ&#x20AC;&#x2122; experience conducting environmental fate studies to meet European, US and Japanese regulatory requirements. Modern open-plan laboratories are provided for the in-life and analytical phases of environmental fate and related studies. There are eight large incubation rooms, each with independent environmental control, ensuring full compliance with worldwide guidelines for chemical product registration.
OO
Joined Charles River in 1988 Has responsibility for all aspects of the services provided by Charles River to chemical, agrochemical and veterinary product companies
Operational Area Manager, Chemistry OO OO
OO
Joined Charles River in 1988 Experienced in xenobiotic metabolite identification, residue analysis and analytical chemistry Responsible for managing a team of study directors handling physico-chemical, analytical and stability studies
Head, Environmental Fate and Metabolism OO OO
Joined Charles River in 1994 Oversees the design and conduct of studies intended to characterise the fate of chemicals in the environment and to study the nature of metabolites and metabolic pathways using a range of chromatographic and spectrophotomic techniques
Analytical support A validated analytical method is required to support many product chemistry and ecotoxicology tests. Experienced analysts are available to establish new analytical methods or to transfer existing methodology using a wide range of up-to-date equipment. The storage stability and shelf-life of the formulated product can be determined under a variety of specified storage conditions. Solid, liquid, semi-solid and aerosol formulations can all be evaluated using real-time and accelerated storage stability testing. We have dedicated facilities to stress the material using monitored heat, humidity or light parameters. ACCREDITATIONS AAALAC, GLP, GCPv, GEP CLIENTS A broad range of companies producing pharmaceutical, agrochemical, chemical, biocide and animal health products. Our client base includes consortia, start-ups, virtual companies and SMEs as well as global corporations. TESTIMONIALS Testimonials can be provided on request CASE STUDY Our clients and their programmes are protected by our strict confidentiality agreements; therefore, we are unable to discuss specific case studies. All our study directors have extensive experience ranging from five to over 25 years, giving them the depth of expertise required to deliver to the highest standard on studies and provide a flexible, solutions-driven approach to the design of both individual studies and entire registration programmes. With emphasis on quality and technical excellence, enforced through continuous training, internal audit programmes and proactive communication, our scientific staff will work together with your own teams to produce work of the highest standard to meet your registration requirements.
Chemical Watch | Global Service Providers Guide 2014
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PROFILE: Charles River
Environmental fate studies
OO
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. Our technical staff has a great experience in all aspects of REACH. Our team has prepared a large number of registration dossiers and chemical safety reports (CSR) and also had provided expert advice on specific areas of REACH, such as data evaluation and/or study monitoring. ChemSafe has a vast experience in programme, project, Sief and consortia management.
PROFILE: Chemsafe
CONTACTS Website
www.chemsafe-consulting.com
chemsafe@chemsafe-consulting.com
Head office
Chemsafe Srl, Via Ribes, 5, 10010 Colleretto Giacosa (TO), Italy
Tel
+39 0125 538888
Fax
+39 0125 538475
Contact
Dr José V Cantavella Cabedo, Lawyer
Directors
Dr Antonio Conto, European Registered Toxicologist (ERT), Managing Director
Ownership
Private company
Locations
Italy, Qatar
Founded
2001
REACH and CLP/GHS ChemSafe provides its clients with strategic, legal and technical support in order to comply with REACH and CLP/ GHS. Our technical support includes full dossier preparation (as lead registrant or joint submissions), data gap analysis, review and analysis of physico-chemical, environmental fate. It also includes ecotoxicology and toxicological data, CSA/CSR preparation, human and environmental exposure scenarios (ES) and risk assessment, and application of alternative strategies to testing such as using a read-across approach and Qsars. Iuclid 5 preparation and submission to ECHA and pre/post dossier submission contact with the authorities.
OVERVIEW ChemSafe’s vision is to offer regulatory and technical /scientific solutions and services in the field of chemical safety with a “key point” approach and customer care attitude. VITAL STATISTICS
2012/13
Turnover, group
€1.8m
Turnover, chemical service provision
€1.8m
No of offices
2
No of countries represented
2
Staff, group
12
Staff, chemical service provision
10
SERVICE AREA BREAKDOWN Legal 10% IT & software 5% Laboratory 5%
Training 5%
Consultancy/ advisory 45%
Information 10% Representation & management 20%
GLOBAL OFFICES ChemSafe Srl, Colleretto Giacosa (TO), Italy ChemSafe International WLL, Doha, State of Qatar
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Sief and consortia management We can help our clients with a full/partial Sief and/or consortia management system, including preparation of all kind of legal agreements, letters of access, data sharing, maintaining contact list, archiving, billing and all the necessary daily aspects for running a successful Sief and consortia. Only representative (OR) and third party representative (TPR) Since 2008 ChemSafe has been acting as only representative (OR) for non-European manufacturers and fulfilling the pre-registration and registration obligations as prescribed in Article 8 of REACH Regulation. Non-EU companies must either rely on their importers, or retain a person in the EU to represent their interests, these are the only representatives (ORs). Appointing your own OR gives your company business freedom and security as you will have regulatory independence from other members of your supply chain; you will have a high level of confidentiality by separating the company name from proprietary product constituents; you will maintain supply chain privacy between buyers and sellers; provides expertise and third-party review for submissions to the European Chemical Agency (ECHA) and provides representation to both substance information and exchange forums (Siefs) and consortia. ChemSafe is acting as OR for different types of companies coming from USA, Switzerland, South America, Middle East and Far East countries. Furthermore we can act as a third party representative (TPR) for companies not wanting to disclose their identity. 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 prepare the technical equivalence data for active substances. We coordinate the regulatory strategy with the national and/or international authorities in order to deliver a successful dossier for biocidal products and for Agrochemicals.
Chemical Watch | Global Service Providers Guide 2014
Endocrine disruptor chemicals (EDCs) services
CASE STUDY 1: REACH testing progamme
Based on US EPA EDSP and the OECD conceptual framework for testing and assessment of EDCs we can offer the following services: a) pre-screening activity based on OO substance characteristics; OO uses and exposure scenarios for: b) data search on the substance and on similar substances OO epidemiological data; OO ADME (absorption, distribution, metabolism and excretion) c) regulatory lists check-out (EPA, OECD). d) in silico pre-screening with a particular emphasis on reproduction and long term studies. OO WOE (weight of evidence) and data gap analysis; OO testing strategy definition, management and monitoring.
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 for one of our clients.
OO OO OO
OO OO
general regulatory support for cosmetic products. competent person designation. data evaluation, data gap analysis, read-across methodology, in silico method application, testing programme design, and study monitoring/ coordination. PIF (product information file) or PSR (product safety report). administrative activity, including robust study summaries and substance information sheet (SIS) with ingredient evaluation.
Petrochemicals We advise our clients on legal aspects of chemical trade worldwide and related chemical control regulations. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2001
Start-up in Italy as “a one man” company.
2007
REACH services offered.
2009
Biocides and agrochemicals group creation.
2010
Technical consortia advisers for three international consortia. Staff increase to ten people.
2011
Petrochemicals derivatives, wastes, cosmetics and pharmaceuticals consortia management. Staff increase to 12 people.
2012
Qatar office opens.
Over 140 REACH dossiers done, including lead registrant and joint submission dossiers are our background; including some done for UVCB substances. An important number of CSR, and hundreds of safety and extended safety data sheets (SDS and e-SDS) had also been developed by our team. CASE STUDY 3: legal case In 2012 ChemSafe successfully settled a legal case with the European authorities on behalf of one of our clients. STAFF SELECTION Dr Antonio Conto – Managing Director Biology degree, European Registered Toxicologist (ERT). Founder of Chemsafe. >26 years of experience in the chemical and toxicological field. Lara De Luca – Head of Technical Department Industrial chemist, with more than 12 years of experience. Risk assessment, exposure scenarios, CSR/CSA. Dr José V Cantavella Cabedo – Head of Legal Department Lawyer, JD in environmental law, with more than 20 years of experience. Environmental, chemical and international law Francesca Fasano – Head of Biocides Department Industrial chemist, with more than ten years of experience. Biocides, agrochemicals and ecotoxicology. Elena Meriano – Head of REACH Registration group Biologist, with more than 11 years of experience. Technical dossier preparation, study monitoring, Iuclid. Loredana Savin – Head of CLP/GHS group Biologist, with more than 11 years of experience. Classification, labelling, GHS.
ACCREDITATIONS ChemSafe is a full member of ORO, the Only Representatives Organisation. ChemSafe is a full member of the Industrial Union of Turin, Italy. PARTNERS OO
ChemSafe is 100% privately owned.
CLIENTS Our clients are manufacturers and importers involved in the market sectors of: chemicals, pharmaceuticals, agrochemicals, biocides, cosmetics, food, medical devices, nanomaterials and petrochemicals worldwide. Their size goes from multinational companies to SMEs and national authorities. TESTIMONIALS Any persons or companies requesting testimonials or references will be provided with them upon individual written request.
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PROFILE: Chemsafe
Cosmetics
CASE STUDY 2: REACH dossier work
GLOBAL OFFICES Chemservice GmbH, Worms, Germany Chemservice S.A., Grevenmacher, Luxembourg Chemservice Asia Co Ltd, Seoul, Korea Chemservice Ltd Sti, Bodrum/Mugla, Turkey Chemservice EHNS GmbH, Worms, Germany Consortia Management GmbH, Worms, Germany ChemCehtra SAS, Bordeaux, France ChemAdvocacy S.A., Grevenmacher, Luxembourg
PROFILE: Chemservice
CONTACTS Website
www.chemservice-group.com
info@chemservice-group.com
Head offices
Chemservice GmbH, Von-Steuben-Str 13, D-67549 Worms, Germany / Chemservice S.A., 5, an de Laengten, L-6776 Grevenmacher, Luxembourg
SERVICES PROVIDED Global regulatory affairs consulting
Tel
+49 (0)6241 95480-0 / +352-270776-1
Fax
+49 (0)6241 95480-25 / +352-270776-75
Contacts
Karl-Heinz Reis / Dr Günter Spang
Directors
Dr Dieter Drohmann, Managing Director Karl-Heinz Reis, Director Global Regulatory Affairs Dr Günter Spang, Director Toxicology and Risk Assessment Thomas Schaefer, Director Data and System Services
Ownership
Privately owned group of companies
Locations
Germany, Luxembourg, Korea, Turkey, France
Founded
2007
OVERVIEW Chemservice is one of the world’s leading global regulatory affairs consulting companies. We support our clients in gaining competitive advantage through the regulatory process. The Chemservice Group has in-depth experience in regulatory affairs and international chemical control legislation, toxicology, risk assessments and environmental sciences. Our substantial network in and knowledge of industry, academia, regulatory bodies and governments will be beneficial in solving regulatory issues. Different in-house disciplines (chemists, chemical engineers, toxicologists, environmental scientists, agronomists, biologists, veterinarian, regulatory specialists etc.) enables broad issue addressing. VITAL STATISTICS
2012/13
Turnover, group
~ €3m
Turnover, chemical service provision
~ €3m
No of offices
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%
Chemservice provides a broad range of services designed to assist clients in preparing for and in complying with international and national chemical control legislation. The application range for chemistry is extensive. Therefore, chemical control legislation is comprehensive in order to assure product safety, producer liability and consumer and environmental protection to regulate the marketing of chemical substances. Beside inventory notifications we conduct registrations of biocides, cosmetics, and compile dossiers for food contact clearances and food and feed additive petitions. With our regional partners and offices we support our clients to comply with the EU-REACH-like chemicals regulations in China and Korea. REACH and GHS/CLP We provide our clients with strategic and technical support for REACH and GHS/CLP. The technical support includes, for example, data gap analysis, registration cost evaluation, testing strategy proposals, placing/ monitoring/reviewing of studies, pre-registrations and registrations, dossier preparation, compilation of chemical safety reports, exposure, hazard and risk assessments, PBT/vPvB evaluation and support on authorisation, REACH-IT and IUCLID 5 assistance, C&L notification, safety data sheet and label creation. Through our legal entity “ChemAdvocacy” we provide REACH authorisation services (including SEA), advocacy and product stewardship consulting. Consortia, Sief and letter-of-access management Independent secretariat, trustee and accounting services to REACH consortia and Siefs in order to enable the chemical industry and its value chain to fulfil their registration obligations according to the REACH Regulation. The automated online letter-of-access tool provides an efficient LoA management for Sief members to acquire access rights for a specific substance for the submission of the joint REACH dossier. Moreover, it will help to reduce resources at lead registrant and consortia level and offers professional accounting support – including trustee account management. Only representative and third party representative We act for manufacturers outside the EU as only representative and cover fully the registration and pre-registration obligations. Furthermore we provide trustee services for indirect non-EU supply chains with final import into the EU. The importers of these non-EU manufacturers would no longer have registration obligations, but will be regarded as downstream users. Only one registration is needed by the only representative. Moreover, we act as only representative for non-EU manufacturers of articles, which intentionally release substances and we act as third party representative (of a community entity) according to REACH Article 4.
Consultancy/ advisory 45%
Representation & management 20%
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Chemical Watch | Global Service Providers Guide 2014
2007
Start-up in Luxembourg
2008
Opening of Chemservice office in Germany
2009
Launch of Consortia Management GmbH as full service provider for consortia and Sief management
2010
Opening of Chemservice offices in Korea and Turkey
2011
Launch of Chemservice EHNS
2011
Launch of JV ChemCehtra with office in France
2012
Launch of ChemAdvocacy S.A. with office in Luxembourg
ACCREDITATIONS We are a member of ORO, the Only Representatives Organisation in Brussels and comply with the quality standards of ORO. Dr Drohmann is chairing ORO as president. PARTNERS
CASE STUDY 3: REACH dossier work Chemservice has experience with about 280 Tier 1 and 2 REACH dossiers, including member and lead dossiers. Moreover, a significant number of new substance registrations (non-phase-ins), inquiry dossiers, PPORDS, chemical safety reports and extended safety data sheets were successfully completed. Furthermore, we have acted on behalf of our clients with more than 1.000 C&L notifications. STAFF SELECTION Dr Dieter Drohmann – Managing Director OO OO OO
Karl-Heinz Reis – Director Global Regulatory Affairs OO OO
Our partner companies are listed on our website. CLIENTS Consultant for the chemical industry and its value chain, including OEMs. Our clients range from multinational chemical companies to SMEs, formulators, traders, retailers and OEMs. We do not disclose our customers publicly, but provide reference names and testimonials upon request. TESTIMONIALS Persons who request testimonials or references will be provided with them upon individual request. CASE STUDY 1: Global inventory strategy and registration We have significant experience in global inventory registrations and conducted around 120 notifications to the Turkish inventory and 300 nominations to the inventory in Taiwan. For multiple clients we have supplied global inventory strategies for new substances and conducted notifications to chemical inventories like Australia (AICS), Canada (DSL), China (IECSC), Korea (ECL), New Zealand (NZIOC), Philippines (PICCS) and USA (TSCA). CASE STUDY 2: REACH-Code-Model REACH does not distinguish between direct and indirect imports into the EU. Therefore, non-EU business followed by export to EU is more complicated – in particular if several non-EU steps along the supply chain are involved and substances have been formulated into preparations with confidential composition. In a multi-level non-EU supply chain the manufacturer of a substance usually does not know through which channels, in which products and finally how much volume of his substances is being imported into the EU. It is an essential business secret (CBI) of traders or formulators what the components of their products and who their suppliers and customers are. Neither the non-EU manufacturer (represented by the OR), nor the importer can fulfil their obligations without disclosing CBI and potentially leading to loss of business. Chemservice has developed a software based solution to track indirect EU export. Many companies with multi-step non-EU supply chains have signed up to this system already.
Chemical Watch | Global Service Providers Guide 2014
PhD in environmental sciences founder of the Chemservice Group >20 years of experience in the chemical industry as regulatory affairs manager master in biology >20 years of experience in the field of risk assessments, PBT assessments and CRO study director
Dr Günter Spang – Director Toxicology and Risk Assessment OO OO
PhD in agronomy ~20 years of experience in regulatory affairs consulting, including risk assessments and dossier preparation
Dr Neslihan Altinbas – Managing Director of Chemservice Ltd Sti, Turkey OO OO
PhD in chemistry ~15 years of experience in GLP and GMP quality assurance in the field of pharmacology and plant protection products, and nanoparticles
Thomas Schaefer – Director Data and System Services OO OO
Data management, indirect non-EU supply chains, SDS and labels >20 years of experience in IT and data systems
Natalia Jansen-Bouriatchenko – Regulatory Affairs Advisor (Ukrainian) OO OO
master in biochemistry ~20 years of experience in analytical and ecological chemistry, ecotoxicology and toxicology
Ah-Reum Seo – Regulatory Affairs Advisor (Korean) OO OO
chemist >eight years of experience in R&D and regulatory affairs
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PROFILE: Chemservice
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
GLOBAL OFFICES DEKRA Industrial GmbH, Handwerkstr 15, D-70565 Stuttgart, Germany SERVICES PROVIDED
PROFILE: Chilworth – a DEKRA Company
Process safety management – consulting CONTACTS Website
www.chilworth.co.uk
info@chilworth.co.uk
Head office
Beta House, Southampton Science Park, Southampton, SO16 7NS, UK
Tel
+44 (0)23 8076 0722
Fax
+44 (0)23 8076 7866
Contact
Dr David Firth, Mr Daniel Baker, Mr Mike Weaver
Directors
DEKRA Explosion & Process Safety Service Unit
Ownership
Wholly owned subsidiary of DEKRA SE
Locations
UK, USA, India, Germany, France, Spain, Benelux, Scandinavia, Eastern Europe, Japan, Brazil, Northern and Southern Africa, Israel, Japan and China
Founded
1925 (DEKRA)
Process safety management is the bedrock of excellence in process safety performance. Our global teams of PSM specialists provide the experience, knowledge and insight to support you with all the elements of your PSM programmes, whether they are concerned with process hazard assessment, risk analysis, mechanical Integrity, commitment to process safety, learning from experience or management of change. Whatever the maturity level of your PSM programmes, we can help you: - design and create relevant PSM programmes; - support your company in implementation monitoring and sustainability; - correct and improve deficient programmes; and - audit PSM programmes, comparing with best practices worldwide. Process safety engineering – specialist consulting
OVERVIEW For over 25 years, Chilworth has believed safer operations are underpinned by improved staff proficiency (competency, ‘know-how’, experience), solid programmes of continuous improvement (safety management systems) and a culture that encourages excellence and candour in the best practices of process safety. The resulting skills and systems must be suitable, correctly applied and monitored and well embedded and sustainable in the long term. We know doing these things well is not easy, but when successful, they will create PROCESS SAFETY EXCELLENCE, generating wealth for all those involved. At Chilworth we bring you our skills, experience and insight gained though operations on every continent in the world. We advise and inform through our consulting and training activities and we provide you access to our world renowned laboratory test facilities. We are the leading provider of expert knowledge and quality test data in the field of process safety, with an international consulting base employing doctorate engineering and scientific staff along with consultant engineers, scientists and technicians.
Implementing process safety programmes requires specialised skills and competencies. Process safety excellence requires technical and management proficiency – sometimes in-house and sometimes called in to respond to a specific requirement or unique situation. Whatever your specialist technical needs, we have the skills and breadth of experience to support your business. Whether you are carrying out a process safety review, implementing safety audits or ensuring compliance with standards or regulations, we have the up-to-date resources and skills to complete the task. If you require help with problem solving or incident investigation, you can rely on impartial advice and support from our experienced team whenever you need it. Most importantly, our team is your team. Chilworth’s consulting services can be built around your precise business needs; whether adding to your capabilities or supporting you on a short, medium or a permanent basis through our partnership programmes. Process safety information – laboratory testing
No of offices
30+
Good process safety practice demands a thorough understanding of the hazardous physical and chemical properties of materials you process. However, we recognise that data alone is rarely useful – it is the interpretation of the data and its implication for your plant that really makes a difference. Chilworth can manage your entire materials testing requirements, offering a turnkey service that not only collects data through rigorous experimentation and testing but also interprets and reports the results. Our global network of testing facilities gives your business full access to cuttingedge techniques and dedicated laboratory testing teams. We offer more than 300 standard testing procedures, as well as the research capability to conduct unusual or complex customised testing. The result is an expert and trusted service that not only delivers quality controlled results, but removes the pressure on resources, continuity and compliance associated with in-house testing.
No of countries represented
80+
Material testing
VITAL STATISTICS
2012/13
Turnover, group
€2.2bn
Turnover, chemical service provision
€495m
Staff, group
25,000+
Staff, chemical service provision
500+
SERVICE AREA BREAKDOWN
Training 5%
Laboratory 50%
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Other 10%
Consultancy/ advisory 30%
Representation & management 5%
Chilworth’s laboratories in the UK can handle powdered materials, gases or vapours, even if they are toxic or highly active and can offer a fast turnaround service if required. We strive to ensure only essential testing is undertaken, that our reports are comprehensive and meaningful, and that specialists are on hand to provide expert advice on the interpretation of results. We pride ourselves on providing a broad range of fire and safety services; including fire risk assessments. Laboratory testing Our CPE teams provide laboratory testing data with expert consultancy, for the identification and assessment of exothermic reaction hazards, thermal stability screening, reaction and adiabatic calorimetry, runaway simulation, engineering solutions and emergency vent design (DIERS). Laboratory Testing Services also available from Chilworth include: OO explosivity, CRH and exothermic chemical reactions, fire and thermal instability and consulting and testing for energetic material assessment, propellants, pyrotechnics and explosives. Chemical Watch | Global Service Providers Guide 2014
CLIENTS
Chilworth’s services include the complete range of physico-chemical tests required for European regulatory purposes. Through our colleagues at DEKRA, we can also provide expert testing for: OO physico-chemical analysis; OO toxicology and ecotoxicology; and OO dossier preparation / project management. Both REACH and CLP require information to be put into an MSDS data sheet. Our range of laboratory services from our GLP compliant testing laboratory enable compliance and regulation for: OO aerosols, explosives and oxidisers; OO pharmaceuticals and agrochemicals; OO biocides and plant protection products; OO explosives and oxidisers; and OO transportation of dangerous goods following the UN Manual of Tests and Criteria (CLP, ADR, IMDG, Iata etc). OO DEKRA fulfils the only representative position for several companies based outside the EU, assisting with portfolio optimisation, representing the company
Chilworth provides consultancy and testing services to a broad range of customers (who, for reasons of confidentiality, cannot be named). We work with a number of multi-site, blue-chip clients in a variety of processing industries including the petrochemical, chemical, pharmaceutical, food, drink, paper and packaging, plastics and rubber, agrochemical, automotive, aerospace and power generation sectors.
Process safety training Sharing knowledge is what we do; it is our guiding principle. By sharing our expertise, Chilworth develops long-term customer relationships that give the in-depth understanding required to achieve excellence in process safety engineering and its management. Successful process safety management requires staff who understand the best principles and practices of process safety. The Chilworth Process Safety Academy has been created to deliver knowledge to the standards that reflect our authority in the field of process safety. We offer a range of structured courses, taught by our team of leading experts, which train, educate and develop skills for a range of audiences, including: OO individual and team training; OO company-wide training to a consistent standard; and OO global group training to a consistent corporate standard. The Process Safety Academy offers the most specific and relevant training of its type in the world, delivered globally in multiple languages across a comprehensive range of platforms and media. Ways to learn include: OO in-company courses tailored for your industry or company - and to different levels; OO open public courses – delivered to a global standard; OO internet-based learning programmes; and OO broadcast and interactive webinars.
TESTIMONIALS Testimonials can be provided on request. CASE STUDY 1: Working closely with a global supplier of metals and minerals, Chilworth devised and delivered a comprehensive testing programme for CLP registration of a range of products and formulations. CASE STUDY 2: Supporting a global manufacturer and marketer of differentiated chemicals, Chilworth – a DEKRA company has tailored an extensive portfolio of tests of a diverse selection of materials under both REACH and CLP criteria. CASE STUDY 3: Co-operating with a number of service providers from Europe to the Far East, Chilworth has carried out a range of physico-chemical properties testing for REACH registration of products across a broad range of applications, while acting as study managers for a range of toxicology and ecotoxicology test programmes. STAFF SELECTION Dr Stephen Rowe – Managing Director With more than 20 years’ experience in process safety, Steve has particular expertise in chemical reaction hazards testing, exothermic reaction hazards consulting and dust, gas and vapour flammability testing and consulting programmes. Dr David Firth – Business Development and Marketing Manager Covering all areas of process safety, David has many years of experience working with customers in a variety of industries including chemicals, pharmaceuticals, agrochemicals, paint, polymers, adhesives, electronics, fuel additives, synthetic fibres and many others. Mr Daniel Baker – Safety Testing Specialist
1986
Foundation of Chilworth Technology Ltd.
1991
Chilworth Technology Inc established in US.
Responsible for the management of our laboratories, Daniel has more than a decade of experience in testing and project management and brings a wealth of knowledge on regulatory test requirements. As a qualified DGSA, he provides guidance on the implication of results on classification of products.
1995
Received Good Laboratory Practice accreditation.
Dr Andrew Starkie – Principal Process Safety Specialist
2001
IChemE safety and environmental awards winner.
2003
Chilworth goes global; capabilities established in France, Italy and India.
2008
Chilworth acquires Spanish facility.
2009
Acquired JCI, the UK’s electrostatic measurement experts.
2011
Wholly acquired by DEKRA, Europe’s leading safety provider.
2013
New office and laboratory open in Shanghai and a new office for the Netherlands and Benelux.
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Managing our GLP programme and with over a quarter of a century of experience in the sphere of process safety testing and consultancy, Andy has particular expertise in the handling and testing of hazardous and sensitive materials and chemical reaction hazards. Mr Jochen Dettke – Head of REACH Registration Team in Germany An expert at DEKRA Industrial GmbH – based in Stuttgart, Jochen heads up the REACH registration team in Germany, providing consultancy and testing advice from portfolio optimisation, through data acquisition and into dossier preparation.
ACCREDITATIONS Good Laboratory Practice (UK); ISO 17025 (US)
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PROFILE: Chilworth – a DEKRA Company
Regulatory testing and support
SERVICES PROVIDED Identification CIS Center provides services for substance identification in compliance with REACH, namely: OO substance's identifiers search and selection; OO search for information on the substance composition and formula; OO Russian laboratories physical and analytical test operations in accordance with REACH Regulation; and OO mini dossier creation.
PROFILE: CIS Center
CONTACTS Website
www.ciscenter.ru
info@ciscenter.ru
Head office
Nakhimovsky prospekt, 31/2, 117418, Moscow, Russia
Tel
+7 495 745 38 00
Fax
+7 495 745 38 00
Contact
Anna Miroshnik
Directors
Dmitry Skobelev
Ownership
Non-profit organisation
Locations
Russia
Founded
2006
Russian safety passport (RSP) All companies intending to import chemicals into the Russian Federation have to be in compliance with national requirements concerning safe handling, transportation and storage. This includes the creation of an RSP, according to GOST 30333, in the Russian language with its obligatory expertise and registration with the relevant authorities shown by the assigning of a registration number. CIS Center has great experience in RSP creation, and extensive communication capabilities with the relevant Russian authorities. We thereby provide our customers with the best level of service on the creation and registration of Russian safety passports.
OVERVIEW CIS Center was founded as a non-profit organisation. It consolidates government and commercial structures with the best experts in the field of regulation and safe handling of chemicals. The mission of CIS Center is to provide professional consultancy assistance for enterprises and regulators regarding chemicals safety across the supply chain and throughout the whole product lifecycle in order to reduce trade barriers. CIS Center’s team includes experts on standardisation, classification and labelling of substances and mixture, expert chemists and REACH and GLP consultants which can help your company find individual solutions. We can offer wide range of services, including: OO identification of chemicals; OO creation, expert examination and registration of Russian safety passports for chemicals; OO SDS and labelling creation; OO consulting in the field of Russian regulation on chemicals; OO REACH, GLP and Russian national regulatory compliance training; and OO other (standardisation, IT, ASTM PTP etc) VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
1
Staff, group
55
Staff, chemical service provision
15
SERVICE AREA BREAKDOWN
Laboratory 5% Information 15%
Labelling according to Russian legislation has some features, especially with regards to transport information. Our experts can help you to classify your product according to the following national standards: OO labelling of chemicals. General requirements; OO dangerous goods. Classification and marking; and OO marking of cargoes. CIS Center will help you choose the right classification code and handling marks. SDS creation CIS Center provides services on classification, labelling and safety data sheet creation of substance and mixture, according to legislation in the European Union, the USA, South Korea, China, Brazil, Australia, Singapore and elsewhere. Consulting in the field of Russian regulation on chemicals Our team has extensive background knowledge and experience of national legislation and can provide you with up-to-date information on chemical regulations within the Russian Federation covering the hazard communication, reporting and testing of new chemicals, chemical inventories and the evaluation of existing chemicals. REACH, GLP and Russian national regulatory compliance training CIS Center organises training and conferences in the field of chemical control and safety regulations. We run regular training sessions and seminars on classification, RSP and labelling creation under Russian national standards; preparation of test facilities to comply with GLP principles and other training. Other
Training 20%
IT & software 10%
Classification and labelling according to Russian national standards
Consultancy/ advisory 45%
Representation & management 5%
CIS Center was authorised by ASTM International to offer the ASTM proficiency test programme (PTP) in Russia and CIS countries. CIS Center in conjunction with ASTM continues and expands the PTP for laboratories, through interlaboratory comparative tests on the measurement of the composition, and properties of petroleum products (gasoline, diesel fuel, motor oil). In the near future CIS Center is planning to provide training on the proficiency test programme. CIS Center is an official distributor of ChemAdvisor’s products in Russianspeaking territory.
GLOBAL OFFICES Russia
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CORPORATE DEVELOPMENTS & ACHIEVEMENTS
STAFF SELECTION
CIS Center founded in Moscow, Russia.
CIS Center team
2006
Development of international standards on GHS for CIS countries.
2008
CIS Center registered as a non-profit organisation.
2009
Organisation of the second annual conference of CIS countries “Safety regulation of chemicals. UN Recommendations and European regulations REACH and CLP” (Minsk, Belarus Republic).
CIS Center team members are highly competent and have great experience in the field of chemicals regulation throughout the whole product lifecycle, including but not limited to chemicals identification, hazard classification, risk assessment, RSP, SDS and labelling creation. Our specialists are directly involved in the development of Russian Federation standards and always have up-to-date information on national and international chemical control legislation.
2009
Development of national standard for GLP.
2010
Organisation of the third annual conference of CIS countries “Safety regulation of chemicals. UN Recommendations and European regulations REACH and CLP” (Baku, Azerbaijan Republic).
2011
Organisation of the fourth annual conference of CIS countries on chemicals regulation (Astana, Kazakhstan).
2012
Organisation of the fifth annual conference of CIS countries on chemicals regulation (Kazan, the Republic of Tatarstan, Russia).
2012
Development of international standards on GHS and GLPOECD for CIS countries.
2013
CIS Center authorised by ASTM International.
2013
Organisation of the sixth annual conference of CIS countries on chemicals regulation (Minsk, Belarus Republic).
2013
CIS Center specialists participated in the OECD pilot exercises on classifications of chemicals (CoCAM-4, CoCAM-5).
2013
CIS Center became an official partner and distributor of ChemADVISOR products in Russian-speaking territory.
PROFILE: CIS Center
2006
PARTNERS OO
ASTM International, ChemAdvisor
CLIENTS OO
Chemical Industry
CASE STUDY: Russian safety passports Until the technical regulation "On Safety of Chemical Products" enters into force (expected to be February 2015), RSPs are not obligatory. However, the reality is that Customs usually demand the presentation of this document at the border. In our practice we are often faced with a situation where companies urgently ask us to help with RSP creation. They want them as soon as possible, because otherwise they will lose a lot of money due to the delay at customs. Such companies usually know about Russian safety passports, but think that if they translate an existing SDS (eg EU-SDS) into Russian it will be enough. Unfortunately they are often unaware that although Russian safety chemical legislation harmonised with GHS, it has a number of distinct features. This means that direct and even proper translation of an SDS into Russian is not a solution. More than that, each RSP has to be registered with the relevant authorities and have its own unique registration number. CIS center knows the subtleties of Russian legislation and offers a service on the creation and registration of RSPs according to national standards, resulting in the assignment of a registration number. This enables our clients to save time and money by avoiding delays at customs.
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SERVICES PROVIDED Registration of chemicals in the EU The CSR regulatory team provides project management to ensure product approval and registration, and to build support and defence packages for product portfolios. We compile supporting data packages, conducting a number of Qsar assessments and in-house evaluations, IUPAC naming of substances as well as literature searches and reviews to avoid new testing, and prepare the regulatory compliance documents. Services include: assistance with late pre-registration; establishing REACH IT accounts; preparation of robust study summaries and registration dossier in Iuclid 5 format; preparation of chemical safety assessments and reports (including exposure scenarios and risk characterisation), production of CLP compliant MSDS (including extended format), submission to and liaison with ECHA and member states authorties.
PROFILE: CS Regulator y Ltd
CONTACTS 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
Contact
Mr Steven Green
Directors
Mr Steven Green
Mr Craig Deegan
Ownership
Private company
Locations
Head office only
Founded
2007
Worldwide notification of chemicals
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 offers a combined experience of more than 45 years of professional experience within the industrial environment; we have 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 and CLP purposes, worldwide notification of chemicals, representation of clients within Europe, production of associated chemical safety documents, liaison with authorities and product defence, advice on testing strategies and project management of data packages, acquisition of existing data and product stewardship. VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
1
Staff, group
7
Staff, chemical service provision
7
SERVICE AREA BREAKDOWN
Information 10%
Representation & management 25%
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 efficiently manage the supply chain interactions, as needed. As the representative, CS Regulatory can work in the Sief and consortium on behalf of our client, representing their best interests, minimising our client’s workload and maintaining and retaining our client’s confidential business information. Data packages CS Regulatory has a wealth of expertise in providing regulatory consultancy services to industry. We can offer our clients detailed advice on provision of their chemical products into the worldwide marketplace. We ensure that provision of your products to your customer base within Europe and around the world is progressed rapidly to meet your business needs. We offer: product evaluation and data gap analysis; literature and inventory searching; application of Qsar and in silico modelling to chemicals; preparation of expert calculations and waivers; read-across and grouping of chemicals; provision of expert reports for data-waiving and IUPAC name derivation. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Training 5%
Consultancy/ advisory 60%
GLOBAL OFFICES Not applicable. CS Regulatory has a global network of independent expert consultants for global regulatory compliance.
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Staff at CS Regulatory are expert in the notification of chemicals in compliance with all notification schemes around the world, having worked with every national registration scheme and benefiting from a global network of independent regulatory experts to ensure that we are in possession of the very latest expert information. CS Regulatory is experienced in preparing notification dossiers in the appropriate format to achieve notification, submitting the notification and corresponding with the appropriate regulatory authority directly from the UK or with the assistance of local expert consultants where necessary.
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, successfully renewed annually since with no non-conformities
2013
Derbyshire Exporter of the Year 2013 finalists
Chemical Watch | Global Service Providers Guide 2014
ACCREDITATIONS
STAFF SELECTION
ISO 9001:2008
Steven Green − Director
CiTox LAB preferred partner CLIENTS Due to strict terms of confidentiality and the nature our business, CS Regulatory does not release the identity of its clients. CS Regulatory works with and assists a broad range of suppliers from international blue chip companies and household names to small and medium enterprises with their regulatory requirements. TESTIMONIALS Specific references can be provided to potential clients upon request CASE STUDY 1: REACH compliance as OR CS Regulatory accepted the transfer of OR duties for a substance registered in the EU as an isolated intermediate. On conducting due diligence, however, it became apparent that there was a need to support non-intermediate uses, albeit at lower tonnage bands. Based on OSOR principles advocated by ECHA and expressed within the guidance, CS Regulatory accepted the role of lead registrant to undertake the necessary updates to the dossier and produce suitable chemical safety assessment to ensure the ongoing compliance for the non EU supplier and downstream users. CASE STUDY 2: 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. CASE STUDY 3: DU compliance
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 regulatory assessment and clearly defined business principles which is essential to compliance with REACH. Craig Deegan − Director Mr Deegan has been working in the field of international regulatory affairs and health, safety and environmental consultancy for 18 years, incorporating development of testing strategies based on risk hierarchy, evaluation and interpretation of client specific requirements to ensure best value for clients with an interest in REACH, CLP and worldwide registration requirements. With detailed experience of the practical application of risk management in the industrial environment, Mr Deegan offers experience and knowledge that many regulatory consultancies lack. Tracey Thomas – Regulatory Specialist Ms Thomas has been working in the field of health and medical consultancy for 15 years. Her work within CS Regulatory incorporates collecting and collating a wide range of information for notification/ registration dossier preparation, analysing study data information (including trials data) and preparing relevant submissions to regulatory authorities. Ms Thomas also acts as an advisor on CLP issues, preparing evaluations of CLP impact and advising organisations of the viability of their products from a CLP perspective. Claire Lowe – Regulatory 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 Regulatory’s clients with regulatory compliance documentation specifically for REACH.
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 determining our clients’ registration and notification obligations. By means 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 relevant notification requirements was also conducted. CASE STUDY 4: 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 scientific principles and the pragmatic use of public domain, read-across and Qsar assessment to reduce the need for animal testing and achieving significant cost reduction of regulatory compliance.
Chemical Watch | Global Service Providers Guide 2014
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PROFILE: CS Regulator y Ltd
PARTNERS
SERVICES PROVIDED
PROFILE: DHI
REACH registration services including exposure scenarios DHI offers manufacturers and importers of substances following technical expert services: OO guidance and strategic counselling on chemicals legislation and REACH tasks; OO preparation of registration dossiers incl. exposure scenarios based on development of individual testing strategies and integrated use of non-test methods (Qsar, read-across, waiving); OO analysis of alternatives and SEA pertaining to REACH authorisation. DHI facilitates and manages Siefs and consortia, and provides third party representation and only representative (OR) services.
Website
www.dhigroup.com www.tox.dhigroup.com
hgf@dhigroup.com
Head office
Agern Allé 5, DK-2970 Hørsholm, Denmark
Tel
+ 45 4516 9200
Fax
+ 45 4516 9292
Contact
Hülya Genc-Fuhrman, Business Development Manager
Directors
Antoine Labrosse, Group Chief Executive Officer
Peter Rasmussen, Group Chief Financial Officer
Ownership
Not-for-profit organisation
Locations
31 worldwide offices and operations
Founded
1964
OVERVIEW DHI is a global and independent consulting and research organisation within the fields of water, environment, health and toxicology. To ensure product safety and mitigate environmental risk, we assess the impact of products and processes on humans and the environment. Our extensive knowledge in this field provides support to authorities and industries around the world. Our expertise in risk assessment, chemicals regulation, toxicology and ecotoxicology help the industry make critical decisions about chemical substances and assist them in complying with regulations on health, safety and prepare applicable documentation. Our integrated approach combines chemical consulting and profound insight in regulatory requirements with leading edge IT solutions and a top professional laboratory. VITAL STATISTICS
2012/13
Turnover, group
€108m
Turnover, chemical service provision
€8.0m
No of offices
31
No of countries represented
40
Staff, group
1,018
Staff, chemical service provision
60
Training IT & software 2% 9%
Laboratory 25% Consultancy/ advisory 63%
GLOBAL OFFICES Australia, Austria, Belgium, Brazil, Brunei, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, India, Indonesia, 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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DHI facilitates company specific GHS strategies for global companies as well as classification and labelling of chemical substances and mixtures. Preparation of safety data sheets, exposure scenarios and software tools for chemical management, SDSs and exposure scenarios. Training courses and webinars are offered in CLP, SDS, exposure scenarios and related areas. Provider of chemicals management systems and content for SDS software including national lists on classification, substance names, exposure limits, CAS numbers, phrase modules with 4,500+ phrases in more than 40 languages. Environmental laboratory The DHI laboratory conducts acute and chronic ecotoxicological studies with organisms in water, sediment and soil and is specialised in carrying out standardised and specialised tests concerning biodegradability, ecotoxicity, endocrine disrupting effects and bioaccumulation of chemicals. DHI has experience as test facility for offshore activities using sensitive marine organisms. Expertise in testing under the scheme for pharmaceuticals according to the European Medicine Agency (EMA). Biocides and pesticides DHI offers regulatory and documentation assistance for both industry and authorities: OO data search, information retrieval, data gap analyses; OO toxicological evaluations; OO ecotoxicological tests; OO preparation of dossiers on biocidal active substances and biocidal products; OO preparation of dossiers on active substances and plant protection products; and OO phrasing of claims, notifications and expert reports. Medical devices, pharmaceuticals and cosmetics Within medical devices, cosmetics, medicinal products, veterinary and herbal medicine, DHI supports industry and authorities with human and environmental risk and safety assessments and documentation. Services include data screening, literature searches, evaluation of biocompatibility, comparative evaluation of materials/toxicity, Qsar for prediction of toxicological effects of chemical substances, preparation of cosmetic dossiers, safety assessments and selection of tests in accordance with ISO 10993 and regulatory services (EMEA, FDA, ISO 10993, ICH).
SERVICE AREA BREAKDOWN
Representation & management 1%
Product stewardship, regulatory services and software tools
Food and feed safety, drinking water Use DHI for regulatory advice and safety or risk assessments of novel foods, food packaging materials, dietary supplements, food and feed additives, contaminants, naturally occurring toxins, technical processing aids, whole foods and drinking water. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1964
Danish Hydraulic Institute (DHI) founded
1973
Approved as Authorised Technological Service Institute by the Danish Minister for Science, Innovation and Higher Education
1982
VKI laboratory accredited by DANAK, the Danish Accreditation and Metrology Fund Chemical Watch | Global Service Providers Guide 2014
VKI laboratory authorised to carry out test in compliance with the OECD principles of GLP
2000
Designated as a resource centre for the Global Water Partnership
2001
Merge with VKI Institute for the Water Environment
2004
Designated the United Nations Environmental Programme (Unep) Collaborating Centre for Water and Health
2005
Merge with Danish Toxicology Centre (DTC) and establishment of the Environment and Toxicology unit.
2013
Offices in 31 countries around the world
ACCREDITATIONS DHI works in accordance with the quality management system standard: OO ISO 9001 as certified by DNV. Ecotoxicology tests: OO in accordance with ISO 17025; accredited by DANAK, the Danish Accreditation and Metrology Fund; OO in compliance with the OECD and principles of good laboratory practice (GLP). PARTNERS Software: OO ECOonline; OO Safeware Quasar Ltd OO Knauf; OO InterSolia AB. CLIENTS Brenntag AG, Cargill Inc, Chevron Products Company, Coloplast A/S, Danisco A/S, Danish Environmental Protection Agency, Delta, FeF Chemicals, Ferring Pharmaceuticals A/S, ECHA, GE Healthcare, Halliburton, Johns Manville, Knauf Insulation, KIST Europe, Leo Pharma, Magna Industrial Company Ltd (Hong Kong), Nickel Institute, Novo Nordisk A/S, Novozymes A/S, Owens Corning, Paroc Group, Rockwool A/S, Saint Gobain, Statoil AB, Sun Chemicals, URSA insulation. TESTIMONIALS Specific references can be provided to potential clients upon request. CASE STUDY 1: Assessment of alternatives DHI has conducted analysis of alternatives (AoA) for a number of substances including various nickel compounds. AoA is used as technical documentation in the context of an application of authorisation but also as documentation in industry advocacy activities targeted member state authorities. A successful AoA is quite detailed and reflects up-to-date knowledge from the sector, eg by including academia and/or specialists from the sector. REACH aims to replace substances of very high concern with suitable alternatives over time. For most substances on Annex XIV of REACH it is, however, mandatory to document that no other suitable alternatives are available before an authorisation can be granted. An analysis of alternatives therefore plays a key role in the authorisation title of REACH. CASE STUDY 2: Assessment of risk management options DHI has conducted a number of analyses of risk management options for industry stakeholders and authorities. The aim is to support decision on possible further regulation, eg candidate list and authorisation, restriction, harmonised classification or non-REACH measures such as deriving an EU OEL. Industry has high interests in providing information and views on this before decisions are made, as do authorities in not making faulty decisions. The RMO paper discuss available information and address concerns of risks to humans or to the environment. Relevant management options for risk reduction are identified and their suitability is discussed from a risk reduction as well as from a socio-economic view. The RMO is a useful way to document implications and benefits of different legislative options and can assist industry in their discussions with authorities. Chemical Watch | Global Service Providers Guide 2014
CASE STUDY 3: Phase out chromic acid usage in products DHI has assisted Accoat in discussions regarding the process of developing and testing alternative techniques to phase out the use of chromic acid in polymer coating products from Accoat. Although chromic acid usage is not currently regulated it will require authorisation before use in the future. As a result of the discussions between DHI and Accoat a number of points were clarified such as: current use of chromic acid (tonne/year); Accoat is exempt from the registration of current use of chromic acid to ECHA and only needs to declare the use to ECHA; Accoat has a good chance to find alternatives to chromic acid before an authorisation of use may become compulsory within EU. STAFF SELECTION Jens Tørsløv, PhD, Ecotoxicology – Head of Projects Extensive experience as project manager with references within REACH eg. on registration and CSR, analysis of alternatives, industry strategy on SVHC and application for authorisation. Jens Tørsløv joined the management team of Department of Environment and Toxicology DHI in 2007 and plays a key role coordinating the REACH services. He has more than 25 years of experience providing services to industry and authorities on environmental and human risk assessment of chemicals, industrial pollution control, capacity building. A position by the Commission (ECB, Ispra) during the years of preparation of REACH gave a solid background within the REACH legislation and its practical implementation. Helle Westphal, MSc, Pharmacy – Head of Department Expert knowledge of European chemicals REACH legislation and broad knowledge on other parts of the European regulation related to chemical products. More than 20 years of experience in strategic and practical consultancy in health and environmental issues, including development and implementation of chemicals management systems and cleaner technologies in a number of companies. Toxicological risk assessments and a good general knowledge of the European environmental regulation. More than 15 years of management experience. Hülya Genc-Fuhrman, PhD, Chemicals – Business Development Manager Has an international background including professional experience from Denmark, Turkey, the Netherlands and Australia. Expert knowledge of REACH legislation including, but not limited to, preparing lead registrant and company specific registration dossiers, forming and facilitating Siefs and consortia. More than 15 years of academic and practical consultancy experience including global regulatory management of chemicals (in the EU, USA, Canada, Australia) and health and environmental issues (risk assessment for environment and human exposure to chemicals, endocrine disrupting chemicals and water and health). Has also experience in organising and presenting at workshops and training programmes. Poul Bo Larsen, MSc – Chief Toxicologist Has more than 25 years 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 was for more than 14 years at the Danish Environmental Protection Agency. Participated as a national expert on human health risk assessment of chemicals in various working groups at national level in OECD and the EU including the Risk Assessment Committee at ECHA. Has worked with regulation and assessment of hydrocarbons and with the EU risk assessment document, and regulation and assessment of manufactured nanomaterials within EU and OECD. Anja Kamper, MSc, Biology – Laboratory Manager Has extensive experience within ecotoxicological and biodegradability testing of chemicals in aquatic and terrestrial systems, managing and performance of laboratory studies according to OECD principles of good laboratory practice (GLP), quality management, quality assurance and quality control of laboratory activities, REACH, environmental risk assessment and classification of chemicals and products, development of environmental quality standards. Page 77
PROFILE: DHI
1989
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 Knoell Iberia SL, Madrid, Spain 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, UK Critical Path Services, LLC, Garnet Valley, PA, US Shotwell & Carr, LLC, Carrolton, TX, US
PROFILE: Dr. Knoell Consult GmbH
CONTACTS Website
www.knoell.com
info@knoell.com
Head office
Dynamostraße 19, 68165 Mannheim, Germany
Tel
+49 (0)621-718858-0
Fax
+49 (0)621-718858-100
Contact
Dr Michael Cleuvers
Directors
Dr Hans-Emil Knoell Dr Runar Eberhardt Torsten Hauck Dr Michael Cleuvers
Ownership
Private company, majority-owned
Locations
Germany, UK, Switzerland, the Netherlands, Spain, China, Thailand, US
Founded
1996
SERVICES PROVIDED Global registration of industrial and specialty chemicals Strategic advice and consulting, literature search, data evaluation, data gap analysis, study monitoring. Testing and registration strategies, in silico methods (Qsar), read-across and waiving strategies. Classification and labelling under GHS, CLP, and Osha HazCom. Dossier preparation, eg Iuclid 5-files for REACH, toxicological and ecotoxicological hazard and risk assessment, exposure modeling, extended safety data sheets. TSCA registration including PMN support. Post submission support, communication with authorities, OR- and TPR-services, full consortia management. Global registration of agrochemicals and biocides
OVERVIEW The chemical business is a global business, and new chemical legislations are emerging worldwide! We are a full service provider in global regulatory affairs, product safety, and consulting for agrochemicals, biocides, industrial/specialty chemicals, human and veterinary pharmaceuticals, medical devices and cosmetics. We will work with you to ensure that your products are in compliance with the latest developments, not only in Europe (EU and non-EU), but also in the US, Canada, South America and the entire Asia-Pacific region (China, Japan, Korea, Australia, and others). With a global network of subsidiaries and co-operation partners, we match our services to support your business needs. VITAL STATISTICS
2013/2014
Turnover, group
> €35m
Turnover, chemical service provision
> €15m
Number of offices
14
Number of countries represented
8
Staff, group
410
Staff, chemical service provision
200
SERVICE AREA BREAKDOWN Training Information 5% 7%
Representation & management 25%
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Strategic advice and consulting, literature research, data evaluation, data gap analysis, completeness check, study management and monitoring. Dossier preparation, biological efficacy, residues and metabolism, dietary safety, toxicology, human exposure, exposure modelling, PEC-reports, environmental risk assessment, ecotoxicology, CADDY-dossiers. Regulatory affairs, communication with authorities, post-submission report, full service provider. Human pharmaceuticals, medical devices, cosmetics Non-clinical/ pre-clinical services (study management, toxicology, pharmacology, metabolism, pharmacokinetics, 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 pharmacovigilance, PSUR, summary of product characteristics (Core SmPC), summary bridging reports (SBR) and post authorisation safety studies (PASS), classification of medical 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. Management of pre-clinical and clinical studies, services for vaccines and neutraceuticals, and feed additive registration. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Consultancy/ advisory 63%
1996
Foundation, Mannheim, Germany.
2002
Office in Leverkusen, Germany.
2007
Foundation of FORIM GmbH, Mannheim.
2007
Foundation of Dr. Knoell Consult Schweiz GmbH, Basel.
2009
Establishment of Knoell Academy for training and in-house seminars covering all our fields of expertise.
2009
Foundation of Dr. Knoell Consult Ltd, in Cardiff, UK.
2009
Knoell contributed to more than 100 dossiers for plant protection products.
2010
Knoell prepared biocide dossiers for 25 active substances (56 products in 15 product types). Chemical Watch | Global Service Providers Guide 2014
2010
Opening of a new office in Wageningen (NL).
2010
Acquisition of Cyton Biosciences Ltd, Bristol, UK.
2010
Extension of regulatory affair services to Japan and Asia/ Pacific region.
2010
Foundation of Dr. Knoell Consult Shanghai Ltd, in China.
2010
Successful preparation of more than 400 REACH dossiers and more than 100 chemical safety reports.
2010
Knoell has been appointed as institution for the training of experts in toxicology.
2012
Foundation of Dr. Knoell Consult Thai Co. Ltd, in Thailand.
> 33 ecotoxicologists
2013
Foundation of Knoell Iberia SL, in Madrid, Spain.
Dietary safety
2013
Acquisition of Critical Path Services, LLC, based in Philadelphia, US.
>18 specialists Product safety specialists (C&L, MSDS preparation)
2013
Acquisition of Shotwell & Carr, LLC, Carrolton, Texas, US.
> 33specialists
Qualified Cefic – partner. PARTNERS SCAS Japan, SCAS Europe, BSL Bioservice, Ibacon, Currenta, Ceres International, Tier3 solutions. CLIENTS Most of our clients are large international companies, but we also work with numerous SMEs. TESTIMONIALS The Spanish Ministry of Environment described our dossier for a wood preservative as, "the best organised and well-done dossier in comparison with the rest of dossiers received from other companies." Additional testimonials can be provided on request. CASE STUDY 1: REACH consortium management and dossier preparation knoell managed a huge consortium with 58 companies covering substances in 11 sub-categories and submitted 157 successful registrations in 2013. To achieve this, we established a team of more than 30 scientists who were dedicated to this project, including chemists, toxicologists, ecotoxicologists, and Qsar-specialists. Our team prepared the entire testing and registration strategy, including developing the category and analogue approach, Qsars and exposure based waiving. We were able to minimise additional testing by writing thorough scientific justifications. CASE STUDY 2: agrochemicals knoell successfully managed the submission of an AIR 2 dossier (Annex-I renewal procedure) on behalf of a task force of almost 30 member companies spread worldwide. knoell wrote and compiled all study summaries, risk assessments, and dossier chapters. knoell also developed and maintained a strong relationship with the authorities to whom the dossier was submitted. The project was well-recognised by the client and the authorities. The team consisted of over 50 individuals who dedicated themselves to this project for two years. Follow-on work is on-going and entails the development of national product dossiers for the respective active ingredient. CASE STUDY 3: biocides knoell supported the introduction and authorisation of numerous biocidal products in multiple markets within the EU according to the specific national requirements. A similar strategy was then applied for a number of non-EU countries in Asia and Latin America, with one main difference – the lack of a uniform global legislation regulating such products. Therefore we firstly had to define the applicable specific legislation for which the biocidal product was subject to and then we prepared the local product registration. Based on our experience label claims are key to this Chemical Watch | Global Service Providers Guide 2014
STAFF SELECTION Toxicology > 33 toxicologists Regulatory affairs agrochemicals/biocides 14 specialists
PROFILE: Dr. Knoell Consult GmbH
ACCREDITATIONS
registration process and can make a huge difference on how a product is to be considered by an authority.
Ecotoxicology
Global regulatory affairs for chemicals > 11 specialists Consortium management, OR, TPR > 11 consortium managers Residues and metabolism > 14 specialists Environmental fate and risk assessment > 44 specialists Efficacy, biological dossiers > 14 specialists Human pharmaceutical experts 11 Veterinary pharmaceutical experts 22 Selected staff Dr Michael Cleuvers – Managing Director Industrial Chemicals and Biocides Torsten Hauck – Managing Director Agrochemicals Dr Marika Suhm-Tintelnot – Head of Industrial Chemicals and Biocides, Human and Environmental Safety Deirdre Lawler, MSc, Head of Industrial Chemicals and Biocides – Global Regulatory Affairs Dr Elisabeth Wekel – Head of Industrial Chemicals and Biocides – Product Safety Dr Iain A MacKinnon – Managing Director, Dr. Knoell Consult, Ltd Dr Jan Tuinstra – Senior Expert REACH, Wageningen office Stefanie Schick – Managing Director, Dr.Knoell Consult Schweiz GmbH Dr Sylvana P Müller – Managing Director, FORIM GmbH Dr Gunnar Kahl – Managing Director, Dr. Knoell Consult Thailand Co, Ltd Maggie, Xiaoyong Xu – Managing Director, Dr. Knoell Consult Shanghai, Co, Ltd Dr Àngeles Rico Rico – Managing Director, Knoell Iberia, SL Paul Carr, PE – Managing Director, Shotwell & Carr, LLC, US Dr Julie E Eble – Managing Director, Critical Path Services, LLC, US
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SERVICES PROVIDED Industrial Chemicals – REACH EBRC offers comprehensive scientific, regulatory and administrative support on industrial chemicals, including: OO data gathering, literature searches and evaluation; OO data-gap analysis, closing of data-gaps and study monitoring; OO chemical safety assessment (CSA) and report (CSR); OO PBT and vPvB assessment; OO technical dossier (Iuclid 5); OO identification of known uses; OO development of exposure scenarios for HH and ENV; OO risk characterisation; OO classification and labelling; OO safety data sheets; and OO 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 Rüdiger Battersby
Ownership
Privately owned
Locations
Germany
Founded
1993
Agrochemicals
Staff, group
55
Active substance approval and national product registration. EU notification of active substances governed under regulation (EC) No 1107/2009: OO support of existing substances in the context of the renewal programme of the EU (AIR); OO support of new active substances; OO completeness checks, validation of existing studies, literature surveys; and OO full dossier preparation including risk assessments, submission and defence of dossiers in the review and evaluation process. Product registration dossiers for national authorisations in EU member states including zonal dossiers: OO aII dossiers (dRRs) for registration and re-registration of plant protection products, label extensions and formulation changes; OO services include compilation of all required documents, conduct of exposure and risk assessments, biological dossiers, advice in closing data gaps, the supervision of experimental studies, as well as submission of the application to competent authorities and attendant contacts / services during the registration process; and OO previous experience (among others) includes herbicides, fungicides, insecticides, rodenticides , nematicides and growth regulators.
Staff, chemical service provision
33
Biocides
OVERVIEW EBRC is a privately-owned consulting organisation based in Hannover, Germany, providing consulting services with a focus on chemical, biocidal and agrochemical industries. Specialised scientific experience is available in all key disciplines relevant for product safety with respect to human health and environment. Task force management and coordination of industry consortia is another important aspect of our work. VITAL STATISTICS
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
1
SERVICE AREA BREAKDOWN IT & Training software 5% 5% Representation & management 15% Consultancy/ advisory 75%
GLOBAL OFFICES EBRC Consulting GmbH Raffaelstr 4 30177 Hannover Germany
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EBRC provides experienced support for all key phases of the evaluation and registration process of biocides. Dossier preparation and defence in the regulatory process both for active substances and biocidal products are our primary services. OO active substances (Annex I inclusion both of existing and new active substances); OO biocidal products (registration/authorisation in EU member states) OO task force/consortia management; and OO evaluation of substances – as specified for industrial chemicals and agrochemicals above. Special services EBRC has in-house experienced scientific support for a wide range of statistical services: OO statistical (re-)evaluation of data; OO implementation of EU-models and/or scenarios (eg as given in OECD emission scenario documents); OO ready-to-use spreadsheet solutions for various applications (eg substance specification); OO probabilistic exposure assessments; OO derivation of species sensitivity distributions; and OO Bayesian approaches for (occupational) exposure assessments. Based on long-term involvement in major EU risk assessment projects, EBRC is very familiar with handling extensive databases, including: OO importing and (re-)structuring of data; OO online generation status update reports; and OO provision of web-interfaces for data-entry and analysis. Chemical Watch | Global Service Providers Guide 2014
STAFF SELECTION
1993
Foundation of EBRC (initial staffing: six people)
Rüdiger Battersby – Director
2014
Continual growth, leading to a current staff count of 55
Dr Rüdiger Battersby is the founder and director of EBRC. After his PhD in biochemistry, he took up a position as manager of a contract research organisation in Hannover (IBR), from where he switched to EBRC. Apart from his responsibilities as managing director and principal coordinating toxicologist, he acts as supervisor for all of EBRC’s agrochemical, biocidal and industrial chemical risk assessments. His professional expertise encompasses involvement in the German government’s review programme (BUA) on existing chemicals, representation of industry consortia in RA conducted under the ESR programme (793/93) and at EU-TCNES level, as well as the conduct of several dozen occupational exposure surveys in various sectors of the chemical industry. Among other professional activities, he is an appointed member of the German Expert Gremium for Chemicals Safety of the German Chemical Society.
PARTNERS ARCHE, Belgium CLIENTS A wide range of companies producing agrochemicals, biocides and industrial chemicals and/or formulated products. CASE STUDY 1: MEASE On behalf of EUROMETAUX, EBRC developed a tool for the estimation and assessment of occupational exposure (MEASE) which combines approaches from the EASE expert system, from the TRA tool and from the health risk assessment guidance for metals (HERAG). It represents a widely-used first tier screening tool for occupational inhalation and dermal exposure to metals and inorganic substances.
Arne Burzlaff – Senior Registration Manager Industrial Chemicals
With its extensive background in metals risk assessments, EBRC was contracted from 2005-2007 by the European Metals Industry to compile a guidance document for the human health risk assessment of metals and inorganic metal compounds. The HERAG documents provide guidance to the worldwide regulatory and scientific community on several aspects of risk assessment methodology for metals where classic tools developed for organics are not applicable.
Dr Arne Burzlaff graduated as a chemist (2000) and obtained a PhD in technical chemistry/biotechnology (2005). He worked for the German Federal Institute for occupational safety and health, Division for Chemicals and Biocides Regulation (2005-2007), on dossier evaluation for biocides, collaboration in EU working groups and scoping issues on borderline cases among legal frameworks. Since 2007 he has been working at EBRC as senior scientist/toxicologist. In this position he has been compiling REACH registration dossiers, with a focus on human health hazard assessment and risk characterisation, and initiation and monitoring of experimental studies on industrial chemicals.
CASE STUDY 3: RiCoG
Andreas Büsing – Senior Registration Manager Agrochemicals
The rigorous containment guide (RiCoG provides guidance to registrants of isolated intermediates on how rigorous containment (RiCo) of their intermediates can be assessed and documented according to the stipulations of regulation (EC) 1907/2006 (REACH). In an integrated assessment of SCC for an entire process (adopted from an approach published by Hirst et al. (2002)), RiCoG can be used to prioritise individual process steps requiring higher tier assessments, and provides an easy and structured way to assess and to document RiCo for the remaining process steps. Experts from various metals' industries have contributed with their practical experience to the development of RiCoG.
Andreas Büsing graduated as a biochemist at the University of Hannover (1984). After years of experience in biochemical analytics with specific emphasis on the development and validation of immunoassays, he has been working at EBRC as registration manager for agrochemicals since 1999. His main responsibilities at EBRC include the co-ordination and supervision of dossiers for product registration and active substance approval under Regulation (EC) No 1107/2009, with focus on ecotoxicological risk assessments, data gap analysis and monitoring of experimental studies on active substances and plant protection products. Silke Burger – Senior Registration Manager Biocides
CASE STUDY 4: Development of standard handling frequencies of rodenticide baits
Dr Silke Burger graduated as a biologist (2000) and obtained a PhD in molecular biology/toxicology (2004). Since 2006 she has been working at EBRC as registration manager for biocides. In this position she has been compiling dossiers in support of active substances approval according to Directive 98/8/EC and BPR (Reg. (EU) No 528/2012) and registration of biocidal products with a focus on human and environmental exposure assessments and risk characterisations, and further initiation and monitoring of experimental studies on active substances and biocidal products.
CASE STUDY 2: HERAG (Health Risk Assessment Guidance)
Due to the non-existence of robust figures describing the handling frequency of baits by professional pest control operators, EBRC was entrusted by the rodenticides industry to derive a suitable proposal. Data were collected from various (quite heterogeneous) sources (industry and pest control business) and analysed statistically. Based on this analysis, the European Commission and EU member states agreed on default bait handling figures which are the current standard for operator exposure assessment and have been a key prerequisite for including anticoagulant rodenticide active substances in Annex I of Directive 98/8/EC.
Chemical Watch | Global Service Providers Guide 2014
Daniel Vetter – Senior Consultant Special Services Daniel Vetter graduated as Dipl-Ing agr at University of Hannover (2003). His main responsibilities at EBRC include the development and implementation of novel statistical techniques in human health risk assessments. He developed MEASE, an assessment tool for occupational exposure providing first tier estimates of inhalation and dermal exposure to metals. As part of his current work, he incorporates probabilistic techniques into the HEC (human equivalent concentrations) approach.
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PROFILE: EBRC Consulting
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
SERVICE AREA BREAKDOWN Training 10%
Consultancy/ advisory 10% Information 10%
PROFILE: EcoOnline
CONTACTS Website
www.ecoonline.com
lgp@ecoonline.com
Head office
Trudvangveien 77, N-3117 Toensberg, Norway
Tel/ Fax
+47 33 01 68 00/ +47 33 01 68 01
Contact
Mr Luis G Paulsen
Directors
Mr Øyvind Thorsen, CEO
Mr Kjell Hamnes, RD Manager
Ms Martina Jonsson, VP Product Management
Mr Luis G Paulsen, VP International Operations
Ownership
Privately held, employees
Locations
Norway, Sweden, Finland, Denmark, Switzerland
SERVICES PROVIDED
Founded
2000
Cloud/online: OO SDS/eSDS authoring; OO SDS/eSDS distribution; OO SDS/eSDS database; OO chemical inventory management; OO workplace risk assessment; OO employee exposure tracking and storing; OO up and downstream reporting; OO supply chain communication; OO metadata and XML data exchange; and OO mobile applications.
IT & software 70%
GLOBAL OFFICES Norway Sweden Finland Denmark Switzerland
OVERVIEW Interested in a user friendly and cost efficient experience that is entirely cloud based? Try one of the most widely used services for SDS authoring, distribution, communication and chemical inventory management in Northern Europe. EcoOnline has pioneered the industry and currently has more than 3,500 enterprises working in services online. And now we’re introducing even more services that you can access from your mobile devices. In use in most industries, of all sizes, EcoOnline is the solution for businesses, institutions and members of supply chains and industry bodies seeking efficient means of exchanging, communicating and managing data. All parts of the platform are offered via the cloud. Connecting suppliers and downstream users online reduces time and costs involved in nearly all aspects of handling SDSs and managing chemical inventories. A device with a web browser and internet connection are the only requirements. The menus in EcoOnline’s services are available in 24 languages, and they are designed to meet your requirements for the REACH area. In listening to our customers and working with leading consultants and members of industry, our aim is to become the most preferred platform for SDS communication and management in Europe,. Try us before you make your decision! A team of 67 employees, and a network of highly qualified consulting partners are ready to give a demonstration and offer a test of the applications and benefits. Welcome! VITAL STATISTICS Turnover, group
2012/13 €7.5m
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2000
Founded by Mr Kjell Hamnes, long time industry professional with a vision to create the first and most widely used online platform for SDS communication and chemical inventory management. HQ in Tønsberg, Norway.
2001
Launched the first integrated online service.
2007
Opened office in Gothenburg, Sweden.
2011
Opened office in Helsinki, Finland.
2011
Launched leading edge solutions for authoring and managing exposure scenarios. Technical documentation and articles covered. Established representation in Germany.
2012
Ready with first mobile applications and XML comm modules. Established representation in Denmark, Iceland and Poland.
2013
Service for SMEs in the building and construction sector. QR code application for mobile More mobile applications, and new features
Turnover, chemical service provision
-
2014
No of offices
6
PARTNERS
No of countries represented
8
EcoOnline works closely with leading local, regional and international consulting partners in many different areas, including SDS authoring, substance inventory management, CLP, risk assessment, dossier preparations, authority notification and occupational health. Work with us!
Staff, group Staff, chemical service provision
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Chemical Watch | Global Service Providers Guide 2014
CLIENTS
STAFF SELECTION
Small and large, public and private, multinationals and locals, our clients represent most segments and industries. A total of more than 3,500 enterprises connect to the services.
Mr Kjell Hamnes – R&D
We’ll be happy to provide you with referrals that are relevant to you! Please contact us. CASE STUDY 1: automotive industry OO OO
OO
auto dealers and their suppliers connect directly auto dealers and repair workshops get their SDS directly in their inventories, and reduce time spent on managing inventory and performing relevant tasks suppliers reduce time and costs in distributing SDS
CASE STUDY 2: diagnostics manufacturer and their suppliers of laboratory products OO
OO
OO
OO
OO
OO
the diagnostics manufacturer is part of a large international corporation, with production sites and laboratories in many locations its suppliers upload the relevant SDSs directly to the diagnostics company’s inventory the diagnostics company can then use all the data from the SDS without having to re-enter them. all designated staff can work and share information in the same system, from any location this improves communication, simplifies work processes, increases speed, and reduces time spent on relevant tasks no installations are required, no local IT maintenance costs involved
Ms Martina Jonsson – Product Management Martina is international product manager, and a key figure in Sweden on the issue of REACH and SDS management. Mrs Christy Whiddon – Product Management Christy is product manager. She has extensive background in the chemicals industry, and a PhD in surface and colloid chemistry. Ms Pirjo Kuoppala – Product Management Pirjo is product manager. She has extensive background in the electronics industry, and has degrees in mechanical engineering and biochemistry. Mr Luis G Paulsen – International Operations and Partner relations Luis is responsible for international operations and partner relations. Mr Øyvind Thorsen – CEO Øyvind has extensive background from the software and computer industry.
CASE STUDY 3: universities, hospitals, municipalities, public institutions OO
OO OO
OO
OO OO
OO
a majority of universities, municipalities, schools and hospitals in Norway are connected to the service. SDSs are uploaded directly to their inventories. all data in the SDS are immediately available for use, and automatically updated. the suppliers benefit from easy authoring and distribution of SDSs, and the service to customers is greatly improved. communication upstream to the supplier is simplified in the platform no local installations are involved, the entire service is available to all users over the internet. this saves time and money in the process of authoring, distributing and managing the SDSs and documentation.
CASE STUDY 4: building and construction sector OO
OO OO OO
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 2014
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PROFILE: EcoOnline
TESTIMONIALS
Kjell is the founder and head of R&D at EcoOnline. He has pioneered the development of electronic tools for SDS authoring and management in northern Europe, and is a widely used resource by industry and authorities on the issues of legislation and compliance.
SERVICE AREA BREAKDOWN Training 8%
PROFILE: eftec
CONTACTS Website
www.eftec.co.uk
eftec@eftec.co.uk
Head office
73 – 75 Mortimer Street, London, W1W 7SQ, UK
Tel
+44(0) 20 7580 5383
Fax
+44(0) 20 7580 5385
GLOBAL OFFICES
Contact
Rohit Mistry
London and Brussels
Ownership
Private London and Brussels
SERVICES PROVIDED
Locations Founded
1992
Consultancy/ advisory 92%
REACH advocacy
OVERVIEW Economics for the Environment Consultancy Ltd (eftec) is the leading environmental economics consultancy in the UK. Established in 1992, we have extensive experience undertaking policy and investment appraisals, socio-economic analysis (SEA) and valuing impacts on companies, human health and the environment. Together with our technical partners and sector specific specialists we provide practical support to small and large clients through the entire REACH authorisation and/or restriction process. We regularly use the following appraisal and evaluation methods: OO market assessments; OO stakeholder consultation; OO supply chain mapping; OO material flow analysis; OO analysis of alternatives; OO valuation of economic impacts; OO valuation of social and macroeconomic impacts; OO valuation of human health and environmental risks; and OO cost benefit analysis (CBA). Our expertise is applicable to all environmental media and sectors and we have experience in: OO chemicals (REACH); OO water and wastewater management (including WFD); OO value of natural capital for businesses; OO biodiversity, marine environment and ecosystem services; OO energy and air pollution (energy efficiency Directive, air quality Directive); OO soil and groundwater contamination; and OO waste management. eftec also oversees the UK Network of Environmental Economics, and organises an annual applied environmental economics conference attended by governments, industry, and research. VITAL STATISTICS Turnover, group No of offices No of countries represented Staff, group Staff, chemical service provision
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2012/13 £1.4m 2 Focus on EU-27 and EEA 19 (plus 30+ associates)
This involves assessing the benefits of the use(s) of a substance to society compared to any possible risks, as well as an assessment of possible alternatives. This enables companies and consortia to communicate to regulators and other stakeholders before any regulatory decisions are made. REACH – scoping studies Preparing for authorisation (or responding to a possible restriction) could require more effort and time than may be expected. It is cost efficient to undertake a scoping study (mini-application) to understand what position a company/consortium is in. We work with partners to provide scoping studies that can range in focus and depth assessing possible risks, the benefits of using the substance and an analysis of alternatives. REACH – socio-economic analysis (SEA) training We deliver tailor-made half day or full day training workshops to develop an organisation’s understanding and ability to produce or respond to an SEA. They are often useful to help companies prepare for gathering data and strategic decisions. REACH – authorisation We work with partners to assist companies and consortia with their applications for authorisation, including production of a; Chemical Safety Report (CSR), Analysis of alternatives (AoA) and SEA. REACH – restrictions We work with partners to support both industry (and regulators) to help determine if restrictions are the most appropriate risk management option and if a restriction is deemed necessary, which uses should be included and excluded. This requires assessing on a use-by-use basis whether the benefits of a particular type of restriction outweighs any costs. ACCREDITATIONS ISO 9001: 2008 PARTNERS In order to provide a complete REACH service, we work with consortium managers and technical specialists, such as ecotoxicologists and human health exposure experts. Our recent REACH partners include: Peter Fisk Associates (PFA), wca environment, EMRC, Apeiron-Team NV, Penman Consulting, AG-HERA and REACH Centrum.
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Chemical Watch | Global Service Providers Guide 2014
REACH: OO HBCDD EPS Consortium; OO the Nickel Institute; OO the Cobalt REACH Consortium (CoRC); OO IZA-REACH Cadmium Consortium; OO Environment Agency (EA) and Health and Safety Executive (HSE) (UK); OO a range of companies (multinationals and SMEs). Non-REACH: OO European Commission (including DG Enterprise, and DG Environment); OO European Environment Agency (EEA); OO European Space Agency (ESA); and OO UK government departments (including Defra, EA and Natural England). TESTIMONIALS “As part of an authorisation consortium under REACH, we have worked closely with eftec as they have helped us develop a complex socioeconomic analysis as a key part of our submission dossier. eftec were receptive to our needs and listened carefully to our position as they compiled the data and as we jointly developed the arguments in a coherent and methodical way. They worked together with the technical experts who were engaged on the other elements of the submission dossier, providing a comprehensive service in line with our needs.”– Stephen Long, Ineos Styrenics International SA (Netherlands). CASE STUDY 1: REACH authorisation – first joint authorisation application (EPS consortium) eftec and PFA (lead), provided REACH authorisation support to a consortium of downstream users of HBCDD who manufacture flame retardant expanded polystyrene (FR EPS). This included developing an AoA (assessing the suitability of alternatives), an SEA (identifying and weighing the pros and cons of an authorisation for society as a whole) and an application specific CSR. The output of this project was the first joint authorisation application in February 2014. CASE STUDY 2: three REACH authorisations – individual applications We are currently supporting confidential applications for three multinational clients (all downstream users) each with different uses of substances on the authorisation list. These applications are expected to be submitted in Summer 2014. OO application 1: by Aperion (lead) and eftec; OO application 2: by PFA (lead) and eftec; and OO application 3: by Aperion (lead) and eftec. CASE STUDY 3: possible siloxanes restriction For this study eftec, ERMC and WCA (lead) provided recommendations to the Environment Agency (England) for a possible targeted restriction that would limit aquatic emissions of two cyclic volatile methylsiloxane (cVMS) substances (referred to as D4 and D5) that have been identified as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). We developed a full SEA for ‘wash off’ personal care products (eg hair conditioners) which are currently the main contributor to D4/D5 emissions to the aquatic environment. CASE STUDY 4: Critical review: economic costs of cadmium exposure We (lead) with PFA provided a critical review of the Swedish Chemical Authority’s (Kemi) assessment of the economic costs of bone fractures caused by dietary cadmium exposure. The project also assessed the benefits to society specifically from the use of cadmium pigments in artist paints.
Chemical Watch | Global Service Providers Guide 2014
CASE STUDY 5: SEA scoping studies in support of an industry response to the possible inclusion of nickel sulphate on Annex XIV eftec, ERMC and WCA (lead) developed a practical framework for undertaking an SEA to support possible future applications for authorisation. The work included substantial consultation within the nickel sector (producers, manufacturers and end-users) to gather data to develop SEAs, and developing internal expertise within the industry needed to undertake future SEAs. SEAs and initial AoAs were developed for three specific uses. STAFF SELECTION Allan Provins – Technical Director Allan is an environmental economist and Technical Director with eftec. Since 2002 he has worked on over 100 projects mainly focusing on valuation of environmental, human health and cultural goods and services and the use of this evidence in SEA. His recent work includes SEAs for industry clients with respect to REACH authorisations. He has also reviewed the application of economic analysis (including cost-benefit analysis and valuation) in water industry investment planning in the UK for Ofwat and UKWIR, and reviewed the role of economic valuation in the implementation of the water framework Directive for the EC (DG ENV). He has also completed (for Defra) guidelines for valuing environmental costs and benefits in SEAs for projects and policies. Rohit Mistry – REACH SEA Expert Rohit Mistry is an REACH SEA expert with over ten years’ experience. He has an MSc in economics and a certified project manager. Rohit has managed and/or worked on numerous projects for industry clients and regulators (UK and EU) related to chemicals regulation; REACH Regulation, carcinogens Directive and biocides Directive. His REACH work started with two REACH implementation projects (RIP); RIP 3.9-2 – Technical Guidance Document (TGD) on preparing SEA and RIP 3.7 – TGD on preparing an authorisation application. Rohit was one of the lead authors on SEA under both the restriction and authorisation process and has subsequently presented at a number of REACH training events on how to undertake SEA. Rohit manages eftec’s involvement REACH projects with industry clients such as the Nickel Institute, Cobalt REACH Consortium (CoRC) and Expanded Polystyrene (EPS) consortium. Rohit has also supported SEA restriction dossiers; on mercury catalysts for the Norwegian Pollution Control Authority and UK authority with a possible targeted restriction on two siloxanes. Dr Mike Holland –REACH SEA Expert (eftec associate) Mike has 25 years of experience assessing the environmental and health impacts and economic implications of exposure of people and ecosystems to hazardous substances for clients including national governments, the European Commission, NGOs and the private sector. Mike is an observer to the REACH socio-economic assessment committee (SEAC), representing the European Association of Environmental and Resource Economists, an independent expert on SEA to the UK’s Chemicals Stakeholder Forum and a member of the organising committee of NeRSAP (the Network of REACH SEA and AofA Practioners). Philip Cryle and Roger Guiu – Consultants Phil, a former economist at the UK Health and Safety Executive, and Roger, a water valuation specialist, have several years’ experience of economic analysis of chemicals in the environment and their impact on human health. Their experience helps to develop robust analysis of environmental and human health impacts of chemicals and alternatives. Erin Gianferrara, Shannon Anderson and Sarah Krisht – Researchers Our researchers have contributed to data collection and analysis for seven REACH SEA authorisation studies. Other clients they worked for include Defra, the EC, and the EEA. They have post-graduate level training in environmental economics.
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PROFILE: eftec
CLIENTS
SERVICES PROVIDED Risk management, strategic support and regulatory compliance (REACH, CLP, biocides, PPP, cosmetics, food contact materials)
PROFILE: ENVIRON
CONTACTS Website
environcorp.com
sbullock@environcorp.com
Head office
Artillery House, 11-19 Artillery Row, London, SW1P 1RT, UK
Tel/ Fax
+44 20 7808 1420 / +44 20 7808 1421
Contact
Sue Bullock
Directors
137 partners worldwide including
Jose Fernandez (FR) Sue Bullock, Dr Aidan Turnbull (UK) Dr Martina Vosteen (DE) Dr Bob De Mott, Dr Joseph Rodricks (US)
Ownership
Private limited company
Locations
92 offices worldwide
Founded
1982
Global chemical notifications and regulatory compliance support
OVERVIEW An international environmental, health, safety and sustainability consultancy, ENVIRON works with clients to resolve their most demanding environmental and human health issues. Our global team helps companies gain regulatory approval for products to comply with chemical regulations around the world. We help industry leaders and innovators engage with policy makers and regulators, and provide effective product stewardship programmes to manage risk, reduce liability and enhance support from stakeholders. At the leading edge of science, we deliver thoughtful and innovative solutions in product safety. Clients around the world benefit from our unique ability to bring clarity to issues at the intersection of science, business and policy. We provide a single point of support for chemical regulation and risk management. VITAL STATISTICS
2012/13
Turnover, group (2012)
€206m
Turnover, chemical service provision
-
No of offices
92
No of countries represented
21
Staff, group
For more than 30 years, ENVIRON has worked in partnership with clients to develop and support product regulatory compliance strategies and prepare robust technical dossiers and risk assessments for substances in industrial, agricultural, biocidal and consumer applications. We balance clients’ technical, regulatory and commercial interests through sound science and strategy; clients trust us with their most critical problems. We provide strategic, scientific and regulatory support for substances targeted for substitution including impact assessment, applications for authorisation under REACH and supply chain management and audit of product regulatory compliance systems. We support communication with the EC, ECHA and MSCA, and development of policy, regulation and guidance. ENVIRON also acts as consortium manager and only representative, and is independent from testing facilities.
1,450
Staff, chemical service provision (dedicated)
50
ENVIRON evaluates obligations and provides support for regulatory approvals required to market products across Asia Pacific, America, Europe and Africa. We assess new market opportunities, substance notification and regulatory obligations, classification and labelling (GHS) and packaging. Our established global network covers Argentina, Australia, Brazil, California, Canada, China, Europe, India, Japan, Korea, Malaysia, Mexico, New Zealand, Philippines, Russia, Singapore, South Africa, Switzerland, Taiwan, Turkey and the US. Product stewardship, substitution and troubleshooting We have tremendous breadth and depth of expertise as well as extensive hands-on process experience, covering: OO toxicology (and toxicokinetic modelling) OO epidemiology OO exposure modelling, measurement and reconstruction OO risk assessment and mitigation OO ecotoxicology OO environmental fate OO chemistry OO occupational health OO regulatory affairs OO supply chain and stakeholder management OO product vigilance OO advocacy We are ideally placed to advise clients on problems across the spectrum of product safety and stewardship including product substitution and sustainable chemistry. We couple internationally recognised expertise and a reputation as a leader in risk management with client-focussed solutions. BOMCheck Substances declarations web database for REACH, RoHS, batteries and packaging compliance to facilitate supply chain management.
SERVICE AREA BREAKDOWN Laboratory 5%
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Representation & management 10%
Consultancy/ advisory 85%
GLOBAL OFFICES
1982
Founded in Washington, DC, USA
2010
Chemical Industry Association (CIA) REACH service provider of the year
CLIENTS Clients span all industrial sectors including industrial and specialty chemicals, petrochemicals, agrochemicals, food and food packaging, cosmetics, medical devices, electronics, manufacturing, aerospace and defence, apparel and consumer products.
Australia, Belgium, Brazil, Canada, China, Finland, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Poland, Russia, Singapore, South Africa, Spain, the Netherlands, United Kingdom, United States
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Chemical Watch | Global Service Providers Guide 2014
TESTIMONIALS
CASE STUDY 7: application for authorisation under REACH
“We are working with ENVIRON in a constructive and successful manner on various REACH projects, covering the entire processes (ie preparation of technical dossiers, exposure estimation and hazard and risk assessment)” – Dr Hans Certa, manager, global product safety, SASOL. “ENVIRON has rapidly integrated into our global REACH team to add excellent technical expertise, and provide timely REACH knowledge for registration, CLP and Sief management. ENVIRON is very well organised to be efficient, cost effective and delivers results as expected” – James E Mumby PhD, global director, product stewardship and regulatory affairs, Elementis Specialties Inc. “This is just perfect. I will never again be influenced by site arguments in other countries that we should hire local firms to perform risk assessments! If they had agreed to use ENVIRON in the first place this whole process would have been so much cleaner and easier. Thank you for all of your hard work on this and in the short time frame requested” – Michelle T Quinn, associate general counsel, regulatory affairs and general litigation, Catalent Pharma Solutions.
Prepared and submitted one of the first applications for authorisation under REACH on behalf of an aerospace/defence sector client. The dossier provided necessary evidence to support the continued use, beyond the sunset date, of two substances in specialist applications. Beyond submission, we supported responses to questions from the public, the RAC and SEAC. Concomitantly, ENVIRON is preparing highly complex applications for authorisation of several chromates, covering the interests of various industry sector groups.
ENVIRON prepared robust and comprehensive REACH dossiers and CSRs for numerous substances for a group of high profile hazardous organic substances with potential endocrine disrupting properties. Involved the use of measured and modelled data and innovative methods to effectively characterise chemical fate, exposure and effects on humans and the aquatic environment and elaborate well-defined, practical and safe exposure scenarios. CASE STUDY 2: advocacy for SVHC under REACH Provided strategic and scientific support to help industry develop and justify to policy makers a more credible, yet effective, risk management option for a chemical than phasing out its use under REACH. Supported a programme of direct engagement with key stakeholders to communicate concerns regarding proposals and inform the policy development.
Sue Bullock – Principal, product safety and stewardship Leading ENVIRON's Product Safety and Stewardship services, for over 20 years Sue has provided strategic, regulatory and technical assistance to industry relating to chemical policy and presence of chemicals in the environment, the workplace and consumer products. Dr Martina Vosteen – Principal, chemist and product safety Martina Vosteen has over 15 years of experience as a consulting chemist. She is experienced in product related regulatory support including global registration of and authorisation applications for chemicals, biocides and cosmetics for international operating companies. Dr Joe Rodricks – Principal, toxicologist Joe Rodricks is an internationally recognised expert in the field of toxicology and risk analysis and their uses in chemical regulation, management and stewardship. Dr Camilla Pease – Senior Manager, toxicologist Camilla Pease has 20 years' experience in chemical toxicology and advises on safety and risk assessment of consumer products including cosmetics. She is internationally respected in the areas of skin toxicology, human metabolism and bioavailability, mechanistic toxicology and alternatives to animal testing.
CASE STUDY 3: assured global compliance of new product
Mike Padgham – Senior Manager, regulatory affairs
Advised on regulatory obligations in more than 50 countries, considering chemical notification, packaging and labelling requirements, for a company wishing to market a new consumer product globally. The process allowed prioritisation of key market opportunities, substitution of one constituent and modification of marketing claims.
Mike Padgham is a chemical regulation specialist with 25 years’ experience in global regulatory affairs and toxicology for industry, as a regulator and in consultancy, and has prepared registrations and applications for authorisation under REACH.
CASE STUDY 4: comprehensive exposure assessment
Thomas Birk is an epidemiologist, with more than 20 years’ experience and expertise in the areas of occupational and environmental health, exposure assessment and exposure reconstruction.
Detectable levels of perfluorooctanoate (PFO) have been measured in the blood of the general population. Our expert team evaluated exposure to PFO from certain articles (eg treated carpets, clothing, upholstery and cookware) in the consumer environment for a multinational client, as a critical component of its product stewardship programme. The findings provided a strong basis for communication with external parties including regulators. CASE STUDY 5: regulatory action related to product contamination A food packaging producer faced numerous challenges when residual levels of a potential carcinogen were unexpectedly found in a key product. We showed that consumer exposure to the contaminant from handling the packaging and ingesting the packaged foods was within safe levels, avoiding regulatory action. The work also informed decisions regarding product viability, consumer perception and communications. CASE STUDY 6: proposal to re-classify as CMR An industry association asked ENVIRON to review all available and relevant evidence in order to comment on the basis and technical merits of EC proposals to re-classify the substance as a carcinogen.
Chemical Watch | Global Service Providers Guide 2014
Thomas Birk – Senior Manager, exposure assessor
Dr Thomas Rücker – Senior Manager, toxicologist Thomas Rücker has more than 15 years of experience in biochemistry and toxicology consulting, including the hazard and risk assessment of chemicals and consumer products, and strategic and regulatory support for a wide range of products under REACH and related legislation. Dr Thomas Sendor – Manager, ecotoxicologist Thomas Sendor is a biologist with ten years’ experience in regulatory support for chemicals regulated under the biocidal products Regulation, REACH and the plant protection products Regulation, specialising in risk assessment of chemical substances. Samantha Deacon – Manager, ecotoxicologist Samantha Deacon is an ecotoxicologist with 20 years’ experience in environmental regulation, consultancy and research in the assessment of chemicals in the environment, particularly agricultural products. Dr Rob Hermans – Manager Rob Hermans has more than 25 years’ experience in pharmacology with extensive expertise in human pharmacology, pharmacokinetics and human toxicology.
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PROFILE: ENVIRON
CASE STUDY 1: REACH registration and evaluation
STAFF SELECTION
SERVICES PROVIDED Regulatory compliance OO
OO
PROFILE: EQUITOX
CONTACTS
OO
REACH: data collection, data gap analysis and testing. REACH registration dossiers (Iuclid) and submission to ECHA via REACH-IT, chemical safety reports (CSR), Inquiry process, etc. biocides and cosmetics. classification and labelling: notification C&L, classification of substance and mixtures according to CLP, UN GHS, DSD, DPD.
Website
www.equitox.eu
contact@equitox.eu
Regulatory information
Head office
63 rue André Bollier, 69307 Lyon Cedex 07, France
OO
Tel
+33 (0)48 253 9018
Fax
+33 (0)97 231 0242
Contact
Dr Benoit Fraysse
Director
Dr Christine Reteuna
OO
Ownership
Private company
Product advocacy and project management
Locations
Lyon, France
OO
OO OO OO OO
OO
2011
Founded
OO
OVERVIEW
product defence strategy . animation and technical representation in consortia and Sief. communication strategy.
Specific and targeted technical support
EquiTox offers a full range of expertise in European chemical regulations (REACH, cosmetics, biocides, CLP…). We can manage your projects from the definition of your duties to the submission of your regulatory dossiers with their follow-up in case of challenge by authorities. We can also train your teams, develop your regulatory strategies, provide technical support for your customer services… The relationships we build with our clients are a reflexion of our core values: excellence, quality, open-mindedness, consideration of client constraints and trust. EquiTox is organised around five highly qualified experts, each with 10-20 years of experience working in toxicology, ecotoxicology and regulatory affairs departments of international chemical and consultancy companies.
OO
OO
OO
VITAL STATISTICS
2012/13
Turnover, group
€360,000
Turnover, chemical service provision
€360,000
No of offices
1
No of countries represented
1
Staff, group
5
Staff, chemical service provision
5
SERVICE AREA BREAKDOWN
OO OO
European chemical regulations (REACH, cosmetics, biocides, CLP). toxicology, ecotoxicology, risk assessment.
ACCREDITATIONS OO
OO
European registered toxicologists (Eurotox). Members of the French Society of Toxicology (SFT). Members of the Society of Environmental Toxicology and Chemistry (Setac).
CLIENTS Our clients range from multinational companies to SMEs, producing industrial and specialty chemicals, petrochemicals, biocides and cosmetics. Our clients include: Bluestar Silicones, L’Oréal, Roquette, UIC RhoneAlpes. CASE STUDY 1: setup of a regulatory support process for an EU chemical importer/distributor
Training 19% Information 3% Representation & management 10%
environmental risk assessment (cosmetics, industrial chemicals, biocides, etc). human health safety assessment (cosmetics, industrial chemicals, biocides, etc). toxicological and ecotoxicological expertise.
Training
OO
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literature review, study assessment and validation. model prediction and Qsar. organising and follow-up of laboratory testing. safety data sheet (SDS) writing, update and regulatory audit. extended-SDS: writing, compliance check, auditing. global product strategy (GPS) summary and (eco)toxicological profile.
Consultancy/ advisory 68%
EquiTox supplies technical and regulatory support to an established EU chemical importer/distributor. We have developed a responsive and trustbased relationship. One of the biggest successes of 2013 was the withdrawal of a draft decision from ECHA concerning a testing proposal. Working within the tight deadline and in coordination with the client (lead registrant), we were able to bring the Sief members together and define a pertinent strategy arguing for the waiver of the required tests. Then we set up a meeting with ECHA’s representatives. Following this, we provided a written and a unanimously agreed response. The outcome was an update of the registration dossier and the approval from ECHA not to perform the requested tests.
Chemical Watch | Global Service Providers Guide 2014
In preparation of the 2013 REACH registration deadline, a SME specialised in organic chemistry for the cosmetics and the food markets launched sub-acute toxicological tests with the advice of a CRO. However, due to a lack of in-house expertise in toxicology, the study design wasn’t appropriate for the chemical specificity of the test substance. As a consequence, the study had to be stopped because of several major deficiencies. EquiTox was contacted at that time. The requirements were clear: to produce a registration dossier without missing data, that would pass the technical completeness check and was scientifically robust. All of this needed to be done in a short period of time. The strategy we developed was based on the physico-chemical properties of the substance (hydrolysis) and a read-across approach with well-known degradation products. We then completed with a weight-of-evidence using some information from the abandoned sub-acute toxicological study. We submitted, on-time, a reliable and valid registration dossier. CASE STUDY 3: the biocide Regulation: how to anticipate the future The new biocides Regulation (BPR, 528/2012) presents a wider field of application compared to the former one (BPD, 98/8/EC). As an example, active substances generated in situ have to be approved with a closed list of precursors. An international company specialised in the production of minerals for the food, manufacturing and chemical industries, was aware of a non-conventional application of their chemicals, as precursors of active substances generated in situ. They have asked EquiTox to help them to understand the biocidal regulations, and to define a strategy to be in compliance with the applicable regulations (national, European). EquiTox frequently provides them with an up-to-date overview of the current discussions at the EU level one this evolving subject. In addition we guide them in the different tasks to deal with: OO being in compliance with national regulations until the couple precursor/active substance is approved; OO communicating with the leaders of the active substance dossier submitted to the rapporteur member state; OO forming a consortium with the other mineral producers to be in a good position to negociate a letter of access. STAFF SELECTION Dr Christine Reteuna – Regulatory Ecotoxicologist After obtaining her PhD in environmental toxicology, Christine began her career in the French Ministry of Environment for the implementation of chemical regulations. She then went into industry for 19 years (Rhodia), as an expert in regulatory ecotoxicology. It enabled her to work for both the consumer market (cosmetics, detergents, etc) and the industrial market (metal processing, oil market, etc), and to address environmental issues in a wide variety of products. She was also an Industry representative in several scientific (ECETOC) and professional organisations (UIC, ASPA, Cefic). Christine has developed specific skills in the assessment of environmental impact of chemical products (eg polymers, surfactants, cosmetics); covering data collection, study monitoring, the establishment of ecotoxicological profiles, product classification and risk assessment. She has taken part in the production of several regulatory dossiers and their support against competent authorities.
Chemical Watch | Global Service Providers Guide 2014
Stéphanie Moulin – Regulatory Toxicologist Stéphanie spent ten years working in the chemical industry for Rhodia, as regulatory toxicologist. She also worked for the CNRS (French national scientific research center) in the chemical risk prevention unit, and has teaching experience. Stéphanie’s main fields of activities are the development of testing strategies and the use of in vitro methods, the cost optimisation based on analogy and weight of evidence approaches, the selection and qualification of CROs, the registration strategies in Europe and in other zones, and chemical product defence. In addition, Stéphanie is specialised in human health risk assessment, with a focus on the safety assessment of cosmetic products. Dr Marie-Laure Teisseire – Regulatory ecotoxicologist Marie-Laure started her career in research, in the field of ground and surface water pollution, and teaching (six years at the University of Reims) then worked as a regulatory ecotoxicologist for a Chemical Company (Rhodia). The main projects managed by Marie-Laure, such as notification of new substances in EU or China or compilation of REACH dossiers, allowed her to improved her expertise in environmental exposure assessment to environmental risk characterisation and the definition of risk reduction strategies. Several other fields of expertise are environmental and physico-chemical hazard assessment of chemical products, study monitoring and hazard communication (SDS, C&L). Dr Benoit Fraysse – Regulatory (Eco)toxicologist Once he had his PhD, obtained in collaboration with the French Nuclear Safety Institute, Benoit developed expertise with three years in postgraduate positions, mixing teaching and research (French institutes and universities). He joined the French chemical company Rhodia, where he spent six years. Benoit specialises in analysis of the hazardous properties of substances (physical chemistry, environment, health) combining experimental tools with in silico (Qsars) methods. With regard to international issues, Benoit has a particular interest in the fields of developmental toxicity and the assessment of health risk to workers (REACH and biocide exposure scenarios). He also has active discussions with the competent authorities. Céline Goulois – Regulatory (Eco)toxicologist Céline is a regulatory (eco)toxicologist, specialising in REACH regulation. She studied chemistry and has a master in environmental toxicology. Before joining EquiTox in 2014, Céline spent 12 years as a consultant in several international consultancy firms (Altran, SGS) where she was in charge of the preparation and validation of technical documents, hazard classification, and REACH (registration, risk assessment, technical support). Céline’s skills are the technical coordination of REACH registration dossiers, with a substantial experience in Sief communication and dossier compilation. Her experience allows her to work with many product profiles and to propose a REACH compliance strategy suitable for each company.
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PROFILE: EQUITOX
CASE STUDY 2: REACH registration dossier: when the clock is ticking and the expertise in toxicology is lacking
OO OO
REACH compliance assessments support advocacy
Toxicology, ecotoxicology and risk assessment Study placement/ protocol review and development, development of (robust) study summaries, review of data for classification purposes EHS risk assessments.
PROFILE: ERM
CONTACTS
Classification, labelling and packaging (CLP/GHS)
Website
www.erm.com
rudolf.wilden@erm.com
Head office
Frankfurt: Siemensstraße 9, 63263 Neu-Isenburg, Germany
Tel
+49 6102 206-247/ +49 6102 206 202
Contact
Dr Rudolf Wilden
Directors
430 Partners globally, including Sal Giolando (US), Dominique Gangneux (UK), Kathleen Goossens (Belgium), Dirk Nuyens (France), Rudolf Wilden (Germany), Vijay Gudivaka and Dailey Tipton (Global IT)
Ownership
Private limited company
Locations
140
Founded
1971
Classification support, safety data sheet (SDS) and label authoring SDS and label review and improvement. Emerging chemical control laws around the world New chemical notification, tracking of emerging legislation bans/restrictions. Downstream product legislation, eg food/food contact, biocides OO OO OO OO OO OO
Lifecycle assessment and sustainability OO
OVERVIEW
OO
Environmental Resources Management (ERM) is one of the world’s leading providers of EHS and sustainability management, technical consulting and IT Implementation services, with considerable experience in providing global product stewardship (GPS) services. Global product stewardship is positioned within ERM as a strategic growth initiative. ERM offers integrated product service across all divisions within the company. VITAL STATISTICS
2013/14
Turnover, group
$658m
Turnover, chemical service provision
$20m
No of offices
150
No of countries represented
40
Staff, group
> 5,000
Staff, chemical service provision
>50
SERVICE AREA BREAKDOWN Training 10%
SERVICES PROVIDED Registration, evaluation and authorisation of chemicals (REACH)
OO OO OO
socio-economic analyses preparation of application for authorisation REACH training/ REACH impact assessments preparation of lead and member registration dossiers chemical safety assessments CLP notifications Sief management
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IT services supporting product stewardship OO OO OO
Global product stewardship implementations IT enterprise sustainability systems Unbiased software evaluations for product stewardship applications
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 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
2013
ERM supports implementation of global chemical compliance programmes (regulatory and IT)
Partner of Cefic, ReachCentrum, SAP, Enablon, IHS
We support our clients in all countries globally.
OO
OO
PARTNERS
GLOBAL OFFICES
OO
OO
ISO 9001 & ISO 14001
Consultancy/ advisory 70%
OO
OO
carbon footprinting and emission inventories lifecycle management (LCM) also to ISO14040 design for environment (DfE) environmental product declarations (EPDs) lifecycle analysis (LCA)
ACCREDITATIONS
Representation & management 20%
OO
food contact notifications compliance with country-specific legislation Fifra / BPD/BPR support national registrations local/ regional registration labelling and claims support
CLIENTS In the past five years we have worked for more than 70% of the Global Fortune 100 and more than 50% of the Global Fortune 500 companies. TESTIMONIALS "We have been working with the ERM team on REACH for a number of years now, and there are very good reasons to continue and expand this collaboration. Both on practical, communicative and technical-scientific levels ERM has provided us with active, solid and high-quality support for MSD's REACH programme. We are pleased to observe that our collaboration has turned into a true partnership." – Frits Wielaard, REACH programme manager, Merck Sharp & Dohme. “ERM have provided support and advice for us throughout the preregistration and registration phase of REACH and have always been totally professional, flexible and quick to respond to our needs. They provide an excellent service and we look forward to continuing our Chemical Watch | Global Service Providers Guide 2014
CASE STUDY 1: supporting the REACH team of Momentive Performance Materials (MPM) MPM required support for its REACH team using ERM’s REACH expertise, including toxicologists, ecotoxicologists and chemists. The ERM REACH project team was fully integrated into the MPM team and early identification and discussions of issues encountered provided timely resolution of such. Benefits and value: OO timely and successful submission of all registration dossiers in 2010; OO comprehensive documentation of approaches and work products to enable MPM to demonstrate compliance to the ECHA/CAs; OO alignment of global teams with same company culture ensures highly efficient co-operation; OO co-operation of the team with a view beyond registration (eg on health and safety management) helped solving upcoming issues; OO lessons learned during the first registration phase will inform and streamline future REACH management. CASE STUDY 2: supporting a multinational pharmaceutical company’s new chemical registration in China An ERM client needed to register a new chemical product with high toxicity (eg fish LC50(96h) < 10μg/L) in China. Due to its high toxicity the registration application was rejected in other countries. The Chinese Ministry of Environmental Protection (MEP) was highly concerned about the toxicological properties of this type of product, making registration a challenge. 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: OO successfully registered the new chemical product with one submission; OO to facilitate the approval, full and comprehensive analysis, which was not formally requested, was provided in addition to MEP; OO utilise the laboratory data, analysis results and ERM’s expertise and experience to forego several expensive and time-consuming laboratory tests, saving time and cost for the client. STAFF SELECTION ERM’s Global Product Stewardship TEAM (GPS) ERM has more than 50 professionals with extensive specific GPS experience located at various offices worldwide. These consultants are able to utilise the full resources of ERM globally to provide full back-up for all GPS-related services. Dr Rudolf Wilden – Product Sustainability Lead Central Europe PhD in environmental sciences with more than 12 years’ consulting experience in the fields of EHS/product compliance, substance registration/notification schemes and risk assessment. Dr Salvatore Giolando – Head of Global Product Stewardship Team
Dr Dave Best – Technical Director PhD in microbial biochemistry, coordinating ERM’s global effort on the provision of REACH. He has 18 years in the chemical industry as an environment, health and safety manager. Dr Steven Peterson – Senior Ecotoxicologist PhD in biological sciences with 20 years of experience in risk assessment, ecological research, environmental science with consulting firms, academic institutions, and government. Dr Alfred Wiedow – Senior Toxicologist, DABT More than 35 years of regulatory toxicology experience from working in the chemical industry, a governmental agency and academic research institutions. He is a recognized scientist in the fields of human and ecological toxicology and risk assessments and has initiated over hundreds of toxicity studies covering many cradle to grave scenarios. Kathleen Goossens – Principal Partner Has 17 years of experience in the field of EHS compliance and 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 Donna Morrall – Senior Qsar Expert 20 years of relevant expertise in both industry and consulting with a strong focus on risk assessment, data analysis and computational modelling. Dr Stephen Morrall – Principal Chemist BS and PhD in environmental and analytical chemistry. Has over 25 years domestic and international experience in product development and product compliance. Expertise includes chemical product hazard classification, environmental risk assessment, environmental chemistry and analytical chemistry. Dr Eckhard Schäfer, Principal Chemist PhD in chemistry, with more than 20 years’ experience in chemical risk assessment and preparation and implementation of safety plans. Health and safety advisor of the Hoechst Corporation between 1986 and 1994. Dr Elsie Millano, Senior Ecotoxicologist BSc in chemical eng and PhD in civil eng environmental area. Supporting the REACH team in the review and preparation of CSRs and safety data sheets, and review of robust study summaries. Over 25 years of environmental consulting experience in human health risk assessments, including exposure assessments, fate and transport evaluations, and risk calculations. Dr Randy Shuler – Senior Toxicologist Diplomate, American Board of Toxicology Inc, 1996-present, with more than 18 years of experience in toxicology, environmental science and consulting. Randy has evaluated toxicology and epidemiology data, and has provided litigation support in toxic tort and environmental litigation cases. Dianne Green – Senior GHS/CLP Expert More than 20 years of experience in the field of global product stewardship and regulatory affairs; diverse experience in US and international product 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.
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.
Carolyn Hammer – Senior Ecotoxicologist
Dominique Gangneux – Product Sustainability Lead UK
Over 20 years of relevant expertise in chemical, pharmaceuticals, discrete and process manufacturing in support of applying enterprise software for chemical compliance. Noted with launching multiple products into the market and development of application to support new regulatory requirements driven into the market.
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. Chemical Watch | Global Service Providers Guide 2014
Before joining ERM Carolyn worked for the US EPA in the fields of ecological risk assessment of pesticides and the development of new Federal rules and regulations related to waste, chemicals and pesticides. Dailey Tipton – Principal IS Solutions
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PROFILE: ERM
partnership with them in the years to come.” – Steve Williams, Regulatory Manager Europe, Knauf Insulation. “ERM has been Momentive’s partner in the implementation of REACH since the beginning and has always provided the expert support we needed through the different stages of the project.” – Ralf Maecker, Momentive Performance Materials
SERVICES PROVIDED General REACH services Exponent's consultants have significant experience in the provision of a wide range of REACH support to our clients. These services include initial work such as regulatory strategy and advice, data evaluation and the use of intelligent testing strategies, followed by study placement and monitoring. We prepare and submit registration dossiers and chemical safety reports and provide post-submission support during evaluation and authorisation phases, including completion of authorisation applications. Exponent has significant experience in programme and project management and Sief and consortia management and we can also act as your only representative registrant or third party representative.
CONTACTS Website
www.exponent.com
jreddy@uk.exponent.com
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
Derby, UK; Basel, Switzerland
Founded
2002
Preparation of REACH registration dossiers and chemical safety reports
OVERVIEW Exponent is one of the world's largest regulatory, engineering and scientific consultancies providing innovative solutions to complex technical problems. Exponent International Limited is a wholly owned subsidiary of Exponent Inc and is the European arm of the Chemical Regulation and Food Safety practice, with offices in Harrogate and Derby in the UK and Basel in Switzerland. Exponent combines unparalleled technical expertise with the ability to focus this knowledge to meet our clientsâ&#x20AC;&#x2122; needs within short timeframes. Our ability to create multidisciplinary teams of scientists, regulatory consultants and project managers means that we can either perform in-depth scientific research and analysis or very rapid-response evaluations to provide our clients with the critical information that they need to make day-to-day strategic decisions. VITAL STATISTICS
2012/13
Turnover, group
Est US$12m
Turnover, chemical service provision
Est US$3m
No. of offices
3
No. of countries represented
35
Staff, group
50
Staff, chemical service provision
30
SERVICE AREA BREAKDOWN Training 2% Other 3% Information 5%
Representation & management 25% Consultancy/ advisory 65%
GLOBAL OFFICES Global head office (Exponent Inc): 149 Commonwealth Drive, Menlo Park, CA 94025, US Other UK office: 1 Pride Point Drive, Pride Park, Derby, DE24 8BX, United Kingdom Switzerland office: Aeschenvorstadt 57, Basel, 4051, Switzerland
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Exponent has prepared in excess of 120 complete lead registrations for phase-in substances for the 2010 and 2013 deadlines on a wide range of chemicals and at the same time have worked on numerous non phase-in registrations. We undertake all aspects of the process such as data evaluation and gap analysis, determination of substance identification, use of intelligent strategies to address data gaps and study monitoring. We can complete all components of the Iuclid 5 dossier and the chemical safety report including exposure assessments, using Chesar and higher tier modelling and if necessary risk characterisation. Once the assessments have been completed we can also produce the extended safety data sheets. Global chemical notifications Our consultants have considerable experience in compiling and submitting chemical notifications worldwide; our team of specialists prepare and submit chemical notifications to all countries that operate a relevant scheme. We can prepare and submit dossiers for Australian, Canadian, New Zealand and Swiss registrations and can act as sole representative notifier utilising our Swiss office. We have a network of well-established local agents to help with the preparation and submission of regulatory documentation in China, Japan, Korea, the Philippines, Taiwan and Turkey and can call upon the experience of our US colleagues for TSCA notifications. Other regulatory regimes Exponent's consultants have significant experience in assisting clients with EU agrochemical, biocide, cosmetics and food regulatory requirements including food contact notifications. 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 regulatory strategy, can prepare the product information files and cosmetic product safety reports and act as a responsible person in compliance to 1223/2009. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1967
Parent company Exponent Inc formed.
2001
Novigen Sciences formed.
2002
Novigen acquired by Exponent. Exponent International Limited established in the UK.
2006
Exponent REACH team formed.
2008
Derby, UK office opened.
2010
Basel, Switzerland office opened.
Chemical Watch | Global Service Providers Guide 2014
CASE STUDY 3: REACH support for the 2013 deadline
ISO 9001 accreditation
Exponent Inc has worked with more than 5,000 clients and Exponent International has undertaken work for over 400 clients globally. Exponent has provided regulatory support to a range of companies across many industries; companies ranging from SMEs working in one industry to global companies conducting business in all areas of the chemical industry.
Exponent has provided full assistance for a fine chemical manufacturer in meeting their REACH requirements for the May 2013 deadline and has now started to work on their 2018 registrations. The company was 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 identity profiles and we prepared the dossiers and chemical safety reports. 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. The expertise we have built up of the type of substances and their uses has led to considerable costs savings, as we have been able to use utilise this knowledge to reduce testing requirements and the time taken to prepare registrations.
TESTIMONIALS
STAFF SELECTION
"Exponent International has consistently provided high-quality REACH and biocides services and support to our company for over five years. They produce work of the highest quality at competitive prices and are always prepared to go that bit further to ensure that they can deliver what we need within challenging deadlines. Their excellent technical knowledge and abilities mean that they are always the company we go to when we need help in these areas." − Regulatory Affairs Manager, global cleaning and maintenance products manufacturer
Dr Caroline Harris – Centre Director (UK)
CASE STUDY 1: Provision of technical support to an organometallic consortium
Julian Reddy – Head of REACH and Chemical Notification Services
PARTNERS We have no formal partners, but use an informal network of legal firms, CROs and in-country agents to provide the best service to our clients for REACH and global chemical notifications. CLIENTS
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, four substances that were registered in 2013 and we continue to provide support as we now head to 2018. The tasks that have been undertaken in support of this project are identification of data gaps, use of intelligent testing strategies to address gaps and, where necessary, placing and monitoring of studies. In addition Exponent has been and is still responsible for the preparation 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. In addition we have also provided support for post registration activities and have been involved with compliance checks as part of a dossier evaluation and a future substance evaluation. CASE STUDY 2: Product stewardship service for an SME Exponent has provided ongoing product stewardship support for a catalyst manufacturer, covering REACH and all other global chemical regulatory regimes for over five years. Taking a holistic approach, we provide global regulatory strategy and advice to ensure that legislative requirements from a number of countries can be effectively overlapped. Exponent also provides more technical support by preparing and submitting regulatory documentation for worldwide chemical notifications, preparing and reviewing European safety data sheets and determining the classification and labelling of the substances for GHS inside and outside of the EU. We also act as a sole representative for their Swiss notifications. Following the sale of part of this company’s business in 2011, we have handled all of the necessary regulatory and administrative work to ensure that all parties involved continued to maintain regulatory compliance for their products.
Chemical Watch | Global Service Providers Guide 2014
Dr Harris is the head of Exponent International and director of Exponent's Chemical Regulation and Food Safety Centre. She has a strong international reputation and has published papers on a range of subjects including dietary risk assessment, infant and child exposure to pesticide residues and risk perception. She acts as a technical consultant to a number of international bodies, including the FAO and the WHO, and has been a member of the UK’s Advisory Committee on Pesticides since 2009.
Mr Reddy is a very experienced regulatory project manager and has supervised complex regulatory programmes undertaken on industrial chemicals and biocides for 20 years. In addition, he has particular experience of Asian chemical notification schemes. Mr Reddy manages Exponent’s Derby office, which specialises in REACH and the global notification of industrial chemicals. He is responsible for the management of individual projects as well as overall programme management for clients and consortia. John Hislop – REACH Regulatory Specialist Mr Hislop specialises in REACH and particularly the registration requirements for phase-in substances. He has almost 20 years of experience working on global notifications of new chemical substances. Mr Hislop has considerable experience in the preparation of regulatory documentation, development of testing programmes for regulatory purposes specialising in the use of an “intelligent approach” to safety testing and is a leading advocate of the principle of the read-across approach. Jonathan Dale – REACH Regulatory Specialist Mr Dale specialises in the EU REACH Regulation, in particular the registration and testing requirements and procedures for both “phasein” and “non phase-in” substances and has given presentations on the Regulation at a number of international conferences and seminars in Europe, US, and Asia. Mr Dale also continues to be actively involved in the worldwide notification of new industrial chemicals.
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PROFILE: Exponent
ACCREDITATIONS
SERVICES PROVIDED REACH registration
Website
www.fobig.de
info@fobig.de
Head office
Klarastraße 63, 79106 Freiburg i Br, Germany
Tel
+49 761 386080
FoBiG provides full-scale scientific support to meet industry’s REACH obligations: OO Iuclid 5 files (including literature searches, data gap analysis, evaluation of reliability, application of read-across and category approaches and inquiry dossiers for new substances); OO classification and labelling according to DSD and CLP Regulation; OO PBT/vPvB assessments; and OO chemical safety reports (including hazard assessment, derivation of DNELs, DMELs, and PNECs, exposure assessment and risk characterisation).
Fax
+49 761 3860820
REACH authorisation
Contact
Klaus Schneider
Directors
Klaus Schneider, General Manager
Ownership
Private company
Locations
Germany
Founded
1992
Together with our partner RPA, we prepare applications for authorisation with: OO updated CSRs, including a refined exposure assessment to demonstrate acceptable remaining risks; OO analysis of alternatives; and OO socio-economic analysis.
PROFILE: FoBiG
CONTACTS
REACH substance evaluation and restrictions
OVERVIEW FoBiG is a privately owned consultant institute specialising in toxicological risk assessment, with more than two decades of experience in exposure assessment and risk characterisation. FoBiG’s REACH experience dates back to 2001 with participation in RIP projects, the Cefic-sponsored SPORT project, the REACH baseline study and VCI projects on exposure-based waiving and the practical guide on exposure assessment and communication in the supply chain. Together with partners, FoBiG prepared the REACH Baseline studies and related reports (part of the REACH review in 2013). FoBiG successfully prepared numerous registration dossiers for the first and second REACH registration deadline. Furthermore, we provide ample experience in authorisation under REACH: FoBiG is currently involved in five authorisation projects with threshold and non-threshold substances at various stages of the application. Further projects deal(t) with providing support for Corap-listed substances (substance evaluation”) and for substances targeted by restriction proposals. VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
€0.8m
No of offices
1
No of countries represented
Europe-wide
Staff, group
11
Staff, chemical service provision
11
SERVICE AREA BREAKDOWN Training Information 5% 3% Representation & management 2%
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FoBiG provides scientific support to companies whose substances are targeted in substance evaluations and restriction proposals. Services include problem analysis, dossier refinement and communication with competent authorities/committees. Biocidal product authorisation Together with REGISGATE partners (see Partners) FoBiG offers full-scale services for authorising biocidal products according to the new BPR scheme, including preparation of the Iuclid dossier and communication with competent authorities/ECHA Cosmetics ingredients and products FoBiG prepares cosmetic ingredients assessment reports for ingredient suppliers and performs cosmetic products safety evaluations as well as safety assessments of consumer products including exposure assessment. Pharmaceuticals Scientific services for pharmaceutical companies and for manufactures of medical devices include: OO derivation of PDE (permitted daily exposure) according to EMA guidelines for residual active substances; and OO assessment of impurities , including application of TTC (threshold of toxicological concern) approaches. Consumer products Potentially harmful substances in consumer products such as textiles and toys rank high in public awareness. FoBiG prepares hazard assessments and develops exposure scenarios to derive scientifically sound product evaluations. Occupational toxicology (Company-specific) occupational exposure limits for threshold and nonthreshold substances (the latter based on an analysis of exposure-riskrelationships according to a German methodology) support companies in their internal evaluations with regard to occupational safety and health.
Other 5%
Consultancy/ advisory 85%
Other services FoBiG provides regulatory support and (eco)toxicological risk assessments in various other areas such as food safety, environmental contaminants and effects assessment for industrial plants requiring permissions.
Chemical Watch | Global Service Providers Guide 2014
1989
Founded as personal company by Fritz Kalberlah.
1992
Reorganised as private company (GmbH) with partners Fritz Kalberlah, Klaus Schneider, Martin Hassauer.
2009
New company partner Jan Oltmanns.
CASE STUDY 3: substance evaluation: refinement of CSR and supply chain information
FoBiG established a successful partnership with RPA Ltd for authorisation projects, providing full-scale services for preparing applications for authorisation. Together with partners Battelle, Hydrotox and ECT FoBiG formed REGISGATE, a sophisticated consortium providing services for biocidal product authorisations.
With more and more substances being added to the Corap list, substance evaluation becomes an additional important activity within REACH. Companies, whose substances are concerned, should adopt a proactive position, communicate with the competent authority, and try to reduce existing concerns. Often, reasons for selecting a substance for evaluation include: OO aggregated tonnages; OO insufficient supply chain information; and OO wide-dispersive use situations. Improved and more detailed use descriptions and elaborated exposure scenarios are central to dissipate such concerns.
CLIENTS
STAFF SELECTION
PARTNERS
OO
OO OO OO
Chemical and pharmaceutical companies (from multi-national to small- and medium sized). EU institutions (eg Efsa, JRC, Eurostat). (German) federal and other authorities (eg BfR, Baua, UBA). Stakeholder organisations (eg VCI, trade unions).
CASE STUDY 1: read across for filling data-gaps Application of read-across and category approaches for filling data gaps in registration dossiers: Read-across proved to be the most successful strategy during the first two REACH registration phases for filling data gaps. Cases, where FoBiG successfully applied read-across in registration dossiers include: OO category formation/grouping based on structural relationship; OO read-across from metabolites to parent compounds or vice versa; and OO read-across along homologous structural changes. At the same time ECHA asks for detailed justifications for applying readacross approaches, which require in-depth analyses of toxicokinetic and other available data. Justifications for read-across are expected to be one of ECHAâ&#x20AC;&#x2122;s focuses in dossier evaluation in the future. CASE STUDY 2: application for authorisation: CSR refinement For non-threshold substances key to a successful application for authorisation is: OO derivation of exposure-risk relationships and DMELs, which are scientifically sound and acceptable to RAC; and OO refinement of the exposure assessment to derive realistic exposure estimates. in order to be able to conclude on low remaining risks associated with the use for which application is sought. Deviations from linear dose-response extrapolation may be justified even for genotoxic carcinogens, if sufficient information is available to conclude on a sublinear dose-response behaviour. A methodology developed under participation of FoBiG and accepted in Germany in a regulatory context allows developing quantitative estimates also for sublinear dose-response data. Experience in current projects clearly shows that CSRs from registration dossiers can be improved with regard to consideration of sublinear doseresponse relationships (where applicable) and by exposure assessments applying measured (eg air and biomonitoring measurements) data and Tier II modelling tools (eg ART, RISKOFDERM, ConsExpo etc.).
Chemical Watch | Global Service Providers Guide 2014
Klaus Schneider, PhD, DABT Klaus Schneider is the general manager of FoBiG and responsible project coordinator for all REACH-related services. With more than 20 years of experience in toxicological risk assessment he provides expertise in many areas, among them risk assessment methodologies, dose-response modelling and exposure assessment. He is member of the BfR expert group on exposure assessment and standardisation. Ulrike Schuhmacher-Wolz, PhD, ERT, Fachtoxikologin DGPT Ulrike Schuhmacher-Wolz is a senior scientist at FoBiG and acted as project leader in various projects related to REACH, food safety and other work areas. She provides special expertise in reproductive toxicology and the assessment of endocrine disruptors. Jan Oltmanns, MSc, PgDip Jan Oltmanns, senior scientist and company partner, is especially experienced in the assessment of physical hazards and in exposure sciences (worker, consumer and environmental exposure). Karin Heine, PhD Karin Heine, a biologist and toxicologist, has ample experience in hazard assessment and DNEL derivation as well as in gathering supply chain information and in exposure assessment, drawn from many REACH registration projects in the recent years. Markus Schwarz, PhD Markus Schwarz is an ecotoxicologist with in-depth experience in assessing environmental fate properties and ecotoxicological properties of chemicals and in performing PBT as well as environmental exposure assessments.
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PROFILE: FoBiG
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
-
No of countries represented
12
Staff, group
PROFILE: Harlan Laboratories
CONTACTS Website
www.harlan.com/crs
crs.eu@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
crs.eu@harlan.com
Directors
Hans Thunem, Manuela Leone
Ownership
Private company
Locations
Worldwide offices and operations
Founded
1931
OVERVIEW Harlan Laboratories is a global leading provider of essential, nonclinical contract research, research models, animal diets and services to the pharmaceutical, biotech, medical device, agrochemical and chemical industries, as well as to academic and government research organisations. Harlan Laboratories is the market-leading CRO offering regulatory advice, safety testing and safety assessment of chemicals. Our project leaders and study directors combine regulatory and scientific acuity with the 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 customers, 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 really all about scientific excellence. Today, research is increasingly being outsourced, and researchers need to have confidence in their supplier partners. Stability, reliability, consistency and quality are all essential. 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. Harlan Contract Research Services provides nonclinical and preclinical laboratory research services supported by state-of-the-art facilities worldwide. Our core capabilities are in: OO rodent and non-rodent toxicology OO genetic toxicology OO ecotoxicology OO inhalation toxicology OO reproduction toxicology OO regulatory affairs, consulting and programme management OO analytical chemistry OO environmental fate and modelling OO in vitro alternative testing OO pathology services OO drug metabolism and pharmacokinetics OO discovery services Page 96
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 Harlan Laboratories can offer all standard and higher-tier studies in the fields of physical chemistry, toxicology, genotoxicology, ecotoxicology, environmental fate and alternative testing. All tests required by REACH Annex VII to X are conducted by our experienced study directors in modern testing facilities. 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 (GLP). 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 physico-chemical tests, environmental fate (lab and field), animal (ADME, DMPK, PK screening and toxicokinetic testing) and plant metabolism studies for the chemical, agrochemical and pharmaceutical industries. 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 multisite studies, if necessary.
Chemical Watch | Global Service Providers Guide 2014
STAFF SELECTION
Harlan Laboratories is committed to the principle of the 3Rs of replacement, reduction and refinement. Harlan Laboratories is proactive in the development and use of in vitro and ex vivo methods, partnering with researchers and clients in pre-validation and formal validation studies.
John Handley, BSc, MSc, CBiol, FSB â&#x20AC;&#x201C; Global Vice President Operations
Genetic toxicology Harlan Laboratories offers a complete range of genetic toxicology studies to support the worldwide registration of pharmaceuticals, industrial chemicals and agrochemicals, meeting current guideline requirements. We offer consulting services to review data already held and to advise on further testing requirements/strategies, if required. These services also include access to in silica analysis to assist in hazard identification and risk assessment. Regulatory services In a world of an ever-increasing number of chemical control schemes, our registration services team plays a vital role in the registration of our clients' products. Our turnkey service, from the initiation of a project to preparation of the final dossier, ensures regulatory compliance. With nearly 3,000 regulatory projects successfully completed in the last 20 years, Harlan Laboratories has extensive experience of chemical control schemes worldwide. This experience, plus an excellent rapport with the regulatory agencies, ensures a successful outcome for your project. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1931
Foundation
2004
Acquisition RCC Ltd.
2005
Acquisition Cidasal SA
2007
Acquisition SafePharm Laboratories
2007
Acquisition IMTC (surgical models)
ACCREDITATIONS Contract Research Services (CRS): OO AAALAC OO ISO/IEC 17025 OO EN 45011 OO GLP OO GMP OO GEP CLIENTS Chemicals industry Agrochemicals industry Pharmaceuticals industry
John Handley is global vice president of operations at Harlan Laboratories, Ltd. and has some 26 years' experience working in the contract research industry. Following the completion of his masterâ&#x20AC;&#x2122;s research in acid rain and the associated toxicity of aluminium on rainbow trout, Handley 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. Handley 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 of environmental safety and metabolism across all Harlan CRS sites. In August 2010, he took control of all operational units in the Harlan CRS structure. Handley is a member of the Society of Environmental Toxicology and Chemistry and participates on UK shadow OECD discussion panels for ecotoxicology and biodegradation. He is a Eurotox registered toxicologist. Ciriaco Maraschiello, MSc, PhD, CRS Strategic Portfolio Manager Director, Drug Discovery & Translational Medicines Dr. Ciriaco Maraschiello (PhD, Biochemistry) is currently employed by Harlan Contract Research Services, a division of Harlan Laboratories Ltd., where he started to work in 1998. Harlan CRS offers preclinical and nonclinical services, including drug discovery and translational medicines to the pharmaceutical, chemical and agrochemical business segments. Maraschiello held various positions in Harlan CRS, from study director to manager of larger teams over the years, and he acquired a solid background, especially in the preclinical pharmaceutical arena. He managed the entire Harlan CRS toxicology platform and is currently in charge of the Drug Discovery & Translational Medicines operational platform. Additionally, he manages the strategic portfolio for CRS and is responsible for opening new business streams for the company. Maraschiello has a mechanistic knowledge and experience in oxidative processes related to aging. He has more than ten years of experience in bioanalytics, pharmacokinetics, toxicokinetics and metabolism, especially in the field of metabolite structural identification and pathways (mechanistic toxicology) and more than ten years of experience in designing and supervising preclinical toxicology programmes from the drug candidate selection process through the entire preclinical development to Phase I with major focus on neurodegenerative diseases, vaccines and biologics (monoclonal antibodies, recombinant proteins). Maraschiello supported various scientific advice provided by the EMA (London) and other regulatory European agencies (eg, Austria and Spain) for human and veterinary medicinal products. He is author or co-author of 43 scientific papers/communications and author of more than 15 lectures on preclinical toxicology topics, including regulatory affairs. 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, for many years, 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. Guest is currently manager of alternative and acute toxicology based at Shardlow, UK, and has been responsible for implementation of the 3Rs in regulatory toxicology by the integration of in vitro and ex vivo tests into tiered-testing strategies.
Chemical Watch | Global Service Providers Guide 2014
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PROFILE: Harlan Laboratories
Alternative and in vitro toxicity
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
SERVICES PROVIDED
Website
www.ihs.com/ehs-sustainability
ehs-sustainability@ihs.com
Head office
15 Inverness Way East, Englewood, Colorado 80112, US
Tel
+1 503 303 6544
Contact
Trish Jones
Directors
Jerre Stead, Executive Chairman
Scott Key, President and Chief Executive Officer
Anurag Gupta, Executive Vice President Strategy, Products and Operations
Scott Lockhart, Sr Vice President, Operational Excellence and Risk Management
Ownership
Publicly Traded Company (NYSE: IHS)
Locations
Worldwide
Founded
1959
IHS Product Stewardship Solution™
OVERVIEW Information management solutions for EHS and sustainability IHS is a global information company with leading experts in the pivotal areas shaping today’s business landscape, including chemicals, energy, economics, geopolitical risk, sustainability and supply chain management. IHS is also the leading provider of information management solutions – combining software, content and insight – for environmental, health, safety and sustainability. In today’s business climate, corporate executives are under pressure to reduce operational costs, avoid potential disruptions, and meet escalating external demands from investors and other external stakeholders for compliance with government regulations, voluntary sustainability protocols and corporate policies. Global industry leaders are increasingly focused on empowering a culture of operational excellence to demonstrate continuous improvement and the resulting financial performance to their shareholders. IHS enables businesses to meet these challenges and their operational excellence goals by providing the key systems that underpin their integrated management systems. VITAL STATISTICS
2012/13
Turnover, group
US $1.84bn
Turnover, chemical service provision
n/a
No of offices
193
No of countries represented
31
Staff, group
More than 8,000
Staff, chemical service provision
150
Empowering Operational Excellence Companies are struggling to address escalating external demands from investors for insight into non-financial performance information, including product stewardship, environment, health and safety, risk management, asset reliability, and supply chain performance. Operational excellence enables organisations to manage risk, drive workflow efficiency and optimise resources. IHS helps companies establishes a structure for managing non-financial performance information by collecting, aggregating and reporting data from the bottom up – from the laboratory to the executive suite – as part of their big data and analytics strategy. Industry and domain expertise
SERVICE AREA BREAKDOWN Training 5%
The IHS Product Stewardship Solution™ helps your business maintain access to existing markets while accelerating opportunities to introduce products in new markets. Powered by industry-leading information management products IHS Intelligent Authoring™, IHS Comply Plus® and IHS DolphinRTK™, this comprehensive solution combines software, content and industry expertise, enabling organisations to efficiently monitor and manage product compliance with rigorous regulatory mandates at every stage of the product lifecycle, from product design through manufacturing, shipping and delivery. IHS supports your company’s compliance programme with these powerful information management capabilities: OO SDS authoring – 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 your products and continued access to global markets; OO documentation and labels – simplify the process of producing labels and regulatory documents while reducing your company’s compliance-related risks across the enterprise; OO product compliance analysis – minimise risks to your company’s go-to-market strategy by aligning regulatory compliance analysis with your product lifecycle management plan. IHS helps you keep your products compliant; OO chemical management – identify opportunities to reduce costs and optimise operational processes while maintaining compliance with regional and national regulations; OO supply chain communications – improve communication between your internal stakeholders and suppliers, so you can maintain your access to key markets; OO managed regulatory content – ensure that you are able to maintain compliance in the ever-evolving regulatory environment. IHS monitors global regulations, interprets changes, and delivers application ready updates to data, rules, templates and logic.
Consultancy/ advisory 20%
IHS domain and technology experts possess a wealth of domain knowledge and have proven experience at global implementations that ensure alignment with our clients’ business requirements. IHS regulatory experts continuously monitor and track legislation changes in order to constantly refine our solutions, which support industry best practices that enable organisations to contain costs while reducing business risks.
IT & software 40% Information 35%
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Chemical Watch | Global Service Providers Guide 2014
1959
IHS founded.
composition and business decision justifications. Yara was also able to streamline work processes by automating distribution of SDS.
2005
IHS becomes a publicly-traded company.
STAFF SELECTION
2007
IHS launches EHS & Sustainability Business
Jeff Ladner, Senior Director, EHS and Sustainability Solutions
IHS acquires Environmax.
Jeff Ladner oversees the development of unified information management solutions that enable global organisations to proactively address EHS and sustainability business challenges, as well as boost operational and financial performance. Under Ladner’s leadership, IHS has established a strong reputation for enabling corporations to develop and execute sustainability strategies through a holistic, integrated view of operational performance. He has nearly two decades of experience meeting market demand for enterprise information management systems.
2008
IHS acquires Environmental Software Providers. IHS acquires Dolphin Software.
2009
IHS acquires Environmental Support Solutions.
2010
IHS named Leader in Carbon and Energy Management Software by independent analyst firm. IHS acquires Syntex Systems. IHS acquires Atrion International.
2011
IHS named Enterprise Sustainability Management Solution Leader by leading research firm. IHS acquires Dyadem.
2012
Analyst study names IHS a leader in environmental management software. IHS acquires CyberRegs Business from Citation Technologies. IHS acquires GlobalSpec and Invention Machine
2013
IHS acquires RL Polk & Co.
CLIENTS For more than two decades, IHS has been trusted by hundreds of enterprise-level clients worldwide across a vast array of industries, including chemicals, pharmaceuticals, energy, mining, manufacturing, transportation, consumer goods, defence and government. CASE STUDY 1: Drom Fragrances Challenge: Drom Fragrances, one of the world’s premier fragrance manufacturers, sought to ensure product compliance with regulations and industry standards in 43 countries – including REACH, CLP and IFRA. Solution: Drom implemented the IHS Product Stewardship Solution™ which enabled the company to streamline its processes and support its globalisation efforts. Results: Drom consolidate seven systems into one centralised system for product compliance data, standardised material safety data and work processes and saved over ten weeks of cleansing and transforming material safety data. They also simplified data management and production of SDS documentation/labelling and were able to lay the foundation for proactively addressing future changes to product regulations/standards in order to maintain and expand access to markets. CASE STUDY 2: Yara International ASA Challenge: Yara, the world’s largest fertiliser company and a leading chemical manufacturer needed to enhance safety data sheet authoring capabilities to comply with higher requirements from REACH, CLP and other mandates. Yara also wanted to establish a new integrated chemical compliance system compatible with their corporate IT environment and drive continuous improvement of SDS work processes and core business operations. Solution: Yara implemented the IHS Product Stewardship Solution™. Results: Yara efficiently managed exponential growth of SDS volume to support their business expansion. In the European market alone, they increased from 3,000 SDSs in 2008 to 15,000 SDSs in 2012. Yara was also able to standardise and enhance the quality of SDSs across their global enterprise. The IHS solution also enabled them transparency/ accountability for audits by offering the ability to track back to chemical
Chemical Watch | Global Service Providers Guide 2014
Francis Trudeau, Solutions Manager Francis Trudeau has worked for nearly 15 years in product compliance and chemical management. Trudeau has significant experience in solutions management and development, global regulations and industry standards enforced worldwide. He has worked on a wide variety projects that support IHS integrated information management solutions, and address legal compliance challenges and the implementation of regulations in databases and software applications. Trudeau is a recognised industry expert, serving both as a featured speaker at international conferences and leading multi-organisation task forces in establishing industry best practices for regulatory compliance. Mary Rudolph, Senior Manager – Global Content Mary Rudolph has more than 25 years of international environmental, health and safety experience, including technical and business implementations of authoring services. She offers IHS customers an in-depth and often sought after understanding of the needs of global EHS departments. She has also managed the development of EHS-related databases, including RTECS®, a recognised toxicology database. Scott Harter, Director Regulatory Content Scott Harter has more than 25 years of experience in EH&S. He has worked for 15 years in implementation, SDS authoring service, and content development. Previously he managed an EH&S department in a consulting business and worked for industry. In industry Harter managed extensive environmental investigations, the Industrial Hygiene Department, and the Radiation Protection Program for Eastman Kodak Company. He is a board certified industrial hygienist or “CIH”. Rosemary Feiter, Senior Operations Manager – Product Stewardship Services Rosemary Feiter has over 25 years of experience in a variety of fields that are correlated to product stewardship activities such as R&D, production, quality control, distribution and EH&S assessments. Feiter leads the Business Process Outsourcing (BPO) team which provides IHS clientswith safety document authoring and consulting services. The IHS authors and project managers are regulatory experts that have substantial experience and knowledge of global regulations and industrial best practices having worked on multiple authoring projects for clients with diverse product portfolio. Carrie Decatur, Regulatory Analyst Carrie Decatur is responsible for monitoring and analysing GHS regulations around the world. She has nearly 15 years’ experience in health and safety management programmes, managing compliance with state and federal Osha, and US EPA regulations, ensuring product safety, and supporting SDS authoring programmes. Sue Barton, Senior Regulatory Analyst Sue Barton brings more than 20 years’ experience in the regulatory compliance arena to help IHS customers navigate ever-changing chemical management regulations. Her expertise in research and development, interpreting regulations and developing system customisations, helps IHS customers meet their compliance challenges. Page 99
PROFILE: IHS
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
PROFILE: International Cosmetics & Chemical Services Ltd
SERVICES PROVIDED Responsible person (RP) for cosmetics CPNP notifications, product information files (PIF) 2009 Dec. 1223/2009 EC Cosmetic Regulation published. 2013 July 1223/2009 EC Cosmetic Regulation enforcement begins.
CONTACTS Website
www.intlcosmetics.com
info@intlcosmetics.com
Head office
947 Manhattan Beach Boulevard, Suite A, Manhattan Beach, CA 90266, US
Tel
+1 310 545 3223
Fax
+1 310 546 6204
Contact
Georgia@intlcosmetics.com
Directors
Janet Winter Blaschke
Â
Georgia Boehm
Ownership
Private company
Locations
USA, UK
Founded
1997
We provide full regulatory services in Europe, including labelling requirements, to meet 1223/2009 EC Cosmetic Regulations for 28 EU member states. Responsible person (RP) services. RP is responsible for: OO cosmetic safety report; OO safety assessment by qualified safety assessor; OO product information file (PIF) for each product; OO EU physical location to hold PIF; OO EU address as required for all product labelling; OO label direction to meet EU requirements; OO access for the competent authorities (28 countries) for PIFs; OO holding and maintenance of PIFs for legally required access by competent authorities. If a company does not own their formulas, we provide an agreement between the brand owner, the contract manufacturer and our company to provide confidentiality. With the agreement in place we only share information with an EU authority through access at our UK office.
OVERVIEW International Cosmetics and Regulatory Specialists LLC, a US organisation and International Cosmetics and Chemical Services Ltd, a UK entity are sister companies comprised of experienced professionals in regulatory affairs, international product registration, and international labelling compliance, with an emphasis on technical services for the EU, US, Canada, Asia, South America, and the Middle East. Please enquire about your specific needs. VITAL STATISTICS
Only representative (REACH), CLP notifications (sole representative)
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
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 reviews to the FDA monograph, training and 21 CFR 211 or ISO 22716 cGMP facility and standard operating procedure audits. Training for GMPs and ISO manufacturing standards
Training 15%
Representation & management 25%
Only representative services for companies needing chemical registrations for the EU scheme under REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). Late pre-registration and full registrations have already been successfully provided for many clients. CLP notification services are also available, in addition to safety data sheets to meet the requirements of REACH and CLP.
Consultancy/ advisory 60%
A wide variety of experience facilitates custom services for international needs with the intricacies of each individual organisation in mind. Focus is given to tailoring these skills to fit the client needs for entire projects, multiple countries, or for an individual project for one country. We provide GMP training and audits to the newly-required ISO 22716 as well as FDA cGMP gap analysis to 21CFR211 for USA compliance. Foreign and US location audits performed. CORPORATE DEVELOPMENTS & ACHIEVEMENTS REACH
GLOBAL OFFICES US: International Cosmetics and Regulatory Specialists LLC UK: International Cosmetics and Chemical Services Ltd
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2007
Formed REACH Chemical Consulting, Ltd now known as International Cosmetic and Chemical Services, Ltd.-UK.
2008
Filed pre-registrations for US and international companies to meet the EU regulation.
2009
Among the first only representatives to successfully complete a cosmetic ingredient full registration in 2009 prior to the first 2010 deadline. This resulted due to a company who missed the pre-registration phase while importing finished product using the ingredient at 1 ton or more the previous three years. Chemical Watch | Global Service Providers Guide 2014
Preparation of safety data sheets (SDS) to meet the REACH and CLP requirements.
2011
Continuing with SDS creations, REACH late-preregistrations, Sief coordination for clients and their chemicals, continue with CLP notifications.
STAFF SELECTION Janet Winter Blaschke, BA, Biology, University Redlands OO OO
ISO OO
CEO of International Cosmetics & Regulatory Specialists LLC. CEO and founder US, and managing director of International Cosmetic and Chemical Services Ltd in the UK, serving the consumer products and chemical industries. 30 years of experience as a product formulator and regulatory expert has given her unique expertise in both the European and US regulatory schemes. founder, instructor and lecturer for cosmetic science programme at UCLA (University of California at Los Angeles). Topics include: regulatory acceptance of cosmetic ingredients in individual countries; R&D and manufacturing for the global market; microbiology and quality control of cosmetic products. past chairman, Society of Cosmetic Chemists; member, board of directors, Society of Cosmetic Chemists; regulatory affairs chairman, contributing author to SCC publications chartered biologist, Society of Biology, UK. post graduate certificate in REACH management, University of Hull, UK
2006
Designated expert in the Cosmetic ISO workgroup for TC217, Cosmetic GMP, Sunscreens and Microbiology in Paris.
2006
Designated expert in Cosmetic GMP and Sunscreen workgroup in Den Haag, the Netherlands.
2008
Designated expert Cosmetic GMP and Microbiology workgroup in Paris.
2009
Designated expert Cosmetic GMP and Microbiology workgroup in Baltimore, MD, US.
2010
Designated expert Cosmetic GMP, Microbiology and Sunscreens workgroup in London
2011
Designated expert Natural and Organic Terminology workgroup in Kyoto, Japan
Georgia Boehm, AA Business Management, Glendale College
cGMP audit
OO
ICRS continues to excel in meeting cGMP compliance training and audits in the US as well as internationally. These activities are designed to meet the individual companies and their unique cultures. Staff use ISO GMPs, FDA cGMPs as well as country specific regulations depending on the market and or country needs. ACCREDITATIONS OO OO OO OO OO
OO
Personal Care Products Council (Formerly CTFA) Society of Cosmetic Chemists (SCC) Regulatory Affairs Professionals (RAPS) American Society for Quality (ASQ). Vrije University of Brussels (VUB), qualified safety assessor training and certificate from the department of Pharmacology and Toxicology Chartered biologist, Society of Biology, UK
PARTNERS Manhattan Repro (graphic design for labelling)
OO
OO
OO OO
OO OO OO
OO
Deborah Rediet, BA French and Minor in International studies, California State University Long Beach OO
OO OO
OO
Chemical Watch | Global Service Providers Guide 2014
regulatory manager – nine years’ experience in regulatory affairs in Canada, the US, Europe and Asia. expert in labelling compliance and PIF requirements. certificated from California State University, San Diego (CSUSD) in regulatory affairs, College of Science. fluent in French, working proficiency in Spanish .
Harmony Gates, MS Chemical Engineering OO
CLIENTS Alterna, Arbonne International, California Tan, CB Fleet Co, Circle of Friends, Contem 1g (Brazil), Davi (Mondavi) Skin, Disney Consumer Products Inc, Dermanew, Econet, Inc, Frederic Fekkai, Freeman Beauty, Giorgio Nardi (Italy), Go Smile, Henkel Consumer Goods, ICN Pharmaceuticals (Valeant Pharmaceuticals), Johnson & Johnson Consumer Products Inc, Jordana Cosmetics Corp, Juvena/La Prairie (Switzerland, Germany), Laboratoire Labothene Cosmetique GMbH (Germany), Leaf & Rusher, Mary Kay Inc, Merle Norman, MERCK (MSD), M&K (JK Mueller & Myung Sun), Nu Skin, Ole Henriksen, Pental Soap Products (Australia), Pierre Fabre DermatoCosmetique (France), Pola Cosmetics (Japan), Procter and Gamble, Rock & Republic, Smashbox, TIGI (Toni and Guy), Twincraft Soap Company, Zenyaku USA, as well as other Fortune 100 and Fortune 500 companies.
VP of Regulatory Affairs – International Cosmetics & Regulatory Specialists LLC, expert in yield and accountability documents for compliance with REACH regulations. 30 years of experience in cGMP compliance, regulatory and quality systems, international registrations, FDA registrations, FDA drug compliance for claims and labelling and facility. corporate experience: ten years at Neutrogena Corporation, six years at Herbalife International, and contract manufacturing management.
chemical engineer – 12 years’ experience in regulatory affairs in the US, Canada and the EU; specialising in environmental regulatory issues.
Robert Blaschke, BA, French, Loyola Marymount University OO
OO OO
regulatory affairs specialist.– four years’ experience in FDA compliance in the USA . expert with FDA electronic registrations and IT portal. IT specialist.
Page 101
PROFILE: International Cosmetics & Chemical Services Ltd
2010
SERVICES PROVIDED Advisory – services to help you advance your business Auditing – services to help you control operations Certification – services to help you reach new markets Outsourcing – services to help you focus on core activities Quality assurance – services to help you meet expectations
PROFILE: Intertek
CONTACTS Website
www.intertek.com/green/chemicals/
Training – services to help you improve your performance
regulatoryaffairs@intertek.com
Testing – services to help you improve your performance
Head office
25 Savile Row, London W1S 2ES, UK
Tel
+44 0161 245 8071
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Contact
Dr Jeremy Ramsden
Directors
Sir David Reid, Chairman, Wolfhart Hauser, Chief Executive Officer, Lloyd Pitchford, Chief Financial Officer
Ownership
Public
Locations
Intertek is the industry leader with more than 36,000 people in 1,000 locations in over 100 countries.
Founded
The Intertek story starts at the inception of the modern testing industry. The history of Intertek spans 127 years, and evolved from the combined growth of a number of innovative companies.
2010
Intertek acquires CIBA Expert Services and Cantox Health Sciences International specializing in developing scientific and strategic global regulatory plans, resolving complex toxicological and scientific issues, and facilitating timely regulatory approvals.
2013
Intertek has partnered with Decernis in order to provide research, content and information systems that supply a comprehensive service to help companies manage global regulatory compliance across the entire supply chain in a wide range of industries and products.
2013
Intertek added granulometry to complement their comprehensive suite of REACH physico-chemical property tests and chemical characterisation.
OVERVIEW
2013
Intertek helps organisations across a wide range of industries to sharpen their competitive edge by providing advanced measurement, expert consulting related technical support services, and sustainability solutions. Our experts and laboratories provide critical support to our clients in their global trade, not just with data, but with essential knowledge to accelerate development of their next generation products, to improve their manufacturing, products or production processes or to enhance their efficiencies.
Intertek has expanded commercial materials and surface analysis laboratory capabilities in Australia with the addition of a Scanning Electron Microscope with Energy Dispersive X-ray Analyser (SEM-EDXA).
2013
Intertek announced that all obligations and agreements with clients pertaining to the 31 May 2013 REACh deadline were successfully fulfilled.
VITAL STATISTICS
2012
Turnover, group
£2,054m
Turnover, chemical service provision
£154.8m
No of offices
1,000+
No of countries represented
100+
Staff, group
36,000+
Staff, chemical service provision
2,000+
SERVICE AREA BREAKDOWN
Other 29%
Training 3%
Consultancy/ advisory 10% Information 3%
Laboratory 55%
GLOBAL OFFICES US: 25025 I-45 North, Suite 111, Spring, TX 77380, US, +1-281-364-2923 Canada: 2233 Argentia Road,Suite 308, Mississauga, Ontario, Canada, L5N 2X7, + 1-905-542-2900 Germany: Stangenstr 1, 70771 Leinfelden-Echterdingen, Germany, +49 711 27311 152 China: 4/F, Block B, JinLing Business Square, No. 801, Yi Shan Road, Caohejing Development Zone, Shanghai, China 200233. Office: +86 021 6127 6132 Page 102
ACCREDITATIONS As a company Intertek believes that acquiring the appropriate quality accreditations and maintaining membership (and in many cases) chairing industry regulatory groups and standards organisations is key to not only our development but to providing quality assurance and insight to our customers; and while the company holds membership to these organisations; individually Intertek has employees that represent the company on different boards. Examples of these would be: OO Dr Ruud Overbeek – board member of Decernis. OO Dr Naeem Mady – industry segment council board member and a national board council member at the Plastics Industry Trade Association (SPI); OO Dr Paul Lambert – committee member of the European Structural Integrity Society (ESIS TC4); OO Dr Ian Fletcher – member of the EPSRC ‘college’ for peer review; OO Dr Jeff Franks – Royal Society of Chemistry, Membership Affairs Board; OO Dr Neil Everall – European editor of Applied Spectroscopy journal. OO Ms Karen Levins – active member of the Industry Coordinating Group (ICG) for the Canadian environmental protection Act (CEPA) and the new substances notification Regulations (NSNR). OO Ms Joyce Borkhoff – active member of the Industry Coordinating Group (ICG) for the Canadian environmental protection Act (CEPA), The Canadian Association of Chemical Distributors (CACD), the Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers (ETAD), the Color Pigments Manufacturers Association (CPMA), Canadian Paint and Coatings Association (CPCA) and the Canadian Consumer Specialty Products Association (CCSPA); and OO Mrs Lois Haighton – diplomate of the American Board of Toxicology. CLIENTS Our clients include: Behr, Bosch, BP, ChevronTexaco, Citgo, ConocoPhillips, Haier, Lubrizol, Petrobas, Siemens. Chemical Watch | Global Service Providers Guide 2014
TESTIMONIALS
Dr Marc Thouin – Vice President, Regulatory Services
"I would like to let you know that I am surprised with the high speed and high quality of the work you and your team have been doing to generate e-SDS for Braskem. I am very thankful for your special support. You made us feel important and we saw your special effort urgency sense dealing with our requests. Your special effort last month was outstanding and helped us a lot. I also wanted to inform you that Braskem Netherlands BV were inpected by Dutch government in regards to OR scope for all Braskem companies and all e-SDS checked were in compliance with REACH / GHS rules. Thank you so much!" – Braskem S.A. “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 provided a series of CLP submissions which fall under the new classification and labelling regulation in Europe supporting us and our EU-customers managing their legal obligations. We have had very good collaboration with Intertek and would like to offer a special thank you for their support, professionalism, and dedication. We look forward to a continued and long excellent relationship with Intertek.” – NOVA Chemicals Corporation
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, US.
CASE STUDY 1: incorrect definition of substance can lead to unnecessary registration One of the first major hurdles to cross in the preparation of the technical dossier for REACH is to ensure the registrant is certain that the substance is well defined. The better the knowledge on the substance definition the easier it is to decide on a registration strategy. In one case our client was uncertain about the handling and interpretation of the product-by-process definition so our expert spent several hours discussing the problem. As the descriptions became quite complicated this led to the point that our expert was invited to the plant and visit onsite to better define the case. After a few hours of explanations onsite it became quite evident that the substance in question was not eligible for registration and hence was exempted. Looking back it was good money invested in thinking it through and well worth the trip to the site as this was a minor investment compared to a full registration dossier; the client easily saved millions in consulting charges and multiples thereof in testing costs. CASE STUDY 2: Intertek’s global network of experts helps clients achieve cost-effective registrations worldwide As most companies focus more and more on core competencies such as R&D, marketing and production, it is our role as true service provider to help our clients with exactly those support services no longer considered core. For instance, our analytical, regulatory and environmental compliance services focus on these competencies ensuring that our clients can draw from our global network of experts, particularly in North America, Europe and Asia/Pacific Rim. Due to our in-depth understanding of the regulatory requirements locally we helped a multinational chemical company save €80k by coordinating the testing requirements for China, Japan and Europe. STAFF SELECTION Dr Ruud Overbeek – Vice President, Global Health, Environmental and Regulatory Services Dr Ruud Overbeek manages Intertek’s Health and Environmental (H&E) business which includes restricted substances, REACH, and climate changerelated services. Ruud and his global team deliver solution-led services to help companies fulfil the requirements of ever-changing global legislation. He is a regular author in respected industry and environmental publications, holds advisory roles on environmental business impact within the US health and beauty industry’s governing association and has a doctorate in chemistry.
Chemical Watch | Global Service Providers Guide 2014
Torben Nörlem, Intertek’s senior legal counsellor, has a LLM in law from the legal faculty at Copenhagen University and 15 years’ experience working with product related legislation and regulatory framework. Torben has been working as chief counsel for health and environment with Interek since 2008. Torben was responsible for legal affairs related to the REACH legislative process and was a participant of the Danish government negotiation team during the negotiations in the European Union. He was also responsible for implementation and administration of EU rules regarding chemicals in electronics in Denmark. Dr Michael Leise – Senior Expert Consultant Michael Leise is one of Intertek’s regulatory affairs senior expert consultant whose responsibilities include consulting on notification strategies for chemicals worldwide, test-programme development, chemical risk assessment, negotiations with authorities and scientific bodies. He studied at Heidelberg, researched in Boston at MIT and acquired environmental expertise at TÜV Rheinland before he joined Ciba Specialty Chemicals in Lampertheim as head of product safety in 1995. Karen Levins – SVP, Global BD and Marketing, Intertek Scientific and Regulatory Consultancy Services (formerly Cantox) Karen Levins serves as Interteks’s senior vice president, Global Business Development and vice president Chemicals Group at Intertek Scientific and Regulatory Consultancy Services. As a regulatory toxicologist with more than 19 years’ experience, Ms Levins helps the chemical industry understand and comply with global regulations controlling the manufacture, importation, distribution, and use of new and existing products. Dr Ashley Roberts – Senior Vice President, Food and Nutrition Group, Intertek Scientific and Regulatory Consultancy Roberts worked in the area of scientific and regulatory affairs for more than 20 years. Dr Roberts is an experienced regulatory toxicologist who has worked in both the food and pharmaceutical industry. Dr Roberts is available to advise and assist our international clients with issues that are scientific, regulatory and toxicological in nature. In addition, he is able to assist those clients wishing to design and develop scientific research programmes and for those developing regulatory strategies for food additives, foods that are generally recognised as safe (GRAS), and novel foods. Sandy Lin Song, M En, DUST – Director, China Office, Intertek Scientific and Regulatory Consultancy Ms Lin is a recognised regulatory expert in the area of food-related regulations, food additives, novel food ingredients and health foods in China. Her qualifications span over 20 years of industry and regulatory experience in which she worked for large international food companies in China. She has developed and maintained extensive networking relationships with the Chinese government authorities responsible for food safety, such as the National Health and Family Planning Commission (previously Ministry of Health), the State Food and Drug Administration Bureau, General Administration of Quality Supervision, Inspection and Quarantine. Helen Xue – General Manager, Chemicals and Pharmaceuticals, China Helen Xue has 18 years of experience in pharmaceutical, public health and environment area. She worked as the medical research scientist of FDA China Office, health and environment specialist of the US Consulate Shanghai Economic and Political section. Helen worked at Intertek from 1998 to 2006 and rejoined in 2013. She is in charge of C&P China which provide services for GMP compliance, EHS compliance, chemical regulatory support, cosmetic testing, consulting and efficacy study, green initiative programme for sustainable development. Page 103
PROFILE: Intertek
Torben Nörlem, Esq – Chief Counsel
SERVICES PROVIDED Software solutions Environmental product compliance and sustainability: ELV, IMDS, RoHS, REACH/CLP, LCA, DfE, RRR, Conflict Minerals, GHG, sustainable open innovation, SDS, dangerous goods management.
PROFILE: iPoint
CONTACTS
Consulting
Website
www.ipoint-systems.com
info@ipoint-systems.de
Head office
Ludwig-Erhard-Straße 52-56, 72760 Reutlingen, Germany
Tel
+49 7121 144 89 60
Fax
+49 7121 144 89 89
Contact
Katie Boehme
Directors
Jörg Walden, CEO
Hans-Gerhard Lang, Director Sales
Ownership
Private (Germany: GmbH, US: Inc, UK: LLC)
Locations
Germany, Austria, UK, France, China, USA, Japan
Founded
2001
Sustainability strategies, business and process analysis, impact analysis, EH&S consulting, sustainable products and brands, sustainable supply chain, sustainable manufacturing. Training Training events in the field of environmental product compliance and sustainability. Data care services Sustainability services for handling data from companies’ supply chain. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
OVERVIEW iPoint is an expert in environmental product compliance and sustainability, specialising in software, consulting and training for managing, tracking and reporting throughout the supply chain from product concept to completion. iPoint delivers adaptive and comprehensive software solutions that give the visibility and control customers seek in managing sustainability. iPoint’s solutions ensure compliance with requirements and regulations such as Dodd-Frank 1502 (Conflict Minerals), ELV, REACH, RoHS, or RRR, at the same time supporting companies in increasing the sustainability of their products. VITAL STATISTICS
2012/13
2001
iPoint-systems gmbh founded in Reutlingen/Germany.
2002
Sales office in UK opened.
2007
Office in North America opened.
2008
Sales office in China opened.
2010
Acquisition of KERP GmbH in Austria.
2012
OO OO
OO
Gartner recognises iPoint-systems as Cool Vendor. Quality seal “Top 100”: iPoint-systems is Innovator of the Year. Launch of iPoint Conflict Minerals Platform (iPCMP). iPCMP is an on-demand software solution which enables companies to collect, manage, aggregate and report Conflict Minerals information and meet the requirements of their customers and regulatory.
2013
New offices in China and Japan opened.
2014
With 13,000+ registered companies, the iPoint Conflict Minerals Platform (iPCMP) becomes the cross-industry, market-leading standard solution for Conflict Minerals reporting.
Turnover, group
-
Turnover, chemical service provision
-
No of offices
8
ACCREDITATIONS
7 2011: 55; 2012: 70, 2013: 80
ISO 9001 ISO 14001
20
PARTNERS
No of countries represented Staff, group Staff, chemical service provision SERVICE AREA BREAKDOWN Training 10%
IT & software 55%
OO
Consultancy/ advisory 20% Representation & management 5% Information 10%
AIAG, IHS, Jonsson Consulting, NTT, TetraTech
CLIENTS OO OO
OO OO
OO
OEMS: Ford, GM, Hyundai/Kia, Jaguar Land Rover, Nissan, Renault Suppliers: Automotive Lighting, Johnson Controls, Lear, Magna, Mahle, Meritor, Valeo Electronics: Arçelik, AKG, Bosch. Machinery and plant engineering: Florida Production Engineering, Pentair, Rexroth, Voith Other industries: Caterpillar, ITW, Eugster/Frismag, Roche Diagnostics, Tesa
GLOBAL OFFICES Reutlingen (Headquarters), Dortmund, Vienna, Manchester, Paris, Southfield, Shanghai, Tokyo.
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Chemical Watch | Global Service Providers Guide 2014
TESTIMONIALS
STAFF SELECTION
Gartner recognises iPoint-systems as Cool Vendor: Why cool? OO “Holistic solutions covering a sustainable supply chain management remain absent from the marketplace. OO In existence since 2001, iPoint’s solutions however provide a robust and well-tested technology platform for managing environmental compliance and sustainability requirements in complex discrete and increasingly regulated manufacturing environments. OO Central to their solution suite is their Compliance and Sustainability Hub which acts as an integration platform for critical compliance, materials and sustainability data”. OO http://www.ipoint-systems.com/en/newsroom/news/news-details/ artikel/weltweit-fuehrendes-analystenhaus-waehlt-ipoint-systemszum-cool-vendor/ Quality seal “Top 100”: iPoint is one of the three main award winners OO “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. OO iPoint-systems convinces by its ability to react to changing circumstances quickly. Due to its excellent monitoring processes, the company can detect new market developments. Moreover, customers are involved in the developing projects. Overall, the company’s management level excels in its extraordinarily strong commitment in innovation management.” OO 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 OO
OO
OO
iPoint-systems optimises global ELV processes at Automotive Lighting with Compliance Agent’s IMDS Solutions. closing the floodgates on data: AL has to create about 750 in-house material datasheets (MDS) for annual average of 75 new products – about two per day. This means that on top of our own MDS, we receive about 20 times as many again from suppliers – which makes for a flood of data. Finding the light at the end of the tunnel by ensuring that delivered data was both on time and correct was therefore the main priority for the new IT-solution http://www.ipoint-systems.com/en/newsroom/brochures/#c1369
CASE STUDY 2: MagnaSteyr Legally Compliant and Sustainably Designed Products for MAGNA STEYR: OO main motivation for the project: use of a software tool that facilitates compliance with regulations governing material recycling and recovery. A steadfast commitment to the environment begins with the development of green products while considering each individual life cycle stage OO in a joint effort with MAGNA STEYR, we have successfully developed iPoint RRR. This tool greatly reduces the time needed to calculate recycling and recovery rates, allowing simulations of different recycling scenarios while emulating novel recycling technologies. OO http://www.ipoint-systems.com/en/newsroom/brochures/#c1369 CASE STUDY 3: iPoint-systems equip Turkish household goods sector leader with new software solution OO
OO
OO
In the EU, housewares producers are faced with innumerable regulations. In particular, surface properties and pure substances of imported products are closely monitored. In order to maintain profitability and ensure a complete overview of the country-specific standards, the Turkish leader in the household goods sector has chosen the iPoint Supplier Entry Portal (SEP) and the Compliance Agent (module SAM-M). www.ipoint-systems.com/en/newsroom/news/
Chemical Watch | Global Service Providers Guide 2014
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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 such as Turkish, Russian, Malay, Chinese Mandarin and Thai, with particular consideration of national requirements MSDS for US/ Canada according to current local legislation. A comprehensive concept of SDS maintenance packages has been successfully introduced allowing customer’s permanent updating of safety data sheets (SDS) pursuant to statutory requirements. The total care service is completed by the latest innovation KFT SDS Control & Care, covering the management of supplier SDS.
PROFILE: KFT Chemieservice
CONTACTS Website
www.kft.de; www.kft-academy.com; www.KFT-ebook24. com; https://kft-chemdoc24.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, Karin Schmidt
Directors
Dr Karl-Franz Torges, Managing Partner
Ownership
Private company
Locations
Griesheim (near Darmstadt), Germany
Founded
1995
Raw materials management Many of our customers have entrusted KFT with the management of their raw material data. This involves the requisition and review of suppliers‘ safety data sheets, and communication with the supplier to eliminate possible deficiencies. We remotely enter the data of the suppliers' SDS into the customer’s IT systems. In addition, we update the regulatory content data in the customer systems. Our many years ‘experience with SAP EH&S allows us to guarantee proper and professional data maintenance also in these systems.
OVERVIEW KFT Chemieservices’ business is its competence in regulatory and product safety affairs. We ensure our customers’ legal compliance for registrations, documentation as well as environmental exposures. Key elements are our experienced and well trained staff, modern, sophisticated software and fair compensation of our services. Our responsiveness to individual customer needs is well recognised in the market. VITAL STATISTICS
Generation and maintenance of exposure scenarios
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
1
Unfortunately there is as yet no standard format for the electronic exchange of exposure scenarios (keyword ESCOM XML). Moreover, for existing registrations the data for the exposure scenarios have to be copied from our own or third party chemical safety reports (CSR) or from suppliers‘ safety data sheet appendices to our own IT system. Based on our experience with major customer projects, we can now remotely enter appendices or exposure scenarios into your IT system, enabling you, after implementation of the appropriate interface, to electronically export your compliant exposure scenarios and make them available to your customers. Research
Staff, group
15
Customised substance data research, marketability check, limitations for chemicals prohibition ordinance and substances of very high concern (SVHC), special packaging and labelling requirements.
Staff, chemical service provision
11
Product registration Registration pursuant to §16e of the German Chemicals Act (ChemG), the German Federal Institute for Risk Assessment (BfR), the German Detergents and Cleaning Agents Act (WMRG) and product registrations in Switzerland, Greece, the Netherlands, the US and other nations.
SERVICE AREA BREAKDOWN Other 11%
REACH
Training 12%
Consultancy/ advisory 40%
Legal 2%
IT & software 2% Laboratory 3% Information 14%
Representation & management 16%
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: OO only representative services pursuant to article 8 (REACH); OO registrations according article 11 and 19 of REACH; and OO preparations of Iuclid dossiers and CSR (chemical safety reports). Our REACH and management services cover: OO impact analysis, strategic and operative REACH consulting, portfolio as well as supply chain communication consultation. Our Sief management provides: OO project management, financial processing and settlement, trustee services, conducting studies and organisation of data sharing, communication with customers, authorities and competitors. Biocide substances With an experienced team we handle registrations of biocide substances, coordinate study generation, prepare the dossiers and do the authority management.
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Chemical Watch | Global Service Providers Guide 2014
Seminars,training and coaching
CASE STUDY 2: marketability study 2
The very popular and appreciated coaching support has been continuously developed to a broad spectrum of seminars around the compliance aspects of REACH, SDS, GHS / CLP and biocides. The available selection can be found at www.KFT-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
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.
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Our strength is the support of the medium-sized industry, whose core competence does not lie within the production or handling of chemical products. The REACH requirements are particularly problematic here. KFT Chemieservice verifies the requirements. If there is no lead registrant or Sief facilitator appointed for strategic products, we evaluate the registration capacity of the material by our customers, check the competition situation and identify possible co-registrants. After a positive economic evaluation by our customer, we facilitate the registration of the material. Thus, we cover all steps of the process. We perform the Sief survey with the available data in consideration of the interests of other Sief participants, find the existing data and data gaps, undertake negotiations with data keepers and contract testing labs to close the data gaps. We create the Iuclid file and the CSR and take care of registration with the ECHA. As a result of this, the client receives the registration number. KFT markets the letter of access to other registrants. As an additional service, we create the safety data sheets with appendix (exposure scenarios) in all EU languages. We provide one-stop service for the client.
Foundation of KFT Chemieservice in Rellingen, near Hamburg, Germany.
1996
First training for the generation of MSDS for Europe and US.
1998
First registration according to the existing substances regulation 793/93/EC.
2000
Relocation of the company to Griesheim, Germany.
2008
First only representative contract with Brazilian company.
2010
> 3,000 pre-registrations, > 60 substances registered, first biocide substance registered.
2010
Launch of KFT-ChemDoc24.de.
2011
First substances in articles notified.
2012
Introduction of SDS Control & Care (raw material management).
2013
Launch of KFT-EBook24.com with laws, regulations and guidance documents worldwide.
ACCREDITATIONS VCH (association of chemical suppliers) subsidiary of FECC (European Association of Chemical Distributors) Member of ENES (European network on exposure scenarios) PARTNERS Tradas Translations and Consulting Services (flexible customised solutions for linguistic and technical needs) Laus GmbH (GLP certified testing laboratory) CLIENTS Chemical manufacturers, distributors, importers of consumer goods, biocide substances, pharmaceutical raw materials, hygiene products for veterinary applications, household cleaner formulations and other products. CASE STUDY 1: marketability study: Consumer goods providers must take many legal stipulations into consideration. Particular attention is paid to hazardous materials and hazardous cargo. Usually, these providers are distributors and not manufacturers of the products. Therefore, a few traders have established a partnership with KFT Chemieservice GmbH, in order to verify product compliance. Together with the tender, suppliers of the consumer goods providers are asked to submit a confirmation from KFT Chemieservice GmbH that all documents and labels conform to legal regulations. KFT Chemieservice checks the requirements and legal conformity with regard to: OO chemical legislation; OO ordinance on detergents; OO cosmetics regulations; OO biocide regulations; OO environmental regulations; OO commodities regulations; OO transport law (hazardous materials) etc; and OO and ultimately issues approval for marketing.
Chemical Watch | Global Service Providers Guide 2014
STAFF SELECTION Dr Karl-Franz Torges – Managing Partner Dr Karl-Franz Torges is founder and managing partner of KFT Chemieservice GmbH, heading the business unit REACH and Registrations. Familiar with hazardous materials, hazardous cargo, MSDS and registrations since 1989. Several years experience in working with software companies focusing on compliance software (SAP EH&S). Since 2001 instrumental participation for the development of software tools for REACH processes. Member of Cefic and VCI working groups. Consulting for the development of Iuclid 5.0. Consulting and training projects and workshops for hazardous materials management, registrations, and chemical compliance. Angelika Torges – Member of the board Board member and heading the division hazardous materials, marketability study and MSDS. Experience and responsibilities in these segments since 1989. Certified dangerous goods officer for several companies. Expertise in toxicology, ecotoxicology, chemical compliance ie. for washing and cleaning agents and has expert certificate for §5 of Restriction Ordinance on Chemicals. Other staff Majority of staff are PhD chemists, biologists and experts in food technology with years of experience for material registrations and MSDS. In-house training is a strong focus and sustainable external training is obligatory.
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PROFILE: KFT Chemieservice
1995
CASE STUDY 3: REACH lead registrant support
SERVICE AREA BREAKDOWN Consultancy/ advisory 15% Representation & management 5%
CONTACTS
PROFILE: Mérieux NutrisSciences
Website
www.merieuxnutrisciences.com
Laboratory 75%
jean-luc.garrigue@mxns.com
Head office
111 East Wacker Drive, Suite 2300, Chicago, IL 60601, US
Tel/ Fax
+33 607 493 701 / +33 472 590 038
Contact
Dr Jean-Luc GARRIGUE
Directors
M. Philippe SANS
M. Jean-François BILLET
M. Tiziano CONTE
M. Luis Fernando Torres MAIDA
Ownership
Institut Mérieux
Locations
Brazil, Italy, China, France, USA
Founded
1979
GLOBAL OFFICES Headquarters MERIEUX NUTRISCIENCES: Chicago, USA Laboratories : Bioagri Laboratorios: Piracicaba, Brazil ; Chelab-Silliker: Resana, Italy ; Biofortis: Nantes, France, Sao Paulo, Brazil, Chicago, USA, Shangai, China. Sales Offices: Lyon, Nantes (France), Piracicaba, Sao Paulo (Brazil), Resana (Italy), Shangai (China), Chicago (USA) SERVICES PROVIDED Toxicology
OVERVIEW Mérieux NutriSciences is the new name of a CRO with 40 years experience, part of the Institut Mérieux, which helps advance science and solutions for the safety evaluation of chemicals and food worldwide. Through its business units Bioagri, Chelab-Silliker and Biofortis, Mérieux NutriSciences provides numerous innovation and contract research services. Chelab-Silliker, located in Italy, is become the main European business unit of Mérieux NutriSciences for safety, efficacy and analytical testing services (GLP; GMP). Bioagri, the Brazilian business unit of Mérieux NutriSciences, is the largest private CRO in Latin America (GLP-OECD, AAALAC). Both labs Bioagri and Chelab-Silliker are serving the chemical, cosmetic, food, pharmaceutical, medical device, biocide and crop protection industries worldwide. Services encompass in vitro and in vivo toxicity, physico-chemistry, ecotoxicity, efficacy of cosmetics and biocides, analytical and microbiological studies, virus inactivation/removal evaluation, and residues analysis (pesticides, heavy metals, allergens, impurities) under applicable regulatory guidelines. Biofortis is the third pillar of Mérieux NutriSciences, and a leader in consumer research and sensory analysis of cosmetics, perfumes, food and nutrition products (11 sensory and consumer labs. in the USA, Brazil, China and France). Globally, Mérieux NutriSciences has become the CRO partner of choice of chemical industry leaders, towards the following unique strengths: OO integrity, scientific quality and accountability; OO reactivity, very short decision-making centres (Brazil, Europe, China); OO international locations able to facilitate the local coordination of projects on the spot; OO highly flexible project management; OO global network and access to key opinion leaders in China, Brazil, USA and Europe. Overall, Mérieux NutriSciences offers to the chemical, cosmetic, food, pharmaceutical, medical device, biocide and crop protection industries one of the best performing turn-key solutions, with high quality standards for a large range of CRO services within undisputed financial robustness and international footprint. VITAL STATISTICS
2012/2013
Turnover, group
US $ 429 m
Turnover, chemical service provision No of offices No of countries represented Staff, group Staff, chemical service provision Page 108
Information 5%
US $ 43m 74 18 5000 900
In vitro toxicity: Mérieux NutriSciences is committed to the principles of the 3Rs of replacement, reduction and refinement: OO acute skin corrosion – human reconstructed epidermis; OO acute skin irritation – human reconstructed epidermis; OO acute eye irritation/corrosion – human corneal epithelium (HCE); OO skin sensitisation – DPRA; MUSST; hCLAT; OO genetic toxicity – Ames; MLA; in vitro micronucleus test; and OO phototoxicity – 3T3-NRU test. In vivo toxicity, under supervision of an animal welfare ethical committee, in an AAALAC-accredited, GLP-OECD testing facility: OO acute oral, dermal or inhalation toxicity; OO acute dermal or eye irritation study; OO skin sensitisation (LLNA, GPMT, Buehler); OO repeated dose (7-d, 14-d, 28-d, 90-d) oral or dermal toxicity; OO in vivo kinetics and metabolism (ADME); OO genetic toxicity (in vivo micronucleus test); OO embryo-foetal developmental toxicity; OO one or two-generation reproduction toxicity; OO reproduction and developmental toxicity screening; OO combined repeated and reproduction toxicity screening; and OO carcinogenicity (alone or combined with chronic toxicity). Physico-chemistry Conducts all required studies on physico-chemical properties of products according to OECD, EU and US-EPA guidelines (eg molecular identification, vapour pressure, n-Octanol partition coefficient, etc) Ecotoxicology Evaluates all classical effects of products on aquatic and soil organisms: OO ready and inherent biodegradability; OO acute/chronic assays in Daphnia magna; OO algae growth inhibition (Pseudokirchneriella subcapitata); OO activated sludge respiration inhibition; OO soil microrganisms (nitrogen test); OO earthworm acute or reproduction toxicity (Eisenia foetida); OO acute/chronic fish toxicity (Danio rerio, or truta); OO fish bioconcentration (Danio rerio); OO honeybees acute oral or contact toxicity (Apis mellifera); OO avian acute oral/ dietary toxicity (Japanese quails); OO sediment/water microcosm biodegradation; OO aerobic or anaerobic soil metabolism; OO leaching in soil columns; and OO adsorption/ desorption. Chemical Watch | Global Service Providers Guide 2014
The largest number of high end chemistry equipment offering flexibility and shorter detection limits for spectral and compositional characterisation of substances, active ingredients, impurities and metabolites: OO spectral analysis (SPFT, XRD, MS, FTIR, NIR, TOF, NMR); OO elemental analysis ((ICP-MS, ICP-OES, XRF, AAS, SEM-EDX); OO mass spectrometry (LC-MS/MS, LC-Q/TOF, LC-ESI/TOF, GC-MS, LC-Orbitrap, GC-MS/MS, GC-HRMS); OO liquid chromatography (HPLC-DAD, HPLC-ELSD, HPLC-RID, IEX, IC, SEC/GPC, amino analyser); OO gas chromatography (GC-FID, GC-ECD, HS-GC, chiral GC); OO titrimetry (acid-base, colorimetric, complexometric, potentiometric, redox, K-F); and OO morphology (optical microscopy, SEM, laser granulometry, sieve granulometry, DLS) Radiochemistry Behaviour and fate of pesticides in plants, animals and soils, according to OECD and US-EPA guidelines.
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
Chelab, the Italian leader in chemical, microbiological and GLP in vitro toxicology laboratory services, becomes a company of Mérieux NutriSciences Corporation and becomes Chelab-Silliker.
ACCREDITATIONS GLP, GMP, OECD mutual acceptance of data for industrial chemicals and biocides/pesticides (Bioagri, Brazil), AAALAC International, ISO 17025, ISO 9001, ISO 14001 PARTNERS European consultants (regulatory, toxicology), working with Mérieux NutriSciences, Bioagri or Chelab-Silliker under confidentiality agreement.
Microbiology
CLIENTS
Bactericidal / sporicidal / fungicidal / virucidal properties of biocides; toxicity and efficacy evaluation of insecticides / repellents on insect vectors, in association with quality control and analytical chemistry of the active ingredients in the tested formulations.
Confidential information. Worldwide leaders and SME from chemical industry, agrochemical, biocide and crop protection industries, cosmetic and perfume industry, household products industry, medical device, pharmaceutical and veterinary drugs companies
Pesticide residues Analysis of herbicide and pesticide residues in samples from field trials. Safety evaluation of cosmetics and detergents in humans In Italy: skin irritation patch test on volunteers, ophtalmological irritation test on volunteers, under appropriate MD control Efficacy evaluation of cosmetics and detergents in humans In Italy: in vivo determination of SPF, water resistance, hydratation test, TEWL, assessment of anti-wrinkle and anti-cellulite products, etc... CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1897
Creation of Institut Mérieux. Institut Mérieux has a comprehensive approach from prevention to therapy through diagnosis. Today, its three companies – BioMérieux, Transgène, Mérieux NutriSciences – have made major advances in the fight against infectious diseases and cancers, as well as in the field of nutrition, food and chemical safety.
1967
Silliker first laboratory founded in Chicago (USA) for food safety and quality analysis
1979
Chelab founded in Resana (Italy), for testing and consultancy for food, non food, environment and pharma industries
1991
Bioagri founded in Piracicaba, Brazil, testing provider for agrochemicals and environmental analyses
2000
Bioagri, first Latin America lab accredited for GLP in 2000 by INMETRO (Brazil) and in 2002 by OECD (Netherlands).
2010
Bioagri accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).
2010
Bioagri becomes a Company of Silliker Group Corporation.
2011
Silliker Group Corporation renamed Mérieux NutriSciences Corporation to reflect the evolution of the company and promote better global health and nutrition. At the same time, three complementary business units were organised to deliver a wide range of services to the chemical, food and nutrition value chain. Silliker – food safety and quality Biofortis – innovation for nutrition Bioagri – analytical and safety services
Chemical Watch | Global Service Providers Guide 2014
CASE STUDY 1: Eighty two GLP pre-clinical safety studies conducted in 2011-2013 in in vitro or in vivo skin sensitisation, genetic toxicity, developmental and systemic toxicity studies for chemical substances for a leading international company, matching sponsor’s expectations in >95% as far as scientific quality, regulatory compliance and time schedules were concerned. CASE STUDY 2: Consequently to an urgent request from one sponsor, ability to react rapidly by multiplying by three the internal laboratory capacity, so as to conduct up to 35 LLNA (local lymph node assay) in four months, with appropriate scientific quality and full respect of regulatory timelines. CASE STUDY 3: Bioagri chosen in 2011 by the Brazilian governmental authorities to represent Brazil for the full membership of Brazil to OECD (regarding GLPs), effective in 2012. STAFF SELECTION Our technical staff includes dedicated and professionally trained scientists qualified in toxicology (including VetD, MD, PhD, EUROTOX toxicologist, expert in immunotoxicology), ecotoxicology, analytical chemistry, physicochemistry, mass spectrometry and microbiology among others. Regular training is provided to staff to maintain reliable, timely, accurate and costeffective testing offer.
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PROFILE: Mérieux NutrisSciences
Analytical chemistry
SERVICES PROVIDED
PROFILE: Modern Testing Services (Global)
Hazardous substance control
Website
www.mts-global.com
Chemical@mts-global.com
Head office
Unit 808, CEO Tower, 77 Wing Hong Street, Cheung Sha Wan, Kowloon, Hong Kong, China
Tel
+852 36041328
Directors
Poniran Tukimin, Chief Operation Officer, Asia
Exposure to dangerous chemical substances in consumer products is of great concern to consumers, retailers and law makers. In addition to posing serious health risks to the general public these chemicals are toxic to the environment. Fortunately, new regulations are appearing with regular consistency from various nations around the world. However, since there is a lack of regulatory harmonisation between countries it is imperative to implement a comprehensive restricted substance policy (Restricted Substance List) for substances of very high concern (SVHC). MTS provides practical solutions throughout all aspects of the supply chain for managing such programs including consulting, factory assessments, socially responsible sourcing audits, product, and packaging testing.
Dieter Sedlak, Managing Director, Germany
Hardlines testing
Derek Yam, Technical Advisor
Ownership
Private
Locations
Global geographic coverage in 16 locations around the world
Founded
2006
CONTACTS
OVERVIEW MTS is an independent consumer product testing company with strategically chosen worldwide locations. Our team is comprised of some of the most technically strong, innovative, and energetic people in the industry. MTS is a privately held company that is dedicated to its core philosophy of being the best in the business without the pressures of short-term financial performance. MTS offers a full complement of quality assurance services and led by a dynamic and experienced group of individuals in their respective fields. VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
-
No of countries represented
16
Staff, group
800
Staff, chemical service provision
200
SERVICE AREA BREAKDOWN Consultancy/ advisory 10%
Laboratory 90%
GLOBAL OFFICES Hong Kong, Dongguan, Shanghai, Qingdao, Taiwan, Indonesia, India, Pakistan, Bangladesh, Cambodia, Thailand, Korea, Vietnam, US, UK, Germany, Australia, Turkey, etc.
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Quality, compliance, pricing, and speed-to-market efficiency are just a few of the main components of managing a successful supply chain. Today, retailers are faced with far more than the age-old dilemma of whether to accept a nominal amount of manufacturing defects. Complex local, state, and federal regulations are challenging manufacturers to produce safer, higher quality, and more environmentally friendly products than ever before. In addition, addressing US standards alone is not sufficient in today’s global marketplace. New international standards and regulations are increasingly appearing without any global harmonisation in sight. While the issue of mastering these complexities has become a major challenge for retailers, organisations such as Modern Testing Services (MTS) thrive in this fast-paced environment. Our hardline services include, but are not limited to, design evaluation, risk analysis, product safety testing, defect evaluations, and consultation. A partnership with MTS promotes quality, decreases customer complaints, and can greatly reduce the chances of a product recall from a variety of different governmental agencies, at home and abroad. Under our expertise, you can be confident that your products are being evaluated by some of the top industry professionals worldwide. Contact your local MTS office for a free, in-depth consultation today and be sure to ask about pricing incentives for first-time customers. Some examples of our most popular hardlines testing categories include: OO kitchen tools and gadgets; OO dinnerware and cookware; OO furniture; OO footwear; OO adult and children’s jewelry; OO watch and clock; OO gift and premium; OO sporting goods; OO garment hangers; OO candles and candle accessories; OO household and decorative accessories; OO luggage and accessories; OO hardware and tools; OO electrical household appliances; OO lighting; OO office supplies; and OO packaging and transit test. Softlines testing While trendy designs and unique colors may initially sell a garment, it’s ultimately the quality and safety that will ensure customer loyalty, generate repeat business, and preserve a brands reputation. MTS provides a complete range of product testing and quality assurance solutions for the softlines industry. Our extensive capabilities cover such areas as bulk fabric, preproduction garments, and children’s sleepwear testing, to home textiles, curtains, table cloths, bedding, upholstery and more. MTS will ensure your products are compliant with all applicable US and international regulations. In addition, physical, performance, and
Chemical Watch | Global Service Providers Guide 2014
Toys, children’s product’s, child care articles and durable nursery goods testing Consumer awareness of potential hazards relating to children’s products, childcare articles, durable nursery goods, and toys, is at an all-time high due to multiple highly publicised product recalls over the last few years. Historically, since the Consumer Products Safety Commission was established in 1972, no other product category has been scrutinised as intensely as toys. Consumers, government agencies, industry attorneys, non-governmental organisations (NGOs), and multiple consumer advocacy groups around the globe have challenged legislatures to enact laws that would further protect its most vulnerable citizens, children. MTS works closely with US and international organisations such as the CPSC, CEN and BSI to help our client’s wade through the myriad of both mandatory and voluntary testing specifications. Our highly trained staff is proficient in explaining the information in a practical and understandable way, building a foundation for a balanced risk-assessment decision making system. In addition to being both ISO 17025 accredited and a CPSC approved testing laboratory, we are also a notified body laboratory (NB number 2377) for the Europe new toy Directive. The MTS team is proficient in ensuring compliance to various domestic and international standards and directives, most notably European Standard EN71, European toy safety Directive (2009/48/EEC), ASTM F963, Canada hazardous product (Toys) Regulation and ISO 8124. Amid all product compliance testing required for toys, children’s products, childcare articles, and durable nursery goods, MTS can also provide the following added-value services: OO development of testing protocols – MTS regularly develops product specific testing protocols including regulatory requirements as well as applicable performance tests. OO potential hazards evaluations – a product specific technical consultations at the earlier stages of product development. OO age grading – psychologist-established product evaluations based on child development factors incorporating domestic and international guidelines such as the European Commission, ISO, ASTM, Australian and Canadian standards. OO conformity certificate assessment – MTS can determine whether your laboratory certificates complies with European requirements OO post-testing consultations – technical expertise offered to assist efforts in improving non-conforming product features identified during product testing
Chemical Watch | Global Service Providers Guide 2014
Arts and crafts testing Distinguishing the differences between a hobby item and a traditional toy can be an arduous task. At MTS, our Arts and Crafts division is dedicated to servicing this industry and providing indispensable guidance to help customers avoid “over-testing” their products. MTS engineers, technicians, and customer service staff have studied, trained, and analysed a wide range of arts-and-craft products for years prior to working directly with customers. Our technical expertise covers a wide range of arts and crafts products, including but not limited to: OO arts supplies including paints and glues; OO writing and drawing instruments; OO scrapbooking and stickers; OO crafting material and tools; OO frames; OO jewelry and beads; OO seasonal and floral decoration; OO parties and gifts; and OO kid’s supplies. Factory compliance audits and inspections (FCAI) As a manufacturer, agent, exporter, importer, distributor or retailer, your primary objective revolves around one main goal: obtaining the best quality merchandise, with the highest speed-to-market efficiency, for the least amount of money possible. There’s an extremely slim margin for error in order to successfully plan and accomplish this objective. All too often certain critical deadlines, including ship dates are missed. The net result is cost overruns, product delays, and strained relationships with your suppliers. Fortunately, the tools necessary to protect yourself from the unexpected are readily available regardless of your factories physical location. Factory and security assessments, product inspections and social compliance audits involves a team of MTS experts visiting a supplier, determining their production capabilities to manufacture an order within a specific time frame, and achieve the level of quality you expect, while not engaging in substandard or unethical business practices. Online services Audit and assessment services Consultant services CLIENTS MTS provides service to a network of active clients in all fields of consumer product industries, from brand and retailer level to even chemical manufacturer level in the international market. Clients cannot be named due to confidentiality reasons.
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PROFILE: Modern Testing Services (Global)
special claims testing with MTS will ensure the product consistently meets or exceeds your customer’s expectations. Our on-demand technical support in conjunction with accredited testing laboratories and US Consumer Product Safety Commission approval will greatly minimise risk throughout all stages of production. Some common testing criteria for fabrics, garments, household and miscellaneous textile items include: OO fibre labelling; OO care labelling and care label development; OO colorfastness evaluations; OO dimensional stability, torque, stretch and recovery and shrinkage; OO fabric construction, fibre ID, and fabric weight; OO fabric, garment and seam strength tests; OO compliance with US and international flammability regulations; OO performance, abrasion, pilling; and OO special claims, waterproof, windproof, antibacterial, antimicrobial.
SERVICES PROVIDED Software
Website
www.the-ncec.com/
Chemdata® – clear and concise chemical hazard information on more than 50 000 substances, at your fingertips. Pocket Chemdata® – Chemdata® for pocket PCs and smartphones running Windows Mobile, Android and iOS operating systems. ChemeDox® – document management system, with functions for COSHH compliance and distribution.
ncec@ricardo-aea.com
Emergency response
Head office
Ricardo-AEA Limited
Shoreham Technical Centre, Old Shoreham Rd, Shoreham-by-Sea, West Sussex, BN43 5FG, UK
Tel
+44 (0) 1235 753654
Fax
+44 (0) 1235 753656
Contact
ncec@ricardo-aea.com
Directors
Daniel Haggarty
Locations
UK
Carechem 24 – for MSDS, labels and packaging, legal compliance and the gold standard of responsible care. Carechem Marine – for transport by sea, guarding your cargo... and your reputation. CERS – for keeping your business running, protect your employees and reduce the risk of business downtime. Chemsafe – 24-hour support for the UK's emergency services. Haulsafe 24 – for UK road transport, guaranteed specialist advice to keep your wagons on the road.
Founded
1973
PROFILE: NCEC
CONTACTS
SDS services
OVERVIEW The National Chemical Emergency Centre (NCEC) offers a 24-hour emergency response service that provides fast, trusted and up-to-theminute advice to emergency services dealing with chemical incidents. NCEC also offers a number of other commercial emergency response services. Since 1973, NCEC’s exceptional products and services have set global standards on emergency response and compliance, and have helped its customers to manage risks associated with working with chemicals. In addition, its commercial emergency response services have helped companies to provide and obtain specialist advice and information when dealing with chemical emergencies. NCEC can help with all aspects of chemical risk management and offers a number of services including training; REACH consultancy; and SDS authoring. VITAL STATISTICS
2012/13
Turnover, group
£229.7m
Turnover, chemical service provision
£2.7m
No of offices
21
No of countries represented
11
Staff, group
2,300
Staff, chemical service provision
32
SERVICE AREA BREAKDOWN Training 10% IT & software 10%
Consultancy/ advisory 20%
Information 10%
Training Chemical training to help you comply with legislation and to help you and your staff deal with chemical emergencies. Bespoke training courses – including hazmat 1st response and chemical spill response. Open training courses – including chemical hazard awareness and making COSHH assessments. Consultancy Classification, labelling, information and advice on chemical safety legislation as well as chemical risk management. REACH Services – help with your responsibilities under REACH and GHS. REACH Glossary – a list of REACH-related terms and abbreviations. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2012
NCEC receives over 4,500 calls per year, approximately 10% of these are through our Chemsafe role advising the UK emergency services.
2012
Chemsafe – providing chemical emergency response services to UK fire, police and ambulance for 39 years through the Chemsafe scheme on behalf of UK government.
2012
Chemdata – chemical emergency response software for emergency responders around the globe from public and private sector. Over 45,000 products listed and available on laptops, PCs and Android phones.
2013
NCEC marks its 40th anniversary with a regulatory conference and celebration event.
ACCREDITATIONS Representation & management 50%
GLOBAL OFFICES UK, China, Czech Rep, Germany, India, Italy, Japan, Korea, Russia, USA, Malaysia
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NCEC's SDS authoring services and SDS management software SDS Authoring – keeping your safety data sheets legal and compliant with REACH and GHS ChemeDox® - document management system, with functions for COSHH compliance and distribution
Quality assurance As part of Ricardo-AEA, the NCEC is recognised via Lloyd's Register Quality Assurance (LRQA) which has issued the certificate of approval to Ricardo-AEA for the Environmental and Quality Management System Standards below. OO BS EN ISO 9001: 2008 OO ISO 14001: 2004 OO The TickIT Guide Issue 5 (Overall business certificate) Certificate expiry: 30 November 2014 Chemical Watch | Global Service Providers Guide 2014
NCEC is part of Ricardo-AEA and also part of: OO REACH Consultant Network; OO Global Chemical Consultants Network; and OO supported by the Department for Transport (DfT) and the Chemical Industries Association (CIA). NCEC works closely with its global partners who include UMCO (Germany), DHI (Denmark), INERCO (Spain), REACH Global Services (Turkey), NSSS (India), REACH24H (China), Chemtopia (Korea) and JCDB (Japan). CLIENTS NCEC’s client list includes governments, industry and trade associations. With 800 industrial customers including 50% of the world’s biggest chemical companies, NCEC has a wide and deep understanding of the issues facing the global chemical industry. However, we take client confidentiality seriously and do not routinely publish or promote individual client relationships. TESTIMONIALS Chemsafe “All requests for information and advice were handled quickly and information explained concisely.” Group Manager David Somerville, Fife Fire and Rescue Service Emergency Response “Carechem 24, like all the services provided by National Chemical Emergency Centre [NCEC] at Harwell, is a robust solution for people working with dangerous goods, be they consignors, consignees, transport and warehousing operations, whether they use road, rail, air or sea traffic. With the continual changes occurring in legislation as well as enhanced security and environmental concerns, you need to be supported by credible and internationally recognised technical specialists. NCEC is such an organisation, and Carechem 24 in my opinion, the premier support service for those in the sector. Their technical support is critical in managing The Hazchem Network operation – the UK’s only specialist pallet network for the carriage of palletised dangerous goods.” Ali Karim, Managing Director, Hazchem Network Ltd, Training and compliance “This is the first time we have used the NCEC for emergency response training and we found it really beneficial to our employees. We had mock incidents planned where our employees had to physically deal with the scenario. It made us think more of our surroundings and the possible incidents we could be faced with - we are going to continue this training with NCEC so that employees are kept focused on their environment.” Sue Clegg, UOP Ltd CASE STUDY 1: Polyurethane foam manufacturing fire, July 2012 incident NCEC recently received a call from a fire and rescue service station manager who was dealing with a major fire at a factory where polyurethane foams were manufactured. Police and ambulance service personnel were also in attendance. The station manager was concerned about the chemicals used in the process – isocyanate solutions, polyols and solvents. He wanted advice about the hazards, thermal decomposition products, personal protective equipment (PPE) and decontamination. Solution: our emergency responder advised the station manager that the isocyanate solutions posed the greatest hazard and explained that they were flammable, toxic, irritant, skin sensitising and hazardous to the environment, and that they may be absorbed through the skin. 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
Chemical Watch | Global Service Providers Guide 2014
breathing apparatus and explained that soap and water should be used for decontamination of equipment. In addition, our emergency responder liaised directly with the manufacturer of the products to provide the most up-to-date safety data sheets to the fire and rescue service. Expertise: NCEC’s chemists work closely with the emergency services and the chemicals industry to provide impartial expert advice in the event of a chemical incident. CASE STUDY 2: Overheated lithium battery, July 2012 incident A lithium battery measuring 25 x 20 cm was undergoing testing at an electrical equipment testing company. It overheated on a workbench and released smoke and fumes. The fire and rescue service was in attendance and had evacuated the building. A fire fighter contacted NCEC for advice on the level of PPE required to enter the building and isolate the battery, and the decomposition products. Solution: the NCEC emergency responder explained that different types of lithium battery would produce different decomposition products, but inhalation of metal oxides can cause metal fume fever, which has a delayed onset and causes flu-like symptoms. The emergency responder recommended suitable PPE including breathing apparatus, in accordance with the emergency action code (4W) for lithium batteries. Furthermore, the emergency responder advised the firefighter that dry agents, such as sand, should be used to smother the battery fire and that the area should be thoroughly ventilated before employees were allowed back into the building. Expertise: NCEC can provide guidance to companies on the safe handling and transportation of lithium batteries, and offers an emergency telephone advice service that is dedicated to providing advice on lithium batteries. CASE STUDY 3: Barn fire, May 2012 incident NCEC recently received a call from a Fire Station Manager who was dealing with a barn fire late in the evening. The barn was constructed of asbestos and contained two tonnes of ammonium nitrate fertiliser. The Station Manager was concerned about the environmental impact of the fire water due to the ammonium nitrate fertiliser. Solution: the NCEC emergency responder advised the caller that ammonium nitrate is not toxic to the aquatic organisms, but caused eutrophication (an algal bloom that uses all of the oxygen in the water as it decomposes, causing fish and other aquatic organisms to die). When asked if ammonium nitrate was toxic in fire, the emergency responder explained that nitrogen oxides would be produced, which pose a risk of pulmonary oedema, and that firefighters should be monitored for 48 hours after exposure. Expertise: NCEC emergency responders are available 24 hours a day, 365 days a year to provide chemical advice to the emergency services, helping them to protect people, property, and the environment. STAFF SELECTION Lynn Aitken – Emergency Response Bethan Davies – Chemsafe Maria Stearn – Chemdata Chris Sowden – SDS Authoring Mike Kent – SDS Management – ChemeDox Kathryn Roberts – REACH Paul Rast-Lindsell – Training
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PROFILE: NCEC
PARTNERS
SERVICES PROVIDED
PROFILE: Pace Analytical Regulator y Services
Onsite staffing, BPO or consulting
Website
www.pacelabs.com/regulatory
Lisa.Rettinger@pacelabs.com
Head office
1800 Elm St SE, Minneapolis, MN 55414, US
Tel
+1 612-656-1147
Fax
+ 1 612-656-1181
Pace offers flexible custom solutions based on the needs of our clients. Our extensive in-house regulatory training system is the driver behind Pace’s ability to offer such unique solutions, including: OO onsite regulatory staffing – Pace employees of all levels are deployed to our client locations with the support of our Minneapolis staff and regulatory training systems; OO business process outsourcing – Pace offers dedicated resources and manage the process at your location (in-sourcing) or at our location (outsourcing); and OO consulting services – experts are available for project-based work that is appropriate to do from our corporate office.
Contact
Lisa Rettinger
Supply chain data collection
Directors
Todd Mitchell, Senior General Manager
Angela Wutz, Assistant General Manager
Lisa Rettinger, Business Development Manager
Ownership
Private Company, division of: Pace Analytical Services, Inc.
Locations
US
Founded
1998
CONTACTS
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 per customer specifications. The RDM team operates under an ISO 9001:2008 quality system ensuring consistent deliverables. Clients are always provided with metrics so they can rest assured expectations are met. Hazard communication Our experts have authored thousands of safety data sheets for both domestic (US) and international markets. Depending on client needs, we can utilise our own software or work within the client’s system to author documents and create label text. Pace can assist you with creation of new SDSs or updating your current documents to meet new requirements. Pace utilises highly skilled hazard communication specialists, AIHA/ SCHC registered authors, and toxicologists to create high quality, globally compliant safety data sheets.
OVERVIEW The Product Regulatory Services division of Pace Analytical offers the following primary services: OO supply chain data collection; OO hazard communication; OO product stewardship. Our flexible custom solutions are based around the following models: OO process in-sourcing (at your location); OO process out-sourcing (at our location); OO onsite regulatory staffing; OO consulting and SDS authoring. VITAL STATISTICS
Product stewardship
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
1
Staff, group
100
Staff, chemical service provision
100
SERVICE AREA BREAKDOWN IT & software Other 5% 4% Laboratory 1%
Information 40%
Consultancy/ advisory 40%
Our product stewardship services are extensive and include: OO regulatory compliance – activities include verifications of status 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 performs VOC calculations OO Product assessments – aid in detection of unacceptable liability risk due to potential impacts to public health or the environment. They can also support sustainability goals. The types of assessments we do include, but are not limited to: - chemical and raw material environmental hazard assessments; - product environmental hazard assessments; - product risk and lifecycle assessments; - exposure scenarios; and - robust summaries. OO Green label claims support – involves guidance through the requirements involved to obtain desired green product labels. ACCREDITATIONS
Representation & management 10%
ISO 9001:2008 AIHA/SCHC Registered SDS authors CLIENTS Our list of clients is confidential; however, they range from start-ups in need of complete regulatory guidance to bring novel chemistry to market to Fortune 500 companies looking for effective strategies to manage their workload.
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Our client retained Pace in order to offload a routine data management 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 essential that the process be efficient, precise, and provide high quality data. Pace worked closely with the client to define a customised process to collect, validate and organise their data. We implemented internal training programmes through our ISO 9001:2008 quality system, ensuring each staff member follows the same process. The result is an ongoing, consistent programme that provides the customer with efficient, validated data in an organised manner for use in downstream regulatory compliance programmes. Pace also provides the client with monthly metrics to ensure deliverables are met. CASE STUDY 2: mid-sized coatings company With the implementation of Osha HazCom 2012, it became clear to this client they were in need of a more proactive regulatory strategy to manage their raw materials and products. Pace worked with the client to develop a strategic plan to meet their long-term regulatory needs. We aided in the selection of a chemical management software program and then provided an onsite, knowledgeable user to populate their system. Due to the short-term nature of the project, the client also chose to outsource the conversion of their SDSs to GHS compliant documents. The client also utilised Pace’s Sr regulatory specialists to meet customer specific regulatory inquiries. CASE STUDY 3: start-up green chemistry company with novel chemistry Our client developed novel bio-based chemistry, 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, site permitting, DOT permitting, DHS support, etc. Confident in Pace’s handling of their regulatory requirements; the client is able to focus on core business activities such as product development, sales and marketing.
John Hutchinson, PhD – Toxicologist Dr John Hutchinson provides technical consulting support in the areas of human and ecological toxicology. He holds a BS in biology and a PhD in molecular and environmental toxicology from the University of WisconsinMadison. His graduate research focused on protein modification and cellular signal transduction events resulting from genotoxic stress. With extensive knowledge of toxicological principles, mechanisms, and human health risk assessments, John helps clients interpret and evaluate toxicological data in order to understand the regulatory implications of their business decisions. Steve Ernst – Senior Project Manager Steve Ernst has more than 20 years’ experience in the chemical manufacturing and biotech industries. Steve has been responsible for comprehensive portfolio of regulatory systems and EH&S programmes spanning a variety product chemistries. He holds a degree in chemical engineering from the University of Iowa. Steve is an expert in both domestic and international chemical regulations and hazard communication. His strong chemical industry background, places Steve in a unique position to assess client needs, understand their challenges and implement practical solutions. Jody Hulne-Strege – Senior Project Manager Jody Hulne-Strege has more than ten years of industry experience in a variety of environmental and product regulatory capacities. She holds a BS degree in geology as well as graduate level toxicology coursework. Her expertise lies in regulations and issues concerning the development, manufacture and sale of consumer products, including children’s products, OTC monograph drugs, and insect repellents. Her past experience in hazard communication, industrial hygiene, groundwater modelling and remediation make her ideally suited to participate and communicate effectively on cross-functional teams. Jody has also been instrumental in the continued development of Pace’s comprehensive internal regulatory training system.
STAFF SELECTION Todd Mitchell – Senior General Manager Todd Mitchell has more than 25 years’ experience in the environmental chemistry sector. He holds a BS in microbiology from the University of Minnesota and a MBA from the University of St Thomas. Over the course of his career he has led a variety of environmental service programmes including field sampling, contract laboratory, and regulatory consulting services. At Pace Analytical, Todd is responsible for the professional service business, which provides creative in-sourcing and outsourcing solutions to scientific based companies. Angela Wutz – Assistant General Manager Angela Wutz has more than ten years of direct industry experience in the chemical regulatory field. She has authored thousands of (M)SDSs, and 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 Regulator y Services
CASE STUDY 1: Fortune 500 conglomerate chemical manufacturer
SERVICES PROVIDED REACH services OO
PROFILE: REACh ChemAdvice GmbH
CONTACTS
OO OO
Website
www.reach-chemadvice.com
info@reach-chemadvice.com
Head office
Am Marktplatz 5, D-65779 Kelkheim / Taunus, Germany
Tel/ Fax
+49 6195 96 199 0/ +49 6195 96 199 33
Contact
Dr Rudolf Staab
Directors
Dr Rudolf Staab, Managing Partner
Ownership
Privately owned company
Locations
Germany, USA, India, Portugal, Sweden
Founded
2007
OO OO OO OO OO
OO OO OO OO OO
OVERVIEW
OO
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 is also providing support to chemical companies within the implementation of the CLP and cosmetics Regulations as well as the biocidal products Regulation.
OO
VITAL STATISTICS
2012/13
Turnover, group
c â&#x201A;Ź1.5m
Turnover, chemical service provision
c â&#x201A;Ź1.5m
OO OO OO OO OO OO OO OO
OO
OO
CLP services OO OO OO OO OO OO
No of offices
5
No of countries represented
5
OO
Staff, group
10
OO
Staff, chemical service provision
10
SERVICE AREA BREAKDOWN
OO
OO
Other 5%
OO
OO OO OO
Information 20%
Representation & management 5%
OO
Consultancy/ advisory 60%
OO OO OO
OO
GLOBAL OFFICES REACh ChemAdvice GmbH, Germany Regional offices: USA, India, Sweden, Portugal
identification of obligations under the CLP Regulation implementation of strategy for CLP compliance CLP workshops and customised training CLP due diligence project management classification and reclassification of substances and mixtures in accordance with the CLP Regulation safety data sheets (SDS) authoring and review CLP notifications dossiers / CLP-group notifications dossiers outsourcing of CLP services
Biocides services OO
Training 10%
identification of obligations under the REACH Regulation implementation of strategy for REACH compliance only representative (Art 8 of the REACH Regulation) third party representative (Art 4 of the REACH Regulation) late pre-registration Sief communication management import certificates for REACH compliance creation and submission of Iuclid 5 dossiers (registration, inquiry, PPORD notification, authorisation, substance in articles notification, downstream user report) to ECHA in REACH-IT consortia management / consortia representation toxicological evaluation / studies / tests / reports SVHC inventory and monitoring SVHC testing and screening creation of chemical safety reports (CSR) strategy development for the registration REACH and Iuclid 5 workshops customised training REACH due diligence data gap analysis project management data vendor management (letter of access purchase) audits of suppliers concerning REACH compliance audits / REACH compliance verification (preparation for inspections) creation and review of REACH-compliant SDS/ e-SDS (safety data sheets) in all EU-member states languages analysis of exposure scenarios and implementation of risk management measures outsourcing of REACH services
OO OO OO
identification of obligations under the BPR implementation of strategy for BPR-Compliance preparation of Iuclid 5 dossiers (active substances and biocidal products) and submission in the R4BP project management data vendor management (letter of access purchase) data gap analysis studies / tests / reports (physicochemical properties, efficacy, environmental fate, ecotoxicology and toxicology) risk assessments liaison with authorities and post-submission support classification and labelling of biocides according to the DSD/DPD and CLP creation and review of REACH-compliant safety data sheets BPR workshops Iuclid 5 workshops customised training
Cosmetics services Once you select REACH ChemAdvice as your consultant, we will be pleased to provide a comprehensive range of services customised exactly for your needs.
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2007
Start up in Frankfurt am Main, Germany
2007
Opening regional office in USA
2008
Opening regional office in India and Korea
2009
Relocation to new offices in Kelkheim/Taunus
2011
Start cosmetics consultancy
2011
Opening regional office Sweden
2012
Expansion into the Iberian peninsula (Portugal and Spain)
2012
Opening regional office in Portugal
ACCREDITATIONS REACH ChemAdvice GmbH is a member of ORO, the Only Representatives Organisation in Brussels and complies with the quality standards of this trade association. REACH ChemAdvice, as an ERPA-member (European Cosmetics Responsible Person Association), supports the cosmetic industry in all REACH-difficulties during the whole complex cosmetics supply chain, as the cosmetic industry needs to comply with the new cosmetics Regulation and REACH. PARTNERS Our partners can be viewed on our website. CLIENTS Our clients are located in Europe, United States of America, Latin America, Africa, Middle East and Asia. TESTIMONIALS Testimonials or references will be provided upon individual request. CASE STUDY 1: The company started offering only representative services for NON-EU Clients in 2007. We represent more than 100 companies with sizes ranging from SME to multinational firms. We also represent European clients as third party representatives and offer consultancy work under REACH. CASE STUDY 2: Consortia management We successfully managed consortia or represented our clients in consortia. We support our clients throughout the whole REACH registration process from registration strategy development, data generation, and dossier preparation to dossier submission. CASE STUDY 3: Cosmetics industry We are a member of cosmetics associations and are actively involved as project managers for the development of guidelines. We help especially SMEs in the cosmetics industry to manage the interface between REACH and the new cosmetics Directive. STAFF SELECTION Dr Rudolf Staab – Managing Partner Dr Staab has held many senior jobs in the industry including: senior vice president Masterbatches Clariant International, responsible for the reorganisation and re-engineering of business processes and the introduction of new marketing approaches for key accounts. He was vice president additives within Hoechst AG and Clariant International and vice president specialty chemicals within Hoechst AG in charge of strategy development and implementation, business re-engineering, efficiency improvement activities and relocation efforts. He looked after the development of new markets and applications M&A transactions, and has been a member and chairman of the board of several companies within the chemical, food ingredients and plastic processing industry. He has an MSc in inorganic chemistry (Diplom-Chemiker – Saarbrücken, Germany, and a PhD in inorganic chemistry (Dr rer nat – Saarbrücken, Germany).
Chemical Watch | Global Service Providers Guide 2014
Carlos Fazendeiro – Regulatory Affairs Consultant (Head Office and Portugal) Mr Fazendeiro has worked in regulatory compliance (CTR Lda, Portugal), and has considerable experience in classification, labelling and packaging of chemicals, safety data sheets and giving regulatory support to clients and business units (REACH, CLP and biocides). He has worked as a consultant (SGS Portugal SA) and on REACH implementation (mainly in the petrochemical industry), with extensive experience of pre-registrations and REACH registration dossiers. He worked as a regulatory officer at INFOTOX in Portugal where he dealt with administrative issues related to REACH, assessment of test data reliability under the biocidal products Directive and gave support to business development activities. He is a licentiate in industrial chemistry (five years degree, University of Beira Interior, Portugal) and has practical education and training on REACH, CLP/GHS, biocidal products Regulation, Iuclid 5, REACH-IT and SDS Silvia Teige – Finance and Administration Ms Teige’s experience includes working as a management assistant at both ChemAdvice GmbH and to the head of regional business unit Europe, NME, Africa, Clariant Masterbatches. She has been executive assistant to head of division pigments and additives, Clariant, and executive assistant to head of business unit additives, Hoechst AG and Clariant, fulfilling the same role to the head of division chemicals, Hoechst AG. Prof Dr Dieter Mayer – Toxicologist Professor Mayer s extensive research experience having worked at the Institutes of Human Genetics, University of Heidelberg, and Environmental Health, University of California, Davis. He was scientific director at the Centre International de Toxicologie, Evreux, France, and professor at Frankfurt’s Johann Wolfgang Goethe University, Institute of Pharmaceutical Technology. He has been a guest professor at Johannes Gutenberg University, Mainz, Institute of Toxicology, Risk Assessment, Methods in Modern Toxicology and also at the German Society of Pharmacology and Toxicology. His industrial career includes having been a toxicologist, and global head of toxicology Hoechst AG, Hoechst Marion Roussel, Aventis SA. Dr Sebastian Hoffmann – Scientific Consultant Dr Hoffman has extensive experience as a REACH consultant (TÜV Rheinland BioTech GmbH), as well as project management and scientific consulting and hazard and risk assessment. He is an expert on human health hazards and in vitro toxicological methods, having worked as a scientific officer at the European Commission’s Joint Research Centre in Italy). His speciality is assessment (validation) of in vitro test methods and management of scientific projects. He is qualified to assess data reliability and relevance, and has 25 peer reviewed publications to his name. Jim DeLisi – Regional Head, North America Jim DeLisi is a president of Fanwood Chemical, Inc, where he looks after the sale of organic intermediates in North America, South America and Europe, as well as tariff and trade affairs, monitoring of imports and exports and REACH. He has been chairman of Socma’s International Trade Committee, and chairman of the Industry Trade Advisory Committee on Chemicals, Pharmaceuticals, Health/Science Products and Services. He has a BA in business administration (Rutgers College, USA), and an MBA in chemical marketing (Fairleigh Dickinson, USA). Barbara Fertl – Regional Head, Sweden Barbara Fertl has extensive experience having worked at: the Institute for Physical Biochemistry, Munich; Munich Municipal Hospital Group; Linde AG, Munich; DQS Deutsche Gesellschaft zur Zertifizierung von Managementsystemen, Frankfurt; Sasol, Hamburg. She has been a chemical consultant for Kemikalierådgivare in Sweden and has experience of safety data sheets, registrations, national and international regulations on chemicals Ms Fertl has an MSc in biology (Diplom-Biologin, Ludwig-MaximiliansUniversity, Munich, Germany), and is a certified auditor for quality management systems
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PROFILE: REACh ChemAdvice GmbH
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
SERVICES PROVIDED
PROFILE: REACH master y
General consulting services
Website
www.reachmastery.com
info@reachmastery.com
Head office
Via Giovio 16, 22100 Como, Italy
Tel
+39 031 269513
Contact
monicalocatelli@reachmastery.com
Directors
Monica Locatelli
Ownership
Private company
Locations
Italy
Founded
2008
OVERVIEW REACH mastery is a provider of a wide range of services in the area of chemical regulatory affairs. The staff is a highly motivated team, skilled in different scientific areas: chemistry, biology, human health and environmental toxicology. Our commitment is to assist clients along the supply chain with our industrial experience and to help them in the cost efficient implementation of the European regulations. Our mission is to look for innovative solutions and develop strategies using, when applicable, alternatives to animal testing like in vitro and in silico methods, through the high quality of our services and the expert support. VITAL STATISTICS
2013/14
Turnover, group
-
Turnover, chemical service provision
-
No of offices
1
No of countries represented
1
Staff, group
8
Staff, chemical service provision
8
SERVICE AREA BREAKDOWN Training Legal 1% Other 2% 5% Information 2% Representation & management 15%
Consultancy/ advisory 75%
OO Supply chain communication Importers and manufacturers, downstream users and manufacturers/ importers of article, are all responsible for the effective communication flow of information. We provide all the necessary support by distributing standard templates or customised forms to properly manage the communication flow between customers and suppliers. OO Strategic implementation of European regulations Participation to consortia, co-registrants agreements, data sharing, deadline and tonnages for registration are decisions that are managed in order to find the most cost-effective solution and the most convenient choice on the market. OO Chemical management and product stewardship The market will constantly evolve over time. Companies will face new challenges to strategically select secure suppliers and to identify growing sector markets. Our business development experts will support companies with the most effective advice, in compliance with the provisions of the regulation. OO Implementation of IT systems for chemical management Companies will internally develop new management systems to integrate existing tools to monitor the presence of chemical substances, including deadlines, total amounts, risk management measures etc.
REACH services OO Consortia management A lot of experience has been gained on consortia rules and management. We provide also legal advice, agreement documents, meeting location, cost calculation, managing of LoAs. OO Data gap analysis and data collection Gathering existing information is the first step in the preparation of any registration dossier, but is not enough. All these data have to be really collected, in respect to the right to use. The latter requires the negotiation of the conditions for use according also to the quality of the data. Each single study is evaluated and rated to check relevance and adequacy to fill the requirements. OO Testing strategy development, in vitro strategies development, Qsar modelling An integrated testing strategy is the first step for cost reduction and building rationale for waiving. International well known partners are helping us in focusing on the right choice. OO Managing of analytical identification and inquiry dossiers Our great expertise in analytics and experience in enquiries let us face without problems one of the most critical aspect of REACH regulation. OO Test monitoring In case new tests are required, REACH mastery will take care of selecting the most appropriate lab, will review the protocol and check the results. OO Dossier preparation (Iuclid compilation) Dedicated expert persons are managing Iuclid compilation. OO Human health and environmental risk assessment The focused experience and the support of high experienced toxicologists let us make of the risk assessment the core part of the developing registration dossier. OO CSA-CSR REACH mastery is part of the consultation group of Chesar in ECHA. We followed the development of the tool since the beginning and we are among the first experts in Europe to use it.
CLP/GHS services OO OO OO
data collection and assessment of classification and labelling CLP notification MSDS compilation
FEED and FOOD registration OO OO OO OO
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dossier preparation risk assessment test monitoring assistance to customer for Efsa calls for data Chemical Watch | Global Service Providers Guide 2014
OO
OO OO OO OO OO
full dossier preparation for active substances and placing a biocidal product in the market testing strategy development study monitoring risk assessment finalisation and discussion with national and EU authorities. post-submission support
PPP services OO
OO
OO
OO OO OO OO OO
support of existing substances in the context of the EU review programme, re-submission of dossiers for active substances Annex III dossiers for re-registration of products post-Annex I inclusion Annex III dossiers for new products or to support label changes and/ or formulation changes testing strategy development study monitoring risk assessment finalisation and discussion with national and EU authorities. post-submission support
EU cosmetic directive OO OO OO OO OO OO OO OO
regulatory compliance support product notifications assistance in GMP certification cosmetics ingredient profiles product information files clinical studies: design and monitoring cosmetic product safety reports product labelling review and support
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2008
Foundation of REACH mastery within HBJ consultancy group.
2009
Restructuring of REACH mastery as independent company.
2010
About 120 successful registrations for the 2010 deadline.
2011
Implementation of the group with operative members.
2012
Implementation of the group to broaden the regulatory area to biocides and plant protection products.
2013
Implementation of the group to finalise 2013 deadline registrations.
PARTNERS RTC, Qsar group of Bicocca University, Vitroscreen, REACH & Colours, CAAT Europe as preferred co-operations. CLIENTS We are working for about 50 customers around Europe; they are manufacturers, distributors, downstream users, from SMEs to international chemical companies distributed in many industrial fields: fertilisers, leather, textile, pharmaceuticals, galvanic, food, cosmetic, polymers and many others. CASE STUDY 1: Tier 2 REACH registration The group has proved itself as one of the most professionally prepared in the European scenario to manage all different aspects of a REACH dossier. Reach mastery prepared about 20 lead dossiers. For the 2013 second Tier registration many of them with a full study plan ordered and monitored, 40 intermediate dossiers and actually about 40 joint registrations. UVCBs and difficult substances are the main specialisation area. The group has gained great expertise in substance identification and difficult inquiries.
Chemical Watch | Global Service Providers Guide 2014
CASE STUDY 2: ECHA compliance check During 2013 ECHA performed a thorough compliance check on many dossiers, including both full and intermediate registrations. Some of the submitted dossiers in 2010 have been revised with the request of additional testing. All dossiers have been updated with scientific justifications or exposure based waiving in order to avoid further testing. CASE STUDY 3: Qsar Toolbox and new tools Members of the group learned and successfully applied the Qsar Toolbox within the dossiers and for Classification and Labelling requirements. A big project is being implemented in co-operation with UNIMIB Qsar group, to develop new tools for disconnected and complex structures. In co-operation with REACH&Colours Italia, the manager of the main dyes consortia, a huge proprietary database has been built and challenged to test a number of new Qsar models applying innovative and new methodologies to broaden the applicability domain to new structures. CASE STUDY 4: authorisation process The group actively participated to the advocacy and the scientific support in the prioritisation process of a 2010 registered substance, Azodicarbonamide, in co-operation with the Reach Centrum Task Force. The group coordinated the Italian group of producers, importers and downstream users in collecting information on the substance and discussion with the national authority. STAFF SELECTION Dr ssa Monica Locatelli – Founder and Director After a degree in chemistry, ten years in R&D and a specialisation in toxicology applied to risk assessment, she has been working in regulatory and implementation of REACH regulation since 2001, when it was still a proposal. The co-operation with many specialists within international companies and universities let her specialise in consortia management and dossier preparation. Dr ssa Costanza Rovida – REACH Regulatory Specialist Graduated in chemistry, after 15 years’ experience in the field of analytical chemistry, she worked for three years at the European Commission, participating in two groups of RIP 3.3 (REACH Implementation Project, Technical Guidelines to Industries) and as a leader of a work package in a European project focused on integrated development of alternative toxicological methods to animal testing. She is responsible for the management of individual projects and global customer assistance. Dr Leon Van der Wal – Eco toxicologist Obtained a PhD in environmental toxicology and chemistry in 2003, and has more than ten years’ experience in the risk assessment of chemicals. He worked as a consultant on risk assessment and risk management for national and international governmental agencies, and evaluated active substances and product dossiers for governmental agencies, as well as private national and multinational companies. For three years he worked at the Joint Research Centre of the European Commission, responsible for the regulatory environmental risk assessment of biocides, the development of guidance documents and exposure scenarios, and the harmonisation of risk assessment strategies between the various EU legal frameworks. He is now responsible for the Biocides and Plant Protection Product Unit and environmental risk assessment for all regulatory frameworks. Dr Daniele Ferrario – Toxicologist Graduated in biological science, he earned a PhD in toxicology in 2009. He gained knowledge in cellular and molecular biology techniques, as well as having a strong background in metal toxicity on mammalian immune and haematopoietic systems. While working for five years at the laboratory of European Centre for The Validation of Alternative Method of the European Commission he was actively involved in the validation of CFU-GM as alternative to animal testing to evaluate immunotoxicity. He is now responsible for the evaluation of toxicological outcomes of testing in compliance with REACH Regulation Page 119
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 ReachCentrum was created in June 2006 by Cefic (the European Chemical Industry Council) to help companies all through the value chain to prepare and implement REACH. ReachCentrum helps chemical manufacturers and importers, 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, project management, consultancy, workshops and in-company trainings. ReachCentrum also offers solutions to companies needing assistance for the CLP and biocides regulations. 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
-
No of offices
1
No of countries represented
-
Staff, group
11
Staff, chemical service provision
11
SERVICE AREA BREAKDOWN Training 20%
Information 2%
Consultancy/ advisory 30%
Representation & management 30%
GLOBAL OFFICES EU supported by partners to have global coverage.
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Admin, financial, data management, audit and legal support Financial issues for a project are handled in-house. Support is backedup by our own financial department and flexible data management system, letting us execute complex data-related cost sharing calculations. Experienced staff analyses and processes 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. Authorisation support ReachCentrum has been involved in REACH since the very beginning and is involved in Authorisation since the first applications (DEHP). ReachCentrum has throughout knowledge of the processes, steps and potential pitfalls, and it keeps companies up to date of any new aspects and developments. Companies can benefit as from the very first inclusion to the substances of potential concern list from of ReachCentrum extensive network and contact to industry association, REACH authorities in member states, EU Commission, and ECHA. Customers can benefit from a proven proficiency in communication facilitation (supply chain, data access) and extensive experience in setting up interest groups/taskforces/consortia to serve a common goal. Training, workshops and e-learning solutions
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. ReachCentrum’s overall services are centered around six core fields of expertise: OO project management support; OO strategic guidance and support; OO preparation of application for authorisation, including the SEA; OO financial and data management support; OO Sief support and supply chain communication; and OO legal support; and audit management support. Moreover, ReachCentrum has set up a series of transversal services beyond REACH regulation: OO DataCentrum (data brokerage); OO trustee service for indirect imports; OO CLP for mixtures; OO biocidal products Regulation support; and OO nanomaterial support.
ReachCentrum organises a series of courses covering all aspects of the REACH legislation by offering practical guidance – what to do, when and how. ReachCentrum applies blended learning to its courses to offer flexibility and convenience to the participants – classroom, web-based 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 of chemical companies to deliver the same standard of training. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006
Founded by Cefic (the European Chemical Industry Council).
2010
LoA e-shop successfully launched.
2010
Through the LoA e-shop 342 lead registrants allowed their Sief members to access the registration dossier. Chemical Watch | Global Service Providers Guide 2014
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 Iuclid 5 and Chesar.
2012
Set up of three authorisation consortia.
2013
Technical partnership with ARCHE for biocidal products Regulation.
2014
Submission of the first joint application for authorisation (HBCDD).
ACCREDITATIONS OO OO OO OO
LPI accredited as authorised training assessment centre. LPI accredited as authorised training organisation. LPI certified online learning facilitator. Certified lead auditor for environmental management systems.
PARTNERS REACH Global Services (RGS) for Turkey; national association services providers; TNO Triskelion; SCAS Europe; ARCHE CLIENTS ReachCentrum offers its services to a wide range of chemical companies, from major multinationals to SMEs and only representatives (OR) from all over Europe and beyond, including downstream users and distributors. TESTIMONIALS “The conference REACH registration 2013 – where should you be now – showed an excellent mix of very good speakers. Good focus on practical aspects. Well organised, a lot of practical advice and motivation for working on 2013 registration.” – Norbert Petereit, Sasol. “My trainer is very forthcoming with his explanations and I find particularly instructive when he makes examples of the possible mistakes that one can make while working on Iuclid” – a participant of Iuclid 5 virtual online training. "ReachCentrum was selected first as the consortium secretariat based on its experience with consortia management, more particular relating to in financial and communication aspects but also due to their knowledge of REACH authorisation process as such. During the preparation for application, ReachCentrum has proven to be very supportive in translating between the language of pure technical service providers and the understanding of our group. Also in reviewing documents for the application, ReachCentrum’s input is very helpful." – Ingrid Brassart, chairperson of the Sodium Dichromate authorisation consortium, Akzo Nobel. CASE STUDY 1: an authorisation consortium case study Authorisation has been fully deployed with the first companies or consortia having submitted their applications. ReachCentrum is accompanying several individual companies and also consortia or taskforces with up to 50 members prior to annex XIV inclusion as well as in preparing the applications as such. An 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 industrial use is so specific that the best way forward would be to prepare the application jointly in a specialised taskforce. The group started early to make sure to be aware and truly understand all requirements in all phase and for all elements, accompanied in their process by ReachCentrum’s dedicated REACH consultancy and training. They are actively preparing the authorisation application and ReachCentrum is supporting it next to the general consultancy, with project management, finances, communication, as well as all related legal matters, and acts as trustee for the business confidential and competition law sensitive information.
Chemical Watch | Global Service Providers Guide 2014
CASE STUDY 2: training attracting downstream users Since the second registration deadline passed, ReachCentrum has been delivering training courses reflecting the post registration tasks which need to be completed. The eSDS training courses has brought together both suppliers and downstream users that want to consolidate their knowledge about producing eSDS for their respective position in the supply chain. Offering training courses relating to mixtures have attracted the DU as they realise the importance of the tasks ahead of them. Moreover for the biocidal product Regulation formulators and DU have attended Iuclid5 and R4BP3 courses to become familiar with the tasks at hand which they need to complete for their submission dossiers that are required. CASE STUDY 3: post submission 2010-2013 activies Several consortia managed by ReachCentrum are currently experiencing further activities on their dossiers submitted in 2010 and 2013, both for substance and dossier evaluation. Legal processes are going in parallel, with evaluation and harmonised classification and labelling. ReachCentrum’s role is getting consortium members on top, and acting as mediator and facilitator between members and official institutions. ReachCentrum helps companies respond to legal activities requests from ECHA. STAFF SELECTION Leo Appelman – Managing Director A toxicologist by profession, before joining ReachCentrum as managing director in 2007, Leo had worked for nearly 17 years in a global paint manufacturing company dealing with all health, safety and environmental issues. He was the REACH facilitator for the coating business, and head of the HSE department servicing its business units worldwide in their marketing approach. He was also involved in the registration of biocidal products and notifications for new chemical substances. Mark Meesters – 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 a variety of audiences and is involved in advising companies in this field. Cornelia Tietz – Project manager and authorisation expert Cornelia joined the ReachCentrum team in April 2009 as project manager. Besides managing consortia, SLTs and Lead registrants support projects, she has been involved in further aligning and developing our services (f.i Sief communication support). Since 2010 she has been looking into all aspects of substance evaluation authorisation under REACH and is the ReachCentrum responsible person for those aspects of the legislation and is managing many of ReachCentrum’s authorisation projects. Leondina Della Pietra – Project manager Leondina joined ReachCentrum in July 2013 as Project Manager, and is in charge of REACH consortia management and EU regulations, in particular of the biocidal products Regulation. Having an industrial chemical background she started her career in R&D moving to manufacturing and chemical industry as a consultant. In this field she assisted companies to adapt to the requirements and obligations imposed by European regulations in health and safety in the workplace and environment. A postgraduate MSc in REACH and CLP Regulations she gained experience as a project manager in London.
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PROFILE: ReachCentrum
2010
GLOBAL OFFICES Helsinki, Brussels, New Delhi and Istanbul. SERVICES PROVIDED REACH and global compliance services We support companies as their service provider or as their only representative in fulfilling all REACH requirements. We manage consortia, lead registrant projects, perform regular registrations and REACH authorisations. Furthermore, we assist companies operating outside of the European Union in managing the applicable market access regulations by analysing their portfolio of products, as well as monitoring and assessing the impacts of upcoming changes in the regulations. We also perform the required notifications and registrations in addition to the authoring of compliant SDSs and labels according to the market requirements in question.
PROFILE: REACHLaw
CONTACTS Website
www.reachlaw.fi
sales@reachlaw.fi
Head office
Vänrikinkuja 3, 02600, Espoo, Finland
Tel/ Fax
+358 (0)9 412 3055/ +358 (0) 9 412 3049
Contact
Mr Stephen van Heerden, Sales Director
Directors
Mr Lasse Kurkilahti, Chairman of the Board
Mr Lasse Musakka, CEO-Partner
Mr Frederik Johanson, Head of Environmental Services – Partner
Mr Jouni Honkavaara, CFO-Partner
REACH authorisation services
Ownership
Private company
Authorisation is one of the most complex challenges for companies under REACH. REACHLaw combines the best expertise and deep understanding of the business and regulatory requirements to provide companies with a full set of services towards authorisation. Our support covers the issues from defining the overall strategy and scope of the authorisation to performing the work needed in all the stages of the authorisation process (eg analysis of alternatives, socio-economic analysis, chemical safety report and full authorisation application). With two applications already submitted, and several ongoing projects, REACHLaw has already gained significant practical experience in authorisation.
Locations
Finland, Belgium, India, Turkey
www.compliantsuppliers.com
Founded
2006
www.compliantsuppliers.com connects buyers and suppliers of compliant chemicals. The service provides suppliers with a way to benefit from their investments in compliance by providing access to chemical buyers searching for compliant products. For the buyers it reduces risks; the number of compliance steps; and reduces costs by providing access to a selection of suppliers and chemicals verified as compliant. REACHLaw Ltd verifies compliance by validating chemicals per regulation, per region, and takes care of all the required documentation.
Dr Mathias Berner, Partner Mr Riku Rinta-Jouppi, Head of Global Compliance – Partner Mr Stephen van Heerden, Sales Director Dr Ying Zhu, COO-Partner
OVERVIEW REACHLaw provides first class solutions in global regulatory compliance, 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 and global compliance, mitigate risks, become more capable organisations and improve internal processes. 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
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
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%
CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006
Established in Helsinki.
2008
Partnerships with 20+ local partners in Asia, Europe, Latin America, USA and India established. 3,000+ REACH preregistrations submitted.
2009
REACHLaw received internationalisation award from the president of Finland. Customers in 40+ countries. Brussels and New Delhi offices opened. REACHLaw delivered more than 50 events globally, having 1,500+ attendees in total.
2010
300+ REACH registrations submitted. REACHLaw launched global compliance services outside the EU. The attendees to our events increased considerably reaching more than 2,500+.
2011
Istanbul office opened. REACHLaw supported large companies to ensure compliance with global chemical regulations.
2012
20+ REACH lead registrant cases. First authorisation cases. Several global notifications were completed. REACHLaw became shareholder in eSpheres Ltd. REACHLaw established a business partnership with BioSafe – Special Laboratories Services Ltd.
2013
REACHLaw launches www.compliantsuppliers.com Currently supporting several hundred REACH registrations, numerous authorisation projects, 20+ lead registrant and BPR cases. Chemical Watch | Global Service Providers Guide 2014
ACCREDITATIONS
STAFF SELECTION
Internationalisation award from the president of Finland in 2009. AAA financial rating in 2010. Innovative – Growth sustainable company by Europe Innova in 2011. Among 200 fastest growing companies in Finland by Kauppalehti in 2011. Young Innovative Growth Company Programme by TEKES completed in 2012.
Mr Riku Rinta-Jouppi, MA (Law), MSc – Head of Global Compliance – Partner
Selected partners: Chemtopia, ChemRisk, Chemitox, Dynamic Orbits, Mourao Henrique Consultores Associados, AIDA, Chamber of Chemical and Petrochemical Industry of Argentina – CIQyP, CICM, eSpheres, BioSafe – Special Laboratory Services Ltd.
Mr Tim Becker, MA (Law) – Chief EU Compliance Officer
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.
Mr Becker has been acting as legal adviser and key account manager at REACHLaw since 2008. He has also worked previously with ECHA in its guidance team. His track record includes internal capacity building and assistance of REACHLaw’s global customer base in obtaining REACH registration, legal status confirmations (exemptions, importer, transfer of registrations, SME, etc) and most recently authorisation. Since 2011 he has been our main person responsible for advising actors in the European space sector on REACH-related issues. Other areas of expertise include BPR, CLP and RoHS.
TESTIMONIALS
Dr Ying Zhu, PhD (Biochemistry), MSc in Economics, COOPartner
CLIENTS
“Over the years REACHLaw has advised OMG on several strategic REACH and CLP issues and in the planning of our 2010 registrations. For one substance REACHLaw managed the whole lead registrant registration process in 2010. We are very pleased with REACHLaw service” – Dr Thomas Slotte, OMG Kokkola Chemicals Ltd. “REACHLaw assisted us in registering our substances as regular registrant and as lead registrant in 2010. We are very pleased with REACHLaw’s services” – Mr Ludo Schyvinck, Minerals Technologies Europe NV. CASE STUDY 1: REACH – joint authorisation for chromates The authorisation requirement for chromium trioxide and other Cr(VI) substances in REACH Annex XIV is special in that it impacts 1,000s of downstream users (DUs) in different industry sectors. It has become clear that the DU’s are in a key role for authorisation, as they often possess the relevant information needed to prepare analysis of alternatives (AoA) and socio-economic analysis (SEA). At the same time they must be proactive to ensure that their suppliers actually apply for authorisation and cover the DU’s use after the sunset date for sufficient time. To this end REACHLaw has been managing the initial data collection and creation of DU task forces for homogeneous groups with similar requirements, and has conducted scoping studies for the determination of roadmaps to joint authorisation, eg for the European space sector (http://eurospace.org/ eurospace-announces-the-creation-of-a-reach-chromates-space-industrytask-force.aspx) and Finnish SME hard chrome platers. CASE STUDY 2: authorisation dossier submission The preparation and submission of an authorisation dossier requires multidisciplinary expertise and active engagement with the whole supply chain. Extensive information on substance uses, exposures and socioeconomic data must be gathered and thoroughly analysed. REACHLaw has prepared and submitted the first two applications for authorisation through the socio-economic analysis (SEA) route (arsenic trioxide), and is currently working on several additional authorisation projects. It has supported its clients at every stage of the process, including developing authorisation strategy, preparing the application documents (eg analysis of alternatives, chemical safety report and socio-economic analysis) and submitting the dossier. REACHLaw conducts all the authorisation related work in-house, utilising its industry sector specific expertise and multidisciplinary team of lawyers, chemists, (eco-) toxicologists, socio-economic analysts and technical specialists.
Chemical Watch | Global Service Providers Guide 2014
Dr Zhu has both a scientific and economic educational background. She has also worked in various management positions in industry for more than ten years. Her unique educational background and work experience enable her to act as a leading expert in the area of REACH authorisation. Dr Zhu has advised companies from four different continents on REACH compliance issues since 2008. In addition, she also has in-depth knowledge on global chemical regulations and compliance issues. Dr Kati Vaajasaari, PhD (Technology) – Project Manager and Specialist in Chemical Safety Assessment Dr Vaajasaari is working as a leader in REACH lead registrant projects for REACHLaw. Her responsibilities include project management and technical expertise in chemical safety assessment. She specialises in environmental fate and pathways of substances, environmental exposure assessment and risk characterisation of chemicals and products. She has many years’ experience in these fields. Mr Sami Vesikansa, MSc (Biochemistry) – Specialist in human health hazard assessment Mr Vesikansa is working as a toxicologist for REACHLaw. His responsibilities include technical expertise in chemical safety assessment, SIEF management and the responsibilities of the REACH Only Representative (OR). He specialises in the field of human health hazard assessment and risk characterisation of chemicals and products. He has over ten years of experience in toxicity tests of pharmaceutical and industrial chemicals. Sini Suomela (M.Sc. in Organic Chemistry) – Technical Project Manager Ms Suomela has been responsible for REACH member registrations since 2010 and has successfully completed hundreds of registrations during this time. She has extensive knowledge of all kinds of REACH registrations and inquiries. She has also worked with the physicochemical part of the REACH Lead Registration projects and has been involved in REACH authorisation work. Sanna Henrichson, M.Sc. in Economics – Specialist in SocioEconomic Analysis Ms Henrichson is responsible for preparing socio-economic analysis reports as part of authorisation applications. She has extensive experience of both quantitative and qualitative analysis in the fields of economics, sociology and environmental management. Ms Henrichson has prepared two of the first socio-economic analysis reports submitted under REACH to date.
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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 to his legal qualifications he holds a masters degree in bio-information technology. Mr Rinta-Jouppi is responsible for REACHLaw global compliance services.
SERVICE AREA BREAKDOWN Training 5%
PROFILE: Risk & Policy Analysts (RPA)
CONTACTS Website
rpaltd.co.uk
post@rpaltd.co.uk
Head office
1 Beccles Road, Loddon, Norfolk, NR14 6LT, UK
Tel
+44 1508 528465
Fax
+44 1508 520758
Contact
Panos Zarogiannis
UK
Directors
Pete Floyd Meg Postle
SERVICES PROVIDED
Ownership
Private
Locations
UK
Founded
1990
Consultancy/ advisory 95%
GLOBAL OFFICES
REACH authorisation RPA assists industry clients with the development of applications for authorisation of SVHCs under REACH. These studies involve detailed analyses of supply chains, of alternatives and the preparation of SEAs. REACH restriction
OVERVIEW Risk & Policy Analysts Ltd (RPA) was established in 1990 as an independent specialist consultancy. RPA has gained extensive experience in undertaking impact assessments and evaluations, including the development of quantitative and qualitative methodologies to assess policy impacts, chemicals policy, chemical risk assessment and management. RPA is the market leader in the development and application of socio-economic analysis (SEA) to chemical risk management and is particularly proud of its reputation for preparing applications for authorisation of SVHCs under REACH for industry clients. RPA has been working with industry clients since 2001 on the implications of the new EU regime for chemical risk management. We have also been working closely with the European Commission (EC) and the European Chemicals Agency (ECHA) on the development and implementation of REACH and many other directives relating to chemical risk management. Our experience covers a wide range of industry sectors including bulk chemicals, ferrous and non-ferrous metals, paints and coatings, oil and gas, speciality and novel chemicals (including nanomaterials), etc, and this has resulted in detailed studies on over 50 high profile chemicals. Building on our experience in preparing risk reduction strategies under the existing substances Regulation, we are now assisting a range of industry organisations in meeting their obligations for REACH authorisation and restriction, and preparing the SEAs needed to justify continued use of a substance. RPA’s multi-national staff routinely undertakes detailed analysis and consultation with industry and regulators in most European languages. VITAL STATISTICS
2012/13
Turnover, group
£2.4m
Turnover, chemical service provision
£1.2m
No of offices No of countries represented
Regulations and impact assessment RPA advises industry clients and regulators on the (potential) impacts of regulations and regulatory change. Recent examples include work on REACH, nanomaterials, OELs, WEEE/RoHS, CLP, CMRs at work, toy safety, cosmetics, biocides, drinking water and WFD. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1992
RPA develops a risk-benefit analysis methodology for chemical risk management for the UK authorities.
1998
RPA wins major framework contract for the UK authorities on chemical risk management leading to numerous risk reduction strategies.
2000
OECD publishes guidance documents on SEA and chemical risk management prepared by RPA.
2004
RPA wins major framework contract for the European Commission on chemicals.
2009
RPA contracted by industry clients to support applications for authorisation under REACH with a focus on SEA work.
2011
RPA leads consortium for the second ECHA REACH framework contract.
2012
RPA completes three studies for DG Environment reviewing the first years of REACH implementation.
2013
RPA leads the market in supporting seven applications for authorisation of SVHCs under REACH.
2 Focus on EU-27, EEA and candidate countries
Staff, group
32
Staff, chemical service provision
16
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RPA assists both industry clients and regulators with the collection and analysis of use/exposure data of chemicals and their alternatives and the preparation of SEAs, which may be used to inform the development of a restriction dossier.
PARTNERS RPA works with FoBiG, Cranfield University, Ökopol, TNO Triskelion, Denehurst, Milieu, DHI, RIVM, ARCHE, ReachCentrum and EPPA among others.
Chemical Watch | Global Service Providers Guide 2014
OO
OO
OO OO
OO
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, Cosmetics Europe (Colipa), Etinsa, Eurocommerce, Eurometaux, European Plastics Recyclers, ICMM, IMnI, International Zinc Association, Lead Development Association, Nickel Institute and UKWIR). A range of companies (from multinationals to SMEs) and consortia.
STAFF SELECTION Meg Postle – Director Meg is an environmental economist and policy analyst with more than 20 years’ experience of consultancy. She has led RPA’s work for the 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 frameworks for SEA under REACH, and has conducted training on SEA to both RAC and SEAC members of ECHA. More generally, she leads the preparation of SEAs to support authorisation applications for a range of industry clients.
TESTIMONIALS
Dr Peter Floyd – Director
“RPA has played the major role throughout this process. At all times they provide excellent advice, based on their leading knowledge of the Regulation and the regulators, and on their impressive track record in all aspects of socio-economic analysis and the chemicals industry. Their fundamentally valuable professional experience and solid, hands-on expertise were fully dedicated to the process of developing and delivering the Application for Authorisation.” – industry client.
Risk assessment expert with more than 25 years’ consultancy experience. He has led studies ranging from hazard and risk assessments relating to the manufacture, storage, transport, use and disposal of flammable/ toxic gases, explosives, oil products and chemicals, to those concerning the establishment of guiding safety criteria at both individual and societal levels. Dr Floyd directs RPA’s framework contract with ECHA.
CASE STUDY 1: provision of analysis of alternative and socioeconomic analysis support services
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.
RPA is currently providing REACH authorisation support to a consortium of manufacturers of a SVHC substance. The work includes preparation of an analysis of alternatives (involving an assessment of the technical and economic feasibility of alternative chemicals and techniques), supply chain communication to develop information on uses and users’ responses to the loss of the SVHC in question and preparation of socio-economic analyses of the impacts of the loss of the SVHC. As part of this work, we are using the services of specialist toxicology and risk assessment consultants to further up-date the chemical safety assessment and to provide additional interpretation of toxicological data for both the substance and the alternatives. RPA assisted with the submission of the application for authorisation and is providing post-submission support. CASE STUDY 2: assistance to the European Commission in reviewing the first five years of REACH RPA assisted the European Commission with preparing a general report on the implementation of the REACH Regulation. The work included a detailed review of reports carried out on impacts and activities including those by competent authorities (in 30 EU and EEA Member States) and by ECHA. The reports cover REACH (registration, evaluation, etc) and CLP, as well as the associated training activities, communications and operation of helpdesks. The full report was published by DG Enterprise in May 2012. CASE STUDY 3: 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 to support the development of an Annex XV dossier for the identification of the substance as a SVHC. The emphasis of the analysis was on uses other than those in which the substance is used as an intermediate (as defined under the REACH Regulation), as well as on those uses potentially resulting in significant 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 2014
Panos Zarogiannis – Technical Director, Chemicals Policy
Phil Holmes – Associate Director, Chemical Science Phil Holmes is an associate director of RPA with more than 35 years’ experience in toxicology and risk assessment, and has worked extensively on a wide range of chemical classes including pharmaceuticals, agrochemicals, food additives, and industrial and consumer chemicals. He is a registered toxicologist with the Society of Biology/ British Toxicology Society/Eurotox. Tobe Nwaogu – Principal Consultant, EU Policy Tobe has degrees in biochemistry, pollution and environmental control as well as an MBA. Since 2003, Tobe has been involved in EU chemicals policy and chemical risk management. He has played a key role in the development of the risk reduction strategies and has project managed studies for the UK, Dutch, French and Danish authorities. Tobe has also managed studies for the EC and ECHA to assess the impacts of (potential) restrictions on chemicals and/or the development of Annex XV dossiers. Dave Fleet – Principal Consultant, EU Policy Principal consultant David Fleet is an economist with wide project management experience and socio-economic analysis expertise. He has extensive experience of managing RPA’s impact assessments and evaluations for the European Commission. He is currently co-ordinating consortium-wide and company- specific SEA outputs for applications for authorisation. Anthony Footitt – Principal Consultant, Chemicals Anthony Footitt is a principal consultant with RPA. He has 18 years of experience and undertook a great deal of the risk and economics work underpinning the EU REACH chemicals strategy on behalf of the European Commission where this included work on all of the business impact assessments (BIAs) and many subsequent analyses/impact assessments. He was also responsible for much of the modelling work that RPA carried out for the Commission on the impacts of introducing the GHS. Most recently, he has been working on REACH impact assessments and on nanomaterials.
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PROFILE: Risk & Policy Analysts (RPA)
CLIENTS
GLOBAL OFFICES HaskoningDHV Nederland BV: Barbarossastraat 35, 6522DK Nijmegen, Netherlands Haskoning UK Ltd: Rightwell House, Bretton, Peterborough, PE3 8DW, UK Haskoning Belgium SA: Schaliënhoevedreef 20D, B-2800 Mechelen, Belgium
PROFILE: Royal HaskoningDHV
CONTACTS Website
www.royalhaskoningdhv.com
Secretariatpci.iem@nl.rhdhv.com
Head office
HaskoningDHV Nederland BV, Laan 1914 nr. 35, 3818 EX Amersfoort
Tel
+31 24 328 4529
Fax
+31 24 322 81 70
Contact
Mr Christiaan van Daalen/ Mr Tjeerd Bokhout
Directors
Mr Steef Strijbos, Director Process and Chemical Industry
Ownership
Private company
Locations
100 Locations worldwide. Key locations Europe: Nijmegen, Amersfoort (Nl), Peterborough (UK), Mechelen (Be)
Founded
1881
SERVICES PROVIDED REACH Royal HaskoningDHV provides a full range of REACH services, varying from consortium management to preparation of registration – and authorisation dossiers. Royal HaskoningDHV experts prepare and submit both lead and individual registration dossiers and provide clients with tailored solutions for 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. Occupational hygiene and safe workplace Companies are overwhelmed with information on operational conditions and risk management measures as a result of the REACH obligation to prepare and communicate exposure scenarios for chemical substances. With the complex and very extensive eSDS as the communication tool, downstream users experience a large burden to analyse and review safety information and incorporate it into their own HSE management. Royal HaskoningDHV assists companies in this process and provides lean solutions with its extensive knowledge on worker safety, hazardous chemicals and systems for information management for both substances and mixtures.
OVERVIEW The firm was founded in 1881 in the Netherlands. Our employees combine a wide range of knowledge and experience. Rooted in a technical background, our consulting services focus on the broad field of the interaction between people and their environment. We are committed to working enthusiastically with our clients to achieve sustainable solutions in an increasingly complex society. The expertise and experience of our professionals in a variety of disciplines allows us to consider all technical, logistical, legal, organisational, social, environmental and economic aspects of the projects of our clients, in order to subsequently develop sustainable and practical solutions. We have been working with the industry on chemicals management for several decades and contributed to the implementation of many legislative programmes. In 2012 Royal Haskoning and DHV merged to the current organisation. VITAL STATISTICS
(extended) 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.
€702m
Turnover, chemical service provision
-
No of offices
100
No of countries represented
35
Staff, group
7,000
Staff, chemical service provision
80
SERVICE AREA BREAKDOWN Training 8%
Information 15%
Representation & management 15%
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Royal HaskoningDHV provides services varying from technical support to total solutions for implementation of GHS. The services include, but are not limited to: regulatory consultancy and compliance checks, GHS/CLP implementation, (re-)classification of substances and mixtures, training on GHS/CLP.
2012/2013
Turnover, group (2012)
Legal 5% IT & software 5% Laboratory 2%
GHS/CLP
Storage of chemicals and (external) safety Royal HaskoningDHV can assist with assessing, designing and permitting of storage facilities for hazardous chemicals, modelling of external safety (SEVESO) and assessing aspects such as explosion safety (ATEX). Sustainable chemistry Sustainable development requires co-operation and integration in the supply chain. The chemical industry is increasingly making use of bio-based resources, while products and side streams find new applications. This change is driven by economic and organisational principles which are then complemented by technical solutions. We have experience with providing new business models, such as Take Back Chemicals and Chemical Management Systems, needed for these developments and as a key player in the chemical industry, we link economic benefits to technical solutions. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
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.
1991
EaSI is developed by Royal Haskoning: a database with hazard information from legislation all over the world
1994
Royal Haskoning developed Rosetta, one of the first programs able to produce multilingual safety data sheets. Chemical Watch | Global Service Providers Guide 2014
2005
RIP 3.10 on characterisation and checking of substance identity is prepared by Royal Haskoning.
STAFF SELECTION
2007
Royal Haskoning joins the organisation of ChemCon Conferences.
2012
Merge between Royal Haskoning and DHV.
2013
Preparation and submission of two REACH authorisation dossiers. Successful completion of EU-Turkey project “Technical assistance for implementation of REACH regulation” for the Turkish Ministry of Environment and Urbanisation.
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 under various regulatory frameworks.
ISO 9001 ISO 14001 OHSAS 18001 PARTNERS ChemCon Conferences EPPA
Dr Ingrid Sterenborg – Senior Expert Toxicology Ingrid Sterenborg studied environmental hygiene and obtained her PhD degree on the physiological mechanism of metal tolerance in springtails, she started her career in environmental consulting, with particular expertise in regulatory toxicology. Ingrid is a EUROTOX registered toxicologist. She prepared several dossiers for biocidal and plant protection products as well as REACH dossiers and prepared data gap analyses, proposed testing strategies and prepared expert statements for several toxicological endpoints. Conny Hoekzema Msc – GHS/CLP and SDS Expert
The clients of Royal HaskoningDHV are located in many different industries. Because Royal HaskoningDHV provides many more services than chemicals management alone, it has service relations with clients covering a wide variety of solutions. Clients are, for example, in pharma, flavours and fragrances, plastics, petrochemicals, paints and coatings, minerals and metals.
Conny Hoekzema has eight years of experience in the field of chemicals management. She has extensive knowledge and experience in safety data sheets and classification and labelling. Furthermore, she is closely involved in the preparation of REACH registration dossiers and chemical safety reports, both with a focus on the environment. She is an experienced trainer who provides training courses on Iuclid5, safety data sheets and classification and labelling for a variety of audiences.
CASE STUDY 1: REACH authorisation application
Tjeerd Bokhout, MSc MBA – Consortium Manager
CLIENTS
A multinational company collaborated with Royal HaskiningDHV and partner EPPA for the preparation of some of the first REACH authorisation applications for two substances. The preparation required a detailed supply chain analysis which provided crucial information on the specific uses of the substances that were eligible for authorisation. Royal HaskoningDHV and EPPA combined their in-depth experience with technical processes, risk assessment, socio-economic analysis, policy and advocacy to prepare the exposure assessment, chemical safety report, analysis of alternatives and the socio-economic analysis. The client highly valued the team’s level of expertise. The applications were filed complete and in time for the further evaluation by the RAC and SEAC. CASE STUDY 2: REACH dossiers and beyond, providing complete solutions REACH hazard and risk information needs to be communicated through the extended safety data sheet. The REACH dossier, CSR, sections 1-16 of the SDS and the SDS appendix need to be consistent. For many of our clients, the creation of eSDSs is a challenge as they need to be both informative and compliant in order to be an effective communication tool. Currently available systems do not allow for efficient handling. In our team we combine experience with exposure assessment (using both the Chesar tool and higher TIER exposure assessment tools) and knowledge on worker protection and environmental regulations. Therefore, we are able to generate and select the relevant information for downstream users. Combined with our long-term experience in authoring compliant SDSs, we are able to provide a tailored service in close collaboration with our clients. CASE STUDY 3: TaBaChem For a client in the Belgian chemical industry we have elaborated the opportunity of ‘Take Back Chemicals’, as an answer to the challenge of the further optimization of a highly mature production process. Our solution was the application of a new business relation between the supplier and the client to reduce environmental impacts of waste streams and the use of virgin material and to strengthen the relationship between supplier and producer. We have served the related stakeholders with support in organisational, legal en environmental issues related to this innovative business model.
Chemical Watch | Global Service Providers Guide 2014
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. He has experience in the support of chemical industry and governmental bodies with requirements of REACH. Tjeerd manages several REACH consortia and provides strategic advice on REACH implementation. Tjeerd is also active as director of ChemCon Conferences, the world’s leading conference on chemical control legislation and trade aspects. ir. Leo van der Biessen Msc – Senior Expert Occupational Exposure Leo van der Biessen has more than 20 years’ practical experience in controlling and managing chemical exposure risk in the chemical process industry and its downstream users. In 1990 he joined a leading health and safety service provider in the Netherlands where he devised chemical risk assessment and control strategies as well as worker protection regimes. He joined Royal HaskoningDHV in September 2002. Leo is a board member for chemical safety of the Dutch Industrial Hygiene Association. Christiaan van Daalen Msc – Project Manager Christiaan van Daalen is trained as an environmental scientist, specialising in both regulatory toxicology and business communication with a focus on REACH. He has been involved in the preparation 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 team leader of the chemicals management team.
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PROFILE: Royal HaskoningDHV
ACCREDITATIONS
ir. Froukje Balk Msc – Senior Expert Ecotoxicology
GLOBAL OFFICES Bad Kreuznach in Germany (HQ) and Tokyo in Japan SERVICES PROVIDED Registration of chemicals – REACH and international programmes
PROFILE: SCC
CONTACTS Website
www.scc-gmbh.de
scc@scc-gmbh.de
Head office
Am Grenzgraben 11, 55545 Bad Kreuznach, Germany
Tel
+49 671 298 46-0
Fax
+49 671 298 46-100
Contact
Dr Werner Koehl (Chemicals, REACH, Consumer Products, Feed and Food)
Directors
Dr Friedbert Pistel, Owner and President Dr Albrecht Heidemann (Agrochemicals and Biopesticides)
Dr Monika Hofer (Regulatory Science)
Dr Hans-Josef Leusch (Biocides)
Dr Werner Koehl (Chemicals, REACH, Consumer Products, Feed and Food)
Ownership
Private company
Locations
Germany and Japan
Founded
1989
OVERVIEW SCC – Scientific Consulting Company – was founded in 1989 by Dr Friedbert Pistel, and is today one of Europe's largest privately-owned and independent consulting companies for the registration of chemicals, consumer products, agrochemicals and biopesticides, biocides, feed and food additives and veterinary medicine. VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
2
No of countries represented
2
Staff, group
100
Staff, chemical service provision
45
SERVICE AREA BREAKDOWN IT & Training software 1% Other 2% 1% Information 10% Representation & management 18%
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Consultancy/ advisory 68%
SCC has prepared hundreds of chemical notifications for new chemical substances (including high volume products of more than 1,000t/a) and successfully filed over 100 dossiers each for the 2010 and 2013 deadline under REACH. In addition, more than 50 PPORD and more than 50 inquiry dossiers were submitted. SCC has notified new chemical substances in China, Japan, Korea, Australia and Canada. Also, SCC has established a network for the competent authorities within the entire EU and abroad and is recognised as a reliable and competent partner by the authorities (eg ECHA) and EU industry organisations (eg Cefic or Hera). SCC can provide you with: OO only representative support; OO trustee service for supply chains (non-EU, EU); OO support in the (late) pre-registration process; OO support in prioritisation/advice on required action in your company for the upcoming REACH deadline and regarding international jurisdiction; OO literature (re)search and evaluation; OO data review and identification of data gaps; OO analysis of potential analogous/family approaches; OO development of registration/ testing strategies (including global programmes) as well as organising and monitoring of these studies; OO support with uses, use categories, PROCs, and (sp)ERCs; OO exposure modelling (eg EUSES, Risk of Derm, CONSEXPO, EASYTRA, ART); OO human and environmental risk assessments; OO preparation of the chemical safety report; OO submission/defence of the dossier at authority level; OO support in the CoRAP and SVHC/authorisation procedure; OO Sief and consortia support/management including trust account; OO C&L support (CLH dossier according to Annex XV); OO eSDS including Annex; OO scientific/regulatory support at EU expert meetings; OO Qsar tools. Registration of consumer products SCC has successfully supported the cosmetics and consumer product industry for more than two decades. Detailed knowledge of all relevant national and international regulatory directives and regulations are the basis to meet all challenges originating for example from the new cosmetics Regulation (EC) No. 1223/2009 or detergents Regulation (EC) No. 648/2004. SCC has proven experience for exposure and risk assessments on different scenarios. Data gap analysis, dossier preparation as well as placement and monitoring of studies are other fields of expertise. SCC has successfully prepared numerous safety dossiers for challenging cosmetic ingredients like hair dyes, UVfilter, preservatives, nanomaterials, botanicals and CMR categorized substances. Registration of agrochemicals and biopesticides The SCC agrochemicals and biopesticides department considers current and future regulatory and legislative needs and developments in the common agricultural policy of the EU, and stays up-to-date on the latest scientific research data. For this reason, the agrochemicals and biopesticides department is at the forefront in strategic planning and defence, negotiations with authorities, or task force support.
Chemical Watch | Global Service Providers Guide 2014
Registration of biocides
CASE STUDY 1: General remark
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.
All the names of our clients and projects are restricted under the highest level of confidentiality. Therefore we are unable to focus on individual case studies. Our consultancy has an excellent proven track record in all regulatory areas where we are active. Only one proof of our success is the fact that in the two decades of our existence, we have grown from a small national business to become a global player.
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 filed. Our expertise and connections with authorities and industries enable us to put together the optimal portfolio of scientific data and expert statements for your products. These portfolios will be as concentrated as possible and as extensive as necessary. Regulatory science The scientific specialists in the SCC regulatory science department are the backbone of the company and the key to its success. SCC unites experts from all regulatory relevant disciplines, such as chemists, physicists, food chemists, biologists, geo-ecologists, toxicologists, ecotoxicologists, environmental fate specialists, agronomists etc. This access to a wide spectrum of expertise ensures that clients of SCC can take advantage of a highly efficient service. GLP archive SCC offers a complete GLP-compliant archiving concept for all regulatory needs to the benefit of all our clients since 2004. SCC can act as your European or worldwide central archive for GLP-compliant storage. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1989
SCC GmbH founded
1989
Establishment of Agrochemical and Biopesticides department
1989
Establishment of Regulatory Science department
1996
Establishment of Chemical and Consumer Products department
2000
Establishment of Biocides department
2004
GLP archive certification
2007
Establishment of Liaison Office in Tokyo, Japan
2007
Establishment of Feed and Food Additives and Veterinary Medicine group
ACCREDITATIONS GLP archive (since 2004) PARTNERS Through our HQ and our liaison office in Japan, we have a global network with CROs, governmental institutions, local regulatory experts and scientists. We can help our clients all over the world.
STAFF SELECTION Dr Werner Koehl - Head of the Chemicals, REACH, Consumer Products and Feed and Food Department Dr Koehl has a PhD in food chemistry and is a certified expert for toxicology. He has been with SCC since 2001 and is head of the Chemicals, REACH and Consumer Products, Feed and Food department. He previously worked for the scientific committee on food safety and a large chemical multinational, and has gained many years of experience in the registration processes of the chemical world. Isabel Kirbach Mrs Kirbach has a master’s degree in chemical engineering. She has been with SCC since 2004 and her focus is on Sief, Iuclid 5 and consortia management since 2006. Dr Charlotte Krone Dr Krone has a PhD in geosciences. She has been with SCC since 2007, where she focuses on general regulatory affairs and consortia management. Also, she is the coordinator of all chemical issues related to notifications/registrations in Asia. 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 Karsten Schilling Dr Schilling has a PhD in veterinarian medicine and a regulatory and scientific background of more than 27 years. He joined SCC in 2013 and is responsible for cosmetics, consumer products, feed and food additives and veterinary medicine issues. Dr Monika Hofer – Regulatory Science Dr Hofer has a PhD in chemistry. She has been with SCC since 1998 and is head of the Regulatory Science department. Dr Albrecht Heidemann – Agrochemicals and Biopesticides Dr Heidemann has a PhD in biology. He has been with SCC since 1994 and is head of the Agrochemicals and Biopesticides department. Dr Hans-Josef Leusch – Biocides Department Dr Leusch has a PhD in agronomy. He has been with SCC since 2000 and is head of the Biocides department. Dr Bernd Brielbeck – GLP Archive Dr Brielbeck has a PhD in chemistry. He has been with SCC since 2001 and is responsible for our GLP-certified archive.
CLIENTS Small to large (global) companies in the areas of chemicals and consumer products, agrochemicals and biopesticides, biocides, feed and food additives and veterinary medicine. TESTIMONIALS Many of our clients have been customers for a long time, some going back to the start of our company. New clients are often recommended to us via existing clients.
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PROFILE: SCC
Registration of feed and food additives and veterinary medicine
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 – 22647, Sweden
Tel
+46 46 2850418
Contact
Shisher Kumra
Directors
Shisher Kumra and Mukta Kumra
Ownership
Private Limited Company
Locations
Sweden, India, Hong Kong
Founded
2008
IT & software 10% Representation & management 10%
GLOBAL OFFICES Sweden, India, Hong Kong SERVICES PROVIDED Late pre-registration (LPR)
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 OO China Chamber of Commerce of Metals Minerals and Chemicals (CCCMC); and OO 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 preparation of Chinese compliant SDS as well as notification of new 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 35 substances by the first REACH registration deadline of 30 November, 2010 – including being the lead registrant. SSS successfully registered around 225 substance; including 75 substances as the lead registrant by the 2013 deadline. SSS also: OO organised LPR for over 1640 substances; OO CLP notification of approximately 1,525 substances; and OO developed MSDS for 2,000 substances (including 550 MSDS translation in various European languages). VITAL STATISTICS
2012/13
Turnover, group
€4.5m
Turnover, chemical service provision
€4.2m
No of offices
3
No of countries represented
20
Staff, group
35
Staff, chemical service provision
25
SSS offers LPR services to help non-European companies, either new manufacturers or first time exporters of substances, to late pre-register their substances that were not pre-registered during the June-December 2008 period. Since the pre-registration deadline, SSS has successfully completed the LPR for 1,500+ substances, with many more in the pipeline. CLP notification SSS provides the CLP notification services to non-European companies in the capacity of an importer for which the company has to furnish the identity of the substance like the CAS No, EC No. SSS has to date successfully completed over 1,500 CLP notifications. Registration Since 2011-12, SSS is constantly working to help its client companies successfully meet the second registration deadline of 31 May, 2013. SSS successfully registered around 225 substance; including 75 substances as the lead registrant by the 2013 deadline and is working for its clients to help them meet the last REACH registration deadline of 31st May’ 2018 REACH compliant SDS SSS is also engaged in compiling the 16 point REACH and CLP compliant SDS for the chemical substances and preparations meeting the criteria of classification as dangerous. Extended SDS (e-SDS): SSS also provides e-SDS for the classified registered substances with the relevant exposure scenarios that have to be annexed to the SDS. SDS translation: since it is obligatory for the exporter of chemicals to provide to his buyer, SDS, originally prepared in English, in the local language, SSS also provides the service of translating the SDS into other languages of European member states (for example, German, French, Spanish, Dutch, or Italian). SSS has till date prepared over 2,000 REACH compliant SDS. SVHC applicability analysis Companies exporting articles to European countries need to confirm the presence or absence of substances of very high concern (SVHC) and the REACH compliance obligations. SSS offers a very economical and technically sound solution to these companies for fulfilling their REACH obligations and certification requirement of their European buyers. This solution is in line with the guidance provided by ECHA. So far, SSS has provided around 90 companies exporting articles to Europe with the most cost-effective REACH SVHC compliance certification SSS also provides compliance assistance for the following: OO OO OO OO OO
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Consultancy/ advisory 50%
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; and compliance with chemical management in Malaysia (EHSNR) Chemical Watch | Global Service Providers Guide 2014
2008
Established and registered as a private limited company.
2008
Successfully pre-registered over 7,000 substances within REACH.
2009
Professionals trained in Iuclid from REACH Centrum.
2009
Trained over 100 industry professionals in use of Iuclid.
2010
35 REACH registrations successfully completed.
2010
Delivered 1,500 REACH and CLP compliant SDS.
2011
Acquired capacity in Chesar and Qsar.
2011
Mandated as lead registrant for 50 substances.
2012
Mandated as lead registrant over 60 additional substances.
2013
Successfully registered over 225 chemicals by the 2013 deadline.
PARTNERS OO OO OO
OO OO OO
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 Associated with Ricardo’s CareChem24 chemical emergency helpline services through its Indian sister concern NS Support Services Pvt Ltd
CLIENTS SSS has clients in the industrial and specialty chemical and petrochemical industry, as well as the following industries: agrochemical, food colour, cosmetic, electrical and electronics, automotive industry, leather, garment and apparel, plastic and rubber, steel, writing instruments, polymers. TESTIMONIALS On the service quality criteria, over 90% of our client companies have rated the REACH compliance assistance services being offered by SSS as very good. CASE STUDY 1: Technical support to a multinational company Technical support provided to a multinational company having its own European legal entity as their only representative for successful submission of REACH registration dossier. Problem: due to the registration dossier failing the technical completeness check (TCC) at ECHA, the company had only one opportunity for resubmission of the registration dossier without losing its ECHA registration fee. Solution: SSS (Europe) AB reviewed the TCC failure report as well as the Iuclid registration dossier prepared by the company to identify the reason for the registration dossier failure. Suitable modifications were 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.
Chemical Watch | Global Service Providers Guide 2014
CASE STUDY 2: Providing guidance to a non-EU manufacturer having own legal entity in Europe on preparation for a REACH audit Problem: A non-European company sought the technical assistance of SSS to guide them in their preparation for a REACH audit proposed by one of REACH enforcement agency Solution: SSS provided guidance to the company in terms of the various documentations and records that the European office of the non-EU company should have in place before the audit, including compliance with the CLP Notification as well as provision of safety data sheets (SDS) and translated safety data sheet (wherever applicable) . Accordingly company verified its compliance status prior to the Audit. CASE STUDY 3: Providing guidance to many Sief members for successfully completing their REACH registration in the 2013 deadline Problem: SSS received requests from considerable Sief members to provide know-how on how to complete the REACH registration process as they were unaware of the same Solution: The technical team at SSS, provided the know-how to the Sief members relating to the finalisation of their registration dossiers, TCC clearance and submission of the member dossier on the REACHIT by joining the joint submission (JS). Some of these requests were received very close to the deadline and the timely inputs from SSS helped companies meet their registration deadline. STAFF SELECTION Mr Shisher Kumra – Executive Director Area of expertise includes specialisation in regulatory affairs, legal expertise, chemical assessment, toxicology. Dr Rashmi Naidu Area of expertise includes REACH data inventory, REACH registration process, environmental toxicology, bio-assay and other regulatory affairs. Mr Shrirang Bhoot Area of expertise includes specialisation in the software’s like Iuclid, Qsar, Ecosar, dossier preparation, eco-toxicology Dr Chitralekha Datta Area of expertise includes chemical safety assessment (CSA), chemical safety report (CSR), toxicology, software like Iuclid, Chesar and CLP Dr Shruti Ralegaonkar Area of expertise includes REACH and Articles, SVHC assessment and REACH compliance verification Dr Martina Holst Responsible for evaluation of toxicological reports and for dossier quality assurance for toxicological endpoints and CSR Mr Johan Holm Toxicologist - assists in quality assurance of toxicological endpoints
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PROFILE: Sustainability Support Services (Europe) AB
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
SERVICES PROVIDED REACH and product safety
Website
www.swissips.com
info.es@swissips.com
Swissi PS assists a high number of companies outside the European Union to comply with REACH Regulation. We prepare registration dossiers of their substances, submit them to ECHA and provide the necessary documentation to their downstream users. We also act as third party representative, offering consultancy services to European companies, preparing their registration dossiers and SDS adapted to the REACH and CLP Regulations. We are members of ORO (Only Representative Organisation).
Head office
C Lope de Vega, 22-24, 08005 Barcelona, Spain
Laboratory testing
Tel
+34 933 036 612
Fax
+34 933 036 612
Contact
Montserrat Fernández (REACH Business Group Leader) Mr Kimmy Wu (Sales office in Taiwan)
Directors
Dr Alexis Pey (Director Swissi Process Safety Spain)
Ownership
TÜV SÜD Iberia
Swissi PS can offer more than 150 different tests in the fields of thermal process safety, fire and explosion protection, electrostatics, REACH and GHS and highly active and highly toxic materials. We also offer tests for classification according to the Orange Book (UN Recommendations on Transportation of Dangerous Goods) ie GHS (globally harmonised system). We are certified in accordance with ISO/IEC 9001 and our test laboratories are accredited under ISO/IEC 17025.
Locations
Spain (Barcelona, Madrid, Murcia), Switzerland, Taiwan
Process safety and loss prevention
Founded
1945
PROFILE: Swissi Process Safety
CONTACTS
OVERVIEW Swissi Process Safety (Swissi PS) Spain is part of the international group TÜV SÜD. Swissi PS 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. VITAL STATISTICS
Environment consultancy
2012/13
Turnover, group
€5m
Turnover, chemical service provision
€1.5m
No of offices
6
No of countries represented
Global
Staff, group
60
Staff, chemical service provision
20
SERVICE AREA BREAKDOWN Training 6% Laboratory 12%
Consultancy/ advisory 82%
GLOBAL OFFICES Swissi Process Safety Spain: C/ Lope de Vega, 22-24. 08005 Barcelona, Spain. Swissi Process Safety GmbH: Schwarzwaldallee, 215 WRO-1055.5.24, 4002 Basel, Switzerland. Taiwan Sales Office: 13F, No 83, Jian Sing Rd, SanMin Dist, Kaohsiung 807, Taiwan, ROC.
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We conduct audits and analyse risk in our fields of expertise: process 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. We perform environmental risk analysis, quantify the consequences of possible damage, help companies to integrate their activities in the environment, and perform administrative procedures associated to each regulation and to environmental licenses. We also implement safety management systems Crisis management We are accredited to prepare emergency plans and also help companies to implement them with training and emergency exercises aimed at both the companies’ management and staff. As part of the global services we give to our clients, we develop crisis management and communication manuals to minimise negative publicity. 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.
2013
TÜV SÜD Iberia acquires Swissi Process Safety.
ACCREDITATIONS Swissi PS is certified in accordance with ISO/IEC 9001 and its test 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.
Chemical Watch | Global Service Providers Guide 2014
CASE STUDY 1: REACH IT tool and customer care
Mariàngels Custal – Consultant (Environment)
Swissi PS developed in 2009 an IT tool for our REACH clients so that they are able to manage all the information derived from the registration process. The information is made available both to our clients and to their respective supply chains. That way their European clients can access the IT tool to download relevant documentation related to the substances they import (Only Representative Certificates,Tonnage Certificates, SDS, etc). We also have a close relationship with our REACH clients. We visit them on a yearly basis to provide them with updates on the latest issues related with the registration process. We organise REACH and product safety seminars and train them depending on their specific needs.
Mariàngels Custal has worked since 2010 at Swissi PS and is a chemical engineer. She is a consultant specialising in environmental safety, explosive atmospheres (Atex), and transport safety (ADR). Before joining Swissi PS, she was responsible for the environment and the industrial wastewater plant at various Clariant factories in Spain and Belgium.
CASE STUDY 2: HSE Management Platform
Berta Albaigés – Consultant (REACH and Thermal Process Safety)
CASE STUDY 3: tailor-made proceedings Companies are increasingly concerned by safety, health and environment. To meet its clients' needs, Swissi PS provides consultancy services to develop tailor-made proceedings to help companies to manage its procedures and thus increase effectiveness and reduce costs. This service is the fruits of years of experience in consulting. STAFF SELECTION Dr Alexis Pey – Director of Swissi Process Safety Spain
Joan Marc Juncosa has worked since 2009 at Swissi PS and is a chemical engineer. He is a consultant specialising in REACH, classification, labelling and packaging (CLP), explosive atmospheres (Atex) and machinery safety.
Berta Albaigés has worked since 2011 at Swissi PS and is a chemical engineer. She is a consultant specialising in REACH and product safety and thermal process safety. Before joining Swissi PS, she worked at RPN, a consultancy for the pharmaceutical industry specialized in regulatory affairs. Ester Pellicer – Consultant (REACH and Crisis Management) Ester Pellicer has worked since 2009 at Swissi PS and holds a degree in communication science. She is a consultant specialising in REACH (supply chain communications), crisis management – crisis communication and emergency exercises. Jordi Campos – Consultant (Emergency Plans and Major Accidents) Jordi Campos has worked since 2006 at Swissi PS and is a chemical engineer. He specialises in emergency plans, major accidents (Seveso) and safety management systems. He has also worked for PQAT group of IQS (Institut Químic de Sarrià).
Dr Alexis Pey started Swissi PS in 2004. He has a PhD in chemical engineering and specialises in electrostatics, process safety, accident investigation and risk analysis. He has also worked at the consumer care Division of Ciba Specialty Chemicals. He is a member of the board of Bequinor and a permanent member of EFCE. Montserrat Fernández – REACH Business Group Leader Montserrat Fernández has worked since 2009 at Swissi PS and holds a degree in chemistry. She is a consultant specialising in REACH Regulation, safety data sheets (SDS), classification, labelling and packaging (CLP) and transport safety (ADR). She also worked at the R&D department of Clariant, where she held various positions. Dr Otto Holzschuh – 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 classifications and REACH registration as well as in preparing safety data sheets. He is coordinating Swissi PS’s collaboration with other laboratories to offer one-stop services for REACH registration. Dolors Vinyoles – Consultant (REACH, ORP and environment) Dolors Vinyoles has worked since 2008 at Swissi PS 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 PS, she worked at Clariant Spain, where she used to be ESHA (environment, safety, and health affairs) country head.
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PROFILE: Swissi Process Safety
HSE Management Platform developed by Swissi PS allows companies to manage all aspects related to health, safety and environment with a single tool, and thus improve efficiency and effectiveness. This IT tool, with customisable modules, integrates all prevention measures, safety regulations and relevant documents. It is a powerful database with integrated and related information from all the modules, can be used to manage one or several sites, generates reports automatically and can be hosted in the company’s own system to guarantee confidentiality and data safety.
Joan Marc Juncosa – Consultant (REACH and Machine Directive)
SERVICES PROVIDED Risk assessment and chemicals management Our focus is on REACH and its implementation. Besides registration, authorisation and building exposure scenarios, we support the evaluation of risk management options. We can audit your own implementation and communication under REACH and its eSDS’s. Additionally, we support biocides and the safe use of nanoparticles. TNO and TNO Triskelion have together developed a range of assessment tools to help evaluate human exposure and to avoid and reduce health risks. Our expertise is available to address regulatory issues as well as to solve day-to-day chemicals management problems.
PROFILE: TNO Triskelion
CONTACTS Website
www.tnotriskelion.com
chemistry@tno.triskelion.nl
Head office
Utrechtseweg 48, PO Box 844, 3700 AV Zeist, the Netherlands
Tel
+31 88 866 16 28
Fax
+31 88 866 69 70
Contact
chemistry@tno.triskelion.nl
Ownership
Private company, wholly-owned by TNO
Locations
Zeist, The Netherlands
Founded
TNO, 1933; TNO Triskelion, 1/1/2011
Experimental toxicology We offer high quality toxicology studies, specifically tailored to the needs of REACH, biocides, pesticides and nanomaterials customers. Our toxicological research centre provides new and improved methods in toxicology, especially inhalation, reproduction, immuno-toxicology and (in vitro) skin adsorption. We have been developing novel methods to reduce, refine and replace animal testing for nearly two decades and are proud of our performance record in this field, especially resource saving combined in vivo studies such as repeat-dose (28/90d), repro screening and in vivo gentox (also Comet assay) in the same study. We can offer the new OECD 443 guideline for an extended onegeneration reproduction toxicity (EOGRTS) study, already validated in our laboratories, as well as the OECD 488 transgenic rodent test.
OVERVIEW TNO Triskelion is a company born out of a rich history of TNO R&D achievements. Our chemical risk assessment services combine research-driven excellence in the classical disciplines of toxicology and advanced analytical chemistry, with new developments in risk assessment, in order to produce intelligent testing strategies and thereby, cleaner, safer, chemical products. We excel in worker exposure assessment, in inhalation and in reproduction toxicology, including nanomaterials. We offer our customers high quality registration and chemicals testing and analysis services characterised by strong communication with a personal touch that larger CROs cannot match. VITAL STATISTICS
2013/14
Turnover, group
€600m
Turnover, chemical service provision
€30m
No of offices
30
No of countries represented
5
Staff, group
3,900
Staff, chemical service provision
200
SERVICE AREA BREAKDOWN IT & Training software 5% 5%
Laboratory 45%
TNO Triskelion’s analytical research centre, with its history of TNO R&D excellence, has expertise in developing challenging analytical chemical methods for a very broad range of substances including: organotins, fluorocarbons, formaldehyde, biocides, pesticides, fragrance materials, to name but a few. At the interface of the fields of toxicology and risk assessment, our tailor-made services can make a difference, for example: OO test substance identification and characterisation; OO mechanistic studies of toxic compounds in vivo using sophisticated analytical techniques; OO human and environmental exposure studies in various settings (industrial, agricultural). Food packaging petitions, migration testing and plastics recycling TNO Triskelion offers regulatory affairs services, migration and toxicity testing of food contact materials (FCM) for petitions to the European Food Safety Authority (Efsa) and for food contact notifications (FCN) to the US Food and Drug Administration (FDA). Examples are monomers and additives used in plastics described in Directive 2002/72/EC. We sharpened our knowledge by participating in the technical committees of the Efsa. How we work
Consultancy/ advisory 30%
Representation & management 10% Information 5%
GLOBAL OFFICES Headquarters group: TNO, Delft, The Netherlands, Headquarters TNO Triskelion: Zeist, The Netherlands Sales Offices: Shin-Yokohama, Japan and USA
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Analytical chemistry
Project management – your assignment with TNO Triskelion is always led by one of our experienced project managers, your primary contact person, who manages your project, interacts with the scientific team, and ensures you that deadlines are met and that the assignment meets your needs. Your project manager maintains contact with you during phone and/or conference calls (scheduled as and when you require), and also provides regular update reports. Quality assurance and reporting – our GLP reports are consistently subjected to the required auditing and control procedures to ensure compliance. All the documentation you receive (proposals, reports, analytical results, Iuclid files, chemical safety reports, eSDSs) is reviewed by a senior staff member before being sent out to you. Relationship management – in addition to strong project management, our sales and account managers are also there to assist you. Our customer services department is there to guide you to the correct technical contacts within TNO Triskelion, who will help you find the right solution.
Chemical Watch | Global Service Providers Guide 2014
1932
TNO The Netherlands Organisation for Applied Scientific Research is founded.
1946
Founding of the Central Organic Chemistry Institute in Zeist.
2004
Completion of five-year HPV programmes on various chemical groups including organotins.
2006
Participated in REACH implementation projects (data requirements, exposure assessment).
2007
Commenced REACH partnership with Sabic Europe.
2010
Successful completion of 325 full and partial REACH dossiers.
2011
Incorporation of TNO Triskelion as a private company.
2011
ReachCentrum and TNO Triskelion join forces to offer REACH workshops and training courses.
2012
Extensive application of our exposure experience to the evaluation of Risk Management Options for SVHCs.
2013
AAALAC accreditation obtained; REACH 2013 dossiers submitted on time!
ACCREDITATIONS In compliance with GLP (toxicology and analytical chemistry); ISO 9001 and AAALAC certified;Some analytical services under ISO 17025. PARTNERS TNO Quality and Safety (R&D): we work together with TNO on development of alternative toxicological methods and (bio)analytical methods. ReachCentrum: workshops and training Where needed we supply additional services like ecotoxicology, physicochemical testing and special evaluations (as SEA) through our network of co-operators. CLIENTS Three top-10 and 12 top-50 global chemicals manufacturers are our clients. We have provided long-term chemical safety services to the following chemical sectors: fluorochemicals, hydrocarbon distillates, organotins, biocides, chlorinated solvents, fuel oxygenates, organic peroxides, formaldehyde, amines, polyols and isocyanates, silicates and mineral oxides (micro and nano grades), coal chemicals, fragrances. TESTIMONIALS “TNO Triskelion recently performed a comprehensive risk assessment on behalf of our industry. As well as their knowledge and experience, and their scientific integrity, we have been impressed by their skill in communicating across the interfaces within the industry.” – Phil Hope, Secretary General, Formacare. "In the past three years TNO Triskelion has steered us safely through the difficulties and uncertainties of REACH registration. It is a thorough, scientifically reliable and pro-active partner for the risk assessment and registration of chemicals." – Harrie Camps, SABIC.
CASE STUDY 1: successful registration within REACH, post-2010 2013 follow-up and 2018 preparations With Phase II REACH registration completed by mid-2013, 2013 was 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, all under the same roof. It has also now become clear with the publication of a definition by the EC of nanomaterials that they will ultimately fall under REACH and ECHA has published its first advice on how that process may take shape on its website. 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. Feedback of ECHA and member states on 2010 dossiers has shown that more data development is needed to support this. CASE STUDY 2: ECHA test proposal evaluations including Eorgts REACH requires that for substance volumes of 100-1,000t and >1,000t, missing higher tier safety studies be included in the registration dossier in the form of a test proposal. ECHA is in the process of evaluating these proposals and (draft) decisions are being sent to lead registrants. Many have already been published on the ECHA website and were open for public comment for several weeks. OO Our advice to clients faced with an ECHA test-proposal that diverges from their own, is to enter, as far as possible, into a dialogue with ECHA. We can help develop and support the scientific arguments to support your case to ECHA. OO Should testing be needed, TNO Triskelion is specialised in higher tier testing with difficult test materials. Our inhalation toxicology skills cover gases, volatile liquids, solids and nano-grade materials, while our reproduction toxicology skills are second to none and include the Eorgts (OECD 443). We have validated OECD 443 in our laboratory, gaining us the necessary experience. CASE STUDY 3: chemicals management 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: OO assist you with the production and implementation of extended safety data sheets (eSDS); OO prepare an audit of REACH readiness in preparation for government inspections; OO evaluate current exposure of workers at your production sites; OO prepare answers to questions from ECHA and competent authorities/ rapporteurs regarding compliance of your dossiers; OO follow-up on any ongoing work on your substances in Siefs and consortia; OO help you in answering questions from your clients regarding their REACH obligations for the substances you supply to them; OO 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 your substances as well. A steady inflow of young academics ensures that we remain vigorous and up to date.
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PROFILE: TNO Triskelion
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
GLOBAL OFFICES Head office: Avenue de Broqueville 116, 1200 Brussels, Belgium. SERVICES PROVIDED
PROFILE: ToxMinds
CONTACTS Website
www.toxminds.com
info@toxminds.com
Head office
116, Avenue de Broqueville, 1200 Brussels, Belgium
Tel
+32 (2) 762 91 45
Fax
+32 (2) 762 91 46
Contact
Mireya Camino
Directors
Dr Thomas Petry
Â
Dr Francesca Tencalla
Ownership
Private company
Locations
Belgium, Germany
Founded
2006
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 and therefore understand the specific needs of industry. Our services are centred on our three competence areas: applied human health and environmental risk assessment; EU regulatory strategy and compliance; and science-based advocacy. Applied human health and environmental risk assessment
OVERVIEW ToxMinds BVBA is a product safety and regulatory affairs firm located in Brussels, Belgium. We provide scientific, regulatory and strategic support 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
2014
Turnover, group
-
Turnover, chemical service provision
-
No of offices
2
No of countries represented
4
Staff, group
10 - 25
Staff, chemical service provision
10 - 25
SERVICE AREA BREAKDOWN Training 10% Information 10%
Representation & management 20%
Consultancy/ advisory 60%
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 various environmental compartments, and derivation of predicted environmental concentrations (PECs) according to the methodologies specific for the different types of industries. Data completion: evaluation of non-testing approaches to support chemical and chemical-based product safety including grouping/readacross approaches, analogue identifications as well as the use of Qsar methodologies; identification of intelligent testing strategies, design and management of in vitro/vivo study programmes. Risk assessment: comprehensive human health and environmental risk assessments. EU regulatory strategy and compliance Chemicals and commodities: strategic consulting, technical registration and post-submission support to ensure success under the REACH as well as compliance with the CLP Regulation: REACH portfolio and consortium management; consortium representation. Cosmetics: Identification and evaluation of non-testing approaches including chemical similarity analysis and SAR-/analogue-based hazard assessments; preparation of Regulation (EC) 1223/2009 compliant cosmetic safety assessment and preparation of product information files; preparation of SCCS submissions. Biocides and agrochemicals: pre-registration/registration support including literature search, data gap analysis; study monitoring and management; human and environmental risk assessment as well as dossier assembly and post-submission support. Plant biotechnology: literature reviews; development of regulatory submissions; scientific post-submission support (eg development of responses to queries from regulatory authorities). Science-based advocacy Strategy: develop and implement strategies to support products against scientifically unjustified health- or environment-related allegations. Authority review: support on science and regulatory matters in discussions with regulatory authorities. Communication: communicate (eco)toxicology and risk assessment findings to diverse audiences (eg academia, authorities, consumer, and 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
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2006
Foundation of ToxMinds BVBA by Dr Thomas Petry.
2009
Opening of ToxMinds office in Brussels in the direct vicinity of the EU institutions.
Chemical Watch | Global Service Providers Guide 2014
CLIENTS
STAFF SELECTION
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.
Thomas Petry, PhD, ERT, DABT
“We have been working with ToxMinds BVBA for many years on various complex toxicology, ecotoxicology and regulatory issues. The professionals at ToxMinds are thorough, knowledgeable and always meet the demands and difficult timelines required by our company. We continue to rely on ToxMinds as experts in the fields of toxicology, ecotoxicology and regulatory compliance.” – Senior manager, Global Product Regulatory Compliance, international specialty chemical company CASE STUDY 1: consortium management and technical support to REACH consortia ToxMinds provides technical REACH support for a number of REACH consortia and individual chemical companies covering more than 80 chemical substances, predominantly UVCBs. Our technical work includes: OO desktop search and data gap analysis; OO Qsar modelling and analysis; OO design of intelligent testing strategies; OO placement and monitoring of testing programmes; OO development of Iuclid 5 registration dossiers, chemical safety assessments and reports (CSR); OO strategy advice and support during registration and evaluation phases; OO client representation in discussions with authorities; and OO applications for authorisation, strategic and technical support during authorisation phase. CASE STUDY 2: human and environmental risk assessment ToxMinds (eco)toxicology consultants have long experience in conducting human and environmental risk assessments of commodity and specialty chemicals for our clients as part of regulatory or voluntary industry programmes or for internal safety assurance purposes. The human health risk assessments considered human exposures to chemicals at the workplace, in indoor/outdoor air or due to their release from consumer products such as cosmetics, cleaning or pest control products. The environmental assessments typically included environmental fate and ecotoxicicty evaluations of chemical releases into the environment at manufacturing or usage sites, field uses in the case of agrochemicals or from “down the drain” consumer products.
Francesca Tencalla, PhD, ERT Dr Tencalla is a (eco)toxicology and regulatory affairs consultant with 20 years’ of industry, consulting and research experience in the human and environmental safety assessment of chemicals, metals, agrochemicals and pharmaceuticals. She is a European registered toxicologist (ERT) and earned her PhD in (eco)toxicology from the Institute of Toxicology of the Swiss Federal Institute of Technology (ETH) of Zurich. Nirmala Ranggasami, MSc, ERT Ms Ranggasami is a toxicology and regulatory affairs consultant with more than ten years’ of industry and consulting experience in the human and environmental safety assessment of substances. She is a European registered toxicologist (ERT) and earned her MSc in toxicology from the University of Surrey, UK. Monica Autiero, PhD Dr. Monica Autiero is a Senior Consultant providing scientific and regulatory support and management to our projects. She leads our efforts in the area of Analogue Identification and Qsar-based hazard assessments. She is a biologist with a PhD in biochemistry and molecular biology from the University Paris XI. Ms Daniela Jeronimo Roque, MSc Ms Daniela Jeronimo Roque is a junior consultant at ToxMinds BVBA since 2011. She leads our exposure modelling group and supports the team in conducting thorough desktop searches, (eco)toxicological hazard assessments and Qsar. Daniela has a biomedical license in life science and health/biology with a specialisation in nutrition. She obtained a master’s degree in health risk sciences at the University of ClermontFerrand in France.
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 scientific external relation programmes. Our work involved the analysis of the scientific basis of the claims on potential health impacts and the evaluation of possible response strategies. On behalf of the industry, ToxMinds presented its scientific views in discussions with the European Commission, EU Member States as well as non-governmental organisations leading to a less emotional and a more rational debate supported by science.
Chemical Watch | Global Service Providers Guide 2014
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PROFILE: ToxMinds
TESTIMONIALS
Dr Petry is the founder and manager of ToxMinds BVBA. He is a product safety and regulatory affairs consultant with 20 years’ industry, consulting and research experience in the human safety assessment of chemical exposures occurring at the workplace, through their use or presence in consumer products, or via the environment. He is a European registered toxicologist (ERT) as well as a diplomate of the American Board of Toxicology (DABT) and earned his PhD in toxicology from the Institute of Toxicology of the Swiss Federal Institute of Technology (ETH) of Zurich.
GLOBAL OFFICES Japan, Singapore, China, India, Croatia, Indonesia, Thailand, Vietnam, Serbia, Russia, Ukraine, South Korea, USA SERVICES PROVIDED Only representative Website
www.tuev-sued.de/technical_installations/reach
REACH@tuev-sued.de
Head office
TÜV SÜD Industrie Service GmbH, Westendstr 199, D-80686 Munich, Germany
Tel
+49 / 89 / 5791-1004
Fax
+49 / 89 / 5791-1174
TÜV SÜD Industrie Service acts as reliable and impartial OR to numerous manufacturers of substances established outside the community. The obligations of an OR outlined in 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 EU can bundle notifications and do not have to address each importer individually. We experience that often manufacturers address to us when their previous OR failed to act to their satisfaction or did not fulfil its obligations.
Contact
Dr Dieter Reiml
REACH initiative for midsized and small companies
Ownership
TÜV SÜD Holding AG
Locations
TÜV SÜD Group employs more than 19,000 people in 80 countries in ca. 800 locations
Founded
1866
All companies must register their chemicals by mid-2018 at the very latest – which is especially challenging for small and midsized businesses! TÜV SÜD aims to help these companies ensure that REACH is not a threat, but a path to safeguarding business. With the special needs of small and midsized companies in mind, TÜV SÜD has created a service package that provides these companies with assistance in all questions related to chemicals. The spirit of initiative: focus on your core competences, not on REACH.
PROFILE: TÜV SÜD Industrie Service
CONTACTS
OVERVIEW The principle of REACH, "No data, no market", may seem alarming. Additionally, comprehensive obligations governing the provision of information along the supply chain and to ECHA are gradually coming into effect. As a globally recognised expert in all chemical law issues, TÜV SÜD continuously pursues the reform process in the EU and supports companies throughout all steps of REACH and GHS implementation. To assist the companies affected by REACH, TÜV SÜD has established an international REACH network. Our environmental experts are tracking REACH implementation in the EU on an ongoing basis. And in addition, we also help to maintain business secrets of our customers in spite of mandatory data sharing provisions. In view of the 2018 registration deadline TÜV SÜD developed a service package custom tailored for small and medium enterprises (SME) as well as for global players. In 2013 we expanded our range of services to biocides. Our maxim is “REACH – Made easy with TÜV SÜD expertise.” VITAL STATISTICS
2012/13
Turnover, group
€1,820m
Turnover, chemical service provision
-
No of offices
800
No of countries represented
80
Staff, group
19,000
Staff, chemical service provision
60
SERVICE AREA BREAKDOWN Training 10% Laboratory 10% Information 10%
Representation & management 35%
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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 granted for their specific use, or the use is exempted from authorisation. Our support extends from the management of authorisation consortia to supporting individual companies in fulfilling their duties in a costly and effective manner. In-house training and seminars Companies affected by REACH or CLP are seeking advice on how to deal with the challenges caused by REACH in a timely effective manner. Desired training events vary depending on participants’ existing knowledge: OO introductory training courses to gain an overview of REACH and CLP; OO seminars on selected topics of REACH; OO workshops to create solutions under the guidance of an experienced expert; OO in-house consulting for the ad-hoc solution of characteristic problems. Any other activities concerning REACH and CLP REACH and CLP shift most of the responsibility for the safe handling of chemicals from the regulatory bodies to producers, importers and downstream users and retailers. The relevant requirements and consequences, however, are not clear at first sight. Consequently we offer all kind of services related to REACH and CLP, from the starting point to implement REACH via testing in our own GLP accredited laboratory to long-term compliance with chemicals regulations. CORPORATE DEVELOPMENTS & ACHIEVEMENTS
Consultancy/ advisory 35%
1866
Established in Mannheim
1926
Introduction of the “TÜV SÜD mark / stamp” in Germany
1960
Establishing chemical services
1990
Conglomeration of TÜVs from the southern part of Germany to form TÜV SÜD and the expansion of business operations into Asia Best brand of technical services, testing, consulting, training, certification in all industries worldwide – energy producers and providers, nuclear power plants, chemical industry
Chemical Watch | Global Service Providers Guide 2014
Expansion of services in ASEAN by acquiring Singaporebased PSB Group
2007
Establishing REACH services. Founder member of the "BUSINESSEUROPE REACH Implementation Network”.
CASE STUDY 5: SVHC
Due to client confidentiality individuals cannot be named. Our clients from more than 30 countries are active in all fields of industry and professional sectors. We support a network of chemical plants. Company size varies from worldwide operating entities to SMEs. We support clients in all their roles under the REACH regulation and for all types of substances. In 2013 we expanded our range of services to biocides as to the biocides products Regulation.
A EU-based group with legal entities in several member states was seeking support in making an inventory of SVHC of the articles put into market, as well as in implementing a system to comply with the duties to communicate information on SVHC in articles. The legal entities were predominantly in the role of importers of articles or retailers of articles. TÜV SÜD offered an integrated approach over all affected legal entities in order to avoid duplication of work. Representative articles were selected for chemical testing in case of uncertainty on the presence or concentration of SVHC. Testing was performed in TÜV SÜD’s own chemical laboratory. As a result of the investigation and consulting, a unified system was implemented in the entire group. The system ensured full compliance with REACH Art. 33 to 36. Furthermore, supply contracts were amended to increase legal certainty, to avoid the risk of lawsuits and to avoid image problems.
CASE STUDY 1: Consortium management
CASE STUDY 6: Only representative
ACCREDITATIONS GLP CLIENTS
A consortium with representatives from five countries took over to register a series of substances with registration deadlines from 2010 to 2018. The duty to act as lead registrant was shared among the individual consortium members. The main bodies of the consortium are the steering committee, the technical committee and the secretariat. TÜV SÜD rendered consortium management to all bodies. Technical REACH consultancy and financial consultancy was part of the services to be delivered.
TÜV SÜD acts as OR for many non-EU manufacturers. In several countries this is performed by involving local TÜV SÜD offices. This approach guarantees direct contact to the end-client and avoids language barriers where applicable. Thus, also smaller non-EU manufacturers can benefit from OR services which are not sufficiently conversant with English and technical terms.
CASE STUDY 2: Support in REACH implementation
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 assistance; the core team was fully integrated in the client’s activities on-site.
Fritz Prechtl is a chemist and certified REACH multiplicator with more than 30 years' professional experience. His core activities are OO only representative; OO preparing registration dossiers; OO communication up and down the supply chain; OO communication in Siefs and with authorities; OO complex role analyses; and OO consultancy on REACH.
CASE STUDY 3: Complete service package for lead registrants Several clients from the chemical industry lacked capacity to prepare lead dossiers. TÜV SÜD prepared and submitted the lead dossiers on behalf of the clients. Additionally, all accompanying steps were performed as well: Sief communication, data-gap analyses, testing, expert statements, Qsar modelling, communication within consortium, preparation of safety data sheets, cost calculation of letter of access, handling of letter of access. CASE STUDY 4: Testing strategies and testing The lead registrant of four substances had to conduct studies in order to fulfil the information requirements under REACH. Two of the substances were classified as hazardous according to CLP, the classification of the others was not yet clarified. TÜV SÜD performed all steps to comply with the information requirements. All available information that had been gathered was assessed for its adequacy for classification and labelling, determination of PBT or vPvB status and the derivation of a dose descriptor to be used in the chemical safety assessment (CSA). The information was evaluated for its completeness and quality (relevance, reliability and adequacy). Cost for data sharing is one of the crucial issues of negotiations in Siefs. High quality data outsell a higher price than data of low quality. Some data gaps were closed by Qsar and read-across. Other data gaps had to be closed by testing. A thorough and meaningful test strategy was set up in order to minimise cost and to comply with the registration deadlines on one hand and to comply with REACH annexes VII to X on the other hand. TÜV SÜD operates its own GLP testing laboratory capable of performing all testing required by REACH. The data gaps were closed by physicochemical properties testing, ecotoxicological studies as well as toxicological studies.
Chemical Watch | Global Service Providers Guide 2014
STAFF SELECTION
Dr Dieter Reiml Dieter Reiml is a molecular biologist and certified REACH multiplicator with more than 30 years' professional experience. His core activities are OO consortium management; OO authorisation; OO only representative; OO preparing lead dossiers; OO CSA / CSR; and OO consultancy on REACH and CLP. Other staff The majority of the Munich REACH team of TÜV SÜD has gained the qualification “Certified REACH multiplicator” from the Austrian Chamber of commerce.
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PROFILE: TÜV SÜD Industrie Service
2006
GLOBAL OFFICES Headquartered in the US, our main facility is in Ashland OH, with support offices in Hillsborough NC, Skokie IL and Boothwyn PA. In Europe, our main agrochemical, biocide and REACH safety testing facility is in ‘s-Hertogenbosch NL. Our other location is in Lyon, France, with support offices in Switzerland and the UK. Additional support offices in Tokyo, Japan.
PROFILE: WIL Research
CONTACTS
SERVICES PROVIDED
Website
www.wilresearch.com
info@wilresearch.com
Head office
1407 George Road, Ashland Ohio, 44805
Tel
+1 (419) 289-8700
Fax
+1 (419) 289-3650
Contact
info@wilresearch.com
Ownership
Privately owned
Locations
Main offices: US and the Netherlands. Support offices in the UK, Japan and Switzerland
OVERVIEW WIL Research consists of over 1,200 dedicated scientific, technical and support personnel with locations in the United States, Europe and Japan. The United States locations include Ashland OH, Skokie IL, Hillsborough NC and Boothwyn PA. WIL Research provides regulatory affairs support and programme management for the chemical industry, helping you to focus on the core activity of your company and advancing your compounds and products to the market. Our experts give advice on the full range of regulatory and exploratory studies you will need. Importantly, they are skilled experts and able to deliver relevant information to you with full transparency. WIL Research Europe specialises in personalised contract research and expert consultancy for the registration of pharmaceutical products, biocides and (agro)chemicals worldwide. More than 290 well-trained and dedicated specialists and modern purpose built laboratories and offices are available to perform your regulatory (eco)toxicology studies. Our operations have been endorsed by the GLP monitoring authorities (OECD/EPA/FDA/JMAFF certification). VITAL STATISTICS
2012/13
Turnover, group
-
Turnover, chemical service provision
-
No of offices
9
No of countries represented
40-50
Staff, group
1200
Staff, chemical service provision
-
SERVICE AREA BREAKDOWN
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 – endocrine disruptor screening programme (complete set of assays) in conformity with EPA requirements. Safety testing including (eco) toxicology and risk assessment Toxicology and ADME, general toxicology ,genetic toxicology, in vitro toxicology, developmental and reproduction toxicology, carcinogenicity, ADME and kinetics, safety pharmacology, special toxicity studies, environmental toxicology, formulation development, juvenile toxicity studies, lead optimisation, single rat PK ACCREDITATIONS OO
Consultancy/ advisory 17% Representation & management 3%
Laboratory 80%
Our objective is to contribute to better human health, environmental safety and industrial progress by accelerating the development process of our client’s products. We support our clients by providing quality driven contract research services. Our added value results from dedicated staff working together with our client’s project team and enhancing the processes through clear communication and scientific interpretation of results. Our staff create the company’s value and this is enhanced by continuous education, exciting career opportunities and personal development. By these means the WIL Research team remains dedicated and its objectives clear.
OO
OO
OO
OO
WIL Research has achieved good laboratory practice (GLP) compliance status for more than 20 years, with the most recent GLP endorsement statement signed in May 2011. WIL Research publication was referenced in the guidance document 117 for OECD 443 guideline. WIL Research published article is referenced in the guidance document 126 for the OECD 203 guideline. We’re proud of our longstanding accreditation through the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC). We never get complacent about quality. Constantly striving to improve it, we regularly analyse our processes and have established quality improvement teams as part of our total quality management (TQM) policy.
CLIENTS Non-disclosure agreements prohibit this level of information.
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Chemical Watch | Global Service Providers Guide 2014
STAFF SELECTION
We understand clearly that each situation is different and we therefore advocate discussing this in a personal meeting going through the following distinct steps: OO Step 1 - Inventory; OO Step 2 – (late) Pre-registration or inquiry Step 3 - Refinement of inventory; OO Step 4 - Data evaluation; OO Step 5 - Determination of data gaps; OO Step 6 - Completion data requirements (Annex VII/VIII); OO Step 7 - Chemical safety assessment/report (CSA/CSR); OO Step 8 - Prepare a test proposal (> 100 t/y); OO Step 9 - Dossier preparation, finalisation and submission; and OO Step 10 - Safety data sheet.
Wilbert Frieling, DVM – Managing Director
CASE STUDY 2: biocidal registration WIL Research’s regulatory affairs department provides a complete service for the registration of biocides under the biocidal products Directive 98/8/EC. Our aim is to provide you with a high quality service which will help you in achieving product registrations in a fast and efficient way. We provide complete hazard characterisation and exposure assessments for operators, workers, bystanders and consumers as well as for the environment (groundwater, surface water, soil, air, non-target organisms). These assessments are carried out using various modelling tools (eg USES, EUSES, etc) and are based on the most up to date guidelines and emission scenario documents. WIL Research’s experienced team consists of regulatory experts in chemistry, environmental fate and 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. Our services are custom made to fit your needs and range from assistance with single sections and smaller regulatory questions to the preparation of complete dossiers.
Wilbert Frieling graduated in veterinary science from the University of Utrecht, the Netherlands, in 1991. From 1991 until 1996 he directed a veterinary practice. He joined WIL Research as a supporting veterinarian in December 1994. In April 1996 he was appointed as section head General and Industrial Toxicology, in 1997 he was appointed as head of Toxicology and in 2004 he was appointed director of Toxicology. When WIL Research joined WIL Holding in 2005, he was appointed as managing director of WIL Research BV. Since 2000 he has been registered as a Eurotox board certified toxicologist. He is also a board member of NVDEC (Dutch society of animal ethical committees). He has presented various papers on international meetings on toxicology (mini-pig in toxicology, continuous infusion technology and preclinical safety testing strategies). Steven D Barkyoumb, DVM, PhD – Sr Vice-President, Global Operations – Nonclinical Safety Assessment Steve has more than 25 years of non-clinical safety assessment experience in the pharmaceutical and contract research industries. He brings extensive experience in regulatory-driven toxicology, pathology and laboratory sciences. Most recently, he served as Vice President, Nonclinical Safety Assessment for Covance Laboratories and held the role of Global Chief Scientific Officer, Pathology and Immunology Services. He directed the growth of Covance’s toxicology business in North America and managed the pathology and immunology services across six sites in the United States, Europe and Asia. Clients describe Steve as a leader with high integrity, strong principles and outstanding operational skills with a sharp focus on scientific excellence and quality. Prior to joining Covance, Steve served as the Executive Director for Nonclinical Drug Safety at Quintiles and the Director of Regulatory Toxicology and Safety Pharmacology for the Drug Safety Evaluation unit at Abbott Laboratories. He began his career with a series of roles with increasing responsibility with Hoechst Marion Roussel and its predecessor companies. Steve holds a Doctor of veterinary medicine degree and a PhD in veterinary pathology from Kansas State University. He is a Diplomate, American College of Veterinary Pathologists (1984 – present) and previously a Diplomate, American Board of Toxicology (1989-2004).
CASE STUDY 3: complete hazard and exposure assessments WIL Research’s regulatory affairs department provides a complete service for the registration of agrochemicals under the regulations 91/414/EC, 1107/2009. We provide complete hazard and exposure assessments for operators, workers, bystanders and consumers, as well as for the environment (groundwater, surface water, soil, air, non-target organisms). These assessments are carried out using various modelling tools and are based on the most up to date guidelines. WIL Research’s experienced team consists of regulatory experts in chemistry, environmental fate and behavior, residues, ecotoxicology and human toxicology. In addition to outstanding technical knowledge, WIL Research has well established contact with EU and national authorities and has a thorough understanding of the procedures involved in obtaining registrations for agrochemicals. We assist you with dossier preparation at EU (Annex II) and member state level (Annex III) – taking into account the national dossier requirements. Our services are custom-made to suit your needs. They include dossier compilation (electronic submissions, CADDY), technical dossier writing, data gap analysis and project management, outsourcing and study monitoring, risk and exposure assessments and post-submission support. We further assist you with classification and labelling issues, import tolerance dossiers, and setting of MRLs or help you with complete dossiers or single sections and smaller regulatory questions. Chemical Watch | Global Service Providers Guide 2014
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PROFILE: WIL Research
CASE STUDY 1: WIL Research ten steps to REACH compliance
ReFaC REACH Facilitation Company
Regulatory compliance solutions ReFaC provides cost-effective solutions to regulatory compliance. Its team of regulatory professionals deliver efficient and expert services to smaller companies, multi-national organisations, industry associations, and consortia. ReFaCâ&#x20AC;&#x2122;s services include: l REACH dossier development and submission l Data Gap Analysis, Hazard & Exposure Scenario Development, CSR authorship l Consortium and SIEF Management l Consultancy and study monitoring l PPORD Notification l OR and TPR Services l SDS and eSDS authorship l CLP compliance management l Worldwide regulatory submissions ReFaC delivers compliance solutions using its own expert staff and a select group of industry partners.
www.refac.eu +44 (0)1270 258 530 ReFaC is a CBA company
CONTACTS
Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
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 Partnership UK 2010
OVERVIEW AG-HERA is a chemical risk assessment consultancy run by Albania Grosso and Mark Crane, who both have extensive technical expertise and project management experience in environmental legislation and compliance. Our unique combination of technical and project management capabilities, trusted partners, and leading edge experience of regulatory systems, provides clients with a seamless solution to any chemical risk assessment challenge. SERVICES PROVIDED We offer a full REACH/CLP registration package including: data gathering; data review and evaluation; Read-across/Qsar strategies; integrated testing strategies; study monitoring; human health and ecotoxicological hazard data evaluation; PBT assessment; exposure modelling and risk characterisation; and CSA/CSR preparation. We develop environmental quality standards, and hazard or risk-based values for water and (if necessary) sediments which are compliant with the water framework Directive and Regulations, Directives and Guidance on plant protection products, biocides, human and veterinary medicines, endocrine modulators, and nanoparticles. We can develop similar standards for other media, and provide robust advocacy in support of technically and economically defensible values in meetings with regulatory authorities. We also provide expert witness and advocacy services.
Website E-mail Head office Tel Contact Ownership Locations Founded
www.bootmanchem.com info@bootmanchem.com Diss Business Centre, Diss, Norfolk, IP21 4HD, UK +44 (0)1379 640534 Chris Lewis Limited company UK 1994
OVERVIEW Bootman Chemical Safety Ltd is an established UK-based consultancy, offering a wide range of scientific and regulatory services to support our clients through the process of chemical safety assessment. We have in-depth knowledge of REACH, CLP and other chemical regulations, in combination with expertise in industrial toxicology and risk assessment to serve a worldwide client base. SERVICES PROVIDED We are focused on providing the best service to our clients whatever the size of project. REACH forms a major part of our work and highlights a number (but not all) of the areas where we provide expertise: Registration strategy, dossier preparation, prior-registration inquiries, PPORD application, chemical safety assessment including exposure assessments and risk characterisation, only representative/third party representative services, SVHC product statements, study monitoring, support on classification and labelling, safety data sheet authoring or review, preparation of CLP notifications and the list continues! We also offer technical support to major Siefs/consortia on behalf of clients or as an independent contractor, discussing strategies for registration or evaluation; literature searches and other critical data reviews are also undertaken.
CLIENTS AstraZeneca; Baker Hughes; CONCAWE; Elevance; Environment Agency; European Commission; Ferro; Frits Consortium; HCSRC; HOPA Consortium; International Lead Association; JTI; LOA Consortium; Marine Harvest; Penman Consulting; Precious Metals Consortium; RSA; Renessenz; Rutgers; Syngenta; wca environment.
CLIENTS Client confidentiality precludes our naming them, but we serve a wide range from SMEs to global corporations. All our clients expect high-quality service and this can be provided to you.
CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded
CONTACTS
www.baytouch.com cw.spg14@baytouch.com Ribble Court, 1 Mead Way, Padiham, Burnley BB12 7NG, UK +44 1282 687000 Malcolm Pollard Private company UK, Netherlands, Belgium, N America 2005
OVERVIEW Baytouch is an established provider of added-value cloud-based solutions since 2007. Operating internationally from offices near Manchester, UK, it is at the forefront of REACH compliance management, product and substance supply chain information management and workplace safety solutions. SERVICES PROVIDED Baytouch’s cloud-based solutions are available direct or through a number of partners/ resellers in the UK and overseas who provide added value services and turnkey solutions within a regulatory context, and include: OO ReachSuite – the leading REACH IT solution supporting substance registration processes for lead registrants and consortia; Sief management and communications; and automated online contracts and LoA processing. OO ProductTraq – a comprehensive, flexible supply chain record management solution. Record, monitor, automate and ensure compliance with REACH, GHS/ CLP and other EU regulations and non-EU regulatory regimes; substance volume tracking; tracking SVHC, conflict mineral and other declarations; and only representative support. OO PSMmonitor – Process Safety Performance Indicator (PSPI) safety solutions for chemical handling operations operating under COMAH / Seveso and US Osha PSM / EPA RMP regulations. CLIENTS ReachSuite clients are corporate lead registrants and key consortia; ProductTraq clients include substance and article manufacturers, formulators, distributors and retailers; PSMmonitor is used in chemical handling facilities in the UK and USA
Chemical Watch | Global Service Providers Guide 2014
Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.calebgroup.net john@calebgroup.net The Stables, Somerset House, Church Road, Tormarton, Badminton, Gloucestershire, UK +44 (0)1454 269330/ +44 (0)1454 216030 John Yates Private company UK, Germany, USA 1994
OVERVIEW Caleb Management Services Ltd is a policy and regulatory consultancy that has been active in the field of chemical regulation since 1994. Caleb’s clients range from governments, multinational companies and worldwide consortia to small companies with a single substance. Caleb tailors its support to take account of a client’s internal resources in order to maximise the value of our contribution. The company has a considerable track record in sustainable management recently adding a sustainable procurement support service for our clients. SERVICES PROVIDED OO consortium management OO REACH dossier development and registration OO REACH authorisation services OO Sief management OO CLP compliance management OO SDS authoring and management OO OR and TPR services OO sustainable procurement support CLIENTS Caleb supports SMEs and large corporations, European and global industry associations and task forces globally. Currently the company is OR or TPR for about 20 companies and provides consultancy support for many more. Caleb also supports more than ten REACH consortia as managers and advisors.
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NICHE FIRM PROFILES
CONTACTS
CONTACTS
NICHE FIRM PROFILES
Website E-mail Head office Tel/ Fax Contact Directors Ownership Locations Founded
www.cfcs-consult.com info@cfcs-consult.com CFCS-Consult GmbH, Essen - Stuttgart, Moorenstraße 8, 45131 Essen, Germany +49 201 79870 191/ +49 201 79870 386 Dr Barbara Lohmann Dr Barbara Lohmann (CEO), Dr Felix Endres (CEO) Private company Germany, Italy 2007
OVERVIEW CFCS is a team of experienced: toxicologists, chemists, 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 finance management, risk analysis, classification and labelling according to GHS/CLP, authorisation of biocides and biocidal products, authorisation of pharmaceuticals and veterinary drugs, assistance with the certification process for the ecolabel, workshops for REACH, Ecetoc TRA, Iuclid 5, Chesar, cosmetic safety assessment, CPNP notification, PIF generation, assistance with the establishment of cosmetic GMP. SERVICES PROVIDED CFCS is a qualified partner offering services in various life science disciplines dedicated to the assessment of the biological or chemical impact of substances on humans and on the environment. We provide ample support on regulatory issues and project management to our clients. Among our services, our clients can benefit from our network of well renowned and certified scientific partners and institutions. Consequently, and even for very complex projects, we are always available as your key reference partner. CLIENTS Manufacturers, importers or downstream users of industrial chemicals, veterinary drugs, plant protection products or cosmetic ingredients.
CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded
www.chymeia.com info@chymeia.com Universitetsparken 7, DK - 4000 Roskilde, Denmark +45 72 40 16 22 Lars Bugge Private, limited company Denmark 2006
OVERVIEW CHYMEIA ApS’ core business are software solutions for complying with the chemical legislation in an efficient and user-friendly way. CHYMEIA ApS is specialised in SDSauthoring with a very high degree of automation and a build-in CLP-calculation. Our main product is the chemical management software AlphaOmega, which is an advanced solution for generating and updating SDS, chemical safety documents and inventory labels. SERVICES PROVIDED The SDS-authoring software AlphaOmega has a build-in CLP-calculation and intelligent selection of phrases. AlphaOmega includes comprehensive chemical management functions, control functions and automatic update functions. SDS output is available in more than 20 languages. AlphaOmega can also be used for authoring of chemical safety documents like APB (DK), COSHH (EN), Skyddsblad (SE) Betriebsanweisungen (DE) etc. Furthermore CHYMEIA provides consultancy including lectures and seminars on chemical legislation. Please note that the AlphaOmega CLP-calculator is one of the most advanced of its kind in the world – and is used by the Danish authorities. CLIENTS CHYMEIA ApS serves a wide range of companies, industries and sectors. AlphaOmega is used by the chemical industry, the pharmaceutical industry, schools, research facilities and manufacturing including paint and coating, flavours and fragrance, detergents, adhesive and sealants, ink and colours etc.
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CONTACTS 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 1995; Aachen, Germany
Fax Contact Ownership Locations Founded
OVERVIEW CONUSBAT specialises in EU/global regulations for cosmetics, personal and consumer health care products and fine chemicals. Our full service spectrum includes REACH only representative, safety assessor responsible person, strategic analysis and compliance filing, CLP review, online or onsite training on global regulations. While focusing on EU compliance issues, we also cooperate with strategic global partners for regulations from: USA/Canada, Brazil and Latin America, ASEAN, China, Taiwan, South Korea and Israel. SERVICES PROVIDED EU cosmetic regulations (1223/2009): strategic analysis, compliance filing, notification. REACH OR: strategic analysis, MSDS/SDS preparation. Safety assessors RP for cosmetic products sold in the EU: strategic analysis, PIFs preparation, notification to the CPNP, toxicology assessment. Global regulatory compliance: for cosmetics, personal care, fine chemicals with the US-FDA & EPA/TSCA, ASEAN, Israel, South Korea, Brazil and Latin America. Training (online/onsite): EU/global regulatory workshops. CLP: classification, labelling and notifications. Product certificates: strategic consulting and application processing. CLIENTS Fortune 500s, SMEs, academic or training institutes, governmental agencies in cosmetics personal and consumer health care, fine chemicals, household products.
CONTACTS Website E-mail Head office Tel Fax Contact Ownership Locations Founded
www.dangerandsafety.it info@dangerandsafety.it Via Bugatti, 53, 56022 Castelfranco di Sotto (Pisa), Italy +390571367427 +390571382829 Paola Ulivi Private company Italy 2000
OVERVIEW With more than ten years of experience, Danger and Safety provides prompt and professional services within the fields of risk assessment, environment, health and in general for chemicals’ regulatory affairs (Reach-CLP-dangerous goods transport). All the staff are highly qualified (chemists and biologists). SERVICES PROVIDED OO full regulatory support for REACH regulation (Sief and consortium management; dossier development and submission; CSA and CSR) OO CLP compliance management OO SDS and e-SDS authoring for substances and mixtures OO risk and hazard assessment for health in working place OO specific training and workshops (generic and in-house) OO biocides: AS approval and product authorisation. OO assistance for outside EU Regulations through local partners CLIENTS We serve a wide variety of clients, from very small to large enterprises, operating in many fields as industrial chemicals, fragrance sector, pigments and dyes. Deep experience in chemicals for leather industry.
Chemical Watch | Global Service Providers Guide 2014
Website E-mail Head office Tel Fax Contact Ownership Locations
www.distefanolawoffice.com flavia.distefano@distefanolawoffice.com Bastion Tower, Place du Champ de Mars 5, 1050 Brussels, Belgium +32 2 733 08 00 +32 2 733 12 72 Ms Flavia Distefano Private company Brussels, Belgium
OVERVIEW Distefano Law Office (DLO) is an independent law firm specialising in EU regulatory and antitrust law, and related EU litigation. Our team has significant experience in a wide range of regulatory and competition matters for international clients. We counsel and litigate on all aspects of EU chemicals regulations, including REACH, CLP, biocides, plant protection products (agrochemicals), food contact materials, cosmetics, as well as medical devices. By drawing on our sector-specific regulatory experience, we are specially positioned to provide tailor-made antitrust advice on chemicals related matters. We have advised REACH registration and authorisation consortia, as well as biocides and pesticides task forces, on antitrust-sensitive issues such as membership conditions, data sharing and licensing, confidential information exchanges and joint REACH authorisation applications. We work closely with a “friendly firm” local counsel network to offer clients seamless regulatory, competition, and litigation representation and counselling across various jurisdictions worldwide. SERVICES PROVIDED Legal regulatory and competition advice; representation before EU agencies and courts; representation in data sharing disputes before ECHA; drafting of agreements (eg on data licensing or setting up consortia/task forces); structuring commercial contracts (including vertical agreements with customers and distributors) to ensure regulatory and antitrust compliance; assist on regulatory aspects of M&A due diligence process. CLIENTS Clients include European and non-European companies and trade associations in the chemicals, metal, energy and downstream industries.
CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.espheres.com charlotte.crauwels@espheres.com Pères Blancs Street 4, 1040 Etterbeek, Brussels, Belgium + 32 (0)2 740 43 36/ + 32 (0)2 740 43 87 Charlotte Crauwels Private Belgium, Netherlands, Finland, Germany, France November 2011
OVERVIEW eSpheres, founded in 2011 as a Solvay spin-out. eSpheres is a global leader in delivering cloud health, safety, environment (HSE) and corporate sustainability solutions to organisations worldwide. Our in-depth IT solutions and HSE support services help industrial companies in improving their management of safety, industrial hygiene and occupational health processes. SERVICES PROVIDED eSpheres supports responsible care all along the product’s lifecycle. From industrial hygiene and accident management, to air emissions and resource consumption – we help companies automate and streamline compliance with HSE and sustainability requirements with SAP® EHSM software. We host, secure and manage your HSE data in a private cloud environment. SAP® EHSM software helps customers address sustainability initiatives to reduce business risk, protect brands, manage scarce 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, and also downstream users like polymers and polymer transformation, electronic, cosmetics and automotive industries.
CONTACTS CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.mach-chemguide.com info@mach-chemguide.com Boernsener Str 16f, 21039 Hamburg-Boernsen, Germany +49 40 729 10 933/ +49 40 729 10 934 Dr Bettina Mach Private Germany 2011
OVERVIEW We guide you through REACH and CLP and the 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 OO identify your obligations OO prepare late preregistrations OO prepare ECHA inquiries OO prepare dossiers in Iuclid 5 OO prepare all kinds of notifications OO represent your interests in Siefs and consortia OO monitor toxicological studies OO advise on classification and labelling and prepare C&L notification OO advice on the implementation of the new cosmetic regulation EC 1223/2009 OO conduct safety assessments and prepare chemical safety reports for cosmetics according to EC 1223/2009 CLIENTS DR MACH Chemical Compliance and Competence focuses on SMEs in the European chemical and cosmetic industry: manufacturers, importers, distributors and downstream users of chemicals and manufacturers and importers of cosmetic products.
Chemical Watch | Global Service Providers Guide 2014
Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.eupoc.de eupoc@eupoc.de In der Neuen Welt 8 - 87700 Memmingen +49 8331 4989052 / +49 8331 974282 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 to understand their specific needs. Together with the SMEs’ customers, Eupoc has gained a lot of experience in managing different interests and corporate philosophies. Combining knowledge with respect to the various visions of the future is making Eupoc’s core business such a success: creating a future in Europe’s regulated markets. SERVICES PROVIDED Eupoc supports clients in communication – between each other (eg along supply chains) and with customers, suppliers, associations, authorities, politicians and lawyers. This is the base for successfully putting specific technological knowledge into regulative processes. Eupoc combines technological expertise with successful interdisciplinary networking. Our main focus is REACH, where Eupoc was the leading manager of one of the first authorisation consortia. Our daily communication is fast, transparent and confidential. We always work towards being practical, working together directly and establishing a co-operative 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 authorisation. We are developing and will expand our activities in this field. Together with our network of external experts we are able to handle European consortia.
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CONTACTS
CONTACTS
NICHE FIRM PROFILES
Website E-mail Head office Tel Fax Contact Ownership Locations Founded
www.eurideastranslation.com translation@eurideastranslation.com 475 Avenue Louise, 1050 Brussels, Belgium +32 (0)2 669 7701 / +32 (0)2 669 77 87 +32 (0)2 627 5655 Kristina Bitvai Private company Belgium 2007
OVERVIEW Eurideas Linguistic Services provides professional translation and interpretation services. We specialise in chemical, technical, medical translations, as well as in other fields such as EU legislation, law, environment, health and many more. Our native speaker chemical translators are experts of the REACH regulation and other related EU legislation. We have great experience in translating MSDSs, exposure scenarios, and other chemistry, environment and health related documents. We have developed our own unique methodology through years of translating REACH documents, and are therefore able to offer 60% discount for the repetitions. SERVICES PROVIDED We provide translation services in all EU languages, in many Asian, African and Latin American languages. The translations are always done by a native speaker translator and proofread by a second native speaker translator. This way we ensure the highest quality of translation and that the correct terminology is used. CLIENTS We have worked on REACH related projects for Cefic, REACH Centrum, ISOPA, EuPC, Glencore International Imports, Rio Tinto, ReachLaw, FEFCO, Codelco, Molymet, the International Molybdenum Association, the International Lead Association, the Nickel Institute, Aurubis AG, DonauChem, Euromines, EcoMundo, Chemtopia, and many more.
CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.item.fraunhofer.de cathrin.nastevska@item.fraunhofer.de Nikolai-Fuchs-Str 1, 30625 Hannover, Germany +49 511 5350-225/ +49 511 5350-155 Dr Cathrin Nastevska Registered society Germany 1949 (Fraunhofer-Gesellschaft)/1984 (Fraunhofer ITEM)
OVERVIEW As one of 67 independent research institutes of the Fraunhofer-Gesellschaft, the leading non-profit organistion for applied research in Europe, we have gained a track record of more than 20 years in supporting our clients in all aspects of their regulatory obligations. We provide the full scale of experimental studies as well as innovative non-testing methodology, for REACH, biocides, (veterinary) pharmaceuticals etc. SERVICES PROVIDED Data gap analysis and data generation strategy: specific experience in integrated testing strategies, model calculations and waiving. The use of category approaches, read-across and structure-activity relationships (SAR) is facilitated by our in-house databases, eg RepDose (repeated-dose toxicity) or FeDTex (reproductive toxicity). Experimental testing according to OECD guidelines and GLP (PC-properties, environmental fate, ecotoxicity and toxicity /human health): Specific in-house expertise in adaptive (inhalation) toxicology, inclusion of mechanistic data and special analytical methods. Other endpoints are provided by experienced partner institutes. Exposure and risk assessment, development of exposure scenarios, dossier preparation including Iuclid preparation, GHS/CLP. Consulting services: Third-party services, trustee services, authorized negotiations with ECHA and competent EU member state authorities. CLIENTS Our clients are national and multinational enterprises and consortia as well as international associations and institutions (EU, OECD, WHO, UNEP). Sectors include, eg, chemicals, biocides, veterinary and human pharmaceuticals, food additives, cosmetics, cleaning and personal care products, lubricants, textiles, coatings.
CONTACTS Website E-mail Head office Tel/Fax Contact Ownership Locations Founded
http://bit.ly/FeraINSPECT inspect@fera.gsi.gov.uk Sand Hutton, York YO41 1LZ, UK +44 (0)1904 462000/ +44 (0)1904 462111 Jane Cotterill Government UK 2009
OVERVIEW Fera’s INSPECT service is backed by a team of experienced computational chemists, toxicologists, ecotoxicologists and environmental scientists. We specialise in the use of in silico assessment of chemical toxicity to provide a rapid, reliable, ethical and cost effective alternative to chemical testing in animals. Our approach uses a weight-of- evidence based on various Qsar models, read-across and expert systems to enhance reliability and regulatory acceptance of toxicity predictions. We also provide quick screening to identify compounds likely to be of high concern at early stages of development. SERVICES PROVIDED INSPECT offers a rapid turn-around and reliable in silico assessments of: OO mammalian toxicity eg carcinogenicity, mutagenicity, reproductive toxicity, acute and chronic toxicity, skin irritation/ sensitisation; OO ecotoxicity eg acute toxicity to fish (96h LC50), daphnid (48h EC50) and honey bee (48h LD50), green algae (96h EC50), bobwhite quail (dietary and acute oral), oestrogen receptor binding, BCF; OO physico-chemical properties eg pKa, Koc, persistence, water solubility, Kow, Henry’s law constant, vapour pressure; OO environmental exposure modelling; and OO we also excel in the use and interpretation of the OECD Qsar Toolbox and are a listed consultant of Lhasa Ltd UK for the use of Derek Nexus®. CLIENTS Major customers include regulatory compliance consultants (eg for REACH, agrochemical registrations) and manufacturers of agrochemicals, human and veterinary medicines, food and cosmetic ingredients and other speciality chemicals.
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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 (eco) toxicology and regulatory compliance. Extensive knowledge of EU regulations, combined with years of experience in toxicology, exposure assessment 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: regulatory impact on business case; independent trustee. Technical consultancy: testing strategies; interpretation of (test) results; alternatives to testing; risk assessment. Toxicology: toxicological review; monitoring services; dossier preparation; alternatives to animal testing. REACH: Sief and consortium management; interpretation and strategic advice; robust study summaries; CSR. CLIENTS Clients come mainly from the chemical industry, governmental organisations and others. Identity of individual clients and the nature of the work performed will only be disclosed after formal approval by the client. Confidentiality is key to the services delivered.
Chemical Watch | Global Service Providers Guide 2014
Website E-mail Head office Tel Contact Ownership Locations Founded
www.infotox.pt info@infotox.pt INFOTOX, Lda, Rua de Moscavide 4.28.02B-7B, Parque das Nações, 1990-160, Lisbon, Portugal + 351 933 289 564 Elsa Casimiro Private company Portugal and UK 2004
OVERVIEW Originally, founded in 2004, INFOTOX is a specialist consulting company providing toxicology, human health and environmental risk assessment and advisory services to the private and public sector. Commitment to service excellence and innovation. We follow a holistic approach to ensure that projects are grounded in both leading edge technical expertise and in the context of current regulation and practical business realities. SERVICES PROVIDED Our regulatory services include expert support for REACH, CLP/GHS, biocidal products Regulation and cosmetic products Regulation in terms of: OO dossier/product information files (PIFs) data gap analysis; OO Iuclid dossier preparation, submission and updates; OO toxicological reviews and expert support (including Qsar); OO design of testing programmes (non-animal testing focus); OO exposure and risk assessments; OO toxicological support for partnership negotiations (Sief, product/brand acquisitions etc); OO production of chemical safety reports (CSR)/cosmetic product safety reports (CPSRs); OO safety data sheets production; OO reviewing and updating marketing/efficacy claims and product label; and OO guidance on setting up a post-market surveillance programme. We also provide a wide range of environmental health services including health impact studies for EIA, soil clean-up and climate change projects. CLIENTS Our clients include regulators, professional organisations, multinational companies and SMEs.
Website E-mail Head office Tel Contact Ownership Locations Founded
www.kreatis.eu contact@kreatis.eu 80 rue Condorcet, 38090 Vaulx Milieu, France +33 428190108 Paul Thomas, CEO Private company France January 2014
OVERVIEW KREATiS aims to offer its clients an alternative to experimentation to fulfil REACH obligations. Each value provided is guaranteed to be as accurate as its equivalent laboratory study at just a fraction of the price. The endpoint values are supported by the appropriate documents for REACH regulatory acceptance. SERVICES PROVIDED KREATiS is building on its existing portfolio of High Accuracy QSARs (HA-QSARs) based on Annex VII and VIII studies for use in REACH. Critical ecotoxicity and physicochemical endpoints are currently available and many more are in the pipeline. For each study ordered from KREATiS, you get a complete service: each requested endpoint is scrutinised individually by our staff to verify applicability domain and then to use the appropriate iSafeRat* algorithm to provide you with a high accuracy result. QSAR Model Reports (QMRF) and QSAR Prediction Reports (QPRF), necessary for successful submission of endpoints to ECHA, are provided in the KREATiS study report. If required a complete Robust summary can be prepared by KREATiS in i5z format. KREATiS offers a money back guarantee on all of its products. For terms and conditions, visit our website or contact us directly. *iSafeRat® (in Silico Algorithms For Environmental Risk And Toxicity) High Accuracy QSAR (HA-QSAR) modules produced by KREATiS. CLIENTS Client profiles include several renowned companies from the chemicals and fragrance industries and several dossiers containing iSafeRat predictions have already been successfully submitted in REACH dossiers.
CONTACTS
CONTACTS 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
OVERVIEW Jongerius Consult BV offers strategic and practical support to the various stakeholders working towards a successful and efficient implementation of REACH, CLP and related EU chemicals legislation. We combine our extended network, thorough legislative knowledge, joy in strategic and practical consultancy, enthusiastic facilitation of group processes and affinity for IT, with our creative, innovative and process-oriented thinking (“out of the box”) up to working solutions, good results and satisfied partners and customers. SERVICES PROVIDED We act as a sparring partner for companies and partners (like Caesar Consult, Apeironteam and Baytouch), organising efficient REACH compliance strategies and practical chemicals management solutions in companies and industry sectors. Providing “out of the box” advice and practical training and workshops (generic and in-company). We provide powerful support tools, eg the practical (ext-)SDS assessment toolkit and REACHsuite Advantage, a web base registration and Sief management tool. Check our website for more detailed services and references. CLIENTS Our clients are those companies that want to deal efficiently with REACH and related legislation in alignment with their business needs. We are proud of our partners, satisfied customers and the many satisfied participants who attended our REACH compliance training programme up to 2013. We’ll continue to focus on providing added value and making REACH work for industry.
Chemical Watch | Global Service Providers Guide 2014
Website E-mail Head office Tel Contact Ownership Locations Founded
www.linmarkconsulting.com martin.richards@linmarkconsulting.com Bernoullistrasse 20, CH-4056 Basel, Switzerland +41 79 500 9719 Dr Martin G Richards Private company Switzerland, France 2007
OVERVIEW Linmark Consulting is a consulting and service company engaged in regulatory affairs, toxicology, advocacy and communications for the chemical and life sciences industries. Linmark Consulting is headquartered in Basel, Switzerland, a major European industrial centre with good communications globally. Its French subsidiary, Linmark Consulting Europe SARL, offers only representative services under REACH, for importers into Europe. SERVICES PROVIDED Particular skills in generating new business and protecting client businesses through regulatory knowledge and practice, stakeholder analysis, problem-solving, global network and communications with diverse stakeholders including value chain, government authorities and NGOs. Offerings based on over 30 years’ senior operational experience in regulatory affairs management, consultancy and product development functions in multinational chemical, agricultural biotechnology and biopharma companies in UK, USA and Switzerland. Commissioning mammalian and ecotoxicology studies. Reach OR and third party representation. Key strengths in consortium management, Reach, global chemical regulation, reputation management and advocacy. CLIENTS Client confidentiality is guaranteed. Recent contracts include management of six REACH consortia, where 2010 and 2013 registration deadlines were successfully met. Consortia support continues for Reach registration, authorisation and other objectives. Linmark Consulting has successfully managed global and EU chemical advocacy programmes for industrial chemical and biocide clients. Global and smaller companies in chemicals, agriculture and life sciences represented in EU and Switzerland.
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Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.LKC-ltd.com LKC@lkc-ltd.com Postfach 167, Hauptstrasse, Fuellinsdorf, Switzerland +41 61 906 8500 / +41 61 906 8509 Dr David Kane Private company Switzerland and UK 2001
OVERVIEW LKC provides European registration and development services to the international chemical industry. The LKC team is multifaceted, offering technical skills, regulatory experience, project management proficiency and strategy planning expertise. Chemical manufacturing clients can benefit from a full range of regulatory services to achieve the successful registration of products in the fields of crop protection, biocides, veterinary medicines and industrial chemicals. SERVICES PROVIDED Services for crop protection products, biocidal products, veterinary medicines and industrial chemicals include: Regulatory sciences: data gap analysis, data evaluation, contracting and managing of higher tier studies, study monitoring of chemistry, analytical, toxicology, ecotoxicology, environmental fate and efficacy studies, PEC-reports, GLP multi-site residue studies. Conducting risk assessments and modelling for dietary, human and environmental exposures. Dossiers: dossier preparation for active substance submissions for Annex I inclusion, product dossiers for national registrations, provisional authorisations and mutual recognition. CADDY. XML-dossiers, IUCLID dossiers, re-registrations, renewals, label extensions,extensions, setting EU import tolerances/MRL’s, REACH, CLP and JMAFF dossiers. Regulatory support: pre and post submission meetings with regulatory authorities, negotiation communications, estimating data package compensation for data-sharing and product defence. CLIENTS LKC’s clients are specialty chemical manufacturers who benefit from technical support in sectors that include crop protection, biocides, animal health and general chemicals.
Ownership Locations
www.mckennalong.com dcornil@mckennalong.com 2 Avenue de Tervueren, 1040 Brussels, Belgium +32 2 278 12 11/ +32 2 278 12 00 Dominique Cornil, REACH Consortium Financial Manager and Office Administrator, Peter Gray, Partner, Robert A Matthews, Partner Partnership USA, Brussels
OVERVIEW Chemical regulation is one of MLA’s marquee practices. Lawyers in our Brussels office counsel and litigate on all aspects of EU chemical regulation, including REACH, biocides, pesticides and cosmetics. MLA handles the administrative and financial management of REACH consortia. See www.mlalaw.eu. SERVICES PROVIDED Anti-trust and unfair competition; chemicals, pesticides and product regulation; corporate; energy; environment, energy and product regulation; EU competition; EU environmental; EU food; financing and lending; government contracts; green chemistry; hazardous waste management; litigation; mergers and acquisitions; private equity, hedge funds and venture capital. CLIENTS Confidential.
Tel/ Fax Contact Ownership Locations Founded
www.ecotoxchem.co.uk peter.fisk@ecotoxchem.co.uk Saxon House, John Roberts Business Park, Pean Hill, Whitstable, Kent, CT5 3BJ, UK +44 (0)1227 470901/ +44 (0)1227 765117 Dr Peter Fisk Limited company UK Originally founded in 1995. Founded as a limited company in 2006.
OVERVIEW Peter Fisk Associates offers specialist services to industry and regulatory organisations in the fields of environmental chemistry, toxicology and risk assessment. We bring expertise and high-level experience to chemical consultancy, tailored to our clients’ needs. We collaborate closely with our clients to harness their insights into their own products. SERVICES PROVIDED PFA provides a wide range of commercial and technical services associated with chemical safety and regulation, based on over 15 years’ experience. Our services include: chemistry, toxicology, ecotoxicology, quantitative structure-activity relationships, exposure assessment and modelling, risk management options, consortium management, supply chain analysis and authorisation support. We apply this range of expertise to support industrial and regulatory clients, within and beyond REACH: in all aspects of REACH and CLP requirements (dossier development and chemical safety assessment for more than 150 substances in Phases 1 and 2); socio-economic analysis, biocidal products Regulation, cosmetics, plant protection products, food safety and other areas of chemical regulation and voluntary assessment. We can collaborate with reliable expert partners to provide complementary services. We have successfully provided secretariat services, including REACH consortium management and Sief communications. We also offer training in our areas of expertise, including custom-built courses tailored to our clients’ individual needs. CLIENTS A wide variety of industrial clients including chemical manufacturers’ consortia from several sectors, downstream users of chemicals and regulatory authorities.
CONTACTS
CONTACTS Website E-mail Head office Tel/ Fax Contact
Website E-mail Head office
Website E-mail Head office Tel/Fax Contact Ownership Locations Founded
www.randis.cn / www.randischem.com frankwang@randis.cn, randis@randischem.com Unit 505, KeChuang Building, #350 Xianxia Road, Changning District, Shanghai, 200336, PR China +86 (21) 6275 7818 / Skype: randischemwise Frank Wang Private company China 2004
OVERVIEW Although not big but very professional, Randis is managed by a team of experts with dozens years of experience working for famous multi-national chemical companies in China, provide timely and cost-effective services on regulatory compliances for China. SERVICES PROVIDED OO full regulatory support for China IECSC registration (China REACH), including being the notification agent (OR), data gap analysis, GLP lab service, full notification dossier preparation, etc. OO GHS classification, (Chinese) GHS SDS/label conversion and compilation. OO cosmetics registration to China FDA. OO hazardous chemical notification to NRCC-SAWS. OO China 24hr chemical emergency hotline service. OO food contact additive registration (GB9685). OO import and export application for toxic chemicals. OO registration of Environment Microbe Microbial Inoculum. OO other China chemical regulation services. CLIENTS Randis provides services to chemical-related industries all over the world that have and want to have business with China, including manufacturers, exporters, importers, distributors, downstream users of chemicals and cosmetic products. Our language ability: English, Japanese, Chinese, Taiwanese and French.
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Chemical Watch | Global Service Providers Guide 2014
Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.reach-chemconsult.com kontakt@reach-chemconsult.com REACh ChemConsult GmbH, Strehlener Str 14, D-01069 Dresden, Germany +49(0)351 4769300/ +49(0)351 47693015 Dr Thomas Gildemeister Private company Head Office: Dresden, Germany; Representative in UK 2008
OVERVIEW First class expertise used for the benefit of our clientele. Professional team of experienced toxicologists, eco-toxicologists, environmental chemists and HSE experts offering tailor made service for regulatory compliance. Support services from A-Z so that you will meet all the requirements of European chemical and safety legislations. SERVICES PROVIDED Toxicology, eco-toxicology and risk assessment services, registration and authorisation and consulting service for: REACH ++ Cosmetics ++ Biocides Regulations ++ Pharma ++ CLP/GHS ++ OR ++ HAZOP ++ SIL ++ Detergents ++ GLP ++ GMP ++ Waste Legislation ++ Plant Safety ++ IUCLID ++ visit our website for more. Do you think you can’t teach an old dog new skills? We can! We also offer a comprehensive training and seminar programme and are renowned for successfully training companies and their teams – at our premises or at yours. We ensure that you can confidently and independently operate work tools necessary for substance registrations. We train your team on all aspects of regulatory affairs for you to comply with all legal requirements. CLIENTS European and overseas companies operating on international level; government bodies and authorities. References on request.
CONTACTS 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, simplifies and manages distribution, audit, archive, update and other compliance functions. SERVICES PROVIDED REACH Delivery is an electronic mail service that works seamlessly with email, yet: OO guarantees delivery and receipt of documents and messages; OO monitors and reports on delivery/acceptance status; OO generates automatic updates to all previous recipients of a document, with new and latest versions; OO provides full audit trails and compliance reports to meet multiple legislative requirements; OO works whenever confirmed delivery and audit is required – externally to other companies and internally to your own staff; OO includes integral data repository, archiving and document management; OO simple to use app installed on your PC, can integrate with existing applications; OO 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
CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership
Locations
Founded
www.reach-gs.eu info@reach-gs.eu Rond Point Schuman, 6 Box 5, B-1040 Brussels, Belgium +32 (2) 234 77 78/ +32 (2) 234 79 11 Mr Richard L Roden Istanbul Chemicals and Chemical Products Exporters’ Association (IKMIB) 95% and Steel Exporters’ Association (CIB) 5%. Two divisions of Istanbul Minerals and Metal Exporter’s Association, a joint venture between Turkish private industry and the Ministry of Economy. Headquarters: Brussels, Belgium; Offices: Istanbul, Turkey. Locations ideal for European and Turkish chemical industry and proximity to the EU Commission and Cefic in Brussels and the European Chemicals Agency (ECHA) in Helsinki. 2008
OVERVIEW REACH Global Services SA (RGS) is a professional regulatory consulting company advising private and public sector clients in the chemicals and allied industries to comply with European Union and Turkish Republic chemicals legislation. RGS’s experienced staff, based in Europe and Turkey consults to a diverse array of chemical and cosmetic companies, international and Turkish operating across a range of industrial sectors. SERVICES PROVIDED REACH audit and related services including only representation to non-EU manufacturers. Responsible person EU cosmetics Regulation compliance services for Turkish exporters to the EU. Turkish chemicals legislation compliance including by-law on chemicals inventory and control, Seveso II, food and biocides regulatory compliance. CLIENTS RGS’s client portfolio range from multinational blue chip and leading Turkish chemical and allied industry companies to small and medium enterprises.
CONTACTS Website E-mail Head office Tel Fax Contact Ownership Locations Founded
www.rorltd.com info@rorltd.com Hippocampus House, Hulme Lane, UK +44 (0)1565 724241 +44 (0)1565 723500 Client services Private limited company Europe, local agents: Asia, Middle East 2006
OVERVIEW Reach Only Representative Ltd (ROR) was one of the first commercial Only Representatives established in Europe. UK based, assisting non-European chemical manufacturers, and EU manufacturers and importers to comply with their REACH obligations. ROR is recognised as one of the most competent specialist Only Representative companies in Europe with the ability to provide compliance services to all members of the supply chain.. SERVICES PROVIDED Only Representative services for non-EU manufacturers to export to the EU. Third party representative services for EU manufacturers, importers and internal Only Representatives so they comply with their obligations. Lead registration representation in consortia, within the Sief or on committees. Document preparation: IUCLID technical dossier, chemical safety report (CSR), safety data sheet (SDS) authoring, provision and distribution. Additionally we can offer auditing services to ensure your company remains compliant with REACH. CLIENTS Countries of clients: China, India, USA, UK, Brazil, Qatar, Egypt, South Africa, South America and other regions.
CLIENTS Clients are from the chemical industry, and downstream users encompassing the entire supply chain worldwide
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CONTACTS
CONTACTS
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NICHE FIRM PROFILES
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
Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.redstonegrp.com info@redstonegrp.com 6397 Emerald Parkway, Suite 200, Dublin, Ohio, US +1 614 923 7472/ +1 614 793 9070 Mark Vagasky Private company US, Netherlands 2004
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. In 2014 this is expanding to include BPR. Our thorough understanding and knowledge of the legislation stems from more than a decade of in-depth involvement in their development at every stage. We offer a flexible, value-for-money service for all your REACH, CLP and BPR compliance needs.
OVERVIEW The Redstone Group is a regulatory affairs and risk management consulting company with practise areas including management consulting, regulatory affairs, operational assessment, mergers and acquisition, project management and global trade. Founded by chemical industry executives with extensive operations and regulatory experience, we are staffed by senior professionals from multiple industries with global experience. Our staff includes engineers, chemists, industrial hygienists, toxicologists, safety professionals, regulatory specialists, international trade attorney and others.
SERVICES PROVIDED We offer a specialist helpdesk staffed by technical experts who can provide a rapid response to your REACH, CLP and BPR questions. Our tailored consultancy service can be used to develop or review a strategic approach to compliance, or deliver practical help in tasks such as classification, Iuclid submissions or Sief support. Our free Matchmaker service can match trusted suppliers of REACH, CLP and BPR services to your particular need. There is also a comprehensive training programme of public or in-house workshops to help you manage your own compliance.
SERVICES PROVIDED We provide support to global clients in areas such as EU REACH (including complete Sief dossier development), international chemical control laws, US TSCA, safety data sheet authoring (multi-jurisdictional and multi-language), product compliance (including FDA, DEA, biocide/pesticide, etc), environmental permitting (air/water etc), EHS auditing, comprehensive operational assessment, global trade issues (including issue resolution, strategy design, process / protocol development, free trade agreements, export liability), mergers and acquisition support (due diligence, risk assessment and quantification) and capital project management.
CLIENTS We have a global customer base with clients from all industries subject to the REACH, CLP and BPR 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.
CLIENTS We support global clients in industries including agriculture, automotive, agro, bio, general, petro and specialty chemicals; electronics, food, flavorings/fragrances; glass; life sciences; lubricants; oil /gas exploration and production; polymers, pharmaceuticals; and refining. Clients include independents, multinationals, US and internationally based, manufacturers and distributors, formulators, governmental, industry consortia, and trade associations. Clients are located in US, EU, Mideast, Eastern Europe and Russia, Africa, Asia, India and Australia.
CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded
www.reachwise.eu info@reachwise.eu 22, St Albans Avenue, London W4 5JP, UK +44 (0)20 87470873 Peter Douben Private company UK, Netherlands, Germany 2007
OVERVIEW With extensive knowledge of REACH and CLP, REACHWise provides tailor-made services overseen by Peter Douben, formerly Director REACH, Cefic, and head of environmental protection, Unilever, 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 cost-effective solutions.
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 258444 Ms Rachel Green, Dr Virginia Gretton Chemical Business Association UK 2007
OVERVIEW ReFaC provides regulatory assistance, primarily to suppliers of industrial chemicals etc, both within Europe and from across the world, who seek to comply with REACH. Our team of regulatory professionals provide efficient and expert services to SME companies, multi-national organisations, industry associations and consortia. Wherever possible ReFaC aims to reduce the burden imposed by REACH and CLP and provides tailored support to clients in order to maximise the value of our contribution. ReFaC delivers REACH compliance solutions using its own staff and a select group of industry partners, including Bibra, Harlan, Intertek and LSM Analytical Services. ReFaC is owned by the Chemical Business Association.
SERVICES PROVIDED Impact of REACH and CLP: in finding comprehensive solutions for companies, we advise you on the best way to approach your REACH and CLP “problem” and to remain compliant. Sief support: we provide the whole spectrum of Sief and consortium management. REACH registration: for individual and groups of companies, our REACH support covers data evaluation and sharing, preparation of the technical dossier, use and exposure requirements, chemical safety assessment and report, and exposure scenarios. Safety data sheets: we prepare and update SDSs (body and annexed ESs) including translations. Exposure scenarios: for individual substances as well as mixtures we ensure they are comprehensive and communicable: you discharge your obligations and your customers find them easy to understand. Downstream user support: using specialist models we ensure that your conditions of use are compliant even when they deviate from the registrant’s information.
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; data gap analysis, hazard and exposure scenario development and CSR authorship; consortium and Sief management; consultancy and study monitoring; PPORD notification; OR and TPR services; SDS and eSDS authorship; CLP compliance management; and worldwide regulatory submissions.
CLIENTS We provide added value and have satisfied customers from the ceramics industry, fertilisers and related industries, fragrance sector, health care sector, home and personal care, lubricants manufacturers and suppliers, metals sector, minerals sector, pigments and colorants sector, speciality chemicals industry.
CLIENTS ReFaC supports SMEs and large organisations from across the chemical industry, both within Europe and Worldwide. In addition, ReFaC assists a number of industry associations and consortia who require management, consultancy and study monitoring services.
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Spring Trading Company CONTACTS
Tel/ Fax Contact Ownership Locations Founded
www.safeware.co.uk info@safeware.co.uk 9 Langley House, Wheatcroft Business Park, Landmere Lane, Edwalton, Nottingham, NG12 4DG, UK +44 (0)115 965 1888/ +44 (0)115 965 1880 Hazi Mistry Limited company UK, US, Turkey, Japan, Ireland, Greece, Netherlands 1988
OVERVIEW Safeware Quasar, a Reach Ready approved supplier, provides automated safety data sheets (SDS or MSDS) authoring software, specialist EH&S chemical management services, support and consultancy for the classification, labelling and hazard communication of chemicals. With over 25 years of experience and hundreds of satisfied customers, Safeware Quasar understands the needs of the market and has created a comprehensive suite of chemical regulatory compliance solutions. SERVICES PROVIDED Safeware Quasar analyses existing business processes and provides a comprehensive chemical regulatory compliance solution to help companies meet their obligations, whether it be expert software, consultancy and/or managed services. Software and services include: safety data sheet authoring software and services; chemical labelling software and services; safety data sheet management software and services; safety data sheet distribution software and services; chemical transportation software and services; exposure scenario software and services; consultancy services; software support; and expert regulatory advice. CLIENTS Safeware Quasar support chemical manufacturers and retailers by providing the knowledge and tools required to comply with chemical regulations across the globe. Clients include Argos, Homebase, Halfords, B&Q, Next, Screwfix Direct, TAM International, Star Brands Limited, Palintest, James Briggs Ltd, Granger’s, Schloetter, MacDermid, Alcohols Limited, Ardex, Aquatreat, Domino and many more.
CONTACTS Website E-mail Head office Tel Ownership Locations Founded
Website: www.siam-it.net Product website: www.chemeter.eu info@chemeter.eu Parque Sta Juliana 7, local 5, 26004 Logroño, Spain +34 941286749 Limited society Europe 2008
OVERVIEW Siam is a company that developed the software Chemeter for the generation of SDS, labels and transport documents according to European legislation. Our vision and commitment is to making sure that all chemical companies have legislative compliance with regards to REACH, CLP, GHS, etc. SERVICES PROVIDED Siam offers complete customer support with data accuracy, quality and integral services. Our main services include reference and integrated regulatory data, SDS authoring systems, SDS distribution and management, transport documentation and support. CLIENTS Since the beginning Siam was oriented to have an international network. Today we have a well-established international presence. Our clients come from the following chemical sectors: cleaning products, coatings, paints, rubber, adhesives, etc.
Chemical Watch | Global Service Providers Guide 2014
CONTACTS Website E-mail Head office Tel Contact Ownership Locations Founded
springtradingcompany.com james@springtradingcompany.com 10805 W Timberwagon Circle, Spring Texas 77380-4030, US +1 281-367-9356/ 877-227-2597 James Yowell, Bradley Hayes Private company US 2009
OVERVIEW Spring Trading Company has the experience and expertise you need to meet the everchanging agricultural registration and regulatory requirements federally, in the 50 states, and in over 80 countries. Your products will be expertly moved through the regulatory process. Our extensive knowledge within the EPA and industry helps you to plan and fulfil all the requirements for difficult registrations, thoughtfully and effectively. Get the best regulatory care available and avoid the additional burden and cost of hiring an employee to manage your pesticide and fertiliser registrations, including conventional and biological products. SERVICES PROVIDED We offer a full range of regulatory compliance services for active and inert ingredients, enduse, and technical products, for new chemistry, and generic products under FIFRA, TSCA and many others. We have experience negotiating data compensation, acquiring new data, and planning corporate strategies. We also provide complete state registration services for pesticides and fertilisers as well as tonnage reporting to keep your products up-to-date. We offer toxicology services, and access to the top laboratories in the industry to produce OECD, US, GLP compliant data, and field testing data to support your applications. CLIENTS Spring Trading Company helps some of the largest to some of the smallest companies in the pesticide and fertiliser industry and includes service supporting conventional and biological products. From unique applicators (precisely targeted pesticide applications and tree injection technologies) to PGR reclassifications to fee and data waivers – our clients are diverse and satisfied.
CONTACTS Website E-mail Head office Tel Fax Contact Ownership Founded
www.thewercs.com coryc@thewercs.com The Wercs Ltd, 23 British American Blvd, Latham NY 12110, USA + 1 800 572 6501 / +1 518 698 1583 +1 518 640 9299 Cory Carson 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 GHS- and REACH-compliant solutions for all types of companies, regardless of size or location. SERVICES PROVIDED OO (M)SDS authoring software and services OO Retail supplier compliance OO Green chemistry and sustainability solutions CLIENTS Manufacturing including: adhesives and sealants; agro-chemical; automotive; chemical; consumer products; distributors; flavours and fragrances; paints and resins; coatings, inks and colours; petroleum; pharmaceutical, healthcare and life sciences; plastics, polymers; specialty chemicals; tyre and rubber; etc. Retail including: big-box; auto parts; grocers; home improvement; pharmacy; warehouse club; specialty retailers; etc. Government
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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
Website E-mail Head office Tel / Fax Contact Ownership Locations Founded
www.toxicon.it info@toxicon.it Via Robolini 1, 27100 Pavia, Italy +39 0382 1938015 / +39 0382 1938026 Raffaella Butera, MD Private company Italy 2010
OVERVIEW Tox Focus, LLC provides the toxicologic and scientific content for REACH, cosmetics Regulation, and other regulatory programmes, drawing upon 20 years experience in corporate and clinical toxicology. The consultancy authors Iuclid 5 dossiers for REACH, CLP notifications and harmonisation, weight-of-evidence positions and REACH evaluation responses to ECHA/member states. Tox Focus LLC is a qualified risk assessor for the EU cosmetics Regulation and for the US Department of Commerce.
OVERVIEW Toxicon provides a wide range of expert advice services in regulatory fields and in the areas of toxicology, pharmacology and occupational medicine for companies and institutions. Our know-how is based on a solid academic background in risk assessment. Our team consists of specialists in different areas: physicians, pharmacologists, biologists, chemists, biotechnologists, food technologists, economists and lawyers. We believe that complex problems can be solved with success and quality only through teamwork.
SERVICES PROVIDED REACH: high-quality toxicology assessments and strategic planning for compliance with data requirements, including data gap filling, adaptations to data requirements, identification of analogues and categories, computer modelling and support (QMRF, QPRF), laboratory test monitoring, robust study authoring, construction of Iuclid 5 files with completeness reports, chemical safety reports, risk assessments, classification, labelling and packaging (CLP), and evaluation support and dossier defence. EU cosmetics Regulation: product risk assessment certificates and cosmetic product safety reports (CPSR) as part of the product information file (PIF).
SERVICES PROVIDED Overall services: guidance on regulatory interpretation, compliance support, auditing. REACH: data sharing, Sief and consortium management. Data gap analysis and testing strategy development, including the use of Qsar models. Dossier preparation (inquiry, lead and member registrants) including CSA/CSR. PPORD notification. SDS and e-SDS. Compliance check with exposure scenario (ES), scaling, CSR-DU development. ES development for mixtures. Applications for authorisation including SEA. CLP/GHS: hazard assessment, classification, labelling and notification. BPR Regulation: data sharing agreements, dossier development for active substances approval and biocidal products authorisation. Cosmetic products: safety assessment, product information file, notification. Medicines: CTD, genotoxic impurities assessment, environmental risk assessment. Occupational medicine: risk assessment and management (Directive 98/24/EC). Other: training for companies, universities and institutions.
CLIENTS 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 Scientific International, AW Chesterton Company, Calumet Specialty Products Partners LP, Gulf Bayport Chemicals LP, Shepherd Chemical Company, Connecticut Business and Industry Association, United States Department of Commerce.
CONTACTS
CONTACTS Website E-mail Head office Tel Contacts Ownership Locations Founded
www.toxcel.com Christine.McAlinden@toxcel.co.uk / info@toxcel.com PO Box 93, Ledbury, HR8 9JE, UK +44(0)1531 638999 (UK) / +1 703 754 0248 (USA) Christine McAlinden (UK) / Alan Katz (USA) Limited company UK, USA 1999
OVERVIEW toXcel’s European and North American offices work closely together to provide a coordinated regulatory resource for seamless development and execution of strategies, designed for cost-effective regulatory approvals, leading to domestic, regional, and global export market expansion. SERVICES PROVIDED toXcel provides a full range of services to support obtaining marketing approvals by governmental agencies, with emphasis on regulatory strategy development and all aspects of preparing applications and dossiers. toXcel advises companies about compliance with REACH, 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 global clientele in our US office. toXcel has global experience in the performance of exposure and risk assessments, environmental assessment, safety and toxicological evaluations, and the design and management of GLP analytical chemistry, residue, efficacy, environmental fate, mammalian toxicity, metabolism/pharmacokinetics (ADME), and ecotoxicity studies. CLIENTS Our leading consultants focus their collective professional talents on assisting chemical manufacturers, formulators, pharmaceutical companies, personal care/consumer product manufacturers and suppliers, trade associations, law firms, and the food industry.
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CLIENTS Toxicon assists large companies and SMEs. Moreover, Toxicon works in partnership with institutions, industries and associations for R&D and compliance projects.
Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.toxservices.com info@toxservices.com 1367 Connecticut Avenue NW, Suite 300, Washington, DC 20036, US +1 202-429-8787/ 202-429-8788 Margaret H Whittaker, PhD, MPH, CBiol, FSB, ERT, DABT Limited Liability Company USA 2003
OVERVIEW ToxServices is a leading global provider of scientific consulting services designed to resolve complex human health, environmental health, and regulatory compliance issues and to promote safer products. ToxServices excels at providing toxicology, regulatory, sustainability, and risk assessment consulting services. SERVICES PROVIDED ToxServices specialises in assessments of industrial chemicals, pharmaceuticals, cleaning products, cosmetics, dietary supplements, food additives/food contact materials, GRAS ingredients, medical devices, and consumer products, among others. Core competencies include: quantitative expoure and risk assessments; MOS/MOE; Qsar; health product declarations; alternatives assessments; chemical and product safety assessments; Proposition 65 NSRLs/MADLs; impurity assessments; dossier and SDS preparation; and expert witness/legal support. We help clients comply with international, federal, state, and local environmental health and safety regulations. We provide third-party auditing services to ensure compliance with GMPs and GLPs. ToxServices is an authorised third-party profiler/assessor for US EPA Design for the Environment (DfE), GreenScreen®, CleanGredients®, and Cradle to Cradle™. CLIENTS ToxServices assists a diverse range of clients located across the world. Our clients are smaller companies and multinational corporations with extensive portfolios, including manufacturers, suppliers, and distributors of dietary supplements, personal care products, medical devices, textiles, food contact materials, household and consumer products, foods and beverages, and pharmaceuticals and over-the-counter drugs.
Chemical Watch | Global Service Providers Guide 2014
Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
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 – professional limited liability company (PLLC) USA with an international network of affiliated providers 2009
OVERVIEW Verdant Law, PLLC is a boutique environmental law firm located in Washington, DC. Although located in the USt capital, the firm has a global perspective, 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 related challenges. The firm’s principal practice areas include green chemistry and chemicals management, right-to-know, and nanotechnology, among others. SERVICES PROVIDED Through a combination of in-house expertise and a network of jurisdiction-specific experts, Verdant is well-positioned to assist companies manufacturing, importing, using, or marketing chemicals and other affected products in major markets around the globe. Verdant’s services include new product/chemical registrations; compliance advice, auditing, and enforcement defence; data rights negotiation; product defence; protection of confidential information; transactional due diligence; and consortium management. CLIENTS Verdant provides services to clients in many different industries, but has particular expertise with respect to the following: coatings, consumer products, electronics, industrial chemicals, medical devices, personal care products and pharmaceuticals, among others.
CONTACTS Website 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 US, 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 customer’s unique regulatory requirements. SERVICES PROVIDED WPS provides: SDS/ hazard label authoring to any region of the world; SDS/ hazard label translation – currently support 40+ languages; MSDS to SDS conversion services – convert existing product MSDS to GHS-compliant SDS; e-SDS authoring/ translation services; regulatory consulting services, sustainability scoring. CLIENTS WPS clients come from industries including: adhesives; agrochemical; chemical; consumer products; flavour/ fragrance; inks; paints/coatings; pharmaceutical / biotech; retail; specialty chemical.
CONTACTS Website E-mail Head office Tel Contact Ownership Locations
www.wca-environment.com solutions@wca-environment.com Brunel House, Volunteer Way, Faringdon, Oxon, UK SN7 7YR +44 (0)1367 246022 Dean Leverett Limited company England, Scotland
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 chemicals regulations such as REACH, CLP/GHS, the water framework Directive, the landfill Directive, EMEA, etc. We also provide guidance on VICH environmental risk assessments for human and veterinary medicines, the biocidal products Directive, and the plant protection products Directive. We also assist in the identification and risk assessment of new or emerging chemical and technological issues. CLIENTS The Nickel Institute, Syngenta, Defra, The European Commission, ERGTC, European Copper Institute, the chemical and pharmaceutical industries, the Environment Agency (England), the Scottish Environmental Protection Agency (SEPA), States of Jersey Environmental Protection, Environment Canada, Alberta Environment (Canada), UK Water Industry Research (UKWIR), Cefic, European Environment Agency, ECMA.
CONTACTS Website E-mail Head office Tel/ Fax Contact Ownership Locations Founded
www.wrcplc.co.uk solutions@wrcplc.co.uk Frankland Road, Swindon, UK 01793 86 5000/ 01793 86 5001 Ian Johnson Private company UK 1927
OVERVIEW WRc’s REACH team consists of experienced mammalian and environmental toxicologists, risk assessment analysts, chemists, Qsar and exposure scenario modellers and REACH legislation experts. WRc has extensive experience of dealing with national and European regulators and industrial clients. SERVICES PROVIDED OO Identification of registration requirements OO Arrangement of toxicological and ecotoxicological testing OO Compilation and evaluation of physico-chemical, environmental, fate, toxicological and ecotoxicological data packages OO Substance grouping, Qsar and read across for data gap filling and test replacement for some endpoints OO Exposure modelling and derivation of exposure scenarios OO Reviews of epidemiological data and health monitoring studies OO Hazard classification and labelling (CLP) OO Preparation of technical dossiers in Iuclid 5, chemicals safety reports (CSRs) and safety data sheets (SDSs) OO Validation of registration dossiers prior to agency submission. CLIENTS A wide variety of clients ranging from single industrial chemical manufacturers to multinational consortia.
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www.wspgroup.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 UK Ltd provide a wide range of environmental, health and safety, product stewardship and regulatory consultancy services. Our global REACH Group includes chemical industry professionals experienced in all aspects of chemical regulation and includes registration specialists, toxicologists and ecotoxicologists experienced in dealing with REACH projects for a wide range and size of clients. We are a leading global design and engineering firm with about 15,000 staff around the world. SERVICES PROVIDED We offer a complete range of services to deal with all our clientâ&#x20AC;&#x2122;s REACH and biocidal product Regulation (BPR) requirements including: identifying a clientâ&#x20AC;&#x2122;s REACH and biocidal registration obligations and developing the registration strategy; Sief and consortium management; all aspects of substance registration dossier preparation and submission; joint registration submission; socio-economic analysis; authorisation of a substance (WSP was the technical advisor on the first ever application for authorisation to clear the ECHA); classification, labelling and packaging (CLP) management and compliance; only representative (OR) and third party representative services; safety data sheet (SDS) preparation and management; REACH compliance checks. CLIENTS WSP assists a large group of companies to fulfil their REACH obligations ranging from SMEs through to large multinational corporations. Our clients include manufacturers, importers and downstream users. We act as only representative for approximately 20 companies and provide support over and above the basic service as required. We specialise in helping companies respond to their business challenges and effectively manage compliance.
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A-Z LISTING
Page 0 42 44
Headquarters Germany UK USA
3S-SafelyServingScience Accenture ACTA Actio Corporation Advinus Therapeutics Limited Aegis Regulatory Inc AG-HERA Alberi EcoTech Alchemy Compliance Ltd Alemare Solutions Altox AMEC Environment and Infrastructure
Greece Belgium 46 UK USA India Canada 143 UK USA UK UK Denmark UK
Antea Group
USA
APC
UK
Apeiron-Team NV ARCADIS
48 50
Belgium The Netherlands
ARCHE Argentum Environment ASCHEM Chemical Consulting Assent Compliance
52
Belgium Sweden Poland Canada
ATOUT REACH Austen Business Solutions Ltd AW-ChemAdvice Baytouch Ltd
France UK The Netherlands 143 UK
Beveridge & Diamond, PC 54 bibra toxicology advice & consulting BIGvzw BioQuanta 56 Blue Frog Scientific Limited Boeije Consulting Bootman Chemical Safety 143 Borenius & Kemppinen, Attorneys at law Ltd BSL BIOSERVICE Scientific Laboratories GmbH 58
Buckman Bureau Veritas Burges Salmon LLP Caleb Management Services Ltd Cambridge Environmental Assessments Cardno ENTRIX CEHTRA Centro Reach CFCS Charles River Chem-Academy ChemADVISOR, Inc. ChemAdvocacy S.A. Chemest Ltd
USA UK Belgium France UK Belgium UK Finland Germany
USA France UK 143 UK UK USA 60 62 144 64
France Italy Germany USA Switzerland USA Luxembourg Finland
Other locations China, Italy, USA Australia Denmark, Canada, Asia
USA, China
UK
Germany, Netherlands, USA The Netherlands, France, Belgium, Colombia, Africa, Germany France, Poland, Australia, Brazil Belgium, USA, Switzerland
Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%
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Global staff 10-25 50-100 100-500
Chemical staff 2-5 50-100 100-500
2-5 5,000 plus 25-50 25-50 100-500 5-10 2-5 1 1 2-5 2-5 2,000-5,000
2-5
5,000 plus
100-500
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25-50
10-25
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10-25 100-500 1 USA, Germany, UK, 100-500 Taiwan, India, Kenya 2-5 2-5 1 Belgium, Netherlands, 10-25 N America 50-100 10-25 25-50 Japan, Thailand, USA 25-50 UK 5-10 1 UK 2-5 100-500 Representatives in 100-500 Switzerland, Japan, India, Poland, Scandinavia, Italy and other countries 2,000-5,000 5,000 plus 500-1000 Germany, USA 10-25 100-500 South America, 1,000-2,000 Canada 50-100 5-10 Italy 2-5 UK, USA 5,000 plus Germany 10-25 Belgium 50-100 5-10 2-5 UK
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Organisation 1cc GmbH 24-7 Response 3E Company
25-50 10-25 50-100 5-10 2-5 1 1 1 2-5 25-50
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e g g e g
Further information e www.1cc-consulting.com g g g www.24-7response.org em e www.3ecompany.com
e e www.3s-chem.gr i e e www.accenture.com e e e e www.actagroup.com www.actio.net m www.advinus.com m www.aegisreg.com e www.ag-hera.com g g www.alberieco.com www.alchemycompliance.com i g e a www.alemare.co.uk i g e www.altox.dk e e e e www.amec.com/reach.htm e e e e www.anteagroup.com
e
www.apc.eu.com
e e e www.apeiron-team.eu e a a a www.arcadis-us.com e e gge ge gg g
me
www.arche-consulting.be www.explizit.se www.aschem.waw.pl www.assentcompliance.com www.atoutreach.fr www.austenbusinesssolutions.co.uk www.baytouch.com
www.bdlaw.com www.bibratoxadvice.co.uk www.big.be www.bioquanta.net m mg e a www.bluefrogscientific.com www.boeijeconsulting.com mg ig e e e www.bootmanchem.com www.borenius.com m www.bioservice.com g m m
me ie
aa eie
100-500 2-5 5-10 10-25 25-50
e g e g e e e www.buckman.com egege e www.bureauveritas.com www.burges-salmon.com m mg e e www.calebgroup.net mg e www.cea-res.co.uk www.cardnoentrix.com m
50-100 2-5 5-10 50-100 5-10 50-100 5-10 2-5
a e e www.cehtra.com e e www.centroreach.it e e e www.cfcs-consult.com www.criver.com m m www.chem-academy.com ge e g e www.chemadvisor.com mge e www.chemadvocacy.com meee e e www.chemest.fi mea mee me
Chemical Watch | Global Service Providers Guide 2014
Information
IT solutions
Laboratories
Training
3S-SafelyServingScience Accenture ACTA Actio Corporation Advinus Therapeutics Limited Aegis Regulatory Inc AG-HERA Alberi EcoTech Alchemy Compliance Ltd Alemare Solutions Altox AMEC Environment and Infrastructure
Antea Group
APC
Apeiron-Team NV ARCADIS
ARCHE Argentum Environment ASCHEM Chemical Consulting Assent Compliance
ATOUT REACH Austen Business Solutions Ltd AW-ChemAdvice Baytouch Ltd
Beveridge & Diamond, PC bibra toxicology advice & consulting BIGvzw BioQuanta Blue Frog Scientific Limited Boeije Consulting Bootman Chemical Safety Borenius & Kemppinen, Attorneys at law Ltd BSL BIOSERVICE Scientific Laboratories GmbH
Buckman Bureau Veritas Burges Salmon LLP Caleb Management Services Ltd Cambridge Environmental Assessments Cardno ENTRIX
CEHTRA Centro Reach CFCS Charles River Chem-Academy ChemADVISOR, Inc. ChemAdvocacy S.A. Chemest Ltd
Key: Icons above represents the extent to which the company provides the service as follows: Core service Service that is occasionally provided Service provided by partners and third parties
Chemical Watch | Global Service Providers Guide 2014
Page 157
A-Z LISTING
Organisation 1cc GmbH 24-7 Response 3E Company
Repre./management
Guidance on regulatory interpretation Product compliance Corporate strategy/strategic planning Testing strategies Supply chain communications Registration strategies Assessment of data quality Chemical transport/warehousing SVHC advisory services Environmental risk assessment Representation Management (Sief, Consortium etc) Business process outsourcing (BPO) Registration services Dossier preparation GHS notification CLP notification Regulatory/policy tracking Managed regulatory content Chemical hazard database (Material) safety data sheets Legal representation Substance inventory management (Material) safety data sheet systems EH&S solutions Regulatory information management Supply chain management Consortia/registration solutions Laboratory management solutions Ecotoxicology Environmental fate & degradation Physical & analytical chemistry Environmental monitoring Exposure testing Human health toxicology SVHC testing Training courses/webinars Bespoke/in-house training CPD/CES certified training Lobbying/advocacy Insurance
Consultancy/advisory
A-Z LISTING
ChemService Srl Controlli e Ricerche ChemSW Chilworth – a DEKRA Company Chilworth Technology Chris Braun Consultancy Chymeia ApS CIS Center CJV Consulting Ltd Clariant Compliance & Risks Compliance Footprint AG compliance2business Consortia Management GmbH CONUSBAT CRAD Crowell & Moring CS Regulatory Ltd CSI CTT Currenta GmbH & Co. OHG Danger and Safety srl DanGoods Training & Consultancy Datalab David Ryberg Defense Logistics Agency DEKRA Consulting GmbH DHI DIPHEX Ltd Distefano Law Office DR MACH Chemical Compliance & Competence Dr Philipp Langenbach GmbH Dr. Andrea Volpato Dr. Knoell Consult GmbH EBRC Consulting ECD Compliance ECETOC Ecolab Ecomatters EcoMundo EcoOnline Ecotox Services International eftec EggCentris EHS Strategies, Inc EHSCareers.com, Inc elc group
Page Headquarters Ireland USA UK Finland UK USA 66 Italy 68 Germany, Luxembourg Italy USA 70 UK USA The Netherlands 144 Denmark 72 Russia UK Italy Ireland Switzerland Italy Germany 144 Germany Turkey USA 74 UK USA China Germany 144 Italy UK USA Norway USA Germany Denmark UK 145 Belgium 145 Germany 76
78 80
82
84
Germany Italy Germany Germany Canada Belgium USA The Netherlands France Norway Australia UK Belgium USA USA UK
Global staff 1 1 2-5 1 2-5 50-100 Qatar 10-25 South Korea, Turkey, 25-50 France Agent in China 25-50 25-50 80+ globally 5,000 plus Gobal 100-500 1 Denmark 5-10 Russia 50-100 1 5,000 plus USA, UK, Belgium 25-50 global offices 5-10 1 2-5 5-10 10-25 UK, Belgium 1,000-2,000 5-10 UK 10-25 100-500 100-500 Italy 5-10 1 2-5 10-25 1,000-2,000 France, Hungary, 100-500 Turkey, UK 31 worldwide offices 1,000-2,000 5-10 Belgium 2-5 1 Other locations
Belgium Sweden, Finland, Denmark, Switzerland Belgium
Czech Republic, India, Romania Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%
Page 158
Chemical staff 1 1 2-5 1 2-5 50-100 5-10 25-50
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Organisation ChemHaz Solutions Chemical Consultant, Joseph E. Sabol, PhD ChemPharmaServe Ltd Chemphex ChemRegs (UK) Ltd ChemRisk Chemsafe Chemservice
Further information www.chemhazsolutions.com chem-consult.com i www.chempharmaserve.com www.chemphex.com g www.chemregs.co.uk www.chemrisk.com e www.chemsafe-consulting.com e e www.chemservice-group.com
m me e i m e m m igeeee ig ee
e
25-50 25-50 100-500 50-100 1 5-10 10-25 1 100-500 10-25 5-10 1 2-5 2-5 10-25 25-50 5-10 10-25 100-500 25-50 5-10 1 1 2-5 10-25 50-100
g
e
50-100 2-5 2-5 1
ma ge a www.tox.dhigroup.com e e m www.diphex.com g m a a e www.distefanolawoffice.com mg e a www.mach-chemguide.com
1 1 100-500 50-100 2-5 5-10 5,000 plus 5-10 25-50 50-100
1 1 100-500 25-50 1 5-10 50-100 2-5 25-50 5-10
i m m m i
5-10 10-25 5-10 1 5-10 50-100
5-10 10-25 5-10 1 2-5 10-25
m i
g g m e i m i e i g
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i i i
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m gi m m g g m g
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g e
m g ee eeeee m ee eei a e eeg ig
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g
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a m ie e
www.chemservice.it www.chemsw.com e www.chilworth.co.uk www.chilworth.com www.cbconsult.nl www.chymeia.com www.ciscenter.ru cjvconsultingltd.wix.com/cjvconsultingltd www.clariant.com www.complianceandrisks.com e www.compliance-footprint.com www.compliance2business.eu m www.consortia-management.com e www.conusbat.com www.crad.com.tr www.crowell.com www.csregulatory.com www.complianceservices.com www.cttlab.com a www.analytik.currenta.de www.dangerandsafety.it www.dangoods.co.uk m www.datalabsj.com
g www.dla.mil e e www.dekra.de/en/reach
e www.dr-langenbach.de www.andreavolpato.it e e e www.knoell.com e e www.ebrc.de e g www.goECD.com m www.ecetoc.org m www.ecolab.com e e www.ecomatters.nl i e a www.ecomundo.eu m e e www.ecoonline.com
www.ecotox.com.au www.eftec.co.uk www.EggCentris.com m e www.ehsstrategies.com m www.ehscareers.com e a e a www.elc-group.com
m m e m ii
e
Chemical Watch | Global Service Providers Guide 2014
Information
IT solutions
Laboratories
Training
ChemService Srl Controlli e Ricerche ChemSW Chilworth – a DEKRA Company Chilworth Technology Chris Braun Consultancy Chymeia ApS CIS Center CJV Consulting Ltd Clariant Compliance & Risks Compliance Footprint AG compliance2business Consortia Management GmbH CONUSBAT CRAD Crowell & Moring CS Regulatory Ltd CSI CTT Currenta GmbH & Co. OHG Danger and Safety srl DanGoods Training & Consultancy Datalab David Ryberg Defense Logistics Agency DEKRA Consulting GmbH
DHI DIPHEX Ltd Distefano Law Office DR MACH Chemical Compliance & Competence Dr Philipp Langenbach GmbH Dr. Andrea Volpato Dr. Knoell Consult GmbH EBRC Consulting ECD Compliance ECETOC Ecolab Ecomatters EcoMundo EcoOnline
Ecotox Services International eftec EggCentris EHS Strategies, Inc EHSCareers.com, Inc elc group
Key: Icons above represents the extent to which the company provides the service as follows: Core service Service that is occasionally provided Service provided by partners and third parties
Chemical Watch | Global Service Providers Guide 2014
Page 159
A-Z LISTING
Organisation ChemHaz Solutions Chemical Consultant, Joseph E. Sabol, PhD ChemPharmaServe Ltd Chemphex ChemRegs (UK) Ltd ChemRisk Chemsafe Chemservice
Repre./management
Guidance on regulatory interpretation Product compliance Corporate strategy/strategic planning Testing strategies Supply chain communications Registration strategies Assessment of data quality Chemical transport/warehousing SVHC advisory services Environmental risk assessment Representation Management (Sief, Consortium etc) Business process outsourcing (BPO) Registration services Dossier preparation GHS notification CLP notification Regulatory/policy tracking Managed regulatory content Chemical hazard database (Material) safety data sheets Legal representation Substance inventory management (Material) safety data sheet systems EH&S solutions Regulatory information management Supply chain management Consortia/registration solutions Laboratory management solutions Ecotoxicology Environmental fate & degradation Physical & analytical chemistry Environmental monitoring Exposure testing Human health toxicology SVHC testing Training courses/webinars Bespoke/in-house training CPD/CES certified training Lobbying/advocacy Insurance
Consultancy/advisory
A-Z LISTING
Emveo Enthone BV ENVIRON Environmental Science Limited EnviroPlanning AB Equitox ERA Technology Ltd ERM ES4chem eSpheres ETC Eupoc Eurideas Linguistic Services Euro Safety and Health Eurofins Air Toxics
Page Headquarters USA
Belgium The Netherlands 86 UK UK Sweden 88 France UK 90 UK The Netherlands 145 Belgium Slovakia 145 Germany 146 Belgium UK USA
Eurofins Product Testing A/S
Denmark
Euromines Eversheds LLP
Belgium UK
Exitss Exponent
92
Fanwood Chemical, Inc Field Fisher Waterhouse LLP
USA Belgium
FinnREACH Flashpoint srl 94 FoBiG Food and Environment Research Agency (Fera)146 Foresite Systems Fraunhofer ITEM Gain Claude Gentrochema BV GHS-expert Ltd Gillies Associates Limited GlobalMSDS Golder Associates
Belgium UK
Finland Italy Germany UK
USA 146 Germany France The Netherlands Hungary UK UK Italy
Global Other locations staff Germany, UK, The 100-500 Netherlands, Japan, Singapore, China, South Korea 1 2,000-5,000 92 in 21 countries 1,000-2,000 2-5 5-10 2-5 50-100 Worldwide offices 2,000-5,000 1 Finland, Germany, 25-50 France, Netherlands 10-25 1 Belgium 5-10 2-5 Denmark, Germany, 5,000 plus France, China Belgium, China, 5,000 plus France, Germany, Italy, The Netherlands, Spain, Sweden, USA 5-10 Offices throughout 2,000-5,000 Europe, Middle East and Singapore 10-25 USA, Switzerland, 500-1,000 China Germany 2-5 UK, Germany, 500-1000 France, Italy 2-5 10-25 Germany 10-25 5-10 25-50 100-500 1 2-5 2-5 2-5 5-10 5,000 plus
Offices in over 20 countries GreenSoft Technology, Inc USA Taiwan, Japan, China, 50-100 Spain Greenwich Chemical Consulting USA 1 H2 Compliance Ireland USA 10-25 Hangzhou RUIO Technology Co. Ltd China 50-100 96 USA France, Germany, 2,000-5,000 Harlan Laboratories Israel, Italy, Japan, Korea, Mexico, The Netherlands, Spain, Switzerland, UK HAZMAT Ltd Israel UK 25-50 herbert smith llp UK 2,000-5,000 HFL Risk Services Ltd UK 10-25 IBACON GmbH Germany 100-500 ICF International USA Belgium, Brazil, 2,000-5,000 China, Russia, India Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%
Page 160
Chemical staff 100-500
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Organisation Elemica
Further information www.elemica.com
m
1 10-25 50-100 2-5 2-5 2-5 5-10 50-100 1 25-50
ig
5-10 1 5-10 2-5 2,000-5,000
me gie me g
m
100-500
e
m
m i m m m m i e
e e a www.emveo.be www.cooksonelectronics.com www.environcorp.com e i e www.esldatasheets.com
e
e
ae eaee e g ig
g g e
www.equitox.eu www.era.co.uk www.erm.com www.ES4chem.eu www.espheres.com
www.ekotox.sk www.eupoc.de m www.eurideastranslation.com e g www.eurosh.com www.airtoxics.com ee ee
www.eurofins.com/galten
2-5 25-50
m
www.euromines.org www.eversheds.com
2-5 25-50
gge mg
2-5 10-25
m eem
2-5 5-10 10-25 5-10
gegg m ma m
5-10 25-50 1 1 2-5 2-5 5-10 50-100
www.foresitesystems.com e m ge i e e www.item.fraunhofer.de m www.gentrochema.nl iiee www.GHSexpert.com i i e m e www.gilliesassociates.co.uk www.globalmsds.co.uk i gg www.golder.com mg
e e e e www.exitss.eu e a a www.exponent.com e
50-100
e www.finnreach.com g www.flashpointsrl.com a e e www.fobig.de e www.fera.defra.gov.uk
www.greensofttech.com
ii
1 5-10 50-100 500-1,000
m ii em g
10-25 2-5 10-25 100-500 50-100
mg
ee m
www.grcci.com www.h2compliance.com e e www.reach24h.com www.harlan.com
ee m
me
e m
m
www.fanwoodchemical.com www.ffw.com
www.hazmat.co.il www.herbertsmith.com www.hflrisk.com www.ibacon.com www.icfi.com
Chemical Watch | Global Service Providers Guide 2014
Information
IT solutions
Laboratories
Training
Emveo Enthone BV ENVIRON Environmental Science Limited EnviroPlanning AB Equitox ERA Technology Ltd ERM ES4chem eSpheres
ETC Eupoc Eurideas Linguistic Services Euro Safety and Health Eurofins Air Toxics
Eurofins Product Testing A/S
Euromines Eversheds LLP
Exitss Exponent
Fanwood Chemical, Inc Field Fisher Waterhouse LLP
FinnREACH Flashpoint srl FoBiG Food and Environment Research Agency (Fera) Foresite Systems Fraunhofer ITEM Gain Claude Gentrochema BV GHS-expert Ltd Gillies Associates Limited GlobalMSDS Golder Associates
GreenSoft Technology, Inc
Greenwich Chemical Consulting H2 Compliance Hangzhou RUIO Technology Co. Ltd Harlan Laboratories
HAZMAT Ltd herbert smith llp HFL Risk Services Ltd IBACON GmbH ICF International
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 2014
Page 161
A-Z LISTING
Organisation Elemica
Repre./management
Guidance on regulatory interpretation Product compliance Corporate strategy/strategic planning Testing strategies Supply chain communications Registration strategies Assessment of data quality Chemical transport/warehousing SVHC advisory services Environmental risk assessment Representation Management (Sief, Consortium etc) Business process outsourcing (BPO) Registration services Dossier preparation GHS notification CLP notification Regulatory/policy tracking Managed regulatory content Chemical hazard database (Material) safety data sheets Legal representation Substance inventory management (Material) safety data sheet systems EH&S solutions Regulatory information management Supply chain management Consortia/registration solutions Laboratory management solutions Ecotoxicology Environmental fate & degradation Physical & analytical chemistry Environmental monitoring Exposure testing Human health toxicology SVHC testing Training courses/webinars Bespoke/in-house training CPD/CES certified training Lobbying/advocacy Insurance
Consultancy/advisory
A-Z LISTING
Jaehak Jung Japan Chemical Safety Institute Jean Warshaw, Esq. Jongerius Consult BV JRF Global JSC International K J Bray & Associates K&L Gates LLP Kathrin Lanz Keller and Heckman KFT Chemieservice Konica Minolta Business Expert, Inc KREATiS LAUS GmbH LG CNS
LGC Linmark Consulting Linnunmaa Oy LKC Switzerland Ltd LSR Associates MB Research Laboratories McKenna Long & Aldridge LLP Mercer
Page 146 98 147 100
Headquarters The Netherlands USA Portugal USA
102 UK UK Poland 104 Germany South Korea Japan USA 147 The Netherlands India UK UK Belgium Germany USA 106 Germany Japan 147 France Germany South Korea
UK 147 Switzerland Finland 148 Switzerland UK USA 148 USA USA
Mérieux Nutrisciences
108 USA
Miami Chemical Micromeritics Analytical Services Modern Testing Services (Global)
USA USA 110 Hong Kong
MSDS Europe
Hungary
National Chemical Emergency Centre (NCEC) 112 UK Neuralog, LP USA NimkarTek Technical Services Pvt. Ltd India Noerr LLP Germany NovaTox Canada Oil Recruitment UK 114 USA Pace Analytical Regulatory Services Paul Illing Consultancy Services Ltd UK Penman Consulting Belgium Peter Fisk Associates 148 UK Pinnacle Associates UK Polgar ACRO Hungary Pöyry Finland Oy Proactima AS Prosacon GmbH PwC
Finland Norway Germany The Netherlands
Other locations Worldwide UK UK 110+ Countries Singapore
Chemical staff 1 100-500 2-5 5-10
5,000 plus 100-500 50-100 Austria, France, USA, 50-100 China, UK China, Vietnam 50-100 1 2-5 1 USA, UK 100-500 25-50 1 1,000-2,000 10-25 Belgium China 100-500 10-25 2,000-5,000 2-5 25-50 Japan, China, India, 5,000 plus Brazil, Indonesia, Europe, USA, Middle East 1,000-2,000 France 2-5 10-25 UK 10-25 USA, Japan 1,000-2,000 25-50 Belgium 100-500 Asia-Pacific, EMEA, 100-500 Americas Italy, Brazil, France, 2,000-5,000 China 10-25 10-25 US, UK, Germany, 1,000-2,000 China France, Germany, 10-25 Poland, Italy, Spain 100-500 Canada 25-50 10-25 1,000-2,000 Ireland, UK 2-5 10-25 50-100 1 UK, Netherlands 5-10 10-25 2-5 Belarus, Kazakhstan, 10-25 Moldova, Russia, Ukraine 2,000-5,000 100-500 5-10 Global presence 2,000-5,000
Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%
Page 162
Global staff 1 5,000 plus 2-5 5-10
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Organisation IGCON IHS Infotox International Cosmetics & Chemical Services Ltd Intertek IOM IPO O/Pszczyna iPoint
mg g m mg
ee ige e e
Further information www.igcon.nl www.ihs.com/ehs-sustainability www.infotox.pt www.Intlcosmetics.com
1,000-2,000 10-25 50-100 10-25
e i a a g www.intertek.com www.iom-world.org meeee www.ipo-pszczyna.pl m ge i e e www.ipoint-systems.com
2-5 1 2-5 1 100-500 10-25 1 25-50 10-25 25-50 10-25 10-25 2-5 25-50 50-100
geegeee eee eme m iee e g e m mg e ii m e gm m ieaaaee ggm ii ee m eeaagia
50-100 2-5 10-25 10-25 25-50 25-50 10-25 2-5
e www.kotiti.re.kr
www.jongeriusconsult.com www.jrfonline.com e www.jsci.co.uk www.kjba.talktalk.net www.klgates.com e www.qualisys.eu www.khlaw.com e www.kft.de www.konicaminolta.com www.kreatis.eu www.laus.de a www.lgcns.com
m i eg e e g m geg
e www.lgc.co.uk www.linmarkconsulting.com www.linnunmaa.fi www.LKC-ltd.com e e e www.lsr-associates.com www.mbresearch.com a g www.mckennalong.com www.mercer.com m
1,000-2,000
ee
e
5-10 1 100-500
em
10-25
eieaege
10-25 10-25 10-25 2-5 1 50-100 1 5-10 10-25 2-5 5-10 10-25 10-25 5-10 25-50
i m m i
m
e
www.miamichemical.com www.particletesting.com www.mts-global.com
m m
e
www.merieuxnutrisciences.com
www.msds-europe.com
e e e a the-ncec.com www.neuralog.com m m e www.nimkartek.com www.noerr.com m www.novatox.ca m www.oilrecruitment.co.uk e aai e www.pacelabs.com/regulatory e g e e e www.penmanconsulting.com e e e e www.ecotoxchem.co.uk www.pinnacleassoc.com i www.polgar-acro.eu g
gi g m i m i m i m
m m me ii
e e www.poyry.com g www.proactima.no/en e e e www.prosacon.eu g www.pwc.nl/nl/reach
Chemical Watch | Global Service Providers Guide 2014
Information
IT solutions
Laboratories
Training
Jaehak Jung Japan Chemical Safety Institute Jean Warshaw, Esq. Jongerius Consult BV JRF Global JSC International K J Bray & Associates K&L Gates LLP Kathrin Lanz Keller and Heckman KFT Chemieservice Konica Minolta Business Expert, Inc KREATiS LAUS GmbH LG CNS
LGC Linmark Consulting Linnunmaa Oy LKC Switzerland Ltd LSR Associates MB Research Laboratories McKenna Long & Aldridge LLP Mercer
Mérieux Nutrisciences
Miami Chemical Micromeritics Analytical Services Modern Testing Services (Global)
MSDS Europe
National Chemical Emergency Centre (NCEC) Neuralog, LP NimkarTek Technical Services Pvt. Ltd Noerr LLP NovaTox Oil Recruitment Pace Analytical Regulatory Services Paul Illing Consultancy Services Ltd Penman Consulting Peter Fisk Associates Pinnacle Associates Polgar ACRO
Pöyry Finland Oy Proactima AS Prosacon GmbH PwC
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 2014
Page 163
A-Z LISTING
Organisation IGCON IHS Infotox International Cosmetics & Chemical Services Ltd Intertek IOM IPO O/Pszczyna iPoint
Repre./management
Guidance on regulatory interpretation Product compliance Corporate strategy/strategic planning Testing strategies Supply chain communications Registration strategies Assessment of data quality Chemical transport/warehousing SVHC advisory services Environmental risk assessment Representation Management (Sief, Consortium etc) Business process outsourcing (BPO) Registration services Dossier preparation GHS notification CLP notification Regulatory/policy tracking Managed regulatory content Chemical hazard database (Material) safety data sheets Legal representation Substance inventory management (Material) safety data sheet systems EH&S solutions Regulatory information management Supply chain management Consortia/registration solutions Laboratory management solutions Ecotoxicology Environmental fate & degradation Physical & analytical chemistry Environmental monitoring Exposure testing Human health toxicology SVHC testing Training courses/webinars Bespoke/in-house training CPD/CES certified training Lobbying/advocacy Insurance
Consultancy/advisory
A-Z LISTING
Page Headquarters 148 China 116 Germany
REACH ChemConsult REACH Delivery REACH Global Services REACH mastery REACH Monitor Reach Only Representative Ltd
149 149 149 118
Germany UK Belgium Italy Spain 149 UK
Reach Registration Services Reach24H Consulting Group ReachCentrum REACHLaw REACHReady ReachSpektrum, sro REACHWise
120 122 150
Redeker Sellner Dahs Rechtsanwälte ReFaC Regulatory Services International Regulatus Ricerca Biosciences, LLC RimaOne Risk & Policy Analysts Ltd (RPA) Riskchem Rivendell International
Germany 150 UK China UK USA Germany 124 UK South Africa Ireland
Roisin McEneany Rovaltain Research Company Royal HaskoningDHV SAFENANO Safety Data Services Safeware Quasar Ltd
Ireland France 126 The Netherlands UK UK 151 UK
SAP AG SAP Japan Co, Ltd SATRA Technology SCC Science & Environnement SciVera Selcia SGS
Germany Japan UK 128 Germany Switzerland USA UK Switzerland
SGS UK Limited ShawCor Shridhar Rajappanavar SIAM S.L.
SIEF-IT Siletz SPRL SiteHawk Sitmae REACH Services BV Smithers Viscient Spetsinterproject Oy Spinnaker Coating, LLC Spring Trading Company, LLC SSS (Europe) AB Stefanie Merenyi
150
UK China Belgium Finland UK Czech Republic UK
UK Canada India 151 Spain
Poland Belgium USA The Netherlands USA Finland USA 151 U.S.A. 130 Sweden Germany
Global Other locations staff China 10-25 USA, India, Portugal, 5-10 Sweden 5-10 USA, Japan 25-50 Turkey 10-25 5-10 10-25 Agents: Asia, Middle 5-10 East 10-25 Canada, Ireland 50-100 EU, Asia-Pacific, USA 10-25 Belgium, India, Turkey25-50 5-10 2-5 The Netherlands, 2-5 Germany Belgium 100-500 2-5 UK 10-25 1 500-1,000 25-50 25-50 2-5 USA, Spain and 10-25 Japan 1 5-10 100 offices worldwide 5,000 plus Singapore 100-500 1 USA, Ireland, Greece, 50-100 Japan, Turkey, Netherlands 5,000 plus 1,000-2,000 China 100-500 Japan 50-100 France 5-10 5-10 USA 50-100 China, France, 5,000 plus Germany, Hong Kong, UK, USA All countries 5,000 plus 2,000-5,000 2,000-5,000 France, Italy, Greece, 5-10 Portugal, Poland, Romania, Finland, Ireland, UK, EL 5-10 2-5 25-50 2-5 UK 100-500 Russia, Ukraine 5-10 2-5 2-5 India, Hong Kong 25-50 1
Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%
Page 164
Chemical staff 5-10 5-10
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Organisation Randis ChemWise (Shanghai) Co., Ltd. REACh ChemAdvice GmbH
Further information e e www.randis.cn, www.randischem.com g e e www.reach-chemadvice.com
meee me
5-10 25-50 10-25 5-10 2-5 2-5
m e m m m g
e e e www.reach-chemconsult.com e www.reachdelivery.com e www.reach-gs.eu ea a a e www.reachmastery.com e e www.reachmonitor.org g e e e e e www.rorltd.com
2-5 50-100 10-25 25-50 2-5 2-5 2-5
g i g g i i m
g e g g e e e
5-10 2-5 10-25 1 500-1,000 25-50 10-25 1 10-25
g m ii gme m ee m
1 5-10 50-100 25-50 1 10-25
i gg e m e ieeaeee m g e m e g m e
5,000 plus 5-10 10-25 25-50 5-10 5-10 50-100
i
g
m
ee e e ge aa e
e e e e a e
e e a e e e
e a www.reach-rs.com e e www.reach24h.com/en g www.reachcentrum.eu e www.reachlaw.fi g www.reachready.co.uk g www.reachspektrum.eu e www.reachwise.eu e e
www.redeker.de www.refac.eu www.rsireg.com
e m g
www.ricerca.com www.rimaone.com www.rpaltd.co.uk www.riskchem.co.za www.rivendell.ie
m m ge iee
www.pole-ecotox.com www.royalhaskoningdhv.com www.safenano.org www.safeware.co.uk
www.sap.com www.sap.com m e www.satra.co.uk a e a a www.scc-gmbh.de e e e www.sci-env.ch www.scivera.com me www.selcia.com m m a www.sgs.com/reach i m
e me me e e
5,000 plus 2-5 50-100 10-25
g
5-10 1 25-50 2-5 5-10 2-5 2-5 2-5 10-25 1
ie m
i www.sgs.com www.shawcor.com i i e www.cae.com e m e e www.chemeter.eu
g m
e
e www.sief-it.com www.siletz.eu www.sitehawk.com ii www.sitmaereachservices.com gmg m www.smithersviscient.com www.spetsinterproject.com ii e a m e a e a a www.spinps.com Springtradingcompany.com me e e iee e g www.reach-onlyrep.eu m g g www.merenyi.net i
Chemical Watch | Global Service Providers Guide 2014
Information
IT solutions
Laboratories
Training
REACH ChemConsult REACH Delivery REACH Global Services REACH mastery REACH Monitor Reach Only Representative Ltd
Reach Registration Services Reach24H Consulting Group ReachCentrum REACHLaw REACHReady ReachSpektrum, sro REACHWise
Redeker Sellner Dahs Rechtsanwälte ReFaC Regulatory Services International Regulatus Ricerca Biosciences, LLC RimaOne Risk & Policy Analysts Ltd (RPA) Riskchem Rivendell International
Roisin McEneany Rovaltain Research Company Royal HaskoningDHV SAFENANO Safety Data Services Safeware Quasar Ltd
SAP AG SAP Japan Co, Ltd SATRA Technology SCC Science & Environnement SciVera Selcia SGS
SGS UK Limited ShawCor Shridhar Rajappanavar SIAM S.L.
SIEF-IT Siletz SPRL SiteHawk Sitmae REACH Services BV Smithers Viscient Spetsinterproject Oy Spinnaker Coating, LLC Spring Trading Company, LLC SSS (Europe) AB Stefanie Merenyi
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 2014
Page 165
A-Z LISTING
Organisation Randis ChemWise (Shanghai) Co., Ltd. REACh ChemAdvice GmbH
Repre./management
Guidance on regulatory interpretation Product compliance Corporate strategy/strategic planning Testing strategies Supply chain communications Registration strategies Assessment of data quality Chemical transport/warehousing SVHC advisory services Environmental risk assessment Representation Management (Sief, Consortium etc) Business process outsourcing (BPO) Registration services Dossier preparation GHS notification CLP notification Regulatory/policy tracking Managed regulatory content Chemical hazard database (Material) safety data sheets Legal representation Substance inventory management (Material) safety data sheet systems EH&S solutions Regulatory information management Supply chain management Consortia/registration solutions Laboratory management solutions Ecotoxicology Environmental fate & degradation Physical & analytical chemistry Environmental monitoring Exposure testing Human health toxicology SVHC testing Training courses/webinars Bespoke/in-house training CPD/CES certified training Lobbying/advocacy Insurance
Consultancy/advisory
A-Z LISTING
Surface Science Western SustChem Engineering Ltd Swissi Process Safety Syska Voskian Consulting TEI Analytical, Inc Telematic srl Tenviro Tetra Tech The REACH Centre Ltd The Redstone Group The Sapphire Group The Wercs TNO Triskelion Tox Focus, LLC toXcel Toxicon Toxikon ToxMinds ToxServices Tradebe UK TRASYS s.a./n.v.
Page Headquarters USA UK Belgium Canada Greece 132 Spain USA USA Italy Sweden USA UK 150 USA USA 151 USA The Netherlands USA UK Italy USA 136 Belgium 152 USA UK Belgium 134 152 152 152
TSGE group
UK
TUV Rheinland Hong Kong Ltd TÜV Rheinland LGA Products GmbH
Hong Kong Germany
TÜV SÜD Industrie Service GmbH
138 Germany
TUV SUD Japan UL
Japan UK
UL VS UNITED KINGDOM LTD
UK
Universit Bordeaux Segalen Verdant Law, PLLC Von Roll REACH GmbH VRS Regulatory wca environment Weeset Advisors Wercs Professional Services
France 153 USA Germany UK 153 UK USA 153 USA
WIL Research Wildlife International, a Division of EAG, Inc Wilmer Tox Consulting WRc plc WSP UK Ltd
140 USA USA Switzerland 153 UK 154 UK
WTConsulting Xiaodan Pei YASH Technologies
Switzerland China USA
Zanos Limited
UK
Global Other locations staff Belgium, China, UK 1,000-2,000 2-5 Japan, China, 1,000-2,000 Singapore 10-25 5-10 Switzerland, Taiwan 50-100 Denmark 2-5 5-10 10-25 The Netherlands 1 Germany, Canada, 5,000 plus UK Italy, Japan, USA 10-25 Netherlands 10-25 5-10 France, Belgium, 100-500 UK, China, Germany, Japan Japan (sales office) 2,000-5,000 USA 2-5 USA 10-25 Italy 5-10 Belgium 100-500 Germany 10-25 25-50 Spain, USA, France 1,000-2,000 France, Greece, 500-1000 Luxembourg, Spain, UK Germany, Spain, 100-500 Slovenia, Poland, France, Slovakia, USA, Canada 5,000 plus China, India, 500-1000 Bangladesh, Turkey Japan, Singapore, 2,000-5,000 China, India 100-500 USA, Switzerland, 5,000 plus Bangladesh Italy, China, USA, 5,000 plus Switzerland, Germany, Turkey, India, Bangladesh, Taiwan, Tunisia 500-1,000 2-5 2-5 5-10 25-50 1 Belgium, Germany, 100-500 China, Japan The Netherlands 1,000-2,000 The Netherlands 100-500 1 100-500 Africa, Asia, Europe, 5,000 plus Middle East, Oceania 5-10 USA 100-500 Europe, Asia, 2,000-5,000 Australia 2-5
Key: Icons above represent the percent breakdown of services provided by each firm as follows: m >60% i 40-60% g 20-40% e 5-20% a <5%
Page 166
Chemical staff 25-50 2-5 25-50
Consultancy/advisory Representation/management Legal services Laboratory services IT & software solutions Information services Training Other(s)
Organisation Steptoe & Johnson LLP Stewardship Solutions Ltd Sumika Chemical Analysis Service Ltd (SCAS)
Further information m e www.steptoe.com e g www.stewardshipsolutions.co.uk a a www.scas-eu.be
eee gg e m
10-25 5-10 10-25 2-5 5-10 5-10 1 25-50
g me m m e e ggg ie
5-10 10-25 5-10 100-500
i e a e e a e e www.thereachcentre.com me g e e www.redstonegrp.com www.thesapphiregroup.com m e ee i i e www.thewercs.com
100-500 2-5 10-25 5-10 5-10 10-25 10-25 500-1000 25-50
g m i g e m m e g
100-500
ii
ee
100-500 50-100
ie
eeee ii
50-100
gg
e
2-5 500-1000
em e
e m
500-1000
ee
maee
100-500 2-5 2-5 2-5 25-50 1 10-25
e g m m m m m
100-500 50-100 1 10-25 50-100
ea e m ii me
5-10 100-500 50-100
mee e www.wtconsulting.ch e e e i e e e a www. hach.com g e m a a www.yash.com
1
ee
e e i ge g m
m e e
e e e g
m m
e gg eeg
www.surfacesciencewestern.com www.sustchem.gr www.swissips.es www.sysvoskconsulting.com www.teianalytical.com www.epyplus.com www.tenviro.eu www.tetratech.com
i e e e www.tnotriskelion.com e a a toxfocus.com e e a a www.toxcel.com e a e e a www.toxicon.it www.toxikon.be m e e www.toxminds.com e e e www.toxservices.com www.tradebe.co.uk e m e www.trasys.be www.TSGEurope.com
www.chn.tuv.com www.tuv.com
e e a www.tuev-sued.de/technical_installations/ reach a a www.tuv-sud.jp e e e ul.com/consumer-products ul.com
e e g e e e e www.u-bordeaux2.fr em e e www.verdantlaw.com e e www.vonroll.com www.vrs-regulatory.net e a www.wca-environment.com g m m
www.thewercs.com www.wilresearch.com a a www.wildlifeinternational.com e www.reachwilmer.com e e www.wrcplc.co.uk e e e www.wspgroup.com
m www.zanos.co.uk
Chemical Watch | Global Service Providers Guide 2014
Information
IT solutions
Laboratories
Training
Surface Science Western SustChem Engineering Ltd Swissi Process Safety Syska Voskian Consulting TEI Analytical, Inc Telematic srl Tenviro Tetra Tech
The REACH Centre Ltd The Redstone Group The Sapphire Group The Wercs
TNO Triskelion Tox Focus, LLC toXcel Toxicon Toxikon ToxMinds ToxServices Tradebe UK TRASYS s.a./n.v.
TSGE group
TUV Rheinland Hong Kong Ltd TÜV Rheinland LGA Products GmbH
TÜV SÜD Industrie Service GmbH
TUV SUD Japan UL
UL VS UNITED KINGDOM LTD
Universit Bordeaux Segalen Verdant Law, PLLC Von Roll REACH GmbH VRS Regulatory wca environment Weeset Advisors Wercs Professional Services
WIL Research Wildlife International, a Division of EAG, Inc Wilmer Tox Consulting WRc plc WSP UK Ltd
WTConsulting Xiaodan Pei YASH Technologies
Zanos Limited
Key: Icons above represents the extent to which the company provides the service as follows: Core service Service that is occasionally provided Service provided by partners and third parties
Chemical Watch | Global Service Providers Guide 2014
Page 167
A-Z LISTING
Organisation Steptoe & Johnson LLP Stewardship Solutions Ltd Sumika Chemical Analysis Service Ltd (SCAS)
Repre./management
Guidance on regulatory interpretation Product compliance Corporate strategy/strategic planning Testing strategies Supply chain communications Registration strategies Assessment of data quality Chemical transport/warehousing SVHC advisory services Environmental risk assessment Representation Management (Sief, Consortium etc) Business process outsourcing (BPO) Registration services Dossier preparation GHS notification CLP notification Regulatory/policy tracking Managed regulatory content Chemical hazard database (Material) safety data sheets Legal representation Substance inventory management (Material) safety data sheet systems EH&S solutions Regulatory information management Supply chain management Consortia/registration solutions Laboratory management solutions Ecotoxicology Environmental fate & degradation Physical & analytical chemistry Environmental monitoring Exposure testing Human health toxicology SVHC testing Training courses/webinars Bespoke/in-house training CPD/CES certified training Lobbying/advocacy Insurance
Consultancy/advisory